chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 5-year-old male with no medical history, who on 27-AUG-2002 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot#642991/0489M). Concomitant therapy included HIB conj-hepatitis B vaccine (MSD), measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 18-MAY-2007, approximately 5 years after receiving varicella virus vaccine live (Oka/Merck) (Lot #642991/0489M) the "patient experienced a breakthrough case of chickenpox. Patient has 50-100 lesions on mouth and trunk." Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
At 45-50 minutes after my injection I was walking and felt my blood pressure bottom out.  I stumbled and felt as if I was going to faint.  I recovered quickly.  Once home I monitored my blood pressure and it was low.  The lowest reading was 88/70.  I laid down and within a couple hours my pressure was more normal. I did not feel faint at that time.  I have severe anxiety and am not sure if that contributed to this episode.  Additionally, my blood pressure is on the low side of normal.
expired vaccine was given as four first doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was given as four first doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was given as four first doses). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine was given as four first doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
I experienced fatigue, headaches, weakness, diarreha, couldn't eat, nausea, achy all over my body and not being able to sleep.
This spontaneous report was received from a nurse refers to multiple unspecified patients of  15 through 19 years old age of unknown gender. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. Nurse reported that on unknown dates, these patients received one to two doses of M-M-R II for prophylaxis. On unknown dates after receiving vaccine doses, the patients developed contracting mumps. Outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
flublok Quadrivalent vaccine was administered to a 13 year old (male), with no adverse event; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.   This case involves 13-year-old male patient who administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 30-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication due to product administered to patient of inappropriate age [Latency: on the same day].   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  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.
No additional AE/PQC reported at time of call.; Caller states a patient who is currently "in her 30's" has received 2 doses outside of the dosing schedule recommended in product prescribing information.; This spontaneous report was received from a nurse and refers to a female patient "in her 30's". The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date in 2002 (also reported as approximately 10 years ago "back in college"), the patient was vaccinated with human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, administered for prophylaxis (strength, anatomical location, lot #, expiry date, and route of administration were not provided), but she did not finish the series at that time. Then on an unspecified date in 2022, she was vaccinated with the second dose of the vaccine, receiving 2 doses outside of the dosing schedule recommended in product prescribing information. Additional information or adverse event was not provided.
Flu; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves adult male patient who had flu (influenza), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past vaccination(s) included flu in Feb-2019, had flu A and Mar-2019, had flu B.  The patient's medical treatment(s), concomitant medication(s) 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 were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in Jan-2021, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Since this is a public post on an influencer post for the Sanofi flu shot campaign, Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine. We have got our flu shots in October every year for the past 5 years. In Feb 2019 my teenage son & husband both had flu A. Then in March 2019 same teenage son had Flu B. In Jan 2021 again same teenage son had Flu A. Going to pass on Flu shots this year & see how we do!"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  There will be no information on lot number for this case.; Sender's Comments:  SanofiPVPortal20211027000309:Portal ID for reporter husband 2021SA355175:Case ID for Reporter 2021SA361607:Case ID for reporter husband
Achy; Headache; Throwing up; This is a spontaneous report from a contactable consumer.  A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 at single dose in left upper arm for COVID-19 immunisation at the age of 66-year-old. Lot number was EL3249. Medical history and Concomitant medications were none The patient woke up on 24Jan2021 morning and he felt like he was coming down with something. The achiness was first; it started early in the morning, then the headache was in the afternoon, and then at night he started throwing up. While the symptoms were developing, they were worsening, but since they started, they have stayed the same. On 24Jan2021, the patient experienced achy, headache, and threw up. The patient did not recover from the events.
Generalized weakness; Pain all over the body; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Generalized weakness) and PAIN (Pain all over the body) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced ASTHENIA (Generalized weakness) and PAIN (Pain all over the body). The patient was treated with PARACETAMOL (TYLENOL) for Asthenia and General body pain, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Generalized weakness) and PAIN (Pain all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
pt recv vax & exp fever which cont for 3-4 days;7/31/98 pt exp a rash;pt was treated w/anti0itch syrup & Ibuprofen;
After 2nd dose, I got fever; rash after second dose (around the vaccination area); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 12:30 (Lot number: EW0183) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Dry eye" (unspecified if ongoing). Concomitant medication(s) included: FLUOROMETHOLONE taken for dry eye (ongoing); RESTASIS taken for dry eye (ongoing). Vaccination history included: Bnt162b2 (1st dose , lot number FA7484, Route, Anatomical Location: left arm, Time: 12:30 PM), administration date: 04Aug2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "I was feeling tired".  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "After 2nd dose, I got fever"; VACCINATION SITE RASH (non-serious), outcome "unknown", described as "rash after second dose (around the vaccination area)".  Additional information: pro-vaccination, Illness/AE, Relevant Tests, AE(s) following prior vaccinations and Family Medical History Relevant to AE(s) was None. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. It was reported that all events occurred the same day as she was given the second dose. No other vaccines given the same day and no problems with vaccines in the past.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110877 Same reporter, different patient, same drug/event (split);US-PFIZER INC-202101110878 Same reporter, different patient, same drug/event (split)
Injection site swelling, pain, chills, rash(itching) along with fatigue. Took tylenol for the pain. The rash is subsiding and was recommended to take claritin for the rash.  Today March 23, 2021, there is still a little itching but the redness is going away.
VERY MINOR SYMPTOMS; This spontaneous report received from a patient via a company representative 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 is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced very minor symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very minor symptoms was not reported. This report was non-serious.
For my first 2 shots, I experienced very mild fatigue. With this booster, around Noon that day I experienced major fatigue. Around 11:00 pm that evening, I then began with extreme chills and began running a fever. I then got nauseated, went to the restroom and passed out. My fiancé called 911 and the EMTs took my vitals, which were okay. I did go to the hospital for evaluation and fluids. The doctor does not believe I had a seizure, but when I went to the restroom, my vagal nerve caused my heart rate to drop causing me to pass out. All bloodwork came back normal. The next day (today) I am feeling much better and almost back to normal.
Information has been received from a physician concerning an 18 year old female student who on 22-JUN-2007 in the pm, was vaccinated IM in the right arm  with a first dose of Gardasil (lot # 658094/0524U).  Concomitant vaccination on 22-JUN-2007 included IM in the right arm with a first dose of MENACTRA (lot # U2106AA) and IM in the left arm with a first dose of ADACEL (lot # C2644AA).  On 02-JUL-2007 in the am, the patient experienced muscle pain in the legs, then progressively involved the back and neck.  On approximately 05-JUL-2007 the patient was seen in the emergency room.  On approximately 05-JUL-2007 laboratory test was reported as negative for serum C-reactive protein test and advised to just observe.  Repeat lab work was negative.  Other laboratory tests included Epstein-Barr virus antibodies screen, Lyme disease, enzyme-linked immunosorbent assay, cytomegalovirus antigen test, and cytomegalovirus antigen test which had negative results.  The patient was then seen by a neurologist and diagnosed with severe myalgia and advised to just observe.  Repeat.  On 27-JUL-2007, the patient recovered from muscle pain in the legs, back pain and neck pain.  Additional information is not expected.
maybe she could have COVID too; maybe she could have COVID too; a rash on her leg; some shortness of breath; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 06Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her first dose of COVID-19 vaccine on Wednesday, 06Jan2021 and today, on 09Jan2021, the patient started having a rash on her leg, some shortness of breath. She used an asthma inhaler. She experienced some of the symptoms before Wednesday. The reporter was concerned that maybe the patient could have COVID, too. The reporter heard that with COVID, sometimes rashes and/or shortness of breath can come, too. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
erectile dysfunction; A spontaneous report was received from consumer who was a 66-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced erectile dysfunction.    The patient's medical history was not reported.  Concomitant medications included atorvastatin.   On 11 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 042L20A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.  Since 14 Feb 2021, patient felt the issue of erectile dysfunction.  Treatment activities for event was not provided.  On 11 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 040A21A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.  Action taken with mRNA-1273 in response to the events was not applicable as the patient received both scheduled doses of the vaccine.   The event of erectile dysfunction was considered not resolved.; Reporter'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.
Pt has extreme swelling on left upper arm, there is also armpit involvement and the side of the left breast, resulting in immobility of left arm to an extent.
Initial report received from a health care professional on 18 February 2011. A -year old female patient received on 15 February 2011 at 11:10 AM a left deltoid intramuscular injection (dose 2) of IMOVAX, sanofi pasteur lot number D1177-1. The patient had no medical history, no allergies, no concomitant medications, no illness at the time of vaccination, no other vaccinations within 4 weeks prior and had no adverse event following prior vaccination. On 15 February 2011 at night, the patient developed a bad headache, chills and diarrhea. The outcome was reported as not recovered. Documents held by sender: None.
Experienced itching in her hand, tingling on the left side from her neck down to left foot. She received BENADRYL for itching with good results.
This is a report for about 20 individuals who all reported very similar outcomes.  Immediately within an hour of vaccination, patients experienced nausea (90%), vomiting (10%), severe pain or site irritation (90%), overnight sweats and other discomforts (80%).  However, those who received vaccines from a different manufacturer/product did NOT have the same reactions.
04/03/22 presents to ED for "chest pain and shortness of breath". PMHx of "HIV, NIDDM"
Pt reported bottom of lips became swollen and he started itching 3-4 days after he received the 2nd dose of SHINGRIX. Also, the site where the injection was given blistered. Pt denied shortness of breath. Event was reported to clinic 5/17/2018 at which time pt reported symptoms were better new (blisterd burst and swelling reduced).
Covid test date=08Feb2023, Covid test result=Positive.; Covid test date=08Feb2023, Covid test result=Positive.; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years 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) and as dose 3 (booster), 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 (medically significant), COVID-19 (medically significant) all with onset 08Feb2023, outcome "not recovered" and all described as "Covid test date=08Feb2023, Covid test result=Positive.". The event "covid test date=08feb2023, covid test result=positive." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Unknown exposure symptoms high fever 101.3 cough sneezing; fatigue then tested positive on 08Feb2023, adverse event start date: 06Feb2023. Patient had Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300062309 same patient different dose/drug/event;
Mom stated on 9/1/10 at 10am client reported having chills, slight headache, shortness of breath and numbness of left arm. Mom states when he came home from school in the afternoon, she gave him his inhaler. Client has hx of asthma. Mom stated that he felt fine after the inhaler. She stated on Fri 9-3-10 that below injection site 2" distal anteriorly was 3" x 1" hot, red, swollen area with red streak following from injection site. She states she gave ibuprofen q 4-6 hrs PRN + it resolved in 4 days. She did not seek medical care nor did she bring him in the clinic to be observed. She reported to PHN by phone.
Received shot on 11/04/09. That evening had fever with redness and swelling at site. Her fever increased to 104 degrees F on 11/05/09. That day the redness expanded to approximately 20 cm. She also complained of shortness of breath starting one day after administration. She began taking BENADRYL & Ibuprofen two days after injection. Still complains of tenderness & redness six days later.
Cough (went away after a week)  Headache, Nausea, Fatigue, Loss of appetite, weakness, light headedness. All of these symptoms are still active and occur randomly though most occur at some point daily.
I had injection site pain about 4 or 5 hours after my injection. Around 9:15 at night I felt slightly warm and could tell that I was becoming febrile, but I wasn't completely there yet. Around 12:45AM on January 9th, I had massive chills and uncontrollable shivering and muscle aches. I took 1000 mg of acetaminophen. I took another 1000 mg of acetaminophen at 6:00AM when my chills came back. At 10:45AM I was feeling febrile again, and took 600 mg of ibuprofen followed by an hour and a half nap. I had slight malaise afterwards but did not feel febrile. By 5PM, I was feeling almost completely normal and was fever free. On the morning of 1/10, I am completely recovered.
Headache, Myalgia, Fever, NauseaVomiting, chills, fever, headache, body aches and nausea
Complained of flu symptoms, fever, stuffiness, aches and pains, loss of appetite.
NO ADVERSE REACTIONS WERE REPORTED - ONLY REPORTING DUE TO AGE OF PATIENT
The pt developed generalized rash which started at noon on 12/05/01. Flu shot given at 09:00 on 12/5/01.
PCV7 given on right thigh 9/22/03.  Presents on 9/24/03 with top of right leg swollen red, hot to touch.  Grandmother will take  to ER to see physician as Children's Clinic didn't have appt till am of 9/25.