chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEAD TO TOE ACHES; SLEEPING ALL DAY; CHILLS; FEVER; This spontaneous report received from a patient 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. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced ache from head to toe, sleeping all day, chills, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, fever, ache from head to toe, and sleeping all day. This report was non-serious.
1st dose on 13Oct2022, 2nd on 28Oct2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 4S37J, expiry date 23rd November 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 28th October 2022, the patient received the 2nd dose of Shingrix. On 28th October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information:  GSK Receipt Date: 28-OCT-2022. Reporter's Comments: Pharmacist reporting having administered Shingrix 2nd dose at less than recommended interval. The first dose was administered on 13th October 2022. Adverse event report contained all reported information. HCP consented to safety team follow up. The reporter had consented to follow-up. Additional supportive information: The patient had received the second dose of Shingrix prior to the recommended interval, which had led to shortening of vaccination schedule. Note- query was raised for the batch no and expiry date confirmation and was coded for both the batch conservatively.
This  71 year old  male received the Covid shot on  2/27/21   and went to the ED and was admitted  on  4/5/2021  and died on  4/25/2021. Lumbar radiculopathy, spondylolisthesis of lumbar region, lumbar stenosis with neurogenic claudication, lumbar spinal stenosis.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
ACUTE NON ST ELEVATION MI 8/26/2021 BPH W LOWER URINARY TRACT SYMPTOMS
Information has been received from a physician concerning a male pt who in October 1998 was vaccinated with varicella virus vaccine live. On 03/11/04 the pt was seen in the MD's office with 50 chickenpox. The pt sought unspecified medical attention. There was no product quality complaint involved. It was also reported that four other pt's developed chickenpox after being vaccinated with varicella virus vaccine live (WAES # 0403USA01611, 0403USA01644, 0403USA01645, 0403USA01647).  Additional information has been requested.
Patient came in to pharmacy requesting a flu shot. Patient incorrectly received a Pfizer Bivalent booster instead of the flu shot. Patient reports she had the Moderna bivalent booster already a month prior at a difference pharmacy. This is her 6th covid shot received.  Patient reports feeling unwell the night of the vaccine and states felt better the day after.
Patient received the COVID vaccine on 12/220/2020. C/O new onset of tachycardia, palpitations while walking to the hospital cafeteria on 12/24/2020 HR was 110-130s  Her baseline HR are in 50s. Went to ED department for evaluation. Discharged on the same day.  On 12/28/2020, sudden onset of SOB, palpitations, tachycardia. Called 911 and was evaluated in ED. Discharged on 12/28/2020.  Denies fever, HA, chills, cough, fatigue, or pain.  No significant PMD. Denies hx of anxiety or panic attacks.   Has Cardiology appointment on 1/5/2021.
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. No medical history was provided by the reporter.  On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced BACK PAIN (Back pain). The patient was treated with ACETAMINOPHEN from 07-Apr-2021 to 08-Apr-2021 at a dose of 1 dosage form. At the time of the report, BACK PAIN (Back pain) outcome was unknown. 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. concomitant medication include Vitamin D Drops takes every day (OTC medication).
vaccines do not stop you from getting covid nor does it eliminate the need for hospitalization and it certainly doesnt stop you from dying. This i state from personal experience; vaccines do not stop you from getting covid nor does it eliminate the need for hospitalization and it certainly doesnt stop you from dying. This i state from personal experience; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Private). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "vaccines do not stop you from getting covid nor does it eliminate the need for hospitalization and it certainly doesnt stop you from dying. This i state from personal experience". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical course: There are no right or wrong answers, no silly or dumb feelings. Don't worry about spelling, punctuation, or grammar. I felt that this ad was spreading misinformation, vaccines do not stop you from getting covid nor does it eliminate the need for hospitalization and it certainly doesn't stop you from dying. This i state from personal experience.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021 at 1:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 1:11 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 66.50  No concomitant medication was reported.  On 16-Mar-2021,vaccine moved to fridge and vaccine BUD date was reported as 15-Apr-2021.  Condition of vaccine prior to administration was reported Not frozen.   On 21-Mar-2021,vaccine excursion time were 9am,10am and 11am at 34,32,34 degree F temperature.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
After the first shot I had a lot of pain and sore in my arm and fatigue. It lasted about 3 weeks. After the second shot, it seemed like the pain was more intense. But the fatigue was worse. My diarrhea turned bloody. I have been in this brain fog. I cannot even find words that I want to say. I went to the hospital on 09/30/2021. They did a CT scan of my torso with and without contrast. They did blood work. They gave me IV because I was very dehydrated. I saw a GI specialist yesterday. He is going to scope me. I am supposed to get a stomach X-ray and blood work today.
headache, achy, shivering tremors for 4 hours, crippling pain, elevated heart rate, chest pain, sweats,
I roomed the patient for a Well Child Check, received report form nurse practitioner. to give the baby the vaccines. withdrew the wrong vaccines. ( pt. needed the pneumococcal 13 and gave them pneumococcal23). realized error after administration and nurse practitioner left. notified MA supervisor about the error. called patient to let them know about the error and the need for vaccination with  pneumococcal 13, left voice message.
cold sore in my mouth; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sore in my mouth) and FATIGUE (fatigue) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-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 ORAL HERPES (cold sore in my mouth) and FATIGUE (fatigue). At the time of the report, ORAL HERPES (cold sore in my mouth) and FATIGUE (fatigue) outcome was unknown.
Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Caffeine allergy. Concomitant products included CALCIUM for Bone disorder NOS, MONASCUS PURPUREUS (RED YEAST RICE) and UBIDECARENONE (COQ10 [UBIDECARENONE]) for Cholesterol, GLUCOSAMINE HYDROCHLORIDE and CHONDROITIN SULFATE for Joint ache, MAGNESIUM and COLECALCIFEROL (VIT D3) for Nutritional supplement, LEVOTHYROXINE for Thyroid disorder, ZINC and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 02-Feb-2021, the patient received first 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 18-Mar-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Dental examination: normal (Inconclusive) normal. On an unknown date, Magnetic resonance imaging: normal (normal) aging of blood vessel changes. On an unknown date, Ophthalmological examination: normal (Inconclusive) normal.         Action taken with mRNA-1273 in response to the events was not applicable. Patient stated getting 4 massages from acupuncturist Treatment medications included one pain shot For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: patient demographics updated , added medical history, added lab data, dosage regimen updated, concomitants was updated.
The patient did not have any symptoms that was witnessed by medical staff on site. It was not known until the shot was being charted into her files that she had both doses of Pfizer in January of 2021. Vaccinator was told that this shot (administered on 6 August 2021) was her second shot.
Presented to office with 2 1/2 in x 2 in erythema raised lesion at the injection site Rt leg, warm to touch. Ice pack/compress every 4 hrs KEFLEX prescribed for early cellulitis.
Pt arrived to facility accompanied by his father to receive 1st dose of pfizer vaccine. Prior to receiving the vaccine pt denied any illness, allergies, or previous reactions to other vaccines. Pt appeared nervous. Received 1st dose on 4/23/2021 at 1000 in right deltoid. Pt and father then walked to front of the room to schedule appointment for 2nd dose of pfizer vaccine. While standing at the table making his appointment, pt experienced a vasovagal syncope episode where he fainted hitting his head on the ground. Pt regained conciousness about 10sec later. Pt then assisted to a chair. On assessment pt diaphoretic/pale, HR bradycardic 42, RR 14, O2 96%, POCT glucose 81, alert/oriented x3. Pt assissted to wheelchair, transported to ED accompanied by father and 2 MAs for further evaluation.
I had severe shortness of breathe, rapid heart rate, bruising on the arm of the vaccinated.  I still experience them to this day.
administering ADACEL to a 22-month-old patient instead of DAPTACEL with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 22 months old male patient who was administered Diphtheria-2/Tetanus/5 AC Pertussis vaccine [Adacel] instead of Diphtheria-15/Tetanus/5 AC Pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis vaccine Suspension for injection of lot U7929AA and expiry: 14-Nov-2025 via unknown route in unknown administration site for Immunization; instead of Diphtheria-15/Tetanus/5 AC Pertussis vaccine Suspension for injection (strength, lot and expiry: not reported) with no reported adverse event (wrong product administered) (latency: same day).  No lab data was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccinia vaccination. Redness/swelling/warmth 120 cm diameter not extending past the elbow, considered to be a robust take. There is no streaking present, and pt denies any cardiac symptoms. No other symptoms aside from the expected minor side effects. Consulted with  IDC, who concurs with findings.
Patient with breakthrough VZV approximately 30 lesions 3 1/2 years after vaccine
Mild swelling in throat 10-15 minutes after flu shot vaccine. Patient sat in clinic for 20 min for observation. During screening prior to flu shot patient answered no to questions re: allergies to food/meds, except chicken, has no problems with eggs.
No known adverse side effects occurred. The patient was given a dose of 0.5ml for their booster shot and should have received a 0.25ml dose.
Morning after booster injection blood pressure was 87/52 (measured with 2 devices)  Previously BP was typically measuring 140/70 with medication in months previous - was 87/51 two weeks later Sustained low blood pressure over 2 months - has stabilized in range of 110/63 AM to 125/75 beginning of Feb 2022. Generally consistent measurements show Systolic seems 20 to 30 points lower and Diastolic seems 10 points higher
local redness, irritation, itching, rash around injection site rt arm DT 36 hrs p/recvd 2nd vax itching, rash spread to chest & back by 48 hrs post vax; now @ 96 hrs feels better has minimal itching left;
Abdominal cramping and extreme discomfort, diarrhea, loose stool, multiple bathroom trips.  Some chills and fatigue.  Started about 2 days after the vaccine shot and lasted for about 2 days.  Took Pepto Bismol 3 times.  It may have helped a little.
Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case is linked to cases 2019SA089010 and 2019SA089011 same reporter. This case involves a 2 years old patient who received 0.5 mL dose of vaccine DAPTACEL lot C5171AA, expiry date- 23-Mar-2019 via unknown route in unknown administration site on 24-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR; and HEPATITIS B VACCINE. It was a case of actual medication error due to Expired vaccine used. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
A non-serious spontaneous report of two doses of FLUMIST given one week apart was received from a health professional concerning a four-year-old female. Medical history and concomitant medications were not reported. The patient was vaccinated on 29-Sep-2011 and then received a second dose on 04-Oct-2011, one week later. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Patient was given a vaccine from a vial that was mixed prior to the 6 hour window, about 48 hours, and vaccine was stored in a fridge that was 48 degrees.
The day after my 2nd shot I woke up with a lot of pain on my heart, the pain got worse, and by the 2nd day I had a small attack where the pain was unbearable and I thought I was having a heart attack, this lasted about 20 minutes. After this attack the pain continued for another couple of days until it went away.  It's now been about 18 days since the shot and I experienced another mini attack now. I just had a coffee (less than 30 min ago) and ate stake and fries for lunch (2 hours ago).
11 days p/shot broke out in a rash, measles looking, fever (hot), runny nose, cranky; seen by MD 27AMY92;
Patient states at 8PM on day of vaccination, his throat felt very tight and he could barely swallow. He also felt very hot all night and today (day after vaccine), he has a very bad headache. Patient was referred to his primary care physician.
felt some skipped heart beats about 2 hours after shot and then my arm has started hurting at site about 4 hours after
For about a month in Feb into March 2021, after my initial 2 doses of the COVID vaccine I had pretty consistent heart fluttering feelings I've never had before. There were intense the first few weeks, would wake me up at times and I would feel headaches and tiredness. Then they started spreading out and eventually after a couple months went away. My tests ruled everything out and was just found to have some PAC's or PVC's, but this resolved, everything else was normal. I did seek a health visit on 2/22/21 and my PCP  on 3/5/21.
pt recvd vax; presented to hosp w/ episode of sz activity & unresponsiveness; a lumbar puncture at that time revealed haemophilus influenza meningitis;
Enlarged and painful spleen; Enlarged and painful spleen; Dose received 3/ dose number=3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 29Nov2021 at 10:30 (Lot number: unknown) at the age of 55 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN; Anatomical location: right arm; Administration time: 11:00), administration date: 04Apr2021, when the patient was 54 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE; Lot number: UNKNOWN; Anatomical location: right arm; Administration time: 11:00), administration date: 05May2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported IMMUNISATION (non-serious) with onset 29Nov2021 at 10:30, outcome "unknown", described as "Dose received 3/ dose number=3"; SPLENOMEGALY (non-serious), ABDOMINAL PAIN (non-serious); both with onset 01Dec2021 at 04:00, outcome "recovering", and both described as "Enlarged and painful spleen". Therapeutic measures were not taken as a result of splenomegaly and abdominal pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.