chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme ringing in both ears, I am deaf in my left ear and have mild ringing in that ear, after receiving my 1st shot I have very extreme ringing in both ears that has not lessened or gone away.  I had extreme fatigue starting 2 days after the vaccination and lasting for 2 weeks often sleeping 12 or more hours a day. I have also had headaches over that 2 week period after receiving dose (1) of the vaccine.
The pt developed induration, erythema, swelling, warmth at injection site. Treated with Benadryl.
middle cerebral artery territory ischemic stroke; systolic congestive heart failure; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 06-APR-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered confusion and altered mental status requiring hospitalization and extensive rehabilitation and was diagnosed with middle cerebral artery territory ischemic stroke and systolic congestive heart failure (onset date of this diagnosis was not specified). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).   Upon internal review, both events were considered to be medically significant. The lawyer considered the events to be disability.
Approximately 5 hours after injection eyes became very swollen and itchy - took a CLARITIN. By morning, eyes were even more swollen, very red and (R) eyelid had a large hive on it. Moderately severe headache.
This is a spontaneous report from a contactable licensed practical nurse from a pediatric office. A 18 year-old male patient of unspecified ethnicity received TRUMENBA (lot number M13066, expiry date 30Sep2016) intramuscularly on 26Jan2016 at 0.5 ml single. Relevant medical history and concomitant medications were not reported. The patient experienced flu like symptoms, temperature of 101, fatigue, redness and swelling at injection site on unknown date in Jan2016, within 24 hours from the injection. The symptoms resolved within 3 days on an unspecified date in Jan2016. The nurse spoke with the doctor regarding the causality of the event and he/she said related to the product.
Mon 12/19 woke up with rash on stomach and under arms, no other symptoms reported by mother.
Headache, body aches, fatigue starting the next day and lasted for 48 hours
Pain on injection site on the day of injection. Patient took OTC pain medication (Advil) the next day, she said she can't move her arm where she had the injection. She wasn't able to sleep next couple days after getting the vaccine. Couple months after, she went to her doctor and they did an X-ray.  Few weeks after that, PCP also ordered MRI.
The patient was immunocompromised and received full booster dose; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (The patient was immunocompromised and received full booster dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OVERDOSE (The patient was immunocompromised and received full booster dose). At the time of the report, OVERDOSE (The patient was immunocompromised and received full booster dose) outcome was unknown.            Concomitant medications were not reported.  The patient was immunocompromised and got three full shot and went for the booster and received a full shot.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-600669, US-MODERNATX, INC.-MOD-2022-600668 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-600669:Same reporter US-MODERNATX, INC.-MOD-2022-600668:Same reporter
Dizzy and elevated blood pressure occurred the day after vaccines were administered - follow up visit 5/31/16.
Extreme energy within 30 minutes of injection  Followed about 2 hours later by extreme fatigue (slept over 3 hours between 11am and 3pm) Severe pain at the injection site and muscles surrounding it (approx. 8pm) continuous as of this report (3/14/21 12:45am) Pain in the lower left jaw (approx 9pm)  continuous as of this report (3/14/21 12:45am)
Swelling and redness at injection site; Pain in upper arm; Nausea; Vomiting; Fatigue; Fever; Shortness of Breath
3/6 arm pain starting about 3pm and continuing until 3/8 when it decreased to mild soreness  3/6 8:30 pm chills,  aches, sweats until approx 8:00 am on 3/7 3/7 8:00 am bad headache across forehead for majority of day until approx 5:00pm. No appetite  Extremely tired and lethargic until   Slept approx 18 hours 3/8 took Tylenol and went to work felt better but ?like a wet noodle?  still not much appetite
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Apr2021 at 19:00 as dose 1, single (Lot number: ER9449), in right arm, on 19Jun2021 at 19:00 as dose 2, single (Lot number: FC9001), in left arm and on 12May2022 at 19:30 as dose 4 (booster), single (Lot number: FN2716) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Dec2021 at 19:00 as dose 3 (booster), single (Lot number: 3005686), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mastectomy", start date: Nov2021 (unspecified if ongoing), notes: mastectomy Nov2021, no spread;; "Radiotherapy", start date: Feb2022 (unspecified if ongoing); "Mild asthma since childhood" (unspecified if ongoing), notes: Mild asthma since childhood.; "Hay fever" (unspecified if ongoing), notes: Hay fever (pollen, mild, house dust).; "Heartburn" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing); "drug allergy" (unspecified if ongoing), notes: Known allergies Allergic to Sulfa antibiotics, cannot take proton pump inhibitors. Concomitant medication(s) included: TAMOXIFEN, start date: 24Feb2022; FERROUS FUMARATE, start date: 26May2022; VITAMIN B12 [CYANOCOBALAMIN], start date: 26May2022; BENADRYL [ACRIVASTINE]; VENTOLIN [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive; (31Jul2022) Negative; (01Aug2022) Negative; (02Aug2022) Negative; (03Aug2022) Negative; (04Aug2022) Negative; (05Aug2022) Negative; (06Aug2022) Positive, notes: when I woke Saturday 06Aug and tested faintly positive on lateral flow; (08Aug2022) LFT line was super crimson strong, notes: my positive LFT line was super crimson strong; (24Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If vaccine received Yes, Other medication in 2weeks Yes. Covid rebound. [This is my first experience w covid19.] Positive for covid on lateral flow test 25Jul2022, after negative PCR done 24Jul2022. Started paxlovid evening of 25Jul, finished morning of 30Jul (10 doses). Tested negative on lateral flow test: Sun 31Jul, Mon 01Aug, Tue 2nd, Weds 3rd, Thurs 4th, and Fri 05Aug. Symptoms started to return Fri eve. Sore upper palate and prickly nose when I woke Saturday 06Aug, and tested faintly positive on lateral flow. Went into isolation on Saturday 06Aug. Symptoms worsened Sat eve, some fever (100.5F). Mostly like a head cold but worse than when I was on paxlovid. I feel bad today (Monday 08Aug), low grade fever intermittent, and my positive LFT line was super crimson strong.  No follow-up attempts are possible. No further information is expected.
Friday 4/30/21 Experienced throbbing headaches, cold sweats, chills, nausea, low grade fever, and small red rash and dryness on my face. Saturday 5/1/21 Experienced throbbing headaches, weakness, cold sweats, chills, 102-103 fever, and small red rash and dryness on my face. Sunday 5/2/21 Experienced throbbing headaches, weakness, cold sweats, chills 102-103 fever, and red rash and dryness spreading to my chest. Monday 5/3/21 Experienced throbbing headaches, weakness, cold sweats, chills, 102-103 fever, and red rash and dryness on my face, chest, and neck. Tuesday 5/4/21 Experienced weakness, cold sweats, low grade fever, and red rash and dryness on my chest, neck, back, face, and groin. Wednesday 5/5/21 Experienced weakness, cold sweats, and red rash and dryness on my chest, neck. face, and groin.
Injection site swollen, headache, left eye pain, bad migraine, arm pain, can't straighten arm, enlarged left breast, cold elbow and shortness of breath.
Following month lost balance often, fell, progressive, had stroke like event in June. 2 weeks in hospital, 3 months rehab.  CAT scan MRA
This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored VAQTA from lot # M047658 with expiration date on 28-OCT-2017, and also lot # M038572 with expiration date on 11-MAR-2018 (strength, dose, route of administration and anatomical location were not provided), for prophylaxis. The storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (34 °F) for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA010492: US-009507513-1705USA006600: US-009507513-1705USA010491: US-009507513-1705USA010488: US-009507513-1705USA010489.
Patient reported that she experienced an injection site reaction after the first dose of SHINGRIX. Her symptoms included extreme redness and soreness/pain radiating down to her forearm. Patient described this reaction as severe but not anaphylaxis. She stated that her symptoms resolved in approximately one week. It was recommended that she still receive the second dose today but in the other arm.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. My son had his second shot, although he had shown a reaction to the first shot which he received somewhere else. He had to be rushed to a civilian emergency room with symptoms similar to meningitis. He could have died. He is now deployed so he cannot testify for himself. He did say that many in his unit had reactions to the shots although no as severe as his.
INJECTION SITE ITCH; ZERO ENERGY; MUSCLE ACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. . No concomitant medications were reported. On an unspecified date, the subject experienced injection site itch, zero energy, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the zero energy, injection site itch and muscle aches was not reported. This report was non-serious.
Pt to ED 5/28 pt to the ED by EMS for testing positive for COVID-19. COVID+ 5/28, placed on 2L NC for spo2 88%, recommended no treatment for COVID-19 infection. Respirations are even and unlabored. 5/30 pt lethargic, SB on monitor for most of shift, lowest HR of 36, cardizem held during 0500 dose, pt asymptomatic. 5/31 pt more awake, aox1, denied pain, SB on the 40's, denied pain. 6/2 pt with no distress, V/s stable, BP stable at this time, pt alert and oriented x3 per family. Pt discharged 6/2.
headache; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Mar2021 for covid-19 immunisation. Caller (patient) had her 2nd dose of the Pfizer vaccine and she has headache (in Apr2021) and is asking if she can take Tylenol. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt with syncope, vasovagal reaction immediately after injection.  LOC x 3-5 seconds, no injury.  Observed for 30 minutes, BP improved with oral hydration and recumbent rest.  Released to homecare.
The patient lost consciousness briefly post vaccination. She began to fall from a chair and was caught and was able to respond to prompts. She became nauseated as well. After laying down and had a cold compress at her neck she felt much better.
Pt reported throat feeling tingly and tighter ~20 minutes after vaccine, thought it was normal. Later that day, pt experienced tongue swelling and trouble breathing. Went to urgent care, got steroid treatment. Still lasted after several days. Went to the hospital, got more steroid treatment. Pt reports it is "on and off" now, 4 weeks after first dose. No history of allergic reactions to other meds/vaccines.
The patient contacted the pharmacy the morning of 03/24/21. She stated that this past monday (03/22/21) she began to have an adverse reaction to her vaccine. She stated that she began to develop tenderness, erythema, pain, and swelling at the injection site. She stated she had looked into her symptoms online and believed it was "COVID arm". After talking with the patient about her symptoms, I agreed. She was applying a topical corticosteroid as needed for the discomfort. I instructed her to contact her physician if her symptoms did not subside within the next few days.
Information has been received from a physician concerning a 2 month old patient who about ten months ago in approximately June 2007, was vaccinated PO with the first dose of ROTATEQ. Subsequently the patient experienced diarrhea and developed a rash on its buttocks. Therapy with ROTATEQ was discontinued. Subsequently, both symptoms resolved and the patient was recovered. No other information was available. There was no product quality complaint. Additional information has been requested.
Per Expiration Discharge summary from Hospital:  Presented to ER on 6/29/21 with SOB & fever. Pt intubated and sedated so hx is from wife. "Apparently received Pneumonia vaccine on 6/25/21. That evening developed abdominal pain, nausea/vomiting/diarrhea, fever/chills. These symptoms progressively worsened necessitating ER visit" Admitted to ICU. Multiple admission diagnosis including "resp. failure due to acute CAP with sepsis/shock, Streptococcus Pneumoniae bacteremia "(found to be drug resistant). Placed on vent, given broad spectrum Antibiotics,vasopressors, IV fluids. Condition did not improve, placed on comfort care. Terminal weaned and expired" Death on 7/2/21 @09:37pm.
Fatigue, dizziness, trouble moving, thinking, and functioning for 24 hours after receiving the vaccine. Tylenol has allowed me to function, but the side effects are worrisome.
I started having unusual stomach pain. I had several lumps come up on my body. I contacted my doctor, and we were going to look at them one at a time. I went out of town and started feeling very nauseous. When I was on my way back to my house, I started having uncontrollable diarrhea. I stopped at an Urgent Care location on the way home and they told me that I needed to go to the Emergency Room.  I rented a hotel room because I was unable to drive. I went to the Emergency Room and was admitted. I stayed there a few nights and they said I had a lot of abnormalities in my stomach, and I needed to decide if I wanted to have the work done there, or at home. I decided to have to hospital work done at home and had several tests done and they diagnosed it as Stage 3 Peritoneal Cancer. I had my first Cancer treatment 1/4/23. I have had multiple tests done, but I do not recall the dates.
1st dose, no issues.  2nd dose experienced redness and swelling at injection site for 3 days then went away.   @4  days knot appeared on back right of head.  On 4th day rash covered bump and lower right side of head and ear.  On 5th day rash continued to face and neck.  On 5th day, swollen lymph node visible on right side of neck.  On 6th day, still have bump on head, rash, and swollen lymph node.   I am currently on day 6 of symptoms.
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported.  The vial was placed in the refrigerator on 21 Sep 2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
pain in injection arm for 3 days hard lump in injection arm, appearing at day 8, gone the next day swollen lymph nodes in both armpits, lasting 2 days  Moderna COVID?19 Vaccine EUA
Severe hives, skin allergy, pancake hives, itchiness, full body rash that lasted more than 24 hours
Itching on arms, trunk, legs. Hives on thighs, trunk, and arms. Took Benadryl and they went away and came back about 24 hours later. Took more Benadryl and they have not returned.
Initial unsolicited report received from a nurse on 30 Sep 2016. This case involves a 47-year-old male patient who was vaccinated with a dose of Fluzone ID (Batch number: UT5569BA, expiry date: 30 June 2017, dose, route and site was not reported) via intradermal route in left deltoid on 28 Sep 2016. Reporter denied pre-existing physician diagnosed allergies, birth defects, medical conditions, illness at the time of vaccination and concomitant medications were not provided. On 30 Sep 2016, two days post vaccination; the patient had hardness at the injection site and some leakage. Lab data and corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
conceived 10- 12 days after vaccine shot administered and ultimately had a miscarriage in first trimester
Dizziness onset 11 min after injection.  Pt was  monitored for 20 min. Upon exit pt denies symptoms.
Sore and swollen bump on injection site (left arm) around 7:15 pm, Tylenol extra strength 1 pill at 500 mg at 10 pm, 7:30 am this morning, & again at 1 pm. Low grade chills and fever at 4 pm, plan on taking Tylenol extra strength 1 pill at 500 mg at 8 pm 10/01/2021.
Due to a look-alike sound-alike error, Moderna Booster vaccine was administered instead of Moderna Bivalent vaccine. The Moderna Booster packaging was labeled "Booster" with no indication of whether it was bivalent or monovalent. Vials had blue caps similar to the bivalent vials. This packaging was sent after it was annouced that only bivalent could be used for booster doses. No adverse events or side effects reported. Mistake detected 12/14/2022.
Fever; Chills; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) 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 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   Reporter did not allow further contact