chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Due for booster; had COVID-19 infection 1 month ago; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Due for booster; had COVID-19 infection 1 month ago) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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, the patient experienced COVID-19 (Due for booster; had COVID-19 infection 1 month ago). At the time of the report, COVID-19 (Due for booster; had COVID-19 infection 1 month ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  This is a spontaneous case concerning a female patient of unknown age with no medical history, who experienced the unexpected AESI of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. At the time of the report patient was due for the booster, she is unclear when to have the booster as she had COVID-19 infection 1 month ago. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no medical history, who experienced the unexpected AESI of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. At the time of the report patient was due for the booster, she is unclear when to have the booster as she had COVID-19 infection 1 month ago. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
large sever rash on my upper arms  and at site of vaccine.  severe itching, arm is very hot.  looks similar to pictures on line of "Covid Arm" so far it is 3 days and has not subsided.  using Benedryl and icepacks  for symptoms
Injection site pain appeared right after vaccine administration. Pain became more severe the next day and it lasted for a total of three days(1/8~1/10) The next day of vaccination(1/9), I have symptoms of low grade fever, chills, fatigue, mild  body aches, headache, vomiting feeling. However, these symptoms only lasted for one day.
pt recvd vax; w/in 1 hr of vax, had large red lump on arm;iced it;on deltoid, area of contusion w/ central 1.3x1.0cm firm area;
Suspected vaccination failure/Had shingles 10 times in the last seven years / I got the two shingles shot; Had shingles 10 times in the last seven years / I got the two shingles shot; Almost lost my hearing; My teeth hurt every day it's an absolute nightmare; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, hearing impaired and toothache. On an unknown date, the outcome of the vaccination failure, shingles, hearing impaired and toothache were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, hearing impaired and toothache to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient had shingles 10 times in the last 7 years and almost lost his/her hearing, teeth hurt every day and it was absolute nightmare. Two weeks after receiving 2nd dose of Shingles vaccine, the patient got shingles. The patient stated that he/she received 2 Shingles shot and neither of them worked. This case was considered as suspected vaccination failure as details regarding event onset time and laboratory confirmation for shingles were unknown at the time of reporting.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899), on 11Jan2021 as dose 2, single (Lot number: ER9231) and on 26Sep2021 as dose 3 (booster), single (Lot number: 301458a) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Allergic rhinitis (seasonal and animal)" (unspecified if ongoing). Concomitant medication(s) included: CETRIZINE; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (05Jul2022) Negative; (06Jul2022) Negative; (07Jul2022) Negative; (11Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Onset of cardiac arrythmia with duration of up to one week, followed by severe neurological symptoms, including limb numbness and weakness, gait problems, ataxia. Four years later, still suffering from intermittent arrythmias, neurological symptoms, limb numbness, fatigue, joint pains. The symptoms described above were at times intermittent and at times acute in nature. Because of the nature of the symptoms, I went to four different physicians including two internists, an ENT and a neurologist. I was afraid of multiple sclerosis and had a MRI which was negative. I have had numerous x-rays and an MRI of my spine because of back and joint pain. The physicians in 2000 did not ask me about vaccinations and I did not suspect this either since we are certainly not warned of the possible side effects of these vaccines, especially hep B. Therefore, treatments were in the form of muscle relaxants, anti-depressants and pain killers. Muscle cramps were another symptoms. I now suffer some of these symptoms intermittently, however the joint pain, fatigue and limb numbness are almost a chronic problem. I have done alot of research into this and have been made aware of the possible side effects of the hep B vaccine. I find it a distortion of truth when people are vaccinated without sufficient warning of side effects (which are stated in the manufacturer's inset) and not properly interviewed as far as family history of auto-immune diseases. The onset of my original symptoms were shortly after my first vaccinations. I have never experienced any of these symptom prior to the vaccinations. It could not be coincidence. Someone has to be responsible for long term side effects of these vaccinations.
Weakness, Headache, Chills, Fever, Nausea, Vomiting, Diarrhea
After getting my booster, I started experience chest pain right where my heart is located. I thought it was physiological so I've been ignoring it all day. Now I'm trying to sleep and it is still persistent. My heart hurts. It has not gone away. Additionally, my left arm is very sore where the injection site is. If I still feel pain in my heart tomorrow, I will see a medical professional.
Extremely soar arm, then vomiting and tightness of the chest, very weak, extreme headache, loss of voice
A report has been received from a health professional via a medical representative concerning an 11 or 12 year old male. The medical history included wheezing, and concurrent disease included asthma. The patient received FLUMIST (intranasal) on an unknown date. In September or Oct-2010, the patient experienced wheezing and was subsequently sent to the hospital. The patient recovered from the event of wheezing on an unspecified date. The reporter considered the event of wheezing as serious due to important medical event criterion. Summary of follow-up information received by AstraZeneca/MedImmune on 26-Sep-2014 from health professional: drug as reported was updated from FLUMIST QUADRIVALENT to FLUMIST, medical history and event outcome updated. Corrected report 02-Oct-2014: source of report was updated to spontaneous, reporter information updated, event onset date added.
Hives for over 2 weeks. (Also had corn for the 1st time this day).
I started feeling weak and dizzy and got a sore throat. I had a fever of 100.1.
Left deltoid red, swollen size 10x17cm. TYLENOL every 6 hours PRN, apply ice for 10 min as needed.
adult patient got Daptacel instead of Adacel/no AE; adult patient got Daptacel instead of Adacel/no AE; Initial information received on 27-May-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an adult patient of unknown demographics who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number not reported) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age and wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered.  At the time of reporting, no 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 holders compliance with the requirements set out in 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, currently..
Red reaction 13cm x 8cm, hot to touch with patient having nausea with vomiting. Pt also had two syncope episodes over. Pt had onset of red reaction to site, nausea with vomiting and syncope within 1 hr. Anaphylaxis reaction, MD Rx Benadryl Epi, Vistiril, Nomec PO meds.  Nurse follow up on 10/30/04 states: "Verbal record: anaphylaxis."  Nurse follow up on 11/01/04 states: "anaphylaxis; hypervent; confused; weak; dizzy."
pt recv vax 10APR97 PM began to have dizziness, fever 102.2 the same noc;took APAP q 4hr;still having fever 11APR97 10PM w/c/o h/a & fever 101;OK by 11APR97 noc;
Information regarding PREVNAR was received from a nurse regarding her grandson, a male patient (age unknown), who experienced reaction on the injection site.  The patient received a dose on an unspecified date.  The patient experienced a reaction on the injection site.  The outcome was not reported.  No additional information was available at the time of this report.
Headache, Myalgia, Fever,  fatigue, sore throat Narrative:
2nd Trimester Miscarriage of Healthy Baby 2nd pregnancy, no hx of miscarriage prior, full term pregnancy with first. All genetic testing on mom and additional health screens of baby were normal. On 4/25/21, lost mucus plug in the AM at 17 weeks pregnant with no other issues, concerns, abnormalities, etc. At 3:50AM on 4/27/21, ruptured membrane/water broke. Hospital testing confirmed 100% break of amniotic fluid with nothing left to sustain baby who had normal heartbeat and was still alive - measuring on target. Induced at 11:20pm on the 27th and delivered at 5:30am on 4/28/21 at 17 weeks and 3 days a baby boy measuring 8.25 inches and 5.6 ounces.   No placental infection or abnormalities. Pathology noted an abruption hematoma that could have resulted from induced labor. No trauma, blood work, or other explanations for early rupture of what was a perfectly healthy and growing baby.
patient was given vaccines at 2:52. Mother asked how he was doing. he said fine. this was his second dose. i asked how he did with his first vaccine and said no issues.  told patient he is supposed to wait 15 minutes but since he had no issues with fist  he could leave.  pcp told me to give vaccine on opposite arm as last time because he was sore  arm and a localized rash.  patient walked out to lobby to check out and he asked for a chair.  patient said he couldn't see, was pale in color,  911 was called , crash team was called , bp, pulse and sugar level were checked and monitored.
Joint pain; Muscle pain; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 66 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "GERD gastrointestinal" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EL8982; left arm), administration date: 08Jan2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2; Lot Number: EM9809; left arm), administration date: 08Feb2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 10Aug2022, outcome "not recovered", described as "Joint pain"; MYALGIA (non-serious) with onset 10Aug2022, outcome "not recovered", described as "Muscle pain". The events "joint pain" and "muscle pain" required physician office visit. Therapeutic measures were not taken as a result of arthralgia, myalgia.   Additional Information: The patient had no known allergies. Other medications were given in two weeks. No other vaccine was administered in four weeks. The facility type where the vaccine was administered was a hospital. The patient was having very bad joint and muscle pain as long-term side effects since vaccination.
every time I got a vaccine or a booster, my PSA readings go up; 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 72-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "every time I got a vaccine or a booster, my PSA readings go up", "I contracted Covid 19". The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious), outcome "unknown", described as "every time I got a vaccine or a booster, my PSA readings go up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter mentioned that he already 2 doses of the Pfizer Covid-19 Vaccine and the booster dose. He took Paxlovid as well. He wanted to know if there is correlations between Paxlovid and Pfizer Covid-19 Vaccine with his PSA increase. Reporter stated "he read several things saying they've been test and show high PSA levels, he had 2 vaccines and 2 boosters and then the paxlovid, because he contracted Covid 19, he have a chart showing when he was taken the vaccine and when he got back my PSA readings back and every time he got a vaccine or a booster, my PSA readings go up. He also heard that they go up when you contract Covid 19, but there's no information about Paxlovid because it's so new, but when you have covid 19 and you feel terrible, anything that helps is considered. Has Pfizer heard anything, he curious, he mentioned this to urologist, but he wanted to know if there's a correlation that you've heard about, with Paxlovid and the vaccine and the booster. He mentioned he didn't know if he received the bivalent or monovalent formulation, he received it when it just came out and his most recent booster was on 25Mar2022. He took Paxlovid took 2 months ago, on 12Aug2022. He wanted to know if the chemical make up of Paxlovid is the same as the booster and the vaccine. he also read in case studies that if you contract covid, that also elevates the PSA, there's a test, 91 people PSA levels went from 1.58 to 4.34 on average, he was wondering if you heard anything about that. he figured you might have heard about it. Offered warm transfer to DSU, reporter declined stating he had a phone meeting with his urologist, but that he may reporter back later.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The pt experienced a sudden onset of fever to 101 on 1/11/01. The pt was presented to the office with a high pitched cry, temp of 102.7 and a bulging fontanel with poor eye contact. It was reported that the pt cried for more than 5 hours. Workup for meningitis was negative. He was admitted to the hospital.  Diagnosed with possible reaction to immunizations
Shaking chills, teeth chattering, Headache--drenched in sweat over night-had to change clothes twice over night. Next day-poor appetite all day, muscle aches, night sweats. Third day, symptoms were resolved.
Still have pink blotch/mark where injection was given over a month later, have been experiencing burning, tingling, and pain in my hands, feet, and joints starting approximately 2 weeks after my second dose. Primary doctor started Gabapentin 100mg 1 per day, Pain management doctor has titrated up from that trying to get me to 300mg 3 times a day, just started 3rd week taking 3 100mg per day at current. Doctor referred me to vascular doctor for my Raynaud's and to do an arterial test, also was referred to neurology, treatment and test still ongoing.
Nauseous, chills, fever, joint pain. Took an Aleve and tried to sleep it off.  Finally have no fever 24 hours later.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown demography. On an unknown date, the patients were vaccinated with improperly stored VARIVAX and PROQUAD (Incorrect product storage). No adverse effects reported. Additional information has been requested.
patient received only the ACT-HIB portion of the PENTACEL with no adverse event; Initial information was received on 23-Feb-2022 regarding an unsolicited valid Social media non-serious case received from other health professional.  This case involves a patient of unknown demographics who received only the act-hib portion of the vaccine Diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(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(MRC5)/HIB(PRP/T) vaccine (formulation, strength, batch number, expiration date: unknown) via unknown route in an unknown administration site for immunization. Information on batch number was requested.  On an unknown date, the patient reported that he/she received only act-hib portion of Pentacel (product preparation error) (unknown latency) following the administration of Diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  Action Taken: not applicable.  At time of reporting, the outcome was Unknown for the event (product preparation error).   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.
No adverse event.  I administered 0.2ml instead of 0.25ml of vaccine.
I have had migraine headaches since my early 20's.  About 2 weeks after my first Moderna vaccine injection, I began to have different headaches.  The pain was in my temples with pressure behind my eyes.  The pain shifts from side to side.  My temple and side of face are very sensitive to touch when I have a headache.  These headaches come for 2-3 days every 7-10 days.
Patient is a 83y.o. year old female admitted w/ CC as copied from DR. note of 11/17:"This is a 83y.o. female with hx HTN, COPD, presented to the ER with c/o weakness, dizziness, and a mild cough x 2 days.  EMS reported patient had a fever of 101.  She reports that she's been feeling weak and fatigued. She lives at an ECF. They provide and give her all her medications. She denies any associated HA, CP, SOB. No reported vomiting or diarrhea. She states she felt so weak that she thought she might fall. Denies any LE edema. No other complaints reported"   .Found to be COVID + w/ L basilar airspace dx on CXR   Discussed w/ Nursing - per their understanding, pt's 2L 02 via NC is, indeed, her baseline. Of note, 02 sat after trail of removal of supplemental 02 is 99%! Upon questioning pt further, however, she denies the use of supplemental 02
A lot of itching; The spot is hot; The spot is red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A lot of itching), FEELING HOT (The spot is hot) and VACCINATION SITE ERYTHEMA (The spot is red) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (A lot of itching), FEELING HOT (The spot is hot) and VACCINATION SITE ERYTHEMA (The spot is red). At the time of the report, PRURITUS (A lot of itching), FEELING HOT (The spot is hot) and VACCINATION SITE ERYTHEMA (The spot is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medication reported.
I have had awful neck pain, I will work it out but it keeps coming back. Isolated to the back/right side of my neck
Received Adacel 6/22/2006. Woke up 6/23 with red swollen arm.