chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an 11 to 12 year old male who on an unspecified date was vaccinated with VARIVAX (Merck) (lot# not reported). Subsequently the patient developed a severe local reaction shortly after receiving vaccination. The injection site had severe edema and redness. The patient was placed on an antibiotic and showed some improvement but the area remained hard and painful, so the antibiotic was switched. The patient also had a fever. At the time of the report, the patient was recovering. Additional information has been requested.
Nausea/vomiting at 0200-self limited. Temp 101 at 7-8 am-ALEVE-resolved. Coughing at 11 am -hot tea, cough drops-resolved. Pain/swelling at injection site-radiated to upper arm/shoulder-progressively diminishing.
sick with the flu; Initial information received on 20-Jan-2022 and live follow-up received on same day (processed together) regarding an unsolicited valid social media serious case received from a consumer/non-hcp (non health care professional).  This case involves Adult male patient who was sick with the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, frequency, formulation, route, lot number and expiry date were unknown) via unknown route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  It was reported that patient get the flu shot seems like 2 years in a row and he was in the hospital right after for 10 days each time (influenza, latency: unknown). The patient was hospitalized for this event.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick with the flu).  At time of reporting, the outcome was Unknown for the event sick with the flu.; Sender's Comments: Sanofi company comment dated 27-Jan-2022: This case involves adult male patient who was sick with the flu (influenza) and was hospitalized with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Chills all throughout the night at 0800 woke to my face completely swollen especially my cheeks were red and swollen, eyes were closing and body was aching called my doctor immediately and was put on Predinsone.
Terrible fatigue, headache, low grade fever, nausea , excruciating joint and muscle pain. Missede day of work
After vaccination on 10/23/2001 the patient developed pruritis and a rash all over his body, except his face. The patient was treated with Benadryl.
Flublok Quadrivalent was administered to a 12 year-old child, No AE; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old female patient who was vaccinated with 0.5 ml vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA1957 and expiry date: 30-Jun-2020) via intramuscular route in the right deltoid on 12-Feb-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was actual medication error due to inappropriate age at vaccine administration.  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
within couple of hours the patient started getting sick, and within 6-7 hours patient was sicker'n hell; High Fever; puking my guts up; Initial information was received on 03-Dec-2020 regarding an unsolicited valid serious social media case from a consumer (patient) via social media.  This case involved a patient with unknown demographic who experienced high fever (Pyrexia), puking his/her guts up (Vomiting) and within couple of hours the patient started getting sick and within 6-7 hours patient was sicker'n hell (Illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included Influenza Vaccine for prophylactic vaccination and ended up in the hospital with High fever, puking guts up and it was within couple of hours the patient started getting sick and within 6-7 hours patient was sicker as hell. The patient's past medical history, medical treatment(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed high fever (Pyrexia), puking his/her guts up (Vomiting) (Unknown latency for both) and within couple of hours the patient started getting sick and within 6-7 hours patient was sicker'n hell (Illness) following the administration of INFLUENZA VACCINE. The patient was hospitalized for all the events.  Laboratory test data was not reported.   Intravenous in arm was received as corrective treatment for puking guts up and unknown for rest of the events.  At the time of reporting the event outcome was reported as unknown for all the events.  There will be no information on the batch number for this case.; Sender's Comments: This case concerns a patient with unknown demographic who presented with pyrexia, vomiting, sickness after vaccination with  INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination, concomitant medication and laboratory tests were not reported. The patient took INFLUENZA VACCINE two years ago as required, ended up in the hospital with same events. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
The pt experienced joint pain, swelling and immobility starting in early 1/00. Joint involved are right more than left hand, (specifically MCP in the 4th digit), both feet and right elbow. Immobility with the right hand was such that she could not perform many of her activities of daily living. She had no relief from Motrin and then tried Naprosyn, (still no relief). Shw now has much improvement with prednisone.
Discovered drooping face on right side about two hours after noting watering right eye.  Immediately went to Emergency Dept.  Diagnosed BOTH Bell's Palsy as well as Acute Spontaneous Subdural Hematoma in Fronto/Parietal Area
Information has been received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, the patients received doses of improperly stored GARDASIL (lot#, dose and route not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Pain and swelling on right arm and right calf-Medium, Additional Details: The pain and swelling were on the opposite side of where pt got injection. They were not at the site of injection.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with PNEUMOVAX 23 (lot # not reported) (dose and route unknown) on 25-AUG-2014 and 18-SEP-2014. No adverse symptoms reported. Additional information has been requested.
Tinnitus both ears began 2 days after vaccine - Symptoms for 12 days and hasn't stopped  Burning nerves (skin?) over whole body onset 1 day after vaccine - lasted 3 days
Pain from injection site on rt. arm to elbow area hard at site of inject several days after inject. Today tender to touch, warm to touch.
Brain stem stroke that started as headache and numbness on left side. Been in hospital/rehab 4 weeks with additional months in rehab planned.
I tested positive for Covid after being vaccinated. I used a home test on 7/30/22. I had a runny nose, was achy all over, had headaches, mild cough, was exceptionally tired. Symtoms started 7/29/22 and abated 8/5/22. I continued to have tiredness for the following week or so.
3 hours after vaccine, severe arm pain, unable to move left arm. Fever 102. Leukocytosis 12/2/08. Still with severe arm pain and unable to perform active range of motion.  12/19/2008 MR received for DOS 11/25-26/2008 with DX: L shoulder myositis s/p pneumonia vaccine.  Pt presented severe, worsening L arm pain. PE (+) for elevated BP 214/88, T=101.9'F, decreased ROM of L shoulder with (+) tenderness. Tx with abx, anti-inflammatories and pain meds and d/c to f/u w/ PCP.
Vaccine vial remained in freezer one day longer than reccommended per manufacturer. Should have been pulled from freezer and refrigerated before 3pm Thursday 5/6/2021 but was not; Administered Friday 05/07/2021 after removal from freezer that morning. "USE BY DATE" on "FREEZER" sticker on original container was noticed Friday afternoon after injection had been admistered.
Vaccination failure; singles all over my abdomen, breasts,and, and keeps spreading; Blisters keep breaking out; Got very sick; Got very sick; This case was reported by a consumer and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In August 2019, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, blister, sickness and sickness. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and gabapentin enacarbil. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, herpes zoster, blister, sickness and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and sickness to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, herpes zoster, blister and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received both the doses of Shingrix in the prescribed time lines. The patient was very sick from both the doses of Shingrix. Two weeks before the date of reporting, the patient experienced very very severe singles all over the abdomen, breasts and were spreading. The patient also experienced blisters that broke out. The patient wondered why the vaccine was received only to get them and get them so severe.  The patient was prescribed Valacyclovir and Gabapentin but it did not help. The patient was at a lost as to why got the terrible outbreak when everything possible was done  to prevent it.  The patient wondered if others have had the same reaction. The case US2019AMR155508 was found to be duplicate of case US2019AMR155496. Hence case US2019AMR155508 would be deleted and all the information of this case will be added in case US2019AMR155496 which is the case of record for this patient.
This spontaneous report as received from a healthcare worker refers to a 13 year old patient of unknown gender. There was no information about the patient's concomitant medications and pertinent medical history reported. On 06-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K023432, expiration date 18-JUN-2016) (strength, dose, route and site of administration were not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Developed chills, nausea, severe body ache day after receiving Pneumovax, flu and Td booster. Vomited once. Improving the following day. Felt febrile but did not check temperature. No further vomiting. Tylenol i-ii q 6h. Patient did not got o work on 12/11/02.
severe vomiting/non-stop vomiting all day; nausea; chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (severe vomiting/non-stop vomiting all day), NAUSEA (nausea), CHILLS (chills) and MYALGIA (body ache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (she takes medicines for those) and Retinal artery occlusion (she takes medicines for those).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VOMITING (severe vomiting/non-stop vomiting all day), NAUSEA (nausea), CHILLS (chills) and MYALGIA (body ache). At the time of the report, VOMITING (severe vomiting/non-stop vomiting all day), NAUSEA (nausea), CHILLS (chills) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported
After getting Moderna covid booster, experiencing hsv1 outbreak. Had this after each of the initial vaccines as well. Have been on valacyclovir daily maintenance since June.
Fever 102 deg Chills Nausea Exhaustion Dizziness like low blood pressure  Lasted approx 18hrs
Appendicitis - admitted to hospital on 9/4/21  Laparoscopic appendectomy 9/5/21
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Aug2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV infection - long term" (unspecified if ongoing), notes: HIV infection - long term. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete- unknown manufacturer), for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had anti-viral therapy of Paxlovid from 26Jun2022 to 30Jun2022 for treatment of COVID-19 and had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Persistent discomfort in left arm at site of immunization, now almost three months after the injection.  No redness, swelling or induration.  Pain increases when the arm is used or elevated above head.
transient multiple neurologic symptoms, suggestive of TIA event.  Aboout 3 hours following vaccination the patient reported that he noticed some dizziness, left arm weakness, and right homonymous hemianopsia. The patient adamantly denied loss of vision within just one eye and, with directed questioning, reported that he could only see the left side of his visual field, with the right side being dark. He was very adamant that the deficits affected the right visual field. His left arm was weak, but not his left leg. Again, he was adamant that it was his left arm and that the right extremities were unaffected. He could not recall if he had any facial droop and was not sure if he had any dysarthria. He did not have have expressive or receptive aphasia. He was able to call his sister and speak with her by phone. She was able to come and bring him to the hospital. His symptoms lasted about 2 hours and have completely resolved. He has had no stroke or TIA symptoms previously.   The patient's symptoms did not localize to one hemisphere or distribution. The patient had extensive evaluation, including head CT scan, CTA head and neck, and carotid duplex, and MRI brain. Moderately severe left carotid stenosis was noted on CTA angiogram, unclear if this is symptomatic as recent symptoms do not all seem attributable to the left ICA/MCA distribution. Carotid duplex demonstrated findings suggestive of high grade left carotid stenosis, with PSV of > 521 cm/s and ICA/CCA ratio of 4.6.  Patient had been on chronic aspirin therapy but had stopped < 3 days ago due to getting ready for right hip arthroplasty.
Erythema multiform all over body; small erythematous rash on chin, 1 day prior to Prevnar. Dx'd with urticarial rash; erythema multiform.
headache; Asthmatic Cough; Taste metallic/ tongue felt metallic; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 04Feb2021 11:40 (Batch/Lot Number: EL9261) (at 59-year-old) as single dose for COVID-19 immunization. Medical history included Hypertension, Gout, Allergy. She clarified that she is allergic to NSAIDS and as well has environmental and food allergies. She clarifies that her Allergies do change from time to time, she is allergic to fragrances. Wheat bothered her before, but not anymore, thats what she meant by her allergies changes. Concomitant medications was not reported. She did not take any NSAIDS because they made her wheeze. She only had her regular medication that she takes on routine schedule.  The patient previously took ibuprofen and allergy. She is Allergic to ibuprofen and had an asthmatic cough after it. The patient had first dose of the Pfizer covid vaccine a week ago Thursday, she has a question. She had that dose, and when she had the injection was fine, she did have a metallic taste in mouth (04Feb2021) but it was no issue. Then she woke up coughing on Friday (05Feb2021) and Saturday (06Feb2021), it was like an asthmatic feeling, she will feel it time to time when having an allergy to something. She had headache on Sunday (07Feb2021). She didnt know if that was an indication to a problem with the vaccine. She wanted to know if it was safe to take the second dose. It was clarified that the metallic taste started 10 minutes after the injections. The Asthmatic Cough started on Friday 05Feb2021, she woke up coughing. She clarified that the metallic taste only last just up to that afternoon. The asthmatic cough subsided Saturday. She experienced a lot of coughing on Friday, then a little on Saturday and that was last day. She was just concerned about it, she did not want it to get worse. She does not normally have metallic taste in her mouth, so she thought it could be related but she really doesn't know. She didn't know if the asthmatic cough is related, it could even be a coincidence, she hasn't experienced something like this in a year. She just wants to know if she should get the second dose. It stated that her second dose is schedule for 25Feb2021 at 11:40AM. The outcome of the event Taste metallic/ tongue felt metallic was recovered on 04Feb2021, Asthmatic Cough was recovered on 06Feb2021, and headache was unknown.
Patient was given 2 month vaccines on 6/16.  On 6/17, he presented to a local ER with fever, severe diarrhea and dehydration. He had significant electrolyte abnormalities.  He was admitted to the ICU and was admitted for 10 days.  Stools were rotravirus + during admission
Pt complained of headache 2 weeks post-vaccine, admitted to the hospital. she had a rapid decline with seizures.  an extensive workup was done while in the Neuro ICU including extensive autoimmune encephalitis. infectious encephalitis and brain biopsy to r/o malignancy were done.  she was diagnosed with serum-negative meningo myelitis encephalitis. treated with high-dose steroids and Plasmapheresis
2/24-25 -fever and chills and exhaustion (101.3); late 2/25 began dizziness; palpitations, feeling flush in chest face; constriction in base of head, neck chest and head feel like I will faint fall over lose consciousness-happening at this moment since this is on and off from 2/25 through today. Missed work since 2/24.
Patient complained of generalized itching ten minutes after receiving the Td vaccine. Diphenhydramine 50mg IM administered. Resolution of symptoms and left clinic 50 minutes after onsent of symptoms.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Patient had dormant MS flare up after the immunization which required her to be hospitalized on 10/25/19
Patient fully vaccinated against COVID with Janssen vaccine, admitted to the hospital with COVID-19.
Information has been received from a mother regarding her daughter who was vaccinated with MMR II. Subsequently the patient experienced an unspecified reaction. No further information was available. No additional information is expected.
BROUGHT BY EMS  FROM THE NURSING HOME   2-9-23 WITH AMS AND INTUBATED.  COVID NEGATIVE AT THAT TIME  , WITH  STROKE  AND BECAME COVID + WHILE IN HOSP ON 2-27-23   TRANSFERRED BACK TO N HOME AND DECEASED 3-3-23   TREATED WITH REMSESIVIR AND DECADRON. FOUR DAYS OF TX.    COVID TEST DONE AS PREOP.    TESTED NEGATIVE x 2 AFTER INITIAL POSITIVE
Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: PATIENT'S MOM CAME TO THE PHARMACY AND REPORTED THAT PATIENT WOKE UP THE NEXT DAY WITH A SWELLING PAINFUL LEFF ANGKLE. PATIENT EVEN CAN NOT WALK. NO PAIN OR BRUISING AT THE INJECTION SITE
Migraine continuously since date of injection, lack of appetite, chest pain, swollen lymph nodes
Tiny bit of arm hurting; This is a spontaneous report from a contactable patient.   A 69-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included diabetes from 2004 and ongoing she has had diabetes since 2004.     The patient's concomitant medications were not reported.  The patient experienced tiny bit of arm hurting on an unspecified date with outcome of unknown.  She received the first dose of the vaccine on 09Mar2021 and had no symptoms, just a tiny bit of arm hurting for a couple of days.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
8/3/99 fainted unconscious for approx 45 seconds;lymph nodes rt & lt neck swollen;mostly in rt achy joints, knees, ankles, shoulders & ankles;mostly in  shoulders fever 101.6 oral for 2 days;nose-bleed early in AM;vertigo;Ibuprofen;