chrisvoncsefalvay/vaers-outcomes huggingface dataset:
right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; This is a spontaneous report from a Pfizer-Sponsored Program COVAX US Support. A contactable consumer reported for a patient.  A female patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 30Jun2021 as DOSE 2, SINGLE for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on unknown date as DOSE 1, SINGLE for COVID-19 immunization. Medical history included autoimmune disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date about 10 (or 12 days per caller) days after receiving the first dose of the vaccine, the patient experienced right ear itching and burning and then the skin started to crack which lasted for 5 days, after a week of vaccination another ear was burning, red, felt hot and started cracking again. Patient also experienced a rash on her skin after receiving the second dose. She reported to DSU that this same side effect happened to her son's wife's father and grandfather, both received the Pfizer COVID-19 vaccine per reporter, and she would like to know if this side effect is "something new or if this is something normal." Sister had the same side effect as well. The caller states that 4 different people from 4 different states have all experienced the exact same side effect after receiving the Pfizer COVID-19 vaccine. All events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Patient received bivalent booster dose of Moderna vaccine, without having completed either of his first Moderna monvalent vaccines.   Per CDC Interim clinical considerations for use of COVID-19 vaccines, this patient should repeat 1 monovalent dose immediately because administration of the booster dose will result in a lower-than authorized dose. After the dose has been repeated, continue the  recommended vaccine schedule. (e.g., complete primary series, then administer a bivalent booster dose at least 2 months after completion of the primary series).
Pt c/o itching/pain left deltoid. Left deltoid has erythema/edema/11mm area of induration over injection site.
pale & dizzy p/multi vax inj, 02 & VS started, MD assessed 1030AM improved, 1045AM ambulatory then home;
Information has been received from a physician concerning a 15 month old female with no pertinent medical history and no allergies who on 05-MAR-2009 was vaccinated with the first dose of VARIVAX (Oka/Merck) (lot# 660668/1380X). Other suspect vaccine received on 05-MAR-2009 included MMR II (lot# 661675/1505X). There was no concomitant medication. Within four hours after receiving the vaccinations the patient experienced vomiting and decreased appetite. The patient recovered from vomiting and decreased appetite within 8 hours of vaccination. Lot checks have been requested. This is one of several reports from the same source. Additional information has been requested. 6/18/10 Standard lot check investigations were performed. All in-process quality checks for the lot number 660668/1380X and 661675/1505X in question were satisfactory. The lots met the requirements and were released. This is one of several reports from the same source.
Patient is reporting pain in her right arm where the TDAP was given for 10 weeks. She did report prolonged pain 16 days after the injection in the left arm. She call in 8/17/2017 with complaint of "no swelling, redness or pain at the site of the tetanus injection the only thing is she is still having pain when she lifts her arm above her head, pt says it feels like she was hit with a baseball bat.' She then contacted the office again today with minimal pain and stiffness to the left deltoid now 10 weeks after the injection.
CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. No adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855835, expiry: 27-APR-2022) dose was not reported, 1 total, administered on 16-FEB-2022 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-FEB-2022, about 10 hours after vaccination, the patient experienced chills, fever, and headache (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on FEB-2022 and had not recovered from headache. This report was non-serious.
After 3 hours of administration of the vaccine my son began to throw up for 8 hours straight. He could not keep anything down and I brought him to the ER where they gave him anti anti naesua medication. He missed 2 days of school after that because he still was not able to eat much and was still feeling ill.
Flu immunization and shingles vaccine were due; This case was reported by a consumer via other manufacturer and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included flu vaccine (received dose on and unknown date) and Shingrix (received dose on and unknown date). Concurrent medical conditions included rheumatoid arthritis and pulmonary arterial hypertension. Concomitant products included sildenafil, ambrisentan (Letairis), treprostinil sodium (Remodulin) and ibuprofen (Advil).   On an unknown date, the patient did not receive Flu vaccine and Shingles vaccine. On an unknown date, unknown after receiving Flu vaccine and Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient was due for flu immunization and shingles vaccines. The patient was informed. Additional Supportive Information: Till the time of reporting, the patient did not receive dose of flu vaccine and shingles vaccine, which led to incomplete course of vaccination. Incomplete course of vaccination event captured conservatively since it was unknown that how many doses of flu and shingles vaccine were received.; Sender's Comments:  USCH2022AMR044838: ID
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.
Patient started to have body aches, chills, fever, and cough.  States symptoms are moderate in nature but started about 12 hours after the vaccination.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: Patient felt an itch in the throat and around her lips. She experienced this with her first vaccination with moderana. Patient was given 50 mg og benadryl and felt fine after 30 minutes.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-NOV-2012, the patient was inoculated with ZOSTAVAX by a health care provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). Patient was diagnosed with shingles and/or other zoster-related injuries (Herpes zoster) after and despite being inoculated with the ZOSTAVAX vaccine. On or about 27-APR-2015, the patient had physician office visit for treatment of shingles (Herpes zoster). As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This initial spontaneous case, was received on 12-Oct-2017, by a pharmacist, concerning a female patient of unspecified age. The patient's medical history and concomitant medications were reported. On 10-Oct-2017, the patient received AFLURIA QUADRIVALENT after a temperature excursion (dose: 0.5 ml route of administration: intramuscular, anatomical location: deltoid (assumed by the pharmacist), batch number and expiry date were not reporter) as active immunization. The patient received the vaccine after a temperature excursion (explicitly coded as drug administration error and product storage error). It was reported that, the patient did not develop any adverse event after vaccination (the patient did not call or any adverse events were reported). Pharmacist doesn't have much information about the patient, stated that the patient has already been discharged. The outcome of the events was not reported. The reporter considered this case as non-serious. Significant case correction received with IRD 12-OCT-2017: Additional event "product storage error" was added and narrative amended accordingly.
Kidney stone; Feeling bad; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4499349-00 (AbbVie).  A 34-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 30Mar2022 (Batch/Lot number: unknown), subcutaneous for hidradenitis; influenza vaccine (INFLUENZA VACCINE), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history included: "feeling nauseous" (unspecified if ongoing), notes: last month he was feeling nauseous; "a lot of abdominal pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 21Apr2021, when the patient was 33-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 12May2021, when the patient was 33-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 20Jun2022, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "recovered", described as "Feeling bad"; NEPHROLITHIASIS (hospitalization, medically significant) with onset 28Jul2022, outcome "recovered" (29Jul2022), described as "Kidney stone". The patient was hospitalized for nephrolithiasis (start date: 28Jul2022, discharge date: 29Jul2022, hospitalization duration: 1 day(s)). The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of nephrolithiasis.  The reporter's assessment of the causal relationship of "kidney stone" and "feeling bad" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event(s) of "kidney stone" with adalimumab was a reasonable possibility. Abbvie's opinion is that there is no reasonable possibility that the events of kidney stone and felt horrible after covid and flu vaccine are related to adalimumab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the reported events nephrolithiasis, feeling abnormal  and suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Coughing, wheezing within 4 hours of vaccine.  Another 4 hours later, tongue, eyes and lips swollen.
The next day after receiving the vaccine I noticed the band aid over the injection site was wet, so I removed the band aid and there was a small (pencil eraser size) area of desquamated skin with clear liquid coming out. Over the next day it developed into a blister that did not rupture, and is now a dark red slightly raised area with scabbing/crusting around the edges. It is mildly pruritic but otherwise not bothersome
rash all over body, red diffuse torso, legs, arms, itchy, red raised
7 doses mixed with non-supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number BA975, expiry date 16th May 2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: The medical assistant reported staff discovered that 7 doses of Hiberix were potentially mixed with non-supplied diluent when they were reconstituted for administration.  It was believed the doses were reconstituted with sterile water diluent from Merck that was used for reconstituting proquad vaccines. The reporter did not have patient details at the time of call.  The reporter did not know dates of administration. The reporter consent to follow up. Additional supportive information: Hiberix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution. This was one of the 7 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR136360:Same reporter. US-GSK-US2022AMR136361:Same reporter. US-GSK-US2022AMR136362:Same reporter. US-GSK-US2022AMR136363:Same reporter. US-GSK-US2022AMR136364:Same reporter. US-GSK-US2022AMR136365:Same reporter.
I woke up with extreme pain in my lymph nodes under my arm. As the day progressed it became more painful and swollen.  6 days later they are still painful and swollen, but have subsided slightly each day.
COVID ARM; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE REACTION (COVID ARM) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID ARM). At the time of the report, VACCINATION SITE REACTION (COVID ARM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-211557 (Patient Link).
fatigued; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 12Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunisation and experienced events which included broke my tooth and infection in gums. The patient was put on antibiotic (amoxicillin) due to infection in gums. The patient experienced fatigued on 12Feb2021. It was reported that the patient felt better after getting the 2nd dose than she did after the 1st dose. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red, swollen, hard, hot from shoulder to elbow. BENADRYL, ibuprofen, ice.
chills, fever, shaking did not take temp;fever cause sweating so profuse that change pajama top, covered bed w/heavy bath towel;was sick in bed 10-13OCt;fever, severe chills, shaking so bad required assistance to walk;
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; CARDIAC FLUTTER (medically significant), outcome "unknown", described as "heart started fluttering"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". Clinical course: Within 2 hours of Covid booster, heart started fluttering and by 3 three weeks after shot she had shortness of breath and cardiologist diagnosed as myocarditis. Event took place after use of product. The lot number for bnt162b2 was not provided and will be requested during follow up.
24 hours after vaccine, began feeling bad. Fever 102. (R) deltoid red, warm to touch, body aches. Taking ADVIL/TYLENOL for fever and body aches.
Mother reports she noted large red warm induration measuring 10 cm across left deltoid at the injection site and temperature of 100.8 degrees Fahrenheit around 10 pm 07/28/2009.
Chills, fever, body aches all over for two days, then splitting headache for one day and then tired for at least a week with very low energy
Severe fever and mild headache for 24 hours. Then mild fever for additional 36 hours.
Nausea; weakness; lethargy; sore arm; vomiting; diarrhea; no appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Sep2023 at 13:45 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: NAUSEA (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering"; DIARRHOEA (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering", described as "diarrhea"; LETHARGY (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering", described as "no appetite"; PAIN IN EXTREMITY (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering", described as "sore arm"; VOMITING (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering"; ASTHENIA (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering", described as "weakness". Therapeutic measures were not taken as a result of nausea, asthenia, lethargy, pain in extremity, vomiting, diarrhoea, decreased appetite.  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.
No additional AE reported; Patient was administered expired GARDASIL 9 on 02/23/2023; This spontaneous report was received from a healthcare business professional referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 23-FEB-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #T026323, expiration date: 22-FEB-2023, (strength, dose, route, vaccination schedule and anatomical location were not provided) for prophylaxis (Expired product administered). No temperature excursions were reported. No additional adverse event (AE) was reported.
High pitch screaming lasting for 3 days now. Called dr office and they stated it wasnt a reaction. But on the web for DTP its a mod. reaction. This child hardly ever cried.