chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient and 2 guardians came to the public health clinic to receive the COVID-19 vaccine from Janssen. Before administering any injections, one guardian asked me to confirm this was a single injection vaccine, which I confirmed with him that was correct. I verified the patient involved in this VAERS report and her birthdate. She and her guardians all confirmed her birthdate. I did not recognize at any point that the patient in this report was under the age of 18 and should not receive the Janssen COVID-19 vaccine. This was brought to my attention after the vaccine was administered and the patient and guardians had left. My supervisor was notified immediately.
CONFIRMED CLINICAL VACCINATION  FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and other pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 09-JUN-2021) dose was not reported, 1 total, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-JUL-2021, the patient presented with COVID symptoms, which included sniffles, loss of taste and smell, shortness of breath, general cold symptoms, severe cough (confirmed covid-19 infection). On 12-JUL-2021, the patient was sent home from work to take COVID test, which returned positive. On 13-JUL-2021, the patient then followed up with a second confirmatory PCR (Polymerase Chain Reaction), which returned positive (confirmed clinical vaccination failure/lack of effect). The patient was currently still actively ill, symptoms ongoing.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210738986- covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Not 100% positive this is from the booster shot, but was told that I should report it.  Started on November 10, 2021. Pain came out of no where.  Pain at base of spine ... especially when go up the stairs, get out of a chair, turn a certain way, lift, stand for periods of time, etc.   Goes into spasms at times.   Going to chiropractor for treatment.  Was told area was inflamed and could be due to vaccine.  Also ice area and take Tylenol.
Fever x 3 day, sleepiness x 3 days, rash devel 2AUG neck/face 3AUG rash spread to body; Rash was blotchy, redder, raised, sore throat, sore mouth/redder eyes, cranky, no appetite;
Inflammation, lymph node tenderness, diarrhea, post nasal drainage, right lung irritation.
Sore injection site Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site Arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore injection site Arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
Swollen lymph nodes in left armpit. Tenderness under left armpit. Bump in left armpit.
Patient was given TDaP and Pnu in Left Deltoid and Hep B IM R Deltoid at off-site vaccine clinic.  Patient called vaccine administrator the next day to c/o warm, tender R deltoid area. Patient was advised to use Tylenol and Motrin and warm compresses and to monitor.  If no better, return call. Patient returned call two days later and stated that she felt horrible. C/o fever, chills, and increased pain in Right arm. RN spoke with patient and advised her to see her doctor immediately. Patient returned call and stated that she had seen her doctor that day and was diagnosed with cellulitis of the Right arm. Patient was placed on antibiotics.
Warm; warm and itchy; red spot; vaccination site pain; vaccination site erythema; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (warm and itchy), VACCINATION SITE RASH (red spot), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE ERYTHEMA (vaccination site erythema) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (warm and itchy), VACCINATION SITE RASH (red spot), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (warm and itchy), VACCINATION SITE RASH (red spot), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE ERYTHEMA (vaccination site erythema) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.   Reporter did not allow further contact; 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.
Red oval shaped rash on left upper arm, hot to the touch, about 4 to 5 inches long extending from mid-shoulder to middle of arm.
Transient Global Amnesia, Acute CVA ruled out, currently hospitalized to rule out seizure
I had difficulty swallowing with pain in my neck. I had a severe headache and was extremely fatigued. It started Jan 8 2021 and it continued until I sought medical help from multiple physicians. I had a headache for over 90 straight days. I had a nogol in my neck, it ended up being diagnosed as acute thyroiditis.  I am in a lull right now after I was able to stop the medicine. My thyroid is functioning again, but we are waiting for it to go into the hyper thyroid stage.
Large area erythema to elbow and swollen, hard with crusted area at vaccine site. Right deltoid.
no adverse event expect the patient age was 11years old and 9months and we missed the age . the mom said later after the vaccination that her son was going to be 12 years old in 2 months
Incorrect dose was given. He was given Moderna Bivalent 0.2 ml pink cap and yellow border vial so got lower than recommended dose. Patient's parent notified and will be coming in to receive correct dose.
Hematoma following 30 seconds after injection. Ice pack and follow up if symptoms prolong. 8/5/19
Patient arrives on day 2 of feeling ill.  Patient has body aches slight cough.  Patient's had fever at home and 100.5.  Patient arrives and has a room air sat 88%.  Patient denies chest pain.  Patient denies history of MI stent or CABG. patient denies ear pain sore throat.  Patient denies nausea vomiting diarrhea.  Patient denies headache.  Patient has had the Moderna vaccine approximately 1 year ago.
Received Pfizer vaccines on 3/31, 4/21/21 Tested positive for COVID by PCR on 10/19/21 admitted to Hospital on 11/2/21 d/t new onset cortical blindness, right PCA infarct.
Pt received flu shot on 9/22/08. He went home directly thereafter and developed vomiting, nausea, diarrhea and fever
12 cm erythema and induration at site of DTAP injection of patient's anterior thigh.
Vaccine was administered 3 days past expiry date. Patient does not report any adverse reactions from vaccine. Pfizer did not have data to support vaccine stability past the expiry date. The information we received from the Pfizer would lead us not to recommend re-vaccination.
Received vaccines at 15 mo. Check up 11/30/15 by afternoon of 12/1/15, patient noted to have fever with seizure activity. Described as shaking of arms, legs, eyes rolling to back of head and drooling.
There was no adverse reaction Saturday August 28, 2021, I was giving vaccine. Patient came to her vaccine after seeing checked by the data entry person. Before I administered the vaccine asked her again if it was her first Covid vaccine, she replied "yes" so I gave Pfizer dose, after the vaccine she sat 15 minutes & no adverse reaction then left
anaphylaxis/allergic reaction; Mast Cell Activation Syndrome; Drug Hypersensitivity Syndrome; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left at age of 47 years, not pregnant on 19Mar2021 14:00 (Lot Number: Pfizerep7534) as single dose for covid-19 immunisation. Medical history included allergies to penicillin prior to vaccine and traumatic brain injury from near fatal accident. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control; fluticasone propionate (XHANCE). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had an anaphylaxis/allergic reaction to the first Covid Pfizer vaccine shot, (her only shot) on 19Mar2021 and since then things had spiraled out of control with her body; many medications to treat had caused more anaphylaxis allergic reactions like Benadryl, Cromolyn and Famotidine/Pepcid (7meds in total as she had been on no new meds since). She presented with Mast Cell Activation Syndrome and Drug Hypersensitivity Syndrome. 5 ER visits, 2 hospital stays and no improvements. The only medications that seem to provide any relief. Hydroxyzine, Singulair and Prednisone and even with these medications she continue to have allergic reactions or intolerances to medications which has now expanded to food, exertion, scents, and temperature changes. Not sure why this was happening, as prior to 19Mar2021 no food allergies and never had anaphylaxis until then. Patient in need of treatment by a vaccine expert. Her body saw everything as a toxin. Adverse event started at 19Mar2021, 14:00, and resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Hospitalization for 7 days. This case was serious with seriousness criteria reported as life threatening and caused hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid test via nasal swab on 12May2021 was negative. The outcome of the events was not recovered.
After the vaccine didn?t feel good with headache for a few hours and that went away. When I work up morning of the 17th I went into the bathroom feeling fine. Suddenly started violently wretching and hurried to the sink. Fell not sure if I fainted or just fell. Violent wretching continued for a couple with no emesis. Then it quit and never returned. Slightly queasy for a couple hours and the fine. No serious injuries but hit my face on the counter with significant bruising
I've developed bell's Palsey; This is a spontaneous report from a contactable consumer.   A 40-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 10Apr2021 (Batch/Lot Number: EW0162) as a single dose for covid-19 immunisation. Medical history and  concomitant medications were not reported.  The patient did not have any other vaccinations within 4 weeks. The patient reported that on 17Apr2021, he developed bell's palsey. The outcome of the event was not reported. The patient did not have COVID prior to vaccination not was tested post vaccination.
SINUS INFECTION; DENTAL ABSCESSES ON THE UPPER LEFT SIDE AND LOWER RIGHT SIDE OF MOUTH; GREEN HUNKS CAME OUT FROM NOSE; IMPROVED BREATHING; WATERY EYES; RUNNY NOSE FOR WHOLE STRAIGHT DAY; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: recurrent sinus problems, and cocaine abuse, and concurrent conditions included: smoker, non-alcohol user, chronic obstructive pulmonary disease (copd), and allergy to hives, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient had drug abuse or illicit drug use when was 19 year old. In 1996, the patient could only sleep on one side or could not breath. The patient had cocaine and was smoking marijuana due to childhood trauma. Currently it was drug use, not abuse, mainly smoking marijuana limited for fun. The patient have never been sick in life, never hospitalized, had a biopsy once but nothing came of it. The patient has been on antibiotics for years for sinus infection, abusive of antibiotics which would help for only 3 days then gets difficult to breath again. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 23-JUL-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2022, the patient experienced watery eyes, and runny nose for whole straight day. On an unspecified date, the patient experienced sinus infection, dental abscesses on the upper left side and lower right side of mouth, green hunks came out from nose, and improved breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinus infection, and dental abscesses on the upper left side and lower right side of mouth, and watery eyes, and runny nose for whole straight day on 04-MAR-2022, and the outcome of improved breathing and green hunks came out from nose was not reported. This report was non-serious.
Chills, mild headache, lowered oxygen levels to 85 SpO2.  Gone after 24 hours.  But this is episodic.  I don't recall when it happened again.  Same pattern and gone after 24 hours.    But on 3/22/2021,  it started in the evening and lasted for 36 hours.  This time the additional symptom of non-productive cough appeared for the first time.  COVID test during that same day (in anticipation of angiogram on the 24th) was negative.  Oxygen levels continued to be low while in hospital for angiogram which resulted in two stents being emplaced and the following day for a TEE to get a better look at the valve.  No chills or cough until evening of the 25th.  Chills lasted for 24 hours, but non-productive cough and low oxygen levels persist up through the present time (March 29th).   This is the first time one of these episodes has lasted for more than 24-36 hours.  Without supplemental oxygen, my oxygen levels are 82 (walking) and 85 (resting).  Supplemental oxygen at 2 lpm brings the SpO2 up to 89-90.
Fatigue, Muscle or body aches, Headaches and Congestion or runny nose AND FEVER
04/16/04: Received Hepatitis B, MMR and Chickenpox Vaccine. 04/24/04: Prior to this date had a runny nose for a couple days. This day started with a fever up to 102 deg and developed 6 marks on his chest and front area plus 2-3 marks on his back.  They were red and approximately 1cm in size with a clear white center mark.  Administered Tylenol.   04/25/04: Fever 98-99.5 deg and was cranky.  Marks faded. 04/26/04: To doctor. Temperature 97.4. Rash cleared, Appears OK. 04/28/04: During day developed rash on 1/3 of body. Rash appears raised. No fever. Behavior fine. Rash lasted 36-48 hours and dissapeared. OK since then.
headache, bone and muscle aches on left side (collar bone, shoulder blade, rib cage, neck, back), fever (99.5-100.5 for 1+ days), nausea (5+ days)
On 4-1 when I assessed take, the client had small red streaks beginning to form on her arm around the vaccination site.  She was afebrile but cx of her arm aching and "feeling tired".  I asked the clinic dr to look at her (he was vaccinated also), telling him I suspected she was getting an infection at the site. and he wrote her a prescription for abt.  I checked with the Infection Control Nurse a week later and she said the red streaks had gotten longer on her arm and her lymph nodes had swollen noticeably from shoulder to elbow.  However, she had begun to and was well into recovery with the antibiotics.  No other adverse events reported to me.  This client stated when questioned that she was not changing her tegaderm dressings daily as ordered.  I advised her in the presence of the ICP and dr that changing dressings daily is imperative.  The ICP agreed to check with her more closely each day.
Throat began to close; This case was reported by a consumer via call center representative and described the occurrence of throat constriction in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date 5th November 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site reaction (received 1st dose, refer case US2019AMR158086).   On 22nd August 2019 10:00, the patient received the 2nd dose of Shingrix (intramuscular). In August 2019, 15 hrs after receiving Shingrix, the patient experienced throat constriction. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the throat constriction was recovered/resolved.   It was unknown if the reporter considered the throat constriction to be related to Shingrix.  Additional details were provided as follows: The Shingrix administered in the left arm. The patient received the 2nd dose of Shingrix and at 10:00 AM and 15 hours later, her throat began to close.   She was treated at the ER with a benadryl cocktail and the issue resolved 4 hours after receiving the treatment.   The reporter did not consent to follow up. Emergency room visit was required.
Information has been received from a registered pharmacist concerning a patient who on 06-MAY-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 09-MAY-2008 the patient developed a zoster-like rash. The patient sought medical attention via a phone call. At the time of the report the patient's status was unknown. A product quality complaint was not involved. No further information is available.
patients armed swelled and bruised. knot/bolus was sitting in arm but no allergic reaction occurred. patient was given a small dose of benadryl but epinephrine was not neccessary
little itchy; rash on neck, bend of arms, across middle of back, hip area; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little itchy) and RASH (rash on neck, bend of arms, across middle of back, hip area) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, CHLORTHALIDONE, DILTIAZEM, SERTRALINE, LOSARTAN and CLONAZEPAM for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (little itchy) and RASH (rash on neck, bend of arms, across middle of back, hip area). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (little itchy) and RASH (rash on neck, bend of arms, across middle of back, hip area) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
2 days after vaccine began to limp  Pain in L hip Had evaluation at our office - Xray, blood work (CBC, ESR, CRP, Lyme) - consistent with Transient Synovitis Ibuprofen and rest and symptoms improved over the next 5-7 days.
Pt's daughter called around 7:00 PM saying patient had chills and shivering, and temp. 99 degrees F.
Headache, NauseaVomiting, chilla, pain at injection site, runny nose Narrative:  Other Relevant History:
Information has been received from a certified medical assistant concerning a 24 year old female who on unspecified dates was vaccinated with the first and second doses of Gardasil. On 29-MAR-2007, the patient was vaccinated with a third dose of Gardasil. On 29-MAR-2007, the patient was feeling fine at first, within the next five minutes or so, the patient was feeling very hot. The outcome was not reported. Additional information has been requested.
Was sleepy; Kind of like the flu; Shortness of breath; Tired; A lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Was sleepy), INFLUENZA LIKE ILLNESS (Kind of like the flu), DYSPNOEA (Shortness of breath), FATIGUE (Tired) and FATIGUE (A lot of fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 028L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, FUROSEMIDE, METOPROLOL, ATORVASTATIN, LOSARTAN and WARFARIN for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced SOMNOLENCE (Was sleepy), INFLUENZA LIKE ILLNESS (Kind of like the flu), DYSPNOEA (Shortness of breath), FATIGUE (Tired) and FATIGUE (A lot of fatigue). On 11-Mar-2021, SOMNOLENCE (Was sleepy), INFLUENZA LIKE ILLNESS (Kind of like the flu) and FATIGUE (Tired) had resolved. At the time of the report, DYSPNOEA (Shortness of breath) and FATIGUE (A lot of fatigue) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include Levothyroxine, Furosemide, Metoprolol,  Atorvastatin, Losartan, Warfarin. The patient did not receive any treatment.  Action taken with mRNA-1273 in response to the event was not applicable.