chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Late February I had headaches. Eye disturbances on the right. I had shoulder and back pain that went back-and-forth. I also had right leg and right foot on the lower end in pain. Has all gone away except I see double now and I have mild headaches since the  VAD and strokes I had an episode where I couldn?t walk. My legs got weak on August 12, 2023 at work. I also gained a headache. The doctor looked at me for a little and said if my headache gets worse to go to the hospital  I went to Hospital around 8 o?clock at night. They did bloodwork, gave me a IV Reglan and Toradol and send me home. I was a hospital working with a patient. I had to leave the room cause I had upper right and left shoulder pain that went away in exactly 20 minutes. My eye disturbances were exactly 20 minutes also. I also had a CAT scan in May 2021 with no contrast showed nothing  NO CONTRAST  MY CHOLESTEROL  was going up. The doctor said my HDL is higher and it should balance out. I think I should?ve been put on medicine. August 13, 2021 in the morning is when it all happened they should have given me TPA in the hospital is what I felt but I was not able to think and I really don?t remember much All in all I felt like I was just getting older and I was not thinking right but that comes with ages is what I thought I also had an episode at work where the screen got fuzzy and I had that eye disturbance again and they did an EKG and also check my blood pressure. It was high. My bullet pressure and I went to the eye doctor downstairs on the second floor and he said both eyes were fine.
Dizziness; Nausea/vomiting; Nausea/vomiting; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nausea/vomiting) and VOMITING (Nausea/vomiting) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021 at 2:15 AM, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nausea/vomiting) and VOMITING (Nausea/vomiting). At the time of the report, DIZZINESS (Dizziness), NAUSEA (Nausea/vomiting) and VOMITING (Nausea/vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatments and concomitant medications were not provided.     Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non Significant FU, Additional information included Anatomical location,Patient initials, Date of birth, event start date and time updated.
Short term memory loss/ Unable to remember what I was doing more than 10x/day; loss of focus and concentration; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 (Lot number: FH8027) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date 10Nov2021. Past drug history included: Codeine, reaction(s): "Codeine: Drug Allergy", notes: known allergies: None. The following information was reported: AMNESIA (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Short term memory loss/ Unable to remember what I was doing more than 10x/day"; DISTURBANCE IN ATTENTION (non-serious) with onset 21Nov2021, outcome "not recovered", described as "loss of focus and concentration". Therapeutic measures were not taken as a result of amnesia, disturbance in attention.  No follow-up attempts are possible. No further information is expected.
First dose / November 2019. Due to COVID / I passed the 2-6-month window. Today (05/21/2021), I received another dose; This case was reported by a consumer via call center representative and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2019).   On 21st May 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient reported case for himself. The age at vaccination was not reported. The patient stated that due to COVID, he was unable to receive the second dose of Shingrix, therefore he passed the 2 to 6 month window. On the day of reporting (21st May 2021), the patient received another dose of Shingrix. The patient's physician said that he should restart the vaccine series, but the patient's pharmacist said that it was not necessary and the dose the patient received on the day of reporting was considered a second dose (completed the series). The patient wanted to confirm whether he should restart the series or the dose he received on the day of reporting was considered as series completed. The reporter was in hurry and did not allow to ask further questions. The reporter did not consent to follow-up.
About a day after vaccination, the recipient developed lymphadenopathy on neck and arm; redness and swelling at injection site; itching and hives.
pt recvd vax & approx 2 hrs p/vax exp a total body rash;tx DPH;sx persist;MD feels that event is unrelated to Engerix-B;
Patient noticed numbness below elbow on day of receiving vaccine. It is slowing improving but not completely resolved.
This spontaneous report as received from a nurse practitioner, concerning to 133 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the an unknown number of patients (of the 133 patients) were vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse practitioner that on an unknown date patients were inadvertently administered GARDASIL that had been improperly stored. No adverse effects reported. This is one (1) of four (4) reports from the same source. Additional information is not expected. The nurse practitioner did not gave the consent to contact her.
Constant Nasal Drainage In Throat Persistent Scratchy Cough Congestion in Chest Ear Infections Low energy due to infections in ears and lungs Lasted 8 weeks getting progressively worse over time Prescribed Standard Antibiotics (Pill and Ear Drops) which cleared it up within 10 days.
16 year old male with no PMH who presented with chest pain. Initially on 6/10-6/11 had expected myalgias and headaches post vaccination similar to dose #1, but later 6/11 developed chest pain that made it impossible for him to sleep. It was waxing and waning but continued through 6/12 which after discussion with PMD ultimately led to referral into our facility for further evaluation. Received a dose of ibuprofen with marked symptomatic relief. No further medications given during his time, his chest pain had resolved after that ibuprofen dose and was at clinical baseline until discharge on 6/15. Prolonged hospital course was to arrange for cardiac MRI to be done for comparison. Otherwise had serial labs (documented below) which had trended in the right direction.
Pt recvd Td p/being stuck in the finger by a needle & exp discomfort in lt upper arm w/movement; Pt did not have an dec or limited mobility;
Pt received Moderna vaccines on 03/22/21 and 04/19/21. Pt presented to the ED on 10/02/21 with complaints of a cough, fever, headache, and body aches. Pt was found to be COVID positive
Swollen lymph nodes - 2.5cm x 3.5cm posterior auricular/1x2cm preauricular/also with diffuse swelling of axilla & 8x10cm area of edema/erythema around injection site. Treated with MOTRIN only.
Patient left the room after the vaccination with her mom and seemed fine. They were shopping out in front of the pharmacy when the mom came back over, approximately five minutes after they left the room. Patient was very dizzy and looked like she was going to faint. She was leaning heavily on mom. We immediately got her a chair, a cool wet cloth, and a bottle of water. Her mom had some crackers and she ate a few of those. After about five to ten minutes patient was able to get up and they left.
12 hours post vaccine: chills, fever, body aches, injection site pain, loss of appetite
Fever of 103.2F, pinpoint macular rash on the chin, neck, upper chest and back.
chills, night sweats, fatigue, joint pain, headache, nausea, diarrhea, inflammation all over body, fever.
First vaccine was given 05/12/2021 and later that day I started menstrual bleeding and have already had my menstrual cycle a week prior. But I thought it was just my menstrual cycle being funny. During t next 7 days my menstrual bleeding was extremely heavy.btoday I received my 2nd dose and approximately 2 hours after I started to have vaginal bleeding and this time I also have an extremely painful migraine on the left side of my head.
Malaise; Dizziness; It hurt at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Malaise), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (It hurt at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (Dose 4), Pfizer (Dose 3) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Vision abnormal (Vision issues, vision was bad.).    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (It hurt at the injection site). At the time of the report, MALAISE (Malaise), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (It hurt at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: temperature was elevated.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient's year of birth was1953. The patient want to report a mild reaction which had experienced after getting the Moderna Covid-19 Vaccine, Bivalent. It hurt at the injection site, temperature was elevated, malaise and dizziness. The lot number print was too small to read also patient had vision issues, it was bad.  No treatment medication was provided.   Reporter did not allow further contact
Initial unsolicited report received from nurse via pharmacist on 03 Oct 2017. This case is linked with 2017SA195908 and 2017SA195913 (Same lot number). This case involves female patient (Age was not reported and reporter thinks that gender was female) who was vaccinated with a dose of FLUZONE QIV (batch number: UT5936LA, expiry date: 30 Jun 2018, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination patient had lips swollen, numbness and pain in arm radiating to under arm. Laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none.
Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case was linked with 2018SA251660, 2018SA251703 and 2018SA251366 (Same reporter). This case involves an eight years old patient (gender not reported) who was vaccinated with FLUZONE QUADRIVALENT. The patients medical history and concomitant medications were not reported. On 31-Aug-2018, the patient received 0.5 ml dose of FLUZONE QUADRIVALENT (batch number UI997AA) (expiration date, route and site of administration was not reported). It was reported that, the product was shipped Tuesday and delivered after the 48 hours shipping. It was an actual medication error due to product storage error. It was reported that, the MA who administered these vaccines said they were still cool. No other vaccine was given to patient. It was unknown whether the patient had any adverse event. 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 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. List of documents held by sender: none.
Insomnia; Extreme sleepiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Oct2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Previous pulmonary embolism" (unspecified if ongoing); "pancreatic neuroendocrine tumor with liver metastasis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 25Oct2021, outcome "recovering", described as "Insomnia"; SOMNOLENCE (non-serious) with onset 25Oct2021, outcome "recovering", described as "Extreme sleepiness". Therapeutic measures were not taken as a result of insomnia, somnolence.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had no known allergies.  Follow-up attempts completed. No further information is expected.
2" x 2 1/2 inch raised indurated area of erythema (L) arm.
Reported by school nurse to Public Health Dept. that the injection site was reddened, hard and the size of a baseball. Patient had discomfort at injection site. School nurse had called grandma to pick her up from school. PHN did call her also but no answer. Message left and she did return call. Grandma was going to take her home but PHN requested that she go to doctors office to have it checked out. Grandma will take her to PED's at this time.
Information has been received from a registered technician concerning a pt who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot651330/1048P;exp: 4/26/07). Subsequently, the pt experienced red, hot sore arm at injection site within 48 hrs post vaccination. Treatment is unk. The registered tech had no other available information and placed a nurse practitioner on the phone. The nurse practitioner stated that she is not comfortable using this lot 1048P until a lot check is performed. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill. Additional information has been requested.
Experienced significant apnea during the first 24 hours post vaccination with Pediarix, Prevnar also given on the same day about 12 minutes after Pediarix. She required significant stimulation, with oxygen delivered by CPAP. Also required bag mask ventilation for a period. 2/6/06 Discharge Summary reviewed stated patient experienced hypotension, enterococcus sepsis, jaundice, prematurity, SGA, RDS, PDA, heart murmur, hyper/hyponatremia, apnea, bradycardia, hyper/hypoglycemia, pulmonary insufficiency of prematurity, BPD, metabolic acidosis, hypo/hyperkalemia, ventriculomegaly, anemia, GERD, retinopathy of prematurity, stage 4.
Got shingles two years after getting the shots/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (severe) and post herpetic neuralgia (painful than shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles two years after getting the shots/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and again experienced very very light case of shingles at the same place. The patient stated that he or she never heard of it but found out 20 percentage of people over 60 years old end up with the shingles. The patient stated that alone is worth of getting the shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Aches in the lower back and legs.; Aches in the lower back and legs.; This is a spontaneous report from a contactable consumer or other non hcp.  A 41-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3247, Expiration date unknown), via an unspecified route of administration, anatomical location arm left on 12Feb2021 09:15, at single dose for Covid-19 immunization. The patient Medical history included hyperaldosteronism. concomitant medication included omeprazole (PROTONIX [OMEPRAZOLE]), spironolactone (ALDACTONE [SPIRONOLACTONE]), amlodipine besilate (NORVASC), nebivolol hydrochloride (BYSTOLIC). Historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3247, Expiration date unknown), via an unspecified route of administration, anatomical location Left arm on 23-JAN-2021 09:00 AM, at single dose for Covid-19 immunization. on 12Feb2021 at 14:00 patient experienced aches in the lower back and legs. The patient did not receive any treatment for the event The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not tested for COVID-19. The outcome of event was recovering.
SLEEPINESS; FATIGUE/VERY TIRED; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered to left deltoid on 06-APR-2021 for prevention covid 19. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 06-APR-2021, the subject experienced sleepiness. On 06-APR-2021, the subject experienced fatigue/very tired. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, sleepiness, and fatigue/very tired, and the outcome of fever was not reported. This report was non-serious.
dose 4 Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing), notes: Hashimoto's, Asthma; "Asthma" (unspecified if ongoing), notes: Hashimoto's, Asthma. There were no concomitant medications. Past drug history included: Imiquimod, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20May2022, outcome "unknown", described as "dose 4 Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid from 03Sep2022 to 07Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was looking pale and getting sweaty and stated they may pass out.  Patient was given apple juice, water, and crackers.  Patient stated he was feeling better after eating the crackers and that he was up all night due to working third shift and didn't eat anything.  Patient remained on site for 45 minutes (including the recommended 15 minutes after vaccine administration) until he felt well enough to drive home.