chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After Injection: Day 1  Foggy and Tried Day 2  Sunday - I woke with both my knees hurting very badly - took  Tylinol   put on Ice and heat on both knees  front & back elevated Day 3  Monday - Bad night of pain Still very painful took Tramdol and  Iced - Elevated Day 4 Tuesday - Painful - Could not bend legs couldn't walk - Very Painful & Knees Swollen  Called 911 and went to ER  (to no relief)  given a pain keller x-rays of knees (Fine)  Went Home and could barely walk - still Pain Day 5 Still in pain - Called  Osteopatic Doctor and will see him next week Knees need drained according to ER?  Using a cain to walk! Still Pain.
Initial report received from a non-healthcare professional on 10 OCTOBER 2014. This case is linked to case Id 2014SA140266. A patient (age and gender not reported), whose medical history and concomitant medication were not reported had received a dose of FLUZONE QIV, (batch number: UI192AA, expiry date: 30-JUN-2015) route and site of vaccination not reported, on an unspecified date. On an unspecified date, patient experienced swelling from shoulder to elbow. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 05 NOVEMBER 2014: The patient did not seek any medical treatment and the final outcome was unknown. Addendum 3-FEB-2015: Upon second medical examination of case at time of internal review the following had been modified in this case: Core unlisted was captured as Y, reaction site was modified as shoulder to elbow. Expiry date of vaccine was taken as 30-JUN-2015 in Product screen and narrative, reported type was taken as non-HCP and CSD was corrected as 10-OCT-2014. The case is for one patient. Reporter screen has been corrected.
This is a  11 Years  old  Male, BIB mom, with history of asthma complaining of skin rash starting yesterday after receiving the HPV, Tdap, and meningococcal vaccines. Patient complains of rash to the right upper extremity.  Received 2 vaccines in the right arm and 1 vaccine in the left arm.  Left arm is okay. Patient states that the rash is getting worse.  Rash is described as moderate in nature and is itchy and painful.  No meds at home.
Sore at site of injection.  GI symptoms (watery BM), Body aches, fever of 101.5 degrees, chills.
Received monovalent booster ( spikevax) in error instead of bivalent booster
patient received Pentacel and  Pediavax vaccines in error/ no AE; Initial information received on 10-Jan-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 10-months-old female patient who received a dose of HIB VACCINE CONJ (OMPC) [PEDIAVAX] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (extra dose administered).  Concomitant vaccination include Pneumococcal13.  On 04-Oct-2019, the patient received a dose of suspect HIB VACCINE CONJ (OMPC) [PEDIAVAX] not produced by Sanofi Pasteur lot 3P252 (exp date: 10-Jan-2021) via unknown route in unknown administration site and a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (0.5 mL) lot UJ110AAA (exp date: 14-Oct-2020) via intramuscular route in the right thigh.  It was a case of actual medication error due to extra dose administered (patient received an extra dose of HIB).  No adverse vent reported at the time of report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Second Pfizer on 3/1, head cold and congestion on 3/7-9, with productive cough, stuffy nose, sore throat,
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Patient recieved vaccination from me at approximately 3:30 PM, 3/12/21. Patient was monitored for adverse reactions for 15 minutes and left without incident. At approximately 7:30 PM patient's wife called the pharmacy and reported that after dinner, her husband began vomiting, breathing shallowly, and became too dizzy to stand. I instructed the patient to immediately call 911 and told her that her husband should not recieve the second dose of vaccine. Currently, patient status is unknown.
SUSPECTED COVID-19 INFECTION (SYMPTOMS INCLUDED RUNNY NOSE, CONGESTION AND BODY ACHES); This spontaneous report received from a consumer concerned a 3 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-APR-2021, the subject experienced suspected covid-19 infection (symptoms included runny nose, congestion and body aches). On 02-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection (symptoms included runny nose, congestion and body aches) on MAY-2021. This report was non-serious. This report was associated with product quality complaint: 90000180984. This case, from the same reporter is linked to 20210554340.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious
Muscle aches; Flu-like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of muscle pain in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced muscle pain and influenza-like symptoms. On an unknown date, the outcome of the muscle pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the muscle pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The medical assistant reported that, several patients experienced muscle ache and flu like reactions after vaccinatin with a dose of Shingrix. The medical assistant denied, she was reporting any adverse event, and refused to provide further details regarding patients, products or events. The reporter did not consent to follow up. This case has been linked with case US2019170910.
Headache, Myalgia, Arthralgia, Diarrhea, fatigue, depression,skin burning Narrative:
First day: Fever, severe chills, whole body aches, bad headache, fatigue, cough, loss of appetite, arm soreness  Second day: severely painful swollen lymph node in armpit near vaccination site, chills, mild headache, body aches, fatigue, cough, arm soreness
Extremely sore for 24-48 hours (which is I believe is somewhat normal) however mild soreness remains one week later.  Couldn't abduct arm for about 24 hours due to pain.  Very faint red rash a few inches below injection site that goes across arm.  Arm is moderately itchy and has been since Monday 1/18/21.  Arm feels tight and is still pretty sore when reaching out and stretching it above my head.   No redness, itchiness, or discomfort around injection site.  Everything is in the middle of the upper arm.  The itchiness and prolonged soreness are my concerns, considering I still need a 2nd dose.
Running nose; Pain in legs/Pain in arm; Fever; This spontaneous case was reported by a health care professional and describes the occurrence of RHINORRHOEA (Running nose), PAIN IN EXTREMITY (Pain in legs/Pain in arm) and PYREXIA (Fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced RHINORRHOEA (Running nose), PAIN IN EXTREMITY (Pain in legs/Pain in arm) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Running nose), PAIN IN EXTREMITY (Pain in legs/Pain in arm) and PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient was having running nose, fever, pain in the legs and pain in his arm after receiving his second dose of the Moderna COVID-19 vaccine on yesterday 13 Apr 2021. Symptom started and patient took Tylenol to help with the symptoms. The symptom was still not better and patient had to call off from work. Patient was not on any medication.
Burning pains around whole body with weakness and fatigue-  still a month later, I am having burning in legs with out exertion.  I could be standing and my legs will start burning.
Urticaria (hives) starting 1 day after vaccination. Treatment: Hydroxizine (5/3/2004)
Approximately 2.5 to 3 hrs after vaccination, I started having trouble breathing with coughing and wheezing. (I was diagnosed as suffering from an asthma attack about 10 years ago after prolonged exposure to small dust particles from construction.  I have 1-2 incidents a year that require me to use an inhaler.)  At approximately 6 to 6:30p.m. I used the inhaler and gradually obtained relief beginning after about 20-30 minutes of using the inhaler. I did alert the nurse at the Health Unit where I work and where the vaccine was administered.  She noted that the time elapsed strongly supported the view that it was not a reaction to the vaccine and did not believe I needed to fill out this form and recommended I contact my doctor. I believe it was a reaction and submit it only for any value it may have in terms of tracking/evaluating. Thank you.
Nausea, diarrhea, early menstrual bleeding, sharp rib pain, labored breathing, joint pain, hives all over the body, fever, fatigue, itchy skin, severe sweating, confusion, altered mental status Took advil for joint pain and fever. Joint pain still present. Took benadryl and allergy meds for hives and itching. Hives and itching still present. Took zofran for nausea. Nausea still present.  All symptoms were present for at least 2 weeks after both injections.
in the subject's own words: I received vaccine on 12/28. on Monday 1/4 I noticed the site of injection was reddened and raised along with mild itching. on 1/6 the redness is twice the size.   Patient spoke face to face with subject and another pharmacist together on 1/6. Subject reports it is not painful. she tried ice and she tried benadryl but neither really helped. She showed it to Doctor who described it as erythema but not cellulitis. It is approximately 7 inches in length. on 1/7 she reports it is the same size, less red, not warm and minimal itch.
real sleepy; tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (real sleepy) and FATIGUE (tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IMATINIB MESILATE (GLEEVEC) for Leukaemia, CHLORPROMAZINE HYDROCHLORIDE (THORAZINE [CHLORPROMAZINE HYDROCHLORIDE]) for Muscle relaxant, HYDROCODONE, GABAPENTIN, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ORLISTAT (XENICAL) for an unknown indication.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced SOMNOLENCE (real sleepy) and FATIGUE (tired). At the time of the report, SOMNOLENCE (real sleepy) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-261818 (Patient Link).
Tired; Arm hurt a bit; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 18Jan2021 at 14:30, at a single dose, for COVID-19 immunization; and ibuprofen (ADVIL; Strength: 200 mg, Lot Number: DC5474, Expiration Date: May2022), via an unspecified route of administration,  on 18Jan2021, at 400 mg, single, as premedication. The patient's medical history and concomitant medications were not reported. The patient's wife was told by a nurse to give ibuprofen before the patient's first shot. So, the patient's wife told the patient to take ibuprofen before the COVID-19 vaccine shot and he took two 200 mg ibuprofen before the vaccine. The patient's wife feels guilty because she doesn't know if the patient is protected or not. The patient's wife gave the patient two ibuprofen before the COVID-19 shot. On 18Jan2021, the patient felt a bit tired and his arm hurt a bit, but he was fine the next morning (19Jan2021). He only felt a little tired that day and the next day, he felt great. It was further reported that the patient's wife gets allergy shots from a nurse, and the nurse told her to take ibuprofen before the COVID-19 vaccine shot. The patient never takes ibuprofen and the patient's wife can't believe she told him to take it. She had a friend who said ibuprofen could minimize the effectiveness of the shot. So, she was asking if the patient should have another shot since he took ibuprofen before his vaccine. It was a very bad advice because the patient's wife just learnt she shouldn't have. The patient's wife wanted him to have a little reaction as she thinks the vaccine is not going to be effective; asked if the patient should take an additional shot. The patient is scheduled for the second dose of the COVID-19 vaccine on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable; and for ibuprofen was post-therapy. The patient recovered from the events on 19Jan2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication  was not provided .
p/vax pt devel chickenpox w/approx 3 lesions;no fever or other sx were noted;pt was not seen by a MD;
Fever, Body Aches, Headache, Tired - General flu like symptoms Treatment - ibuprofen for body aches, bed rest Symptoms appeared within 12 hours, 40 hours later - I am feeling a little better and expect to progress through the day and tomorrow.  I do not have concerns for long-term effects based on how I feel so far.
Mild pain at injection site day of receipt (3/14/19) during the evening with mild temperature elevation (99-100). Fever of 102.2 the following morning with significant pain at the injection site which limited range of motion (specifically abduction and rotation) at the left shoulder. Malaise, nausea with intermittent fever throughout the day of 3/15/19 until the evening. Patch of erythema/redness developed over left deltoid region 3/15/19 in the evening after fever resolved. Erythema persisted with some edema and distal extension 3/16/19 with low grade fever but range of motion returned at the shoulder. Erythema waxed and waned and did not respond to antihistamines, prednisone, or OTC antipyretics 3/16/19-3/17/19. Erythema worsened the morning of 3/18/19 prompting an office visit at my place of work and a subsequent vascular ultrasound. Around 4:30 PM on 3/18/19 range of motion began to decrease significantly with pain and worsening induration noted at the injection site, along with a gradually increasing temperature. This prompted a visit to the ED and a subsequent admission to the hospital for a left upper extremity cellulitis. *I am a physician which is why I used all of the medical terminology.
MIGRAINE HEADACHE WITH AURA,103 TO 104 FEVER,COUGH,WHEEZING, DIFFICULTY BREATHING
First Adverse Symptom notice about a week after vaccination was that any drink that was hot (coffee, tea, hot chocolate) will produce a extremely itchy feeling of having a rash all over the body without showing visible signs.  The solution had been stayed away from hot drinks and wait for ambient temperature-warm.  Reaction is starting to go away after 5 weeks.  Second Adverse symptom has been a sudden reaction to detergent (hard soap bar or liquid) but only to specific ones. Since not sure which one (s) wearing gloves had been the way of aggravating the skin break down and sensitive pain on both hands from the moment it did get started.  It's healing in a very slow pace however I had to use gloves to keep the skin on the hands not dry since nothing else is working.
Inflammation/swelling in thyroid. Thyroiditis under control for several years. No treatment sought, just  reporting.
Got sick 3 times after shots. Back pain and irritated. 5 weeks after shots, bad back pain then fever. Continued back pain and irritation, daily. Rare now (first 3 times had fever).
Bleeding from the rectum; Flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of RECTAL HAEMORRHAGE (Bleeding from the rectum) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 18-Apr-2021, the patient experienced RECTAL HAEMORRHAGE (Bleeding from the rectum) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (Bleeding from the rectum) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medication reported. No treatment medication reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Left deltoid develop redness and swells 24 hrs post vaccine; given at Dept of Health  11/30/09 ED notes received for DOS 11/20/09 - Final DX: Rhabdomyolysis and presumed postviral myositis. On 11/19/09, Pt c/o lower leg pain bilaterally, swelling and macular rash. On examination: bilateral edema with tenderness to deep palpation below the knees bilaterally. Pt developed difficulty urinating, inability to walk due to pain; tx: IV D5 normal saline. Pt discharged.  12/01/09 H&P and MR received DOS 11/22/09  11/24/09. DX: rhabdomyolysis, myoglobinuria, possible viral infection or post vaccination associated myositis. Pt continues c/o pain in legs and arms, which is described as pressure pain. Pt c/o fevers, rash in arms, swollen legs. On examination: no fever, Pt ill-appearing, swelling of LE, tachycardia. According to Dr. this event was not of oncologic origin. tx: Tylenol, morphine, IV fluids. Pt's condition improved. Pt was able to ambulate. Pt discharged with ibuprofen prn and scheduled for physical therapy.
C/o very sore arm 2/9, 2/10 with mild fever of 99-possibly 100; Was very tired for about a week. Developed HA GI symptoms of (R) sided abdominal pain which last a few hours on 2/12/10. Saw NP, who felt abdominal sx too delayed to be related to shot. But patient adamant that she wanted VAERS report.
ectopic pregnancy; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient (not pregnant at the vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took biaxin and experienced allergies.  It was reported the Pfizer covid shot caused the patient to have an ectopic pregnancy. She ovulated the day before her shot while trying to get pregnant and just found out due to the shot she had an ectopic pregnancy on 04May2021.  Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovering.   Information on batch number has been requested