chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt exp 2nd dose of Engerix-B & 2 hrs p/dose of vax exp raised red facial rash on lt cheek, body aches & nausea;
Pt has developed a blister at the vaccine administration site with an area of redness surrounding the blister.
Pt rec'd bone scan w/dye 12/20/01. Rec'd flu vaccine 12/21/01. Pt states arm was painful after shot, woke at 2am 12/22/01 with pain in R arm, used a heating pad. Pain worsened over the next 2 days accompanied by swelling in R axilla and palpation of a lump. Pt went to ER 12/24/01, Temp - WNL she was told she had a swollen lymph node  related to the vaccine. Pt states swelling is slowly subsiding.
She got her vaccine on Monday, she was OK after that.  By Tuesday she could not get out of bed, was sick.  Has sick on and off, weak, fatigue, no appetite, her joints hurt.  She started itching where she had surgery where she had her breast surgery due to cancer which was 10 years ago.  This area has never bothered her until now.  Also having fever and headache which subsided after taking Tylenol.  Her appetite continues to be bad, she has no taste, and she is weak which is more than anything else.    She saw her doctor and went to the UC where she had the vaccine, and they informed her it was a AE of the booster vaccine.  This has been a while now, today makes 7 weeks and she is still having the weakness and loss of appetite as well.   She can barely drink a little tea, is very constipated and can barely get out of the bed today.    She has had the constipation after each vaccine, and goes back to normal and with each additional vaccine her constipation has worsened.
THE PATIENT FAINTED AFTER VACCINE WAS ADMINISTERED. PATIENT REGAINED CONSCIOUS BACK WITHIN FEW SECONDS. SAT DOWN AND OBSERVED FOR 30 MINS. PATIENT WAS NORMAL BY THE TIME SHE LEFT THE PHARMACY.
My neck feels stiff; I have awaken with a mighty headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (My neck feels stiff) and HEADACHE (I have awaken with a mighty headache) in a patient of an unknown age and gender 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 MUSCULOSKELETAL STIFFNESS (My neck feels stiff) and HEADACHE (I have awaken with a mighty headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (My neck feels stiff) and HEADACHE (I have awaken with a mighty headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. No treatment medication were reported.
Lump on breast!!!!!!  ? fatigue .. constant headache ? sleep deprivation . This shot is a disease
headache, flushed in face, itching on face, heart racing, chlostrophobic, chills about 15 minutes after Pfizer vaccine administered in left deltoid muscle. Patient felt need to remove protective mask to breathe more easily.  Pfizer vaccine administered at 11:15am;  Vital signs: 11:30 - 179/84, 134, 22, 98.3 1:L40 - 180/86, 87, 20, 87 11:50 - 180/80, 74, 20, 12:10 - 160.84, 71, 19, 98.1
pt recvd vax & had t 103.2; rash light pink; blotchy face, back, trunk; swollen neck glands; tx w/ atb for 10 day;
Storage unit temperature excursion, vaccines deemed non viable by manufacture. Contacting patient for re-vaccination.
About 8 hours after 2nd dose, had chills, fever, nausea, pain everywhere (head, arm, back...)  About  20 hours after had strong fatigue.  About 40 hours after, had lymph nodes swollen and painful in injected arm.  Still experiencing that part.
Very high fever, confusion, delirium, unable to recognize family, unable to walk on her own. She was taken to the ER for evaluation.  Then she was given Acetaminophen for the fever and labs were drawn.
Client was given FLUMIST @ 1 yrs of age. Client was a large baby/child and the assumption was make the child was much older than actual age. Age was not verified prior to administration.
Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
I am feeling chills/I have chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (I am feeling chills/I have chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced CHILLS (I am feeling chills/I have chills). At the time of the report, CHILLS (I am feeling chills/I have chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
12/21/05-received Td in left arm, 12/23/05 seen in office with red, edermatous, tender left arm-warm soak TID
Patient developed metallic taste in mouth within 10 minutes of vaccine and tingly lips within 20 minutes of vaccine. Metallic taste resolved after 15 minute duration, the tingly lips resolved after 2 hours. No treatment, only monitored at home. Full resolution.
Extremely sore arm at the injection site and entire arm. Nausea and body aches. Itchy scratchy throat, coughing and sneezing. Body aches and lethargy still present 3 days after injection.
Dizziness, Headache, Fever, Diarrhea, lymphadenopathy, site pain redness, swelling,chills - lost 1 week of work Narrative:
On 11/14/2021 collapsed and taken to local ER.  Blood clots found in each lung with acute hypoxic respiratory failure.  Remained there for four days in ER on oxygen, heparin drip and Nitro via nebulizer, as there were no beds available at the Medical Center.  On the fourth day was transferred there by ambulance where they also found a blood clot in my right calf, in addition to the clot in each lung.  Was there for five days with oxygen, heparin drip, and starting Eliquis in addition to long term Plavix.
Information has been received from a pharmacist concerning a geriatric or patient less than 60 years of age who on 12-OCT-2006 was vaccinated IM with a dose of Pneumovax 23.  On approximately 12-OCT-2006, the patient experienced intense pain and soreness in the arm, nausea and diarrhea.  Unspecified medical attention was sought.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information is not expected.
Moderna COVID vaccine #3 given 11/12/2021, lot # 002C21A; pt stays in a local facility; pt had a positive COVID test on 9/19/2021; DNR; per death certificate, pt died in the facility with coronavirus pneumonia being a condition contributing to death; death certificate and med records sent to info@vaers.org per VAERS request
10JUL93 745AM rt arm swollen & red felt very warm; recvd APAP since inject given; t102; began to have pruritus w/little blisters on legs, back & site of inject; seen by MD on 12JUL93 dx as severe local reaction;
Vaccination site swelling; Vaccination site erythema; Heat at the injection site; itching at the injection site; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE WARMTH (Heat at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR) and VITAMINS NOS for an unknown indication.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE WARMTH (Heat at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPRIN) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE WARMTH (Heat at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and HEADACHE (Headache) 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.   Treatment information: anti-inflammatories and ice
PT admitted 5/21/21. SARS-COVID-19 resulted positive   5/21/21. Patient received Janssen covid vaccine 04/9/21 Lot 1808982. PT had presented to ER for with 1 week history of intractable nausea, vomiting and constipation. PT documented to be COVID -19 asymptomatic.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering", COVID-19 (medically significant), 9 days 13 hrs after the suspect product(s) administration, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Symptoms returned. Positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks reported as no. Paxlovid used for the treatment of covid 19. Known allergies reported as no.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201231877 Same patient, different product and event;
pt recv vax & 2wks later devel GBS sx;exp numbness in hands & legs which lasted approx 1month;no further details were provided;
Immediate pain/burning at injection site which radiated to neck, became nauseous within 3 minutes. Ice pack was applied which helped. The patient did not want the doctor to be contacted. It was recommended that if she still had pain to follow up with her healthcare provider. The next morning, patient reported being unable to sleep last night and pain radiated to back/spine and down left arm.
some problems with tooth; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTH DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "some problems with tooth". The event "some problems with tooth" was evaluated at the physician office visit. Additional information: The dentist prescribed amoxicillin as treatment for the event. The patient wanted to know if it's advisable to take antibiotics.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
According to this patient's Covid 19 card, she was given her 1st Covid 19 vaccine at age 4yrs on 12-18-2021 at the Site. The Covid 19 vaccine card shows a DOB.
Needle came out so the vaccine started dripping on the floor; All of the vaccine did not get into the arm; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (Needle came out so the vaccine started dripping on the floor) and UNDERDOSE (All of the vaccine did not get into the arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for an unknown indication.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (Needle came out so the vaccine started dripping on the floor) and UNDERDOSE (All of the vaccine did not get into the arm). On 09-Apr-2021, DEVICE CONNECTION ISSUE (Needle came out so the vaccine started dripping on the floor) and UNDERDOSE (All of the vaccine did not get into the arm) had resolved. Not Provided      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.   It was reported that the nurse thought that patient did get some vaccine.  No concomitant medications were reported.  No treatment information was provided.
Mild case of shingles; got a single dose months ago. I am going to get the new one.; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's mother sufferred severe stabbing nerve pain (for 6 years), until she passed away).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient stated that got shingles shot and got a mild case of shingles a few months ago. The patient stated that going to get newone, which led incomplete course of vaccination.
1/8/21: Moderna Covid 19 injection (no side effects) 1/19/21: Patches of red rash, like Hives, with severe itching  on arms, legs, back, abdomen, buttocks and other areas 1/20/21: Diagnosis:  My GP doctor diagnosed an  internal allergic reaction - prescribed Prescription hydrocortisone and over-the-counter Antihistamine /  Also conducted a Covid 19 Test 1/22/21: Covid 19 Test results: Negative 2/1/21:  Symptoms continuing - doctor diagnosed an infection due to the rash/itching  - prescribed Prescription Prednisone and Prescription Doxycycline and increased the over-the -counter antihistamines
Patient received vaccine on 04/17/2021. Reaction started on 04/30/2021. Came to pharmacy and showed left arm was covered sparsely but with red blisters located on left arm, arm pit, left chest, and a little bit on the back arm. Reported soreness and itchiness as well. Has not tried medication but has been putting on a warm washcloth over the area to ease the soreness. Spoke about using otc pain to help ease until seen on Tuesday by doctor as the doctor office is closed today (sunday 05/02/2021).
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against covid 19 date vaccine was administered.  Also patient did not call in  to complain of adverse event. This is administrative error without adverse event.
0928 Patient received Pfizer booster after consulted Dr. because of previous reaction of lips/tongue swelling, rash on face with 1st vaccine and second vaccine tingling of tongue and lips while resolved without treatment. Patient  premedicated at home with Zyrtec 10mg at 0830 1/3/22.  Patient alert oriented x4 talking in full sentences able to swallow. Lungs clear, no stridor, intra oral swelling, wheezing, chest pain or tightness ,   0930 Patient reports feels lips puffy and looks mildly swollen but denies intraoral swelling,drooling, difficulty breathing, wheezing, chest pain/tightness. Talking in full sentences.  Consulted Dr. regarding symptoms and advised may give Benadryl 25mg orally if necessary and continue to monitor symptoms for another 45 minutes.  0935 Vitals  BP 123/76 Temporal Temp. 98.8 Pulse 63 SPO2 98% on room air RR 12  0940 Patient states lips swelling resolved,  0958 Patient reports  mucus in throat and feels need to clear with cough, but no difficulty breathing/throat tightness/ lungs clear with no wheezing  no stridor or intra oral swelling, swelling of face/lips.  1001 Patient given Benadryl 25mg tab orally with water and tolerated well.  1007 Patient states feels mild throat tightness with mild cough, but able to swallow and not drooling, no stridor, lungs clear.Patient sitting up in bed talking in full sentences, and laughing. Has called dad to come to observation area. Bp 112/72 Spo2 98 % on room air  Pulse 75 RR 18  1014 states throat tightness resolved but feels mild cough not related to clearing throat/mucus but clearing chest. Rechecked Lungs and  clear to ascultation, no wheezing, stridor, drooling or difficulty breathing/chest tightness or pain  1020 Consulted Dr. regarding new symptoms and advised may observe until 1030.and if patient symptoms not worse may discharge home with driver. Patient may observe symptoms at home and  may call 911/Ed if necessary and should follow up with primary care Md regarding symptoms.  1030 Vitals Bp 117/70 SPO2 99% on room air Pulse 69 Patient states she feels fine to go home with her dad sitting next to her. Denies throat tightness/facial swelling/wheezing and hasn't coughed in last 5 minutes. Patient states she fine, has vaccine info sheet and verbalized understand regarding 911/Ed precautions.Patient passed the walk test with Rn and father at side.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for COVID after receiving all three Moderna vaccines) in a 55-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, the patient experienced COVID-19 (Patient tested positive for COVID after receiving all three Moderna vaccines). At the time of the report, COVID-19 (Patient tested positive for COVID after receiving all three Moderna vaccines) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive. No concomitant medication was reported. No treatment medications were reported. Company comment: This is a spontaneous case concerning a 55-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 in an unknown timeframe after the third dose of mRNA-1273 vaccine. The exact details regarding the either of the doses were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-445636, MOD-2022-444983 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 55-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 in an unknown timeframe after the third dose of mRNA-1273 vaccine. The exact details regarding the either of the doses were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.