chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # K005958, expiration date 09-FEB-2017, dose and route not reported). The dose of vaccine were improperly stored at 34 degree Fahrenheit for 228.5 hours. There were no previous excursions. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever Blisters (Lip); Ulcers (Mouth); Fever; This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER (Fever Blisters (Lip)), MOUTH ULCERATION (Ulcers (Mouth)) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced LIP BLISTER (Fever Blisters (Lip)), MOUTH ULCERATION (Ulcers (Mouth)) and PYREXIA (Fever). At the time of the report, LIP BLISTER (Fever Blisters (Lip)), MOUTH ULCERATION (Ulcers (Mouth)) and PYREXIA (Fever) outcome was unknown.
PENTACEL was administered to a patient without reconstituting with the HIB portion of the vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via a consumer/non-health care professional via Agency (Reference number- 00838521) and transmitted to Sanofi on 02-Nov-2021.  This case involves a 4 month old patient (unknown gender) who was received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] without reconstituting with the Haemophilus influenzae type b (HIB) portion of the vaccine (product preparation issue).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate reconstitution technique (latency same day).  It was reported "Call received from Sanofi Sales representative reporting a dose of PENTACEL was administered to a 4 month old without reconstituting with the HIB portion of the vaccine. Caller did not have any other patient or vaccine data available. Caller questioned if additional actions on his part needed to take place, informed caller he can either use the electronic submission for reporting in the future or have the health care professional (HCP) contact us directly so we are able to collect patient and vaccine data."  No other adverse event 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  There will be no information available on the batch number for this case.
This spontaneous report was received from a medical assistant via a company representative concerning to an unspecified patient of unknown age and gender. Medical history and concurrent conditions were not provided. The medical assistant reported that the patient may have received one of the improperly stored lots on an unspecified date. Medical assistant stated that she was not sure which of the vaccines the unspecified patient received. There was no concomitant medication provided. No adverse effect reported. Names of vaccines involved: RECOMBIVAX HB lot # M034894, the expiration date: 11-NOV-2018 (dose and route were not reported) for prophylaxis. Other possible suspect therapies included M-M-R II lot# reported as M029918, expiration date: 13-JUN-2018, lot# M028130, the expiration date: 03-JUN-2018, lot# M006544, the expiration date: 03-FEB-2018, or lot# M017348, the expiration date: 06-APR-2018 (dose and route were not reported) for prophylaxis, VAQTA lot# M033611, the expiration date: 02-MAR-2018 or lot# reported as M038572, the expiration date: 11-MAR-2018 (dose and route were not reported) for prophylaxis, GARDASIL 9 lot# M034780, the expiration date: 15-APR-2019, lot# M032650, the expiration date: 31-MAY-2019 (dose and route were not reported), PNEUMOVAX23 lot# M032635, the expiration date: 05-MAY-2018, lot # M043987, the expiration date: 30-JUN-2018, lot# M036161, the expiration date: 06-MAY-2018, lot#  M036728, the expiration date: 20-MAY-2018 (dose and route were not reported) for prophylaxis or ROTATEQ orally lot# reported as M0381807, the expiration date: 02-APR-2018, lot# M038744, the expiration date: 26-APR-2018, lot# M038717, the expiration date: 24-APR-2018 or lot# M025572, the expiration date 20-JAN-2018 (dose was not provided) for prophylaxis. The temperature excursion reported was >46°F but <77°F during 30 minutes registered in a data logger. There was no previous temperature excursion. No Product Quality Complaint (PQC) involved. Additional information has been requested.
Developed rash, itching on arm and on chest, tingly feet and dry cough, dry mouth
Mom reports began to have fever of 103 degrees and nausea and vomiting off and on until 2 pm next day. Denies any rash, anaphylactic symptoms, or any local injection site issues
The patient presented with an itchy rash to his forehead that began 30 minutes after receiving the Pfizer Covid vaccine. Patient denies shortness of breath and chest pain/tightness. Patient denies additional symptoms/concerns. Patient was monitored in the urgent care for about an hour and was given prescriptions for prednisone and Benadryl which were filled and picked up by the patient. Patient was told to reach out to the pharmacy and/or urgent care if his condition did not subside or if it got any worse.
I lost consciousness for several minutes.  I had some tremors coming out of it, and vomiting.   Otherwise, expected arm soreness, tiredness, etc. for a few days.
Patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st August 2021) for prophylaxis.   On 21st September 2021, the patient received Menveo. On 21st September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The medical assistant reported that, the patient received expired dose of Menveo, which led to expired vaccine used. The reporter did not consent to follow up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232198:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same repoter US-GLAXOSMITHKLINE-US2021232206:Same reporter US-GLAXOSMITHKLINE-US2021232194:Same reporter
Pimple-like red spots (20-30 of them) on my right chest under my breast. Still appearing on this date, 08/26/2013. Vaccine was given in my left arm. I haven't done anything to treat it. It doesn't seem to itch or hurt at this time.
I have what people are calling Covid Arm. I have a huge red blotch on my arm that goes from bright red to pink depending on how hot it is. I took my temperature on forehead and it was at 98.5 and then I decided to use same thermometer and temp my injection site. The temperature was 100.8. It continued to fluctuate with temp from 99.8 to 101.5 for three days. I started to ice it with a cold compress. Which strangely for the first two days of doing this it wouldn?t cool down with the ice cold compress. Injection site was very tender and hurt if was touched. It felt like my skin was on fire. It was super swollen and raised. As it?s fever broke the site got less red. But it got itchy and spread a little more over my arm.
satellite lesions appeared after pt applied moisturizer to vaccine site; area clean, applied dressing, started Bactrim f/u 3 days. further education provided
No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported.  Since 23-AUG-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) which had the lot # N008829, expiration date 16-MAR-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided.  Additionally, it was reported that the lowest temperature was 34 and the higher was 50 degrees Fahrenheit for 46 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved.   Follow up information was received from the physician on 16-OCT-2017 and on 27-OCT-2017.  This report refers to 12 months old patient.   On 30-AUG-2017, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).   This is one case from several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA007325: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012770: US-009507513-1710USA015221: US-009507513-1710USA015223:
Issues with cognitive functioning, cognitive delays, simple work tasks for difficult and made a lot of mistakes, initially without even realizing it. Had to keep triple-checking my work. Slight memory delays - ex. remembering the name of my mortgage company when paying bills or remembering the name of other payors. Headache, slight dizziness, slight nausea, mild diarrhea, fatigue.
Re-appearing, larger red circle at injection site - warm to touch; 1 week after administration.
low grade fever 2-3 days;on lt arm only-pain, significant rash 9area 8x15cm) x 5 days;urticaria;tx w/DPH & hydrocortisone cream entire upper arm markedly swollen for 4 days;
102.5 f fever 12 hrs after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102.5 f fever 12 hrs after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   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 an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (102.5 f fever 12 hrs after 2nd dose). At the time of the report, PYREXIA (102.5 f fever 12 hrs after 2nd dose) outcome was unknown.          No concomitant medications were reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
DECREASED QUALITY OF LIFE; POSSIBLE GUILLAINBARRE SYNDROME; CHILLS; LOW GRADE FEVER; COLD SYMPTOMS; STABBING MIGRAINE; This spontaneous report received from a pharmacist concerned a 50 year old old female. Initial information was processed along with the additional information received from Central Complaint on 03-NOV-2021. The patient's height, and weight were not reported. The patient's past medical history included shoulder injury and concurrent conditions included hypothyroidism and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: UNKNOWN)1 total, dose was not reported, administered to left arm on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient had stabbing migraine and had pain from her head to her big toe Immediately after vaccination. On 21-SEP-2021, the patient had a low grade fever with cold symptoms and chills. On 27-SEP-2021 (a week after the vaccine) the patient was not being able to sleep due to tingling pain in her feet. Later on in mid-october, these symptoms started getting worse, patient was unable to do daily activities such as carrying an infant, cooking, driving, etc. Around (oct 18th/19th) patient was prescribed lyrica, which helped her few hours or moments and then the symptoms returned. Patient described lethargy, pain and tingling. Patient had decreased quality of life and had been out of work, does not drive, clean, cook, swim, walk or do activities because of these symptoms. Daughter (HCP) states patient was fine before the vaccination. Physician/neurologist reported that it was a uncharted territory to state the reason behind these symptoms but possible guillain barre syndrome. On an unspecified date patient went to physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stabbing migraine, cold symptoms, low grade fever, chills, decreased quality of life and possible guillain barre syndrome. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000200300. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211107992-COVID-19 VACCINE AD26.COV2.S-Possible Guillain barre syndrome. This event is labeled per RSI and is therefore considered potentially related.
If someone is fully vaccinated and goes around someone who tests positive for the covid; If someone is fully vaccinated and goes around someone who tests positive for the covid; This is a spontaneous report from a non-contactable consumer via a Pfizer sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient was fully vaccinated and who tests positive for the covid, should he wait a week to get tested for covid. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flu-like symptoms; coming down with something; chills; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to the company on 11-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (coming down with something), CHILLS (chills) and PYREXIA (fever) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Nerve damage (The patient developed nerve damage in his feet after he took the antibiotic Levaquin,) and Burning sensation (Has not had burning sensation for the past 15-20 years (since about year 2000)). Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE and VALSARTAN for Hypertension.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (coming down with something), CHILLS (chills) and PYREXIA (fever). On 07-Feb-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (coming down with something), CHILLS (chills) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment of events was reported.
Gave Tdap and soon after Gardasil close to the Tdap site. Was injecting PPD in same arm, patient developed syncope within 2-3 minutes.
Moderna Lot Number 045J21A was inadvertently used one day beyond the expiration date of May 2, 2022.  Guidance, Moderna was contacted on May 3, 2022 about the vaccine storage error.  Moderna conducted research on the same lot number and simulated the same conditions noted by Public Health.  Moderna found that the vaccine met the required activity to produce the needed immune response.  This is Moderna Case Number CEA-2351.  Although Moderna noted this vaccine was sufficient to produce the needed immune response, patient was encouraged to speak with their provider to determine the next steps appropriate for them.  Patient has experienced no known adverse events.
Paxlovid indication=COVID-19 Treatment; Paxlovid indication=COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid indication=COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was confirmed that patient received the vaccine. It was reported that no other medication in 2 weeks. Patient received treatment for COVID 19 with Anti-viral as Paxlovid (lot number: GC8236). Treatment starts on 21Jun2022 and stop on 22Jun2022 due to some side effect with treatment drug as Bitter, metallic taste present in mouth after taking dose of medication on the same of treatment received at 07:00 PM. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I took a tylenol when I got home. I fell asleep and when I woke up that afternoon I had a large fever blister on my upper lip that is very swollen. I applied Embersole
Erythema, pain, tenderness, swelling, warmth, and pruritus 6" long and there is a knot at the injection area.
A non-serious spontaneous report of hives, red blotchy skin/redness, both hands swelled and 55-year-old administered FLUMIST has been received from the patient, as 55-year-old male. The patient had no relevant medical history nor concomitant medications. On 08-Oct-2008, the patient received FLUMIST via intranasal administration as a flu vaccine. Within 18 hours on that date, the patient developed hives on his buttocks and ribs and both hands swelled (not his feet). This peaked at 24 hours then diminished in the next 24 hours. At that time, he had just red blotchy skin/redness where the hives were. The patient did not see a physician. He self-treated with fexofenadine hydrochloride 24 hours after his FLUMIST dose. On 11-Oct-2008, the patient recovered. Additional information received on 13-Jan-2009 and incorporate into the above narrative included therapy dates, treatment medications, additional events and outcome dates.
14 yo F was given Covid 19 booster when it is currently not indicated for this age group.  Mistake was made when the medical assistant forgot to check this person's age and the other two family members also present in the same clinic officer were 16 years of age and older.
Approximately 5-8 minutes after receiving the dose, the patient became diophoretic  and nauseous.  Patient did vomit a dark colored small amount of emesis. His symptoms resolved within 10 minutes.
Error giving Trumemba to 11 year old. Order was for MenQuadfi. Despite double check process, Trumemba was administered. Notification of family underway. Patient suffered no ill effects.
her migraines it went out of control; suffering from heart problems; last night because the pain flared up so bad that she was just in tears/excruciating pain; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A non-contactable consumer (patient) reported that a female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included she is immunocompromised and is suffering from heart problems (both ongoing), had a hysterotomy 2 months before an unspecified date, ongoing auto-immune issues. Concomitant medications included had botulinum toxin type a (BOTOX) injections 2 weeks prior to her first injection; golimumab (SIMPONI) for auto-immune issues. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at single dose for COVID-19 immunization and experienced migraines. Patient reported that she suffered from migraines and when she got the Pfizer COVID vaccine, her migraines it went out of control on an unspecified date. Her chronic pain was so bad that if she would rate her pain from 1 to 10 it would be in her 30s. She was in excruciating pain. She suffered heart problems on an unspecified date and had a hysterotomy 2 months before and had some hydrocodone left over and took a couple of those last night (08Apr2021) because the pain flared up so bad that she was just in tears. She already had the injections of golimumab done. After receiving the first dose of Pfizer's COVID vaccine, it kicked her migraines to overdrive. Her migraine doctor started another medication and started another side medication on top of that. And she was still having migraines. She had 2nd injection and she was still having the same effect even 2 days after the 2nd one. Therapeutic measures were taken as a result of events 'migraines it went out of control' and 'pain flared up so bad'. The outcome of the event migraines was not recovered, outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt was given incorrect vax, was supposed to get phizer but received monderna, clinic let parent know they made the mistake  sore arm and fever