chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 hrs. After injection mild chills & fatigue. 14 hrs. After injection mild chills, mild headache, very tired/fatigue, moderate to severe upper body muscle aches, mild migratory chest pains for about 30 minutes. 24 hrs after injection just overwhelming fatigue& mild headache continued for another 12 hrs. 48 hrs. After injection  symptoms gone.
Right hand tingling and left hand itchiness/redness 20 minutes after vaccine. After vitals taken, left hand tingling resolved. PO Benadryl 25 mg given. BP 147/80 (pulse 80), then 151/82 (pulse 78).
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unspecified dates, the patient was vaccinated with a dose of MMR II (lot number, expiry date, route and dose were not reported) and a dose of (Merck) VARIVAX (lot number, expiry date, route and dose were not reported) one week apart and no adverse effect reported. Additional information has been requested.
Knee pain (bilateral) from 3/95 to 12/95; hand pain from 6/95 to present; short-term memory problems from 3/95 to present; persistent flu-like symptoms and malaise. When not taking ? 100mg taken in AM and 1300mg of ? medication, HS. The 2nd Lymerix/IM given on 3/17/95 and the 3rd Lymerix/IM given on 2/16/96.
Started with small hives on face and neck on 1/14/2021 and continued on 1/15 and 1/16.   I also had a swollen upper lip which occured at 11pm on the 16th lasting until 10am on the 17th.  After taking Benedry at bedtime on 1/17, hives have gotten fewer and no more swelling on upper lip.
Developed chicken pox on 9/27/02. Had varicella vaccine at age one.
2 short sz w/fever during 5JUL91 p/shot; sz last only seconds; 1st 5-10sec est; 2nd 25-30sec est;
This is a spontaneous report received from a contactable consumer or other non-HCP (patient).  A female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 13, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty), for COVID-19 immunisation; and had a reaction(s): stomach cramps (after first dose of vaccination as well but not as intense). The patient again experienced upper abdominal pain/extreme stomach cramps and nausea/nauseous, onset Mar 14, 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This spontaneous report was received from a medical assistant regarding unspecified multiple patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, unspecified multiple patients were administered improperly stored GARDASIL 9 (lot# L0432123 with expiry date: 28-AUG-2017, lot # L043214 with expiry date: 30-AUG-2017 and lot# M005714 with expiry date: 03-OCT-2017) on multiple unspecified dates. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Patient complained of agitation, tremors of hands and headache.  Required a quiet place to sit.  Determined this was not her usual behavior.  Provided her lunch tray at 11:45 and encouraged her to eat something, but refused.  Monitored for 45 minutes.  Stated feeling a little better - friends drove home and would stay with her and amke sure she ate.  If her symptoms did not improve they stated they would take her to the community clinic.
Pt vaxed w/Hep B vax & pt exp an allergic reaction w/local swelling @ inject site, paralysis memory difficulties, & brain damage;
Mother called on 9/8/16 reporting left arm "swollen, fever in it, and red bumps". "Bumps just started popping up today-describes as red-not like blisters. Indicated upper muscle site of deltoid injection-not the SQ injection which was placed lower. 9/13/16 Took to NP on 9/8/16. Told mom it was a common reaction and if gets worse to take to ER. Was also given BENADRYL to prevent itching. Did not get any worse and is feeling ok know-only small amt redness, swelling and very few bumps at site.
medication error due to an extra dose in a short time frame wtih no reported adverse event; Initial information received on 05-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an Adolescent female patient who experienced medication error due to an extra dose in a short time frame wtih no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Aug-2022, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength, dose, lot number not reported) via unknown route in unknown administration site for immunization.  On 05-Aug-2022, the patient had medication error due to an extra dose in a short time frame wtih no reported adverse event (extra dose administered) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported, "The pharmacist stated that he administered Menactra to a patient today, and then later the mom called and informed that her daughter had already received Menactra in Jun2022. The daughter therefore received two doses of Menactra within approximately two months. The pharmacist indicated that the patient was 17 or 18 years old".  Action taken was 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.
ALTERED MENTAL STATUS, FALL, WEAKNESS, SOB,   AT HOME COVID TEST 11/30. VISITED ED 12/6 - WAS NOT SEEN DUE TO WAIT ADMITTED 12/10 FOLLOWING FALL
PT EXPERIENCED FEBRILE TYPE SEIZURE APPROXIMATELY 9 HOURS POST VACCINATION WITH VOMITING. FELT WEAK FOR 1-2 DAYS FOLLOWING. CONTACTED PCP WHO TOLD HER THEY HAD NEVER HEARD OF THAT HAPPENING.
This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patients' concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days). No adverse effects were reported (the reporter stated that the vaccine administered were RECOMBIVAX HB and VAQTA) but on a second call was reported that no doses of VAQTA were involved in this excursion). Follow up information has been received from the certified medical assistant which reports that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 06-SEP-2013. This is one of several reports from the same source. J0030722 is not valid lot number for RECOMBIVAX HB. Additional information has been requested.
A report has been received from a Health Professional concerning a, subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 ml 10 pre-filled, single-use sprayers. FLUMIST QUADRIVALENT (intranasal) started on 04-Mar-2016. Health Professional stated that FLUMIST was given in error to a 2 month old child on 04-Mar-2016. The outcome of the event of FLUMIST given in error-medication error and FLUMIST given to a 2 month old child-off label use is unknown. The reporter's description of the event was as follows: No medical history provided. The report was considered to be non-serious.
Urticaria on arms / legs about 1 hour after receiving,MENACTRA, HPV #1, HEP A #1, on 5/27/09 no other complaint.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Additional Details: Pt reports redness and itchiness at injection site. Told pt to put some ice on it and take otc pain medication and speak with prescriber if there isn't any resolution.
I had vertigo, unsteady gate, nausea, vomitting, difficulty with visual tracking.
This case was reported by a physician via sales rep and described the occurrence of cellulitis in a 18-year-old female patient who received BEXSERO. In June 2017, the patient received the 1st dose of BEXSERO. On an unknown date, 5 days after receiving BEXSERO, the patient experienced cellulitis (serious criteria GSK medically significant), rash, swelling, feeling of warmth and erythema. The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis, rash, swelling, feeling of warmth and erythema were unknown. It was unknown if the reporter considered the cellulitis, rash, swelling, feeling of warmth and erythema to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The adverse event was reported from the physician's office, which happened about a month before the reporting date. One of their patients received their first dose of BEXSERO and about five days after that the patient experienced rash on her whole arm. The patient went to emergency room and was diagnosed with cellulitis, rash, swelling and warm erythema on her right shoulder.
Light pink color developed over the vaccine site; Bump in the arm; Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Bump in the arm), VACCINATION SITE PAIN (Soreness in the arm) and VACCINATION SITE ERYTHEMA (Light pink color developed over the vaccine site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included EZETIMIBE, SIMVASTATIN (VYTORIN), PLANTAGO OVATA (METAMUCIL REGULAR), LISINOPRIL, BIOTIN, VITAMIN B COMPLEX (B-COMPLEX [VITAMIN B COMPLEX]), IRON (IRON COMPLEX [IRON]), MULTIVITAMIN [VITAMINS NOS], CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]), TOCOPHEROL, UBIDECARENONE, ZINC (COENZYME Q10+), DOCUSATE SODIUM (COLACE), TURMERIC [CURCUMA LONGA RHIZOME], FINASTERIDE, PROBIOTICS NOS, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), FDgard, IBgard, METFORMIN HYDROCHLORIDE (METFORMIN ER), HYALURONIC ACID, Aspirin, ASCORBIC ACID (VITAMIN C ACID), CALCIUM, LEVOTHYROXINE and MAGNESIUM.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Bump in the arm) and VACCINATION SITE PAIN (Soreness in the arm). On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Light pink color developed over the vaccine site). At the time of the report, VACCINATION SITE INDURATION (Bump in the arm), VACCINATION SITE PAIN (Soreness in the arm) and VACCINATION SITE ERYTHEMA (Light pink color developed over the vaccine site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medication were not provided by reporter.   This case was linked to MOD-2021-012030, MOD-2021-012030 (Patient Link).
Patient, Patient's wife, and Pharmacist were in immunization room talking post vaccination when after a few minutes the patient stated "I don't feel very good, it's happening." and his eyes rolled backwards. Patient was sitting and did not fall. Patient came to about 20 seconds later. Patient was helped to the ground and 911 was called. Patient was sweating, dizzy, and pale. EMT's arrived and took patient's vitals which were all normal. Patient told EMT's that this often happens post immunization and even when just visiting the doctor. Patient recovered and EMT's concluded patient did not need additional treatment. Patient left on his own accord with his wife.
lymph nodes under both my arms are swollen, sore. Hurting bad; lymph nodes under both my arms are swollen, sore. Hurting bad; This is a spontaneous report received from a contactable Consumer for a Pfizer sponsored program (005570). The reporter is the patient.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE),  (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "lymph nodes under both my arms are swollen, sore. Hurting bad".  The lot number for BNT162B2 was not provided and will be requested during follow-up.
This spontaneous report as received from a physician via the Company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated intramuscularly with PNEUMOVAX23 (dose, lot number and expiration date were not reported). On an unknown date the patient experienced chills, arthralgia, myalgia, rash and fever. The physician reported that on an unknown date the patient recovered from adverse events. The relatedness between chills, arthralgia, myalgia, rash, fever and the vaccination with PNEUMOVAX23 was not reported. Additional information is not expected.
Extreme fatigue continuing  1st,3rd.5th and 7th day after 2nd shot.  Every time I thought I was recovering, the extreme fatigue came back the next day.; Fuzzy head; Headaches on and off; Pressure inthe head with the fatigue. ( no temperature); This is a spontaneous report from a contactable consumer, the patient. A 88-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 13:45 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient included hypothyroidism, and unspecified penicillin allergy. Concomitant medication included levothyroxine sodium (SYNTHROID) for hypothyroidism from an unknown date. The patient previously received aspirin (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 14:00 (at the age of 88-years old). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, at 10:00, the patient experienced event extreme fatigue which continued on the 1st, 3rd, 5th and 7th day after the second dose of vaccination (on 23Mar2021). Every time, the patient thought she was recovering, and an extreme fatigue came back the next day. On the same day at 10:00, the patient had very fuzzy head, headaches on and off and pressure in the head with the fatigue (no temperature). The patient did not receive any treatment for the reported events. The clinical outcomes of the events extreme fatigue, very fuzzy head, headache on and off and pressure in the head were not recovered.  No follow-up attempts are needed. No further information is expected.
High fever, flu-like symptoms, chest hurt, muscle aches for 2 days. No treatment.
The patient received the first dose on 4/13/18, on 4/17/18 the patient went in to the doctor and had blood work done that determined she had altered thyroid function. The patient was then prescribed Levothyroxine 25mcg (which she did not pick up). When she was tested again a week later, her thyroid levels were back to normal.
Patient was given the MMR vaccine on 2/11/19. On the morning of 2/28/19 dad called the office reporting that patient broke out in a rash last evening and they were not sure what it was, if a reaction to the change in the laundry detergent (as they did change this). Informed dad to send a picture via patient portal. The rash look suspicious and dad was informed that we should make an appointment to have patient seen. Appointment was made. Parents arrived with patient and they were immediately brought into the room. Patient's vitals were taken, parents denied any other symptoms other than the rash, denied itching. Rash was located to the abdomen, chest, back and some on the patient's neck. Parents stated rash started last evening. Dr. stated he felt the rash was a Measles like reaction (viral) and it just needed to run its course. Patient was sent home with the parents.
Immunization site-Lt upper arm developed 1/2" x 2" area of redness increased warmth and firmness. These symptoms except for redness. Started Thursday 7/29/10. Redness developed 7/30/10 AM. Pain started 7/29/10.
I was not shown the bottle of vaccine I was given unlike my other doses. I experienced arm pain after my initial vaccination, and in the middle of the night I woke up with nausea, loss of appetite, myalgia, tossing and turning, fatigue, and insomnia. Then I started having a cough, runny nose, congestion, and severe headache. I took TYLENOL and baby aspirin for my symptoms. I called my employer's health line, but was not given any treatment recommendations. I had to work from home due to the severity of my symptoms. These symptoms began to abate on the fifth day. I am still experiencing lingering fatigue, which has affected my stamina and ability to go to the gym consistently.
congestive heart failure. about 3am i woke and went to the bathroom and went back to bed, from that walk i couldn't breathe. i guess i was making noise while trying to breath woke up my wife and she called 911 and they took me to the hospital. the hospital stay was a big blur in my memory. and i remember getting out of there.  they informed me i had congestive heart failure, my lungs were filled with fluid, my heart and kidneys were affected but i'm not able to describe what they told me was wrong.
Soreness of arm; Patient possibly has waited longer than 35 days to get second Moderna covid 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient possibly has waited longer than 35 days to get second Moderna covid 19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient possibly has waited longer than 35 days to get second Moderna covid 19 vaccine). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient possibly has waited longer than 35 days to get second Moderna covid 19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: significant FU : AE details updated
Systemic: Dizziness / Lightheadness-Severe, Additional Details: patient state he started to have dizzyness and light headedness for about 3 days starting 5/9 and lasting and getting worse until today. patinet has already tried resting and re hydrating
Ear infection; Treated for allergies; She had a cold; This is a spontaneous report from a contactable consumer (Medical Assistant) and a contactable consumer.   A 6-month-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot # T78675, Expiry date: 31Mar2020, NDC # 00005-1971-02) intramuscular at 0.5ml on 27Aug2018 for immunisation, prescribed by a Pediatrics. There were no other medical conditions, or concomitant medications, or relevant investigations to provide. On unknown date he patient experienced allergies, she had a cold and ear infection and was prescribed ZITHROMYCIN on that same day. The reporter did not provide a seriousness criteria or outcome.   Follow-up (29Aug2018): New information reported from the same contactable consumer, an Office Manager (Medical Assistant) includes: reporter occupation; patient age/gender and details; suspect details; no medical conditions, concomitant medications or relevant investigations.  Follow-up (29May2019): Follow-up attempts completed. No further information expected  Follow-up (16Jul2019): additional information received from a contactable consumer includes no patients were given the vaccine during temperature outage.  Follow-up attempts completed. No further information expected
a 74 year old male patient was being treated with OncoTICE. At catheterizaton for the fifth instillation some bleeding was noticed, possibly due to scar tissue from previous surgery. After this instillation the patient presented with uncontrollable shaking and fever. The shaking and fever both subsided within 24 hours. The shaking could have been possibly caused by hypoglycemia brought on by the fact that the patient did not have anything to eat since the previoius evening. The patient was treated with an antituberculin for 7 days as a precaution.
Pt in clinic today for raised, red area where injection was given. She reported it started the night of the injection the area was red, warm and raised. Area has been slowly going down in size, still noted today a quarter sized area that was red and raised.
5/7/04: Received phone call from doctor's nurse. States patient who was vaccinated with Varivax 01/08/2002 and now has approximately 10 chicken pox. States vaccine was stored appropriately.