chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate allergic reaction after vaccine; lip swelling; swollen lymph node under chin/lymph node under left armpit was extremely swollen, formed a large bump and was still swollen; hard to swallow; racing heart; lymph node under left armpit was extremely swollen, formed a large bump and was still swollen and tender 3 days later; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 26Feb2021 18:45 (at the age of 29-year-old, Batch/Lot Number: EN6202) at arm left as single dose for COVID-19 immunisation. The patient previously took minocycline and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with or tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications taken in two weeks included: ashwaganda gummies and botulinum toxin type A (BOTOX) for forehead 1 week prior. The patient experienced immediate allergic reaction after vaccine including lip swelling, swollen lymph node under chin, hard to swallow, racing heart. Next day lymph node under left armpit was extremely swollen, formed a large bump and was still swollen and tender 3 days later. All events started on 05Mar2021 18:15 (as reported, pending clarification) and were serious due to medically significant. The events resulted in doctor or other healthcare professional office/clinic visit. Diphenhydramine hydrochloride (BENADRYL) taken as treatment. The patient received second dose of BNT162B2 on 19Mar2021 18:15 (at the age of 29-year-old, Batch/Lot Number: EN6207) at arm left as single dose. The outcome of all the events was not recovered.  Follow-up attempts are possible. Further information is expected.
I have never been so cold; freezing to death; My neck was killing me; I got sick with my first one; severe chills; ache all over; my whole body hurt; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma; "Blood pressure" (unspecified if ongoing), notes: Blood pressure. Concomitant medication(s) included: ARFORMOTEROL TARTRATE taken for asthma; AMLODIPINE BENAZEPRIL taken for blood pressure measurement. The following information was reported: FEELING COLD (non-serious), outcome "unknown", described as "I have never been so cold; freezing to death"; CHILLS (non-serious), outcome "recovered", described as "severe chills"; PAIN (non-serious), outcome "recovered", described as "ache all over; my whole body hurt"; HEADACHE (non-serious), outcome "recovered"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "My neck was killing me"; ILLNESS (non-serious), outcome "unknown", described as "I got sick with my first one".  Additional Information: The patient received severe chills and headache and ache all over. The patient had it for only 8 hours and then it was gone. The patient stated that she had her whole body hurt. Her neck was killing her and she had never been so cold. She had the chills so bad, she have never been so cold. The patient stated that she did not take anything because she did not run fever. The patient received second booster on 16Apr2022.
Case number PHEH2014US021277, is an initial spontaneous report from a nurse received on 22 Oct 2014. This report refers to a 6-month-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was erroneously vaccinated with MENVEO (batch number: A12024) intramuscularly instead of pneumococcal conjugate vaccine (PCV) on 22 Oct 2014, without any complaints of patient harm. No adverse event was reported.
Administered Menveo, Hep. A,  HPV. Was at table side, witnessed patient fall forward & hit his head, he rolled to the left side.
Patient presents with a potential reaction to the COVID19 vaccine. The patient presented with symptoms of diaphoresis, nausea, mild confusion, dizziness consistent with a vasovagal episode. He was placed in a supine position with legs elevated. He was given aggressive oral hydration.   Additional Monitoring and he returned home with his wife as the driver.
flu like symptoms progressing to chest Pain and Cough requiring an ER visit on Apr 14
Patient received a vaccine that was 10 days beyond its use-by date (3/6/23).  (Mislabeled 4/6/23).  Per physician, patient experienced no adverse effects
They provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (The patient had Pfizer series dose before getting Moderna COVID-19 booster dose.). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (They provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no adverse reactions post expired vaccine administration.  No concomitant medication was provided.  No treatment medication was provided.
Swelling at the injection site; redness; heat; pain; itching; COVID arm?  4 in by 3 in red mark slightly purplish in center. Soreness in armpit area.
The pt experienced convulsions, eye contusion, lethargy, encephalitis, high pitched screaming, pneumonitis, apnea, anaphylaxis, sclerosis. Autopsy states cause of death as a result of blunt head trauma injuries. Autopsy reports contusions of the scalp, fractures of the parietal bone, subdural hematoma, subdural hemorrhage, subarachnoid hemorrhage, retinal hemorrhages, hemorrhage in the optic nerve, cerebral edema, contusions, abrasions.
Woke up at 1 am with irritation in throat causing me to cough until I sat up . Throat just kept feeling very scratchy and irritated and like something was  ? stuck ? in the back of my throat . Tried drinking some water and continued trying to clear throat . Eventually took Benadryl 50 mg orally  And if it didn?t improve was contemplating going to ER. Was able to fall asleep about an hour and a half later . When I woke up throat was still sore and scratchy feeling but didn?t feel like there was anything ?stuck ? anymore . Also had some mild itching on face especially my eyelids .
Tested positive after getting the Moderna COVID 19 vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive after getting the Moderna COVID 19 vaccine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (Tested positive after getting the Moderna COVID 19 vaccine). At the time of the report, COVID-19 (Tested positive after getting the Moderna COVID 19 vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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.   Concomitant medications have not been provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Non significant follow up received as email response
Shortly after receiving my second Pfizer Covid vaccine, I started having ringing in my ears.  This is continuous and has not stopped 3 weeks after the last dose.  The tinnitus is loud enough that I am able to hear the ringing even when there is moderate ambient sound in a room.
Cough, fever- Sat morning (3/28/09) all at once (10am).  Seizure from fever (102.9) (at 1:45PM).  (Hep A given on 3/19/09) (MOTRIN given even today to help control fever)
After showering the day after receiving the booster a red rash appeared below the injection site (2/11/22 10 pm). It is still there with few changes in size or color (2/12/22 11 am) and itches frequently.
Pt received Prevnar along with DTAP, Hib and IPV at 10:30 on 7/31/01 and within 2-3 hours, had a fever to 103F. Subsequently, it increased to 104F and decreased with Tylenol. Resolved over the next 48 hours.
felt like I would pass out; metallic taste in my mouth; fainting feeling; headaches; muscular pains; extreme lethargy; palpitations; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Symptoms after first of COVID vaccine. Within seconds in the pharmacy, the patient experienced a metallic taste in mouth, which was immediately followed by a fainting feeling and palpitations. The patient tried to get up to leave the pharmacy but felt like would pass out so the patient waited for about 20 mins after which the palpitations subsided but the faintness persisted, albeit less. Over the next three weeks, the patient experienced headaches, muscular pains and extreme lethargy. They progressively got worse over a one week period and then started to improve over two weeks subsequently. Muscular pains and lethargy have now finally subsided. Headaches are now subsiding. The outcome of event fainting feeling was not recovered, of events palpitations, muscular pains and extreme lethargy was recovered, of event headaches was recovering and other events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 25-NOV-2015, the patient was vaccinated with improperly stored GARDASIL, lot # K011215, expiration date 05-MAY-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Seeing floaters in my vision all of a sudden.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ew0153) via an unspecified route of administration in the right arm on 09Apr2021 at 15:30(at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. It was not reported whether the patient had received any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er2613) via an unspecified route of administration in the left arm on 20Mar2021 at 13:00(at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 13:00, the patient experienced floaters in her vision all of a sudden. The events 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 events. The clinical outcome of the event seeing floaters in vision all of a sudden was not resolved at the time of report.   No follow-up attempts are possible. No further information is expected.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case is cross linked to case 2018SA286322, 2018SA286331, 2018SA288492, 2018SA288492 (same reporter). This case involves a 75 year old female patient who experienced swollen about 10-15 cm at the injection site with redness, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medications were not provided. On 10-Oct-2018, the patient received a single dose of suspect FLUZONE HIGH DOSE lot UI985AC, expiry date 22-MAR-2019. On an unknown date, the patient developed a non-serious swollen about 10-15 cm at the injection site with redness, following the administration of FLUZONE HIGH DOSE. Relevant tests were not reported. Final diagnosis was swelling at the site about 10-15 cm in size with redness. Corrective treatment with ice and alcohol compresses. The outcome of the event was not reported. List of documents held by sender- none.
Vaccinated as of 08/10/2005, per mother of pt fever beginning 08/11/2005 thru 08/14/2005, infant given Tylenol, fever as high as 102, decreased to 98 after Tylenol. Rash on face, arms beginning am of 08/14/2005. Advised to take infant to PMD.
approx 2k p/vax several nursing home pt devel a gen rash;reporter was not able to specify the number of pt who exp this event;addtl reports will be generated when identifying info is provided;
PATIENT RECEIVED THE SECOND COVID-19 VACCINE DOSE ON 01/18/2021 THROUGH A PHARMACY CLINIC THAT CAME TO THE FACILITY.  THE FOLLOWING DAY SHE HAD  CHANGE IN MENTAL STATUS AND HYPOXIA.    LATHARGY WITH OXYGEN SATURATION OF 84%.    DEHYDRATION
fever, chills, headache, arm pain, nausea, tiredness -2 days
About 30-45 minutes post dose. Dizziness, lightheadedness, warmth, chest pain/pressure, SOB
aches, fever (100.4), chills, lethargy, cough, sore arm. Treated with Ibuprofen and rest. Symptoms abated in about 24 hours.
Mom felt she noticed "an immediate difference in his personality. " He was smiling, communicative since "the first day in the hospital." Mom felt he became "subdued"- "eyes became blank." Mom described "he looked muted." "I dont know it it affected him neurologically." Mom felt it seemed like he wanted to smile, but could not. Mom felt this started the day of the vaccines. The morning of he was "bubbling," "beaming." 2-3 weeks he wasn't himself.   Now is is back to himself, "fully recovered" 6 d ago.  2 month vaccines were given on 4/26.  12 yo sib has autism
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 32-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 397B5) for prophylaxis.   On 24-FEB-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-Apr-2023 The patient received unstable vaccines after a temperature excursion. The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
PATIENT STATES THEY FAINTED AND FELL TO THE GROUND APPROXIMATELY 6 HOURS AFTER THE VACCINE WAS ADMINISTERED
pt recv vax & devel a rash that looked like red bumps like little blisters located on back, & on stomach, two on head & one on leg;
1 month post vaccine patient developed Chronic Lymphoid Leukemia. Pt had a normal routine exam with her previous PCP in Dec of 2020 with no issues on her routine labs. 1 month post vaccine she did develop CLL. She is following with oncology for now and they are monitoring her labs.
3 hours after shot my while body started itching. I took benadryl, but the itching only subsided. The itching lasted for about 72 hours.
cramps and bleeding for period when it's not period time; due to birth control pills (not skipped and consistantly taken) a period has not occurred for years and cramps had not been an issue.  also, the period is going on 3 days currently.
patient came into a mobile clinic organized at college  where he was asked by registration staff if he had received any other COVID-19 vaccine, client denied ever receiving any previous COVID vaccine. When Client preceded to RN for his vaccine RN also asked him if he had received any other COVID-19 vaccine, again patient denied ever receiving any other COVID vaccine prior to the dose being administered on the day of the mobile clinic at College. Client also marked no for ever receiving any other COVID-19 vaccine on his registration form. after gathering his information RN proceeded to administer Janssen vaccine to the patient. During the registry entry process he was found to have received a Pfizer vaccine (04/23/2021) prior to the Janssen vaccine given by Public Health according to registry. RN attempted to call Patient multiple times on 2 different occasions. When calling clients number on his registration form the person answering the phone would hang up on RN as soon as the RN identified himself.
Patient went to the medical center for appointment with primary care for blood work and to receive the COVID-19 vaccine. When he returned home with his wife, he started feeling bad. He took a nap and woke up with sweat and chills. Patient's wife attempted to call his PCP and the Medical Center with no success and transported patient to the local Emergency Department. There it was discovered he had a fever and he was admitted for possible urinary tract infection. Overnight, while in his room he became agitated and had a sense of impending doom. Per his wife, he grabbed his chest and turned blue, falling to the bed. A code blue was called and CPR was performed. He was intubated and put on some sedation.  He was transferred to the ICU. After a couple days of a poor prognosis he was put on comfort care or hospice. He passed away on January 24, 2021
This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with VAQTA (lot # N005274, expiry date: 03-APR-2017) (route: intramuscular), that was improperly stored. The vaccine was stored at a temperature of 32°F to 35°F (34.8F) for 1 hour and 15 minutes, at 32°F to 35°F (35.4F) for 4 hours and 24 minutes, at 32°F to 35°F (35.4F) for 4 hours and 12 minutes, at 32°F to 35°F (35F) for 4 hours and 36 minutes, at 32°F to 35°F (35F) for 4 hours and 18 minutes, at 32°F to 35°F (35F) for 4 hours and 42 minutes, at 32°F to 35°F (35.4F) for 2 hours and 30 minutes, at 32°F to 35°F (35.4F) for 3 hours and 18 minutes, at 32°F to 35°F (35.2F) for 4 hours and 54 minutes, at 32°F to 35°F (35.2F) for 4 hours and 42 minutes, at 32°F to 35°F (35.2F) for 4 hours, at 32°F to 35°F (35.4F) for 2 hours and 24 minutes, at 32°F to 35°F (35.4F) for 2 hours, at 32°F to 35°F (35F) for 4 hours and 6 minutes, at 32°F to 35°F (35F) for 5 hours and 24 minutes, at 32°F to 35°F (35.2F) for 5 hours and 6 minutes, at 32°F to 35°F (35.2F) for 5 hours and 18 minutes, at 32°F to 35°F (35.4F) for 3 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse symptoms reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA011555: US-009507513-1707USA011601: US-009507513-1707USA011419:
This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 07-MAR-2014, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J002618, exp date: 01-MAR-2015, 0.5 milliliter (ml), subcutaneous) (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celcius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Redness and swelling at inj. site (the size: 3 inches x 3 inches) inj. site was also very warm to touch and painful. Pt also reported having a fever for a few days after inj.
Client felt the injection enter high on his shoulder.  He felt pain "in the bone" of his shoulder.  The pain was immediate, went away for 1.5 weeks, and then came back.  It still hurts and now his palm and thumb are "going numb."
Rash and itching to arms bilaterally Body aches Vomiting Diarrhea  Heat at injection site (Right side)
This spontaneous report was received from a nurse practitioner and refers to an adult patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was inadvertently vaccinated with a 0.5 ml dose of PROQUAD injection via subcutaneous route, lot number M044719 with expiration date on 07-MAY-2018 instead of M-M-R II injection (dose, lot number and expiration date were not reported). The vaccine was reconstituted with Merck sterile diluent injection via subcutaneous route, lot number M037769 with expiration date on 16-MAR-2019. No adverse effects were reported.
Pt collapsed to floor after waiting 5 min after vaccine was administered. Pt remained on exam table during that time. With help got down from exam table. Father was present and talking about his history of fainting and passing out with blood draws. RN tried to change subject multiple times to redirect the conversation. RN noticed pt became restless and anxious right before event occurred. Pt collapsed to floor few min after. Cold compress applied to back of neck. Pt was asked if she had breakfast which she denied. Provided with orange juice. Dr. then examined pt. She hit her right side of head and front tooth. Pt was discharged home with parent. Father stated he would take pt to dental for evaluation of tooth.
Extreme sleepiness. Awake for 1-2 hours and sleep for 3-5 hours all day long. Slept through night from around 9:30pm-7am. Woke up with horrible headache behind eyes following day. Feeling more normal on third day following vaccination.
After recieving 2nd dose on 4/2/2021, patient stated on monday 4/5/2021, he started having sharp ear pain in the right ear. he want to doctors and they told him it was not covid vaccation related. Patient insist that after receiving his 2nd dose of moderna, he started to lose his hearing in the right ear.
pt exp soreness of the injected arm p/receiving Typhoid vax; the reaction lasted 3 days;