chrisvoncsefalvay/vaers-outcomes huggingface dataset:
so immediately after the shot my arm starting burn and my arm felt like very heavy and as the day went on my whole arm and shoulder were numb by the evening. The next morning my whole arm and shoulder was the same and couldn't move it at all.  Back pain, numbness and itchiness.  Because of my itchiness i took prescription medicine and all of this. Few weeks later my eye started twitching and it was constant for a month and the doctor told me not to anything and neither he did any testing
Tingling in lips, constipation, and ongoing uterine bleeding.  The uterine bleeding is post menopausal and occurred 5 months after last menstruation 9/15/2021.  Uterine bleeding has lasted for 5 days  since 2/17/2022.  Soreness of breasts and swollen lymph nodes are present as well.  Constipation since second dose. No bowel movements for 5 days either since 2/17/2022.  Also severe depression and thoughts of suicide since first shot on 1/17/2022 that has not abated.
menstrual cycle started 8-9 days later than expected. almost 4 weeks after second dose and still feel pain in lower right back side, worse in the morning.  constantly feel thirsty, drinking 2.5-3L of water a day and still thirsty(wasn't experiencing the same before vaccine)
Patient had pcr test which confirmed he was covid positive; Patient had pcr test which confirmed he was covid positive; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0150) on 02Apr2021 (at the age of 52 years old) as dose 1, single and on 23Apr2021 (Lot Number: ER8735) as dose 2, single both via an unspecified route of administration for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. Patient 6 months following primary series was close contact to a household member with covid. Patient had pcr test which confirmed he was covid positive. Symptoms include mild cough. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on an unspecified date in 2021 and sars-cov-2 test: positive on 06Nov2021. The outcome of the event vaccination failure was not recovered and for all other events unknown.
Hospitalized 11/10/2021; COVID-19 positive 11/10/2021; fully vaccinated  Admission Date: 11/10/2021 Discharge Date:  11/18/2021 Admitting Physician:  MD Attending Physician:  MD Discharge Clinician:   MD Primary Care Provider at Discharge: No primary care provider on file. Hospital Course:    Pt is a 69 y.o. female with PMH of Non-ischemic cardiomyopathy EF 35%, DM type 2, CKD3, and GERD. She was hospitalized at BW on 11/10 concerning for hypoxic respiratory failure secondary to COVID19 pneumonia. She has been vaccinated.   Onset of symptoms were on 11/5. Patient tested positive on 11/10.    Initially hypoxic and requiring up to 2L of supplemental O2. Her Procal was normal. She was started on Decadron 6 mg daily and Remdesivir. Initial lab work up revealing for mild AKI likely pre renal and due to poor po intake which improved after gentle fluid hydration. Home diuretic held during hospital course and this should likely be resumed as outpatient. She is euvolemic on day of discharge. Similarly her home carvedilol has been hold for lower BP and HR in the 50's-60's. This can likely be resumed as outpatient. Her lisinopril is resumed on discharge.    Follow up CXR on 11/14 with predominantly right sided infiltrate which developed since 11/10. She was started on Rocephin and Azithromycin and completed 5 day course of therapy for CAP with improvement. She should continue dexamethasone through 11/20 given mild continued oxygen needs.    She has moderate protein calorie malnutrition and should continue with supplements. She refused subacute rehab placement and was established with home care services. Daughter is a former nurse and willing to take care of her, they will live together. Her diabetes is poorly controlled with an A1c of 9.3 and this should be followed up outpatient.    She was weaned to room air at rest with 2L oxygen with exertion and bedtime. CM assisted in establishing new PCP and safe discharge plan. Cardiology office will act as PCP until new physician established.
Achiness in legs, fatigue, some chills and cold sweats. It's about the same intensity as the first shot.
1 day after receiving PREVNAR vaccine pt. c/o pain to (L) deltoid, redness and swelling to (L) deltoid and feet bilat and pain to (L) deltoid. Symptoms persisted x 2 wks. No treatment as pt. reported symptoms 2 wk. after vaccine. No cellulitis present per MD.
Joint pain; Muscle pain; Tiredness; headaches; Nausea; arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 89-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Mar2023 as dose 4 (booster), single (Lot number: GL0446) at the age of 89 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (3rd dose, Intramuscular, Batch/Lot number: FL3197), administration date: 02Dec2021, when the patient was 87-year-old, for COVID-19 Immunization; BNT162b2 (2nd dose, Intramuscular, Batch/Lot number: EN6207), administration date: 23Mar2021, when the patient was 87-year-old, for COVID-19 Immunization; BNT162b2 (1st dose, Intramuscular, Batch/Lot number: EN6203), administration date: 02Mar2021, when the patient was 87-year-old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (medically significant) with onset 11Mar2023, outcome "not recovered", described as "Joint pain"; MYALGIA (medically significant) with onset 11Mar2023, outcome "not recovered", described as "Muscle pain"; NAUSEA (non-serious) with onset 11Mar2023, outcome "unknown"; FATIGUE (non-serious) with onset 11Mar2023, outcome "unknown", described as "Tiredness"; PAIN IN EXTREMITY (non-serious) with onset 11Mar2023, outcome "unknown", described as "arm pain"; HEADACHE (non-serious) with onset 11Mar2023, outcome "recovered", described as "headaches". Therapeutic measures were taken as a result of arthralgia, myalgia which included physical therapy. Clinical course: When asked for regarding his concomitant medications, the patient stated he is on about 6 regular drugs and 4 supplements and declines to go through the medications at the time of report. The patient received the 4th shot of the COVID shot that is the Bivalent last Thursday (09Mar2023). He is having several problems. He is reading in the book that says 5 days usually gone. He has tiredness, headaches, joint pain, muscle pain, nausea, and arm pain. He asked is there anything he can do. He stated the headaches are gone. He got the shot last Thursday (09Mar2023) and last Saturday (11Mar2023) started with symptoms, and the symptoms really kicked in on Saturday (11Mar2023), Sunday (12Mar2023), and Monday (13Mar2023). Joint pain and muscles are killing him. He had to go to therapy and do lower body. The physical therapy girl said the stretching and relief wouldn't last and therapy was not helping with this joint and muscle pain.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were Reported. No Treatments were Reported.   This case was linked to MOD-2021-395985.
Fever, chills, sinus congestion, extreme fatigue, general body aches.  Followed by migraine.  Symptoms residing 24 hours later
Pt was given a booster with Moderna instead of Pfizer, no adverse events. Pt is only experiencing common side effects: pain at injection site and a slight fever on the day of the booster was given.
fever; vomiting; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain". Additional information: Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After receiving the vaccine a couple hours later my left arm started burning and had extreme itching  below the site  with redness appearing and nausea. About 9 hrs after injection  I then  spike a temp of 103 that lasted about 7 hr. aching some sob and  and was unable to get out of bed no energy.  Taking Tylenol and Zophran Nausea continued for 4 days. Redness worsened on day 2  to  left arm 4x5 inches was severe tender and extremely hot to touch  applied ice pack for 15 -20 min. 3-4 times a day as you could stand to touch your arm. Applied cortisone cream on with no relief . Took Benadryl 50 mg 3xday  . To the doctors on  Monday 13th
At a vaccination clinic, Patient requested a Pfizer Bivalent booster shot, but was given FluzoneHD instead.  He stated he already received the flu shot previously.  After the error was made, we gave him the Pfizer Bivalent booster shot.
Pt had slight tingling of left pinkie finger after receiving vaccine.She felt flushed and felt slightly sweating. Pt was anxious and felt she had heightened sense of awareness. Called paramedics. Pt had a BP of 107/60 and a HR of 70. Pt states her BP is usually low and 107/60 was normal for her. Patient states she feels tingling over entire body. Gave pt 50 mg of Benadryl IM. Released patient to EMT. After examining patient, EMT released pt and asked her to buy some oral benadryl. Warned patient about possible drowsiness with Benadryl injection.  Followed up with patient on 10/06/06. Pt states she is fine and has had no further problems.
Itchy throat, tightness in chest, rapid heartbeat, cold chills, dry cough.
Fever 102.4, Headache, Lethargy/fatigue, nausea, stomach ache
Pt vaccinated /w DTP/OPV & died same evening. Prior to death, infant was alone & had been drinking from a bottle of milk, found non-responsive. Taken to ER- pronounced dead on arrival. There was some possible aspiration.
VAERS PT admitted 5/1/21. SARS-COVID-19 resulted positive 05/01/21 12:06. PT received dose 1 Pfizer vaccine Lot EN6198 on 3/16/21. Dose 2 Pfizer vaccine received 4/6/21 Lot ER8734.
her balance has been off; falling; wrist fracture; muscle tightness; Patient can not walk; pain all over the body; leg weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: ER8733) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose administered on 01Mar2021 around 15:00 in left arm., Lot number: EN6203, NDC: Unknown , Expiry date: Unknown), administration date: 01Mar2021, when the patient was 70 years old, for covid 19 immunization. The following information was reported: BALANCE DISORDER (medically significant) with onset 2021, outcome "not recovered", described as "her balance has been off"; FALL (medically significant) with onset 2021, outcome "unknown", described as "falling"; WRIST FRACTURE (medically significant) with onset 2021, outcome "unknown", described as "wrist fracture"; MUSCLE TIGHTNESS (non-serious) with onset 2021, outcome "not recovered", described as "muscle tightness"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "not recovered", described as "Patient can not walk"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain all over the body"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "leg weakness". The events "her balance has been off", "falling", "wrist fracture", "muscle tightness", "patient can not walk", "pain all over the body" and "leg weakness" were evaluated at the physician office visit and emergency room visit.  Clinical information: Patient has been having muscle tightness: Began after the second dose of the Covid vaccine. After the first dose of the Covid vaccine, patient was okay. Patient constantly wakes up crying. Patient cannot walk: Began after the second dose of the Covid vaccine. Patient has pain all over her body: Began at least one and a half to two weeks after receiving the second dose of the Covid vaccine. Reporter does not have exact dates. Patient's legs are weak, and patient has no balance: Began at least one and a half to two weeks after receiving the second dose of the Covid vaccine. Patient fell and could not get up: Whenever patient fell and fractured her wrist that was the first time. Patient has fell again since then. Patient fell in the house. Reporter has been having to help patient get in and out of the bathtub. Reporter has been having to help patient put her clothes on. Patient is completely different than what she used to be. Patient cannot stand up, reporter has to help her. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks) and no AE(s) following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 at 12:30 as dose 1, single (Lot number: EP7534), in left arm, on 08Apr2021 at 13:00 as dose 2, single (Lot number: EW0158), in right arm and on 20Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FH0827) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hashimoto's" (unspecified if ongoing), notes: hashimoto's. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19; was treated with Paxlovid from 10Jun2022 to 15Jun2022.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Small patch of hive on my inner thigh. Grew into four separate patches, two on the inner part of my thighs and two on the underside of both my arms. Have come and gone consistently to this very moment, October 30, 2010
Per Client on 3/10/2021 received a Pfrizer COVID 19 vaccine in left arm, at Walgreen location. Per Client, vaccine was given into "my rotor cuff", and pain started immediately after vaccine. One week later, mid-day, pain worsen in left arm, and unable to have full use of left arm. 2-3 weeks later seen at Clinic, and was instructed to follow up with PCP. Client able to be seen by PCP six weeks after 3/10/2021, which was 5 days after the 2nd vaccines, and pain in left arm, along with other concerns in arm still present. Per Client, PCP prescribed  five days of steroids, and Meloxicam for pain. Per Client one week after completing the steriods, in to see an Orthopedic MD, and two or three weeks later started physical therapy on left shoulder and arm. Per Client, also have been taking Ibuprofen for pain, which seem to be helping to decrease the pain severity. Per Client, continuing to follow up with PCP, and has been in communication with the Walgreen, were the vaccine was administered. PHN suggested that Client continue to follow up with PCP, go into Urgent Care, ER, and to call 911 if having a medical emergency. Client verbalized understanding information provided.
Fever, myalgias x 2days. T max 102.7 Right arm weal red, hot injection site reaction
pt recvd vax & thigh was red & swollen w/ heat; blue tinged bruise; no t; saw er MD; was given prednisone;
She got her vaccine, she was having very bad shakes, was kind of cold and running a fever, and having a headache.  She didn't feel super dizzy.  A week after her vaccine she was bleeding (pregnant) and was diagnosed as having a miscarriage.  She was 9 1/2 weeks pregnant.  The hospital did an ultrasound and some blood work and they did not find a heart beat on the US.  She is currently bleeding but it's like a period, doesn't know if she is passing it or not, but has an APT today to see the doctor to see what is going to happen from there.
Sudden onset tired, exhausted, noted to be tacky cardiac.  Check my pulse (retired RN, BSN,OCN.)  over 150., peripheral and attempted to reck apical w stethoscope,   Hard to count.  Noted pulse 156 on Fitbit.  Called local Urgent Care, Staff noted I sounded SOB on the phone, I was.  Drove self to Urgent Care Office,  EKG done -tacky, VS done,  labs drawn.  All labs WNL except D Dimer as >2. ++, (do not have in front of me).  Was recommended that I go to ED- to be r/o for PE.  Went to ED repeat EKG, Labs, CT scan w contrast and negative for PE.  Discharged to home.
fever; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and PAIN IN EXTREMITY (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (fever) and PAIN IN EXTREMITY (Sore arm). At the time of the report, PYREXIA (fever) and PAIN IN EXTREMITY (Sore arm) had not resolved. Not Provided          Treatment details were not provided.
General fatigue, nausea and lip swelling started about 1-2 hours after injections. Given Benadryl per advice of on -call physician. Symptoms improved but not resolved until following day
ActHIB mixed/ reconstituted with diluent that expired on 22Mar2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00559740) and transmitted to Sanofi on 13-Apr-2021.  This case is linked to cases 2021SA124061 and 2021SA133014 (same reporter).  This case involves an 1 years old female patient who was administered with expired 0.5 mL dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ143AA and expiry date: 22-Mar-2021) via intramuscular route in the left thigh (expired product administered) for prophylactic vaccination on 02-Apr-2021.  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   No other vaccines received by patient.   It was an actual medication error case due to expired vaccine used (latency: same day).   It was reported that patient received ACTHIB in which diluent expired but the powder doesn't expire until May. Reporter states that 3 different patients received the Act-HIB on 08-Apr, 24-Mar and 02-Apr. She requests to know what they should do, should they revaccinate. Box had batch: UJ143AAA and expiry date: 22-Mar-2021.   At the time of reporting, No specific 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 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.
Information has been received from a licensed practical nurse concerning a 13 month old male who on 12-AUG-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot # 664021/0502Y) 0.5 mL subcutaneously.  On 13-AUG-2009, the patient experienced large area of redness and swelling at the injection site of the left upper arm.  The patient's mother called the office and was recommended to give the patient TYLENOL and apply cool compresses.  The patient had subsequently fully recovered.  No laboratory diagnostic test were performed.  The nurse added that quite a few other patients have had similar injections site reactions over the last couple of months.  This is one of two reports from the same source.  Additional information has been requested.
Patient had chills and a fever that started on 12/30/2020 @ 12:00am.  The highest fever recorded was 100.6.  He took Tylenol on 12/30/2020 @ 6:00am.  His symptoms resolved on 12/30/2020 at 8:30pm.