chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned an adult female. 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, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced ache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from fatigue, and had not recovered from ache. This report was non-serious.
Fever; Headache; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) in a female patient of an unknown age 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) dosage form. On an unknown date, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment or concomitant medications were reported.
feels like he's a little warm; persisting flu like symptoms; congestion in nose; pressure build up in ears; throat not 100 percent; soreness in injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 26Feb2021 12:00 (Lot number: EN6200) at the age of 28 years 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: VACCINATION SITE PAIN (non-serious) with onset 26Feb2021, outcome "recovering", described as "soreness in injection site"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03Mar2021, outcome "not recovered", described as "persisting flu like symptoms"; NASAL CONGESTION (non-serious) with onset 03Mar2021, outcome "not recovered", described as "congestion in nose"; EAR DISCOMFORT (non-serious) with onset 03Mar2021, outcome "not recovered", described as "pressure build up in ears"; PHARYNGEAL DISORDER (non-serious) with onset 03Mar2021, outcome "not recovered", described as "throat not 100 percent"; FEELING HOT (non-serious), outcome "not recovered", described as "feels like he's a little warm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, influenza like illness, nasal congestion, ear discomfort, pharyngeal disorder, feeling hot.  Additional information: The patient had not received any other vaccines within 4 weeks prior COVID vaccine. Ibuprofen, DAYQUIL, and NYQUIL as needed were taken as treatment of the events.  No follow-up attempts are possible. No further information is expected.
Pt exp arthritis-like sx following the administration of Hep B vax; no further details were provided;
presented to Emergency room with complaints of approximately 5 days of progressively worsening shortness of breath with a dry nonproductive cough, increased weakness, and wheezing.  Symptoms not controlled with increased use of rescue inhaler albuterol.  Patient's daughter reached out and spoke with patient's pulmonologist Dr. today who ordered oral steroids however patient reports she had not started taking them yet.  Patient was initiated on 15 L non-rebreather and received 2 duo nebs EN route to the hospital.  It was reported she did have some intermittent chest tightness although on my review, she denied this.  Upon arrival to the emergency room, patient was initiated on BiPAP and receive 40 mg of IV Lasix at 125 mg of IV Solu-Medrol.   Patient expired 4/19/2021
Patient's arm swelled when the injection was given and began to bleed immediately after the needle was pulled out of the arm.  The patient was called later and he said he was sore, but otherwise he was fine.
Light headedness,Loss of balance, vomiting, sick feeling on 2nd day @ 12:00 pm  recovered after laying down for 3 hrs.
injection site swelling; injection site redness; injection site pain; warm to touch at injection site; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva759a, expiry date 30-NOV-2023) for prophylaxis.   On 02-MAY-2023, the patient received Menveo (right deltoid). On 02-MAY-2023, less than a day after receiving Menveo, the patient experienced injection site swelling (Verbatim: injection site swelling), injection site erythema (Verbatim: injection site redness), injection site pain (Verbatim: injection site pain) and injection site warmth (Verbatim: warm to touch at injection site). The outcome of the injection site swelling, injection site erythema, injection site pain and injection site warmth were not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain and injection site warmth to be related to Menveo.     It was unknown if the company considered the injection site swelling, injection site erythema, injection site pain and injection site warmth to be related to Menveo.   Additional Information: GSK Receipt Date: 04-MAY-2023 The health care professional was the reporter. The patient received Menveo and on the same day evening experienced localized swelling, redness, pain and warm to touch at the injection site. The adverse event had not recovered. The reporter consented to follow up. The case is linked with US2023064925 case, by same reporter.; Sender's Comments:  US-GSK-US2023064925:Same reporter - Female case
Redness to (R) leg at injection site which worries mom so she brought to doctor.
This is a spontaneous report from a contactable consumer (reporting for herself). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (left arm) on 28Jan2021 18:30 (at the age of 35 years) at single dose for Covid-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonazepam, and "omniprozol" (as reported); all taken from an unspecified date (reported as received within 2 weeks of vaccination) for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 18:30 (also reported as "24 hours after vaccine"), the patient experienced pain and swelling at injection site. The patient also experienced rash on leg and elbows starting day 3 (as reported) to present. There was no treatment received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  Information on the lot/batch number has been requested.
Patient reports intermittent dizziness, nausea, generalized malaise, low grade fever.
pt recv vax 9FEB97 & the next day parents reported to local mD that pt had exp redness & swelling @ the inj site;the following day 11FEB it was reported that pt exp redness & swelling that progressed below the elbow;this was the fifth dose
large red hive like lump @ site of inj;swelling entire upper arm to shoulder which is rock hard;tx w/ice & advil, APAP;to hosp ER;unable to work as nursing assistant today;
Fever, Tachycardia, weakness Narrative:  Employee called and stated she experienced fever 100.4, heart rate 112, and weakness. Taking Tylenol for the fever, drinking fluids and resting
Ever since I received the Moderna booster shot, I have experienced something new, shortness of breath. This has gotten worse in the last year. Now I am limited in my activities and almost always am dealing with this shortness of breath issues.  Please help. I had an extensive pulmonary test, no issues shown there. 9/30/2021 No know causes to date. Now my Dr. is going to order a calcium test and?? My symptoms are worsening more rapidly now.
p/vax exp severe shaky chills; joint & muscle pain, looked ``kind of bluish''; paramedics were called; by 16.10 symptoms were dec;
The Pharmacist gave the injection then when we went to bill the vaccine we noticed that the patient should have received the vaccine on Monday, Sept 13th, not today, Sept 10th. The patient received the 1st dose on 8/23/21 and I wrote down 9/10/21 on the back of the card for the return trip. I didn't catch it at the time of vaccination...totally my fault. The patient was notified of the error and was experiencing no symptoms when she left the store
fever, cold hands, fatigue, congestion, chills, pain and inflammation at injection site, muscle aches
The patient presented to the pharmacy on 3-31-12 with a sore upper arm. In the location of the vaccination, there was redness and inflammation.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-SEP-2016, the patient was treated at a hospital for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. 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.
21OCT96 parent called clinic c/o red, warm itchy welt approx 2 1/2 x 4" on arm since 20OCT96 PM;states applied ice to area 20OCT96 which dec warmth to area this AM;pt referred to MD for eval;
Bipolar I Disorder Exacerbation Following COVID-19 Vaccination; This is a literature report.  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "BD1" (unspecified if ongoing), notes: when she was 35 years old; "hospitalisation" (unspecified if ongoing), notes: for depression, mania, and paranoia; "depression" (unspecified if ongoing); "mania" (unspecified if ongoing); "paranoia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Risperidone for psychosis, notes: 2mg; Mirtazapine. The following information was reported: CONDITION AGGRAVATED (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "Bipolar I Disorder Exacerbation Following COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: Patient Health Questionnaire-9: 5, notes: (PHQ ) score of 5; 0, notes: assessed 17 days prior to vaccination. Therapeutic measures were taken as a result of condition aggravated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event CONDITION AGGRAVATED and the vaccine (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."
ACHINESS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 70 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN ) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced achiness, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever and achiness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210943871.
Received dose 1 pfizer 12/24/2020 and second dose 1/14/2021.  Has covid exposure. Developed symptoms on 4/22/2021. Tested positive on 4/26/2021.
Severe arm swelling, warmth and and erythema improved without antibiotics over several days (still resolving but much better).
Chest pain; Heart fluttering; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In August 2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CARDIAC FLUTTER (Heart fluttering) and CHEST PAIN (Chest pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  The patient received COVID vaccine and had flutter in the heart after the fifth day. She had chest pain as well.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company comment.  This spontaneous case concerns a 61  year  old, female patient, with current condition of Rheumatoid arthritis, who received a dose of mRNA-1273 vaccine (reported as first dose of her COVID  19 immunization schedule) and experienced the serious (medically significant) unexpected AESI of cardiac flutter. The event was reported as occurring on the same month of vaccination; since exact onset date was not provided, latency and temporal association cannot be properly assessed. On an unspecified date, the patient presented chest pain, which could be related with cardiac flutter. No further clinical information was available for medical reviewing. Patient´s mentioned medical history and co  suspect product Upadacitinib remains as confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61  year  old, female patient, with current condition of Rheumatoid arthritis, who received a dose of mRNA-1273 vaccine (reported as first dose of her COVID  19 immunization schedule) and experienced the serious (medically significant) unexpected AESI of cardiac flutter. The event was reported as occurring on the same month of vaccination; since exact onset date was not provided, latency and temporal association cannot be properly assessed. On an unspecified date, the patient presented chest pain, which could be related with cardiac flutter. No further clinical information was available for medical reviewing. Patient´s mentioned medical history and co  suspect product Upadacitinib remains as confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Felt tipsy; Dizzy; was seeing stars; This spontaneous case was reported by a consumer and describes the occurrence of FEELING DRUNK (Felt tipsy), DIZZINESS (Dizzy) and PHOTOPSIA (was seeing stars) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FEELING DRUNK (Felt tipsy), DIZZINESS (Dizzy) and PHOTOPSIA (was seeing stars). At the time of the report, FEELING DRUNK (Felt tipsy), DIZZINESS (Dizzy) and PHOTOPSIA (was seeing stars) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
This report describes the occurrence of a raised rash in a 19 month old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. This report was received from the subject's mother and has not been verified by a physician or other healthcare professional. The subject was reportedly allergic to ibuprofen. The mother stated that at the age of 10 months, the subject received ibuprofen and subsequently turned blue and was swollen and was taken to the hospital. No other medical history or concurrent conditions were reported. The subject reportedly received no concurrent medications or vaccines. On an unspecified date, the subject received her first injection of Infanrix. Reportedly, the subject subsequently developed a rash which went away before seven days. In April 2003, the subject reportedly received her second injection of Infanrix. The mother stated that on 4/25/03, the subject developed two tiny pimples on nose which became worse. Reportedly, after 4/25/03, the subject developed hives everywhere except scalp. The mother stated that, additionally, the subject developed a raised rash that looked like strep rash which was more prominent on the right leg. The mother reportedly called the physician. The mother reported that she administered diphenhydramine hydrochloride to the subject. As of 5/2/03, the raised rash and hives reportedly persisted.
Left hand numbness/tingling followed 1-2 wks later by right hand tingling, followed by left hand weakness and bilateral lower extremity weakness. Now largely recovered after 3 months.  MRI pending.
pt recv vax 11NOV98 & had allergic rxn devel hives all over body;seen @ ER;
This spontaneous report was received from a medical assistant via a field employee regarding an older male patient of unknown age. Medical Assistant said that the patient had "multiple unspecified comorbidities" regarding his health. No information about drug reactions and allergies was specified. On an unknown date in October 2013, The patient received ZOSTAVAX vial (dosing regimen unspecified). No concomitant medications were reported. Approximately on an unknown date in 2013, the patient developed a rash 3 days after the ZOSTAVAX was given. The rash was diagnosed as a severe case of shingles on an unspecified date. Medical Assistant stated that the patient died a few weeks later on an unspecified date. There was no product quality complaint with ZOSTAVAX. Cause of death and autopsy details were not provided. The outcome of the event severe case of shingles is unknown. The causality of the events was not specified by the reporter. Additional information is not expected.
Moderate to severe facial pruritus with some eyelid edema for about 1 week taking Loratadine 10 mg qd; Benadryl qhs; Albuterol prn
The patient complained of swelling and redness of her arm. The patient applied ice. The patient also complained of electric shocks down her arm. The patient's spouse left a message on the clinic's answering machine.
Received Vaccine at about 9 AM 1/20/21. At 4 pm on 1/20/21 developed a raised rash that itched on upper body front, back and arms. Face not involved.  Spoke with Dr. and ordered to take Benadryl and call PCP.   I/21/21 Reported Benadryl was taken at 5 pm on 1/20/21and symptoms were relieved but returned at 9 pm 1/20/21. Took 2 more Benadryl.  Reports no rash 1/21/20 but weak and tired.
Pt. given HIBERIX instead of HIB through nurse error. Unknown at this time if pt. had adverse rx'n-will have Dr. phone family.
Severe vertigo. Not typical dizziness.  So severe that it wakes me from my sleep. It's been 36 hours since it started and I've ready fallen once. Scared to drive. The slightest movement of my head starts it again, and each episode lasts approximately 10 minutes.
I experienced severe pain throughout my body after 1.5 weeks of first shot.  The pain was unbearable and I had much difficulty moving and sleeping
Child was administered Pfizer adult dose of 0.3ml instead of pediatric dose of 0.2ml. Was observed for 15 mins after administered no adverse side effects were noted.
Pt states that 1 1/2 hrs after flu shot administered experienced symptom of a seizure. Was not severe enough for patient to feel need to consult physician.
Started with sore arm. During the day following the shot I developed a very low grade fever not going above 99.9. Had severe headache from the left ear to the right ear and going up around my forehead, as if my head was in a vise - all day. Heart was racing all day and night, couldn't sleep on my side because of it. around 24 hours after the shot I felt chest heaviness, which went away after a few minutes. Face was flushed, and I felt clammy. Went to the bathroom more than normal.  Aches  and joint pain, which weren't too bad. When I woke up the next day, symptoms were gone, except my arm was still sore and had slight fatigue.
patient declined 12/30/2020 and was transferred to hospital where he did not respond to treatment and passed away 1/4/2020
Pt c/o ringing in ears, nausea and dizziness. Pt was pale and shaking. Pt was taken to Exam Room #6 via wheelchair to lay down. Temp 98, BP 120/74, HR 68, Resp 20, Hgb 12.8g/dl, Serum Glucose 111 mg/dl. Pt stated body felt heavy. After approximately 30 mins pt stated she felt better and left clinic with mother. Less than 30 mins after leaving, pt's mother called - stating pt was having another episode. Pt's mother was instructed to take pt to MD or ER. Pt was taken to MD. Pt's mother stated pt had passed out and was unable to focus while taking to MD. Pt was admitted to hospital overnight for further observation. 10/29/08-records received for DOS 9/25-9/26/08-DC DX: Vasovagal syncope. Presented with C/O feeling weak and somewhat nauseated with a syncopal episode which resolved spontaneously. In ED lethargic. PE normal. Admitted for observation.  Headache. On day of admission received Depo Provera shot.