chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccinator spilt some of the shot out and administered it so quick in his arm that he believes he did not get the full dose; vaccinator spilt some of the shot out and administered it so quick in his arm that he believes he did not get the full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (vaccinator spilt some of the shot out and administered it so quick in his arm that he believes he did not get the full dose) and DEVICE CONNECTION ISSUE (vaccinator spilt some of the shot out and administered it so quick in his arm that he believes he did not get the full dose) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (vaccinator spilt some of the shot out and administered it so quick in his arm that he believes he did not get the full dose) and DEVICE CONNECTION ISSUE (vaccinator spilt some of the shot out and administered it so quick in his arm that he believes he did not get the full dose). At the time of the report, ACCIDENTAL UNDERDOSE (vaccinator spilt some of the shot out and administered it so quick in his arm that he believes he did not get the full dose) and DEVICE CONNECTION ISSUE (vaccinator spilt some of the shot out and administered it so quick in his arm that he believes he did not get the full dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 21-Aug-2017, Malignant hypertension since 18-Oct-2013 and Mixed hyperlipidemia since 18-Oct-2021. Concomitant products included SERTRALINE from 18-Sep-2013 to an unknown date for Depression, ATORVASTATIN from 15-Jan-2014 to an unknown date for Hyperlipidemia, LEVOTHYROXINE from 21-Jun-2017 to an unknown date for Hypothyroidism, TRAZODONE from 18-Sep-2013 to an unknown date for Insomnia, MELOXICAM from 18-Sep-2013 to an unknown date for Joint pain, IBANDRONATE SODIUM (IBANDRONATE) from 08-Aug-2016 to an unknown date for Osteopenia.    On 17-Nov-2021 at 9:53 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 17-Nov-2021 at 9:53 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Nov-2021 at 9:53 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-407640 (Patient Link).
This spontaneous report as received from a pharmacist and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was inadvertently vaccinated with an expired dose of M-M-R II (human serum albumin, rHA), lot # L009544, expiration date 19-MAR-2017 for prophylaxis. The pharmacist reported that the administration of M-M-R II was a recent date after the product had expired. No adverse events were reported. Additional information has been requested.
Patient with urticaria multiforme & severe edema. Was hospitalized locally & transferred to another hospital. Rash appeared 12-13-12. Also had RSV, fever, (+) PCR. Tx with AMOXIL same day.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 15:00 as dose 6 (booster), single (Lot number: GH9694) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "dry eye" (unspecified if ongoing); "DDD" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Levaquin" (unspecified if ongoing); "Known allergies: Bactrim DS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid from 12Apr2023 to 17Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300167034 same patient, different drug/ event;
Heavy sound sleep and need more sleep; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Heavy sound sleep and need more sleep), HEADACHE (Headache) and FATIGUE (Fatigue) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Obesity.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Heavy sound sleep and need more sleep), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, HYPERSOMNIA (Heavy sound sleep and need more sleep) had not resolved and HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.            No concomitant and treatment medication information was reported. Patient stated that she generally have intolerances to pharmaceuticals and avoid them and she does not eat meat and have a heathy diet and that she is overweight and exercises regularly.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow-up received: updated event outcomes headache to resolved and hypersomnia to not recovered.
RECEIVED PFIZER MONOVALENT VACCINE INSTEAD OF THE BIVALENT VACCINE
4 days of progressive worsening paresthesias in both feet that interfered with his ability to walk.  This progressed approximately primarily on the left side.  With otherwise no clear weakness.  Because he had the tingling in his left arm he thought it might have been related to a heart attack and came to the hospital for further evaluation.  Neurology was consulted and diagnosis was made of Guillain-Barré syndrome and he was given 2 days of IVIG with marked clinical improvement.
Rash beginning 13JAN92 no fever or other s&s of illness or discomfort;
Extreme itchy on and around the sight, hives, large red rash, large knot like bump beneath skin.
Itching  of head, trunk and extremities.  No rash or hives noted.  Apprehension and flushing of face noted.  Patient had taken Benedryl 50 mg po at 2 pm prior to vaccine due to having itching with 1st dose of moderna vaccine as recommended by her pcp.  Benedryl 25 mg  po administered at 3:37 at vaccination clinic.  VS remained stable, no difficulty breathing.  Observed for 1 hour past vaccine administration, no other issues.  Follow up phone call to pt. on 04/13/2021- states she is still having some itching and has soreness of site of injection, but no other issues.
dizziness; weakness; confusion; cramps; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), CONFUSIONAL STATE (confusion) and MUSCLE SPASMS (cramps) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), CONFUSIONAL STATE (confusion) and MUSCLE SPASMS (cramps). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), CONFUSIONAL STATE (confusion) and MUSCLE SPASMS (cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Patient developed small red bumps/rash on legs, then spread to body, arms, and face less than 5 minutes after vaccine administration.
Still dealing with it on day two following the 2nd vaccination.  Fever persists but not getting over 100°
9/10- Mother reports patient crawled headfirst into a plastic gate around 3PM. She says he landed on his buttocks and did not lose consciousness at the time of the impact. 5 to 10 minutes later his mother noted he held his head slanted to the side related an episode of becoming flaccid and passing out, unresponsive for 30-60 seconds.  She took him to the neighbor's house uncertain what to do.  There, he became responsive again but was less interactive than previously. On a pickup, EMS reported normal, baseline behavior. Patient presented to the ED in stable condition at 1555 on 9/10 . His physical exam negative for visible signs of head trauma and no focal neurological deficits were noted. He was behaving normally. After being monitored, patient discharged home at 2033.  9/11- Patient's mother called EMS because he went limp and unresponsive and looked to be turning blue. EMS witnessed patient having an event. He maintained his airway, breathing and saturations during that time. EMS reports that his eyes rolled to the back of his head but had no abnormal movements of his extremities or incontinence. He has no personal or family hx of seizures. No recent illnesses, sick contacts or travel.
Headache Injection site pain Feverish Chills Nausea Dizziness Feelin Unwell Tiredness Stomach Upset  Diarrhea
SWELLING, RASH, ITCHY, HOT, RED. WAS TREATED WITH BENADRYL
Patient reports having the worse headache of her life started within 24 hrs after getting covid vaccine Pfzier last week Weds. She states is getting worse. Calls it a "migraine" states her "migraines are usually behind her eyes. This is different. This is in her temples and posterior neck and head. Notes visual changes/Photosensitive. Tylenol and imitrex are not working like her usual migraine medication. Denies fever, chills, nausea, vomiting, diarrhea, cough, shortness of breath. Blood sugars are "normal". Wearing glasses. Last eye exam is up to date.
Mouth Burning; break out with bumps around his mouth; Scrotum blood blisters; Severe pain in legs and joints; Severe pain in legs and joints; First dose: pain in shoulder; This is a spontaneous report from a contactable consumer.   A male 74-years age patient of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 02Feb2021 at 11:00 (at the age of 73-years-old) as dose 1, single for covid-19 immunisation at Pharmacy/Clinic. Medical history included cardiac failure congestive from unspecified date in 2018 and ongoing (he was diagnosed with congestive heart failure after having a heart attack in Nov2018), myocardial infarction from unspecified date in Nov2018 to an unknown date (Verbatim: Heart attack), pacemaker syndrome from unspecified date in 2020 and ongoing (Verbatim: Pacemaker), ongoing vertigo (he was diagnosed with vertigo 5 years ago but had vertigo long before that), ongoing chronic obstructive pulmonary disease (he was diagnosed with COPD 12 years ago), ongoing emphysema (he was diagnosed with emphysema 12 years ago), ongoing asthma (he was diagnosed with asthma 12 years ago), ongoing abdominal discomfort (he had gastric bypass back in the 80's) and ongoing gastric bypass (he had gastric bypass in the 1980's). Concomitant medications included B12 shots, Unspecified medications and Unspecified water pill. The patient previously received flu shot in an unspecified date in Nov2020 at local pharmacy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021, the patient experienced first dose: pain in shoulder and on an unspecified date, mouth burning, break out with bumps around his mouth, scrotum blood blisters and severe pain in legs and joints. The reporter reported that the pain in his shoulder began on the night of 02Feb2021 and lasted a day and a half. The patient underwent lab tests and procedures which included blood test: nil, electrocardiogram: nil and x-ray: nil on an unspecified date Apr2021. The event first dose: pain in shoulder was resolved on an unspecified date in Feb2021 and other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Diagnosed with shingles; passed away suddenly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (passed away suddenly) and HERPES ZOSTER (Diagnosed with shingles) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On 28-Dec-2020 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles) (seriousness criterion hospitalization). The patient died on 13-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HERPES ZOSTER (Diagnosed with shingles) outcome was unknown.            Treatment included antiviral medication valtrex 1 mg.  The action taken with mRNA-1273 with events was not applicable.  Cause of death was unknown. Plans for an autopsy were not provided.  This case concerns a 75-year-old, male patient, who experienced herpes zoster 5 days after and died 1 month 15 days after receiving the first dose of mRNA-1273. 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. The cause of death was not reported. It is unknown if an autopsy was performed.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2021: Follow-up included fatal event.; Sender's Comments: This case concerns a 75-year-old, male patient, who experienced herpes zoster 5 days after and died 1 month 15 days after receiving the first dose of mRNA-1273. 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. The cause of death was not reported. It is unknown if an autopsy was performed.; Reported Cause(s) of Death: Unknown cause of death
Reactive Arthritis and burst bakers cysts behind knees/si joint inflammation  about 5 months after 2nd shot.  Assumed to be related to possible GI /salmonella infection (though GI symptoms were only very mild and never tested) but other infections/vascular issues ruled out for leg swelling and pain.  Treated with antibiotic/elevation/ice/rest/physio and slow improvement. Was unable to walk ~ 1 month. Still  ongoing pain knees and all around knees in the morning.  Not certain if rel?d to vaccine but was a major issue and I?ve never experienced a reaction like this and have had food poisoning  twice before in my life.  Reported to vaccine  reporting system and was suggested to report it Vaers even if not sure of causality.
Initial report received from a non-healthcare professional on 03 OCTOBER 2014. This case is an invalid case as patient identifiers were not reported. This case is linked with: 2014SA138166, 2014SA138174 and 2014SA138175. Few patients (manager and few others) whose medical history and concomitant medications were not reported, received a dose of INFLUENZA vaccine (lot, route, site, expiration date not reported) on an unspecified date. On an unspecified date, post vaccination these patients developed certain adverse event (had developed reactions). Corrective treatments and laboratory details were not reported. At the time of this report, the outcome of the events was not reported. Document held by sender: None. Follow-up information received from consumer on 04 MAY 2015. A 49-year-old female patient, after vaccination experienced swelling and itching at site of injection. The patient had not received any vaccine within 4 weeks prior to vaccination. Illness at the time of vaccination and adverse event following prior vaccination, adverse event prior vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as none. At the time of this report, patient had recovered from events on an unspecified date. List of the documents held by sender: none.
NO INITIAL REACTION NOTED AFTER INJECTION, HOWEVER BY 6PM EVENING OF INJECTION, PT NOTED SWELLING IN RIGHT DELTOID NEAR INJ SITE WITH MILD PAIN AND  SLIGHT ITCHINESS. PRESENTED TO WORK THIS MORNING AND REPORTED SYMPTOMS. 1 1/2 X 1 7/8 MINCH MILD SWELLING WITH SLIGHT PALE REDNESS INCETNER. REPORTS SORENESS AND SOME TICHINESS. AFEBRILE, NO OTHER COMPLAINTS. SEEN BY DR & REPORTED TO CORPORATE MEDICAL OPS DR. ENCOURAGED COLD COMPRESSES TO AREA AND REST ARM WHEN ABLE. INFORMED TO REPORT ANY WORSENING OR CHANGE IN CONDITION
Pt developed lightheadedness, tingling of tongue and mild nausea 1-2 minutes after injection.  She suspects that she may have passed out momentarily. BP was 105 systolic. HR: 98, SP02: 100%. She was given snacks and a drink and improved without intervention.  She left appx 45 minutes after injection and noted that she felt back to normal.
Severe shoulder/arm pain since injection.  Cannot move arm without pain.  Pain is constant.  Most severe pain is in shoulder.
pt recv vax & several hrs later devel confluent rash & fever to 103 w/h/a & malaise;pt was taking med;
I woke in the night to go to the bathroom.  When I sat up,  I found that parts of my visual field were missing. I started toward the bathroom, but even before I got out of the bedroom I was out of breath. I had trouble catching my breath, as if I had been running. I sat for a moment on the floor in the hall,and still out of breath,made my way to the bathroom.  I sat on the toilet.  In a few minutes the breathlessness passed.  I made my way back to the bedroom.  I eventually went back to sleep.  The next morning I experienced some brief short-term memory loss. I couldn't remember what had happened in the past few minutes.  This memory gradually came back to me over the next hour or so.
pt recv vax following delivery;By following day, had Bell's Palsy & was paralyzed on rt side of face;to MD;sx lasted approx 6-8 wk;28jul94 approx, was placed on therapy w/ pcn;subsequently Bell's Palsy returned;
Fatigue, seizure, low fever, inability to walk that day.  Headaches, high fever site pain and swelling persisting for several days after.
Woke up with a high-pitched screaming. He had been projectile vomiting for 9 days prior, since 8/15/09, at about 5 am. He had been to the doctor 3 times for the vomiting. He had a seizure on 8/24/09, at about 5:30am, and went into respiratory-cardiac failure. He spent 30 days in the hospital, 11 in intensive care. He had subdural hemorrhaging, requiring 2 bilateral shunts about 2 weeks after his seizure. He has sustained brain death of about 80%.
Swelling in ankles, back of knees, hips, and wrists. Trouble walking. Client currently being worked up by rheumatology for sarcoidosis or rheumatoid arthritis. First symptom developed two weeks after Tdap vaccination.
growing rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (growing rash all over his body) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5. On an unknown date, the patient experienced RASH (growing rash all over his body). The patient was treated with CLOBETASOL ongoing since an unknown date at a dose of 1 dosage form and PREDNISONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, RASH (growing rash all over his body) had not resolved. Not Provided      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.   No concomitant medication information was mentioned   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Route of administration Added On 29-Jun-2021: live follow up recived on 29-JUN-2021
Redness  and ache at injection site since noted 12/21/2020, left arm itchy since 12/20/20
chilling; aches; pain; fever; This is a spontaneous report from a contactable Consumer. This consumer reported similar events for 2 patients. This is 2nd of 2 reports. This Consumer reported for a female patient that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced chilling, Aches, Pain, Fever on an unspecified date. The outcome of event was unknown.  Information about Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021204976 Original Case : 2021171190  Same product/Event, diferent patient
Developed diffuse macular/papular rash over torso with areas of confluence approximately 11 days after MMR #1 vaccine.  No s/sx of anaphylaxis.  Incidental bilateral otitis media on this exam.