chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's Palsy; A spontaneous report was received from a consumer, concerning herself, a 62-years-old, male patient, who received Moderna's COVID-19 vaccine and experienced event Bell's palsy.   The patient's medical history included Hypertension. Products known to have been used by the patient, within two weeks prior to the event, included Amlodipine, Valsartan 5mg /320mg indicated for Blood Pressure, megarad to lower cholesterol.  On 2 Mar 2021, approximately 2-3 weeks prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) via unknown route in left arm for COVID-19 infection prophylaxis.   On 17 Mar 2021, The patient experienced Bell's Palsy. The patient felt sore in mouth. on 18 Mar 2021, it was full paralysis of mouth and the drooping face. Eventual diagnosis made was Bell's Palsy.   Treatment information included 80 mg of prednisone once a day for about 7 days and valacyclovir hcl 1gm tablet - TID for 7 days  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event Bell's palsy was unknown.; 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.
36 hours after vaccination, I woke up at 3am with ringing in both ears for the first time in my life.  I've seen two ENTs and a chiropractor. My hearing test was normal and showed no loss of hearing. The ENT said the pressure test was normal.  I have had periods of ear pressure, clogging and the feeling of water in the ears.  Over the past 10 weeks, those specific symptoms have diminished and only now happen a few times a week, but the ringing in the ears persists.  It is constant.  I have gotten more used to it, and there are times when it's louder and times when it's less loud, but I cannot say that it is "disappearing".  The ringing is definitively not resolved.  I have tried prescription nasal spray and allegra, which possibly help. In addition, 13 days after vaccination, I started experience chest tightness, sternum pain, aches and pains throughout my upper body: both arms, back.  The tightness in the chest is exacerbated by exercise. Those symptoms have diminished over time but have not resolved. I have not gone back to exercise. Chest xray was negative and stress test was normal. Transthoracic Echo showed some abnormalities. Blood pressure became elevated post vaccination and remains elevated.
Doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  Company comment : This is a case of Expired Product Administered concerning a male patient of unknown age, with no relevant medical history, who experienced no other adverse events. The event occurred the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a male patient of unknown age, with no relevant medical history, who experienced no other adverse events. The event occurred the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Large amount of swelling and redness at site of injection, lasting several hours after administration.  No treatment.
This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 62-year-old male patient received the 3rd dose (booster) of BNT162B2 (Comirnaty, batch/lot# FF8841), at the age of 61, in left arm, on Oct 7, 2021, single dose, for COVID-19 immunization. Vaccination history included the 2nd dose of BNT162B2 (Comirnaty, batch/lot# ER8730), in left arm, on Mar 31, 2021, and the 1st dose of BNT162B2 (Comirnaty, batch/lot# EN6203), in left arm, on Mar 10, 2021; both single dose, for COVID-19 immunization. No  medical history. Concomitant medications not reported. The patient experienced vaccination failure (medically significant) and COVID-19/COVID-19 treatment (medically significant), with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul 2022) positive, notes: Still tested positive 5 days after last dose. Therapeutic measures were taken as a result of vaccination failure and COVID-19. Clinical course: Antiviral drug Paxlovid given from Jul 6, 2022 to Jul 10, 2022.
I developed a rash below my injection site on my mid upper arm 8 days post vaccine.  It kept spreading over 3 days.  I went to the ER after visiting the employee health & the advised I file a claim.   I was in contact with my PCP.  I was advised to use ice on the rash/reaction, take oral benadryl & use topical hydrocortisone cream.
Continuous tinnitus in both ears; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration on 05Apr2021 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 08Apr2021, the patient experienced continuous tinnitus in both ears. The event 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event continuous tinnitus in both ears was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Pt has been experiencing a dull pain in your left arm near the injection site of the vaccine. Symptoms started mildly around August 7th and have persisted. Trying to get in to see MD
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Drug Allergy: Cipro"; Quinolones, reaction(s): "Drug allergy: quinolones". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: product-COVID 19 Treatment, brand-Paxlovid, Treatment start date-21Jul2022, Treatment stop date-25Jul2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nurse incorrectly administered Fluzone High Dose to patient. Nurse overrode alerts in our system about patient age in order to give.  Nurse was new to the area and unfamiliar with pulling from system. Nurse had come from another area with an system so supervisor was not aware that she needed additional training. Nurse stated she felt rushed because provider was ready to see patient and pulled rather than asking another nurse for help.
slight headache after second dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache after second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (slight headache after second dose). At the time of the report, HEADACHE (slight headache after second dose) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-261577, MOD-2021-261786 (Patient Link).
This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8734) via an unspecified route of administration, administered in Arm Left on 28Apr2021 (at the age of 47-year-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included VYVANSE. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection, lot number: ER2613) via an unspecified route of administration, administered in Arm Left on 07Apr2021 (at the age of 47-year-old) as dose 1 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient experienced Symptoms of Covid virus and positive test results on 20Aug2021 and sick for several days with sore throat, slight fever 99.9 for two days, fatigued, headache, and sinus congestion. The patient underwent lab tests which included body temperature: 99.9 and SARS-COV-2 test: positive on 20Aug2021 (Nasal Swab). The patient received treatment for the events with Hydroxychloriquine, Zithromax, and monoclonal infusion. Since the vaccination the patient was tested for COVID-19. Outcome of the events were recovering.  Follow-up attempts completed. No further information expected.
After getting out of the bathtub as I was reaching for my towel, A VERY SUDDEN ONSET of severe weakeness hit me and I had to sit on toilet.  I was unable to move my arms or legs  for 20 minutes, then was able to get up but walked VERY WOBBLY AND WEAK to my bed just a few feet away.  I collapsed on my bed and turned my fan blowing on me directly. {Im NEVER hot, usually cold ALL the time}.  I layed there so weak I could barely move for another 20 to 30 minutes.  I thought I was having a stroke honestly and my thoughts were about my doors being locked so nobody could get in to help me and my phone was in the living room and for that time period I WAS TOTALLY UNABLE to go get it.  THANKFULLY, after about 45 minutes total, all symptons went away and I returned to my baseline mobility.  Im very grateful that this was not a stroke as I thought. but I do believe it may have been a reaction to the vaccine.  I did not notify any physicians yet, and as of this writing Im perfectly fine, Thank the Lord.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in right arm, on 21Apr2021 as dose 2, single (Lot number: ER8732), in right arm and on 16Dec2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "collapsed trachea" (ongoing), notes: 90% collapsed trachea post CPR- tracheostomy fully recovered, still have unable to insert stent; "post CPR- tracheostomy" (unspecified if ongoing); "unable to insert stent" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Headache; extreme exhaustion; sometimes short of breath; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot Number: EP7534), dose 2 via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 13:15 as a single dose for covid-19 immunization at the age of 56-years-old. Medical history included Primary lateral sclerosis, Ehlers Danlos Syndrome, Gastroparesis, known allergies of Penicillin, sulfa, and latex. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN6202), dose 1 via an unspecified route of administration, administered in left arm on 27Feb2021 at 01:15 PM as a single dose for COVID-19 immunization at the age of 56-years-old. Concomitant medications included Gabapentin, Meloxicam, Vitamin D, and Baclofen taken for an unspecified indication. The patient previously took Tylenol and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient had not taken any treatment for reported events. On 23Mar2021 (at 02:00), the patient experienced headache, extreme exhaustion, and sometimes short of breath. The outcome of all the events was unknown.  No follow-up attempts are required. No further information is expected.
Shortness of breath; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and FATIGUE (Extreme fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.    Co-suspect product included non-company product TREPROSTINIL SODIUM inhalation gas for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included AMBRISENTAN, WARFARIN SODIUM and TADALAFIL (ADCIRCA) for an unknown indication.   On 28-Dec-2017, the patient TREPROSTINIL SODIUM (Nasal) dosage was changed to 0.6 mg/ml, Inhalation. In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TREPROSTINIL SODIUM (Nasal) at an unspecified dose four times per day. On an unknown date, TREPROSTINIL SODIUM (Nasal) dosage was changed to 42 microgram. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and FATIGUE (Extreme fatigue). At the time of the report, DYSPNOEA (Shortness of breath) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A) and the current dose was reported as 30-60 µg (5-10 breaths), four times a day (QID) via inhalation (IH) route. The patient had th events after the COVID (coronavirus disease) vaccine and when using IH Tyvaso. The physician decreased IH Tyvaso to 42 µg (7 breaths) per session. The reporter's causality for the events of fatigue and dyspnoea with IH Tyvaso was considered to be possibly related.  Treatment information was not provided by reporter.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 19-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 19-DEC-2018, the patient was vaccinated with improperly stored  ROTATEQ (lot # R015435, expiration date 17-APR-2020) and RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Fever up to 103 next day still  at 101.6. Third day  100.7( today).  Swollen right deltoid, hard, painful.  ( cut my finger with a chainsaws, shoulder hurts more than the finger!) , chills, sweating, diarrhea, achy, tired.
Pt. presented to PMD on 3-12-03 with c/o intermittent "deep" aches in hands, knees, elbows, beginning around 2-21-03.  Normal joint exam.  No fever, no rash, normal vaccination eschar.  Conservative treatment advised.  f/u 3-17-03.  Pt. also with URI symptoms. arthralgias reportedly unchanged as of 3-17-03
Patient experienced after 3-4 hours of vaccination:  thigh pain in right hip, right back pain (pt states kidney pain), chest tightness and heavy breathing. Symptoms resolved
I got my period 10 days early and pretty heavy bleeding. Swollen lymph nodes in my neck.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 15-JUL-2016 a dose of improperly stored M-M-R II (lot# L027591, rHA, expiration date 23-JUL-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
08/30/21 The patient presents with 7 day hx of general weakness. Pt reports general weakness with noted hypotension. Pt is currently COVID-19 positive, tested positive at onset. The patient presents with 7 day hx of general weakness. Pt reports general weakness with noted hypotension. Pt is currently COVID-19 positive, tested positive at onset.
Initial report receive from a patient on 09 December 2008. A 44-year-old female patient received a left deltoid injection of FLUZONE SV 2008-2009 (lot number unknown) on 06 December 2008. Ten minutes after the vaccination, the patient felt like there was a baseball in her throat and she took BENADRYL. A few hours later, it was still difficult for the patient to swallow and cough and she had chills and blood shot eyes. She took more BENADRYL and felt better the next day. The patient recovered. Follow-up information received 29 January 2009 from a health care professional. The patient received FLUZONE, lot number U2849AC and the patient fully recovered from the symptoms in 24 hours. According to the reporter, the patient experienced these same symptoms following receipt of last year's FLUZONE vaccination. No additional information was provided at the time of the report.
Significant pain at injection site for three days. Intense aches and pain in left side of body, mostly in left leg. It was so bad on the day following the injection that it was difficult to walk or lift my left leg. It lasted until the second day following the injection.
Within 5 minutes of vaccination, becaome short of breath, pale lightheaded and complained of not being able to breathe.  Received epinephrine at the office - 0.3 mg IM symptoms improved.  EMS called and taken to emergency room. Benadryl 50 mg IV was administered by EMS.  Still felt shaky on arrival to emergency room. Observed in ED for 2 additional hours with no further intervention required. No stridor, clear airway and able to walk without difficulty. PMH for childhood asthma.
Large area of redness on left deltoid surrounding injection site. Sore arm. No treatment needed.
Patient presented to the ED and was subsequently hospitalized for left femur fracture within 6 weeks of receiving covid vaccination.
death J96.90 - Respiratory failure J96.01 - Acute respiratory failure with hypoxia
profound vertigo and nausea, I was literally falling into the walls. Treated with meclazine which has decreased the vertigo but not alleviated it. On 11/11/23 I was unable to stand without risking falling and stayed in bed until 11/12/23. Also experienced, generalized muscles aches and fatigue, chills, hot flashes. Pain noted in lumbar area and R kidney area on day 4 post injection. Also more fatigue than with any previous vaccine, slept for 9+ hrs (I usually sleep 4-5 hrs) after spending the entire day in bed. Very severe frontal headache x 3 days , now headache is mild. I was part of the Moderna covid study and never had side effects like this for any of the other vaccines.,
10 minutes after shot sharp pain for about 10 minutes then it went away. Light itching also went away at same time. About an hour and a half after, stinging and burning eyes that has not gone away. started 11:30am and it is now 5pm at time of report. Been advised to call eye doctor tomorrow. Burning not so much it tears up but a constant burning feeling in both eyes.
pt recv vax 9DEC93 & DEC96 pt did not feel well & beg exp SOB;sx cont to worsen until 6JUN97 when became febrile (t103.8);adm to ICT dx w/pneumococcal pneumonia & tx w/IV PNC;
Fast heart rate approximately 115 and temperature of approximately 99.7F around midnight for approximately 5 hours