chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; I had both of my shingle shots and have shingles now; 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.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd 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) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had both shingle shots and had shingles at the time of reporting. The patient did have a milder case because the patient had both shots. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation was not reported. No further information would be available.
Felt miserable the next day from the vaccines; she got both the covid vaccine booster and the shingles vaccine at the same time; she got both the covid vaccine booster and the shingles vaccine at the same time; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: (141003). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing), notes: Diagnosis or Reason for Use:, Rheumatoid Arthritis. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Unknown Manufacturer.), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt miserable the next day from the vaccines"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "she got both the covid vaccine booster and the shingles vaccine at the same time".  Additional information: Patient reported she got both the covid vaccine booster and the shingles vaccine at the same time at the end of February (exact date unknown) and her MD advised her to stop taking xeljanz for 1 week after the vaccines. patient reported she felt miserable the next day from the vaccines but no change in rheumatoid arthritis symptoms were reported related to missed doses and patient has since restarted the medication. MD was aware.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101638959 same reporter, patient; different drug/event
Pain at time of injection, within 24 hours increased pain and redness at injection site.  On PE on 3/14 with erythema, induration and warmth and increasing pain.
The decedent was a 61 year-old male who passed away suddenly at home. No complaints of well-being were reported the evening before. No resuscitative measures were attempted as the patient was already dead by the time EMS arrived (EMS incident time, 0932-0954).The patient was pronounced dead on 8/12/2021 at 09:38.
Developed paresthesias, migraine headaches, and then was admitted on 3/20, three days after dose #2 with acute dysarthria thought to be due to complex migraine. MRI was negative for stroke. Additionally she had accelerated hypertension. She reports that migraines have not been a problem for 10 years prior. Hypertension has been an ongoing issue.
very dizzy/ terrible dizziness; so bad that it was hard for her to walk; she probably has benign vertigo; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscularly on her left Arm on 03Apr2021 15:30 (Batch/Lot Number: ER8735) (at the age of 63-years-old) as single dose for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic chromosomal abnormalities, endocrine abnormalities (including diabetes), obesity, brain surgery for a benign tumor (5 years ago), bipolar (diagnosed 20 years ago). Family medical history was none. Concomitant medications included other medication (unspecified) for 20 years. History of all previous immunization with the Pfizer vaccine considered as suspect included none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Saturday, she had the first shot and was fine that day, but the next morning, on 04Apr2021 10:00, the whole room was running around like a merry go round. She was very dizzy. She panicked and closed her eyes and opened and was not better. It has gotten much better now, but she was still dizzy after 1 week. She said that it was so bad that it was hard for her to walk. She went to her doctor and they said it has nothing to do with Pfizer. They said she probably has benign vertigo and gave her some exercises. She examined her and said it was benign vertigo and gave her some exercises on YouTube. Her doctor said if she doesn't get better, call back on Monday and she will prescribe a pill, but she does not want to take any pill, but she mentioned it did not work. She mentioned that her doctor told her to take the 2nd dose, which was scheduled on 24Apr2021. She was asking for Pfizer's thoughts on what to do as she heard that second dose effects might be worst that first dose. Patient also wanted to know if she can delay her second dose for 3 to 4 weeks due to her upcoming project. The outcome of the event dizziness was recovering, and other events was unknown.  No follow-up attempts are needed. No further information is expected.
On 3/7/01, developed a shrill cry at approx. 18:30. Right leg was red and warm. Bulging fontanel, P-170 (mom is a nurse). Took to ER and they recommended Advil instead of Tylenol. On 3/8/01, pt was irritable with no appetite. On 3/9/01, pt was not sleeping well and had 2 loose stools. On 3/10/01, had a fine red, rash on trunk and back of neck, a shrill cry and took to Urgent Care and was told to "watch him". On 3/11/01, eating better and was his happy self and rash was fading.
patient had vaccine on 9/5, had arm pain x48 hours, called md to report discomfort, went in for xray on 9/13, recommended use of OTC anti-inflamatories and stretches, still significant arm pain, going to Physical therapy starting 9/23
Earache (right ear); Bit of redness on the left arm; bit of itchness on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Earache (right ear)), ERYTHEMA (Bit of redness on the left arm) and PRURITUS (bit of itchness on the left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Mar-2021, the patient experienced EAR PAIN (Earache (right ear)), ERYTHEMA (Bit of redness on the left arm) and PRURITUS (bit of itchness on the left arm). At the time of the report, EAR PAIN (Earache (right ear)) had resolved and ERYTHEMA (Bit of redness on the left arm) and PRURITUS (bit of itchness on the left arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing was delayed on an unknown date.       This case was linked to MOD-2021-081317 (Patient Link).
Slight headache and chest pain around the heart. Happened around 9pm that night. Chest would squeeze that around near my heart and made it hard to move. Anxiety would kick as well and make it worst. Slowly tamper off when days went by but still have the effect until now.
Patient was counseled and consented to receive Men B vaccination in our office.  Patient had not disclosed that he had received 2 doses of the Men B vaccine at a local pharmacy.
9/28 Almost immediate left shoulder pain, spreading down from deltoid muscle. 9/30 Limited ROM, left arm. 10/6 Pain begins in right hand, stiff and swollen by evening, increasing ROM problems. 10/8 Trouble dressing. Right shoulder pain begins, hand gets better, extreme pain in shoulder at night. 10/10 ROM better and pain decreased. 10/11 Left hand symptoms begin swelling, pain, difficulty with dressing, neither heat nor ice is a relief. 10/13 Swelling decreases, much improved. 10/24 Left shoulder pain begins, increases overnight, limited ROM. 10/26 More limiting ROM and pain. Trouble drying after shower, applying deodorant. 10/27 Slowly improved. 11/10 Right arm pain begins, decreases next day. 11/16 Left hip pain begins after nap,  still limping next day. 11/18 Left arm pain begins, not near joint. 11/19 Limited ROM in dressing in the AM, got better throughout the day.
pt recv vax & c/o stomach hurts, lips cyanotic, lay down on exam table;became diaphoretic, pale, eyes closed, disoriented time/place, BP 88/48;pt given 02 & epi w/good response
mom reports that initially pt fell asleep x 4-5hrs p/inj;woke up & started screaming & leg swelled up real bad @ inj site;unable to reach family MD;to ER blood count w/WBC 20,000;t102.7;pt irritable, dec appetite
I had a sore arm for a little less than 2 days, which subsided, on its own, but by 48 hours after my first dose, I started experiencing pins and needles up and down my left arm/leg/hand/foot. The same side as my injection. By 72 hours after my 1st dose, I was experiencing the pins and needles up and down both arms, legs, hands and feet. I have had these symptoms for 2 1/2 weeks. The pins and needles continually move. I also started feeling tingling in the lower right side of my face/chin/lip 5 days after my 1st dose. One week after these symptoms showed up, I had severe ?brain fog? where it was difficult to keep my thoughts straight as well as dizziness. The ?brain fog? and dizziness s haven?t been as severe as that
p/vax pt exp local area soreness; erythema; edema at inj site lt posterior arm tricep muscle;area affected approx 15cm span erythema/edema
H/o multiple known allergies, Bronchial Asthma, DM, HTN, HLD who was BIBEMS from after developing progressively worsening dyspnea, wheezing and facial puffiness following administration of his first dose of Pfizer COVID vaccine, with signs of severe generalized allergic reaction. Pt given IV solumedrol, Benadryl, IVF, Pepcid, and one dose of IM epinephrine on site and then EMS activated.  According to EMS records, on arrival at hospital pt's sats were in the 80s, and his lung sounds were very tight, almost no air movement detected, with pt in severe resp distress and anxious.  On arrival in our ED, pt tachycardic, with good air entry with good b/l breath sounds, remains mildly anxious but answering questions well. Initial BP here was 143/91.  Except mild hypokalemia and metabolic acidosis, patient's initial labs were within normal limits. He reports occasional wheezing, sore throat/dryness, dry cough intermittent SOB and palpitations but denies any current chest pain, fever, headache, nausea/vomiting. Patient still in hospital as of 8/11/21.
Pt was given his vaccines at his 11 year WCC and was admitted to the hospital on 9/13 due to decreased LOC, confusion, was hospitalized for almost 2 weeks and diagnosed with meningitis but the cause was never discovered
no adverse event happened however, wrong drug was administered. Pt. was intended to receive Pfizer monovalent to complete series vaccines. Pt was given Pfizer Bivalant instead. RN observed  and pt did not have any adverse reactions. On call MD consulted and suggested pt needs to go back in 2 months to receive additional covid bivalant vaccine to complete
Patient presents to the ED 11/5/21 due to recent decline following COVID-19 diagnosis 5 days prior. The patient was recently admitted to hospital from 10/10/2021 to 10/16/2021 due to acute respiratory failure and suspected acute on chronic diastolic heart failure exacerbation. He was discharged to a nursing facility and subsequently tested positive for random rapid Covid test on 11/1/2021. He was moved to another nursing home following positive test. Initially he was asymptomatic but developed fever, myalgias, and increased fatigue on 11/2/2021. He then became more short of breath especially with ambulation. SPO2 reported down to 88% on room air with ambulation. He has reportedly not been eating or drinking well for the past several days and has had an increased cough that is intermittently productive. He has also experienced mild nausea and diarrhea. He denies any loss of taste or smell. He has reportedly had a significant functional decline over the last several months.
Felt a little bit foggy; Cough; Headache; This spontaneous case was reported by an other and describes the occurrence of CONFUSIONAL STATE (Felt a little bit foggy), COUGH (Cough) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), LOSARTAN POTASSIUM (LOSARTAN POTASSSIUM), HYDROCHLOROTHIAZIDE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and PHLEBODIUM AUREUM EXTRACT (HELIOCARE) for an unknown indication.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced CONFUSIONAL STATE (Felt a little bit foggy), COUGH (Cough) and HEADACHE (Headache). At the time of the report, CONFUSIONAL STATE (Felt a little bit foggy), COUGH (Cough) and HEADACHE (Headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by reporter.
Full body aches, slight fever, muscle weakness, extreme fatigue, and severe neck pain. Acetaminophen, Ibuprofen and water did not lessen symptoms. Symptoms lasted until 4:00 a.m. on 9/12/2021.
Immediate loss of use in right hand, wrist and elbow. Numbness and tingling and swelling in fingers on both hands and fingers. Still ongoing to this day with flare ups 5 times since vaccination. I still can?t raise my right arm over my head and there are times I?ll lose the use of right arm entirely. During flare ups there is inflammation in my hand joints extending to my wrists and then my entire arm. I used to be able to see knots on my joints and it would be very painful.. when I get a flare up I can go 2-3 days of being unable to use my hands or move my arm.. it can happen in both arms but it happens always and more with my right arm. I?ve been to my ortho clinic about 4 times and they had me wear a wrist brace but it really didn?t help. I have tried the TENS unit and take Motrin for pain. The ortho clinic has given my steroid shots which help for awhile but the flare ups always come back.
had a bad reaction that looks like a non-specific systemic inflammation and developed toxic neuropathy; had a bad reaction that looks like a non-specific systemic inflammation and developed toxic neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: TOXIC NEUROPATHY (medically significant), INFLAMMATION (non-serious), outcome "unknown" and all described as "had a bad reaction that looks like a non-specific systemic inflammation and developed toxic neuropathy". The events "had a bad reaction that looks like a non-specific systemic inflammation and developed toxic neuropathy" required physician office visit. Therapeutic measures were taken as a result of toxic neuropathy, inflammation. Clinical course: The patient took the Pfizer booster about a year ago and had a bad reaction that looks like a non-specific systemic inflammation and developed toxic neuropathy, the specialist suggested the Evu shot, so she took it and was subsequently shown that it was ineffective, and then she was looking to take Novavax. She was worried about taking Novavax.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right shoulder where vaccine was administered, was very sore, to touch and to movement, this soreness is still there today sometime worse then other. Saw dr, my physician, he said it was bursitis and gave me some range of motion exercises to do and warned that it would probably get worse before it got better, this was 07-18-2013. No other treatment has been sought.
I had a sore throat that I thought was just an upper respiratory infection. I called my doctor and had a telehealth visit, they called in a prescription for Augmentin to prevent me from getting a bacterial infection. Once I started taking the Augmentin 11/17/22 we discovered that my body is very sensitive to it as I developed diarrhea for 10 days. The symptoms did go away but I had a bit of residual symptoms left over and on 12/27/22 I tested positive for COVID-19. I will be calling the doctor to find out if they want me to just stay in quarantine or will be prescribing Paxlovid.
fell/passed out (unknown) at home, taken by ambulance to local hospital, small bleed noted on CT scan, transferred to tertiary care center, f/u scan after 6 hours unchanged. Sent home. next morning unresponsive, transported back to tertiary care center. required ventilation en route.. massive cerebral hemorrhage noted on CT scan in different area. due to advanced dementia and unresponsiveness life support removed around 9pm that night. passed away at 9am on 3/1.
on 7/30 at night, 12 hours after vaccine ter, he was tired, he had chills, headache, he was sweaty and had body aches. He woke up in the morning, took an Advil, felt better. At night his symptoms of fever returned, but managed without antipyretics. Sunday, 08/01/2021, he developed chest pain at 10 a.m., which was transient and lasted only a few minutes. He felt better all day that day, then at 6 p.m. he had another episode of chest pain which lasted for 30 minutes. It was not radiating. It was sharp, but he had no shortness of breath. It did not go up his jaw or to the back. He also had some shortness of breath and generalized fatigue, so he was taken to Hospital by family. He was noted to have normal vital signs, mild ST elevation on a 12-lead EKG and elevated troponin of 1.92 Transferred to Hospital ECHO cardiogram Normal
05/06/2022 I started getting double vision. I went to my eye doctor and was diagnosed with Esophoria on 5/17/2022. I had a round of testing and then a second round of testing on 5/19/2022. The material that the lens in my glasses is made of a different material because they can't use a standard lens. It is a prism greater than 5 diopters.
Expired dose of ActHIB and Daptacel were administered to two month old patient, No AE; Initial information received on 10-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two months old female patient who was administered with an expired dose of HAEMOPHILUS TYPE B (HIB) (Act-HIB) and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (DAPTACEL).  Medical history, medical treatment, vaccination and family history were not provided.  On 10-Mar-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (DAPTACEL) (lot C5367A and expiration date 30 -Jan-2020) via an intramuscular route in the right leg and also 0.5 ml dose of suspect HAEMOPHILUS TYPE B (HIB) vaccine (Act-HIB) (lot UI937AAA and expiration date 05-Nov-2019) via an intramuscular route in the left leg for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of report, 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 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.
felt very sick; fever of 100 during late afternoon; body was sore; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt very sick), PYREXIA (fever of 100 during late afternoon), MYALGIA (body was sore) and FATIGUE (exhausted) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21 and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced ILLNESS (felt very sick), PYREXIA (fever of 100 during late afternoon), MYALGIA (body was sore) and FATIGUE (exhausted). On 03-May-2021, ILLNESS (felt very sick), PYREXIA (fever of 100 during late afternoon), MYALGIA (body was sore) and FATIGUE (exhausted) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported Treatment medication include Motrin Action taken with mRNA-1273 in response to the events was not applicable.
about 2 hours afterwards i had slight problem breathing. Chest pains have been on and off ever since. Sometime i feel like my heart is thumping.
There was common symptoms of body arc, high fever, headache, dizziness etc. after few hours of 1st dose (03/02/2021) and worse with 2nd dose (04/02/2021). Symptoms got better after ~48-72 hours. Then after 72 hours (~04/06/2021) I woke up with so much pain and stiffness in my joints of hands, arms, shoulder, ankle, feet. Symptoms get better and worse in a day but it never went away even after 10 days.
resident was on hospice, chronically ill w dementia, COPD, HTN, failure to thrive, passed away 1/13/21. Not certain injection related as he was declining already.
severe pain & swelling;inflammation extended from elbow to shoulder & half way around arm;other sx included fever, chills, joint pain, inc WBC & inc sed rate;