chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe eye floaters; This is a spontaneous report from contactable consumer, the patient. A 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er8733); via unspecified route of administration in left arm on 26Mar2021 at 09:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and was not tested for COVID-19, since the vaccination. The patient did not receive any other vaccine within four weeks of vaccination. On 26Mar2021 at 10:45, the patient experienced severe eye floaters. The adverse event result in consultation to doctor or other healthcare professional office/clinic visit. It was unknown, if the patient received any treatment for the reported events. The clinical outcome of the event severe eye floaters was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Received varicella imm and MMR imm on 7/26/05. Presented 7/27/05 with rash on left side of face left shoulder. No fever, cranky. Benadryl 1/8 tsp every 8 hrs as needed. Mom to call if worsens.
R lower posterior arm, 6cm wide x 10 cm length, erythema, not hard.
Fever 102F last pm and today. Sweating, vomited up bottle of formula this am, and diarrhea this am, and very fussy and won't settle down.  3/19/08 Reporter called back to report that patient still having health problems but had not been hospitalized.  Not gaining weight.  When last seen this week, had oral & diaper thrush & was irritable.  Pediatrician making formula change & if no improvement will refer to GI specialist.
eye pressure; watery eyes; blurred vision; vertigo; headaches; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (eye pressure), LACRIMATION INCREASED (watery eyes), VISION BLURRED (blurred vision), VERTIGO (vertigo) and HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    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 OCULAR DISCOMFORT (eye pressure), LACRIMATION INCREASED (watery eyes), VISION BLURRED (blurred vision), VERTIGO (vertigo) and HEADACHE (headaches). At the time of the report, OCULAR DISCOMFORT (eye pressure) and LACRIMATION INCREASED (watery eyes) outcome was unknown and VISION BLURRED (blurred vision), VERTIGO (vertigo) and HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported. No concomitant medicine  was reported.
Lymphadenopathy on right side of body, lymph node pain, fatigue, nausea, muscle pain, joint pain, fever
Right eye twitch, right side of face swelling, pressure right side of face, shingles like rash up left side of torso. The rash lasted a week the face swelling and twitching non stop since about day 7 and has not let up
Varicella adm 07/27/01, mother states had chicken pox 07/2004.
This is a spontaneous report from a contactable consumer (patients' wife). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 26Apr2021, as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.On 28Apr2021,the patient experienced cough and fever. On 29Apr2021 next morning (2 days later),patient was diagnosed with COVID-19. The patient still had cough and stuff. His rapid test was negative but his PCR was positive still, so he had been positive for a while. He tested negative with the rapid test but the PCR test still come back positive.The patient was supposed to get his second vaccine on Monday. The reporter inquired about the recommendations, like patient still have lingering symptoms, does he wait, does he have to start over.The patient underwent lab tests and procedures which included COVID rapid test : negative on Apr2021 and PCR test : positive on 29Apr2021. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
ringing on the ears; 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 TINNITUS (ringing on the ears) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing on the ears) (seriousness criterion medically significant). At the time of the report, TINNITUS (ringing on the ears) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information was provided.  This case concerns an adult of unknown age and gender with a serious unexpected event of tinnitus. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. Based on 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.; Sender's Comments: This case concerns an adult of unknown age and gender with a serious unexpected event of tinnitus. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. Based on 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.
DTaP given June 10.  24 hours later T 104.7ºF 36 hrs later T 105.6ºF.  Vomited while riding in car at 24 hrs.  No headache or meningismus.  Fever controlled with Tylenol and sponging.
Slight loss of taste for one day; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Arm on 18Mar2021 18:45, at the age of 35-years-old, (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history included none.   The patient did not have COVID-19 prior the vaccination. The patient's concomitant medications were not reported.  On 20Mar2021 07:00, the patient experienced slight loss of taste.  The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 20Mar2021. The event involved physician office visit. The with outcome of the event was recovered on 21Mar2021. No treatment was received for the event.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Headache; very ill; feeling as though his sinuses are impacted; chills; Lost sense of smell; Lost sense of taste; Cough; Tightness of chest; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost sense of smell), AGEUSIA (Lost sense of taste), COUGH (Cough), CHEST DISCOMFORT (Tightness of chest) and PYREXIA (Low grade fever) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (Uses albuterol).  On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced ANOSMIA (Lost sense of smell), AGEUSIA (Lost sense of taste), COUGH (Cough), CHEST DISCOMFORT (Tightness of chest) and PYREXIA (Low grade fever). On an unknown date, the patient experienced HEADACHE (Headache), MALAISE (very ill), SINUS DISORDER (feeling as though his sinuses are impacted) and CHILLS (chills). At the time of the report, ANOSMIA (Lost sense of smell), AGEUSIA (Lost sense of taste), COUGH (Cough), CHEST DISCOMFORT (Tightness of chest), PYREXIA (Low grade fever), HEADACHE (Headache), MALAISE (very ill), SINUS DISORDER (feeling as though his sinuses are impacted) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.   Concomitant medications were not reported.  Treatment includes albuterol and azithromycin.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: Permission to contact.
Headache; This is a spontaneous report from a Pfizer-sponsored program  from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 01Mar2021 (Batch/Lot number unknown) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were not reported. On 01Mar2021 the patient received the first dose of the vaccination. In Mar2021, she experienced headache for 2-3 days after the first dose. On 07Mar2021 she started taking Doxycycline 40 mg. On 22Mar2021 she received the second dose, but no symptoms were experienced after the second dose. She was wondering if the Doxycycline may have changed the efficacy of the vaccine. The outcome of event headache was recovered.  No follow-up attempts possible; information about lot/batch number cannot be obtained.
Approx 20 min after vaccine was given patient began to have a cough and itching.  This progressed to throat feeling tight and difficulty breathing.  Epinephrine 0.3 cc's was given.  O2 at 4L/NC.  Patient began to feel better within 3 min.  Squad was called and the patient was transported to the ER.
Itchy rash to arms and legs that immediately resolved with 25mg IM Benadryl.  No airway issues.  No swelling, no nausea.  Observed and Father drove home.
Arm soreness, fatigue, diarrhea, headache  Pregnant-due 9/3/2021
IPOL was used post excursion but upon further probing with no reported adverse event; Initial information regarding an unsolicited valid  non-serious case received from a other health professional received on 06-May-2022.  This case involves a 4 years old male patient who reported administration of IPV (VERO) [IPOL] was used post excursion but upon further probing with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (mmr) for immunization; varicella zoster vaccine (varicella vaccine) for immunization; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (daptacel) for immunization.  On 18-Mar-2022, the patient received a dose 4  dose of suspect IPV (VERO) at dose 0.5ml (lot T1D481M, expiry date 25-Jul-2022 ) via intramuscular route in unknown administration site for prophylactic vaccination.  The vaccine was exposed to highest temperature of 48 degrees F for 30 minutes at most. On 18-MAR-2022, the patient developed a non-serious ipol was used post excursion but upon further probing with no reported adverse event (product storage error) latency same day following the administration of IPV (VERO).  Action taken: Not applicable.  At time of reporting, the 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 guidelines. 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.
Missed next menses. was to have have period in December. Had symptoms but no period.  Symptoms of period/pregnancy - bloating, cramping and breast tenderness.
Fever 100.5, chills, body aches, joint pain, severe headaches, nausea, tachycardia (110s)
Patient received TIV Fluvirin 0.5 ml in right deltoid. Within 10 seconds, some bleeding occurred and large lump the size of a golf ball appeared underskin. Patient applied an ice pack for 20 minutes to swelling. Site was rechecked at 11:25am and was less swollen, a little bruised but not bleeding. Patient denied any pain at site.
From the afternoon of Tuesday, March 23 through early afternoon of Saturday, March 27 gastric cramping, explosive diaherra, stomach pains, vomiting, and belching.  The stomach pains were the worst in the first 36 hours, the gastric cramping gradually lessened over four days.  Vomiting was confined to the mornings of March 24 and March 25.  The explosive diaherra happened every two hours for the entire period.  Small sips of water, diluted apple juice, peppermint tea all resulted in increased gastric cramping.  The first food (two scrambled eggs) I was able to eat was on Friday morning, March 26.
Pt called clinic in the afternoon after having been vaccinated in the am under the provision of another nurse (not me). Chief pt complaint at time of afternoon call: Leg/upper thigh pain not addressed after pt had taken otc Tylenol. Pt reported swelling and significant discomfort in involved lower limb. Recommendation: Pt seek immediate attention in ER setting to rule out blood clot, given pt's dx of Heterozygous factor V Leiden mutation and possibility of a clot having formed. Pt verbalized understanding and intent to seek immediate medical care.
Around 9pm on the day of the shot, I began to feel nauseous and fatigued. The next morning (4/17/21) I felt achy, fatigued, and had a headache. I noticed a rash on my left arm the evening of the 17th near the injection shot. Left arm remains swollen with rash the morning of 4/18/21. The other side effects subsided by the morning of 4/18/21.
Both thyroid nodules blew up for a week and patient crashed with typical thyroid symptoms. (1st shot)  Subsequently also developed flaking /cracking of skin around the eyes and in the ears.  As of August 16th, this has not gone away.  I suspect it is the development of psoriasis which I have never had before.  Went to Dr.  (within the 1st few weeks)and he did not want to do a steroid shot as it would negate the vaccine. Suggested hydrocortisone and washing with baby shampoo around the eyes and ears.   It has not gone away.  I am very Leary about getting a booster. Would prefer a blood test to see if the previous two shots are effective.  Looking for input.
DIED 4 DAYS AFTER THE VACCINATION; This spontaneous report received from a consumer via social media concerned a young female of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient had no pre-existing medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died 4 days after the vaccination from an unknown cause of death. It was unspecified if an autopsy was performed. The consumer reported as "Doctors are threatened with having their licences cancelled if they represent adverse reactions and self reporting of adverse reactions is not considered reliable. A young, healthy, active mother was dead 4 days after the vax and no connection was found to the vax. She just died. No pre existing conditions."  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220316156.  Version created to amend previously reported information on 07-MAR-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of invalid).; Sender's Comments: V1. This follow-up version was created to amend following information: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of invalid). This amended information doesn't alter previous causality assessment made for the events in the case.  20220316497-covid-19 vaccine ad26.cov2.s-died 4 days after the vaccination. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pt with red, swollen area at injection site c/o diarrhea, temp to 100.3, cranky, decrease appetite. Tx: Benadryl q 6 hrs, warm mist packs, Tylenol-call in 2 days or sooner and symptoms worsen.
Per Pt report, "while driving home experience facial numbess, tingling in tongue, tingling in RUE. Pt went to the ER.
Per mom approx. 7 hours after receiving vaccines. Patient had temperature at home of 101.8 and then eyes rolled in back of head, drooling from mouth and body twitching. Mom immediately took patient to hospital ER and pt. was examined and no treatment necessary.
Lost 8 pounds since the adverse event; has no energy; trouble breathing upon exertion; her arm was left sore and uncomfortable; She stated she was feeling heart failure symptoms at the time; allergic reactions; hives; her arm was left sore; itching; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (her arm was left sore), PRURITUS (itching), WEIGHT DECREASED (Lost 8 pounds since the adverse event), ASTHENIA (has no energy) and DYSPNOEA EXERTIONAL (trouble breathing upon exertion) in a 75-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no.) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hives. Concomitant products included ACRIVASTINE (BENADRYL OTC) for Hives, CORTISONE for an unknown indication.    On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced PAIN IN EXTREMITY (her arm was left sore), PRURITUS (itching), HYPERSENSITIVITY (allergic reactions) and URTICARIA (hives). On an unknown date, the patient experienced WEIGHT DECREASED (Lost 8 pounds since the adverse event), ASTHENIA (has no energy), DYSPNOEA EXERTIONAL (trouble breathing upon exertion), LIMB DISCOMFORT (her arm was left sore and uncomfortable) and CARDIOVASCULAR SYMPTOM (She stated she was feeling heart failure symptoms at the time). The patient was treated with TRIAMCINOLONE DIACETATE (PROCTOSTEROID) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her arm was left sore), PRURITUS (itching), HYPERSENSITIVITY (allergic reactions) and URTICARIA (hives) was resolving, WEIGHT DECREASED (Lost 8 pounds since the adverse event), ASTHENIA (has no energy), LIMB DISCOMFORT (her arm was left sore and uncomfortable) and CARDIOVASCULAR SYMPTOM (She stated she was feeling heart failure symptoms at the time) outcome was unknown and DYSPNOEA EXERTIONAL (trouble breathing upon exertion) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: loss.         It was reported that patient had to go to urgent care for these symptoms. The urgent care physician prescribed her a steroid injection and tablets to take for the week. She stated she was feeling heart failure symptoms at the time.
8 days after my first Moderna shot, my right arm got very itchy at the injection site.  It continued to be itchy, swollen, a bit warm to touch since the afternoon of March 5.  The itchiness and redness has slowly spread about 3 or 4 inches below the injection site in my right arm.
This spontaneous case reported by a consumer, describes the occurrence of injection site rash (rash at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included: No historical conditions reported. On Feb 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced injection site rash (rash at the injection site). At the time of the report, injection site rash (rash at the injection site): not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitants or treatment medications reported.
Approximately 4 hours after vaccination Pt began with epigastric abdominal pain and persistent diarrhea, unable to tolerate liquids or food PO since that time without vomiting or episode of diarrhea within a few minutes.
Began 8/1/11 with redness & itching to (L) deltoid. No fever. No pain with palpation. Area of redness below site of injection.
Sudden onset of chills, fever under 101.0, occastional heart palpations.  No other concerns other than these noted.
COVID-19 (nasal swab) test showed positive; COVID-19 (nasal swab) test showed positive; This is a spontaneous report received from a contactable Other HCP (patient). A 39-year-old non-pregnant female patient received first dose of BNT162B2 (LOT#: EL1283) intramuscularly administered in left arm on 12Jan2021 at single dose, and second dose of BNT162B2 (Lot Number: EL9265), via an unspecified route of administration, administered in left arm on 02Feb2021 at single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), depression, seasonal allergies. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was Hospital. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XL), dextroamphetamine hydrochloride, amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), vitamin D3, loratadine (CLARITINE). On 27Mar2021 at 07:00, patient performed COVID-19 (nasal swab) test showed positive. The event resulted to doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. The outcome of event was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Sickness including very lethargic, achy, headache, rapid heart beat. Achiness, tiredness, and headache went away after day 5 but still have rapid heart rate. My typical heart rate before vaccine was between 70-80, now it shoots up to 140-150 for no reason. Was prescribed beta blocker by family physician but it made me dizzy. I have a follow up appointment in two weeks.