chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site ache from time of injection that has not subsided, general body ache onset from approximately an hour after injection that has not subsided, general body weakness onset within 12 hours after injection that has not subsided, headache onset from approximately 15 hours after injection that has not subsided, dizziness onset approximately 19 hours after injection that has not subsided, fever onset approximately 24 hours after injection
swollen larnyx and hoarseness; persisting still after 18 days; currently being treated with 10 day course of Doxycycline Hyclate
interchange of vaccine products; Covid-19; 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 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 78 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Feb2021 as dose 1, single (Lot number: 011M20A), in left arm, on 15Mar2021 as dose 2, single (Lot number: 048A21A), in left arm and on 09Sep2022 as dose 4 (booster), single (Lot number: A57143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type2 Diabetes" (unspecified if ongoing), notes: Other medical history: Type2 Diabetes; "Penicillan Eurthromycin Januvia" (unspecified if ongoing), notes: Known allergies: Penicillan Eurthromycin Januvia. Concomitant medication(s) included: METFORMIN HCL, start date: 01Jan2021; LOSARTAN, start date: 01Jan2021; FARXIGA, start date: 01Jan2021; KRILL OIL OMEGA 3, start date: 01Jan2021; ASPIRIN [ACETYLSALICYLIC ACID], start date: 01Jan2021; VITAMIN E [VITAMIN E NOS], start date: 01Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Covid-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment included Paxlovid from 01Oct2022 to 05Oct2022. Known allergies included Penicillan Eurthromycin Januvia. other medication in 2weeks included Metformin HCL, Losartan, Farxiga of brand Astazenec, Krill, Vitamin E, Aspirin.
Had tinnitus before but it much louder after dose #2. Difficulty falling asleep and unable to distract myself from the sound as I had been able to previously.
Information has been received from a registered nurse concerning a female over the age of 60 with no pertinent medical history who on approximately 13-JUL-2007 was vaccinated with Zostavax (Oka/Merck).  On approximately 15-JUL-2007 the patient experienced a varicella-like rash.  The patient sought medical attention and no labs/diagnostics were performed.  Subsequently, the patient recovered from the varicella-like rash.  Additional information has been requested.
Initial report was received 17 September 2008 from a consumer. A 43-year-old male patient with no reported medical history, had received an injection of IMOVAX Rabies vaccine (lot number, route and site not reported) on 30 July 2008, and two days later, he complained of tension headaches, dizziness, and generalized body weakness to the point of falling when attempting to stand. While driving, the patient also experienced a feeling like he was "zoning out, everything closing in" and tunnel vision. The symptoms became worse when the patient was driving (the patient is employed as a truck driver). At the time of the report, the symptoms had decreased, but still occurred. The patient had been seen by a neurologist; MRI and EEG results were normal. No corrective treatments were prescribed. The patient had begun post exposure prophylaxis due to a bat bite on his ear. No additional information was provided.
I went in for my check up because I had colon cancer. In the CT scan they found a swollen lymph node in the left side of my armpit which I have not noticed before. They did a biopsy, and it was not cancerous. I am due for a follow-up.
A few weeks prior to the injection, she had an allergic reaction to new carpet at her place of employment. She had difficulty breathing and has avoided the area with new carpet, but still works in proximity. The day after the injection, in the evening, she started with difficulty breathing described as shallow breathing. She was not in distress and did not seek treatment. Later that evening she reports joint pain and swelling mostly in lower extremities. The following day (2/18) she complained of more joint pain. Today, she reports joint pain is improved and swelling has worsened. She denies acute distress and need for evaluation by MD. Advised to at least contact provider for update and to document incident and determine if evaluation is needed. Receptive to plan. To date she did not seek MD attention or treat s/s with OTC meds. Advised MD eval if s/s worsen or she experiences s/s of distress. Receptive. Discussed past imm hx. Had childhood immunizations, most likely DTP. Does not remember any reactions. Reports having Td booster while in her 20s without any reaction.
Itchy  all over body and hands red hot and swollen . Severe lymphedema under left axillary region and left breast.  Inability to sleep at night and numbness to hand and arms
Chilling, moist cough,and fever of 103 degrees last 24 hrs, feeling tired lasted 1 week
I felt an abdominal pain, Strong abdominal pain; My face had a little rash, a butterfly rash; not really bad and it didn't feel hot; I didn't have any other itches; I started feeling, my body itching on the inside; It spreading through the day; oozing blood from the injection site; The bandage was soaked in blood; there was oozing blood from the injection site; the bruise was forming; My arm started hurting like a regular after flu-shot; maybe a little more than a regular flu-shot; The bruise was getting bigger; the swelling was about the same and the pain, the discomfort was there but nothing out; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200 and expiration date: not reported), via an unspecified route of administration, in Right Arm on 27Feb2021, as DOSE 1, SINGLE for covid-19 immunization and prednisone via an unspecified route of administration, on an unspecified date, 5mg, for immune thrombocytopenic purpura. Medical history included thrombocytopenic purpura, the patient had ITP, low platelets and the day before shot, platelets were 43,000.  The patient had thrombocytopenia prophylaxis, for 30 years, In Oct2020, patient got very bad case of shingles and platelets dropped after few weeks of being on prednisone and was being taken off the prednisone they dropped to the 20,000 and then they increased the prednisone. The patient had blood pressure. Concomitant medications included cholecalciferol (VITAMIN D3) and metoprolol taken for hypertension.  On 27Feb2021,20 minutes after patient got the shot, patient looked in the mirror and her face had a little rash, a butterfly rash. Not really bad and it didn't feel hot, patient didn't have any other itches. The patient came home and within about 2 hours, the patient started feeling, body itching on the inside. It is spreading through the day. On 27feb2021, 6 hours after the shot, patient's husband took the bandage off and the bandage was soaked in blood and there was oozing blood from the injection site and the bruise was forming and that night patient arm started hurting like a regular after flu-shot, maybe a little more than a regular flu-shot and then by the next day, the bruise was getting bigger, and the swelling was about the same and the pain. The patient felt an abdominal pain, Strong abdominal pain on an unspecified date.  The patient underwent lab tests and procedures which included full blood count: normal on an unknown date, platelet count: 43,000  on day before shot. Therapeutic measures were taken as a result of butterfly rash included Benadryl and hydrocortisone cream. The outcome of the event Butterfly rash was not recovered, while that of all other events was unknown at time of report.  No follow-up attempts are possible. No further information is expected.
PT WAS CONCERNED THAT THE SHOT WAS ADMINISTERED AS SUBCUTANEOUS DUE TO THE FIRM SQUEEZE OF THE ARM INSTEAD OF INTRAMUSCULARLY.  NO ADVERSE EVENTS AT ALL REPORTED BY THE CUSTOMER.  IN FACT SHE WAS CONCERNED BECAUSE SHE HAD NO SYMPTOMS AFTER PREVIOUSLY HAVING THE USUAL SYMPTOMS FROM HER PAST MONOVALENT SHOTS.
Cellulitis spreading from left shoulder towards chest.  Prescribed course of Cephalexin to clear.
8/22 Client reports arm reddened with slight itching and irritation starting on 8/21/02 where YF vaccine was given; approximately size of a quarter. 8/26/02 client states area of redness has increased to about double the size; states only painful if touches area with some itching. Encouraged client to apply Benadryl cream or OTC hydrocortisone cream to area as needed and follow up with physician.
This spontaneous report as receive from a healthcare worker refers to a 20 year old female patient with no pertinent medical history or drug reactions/allergies. On 19-OCT-1995 and 27-AUG-1998 the patient was vaccinated with first and second doses of M-M-R II (lot#, expiration date, dose, route, indication not reported). There was no concomitant medication. On 09-MAY-2014, the patient experienced the patient had titers drawn and results of the titers showed that the patient was not immune to rubella. There was no treatment given for the event. The patient did not seek medical attention. The outcome of the patient the event was unknown. Additional information has been requested.
She experienced soreness at the site; fatigue; numbness in the left pinky finger; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 27Dec2020 at SINGLE DOSE for COVID-19 IMMUNIZATION. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer Covid Vaccine at on 27Dec. She experienced soreness at the site and fatigue on 28Dec-29Dec and numbness in the left pinky finger (same arm as vaccination). She also started another med the same day, so she is unsure if the fatigue is from vaccination or the other drug. I do not know the name of that drug. The outcome of the events was unknown.   Information about lot/batch number has been requested.
pt recvd vax; 24oct94 c/o myalgia until 26oct94; 25oct94 c/o urticaria on soles of feet & palms lasting until 27oct94 & asymptomatic by 28oct94;
Moderna COVID-19 Vaccine EUA: side effects very in line with the general side effects listed on  your factsheet: severe headache, nausea, vomiting, muscle/joint pain, chills, and fever
Information has been received from a registered nurse concerning a child who on 18JUN1996 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Subsequently , the child developed a mild case of chickenpox. It was noted that there was no hospitalization or complications", no treatment was required and patients were not seen by the nurse , but were reported by parents as explanation of an absence. It was also noted that th child was part of six cases that took place over the last school year from 9/02 to present. Unspecified medical attention was sought. There was no product quality complaint reported. At the time of this report the child was 12 years of age. The nurse also reported that one sibling and four other children developed mild chickenpox. Additional information has been requested.
expired ACTHIB vaccine was given, with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 1 years old and unknown gender patient where expired acthib vaccine was given, with no reported adverse event while receiving vaccine hib (prp/t) vaccine [act-HIB].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 07-Apr-2023, the patient received a dose of suspect hib (prp/t) vaccine (batch number- UJ679AAA) via unknown route in unknown administration site (dose, frequency, route, formulation, strength and expiration date: not provided) for Immunization.  On 07-Apr-2023 expired acthib vaccine was given, with no reported adverse event (expired product administered) (latency- same day) following the administration of hib (prp/t) vaccine.  It was reported asking guidance on giving an expired ACTHIB to a patient on Friday, 07Apr2023. Product used : Used  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: K026666, expiry date: 22-OCT-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient received Vaccine and during observation period began starring forward and not responding to staff.  Patient was taken to the emergency room and evaluated and noted to have a flat affect and general weakness.  Patient did not loos consciousness or have any signs of distress. Was admitted to the hospital and noted that she had been in out of country for a week (possibly had cosmetic surgery)
Vax at 1645hrs on 07 Feb 2021. At about 1830hrs starting feeling hot, upper left arm sore, mild shaking, decided to sleep it off. I went deeply under. At various times after I would become aware I was home, alone, on couch, unable even sit up. On one occasion I determined it was 1437hrs, Tuesday, 08 Feb 2021, and sent two text messages with great difficulty just saying HELP. IT was actually 0237hrs, Monday, 08 Feb 2021. Both HELP messages had been replied with questions about what the problem was. At 1200hrs, Tuesday, 09 Feb 2021 I became lucid again though at first I believed it to be Wednesday, 10 Feb 2021.
discharge summary "Hospital Course: 68 YO female with a history of  psoriatic arthritis on prednisone and methotrexate, DVT/PE on Eliquis, type 2 diabetes mellitus who presents with nausea, vomiting, diarrhea, chest/abdominal pain.  Found to have small-bowel obstruction.    SBO - resolved with NG tube decompression - Originally NPO. NG tube removed 03/16; pt tolerated low fiber, low residue diet, able to pass gas and stool - Home pain meds - PRN Zofran - General Surgery onboard, OK for D/C   COVID-19  Patient is not displaying respiratory symptoms at this time - Symptomatic management   HTN Acute pain may be contributing to elevated blood pressures - resume home amlodipine and losartan    HLD 10-year ASCVD risk is 28.4%. No statin therapy recorded in Home Meds.  - Initiate lipitor 40 mg   T2DM - Resume home oral diabetic medications   Fever, 03/15 - resolved  May have been 2/2 COVID-19 - 03/15 BCx NGTD   Plaque psoriasis Multiple joint pain, chronic' ?Psoriatic arthritis  - Sees Dr. (Rheumatology) - Followed by Dr. (Derm) for psoriasis who recommended initiation of Stelara - Reportedly taking Methotrexate 2.5 mg (5 pills weekly) and folic acid daily - Home Tacolnex ointment not on formulary - Restart home ibuprofen, Norco, methotrexate, and prednisone   Hypokalemia, resolved    History of pulmonary embolism, Nov 2021 Patient on Eliquis, Continue "
Narrative: Patient reported no change to diet, exercise or medication prior and after receiving the vaccination. Patient reported no change to activities of daily living. Patient only reported a influx and reduction of blood sugar level throughout today, 03/29/31.
Cramping, soreness in left jaw. Progressed to numbness and tingling in Left side of face and tongue over next few hours.  By 11/01/2014 had partial paralysis of left side of face.  Paralysis continued to progress as of 11/03/2014, date of reporting.
Around 4pm patient felt weak and was unable to lift arms in order to get a drink from  kitchen sink and legs were also very weak. Patient went directly to bed. After about an hour she couldn't even have the strength to roll over or put arms up under pillow so she laid there all night. Patient states muscles were sore all night and she didn't sleep all night as well. In the morning she was able to get up and made it to the sofa where she stayed from 7am til 3pm laying on side and maybe slept 2 hours. Around 3 she felt better and was able to roll over and then got up and was able to get a drink, finally and started doing better. She was feeling stronger and able to eat a little bit. That evening she went to bed as normal and then woke up on the next day feeling normal.
Infant received a second dose of Hepatitis B vaccine on the 6th of June around 1500.
Moderna COVID-19 Vaccine EUA dose given 10 days after BUD for refrigeration.
The patient had tingling & paralysis in right side of mouth. He also had tingling right arm. These resolved in a few days. The patient has also been exhausted w/ a cough since the Thursday after the shot.
He felt like he had something he needed to cough up but couldn't.; Lack of efficacy; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), FEELING ABNORMAL (He felt like he had something he needed to cough up but couldn't.) and DRUG INEFFECTIVE (Lack of efficacy) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). On an unknown date, the patient experienced FEELING ABNORMAL (He felt like he had something he needed to cough up but couldn't.). At the time of the report, COVID-19 (Tested positive for COVID-19), FEELING ABNORMAL (He felt like he had something he needed to cough up but couldn't.) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient was treated with unspecified antibodies on 08-Aug-2021.   This case was linked to MOD-2021-125093, MOD-2021-128278, MOD-2021-128330 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Upon internal review on 30-Sep-2021, events of tested positive for COVID-19 and lack of drug effect were added.; Sender's Comments: This case concerns an 82-year-old, male patient with no disclosed medical history, who experienced the unexpected events of Covid-19 and feeling abnormal; Drug ineffective was considered as an additional event. The events occurred approximately 5 months after second dose of Moderna vaccine. The patient's old age may have increased his risk of getting infected with Covid-19. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Pain/swelling/fever @ injection sight 4pm 1/26/2022 to current 3:00pm 1/27/2022 Headache 1/27/2022 6am Gland in neck left side swollen 10:00pm 1/26/2022 to current 3:00pm 1/27/2022 Chills during sleep 1/27/2022
Hospital Course:    COVID-19 PNEUMONITIS Patient was sent from his extended care facility with shortness of breath on the 28th and was found to be COVID-positive on that day.  His symptoms started on the 26th.  He had been at facility from the fourth of 15 November for resection of tongue cancer.  His COPD was found to be mildly exacerbated.  He was seen by pulmonology.  He was started on frequent inhaled bronchodilators via his trach mask and his oxygen was able to be weaned down nicely.  He was cleared by pulmonology to return to his extended care facility.  His exam on the day of discharge was unremarkable and he was asymptomatic.
Client called 10-2-08 left message that besides soreness , redness at the site of vaccination she had swelling of lymph's nodes in (L) axilla day of vaccination. She reported this to a Community telephone at a Medical Center on 8-10-08. No fever, slight malaise reported plus LA swelling and tenderness limiting range of motion. she was advised to see provider or go to ED, client did not see provider. symptoms improved after one week. Client carpolled 10-3-08. She reports __(L) lymph node again sore-about size of pea. Advised to see provider
itching on the right side of the back/Itching at the vaccination site; sensation prevented her for sleeping; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (itching on the right side of the back/Itching at the vaccination site) and INSOMNIA (sensation prevented her for sleeping) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     The patient's past medical history included Back surgery (An inserted metal in the spine and right shoulder blade).    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced PRURITUS (itching on the right side of the back/Itching at the vaccination site). In August 2021, the patient experienced INSOMNIA (sensation prevented her for sleeping). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of 1 dosage form. At the time of the report, PRURITUS (itching on the right side of the back/Itching at the vaccination site) and INSOMNIA (sensation prevented her for sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The sensation started after vaccination, but it shortly disappeared, then started at the shoulder blade. She also commented that the sensation prevented her for sleeping. Patient also took steroid cream to alleviate the symptoms.