chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it gave the flu every time i took it; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 12-Nov-2020.  This case involves a patient with unknown demographics who reported it nearly killed (Ill-defined disorder), when received vaccine influenza vaccine (Flu shot).  Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) after administration of influenza vaccine, the patient reported it nearly killed (Ill-defined disorder).  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Patient presented to the ED on 11/12 for GI hemorrhage and was subsequently hospitalized on 11/13. This was within 6 weeks of receiving covid vaccination.
This case was reported by a healthcare professional, via a sales representative, and described the occurrence of not responding to therapy in an adult subject of unspecified age and gender who was vaccinated with ENGERIX vaccine (manufacturer unspecified). About three years prior to the date of reporting (06 April 2009), the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown). After these initial three doses were given, two additional doses of Hepatitis B vaccine were given on unspecified dates. It was reported that the subject did not respond to vaccination with Hepatitis B vaccine. The subject, who was a nurse, received the Hepatitis B series about three years ago. The subject did not respond to the initial three dose series. Two additional doses were given and still titers were not indicative of sero-protection. Limited data was available since this occurrence took place three years ago. The reporter also indicated that two additional subjects, who were also nurses, did not respond to initial three dose series of Hepatitis B vaccine series administered about three years ago and additional two doses were given and still titers were not indicative of sero-protection (please see case id's A0778492A and A0778561A for more details on these subjects).
Felt a flush of heat, and then HR elevated for a few minutes, making it hard to catch my breath for a brief amount of time.
eczema from her neck down to her feet/ Eczema aggrevated; swollen legs, arms, and ankle/swollen arm; swollen ankles; ankles are still stiff; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (eczema from her neck down to her feet/ Eczema aggrevated), PERIPHERAL SWELLING (swollen legs, arms, and ankle/swollen arm), JOINT SWELLING (swollen ankles) and JOINT STIFFNESS (ankles are still stiff) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. In 2021, the patient experienced ECZEMA (eczema from her neck down to her feet/ Eczema aggrevated), PERIPHERAL SWELLING (swollen legs, arms, and ankle/swollen arm), JOINT SWELLING (swollen ankles) and JOINT STIFFNESS (ankles are still stiff). At the time of the report, ECZEMA (eczema from her neck down to her feet/ Eczema aggrevated), PERIPHERAL SWELLING (swollen legs, arms, and ankle/swollen arm), JOINT SWELLING (swollen ankles) and JOINT STIFFNESS (ankles are still stiff) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  On an unknown date in 2021, patient developed events following first and last dose intake of Dupilumab (unknown latency) and following the first and last dose intake of Moderna covid-19 vaccine.  The treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Significant follow up was received . Updated patient age, gender, suspect product information updated
pt recv vax 28OCT95 & exp numbness & tingling in arm;sx gradually lessened throughout the day;pt recovered;
A non-serious spontaneous report of a pregnant female received FLUMIST has been received from a MedImmune representative concerning an adult female subsequent to FLUMIST. No medical or obstetrical history or concomitant medications were reported. On an unknown date, the patient received FLUMIST and the next day, she found out she was pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
It started the night of the vaccination. I spoke with my General Practitioner and they just had me take some TYLENOL, and some medicine for upset stomach and headache. I was throwing up, I had body aches, I couldn't get out of bed. We were basically just treating the symptoms and waiting for it to pass. It lasted about two days - but fatigue and body aches lasted about 2 weeks, which was longer than I expected. At this point I've had all four doses and haven't had any issues with them except for the second dose, but I would do it all over again.
Maculopapular rash in both forearms followed the following day by plantar and ankle pain and petechial rash in lower extremities. Started a steroid taper on 01/01/2022 for 6 days. The day after stopping the steroid taper plantar and ankle pain followed by a new crop of petechias over both lower extremities. Restarted a steroid taper.
COVID-19; COVID-19; Vaccination adverse reaction; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4421253-00 (Agency).  A 56-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 25Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "COVID-19"; IMMUNISATION REACTION (non-serious) with onset 01Jun2022, outcome "recovering", described as "Vaccination adverse reaction". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: diagnosed with covid-19 with humira. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: On an unknown date, the patient experienced reaction to COVID shots. 01Jun2022, the patient experienced diagnosed with COVID-19. Pfizer BioNTech COVID-19 vaccine (Tozinameran) and Moderna COVID-19 vaccine (Elasomeran) were also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporters causality for the event of reaction to both COVID shots and diagnosed with COVID-19 was not provided. Patient had no known allergies.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "vaccination adverse reaction" probable to BNT162b2.  Causality of Humira: Causality as per reporter for events COVID-19 and Vaccination adverse reaction was not reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, vaccination failure,  Vaccination adverse reaction and the administration of the vaccine cannot be excluded.
Information has been received from a pharmacist concerning a patient of unknown age and gender. No information was reported regarding the patient's past medical history, concurrent conditions, or concomitant medication. The pharmacist stated that the patient received several concomitant vaccines on 27-APR-2017 at an unspecified physician's office. The vaccines included: M-M-R II, ADACEL, and "flu shot" (unspecified) (lot numbers, expiration dates, dosages, and routes of administration not provided). Product information indicated that M-M-R II is not recommended concurrently with ADACEL. No adverse effect reported. No further information was provided. Additional information has been requested.
Body aches, mild headache sore throat,mild cough. Started 12/20/20
lost their babies; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: A 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: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "lost their babies".  Clinical course: The report was related to a study or program. The caller mentioned there were four girls who got the vaccine, and three of them lost their babies. The caller also mentioned that one of his friends took the shot and had a massive heart attack. They also recently found out they have stage 4 cancer of the prostate. The caller also mentioned that after getting the shot, had COVID twice already. Caller said that he called Pfizer because of a problem with the approved Comirnaty. Caller stated that he had not seen a bottle or label for Comirnaty, but over Labor Day weekend it went Bivalent. Caller said that instead of putting 2 in front of it, they used Bivalent. Most people did not know what the word Bivalent means. Caller said they said it was for two different variants, but it isn't, it was for 5 different variants. Caller stated that bivalent means double the dose and basically Pfizer doubled the dose over Labor Day weekend, and then RSV started. The information on Product strength and count size dispensed, Additional lot numbers, Packaging sealed and intact was not willing to verify or clarify any information provided. There was a product complaint to report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After second shot, slight fever the night of, for an hour, and fatigue the next day with itching at shot site. Itching and rash became more intense and spread over the right deltoid, then spread under both arms, then neck, upper shoulder and chest, then lower back and stomach, thebuttocks and stopped at knees. Itching would stop in an area and then come back, it still continues but not as intense.  Using triamcinoloneacetonide cream, .05%
DVT in left leg while 36 weeks pregnant with twins. Was put on blood thinners and induced 4/8/21 at 36 weeks, 6 days pregnant. Babies were 5lb 5oz and 5lb 11oz.
Fever - 100.1, erythema/pruritus/bruising/swelling around injection site.
Uncontrollable prolonged crying. from hour 24 to hour 27 after vaccine, accompanied by minor paranoia and despondency.
Severe muscle pain and weakness in back of both legs from gluts, hamstrings, calves to bottom of heels. Difficulty walking and running. Into my third week, Since SHINGRIX injection, some improvement, but still pain and weakness in both legs. Right heel has no pain. Four days after shot, my fourth and fifth fingers on my right hand were numb. Some tingling still exists. I made an appointment with my primary doctor to discuss adverse effects on April 23, 2019.
pt recv vax 29SEP98 1PM & 115PM wheezing-inhaled 2 puffs proventil @ work site;130PM c/o wheezing, itchiness @ inj site;130PM DPH given P86, R24;redness noted @ inj site;cont wheezing c/o lightheadedness noted;diff breathing;
Overall feeling little unusual; fever - 102F; little nauea; head was hurting whenever he stands up or turns hid head faster; muscle aches/body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Overall feeling little unusual), PYREXIA (fever - 102F), NAUSEA (little nauea), HEADACHE (head was hurting whenever he stands up or turns hid head faster) and MYALGIA (muscle aches/body aches) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced FEELING ABNORMAL (Overall feeling little unusual), PYREXIA (fever - 102F), NAUSEA (little nauea), HEADACHE (head was hurting whenever he stands up or turns hid head faster) and MYALGIA (muscle aches/body aches). On 11-Apr-2021, PYREXIA (fever - 102F) had resolved. At the time of the report, FEELING ABNORMAL (Overall feeling little unusual), NAUSEA (little nauea), HEADACHE (head was hurting whenever he stands up or turns hid head faster) and MYALGIA (muscle aches/body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: 102 °f High.         No concomitant medications were reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable
exacerbation of her chronic neck pain and migraine symptoms the day after she got dose 1
11/19/2022 - 9:00 PM chills and fever, 11/20/2022 5:00 AM - legs so weak that they would not hold him up.  Could not walk or stand.  9/20/2022 - 10:30 AM able to stand and walk, but still feeling weak
Vaccine given 11 days after 30 day refrigeration expriation date of capped refrigerated vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 11 days after 30 day refrigeration expriation date of capped refrigerated vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Acute myeloid leukaemia (started clinical trial drug in February 2021) since 2013, Pneumonia fungal and Blood pressure abnormal. Concomitant products included AMLODIPINE for Blood pressure, VALACYCLOVIR [VALACICLOVIR] and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Cancer, FLUCONAZOLE for Pneumonia fungal.    On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 11 days after 30 day refrigeration expriation date of capped refrigerated vaccine). On 03-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 11 days after 30 day refrigeration expriation date of capped refrigerated vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications taken were clinical trial drug Belumosudial 200 mg BID PO.  No Treatment medications were reported.     This case was linked to MOD-2021-209266, MOD-2021-209266 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up received on 10-Jun-2021,It contains no new information.
Patient developed temp to 105 deg about 12 hours after receiving ProQuad. He also was irritable.
A 5 month old patient received FLUZONE QIV vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via a consumer/non-health care professional via Medical Information (Reference number- 00808894) and transmitted to Sanofi on 12-Oct-2021.  This case involves a 5 month old patient (unknown gender) who was received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (product administered to patient of inappropriate age).  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 INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiry not reported, formulation: pre-filled syringe) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  It was reported "Nurse manager calling in regard to FLUZONE quadrivalent (QIV) pre-filled syringe (PFS). Nurse would like to know if there are any studies or information available for administration to patients less than 6 months of age? Caller states they may have administered a dose to a 5 month old that is turning 6 months in 2 weeks, but they are unsure if it happened. Caller states they wanted preliminary information just in case it was administered. Caller also stated they do not have any patient or visit related information at this time."  No other adverse event 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.
Ten minutes after administration, patient started complaining  that he was filling very dizzy, heaviness in neck and stomach/chest burning. He also stated that he was having chest tightness.  Vitals were checked using pulse oximeter and blood pressure cuff.  Vitals looked good, but patient was complaining he's not feeling well and was rubbing his chest. Patient had a dazed look on his face. Paramedics were called  to the scene. Once they arrived, vitals were checked again and came out with normal values. Paramedics offered to take him to the hospital to be evaluated, but he refused.
Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with GARDASIL 9 (lot # M003659 with expiration date 20-SEP-2017) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature 47.1°F for 24 days without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006507: US-009507513-1707USA006678: US-009507513-1707USA006679: US-009507513-1707USA006675: US-009507513-1707USA006676:
pt recv vax 21NOV97 & 22NOV97 pt exp stiffness, soreness & tingling on the rt side of the body (inj side)
1st dose 1/29 reaction gave me little dime-sized red bumps all over my body and a lot of itchiness. I had 2 larger brown  places on my body that were oval shaped about 1 inch across and it was crusty and had liquid and blood coming  from it. One was under my left breast and at the base of my spine. I had to get a mammogram because I had brown and bloody discharge from my left nipple. It looked like someone had painted bright red paint around the nipple. Dermatologists said it was mild duct ectasia bilaterally benign, nipple dermatitis, left nipple bloody discharge, and an eczamatatious rash. Right breast had a brown bump on the areola to the side of the nipple. 03/03/21 second dose: Sore arm, Fever of 100.9 next day that lasted all day. fatigue and a headache. I also had dizziness especially when I lie down or get up. fever went down and then I developed a rash on my body that made it look like I was sunburned all over my body. not spots, just redness all over. I felt pretty weird. it was an itchy rash that stayed about 24 hours, then changed into a spotty rash that traveled to my inner arms and inner thighs. The next day it traveled down my legs to my ankles. It went away mostly after a few days. I do still have spots that look like bites that are quarter-sized brown crusty spots. then I have eczema patches on my forehead. Its flaking and itching and is too sensitive to wash with soap. Also, my right eyelid has 3-4 places that has welt on it so much so that I cant see well from the eyelid, and under eye being swollen.
Full body aches; nausea; anxiety; shortness of breath; cold chills; fatigue; This is a spontaneous report from a contactable Other HCP. This 32-year-old male Other HCP (patient) reported that:  A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), dose 1 via an unspecified route of administration, administered in Arm Left on 03Jun2021 10:30 (at the age of 32 years old) as dose 1, single for covid-19 immunisation. Medical history included ongoing anxiety other medical history: Anxiety. Concomitant medications included sertraline hydrochloride (ZOLOFT), propranolol (PROPRANOLOL) and Multi vitamin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 00:15, the patient experienced full body aches, nausea, anxiety, shortness of breath, cold chills and fatigue. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
One week after shot a bump of red turned into red rash with some swelling  Tender to touch and  Rash still present today.  Self medicated with Benadryl
Vaccine administer IM to pt. per pt's requests. No problems with previous dose or allergy to egg products. Within 20-30 minutes pt experienced swelling of throat no difficulty breathing pt's signs and symptoms resolved within the hour. Administering nurse not informed of reaction until over and hour later. No treatment given.
1 day following vax pt devel an inj site rxn characterized by pain, redness, & swelling;the area around inj site oozed & then scabbed;pt had recovered @ the date of this report;