chrisvoncsefalvay/vaers-outcomes huggingface dataset:
adverse side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.  On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ADVERSE EVENT (adverse side effects). At the time of the report, ADVERSE EVENT (adverse side effects) outcome was unknown. Not Provided    No relevant concomitant medications were reported.  No treatment information was provided.
hearing loss; COVID-19; COVID-19; Pain; This is a solicited non-interventional study report received from Pfizer (Mfr control no: 21K-163-4055090-00) via the marketing program facilitated collect received from a non-contactable consumer or other non hcp (patient). A 56-years-old female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported), dose 1 via an intramuscularly administered on 05Apr2021 (age at vaccination 56-years-old) as DOSE 1, SINGLE and dose 2 (Lot number: not reported) via an intramuscularly administered on 15May2021 as DOSE 2, SINGLE both for covid-19 immunisation. Co-suspect of adalimumab (HUMIRA, batch/lot number and dose: not reported) via subcutaneous route of administration on an unspecified date for polyosteoarthritis. Medical history included fibromyalgia, penicillin allergy, lost hearing in right ear and children's neuropathy from an unknown date and unknown if ongoing. There were no concomitant medications reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On an unspecified date, the patient experienced covid-19, drug ineffective, hearing loss and pain. It was reported that mfr opinion was that there was no reasonable possibility that the events of lost hearing, taking humira for years still having pain unknown onset, covid and taking humira for years still having pain unknown onset are related to humira. Therapeutic measures were taken as a result of lost hearing, covid-19 and pain taking humira for years still having pain and covid. The outcome of the event hearing loss was not recovered and other events were unknown.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events drug ineffective, COVID-19, deafness, pain and suspect drug 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.
rash at the injection site; red patch on my face; rash on the right side of the chest; he got shingles; he got shingles/vaccination failure; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 274YD, expiry date 15-SEP-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number YC56Y7) for prophylaxis.   The patient's past medical history included shingles (had episode of shingles 20 years ago on the right side of his chest). Concomitant products included valaciclovir (Valacyclovir).   On 03-AUG-2023, the patient received the 2nd dose of Shingrix (intramuscular, right arm). On 22-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 24-SEP-2023, 52 days after receiving Shingrix and 186 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: he got shingles/vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: he got shingles). On an unknown date, the patient experienced injection site rash (Verbatim: rash at the injection site), skin red (Verbatim: red patch on my face) and rash (Verbatim: rash on the right side of the chest).  The outcome of the vaccination failure, injection site rash, shingles and rash were unknown and the outcome of the skin red was not resolved.   It was unknown if the reporter considered the vaccination failure, injection site rash, shingles, skin red and rash to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, injection site rash, shingles, skin red and rash to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 27-Sept-2023 The patient reported he got his 1st and 2nd dose of Shingrix at his physician's office and developed a rash on the right side of the chest.   The patient reported that it was a pretty good size rash at the injection site and it was from 1/2 to 3/4 wide and about 4 inches long and described like a band. The patient also got shingles and red patch on his face. The patient was prescribed Valacyclovir and steroid, but patient reported that he only took the Valacyclovir and not the steroid. Not all information was available. The patient's address was requested but patient forgot to provide.  Agent attempted to contact for full address information, but patient was not available. Only email information and zip code were provided.  The Vaccine Administration Facility was the same as Primary Reporter. The patient provided consent to follow up with him and with his PCP. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.
Dizzy, fast heart beat & shortness of breath. All lasted up to 2 minutes then all symptoms subsided. Did not seek medical attention due to single episode and felt of rest of the day. I'm fine to date 12-28-09.
Pt sitting in waiting room after vaccine administration waiting for Mom. He began to notice the he could not see well to his right side. He then realized that he could not move his eyes to the right. Symptoms continued and he was seen in the office on 7/27/11 pt was then referred to ER for loss of vision where an MRI of Brain was done (Negative) and was later referred to pediatric neurologist and pediatric ophthalmologist.
After the second dose at approx. 2pm on 10/29 about 24 hours prior of receiving the injection my supraclavicular, cervical and axillary lymph nodes are swollen and painful.
Pain and difficulty moving her left arm (extreme pain) urgent care prescribe antibiotic x 10 days, Ibuprofen, and narcotic 11/12/13 recovered.
Information has been received from a medical assistant concerning a female pt who in April 2006, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. In April 2006, the pt experienced hives. Unspecified medical attention was sought. The pt's outcome was unk. No product quality complaint was involved. Additional information has been requested.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for advanced age, hypercholesterolemia, secondary malignant neoplasm of bone, prostate cancer, HTN, glaucoma, diabetes, vitamin d deficiency. Patient was under the care of palliative medicine, with poor prognosis. 3/12 per note, patient got nausea. Patient deceased 4/27/2021. No cause of death documented
11/14/22 presents to ED for "weakness, cough and sputum production". PMHx of "end-stage renal disease on hemodialysis, anemia of chronic kidney disease, iron deficiency anemia, hypertension"
Nerve sensation and irritation in left thigh 7 or 8 inches in diameter, lasting 3 days, starting 3/18 approximately at 6: am. Fatigue and dizziness through the weekend.
Information has been received from a certified medical assistant concerning an 11 year old female with no pertinent medical history, who on 30-JUL-2007 was vaccinated IM in the deltoid with a dose of Gardasil (lot # 658100/0525U).  On 02-AUG-2007 the patient experienced a large red area at the injection site the size of a "50 cent piece".  Medical attention was sought and the patient was placed on antibiotics (unspecified).  On an unspecified date, the patient recovered.  Additional information has been requested.
Felt mild numbness on left side of face the same night as I received the vaccine. It got worse the next day. I contacted a doctor via telemedicine and she did an evaluation. She said it was a mild Bell?s Palsy but likely not serious because she couldn?t observe it when asking me to raise my eyebrows or smile ? it was just  something I could feel. It went away on its own within another day or so.
no reported adverse events- vaccine administration error- Shingrix adjuvent only injected, no active antigen
Nausea and headache began the evening of the injection. The next morning at approximately 3:00 am, severe nausea, chills, fever, body aches. Symptoms were treated with Zofran and Nyquil. Symptoms abated by Wednesday morning.
Severe stomach pain began August 7. Including fever and chills that came and went for 3 weeks. On August 21, took him to local hospital Emergency room when the stomach pain became unbearable. CT Scan demonstrated acute appendicitis and his appendix was subsequently removed.
INTENSE CRAMP ON PELVIS AND LOWER BACK; BODY ACHE; INDUCED PERIODS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced intense cramp on pelvis and lower back, body ache, induced periods, chills, fever, and headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense cramp on pelvis and lower back, and the outcome of chills, fever, headache, body ache and induced periods was not reported. This report was non-serious.
Sloane was tired all evening of 3/8/2021, and in the morning, she was still a little tired, but also had Covid Arm on 3/10/2021,  - rash spreading out 4 inches from vaccination innoculation site.
Abdominal cramps started 1/12 Diarrhea started 1/17 Hives all over body started 1/19 Symptoms still ongoing
Adverse reaction after recieving Moderna Covid-19 vaccine; A spontaneous report  was received from a consumer concerning a 28-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an adverse reaction.  The patient's medical history was not provided. Relevant concomitant medication was not reported.  On 23 Dec 2020, prior to the onset of event, the patient received their planned dose of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced an adverse reaction.   No laboratory details was provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, adverse reaction after receiving Moderna COVID-19 vaccine was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Bronchus pain,  congestion, nose pain, tearing, eye swelling and yellow discharge, running nose,  toung pain, difficult to swallow,  headache,  heartbeat increase from 70 to 95.  Take  Tylenol 650 mg at 1:00 am at 10/17. Second day felt better,  but still headache and high heartbeat.  On 10/18, toung still pain, heartbeat at 82.
I am currently 28 weeks pregnant (EDD is 01/24/18). I have had no complications during my pregnancy. I woke up with a severe headache, low grade fever, chills, body aches, sore throat, nausea, and heartburn.
Client reported fatigue, chest pain, headache, and upset stomach the day after receiving the 2nd dose of Moderna covid-19 vaccine.  Chest pain worsened and was accompanied with pain in left arm. The client was taken to local ER via ambulance. Client was diagnosed with severe hypertriglyceridemia, diabetes mellitus (early onset) and atypical chest pain after undergoing an array of medical tests while at ER.
Pt given 0.3ml of undiluted Pfizer dose. Informed pt. immediately after error discovered. She stayed with us for 30 minutes of monitoring and reported feeling okay at that time. We discussed possible side effects including a stronger immune response. Today, patient feeling pretty bad and called into work. I am calling patient this morning and again at 24 hours post-dose this afternoon for monitoring.   Email indicated that there were no symptoms.
Swelling and redness around injection on left shoulder. Muscle pain left shoulder and neck. Headache, sore throat, shivering, nausea and ache all over. Tired and sluggish preventing regular activity.
Received vaccine at 830AM. Around 1245p started itching head, arm, neck, face, hands slightly on legs. No rash seen. Has never had a flu vax before.
Positive COVID-19. Reports 2-3 day history of anorexia and emesis without cough/SOB and on satting well on RA. Afebrile.
Twelve hours after vaccine, he developed severely sore arm, shoulders and down back.  This was followed by severe vomiting, to which he lost two pounds in 4 hours.  Arriving at the ER at 5:45 AM, he had horrible stomach pain, (we could see his stomach move), nausea, vomiting.  His hands, arms and face became fuzzy then numb. He was given multiple medications to ease symptoms, along with IV. He had tests of blood, urine and a CAT scan.  This was followed by morphine. Discharge around noon on 7-8-21
Swelling / at the injection site / kept getting bigger and bigger; Redness at the injection site / kept getting bigger and bigger; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included acetylsalicylic acid (Aspirin (Baby)).   On 3rd December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved.   The reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in left deltoid and experienced swelling and redness at injection site, which kept getting bigger and bigger. The events lasted for 6 to 7 days and then resolved. The patient had taken pictures of her left arm. The patient believes that these events were due to the Shingrix shot. The reporter consented to follow up. For the tolerance of 2nd dose, refer case- US2021AMR073347, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073347:Same reporter
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Apr 3, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed a headache (pain on the left-side of head/twitching pain in head), onset Apr 4, 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
bronchial infection, chest discomfort and cough; bruise, erythem and swelling; body aches; fatigue; fever of 100.9 degrees Fahrenheit for 5 days; lethargy; shortness of breath; chronic back pain issues; A spontaneous report was received from a consumer concerning a 71- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bronchitis, chest discomfort, back pain, dyspnea, cough, fatigue, myalgia, lethargy, contusion, swelling, erythema and fever.  The patient's medical history included, common variable immune deficiency and reccuring bronchial infections back to 2014.Concomitant medications included,gamma globulin was reported.   On 29-jan-2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch 010W20A) for prophylaxis of COVID-19 infection.On 26-Feb-2021,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 013A21A) for prophylaxis of COVID-19 infection  On 26-Feb-2021,the patient experienced arm began to swell,getting to the size of a baseball and had an indent in the middle, it was red on the outside and white in the middle, the next day it turned into a bruise, she had a fever of 100.9 degrees Fahrenheit for 5 days, lethargy, body aches and she continues to feel fatigue, soon after the vaccination, she developed a dry cough and continues to have it, also experienced shortness of breath which did not allow her to lay flat on her back in her bed.   She got a steroid injection to treat her chronic back pain issues, after the injection the symptoms she was having improved her discomfort, her cough is little bit better. Patient has an autoimmune disorder CVID (Common variable immune deficiency).No laboratory data was provided.  Treatment information included, steroid injection to treat her chronic back pain issues, gamma globulin injections every Friday for CVID (Common variable immune deficiency) and steroid inhaler for bronchial infection.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the event pyrexia was considered as resolved on 02 Mar 2021. The outcome of the events, bronchitis, chest discomfort, back pain, dyspnea, cough, fatigue, myalgia, lethargy, contusion, swelling, erythema was considered as unknown at the time of the report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
started crying & screaming @ approx 1030AM; cont for the next 5-6 hrs; pt would not breastfeed & was inconsolable; had given APAP when crying began; pt fussy;
FLU-LIKE SYMPTOMS; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (dose series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced flu-like symptoms, chills, and fever (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and flu-like symptoms was not reported. On unspecified date, the patient received booster dose (unspecified manufacturer and dosage regimen) (dose series 2). No events were reported. This report was non-serious.
warmness at the injection site; Itchiness at the injection site; Redness at injection site; Swelling at the injection site; soreness at injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (soreness at injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (soreness at injection site). On 10-Jan-2021, VACCINATION SITE WARMTH (warmness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (soreness at injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) 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.   The patient also stated that the itchiness and redness increased on 11 Jan 2021.  Treatment for the events included hydrocortisone and clarithromycin.    Based on the current available information and temporal association between the use of the product and the start dates 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 dates of the events, a causal relationship cannot be excluded.
Patient c/o throat tingling and was assessed by MD and prescribed Zyrtec 10 mg sublingually. Patient was observed for further 15 mins as recommended by MD. DC home at 1210.
Received the 2nd dose of Hep. B vaccine around 12:40pm and about 30 min after receiving the injection I started feeling nauseous and light-headed. After an hour it progressed into shakiness, hot flashes, cold sweats and short of breath. My PCP was able to see me given the symptoms I was experiencing. They has me lie down for about 20 min then it progressed worse into numbness/tingling throughout my legs, arms and face. Started having involuntary muscle spasms and felt so weak in the legs I could not bear my own weight.
Pateint recieved COVID19 (Pfizer-BioNTech) vaccine on 12/30/2020 and statrted to develop a rash on hands and sole of her feet onsetting 01/01/2021. Per patient, she took OTC allergy medication and applied OTC Cortizone onto hands and feet. Pateint denies sypmptomes of headcaches, fever, diarrhea, or nausea.
Wrist swelling - Intense pain while wrist was at rest, starting 2 says after the surgery. Pain dramatically decrease to tender the following day.   Arm soreness - started a few hrs after injection. More intense pain and firmness at injection site the next day. Difficult to raise arm. Resolved the following day.
FLUCELVAX was administered to this 17 yr old. Appropriate age is > 18 yrs.
Pt developed fever of 105 degrees, burning in chest and stomach, and swollen sore left arm and axilla 48 hours (approximately) after vaccine. Vaccine on Monday, Fever Wednesday.  Seen Thursday about 72 hours with no fever but markedly swollen, red, indurated deltoid area with central red spot at site of injection.  Tender axillary node palpated.  Lump clear, heart normal, abdomen soft and not significantly tender.  Pt being treated for cellulitis and recovery is probable.