chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE PROVIDED TO A 17 YEAR OLD/VACCINE ADMINISTERED IN INAPPROPRIATE AGE GROUP; OFF LABEL USE; This spontaneous report received from a patient concerned a 17 year old female. The patient's weight, height, and medical history were not 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the subject experienced vaccine provided to a 17 year old/vaccine administered in inappropriate age group. On 07-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine provided to a 17 year old/vaccine administered in inappropriate age group was not reported. This report was non-serious.
Severe muscle soreness in left calf starting on 4-14; continued for several days, leading to ultrasound of the legs on 4/16. Two blood clots were found, one in the left calf, one behind the left knee.
pt recvd vax APR95 & the evening of vax pt devel a fever of 103-104 & was extremely irritable;fever persisted approx 3 days & irritability persisted 24hrs;tx w/Ibuprofen;
Fever for 4 days following measle rash all over the body for another 4 days.
Client received AstraZeneca covid vaccine, no reaction. Previous vaccine unavailable in the Janssen given as an alternative 9.15.2021.
Extremely sore arm to the point that I could not lift it.  Dizziness with headache and nausea for 6 full days. Could be a coincidence but after 8 months of not menstruating, my period started 3 days after receiving the 2nd dose.
The pt developed a fever of 102F X 5 days, lot of purulent sinus discharge, right otitis media, severe cough, lethargy and decreased appetite.
Excessive and progressive pain, swelling, redness in Left Arm (Arm with Prevnar 20). Patient stated this started a couple days after vaccination and progressively worsened. Pt reported back the pharmacy 5 days later. Pharmacist advised patient to go to Urgent care or ER. Patient went to ER and was prescribed steroid and antibiotics.
C/o flushing feeling to face ("like sunburn") which was gone after 12 hours. No other symptoms or signs of reaction reported. Came on within 5 minutes of vaccination.
The day after receiving vaccine (2/19) she experienced shortness of breath while shopping at store. She returned home without incident. She thinks she took a Benadryl because that is her usual response.  She took a shower on 2/20 and her torso turned bright red from neck to waist - she remembers taking a Benadryl for this   - the redness disappeared within about 20 minutes and has not returned. She called her doctor on Friday, possibly Monday she thinks. The MD office called and had her come in on Monday 3/8 for an evaluation. The SOB continues even now. It is worse with activity.
Sever night sweats, fatigue, and body aches started the night after the vaccine. Slightly better by the AM
Narrative: Patient received two doses of covid vaccine. Patient reportedly died tw weeks after second dose from covid complications. No other details available. reporting per Regulatory Authority instructions.
PATIENT FAINTED WHILE SITTING DOWN, MOM CAUGHT HER AND HELPED HER STAY IN THE SEAT. PATIENT LOOKED PAIL AND WAS FEELING NAUSEATED. MEDIC ARRIVED AND TOOK VITALS AND OBSEEREVED. PATIENT WENT HOME WITH MOTHER
AS REPORTED BY THE MOTHER OF THE PATIENT THE SIGN AND SYMPTOMS PRESENTED WERE DIZZINESS, VOMITING, HEADACHE, IMBALANCE AND RIGHT EYE VISION LOSS.
pericarditis 5/30/21 Tested + for rhinovirus/enterovirus on PCR Resp Pathogen Panel at time of admission, so unclear if from rhinovirus (more likely)
p/recv vax pt exp varicella like rash, dew drops on back, chest, not hands; 7/27 another rash about 12 lesions; T102; 8/11, rash gone now back, worse, now seems to be itchy;
R29.810 LEFT FACIAL MUSCLE WEAKNESS 4/26/2023 RIGHT KNEE JOINT PAIN
Continuous crying, temp 97.8; 6-12hrs p/inject; Hospitalized overnight; Discharged in AM;
Patient complained of pruritis around eyes, face.  No rash on face trunk appeared.  Vitals within normal limits.  Quick dissolve strip (19 mg).  No reactions 25 mg after 15 minutes.  Called at 12:30 pm.  Mom said patient slept when came home.  Is fine and is not itchy anymore.  Mom aware when to call 911/MD.
terrible diarrhea; terrible throwing up; pain started, right shoulder, left shoulder, right shoulder so painful couldn't lift arm to move the mouse on my laptop without the help of my left hand, bicep, knees wrist, left hand; pain started, right shoulder, left shoulder, right shoulder so painful couldn't lift arm to move the mouse on my laptop without the help of my left hand, bicep, knees wrist, left hand; I had exhaustion and could not lift either arm; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Mar2021 as second dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Mar2021 the patient experienced terrible diarrhoea, terrible throwing up, the pain started, right shoulder, left shoulder, right shoulder so painful I couldn't lift my arm to move the mouse on my laptop without the help of my left hand, then it went to other areas, bicep, knees wrist, left hand so painful I couldn't play, I had exhaustion and could not lift either arm. It is been 10 weeks and still having side effects. The outcome of the events was unknown.  Information about batch/lot number has been requested.
pt recv vax & devel bloody stools & resp congestion;pt was hosp on 13JAN99 for 2 days & again on 15FEB99;A CXR taken during the second hosp revealed pneumonia;the reporter declined to provide additional information;
Noticed pain in wrists/hands (mainly R side).  When moving wrists movement is shakey (tremor?) nerve can be felt vibrating up both forearms with movement.  C/O back pain between both shoulder blades.  Headache, dyspnea, neck pain. Had appt with MD on 9/15/15.  Behavior changes: quiet, c/o pain frequently, tired all the time, no energy, tearful.
my left shoulder feels like it has what I would relate the pain to as a rotator cuff pain/injury. They gave me the injection at the joint of my shoulder. I could not lift my arm. I have had to go to therapy which is helping.
Tested positive for Covid on 24Mar2021; Started to feel sick; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid on 24Mar2021) and MALAISE (Started to feel sick) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient reported history of cancer 3 years ago) since 2018. Concomitant products included ANASTROZOLE from 01-Sep-2018 to an unknown date for Cancer, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) from 01-May-2018 to an unknown date for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced MALAISE (Started to feel sick). On 24-Mar-2021, the patient experienced COVID-19 (Tested positive for Covid on 24Mar2021). At the time of the report, COVID-19 (Tested positive for Covid on 24Mar2021) and MALAISE (Started to feel sick) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-1 test: positive (Positive) tested positive for Covid.         Action taken with mRNA-1273 in response to the event was not applicable.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up received on  26-jun-2021 include concomitant medication added on anastrozole, aspirin and 2nd dose Vaccine information was added and weight added.
In the evening while making dinner I noticed mild pain at injection site and began to notice increasing chills, and unusually intense tiredness, which were followed that night by a low grade fever, headache, and nausea which led to vomiting.  Was unable to sleep that night and unable to eat most of the following day due to these symptoms, primarily the nausea. Symptoms began to resolve during the later afternoon of April 11th. No medical treatment sought as these were side effects listed on the fact sheet and expected to go away which they did. Still experiencing mild arm pain in injection arm but expecting that to resolve soon on its own.
Left sided Bells palsy. Notably pt with remote hx of Bells palsy on the same side. occurred approx 12 hours after injection.
Nosebleed, it was stoppable through pinching nose. Pt doesn't normally get nosebleeds.
Vaccine stored at improper temperature for longer than recommended time. Mom will take daughter to MD office.
On the 21st, I had acute fingertip numbness in the last three digits of the hand, bilateral facial numbness . I did go to the Hospital  and everything was NEG. I started developing night sweats within a day or so. The hot flashes are between 2 and 4 am always.
A week after the vax, I began to feel more fatigued and out of breath. I went to the ER in May 2021 and they thought I had a stroke. I went to a neurologist who didn't think it was a stroke. I went to another Doctor in July 2021. Received a transplant evaluation. I ended up in the hospital in Sept. I haven't had any problems since the l-vat in Sept.
12/11/2021:  Around 8 hours after receiving the vaccine, fatigue, body aches, chills, mild dizziness, a sore throat, and runny nose began. On 12/12/2021, conditions worsened with the sore throat and runny nose. Fatigue and body aches continued. On 12/13/2021, all conditions improved or were resolved except the sore throat and runny nose, which worsened. A rapid COVID test was conducted, which was negative. On 12/14/2021, conditions worsened and chills, fatigue, and body aches came back. Lightheadedness and a cough developed.
Pain noticed in right calf (8/6/21). Pain got worse and prompted ER visit. Blood clot diagnosed in right leg/calf area via Doppler ultrasound (8/11/21). Eliquis prescribed for three months minimum and compression sleeve to be worn daily.
Third shot (booster). He woke up at 7:00am (said he felt it starting at 4am and didn't want to wake anyone up). Chest pain, swelling under arm pit. I took oxygen level which was 88 and his pulse was 39.
Severe fever/fever is getting really bad it is up to 102 degree; Feeling sick; Aches and pains; Headaches; Fever is getting worse; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a female patient (reporter's wife) that. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on 18Aug2021 12:00 (Batch/Lot Number: FC3182; Expiration Date: 19Aug2021) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that reporters wife got the shot yesterday afternoon around (18Aug2021) and she was getting really severe fever and she has been feeling sick for day and half now her fever is getting really bad it is up to 102 degree so, wondering if that was normal or if there was anything they should do. Reporter stated, she had been sick with aches and pains and Headaches and fever for about a day and half for about one and one half day she had been sick and now her fever was getting worse all events on unspecified date in 2021. Outcome of the event Severe fever and Fever is getting worse was not recovered. Outcome of the other events was unknown.
Approx. 7cm area around injection site, slightly red, warm to touch and raised. Inside circle area of reaction was a 1x3cm rectangular shape lighter area. Applied ice to area, administered oral Benadryl per pt weight. Sent home with ice packs and advised to get Benadryl for home. Mom verbalized understanding as well as stated she did not "hear" the instructions regarding ice after IZ admin r/t sibling in room having tantrum. Advised mom to return to office for recheck.
This spontaneous report as received from a registered nurse refers to a 5 year old male patient who 26-JUL-2013, was vaccinated with a 0.5 ml dose of GARDASIL intramuscularly (lot # H017698) instead of KINRIX. No adverse effects were reported. Additional information has been requested.
patient felt dizzy, sweaty, and complained of foggy-like vision. Blood pressure taken 100/60, heartrate 72, RR 16, oxygen saturation 99%. Patient lying down until blood pressure rises. Pt states she is feeling better and signed patient release form.
Delayed (did not start until 8 days after vaccine administration) injection site redness, tightness, hot to touch, itchiness and hardened subcutaneous tissue. Also feels like some sort of muscle knot or cyst. No treatment or resolution as of yet
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium
Admission Date: 7/23/2023 Discharge Date: 7/26/2023    DETAILS OF HOSPITAL STAY:   Clinical Narrative:   The patient is a 70-year-old gentleman with a Gold-stage IV disease/mMRC functional status presented for a recurrent hospital admission.  He has been offered hospice and palliative care on multiple previous occasions, given his appropriateness, but had deferred secondary to concerns regarding his disabled son.  On this occasion you does desire to enter hospice in the home in an effort to stay in the home and avoid a return to the hospital.  He hopes to die in his own home.  We discussed his son circumstance in some detail including the 13 months of bereavement services available to his son after his death.  We discussed the Social Work and Case Management availability with a hospice company and that this may facilitate better care coordination and reaching out to community resources to hopefully provide alternatives for his son.  He will be discharged home to home hospice today at his request.
Started to become fussy, crying - had to console approx 2 hrs- 3 vaccines were given crying lasted for approx 9 hours- Mom had to hold Pt constantly. Remained afebrile - no swelling vaccine site - no redness. TYLENOL given
Weakness Worsened; Ear Wax; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (Weakness Worsened) and EXCESSIVE CERUMEN PRODUCTION (Ear Wax) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diabetes since 2000, Emphysema since 2009, Tobacco user in 2009 and Chronic pain (fell from stairs nd injured at work) since an unknown date. Concurrent medical conditions included Drug allergy (manifested by frequent visits to the bathroom). Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Back pain, LISINOPRIL and ATENOLOL for Blood pressure, PRAVASTATIN for Cholesterol, METFORMIN for Diabetes, SALBUTAMOL SULFATE (VENTOLIN [SALBUTAMOL SULFATE]) for Emphysema, RANITIDINE for Heartburn, GABAPENTIN for Pain, ADALIMUMAB (HUMIRA) and PANTOPRAZOLE for Ulcerative colitis, RISPERIDONE (RISPERDAL CONSTA) for mental illness, vitamin d and IRON for supplement.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. In May 2021, the patient experienced ASTHENIA (Weakness Worsened) and EXCESSIVE CERUMEN PRODUCTION (Ear Wax). The patient was treated with IBUPROFEN at an unspecified dose and frequency; AMOXICILLIN at an unspecified dose and frequency and CELECOXIB (DEBROX [CELECOXIB]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness Worsened) and EXCESSIVE CERUMEN PRODUCTION (Ear Wax) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-131958, MOD-2021-131958 (Patient Link).
8/15/21: Presenting today for evaluation of shortness of breath and constipation.  According to EMS report patient oxygen saturation was 90% on room air and was placed on 4 L oxygen with brought patient oxygen saturation up to 97%.. She reported her last bowel movement was 3 days ago, she has been experiencing decreased appetite for the past 7-10 days. Note: patient previously received the COVID-19 Moderna Vaccine: First dose: 03/24/21 Lot Number 0474A21A; Second dose: 04/21/21 Lot Number 039B21A Diagnosed with acute hypoxic resp failure due to COVID, pneumonia 8/18/21: patient discharged
lower lip swelling-poss d/t vax vs viral, food, OTC med or other cause;
fatigue; chills; headache; nausea; pain at injection site for a couple of days; not sure if the vaccine was correctly injected / vaccine was injected incorrectly; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (not sure if the vaccine was correctly injected / vaccine was injected incorrectly), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037142B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (not sure if the vaccine was correctly injected / vaccine was injected incorrectly) and INJECTION SITE PAIN (pain at injection site for a couple of days). On 19-Apr-2021, the patient experienced FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. In April 2021, INJECTION SITE PAIN (pain at injection site for a couple of days) had resolved. At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (not sure if the vaccine was correctly injected / vaccine was injected incorrectly) outcome was unknown and FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. On 19-Apr-2021 he was feeling like getting the flu or COVID   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: follow up received contain no significant information
Pt received Hep B vaccination when all 3 doses of Hep B vaccination were already received.
Shingrix reconstituted with other diluent.; Shingrix reconstituted with other diluent.; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 4G94Z, expiry date 3rd February 2023) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received powder component of Shingrix reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not want to provide patients demographic data. The reporter consented to follow up. This case was 1 of 8 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR232925:Same reporter US-GLAXOSMITHKLINE-US2021AMR232924:Same reporter US-GLAXOSMITHKLINE-US2021AMR232923:Same reporter US-GLAXOSMITHKLINE-US2021AMR232927:Same reporter US-GLAXOSMITHKLINE-US2021AMR232928:Same reporter US-GLAXOSMITHKLINE-US2021AMR232929:Same reporter
I woke up Tuesday, the 28th, with cold symptoms and sore ears. I took over the counter cold medicine. The cold went away, but I was stuck with a really harsh cough that got progressively worse. I was going to go to urgent care, but I knew the first thing they would ask would be if I did a COVID-19 test. I was shocked to find out that I tested positive. I took a second COVID-19 test and it was positive, too. Urgent care didn't have any appointments until Monday. I had a telehealth visit with my doctor instead. He ordered PAXLOVID. I started it right away. I would like to say that it knocked it right out of me, but I still had the cough. The cough is much better. I have no other symptoms.
Pt devel generalized red, papular rash 6 hrs p/receiving DPT/OPV/HIB vax; Rash accompanied by fever & irritability; Mom did not take temp; Pvt MD consulted by phone; poss rxn to DTP;
Received vaccine: 8:46 am on Thursday. Around 7 pm started having GI symptoms vomited all night and into Friday morning. Felt fatigued on Friday.
Pt recvd 2 doses of Hep B vax in FEB91 & MAR91 & lab eval revealed pos Anti-HBs; JUN91 devel fever which varied between 99.8 & 100.2; also devel abd distress;
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to  (Patient Link).
Information has been received from a registered nurse concerning a 9 month old male with no medical history or allergies who on 01-MAR-2001 was vaccinated with a first dose of Varivax (lot # 635461/1246K). There was no concomitant medication. There was no illness at the time of vaccination. On 03-DEC-2006 the patient developed a rash described as "25 scabbed papular." There were no blisters, they were all scabbed. Medical attention was sought. Treatment was symptomatic. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Acute muscle pain between shoulder and elbow, especially in rotator cuff area from 12/08/2017 till today.
Swelling, hard knot, fever in arm, rash around injection area and up into the neck. Pain in left arm and neck.
day of vaccine:  sore left arm, dizzy/light headed for several hours, nausea/upset stomach for several hours.  By end of day: body aches, fatigue, chills, which continued to next day.  About a week after I experienced episodes of vertigo, and a lower threshold to my head/facial pain. These sx continue.