chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site was painful and swollen; injection site was painful; injection site was swollen; irritation of the nerve; radiated pain up her neck; nausea; vomiting; headache; swelling of the deltoid; Initial information received on 22-Jan-2020 regarding an unsolicited valid serious case received from a physician.  This case involves an adult female patient of unknown age who presented injection site was painful and swollen (vaccination site inflammation), irritation of the nerve (radiculopathy), radiated pain up her neck (pain), nausea (nausea), vomiting (vomiting), headache (headache), swelling of the deltoid (swelling), injection site was painful (vaccination site pain), injection site was painful (vaccination site pain), while she received vaccine INFLUENZA VACCINE.  The patient medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Dec-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious injection site was painful and swollen (vaccination site inflammation), irritation of the nerve (radiculopathy), radiated pain up her neck (pain), nausea (nausea), vomiting (vomiting), headache (headache), swelling of the deltoid (swelling), injection site was painful (vaccination site pain), injection site was painful (vaccination site pain) few hours following the administration of INFLUENZA VACCINE. The patient was hospitalized for these events on 01-Jan-2020.  No lab test reported.  Final diagnosis was vaccination site inflammation, radiculopathy, pain, nausea, vomiting, swelling, vaccination site pain, vaccination site pain.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the events.  The information of the batch number was requested.; Sender's Comments: Patient experienced vaccination site inflammation, radiculopathy, pain, nausea, vomiting, swelling, vaccination site pain few hours after vaccination. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
After taking his first Pfizer COVID shot, he got pretty sick since, then he is in and out of the hospital; after he took the shot his life just went downhill right now he is at the hospital; He is too ill to talk; he has low appetite; He has lost numerous weight; He can't even walk; he has not been able to look; This is a spontaneous report from a contactable consumer (patient's brother).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that 3 days after taking his first Pfizer COVID shot on an unspecified date, he got pretty sick since, then he was in and out of the hospital, he had lost numerous weight, he had low appetite, he could not even walk, he had not been able to look and I just need to know how did Pfizer go about dealing with situation like that and that was a healthy person who was very conscious about his life and health never got sick before but 3 to 4 days after he took the shot his life just went downhill right now he was at the hospital. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Aprrox  18 hrs after first dose vaccine I had muscle and joint pain, very stiff neck, severe fatigue.  Then sore throat and chills.  This lasted 5 days.  On day 4 I was advised to get tested for COVID, both rapid and nasopharngeal tests were negative.
High Fever 103.5 Migraine Headache  Body aches  Chills Ringing in ears Exhaustion  Loss of appetite
Notified on 8/18/03 at 6am that she had developed a hard white area on her smallpox vaccination site (vaccinated 3/13/03). The area was itching, red and had a white area that almost looked like a pimple. Three 1/2 hrs later she was complaining of the area all around being red and inflammed looking. Arrangements were made for her to see Dr. for evaluation and treatment as needed on that day. She elected to be seen by Dr. the following am (8/19/03).  On the afternoon of 8/22/03 we received a faxed evaluation from Dr that this was a local reaction of 1 cm erythema and induration. There were no vesicles or satellite lesions. This did not appear to be virally mediated but rather allergic or early cellulitic in nature. No therapy is required at this time, but it was advised that she begin antibiotic therapy if the lesion enlarged.  On 1/22/04 PT called with a second occurrence of ~1 cm indurated, red, itchy area on the vaccination site. Forearm is also reported to be hot to the touch and very achy. She denies any fever and was initiated on Tequin 400 mg qD po antibiotic therapy 1/21 for a sinus infection. She has an appointment with Dr Tues am (1/27) and spoke with Dr via phone on 1/25. Photos were taken with digital camera and sent to Dr on 1/23.
10MAR92 pt devel a t105.7 unresponsive to APAP & pt had a brief febrile sz lasting a couple of seconds;
Tested COVID positive on 2/8/21 after second dose  given 2/2/21 , became febrile 2/2-2/3/21
Patient said she had a lot of pain the day of shot and is still in pain and having problems moving the arm she got the injection. She took ibuprofen, which didn't make the pain go away. She said both shots were given high on the arms felt like they hit the bone. The pain was spreading into the muscle in her neck on the side of the pneumonia shot. She has some weakness (nerve issue).
This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 22nd January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, 2 days after receiving SHINGRIX, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the sister of the patient. The age at vaccination was not reported but it could be 63 or 64 years old. The reporter stated that the patient was unable to move her arm or lift her arm. The reporter stated that the patient did follow up with her physician. The reporter did not know which arm and has no further information. The reporter did not consent to follow up. No physician information was given.
HEADACHE; 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, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Oct2021 at 12:30 as dose 3 (booster), single (Lot number: FF2587), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications within 2 weeks. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 29Mar2023 to 02Apr2023.
positive for Covid; positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 77-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial information received on 29-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old male patient who received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ADACEL. On 29-Aug-2018, the patient received a dose of suspect ADACEL VACCINE lot number not reported via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. MENACTRA had been drawn up on 28-Aug-2018 at the end of the day into a syringe and placed in the refrigerator. It was unknown whether any adverse event occurred or not. 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 and Module VI of the 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.
Rheumatoid arthritis; kidney failure /dialysis; could not walk due to severe joint pains; fever; severe joint aches; severe body aches; extreme chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and RENAL FAILURE (kidney failure /dialysis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (Rheumatoid arthritis).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (fever), ARTHRALGIA (severe joint aches), MYALGIA (severe body aches) and CHILLS (extreme chills). On 05-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criteria hospitalization and medically significant) and RENAL FAILURE (kidney failure /dialysis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced GAIT INABILITY (could not walk due to severe joint pains). The patient was hospitalized from 05-Mar-2021 to 15-Mar-2021 due to RENAL FAILURE and RHEUMATOID ARTHRITIS. On 15-Mar-2021, RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and RENAL FAILURE (kidney failure /dialysis) outcome was unknown. At the time of the report, GAIT INABILITY (could not walk due to severe joint pains), PYREXIA (fever), ARTHRALGIA (severe joint aches), MYALGIA (severe body aches) and CHILLS (extreme chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 103 (High) 103 Fahrenheit. In 2021, White blood cell count: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient was prescribed Mobic at urgent care. In urgent care blood work was performed, white blood cells were elevated and inflammatory rate increased. Two doses of antibiotics ((product name not provided) were prescribed.  Based on the information provided, a causal association between the event of renal failure and the administration of  mRNA-1273 - is assessed as not related as event was reported as due to treatment with Mobic and more likely pre-existing. Based on temporal association between the other reported events and the product, causal relationship cannot be excluded. Pyrexia, arthralgia, myalgia and chills are consistent with the product known safety profile.; Sender's Comments: Based on the information provided, a causal association between the event of renal failure and the administration of  mRNA-1273 - is assessed as not related as event was reported as due to treatment with Mobic and more likely pre-existing. Based on temporal association between the other reported events and the product, causal relationship cannot be excluded. Pyrexia, arthralgia, myalgia and chills are consistent with the product known safety profile.
10 minutes after injection my throat got tight and it was hard for me to breathe for the next 15 minutes.  That night I sneezed 11 times in a row followed immediately by 6 bouts of emesis.  This happened the following night as well.  I slept for 20 hours after the emesis stopped.
Lump developed in neck near shoulder.  Monitor for a few weeks and determine if further intervention is needed
2 episodes of 30-60sec tonic/clonic movements @ sleeping;no meds needed;
Swelling of left side of face and neck same side as vaccination. Severe ear pain/possible ear infections  thought to also have lymphadenopathy.
Dose Number: 3; Vaginal bleeding(post menopausal); Breast pain; Arm pain; Armpit pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Lot number: FF8841) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; LEXAPRO; VIT D [COLECALCIFEROL] and Multi vitamin. Past drug history included: Omnicef, reaction(s): "Known allergies: Omnicef". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 22Apr2021, when the patient was 57 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 57 years old, for COVID-19 immunization.  The following information was reported: IMMUNISATION (medically significant) with onset 10Dec2021, outcome "unknown", described as "Dose Number: 3"; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 10Dec2021, outcome "not recovered", described as "Vaginal bleeding(post menopausal)"; BREAST PAIN (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Breast pain"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Arm pain"; AXILLARY PAIN (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Armpit pain". Therapeutic measures were not taken as a result of postmenopausal haemorrhage, breast pain, pain in extremity, axillary pain.  Additional information: The adverse event did not result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
PT HAD A DELAYED REACTION TO THE PREVNAR SHOT. PT GOT REDNESS, ITCHING, AND SWELLING 2 DAYS AFTER RECEIVING THE SHOT.
Left arm developed a rash: Rash was from her left deltoid to her left wrist. Onset provider evaluated the patient and 50 mg of Diphenhydramine was given orally
Full body Dermatographia onset about a week after booster. Still exists 3 months later. Any scratch to skin causes hives and redness, inflamed skin.  Decrease after 30 min or so.  Zyrtec a few times a week helps.
patient given full dose 0.5ml instead of booster 0.25ml.  patient received Janssen-j&j covid 19 vaccine 05/11/2021
Pt recvd 2 doses of Hep-B vax 20MAY91 & 5 min p/inject pt indicated that felt shaky & pulse was 120; pt also indicated that sat about 30 min in office; pulse slowed to 80; shakiness dec; following 2nd dose exp tachycardia;
horrible headache; nausea; loss of appetite; diarrhea; The stomach issues; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pseudo tumor cerebri" (unspecified if ongoing), notes: Pseudo tumor cerebri; "Medullary sponge kidneys" (unspecified if ongoing). Concomitant medication(s) included: ACETAZOLAMIDE. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: Morphine. The following information was reported: HEADACHE (non-serious) with onset 14Aug2021, outcome "not recovered", described as "horrible headache"; NAUSEA (non-serious) with onset 14Aug2021, outcome "not recovered", described as "nausea"; DECREASED APPETITE (non-serious) with onset 14Aug2021, outcome "not recovered", described as "loss of appetite"; DIARRHOEA (non-serious) with onset 14Aug2021, outcome "not recovered", described as "diarrhea"; ABDOMINAL DISCOMFORT (non-serious) with onset 14Aug2021, outcome "recovered", described as "The stomach issues". The events "horrible headache", "nausea", "loss of appetite", "diarrhea" and "the stomach issues" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of headache, nausea, decreased appetite, diarrhoea, abdominal discomfort.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that "Got my shot on Wednesday and by Saturday I had a horrible headache and nausea, loss of appetite and diarrhea. The stomach issues lasted a few days but headaches still on going. This happened with both shots and got worse with the second. This shot flared up my pseudo tumor cerebri.  Still having issues with headaches, eye sight and  brain fog." Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large swelling and pain in the armpit corresponding with the same arm I received the shot.  I also have had a soreness to my neck on the same side, for the same amount of time.
I started having severe abdominal pains for several days. I went to urgent care and they referred me to the ER at a local facility I was diagnosed with a Peptic Stomach Ulcer I was prescribed pantoprazole which I am still taking at this time.
Information has been received from a nurse concerning a female who in February 2007, was vaccinated IM with 0.5 mL Gardasil. In approximately February 2007, the patient developed a flesh-colored, dry, flakey, itchy rash on her face a couple days after administration of Gardasil. The rash resolved in about 5 days. Additional information has been requested.
The patient developed pericarditis. He also developed rapid atrial fibrillation.  He was treated with colchicine. He had a moderate sized pericardial effusion. Symptoms improved with medical treatment.
Swelling & redness to left upper arm. Instructed to use warm compresses prn. Call if worse.
nurse gave an inmate the two doses of the Moderna Covid-19 vaccine 14 days apart; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT PRODUCT ADMINISTRATION DURATION (nurse gave an inmate the two doses of the Moderna Covid-19 vaccine 14 days apart) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history was not provided.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INCORRECT PRODUCT ADMINISTRATION DURATION (nurse gave an inmate the two doses of the Moderna Covid-19 vaccine 14 days apart). At the time of the report, INCORRECT PRODUCT ADMINISTRATION DURATION (nurse gave an inmate the two doses of the Moderna Covid-19 vaccine 14 days apart) outcome was unknown.      The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of incorrect product administration duration for mRNA-1273, lot # unknown  with no associated AEs.
Within 4 hours after receiving the vaccine she started having pain and weakness throughout her body. She had a stroke several years ago and 5 by pass heart surgery in 2000. Since her husband has the same symptoms, we thought it was from the flu shot and would soon end, but about 8, 11/09/06 she was taken to hospital by rescue squad. 12/19/06-records received and reviewed. DC Summary: Acute non-ST elevation myocardial infarction. Congestive Heart Failure due to Ischemic left ventricular dysfunction Coronary artery disease with previous coronary artery bypass graft surgery Transient ischemic attack with right arm weakness. Hypertension Hyperlipidemia Status post bilateral carotid endarterectomy and cholescyctectomy. Presented to ER with dyspnea and wheezing, flu vaccine 2 weeks ago and had prolonged viral syndrome that she did not seek treatment for. On day of admission developed 2 episodes of right arm weakness and right facial and tongue weakness with slurred speech and she developed sudden dyspnea, orthopnea and wheezing. 12/1/08-copy of death certificate received-COS multisystemic organ failure. Date of death 4/15/08. Information received on annual follow up: Adverse event unrelated to vaccination. Patient has multiple on going health problems. Date of vaccination was 10/27/06 not 11/3/06 as originally reported.