chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain is foggy), LYMPHADENOPATHY (Lump under arm pit (size of a grape fruit)) and PYREXIA (High fever I reach temp 103.9) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 (patient was in the hospital for a week. Patient was a plasma donor.) in March 2020. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain is foggy), LYMPHADENOPATHY (Lump under arm pit (size of a grape fruit)) and PYREXIA (High fever I reach temp 103.9). On 28-Jan-2021, DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain is foggy), LYMPHADENOPATHY (Lump under arm pit (size of a grape fruit)) and PYREXIA (High fever I reach temp 103.9) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Body temperature: 103.9 (High) (103.9). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported.
PATIENT STATES IT FELT LIKE COTTON WAS IN HER EARS AND SHE FELT LIKE BOTH EARS WERE RINGING. SHE ALSO STATED SHE FELT DIZZY.
Moderna COVID-19 Vaccine EUA.  Several hours later develop sweats, feeling hot and cold, felt like a fever but temperature was normal, severe muscle and joint pains, unable to sleep, very tired next two days.  Most symptoms have resolved although joint pains persist.
blisters; a little burning on legs; redness; itchy skin; Hives; Tingling sensation; rash on both lower legs, wrists, and thigh; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (blisters), BURNING SENSATION (a little burning on legs), ERYTHEMA (redness), PRURITUS (itchy skin) and URTICARIA (Hives) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ERYTHEMA (redness), PRURITUS (itchy skin), URTICARIA (Hives), PARAESTHESIA (Tingling sensation) and RASH (rash on both lower legs, wrists, and thigh). On an unknown date, the patient experienced BLISTER (blisters) and BURNING SENSATION (a little burning on legs). At the time of the report, BLISTER (blisters) and BURNING SENSATION (a little burning on legs) outcome was unknown and ERYTHEMA (redness), PRURITUS (itchy skin), URTICARIA (Hives), PARAESTHESIA (Tingling sensation) and RASH (rash on both lower legs, wrists, and thigh) had not resolved.            No concomitant medications was reported by the reporter. No treatment medications was  provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information contains updated patient demography, first dose information, second dose batch/lot number, Added new events( Urticaria, Paresthesia), Events start date and Updated events outcome.
Moderate to high fever starting at 3 p.m., treated with Tylenol and ibuprofen at 7 p.m. Fever broke with medication Body aches in mid back starting at 2:30 p.m. and still in effect as of 9 a.m.
The morning after I took the vaccine I fainted while using the bathroom and when I came to I was confused and had irretractable vomiting for nearly twelve hours. I could not speak well for several hours and I have memory loss from this time. I was foggy for several days.   I am sure that was due to the vaccine. I. The ten weeks after I took the vaccine I lost 45 pounds without dieting and have had two more episodes of irretractable vomiting. Despite thorough tests, many doctors and ER trips, I have been given no diagnosis that explains the persistent stomach problems and the vaccine may be the cause.
This is a spontaneous report from a contactable female consumer reported for herself. A 65-year-old female patient of an unspecified ethnicity started to receive PREVNAR 13 via an unspecified route of administration at 0.5ml, single for immunisation, influenza vaccine (FLU SHOT) via an unspecified route of administration at 1 DF, single, both on 23Oct2016 for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced sore in both arms from shots on 23Oct2016 with outcome of unknown. She stated this was normal for her, she got sore every time she gets those shot. She just called, because she wanted ask if she could have them together.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-JUN-2014, the patient was inoculated with the ZOSTAVAX vaccine at a drug store 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 of herpes zoster. On or about 03-FEB-2015, he was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of 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.
Approximately 8-9AM today (3/28/03) client developed 4" knot at site of varicella injection. Site has a large area of inoculation, is reddened, hot, itchy and swollen. Client also developed itchy, deep cracks at corners of her mouth that were slightly swollen. No other symptoms. Client will treat local reaction with Benadryl and dice. If symptoms worsen will seek medical attention.
pt recv vax 7APR98 & 9APR98 pt reported petechia which was subsequently dx as idiopathic thrombocytopenia when pt was hosp the same day;it is not known if the pt has been discharged;
Left arm swelled down to wrist. Pt saw private physician who put her on steroids and antibiotics
This spontaneous report as received from a pharmacy intern refers to a patient of unknown age. On 20-AUG-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J009827, expiration date 10-AUG-2014, route not provided). No adverse effects reported. Additional information has been requested.
Pt DOB: 12/10/70 presented to the vaccination site on 10/18/21. The client notified RN that he received a single dose of the (Sputnik) COVID vaccine on (05/12/21). RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Pfizer. Per CDC guidance, approval to proceed with COVID vaccine Pfizer first dose with 15 minute observation was obtained from medical consult team, Vaccine Operations Lead via text message. Client received COVID vaccine Pfizer Lot# 30145BA on 10/18/2021. The client did not report any symptoms during the observation period. The client left the vaccination site at 2030.
Child began to cry (described by mother as shrill screaming cry) at 4pm Friday and continued until 7:45 when child finally slept. Mother read V15 and called hospital between 7 and 7:30pm. Nurse recommended warm bath. Child was quiet during bath but when removed began to cry again. Child slept through night and awoke Saturday 12/28 7:30am and seemed OK but began crying again at approx. 10:30am and cried until 8pm with 2 short (1/2hr) naps during this time. Sunday 12/29 was not fussy or crying but seemed exhausted. Monday was normal self again. Mother notified her doctor of the incident during routine doctor's visit on 1/2/03 and notified person filling this report on 1/18/03.
Within approximately 1 1/2 hrs of injection had 1 hr of extreme coldness and shivering before falling asleep. Next am muscles seemed stiff and sore. No temp recorded - next night woke up with bloody emesis x 4. Fine after that.
Information has been received from an office manager concerning a 79 year old female who on 10/30/06 was vaccinated SC in the right arm with a 0.5ml dose of varicella virus vaccine live (lot 654693/1052F). Concomitant therapy that day included a dose of Pneumococcal 23v polysaccharide vaccine and a dose of Diphtheria toxoid/tetanus toxoid. The vaccinations occurred during an immigration physical exam. On approx 11/14/06 the pt developed encephalitis and brain lesions and was hospitalized. The pts encephalitis and brain lesion persisted. There was no product quality complaint. The reporter considered the events to be other important medical events and life threatening. Additional information has been requested.
marked local rxn lt deltoid;mid humeral area to shoulder swelling, erythema venous distention;no fever almost 2wk before complete resolution;tx cool compress;
Information has been received from a 19 year old female with no medical history, who on 29-OCT-2007, was vaccinated with a 0.5 mL dose of Gardasil vaccine. Concomitant therapy included Yaz (started on 30-OCT-2007). ON 29-OCT-2007, the patient mentioned some injection site pain after vaccination. On 30-OCT-2007, the patient developed tenderness in pelvic area and 2 quarter sized bumps above groin. The patient's tenderness in pelvic area and 2 quarter sized bumps above groin and injection site pain persisted. Additional information has been requested.
a patient that received the first dose of Shingrix; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: a patient that received the first dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-JUL-2023 The reporter reported that the patient received the first dose of Shingrix and it had been longer than 12 months. The reporter wanted to know if it was recommended they start over or just get the second dose.  Also, what was the efficacy of 1 dose only. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
This case was reported by a nurse representing a law firm and described the occurrence of diabetic coma in a male child who had received hep A vaccine inactivated (Havrix). On an unspecified date, the pt received an "adult dose" of Havrix rather than recommended pediatric dose. Approximately two to three days later, the pt experienced a diabetic coma and was hospitalized. The nurse stated that the pt was "near death." Diagnostic tests revealed a glucose value of 667, and a calcium value of 11.1 (units not specified). The vaccination series was discontinued. The events, which were considered to be life threatening and jeopardized the pt/required intervention, were unresolved at the time of reporting. In the reporting nurse's opinion, the events were possibly related to vaccination with Havrix. The nurse also noted that the events may have been associated with the erroneous administration of an adult dose of Havrix. Diabetic coma was assessed as medically serious (OMIC) by manufacturer. Information from Annual Follow-up report states this report was received through the litigation process. Additional information including outcome information is being pursued through the litigation process and will be reported if obtained.
On the morning of October 19 approx 3 days after my vaccine I woke up at 5:30am to severe dizziness to the point where I could not get out of bed and had to be escorted by my husband to the rest room to keep from falling. At resting my heart rate was 135 bpm when standing it shot up to 151 bpm. I then had full body tremors for roughly 15 minutes. At around 6 am I tried to contact my doctors after hours line and their systems were down. I left a voicemail and an email for my doctor. I called at 8am and the doctor was not available. I made a telehealth appointment where I was told by that NP that I needed to be seen in person due to my reaction. I called the doctor back and the nurse reported that she would call me right back. About 9:45 I received a call back from the nurse my doctor instructed me to rest and drink lots of water and symptoms would decrease in a few days. My symptoms lasted about 4-5 days and I still get dizzy spells here and there now and a weird feeling in my chest (like I have a chest cold) without a cough. It also should be noted that the day before the severe dizziness I had a very stiff and sore neck.
59 years old patient received Fluzone High Dose/no AE; 59 years old patient received Fluzone High Dose/no AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case is linked to cases 2020SA057067 and 2020SA057137 via same reporter.  This case involves a 59 years old patient (unknown gender) who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported via an unknown route at an unknown administration site) on an unknown date for prophylactic vaccination(PT: Overdose and Product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.   It was actual medication error case due to inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Caller also experienced a little bit of nausea just this morning.; Caller started to feel weak and not that well yesterday until today.; Caller started to feel weak and not that well yesterday until today.; Caller experienced stomach ache, ache in her thigh muscle and lower back.; Caller experienced stomach ache, ache in her thigh muscle and lower back.; Caller experienced stomach ache, ache in her thigh muscle and lower back.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious) all with onset 31Mar2021, outcome "not recovered" and all described as "Caller experienced stomach ache, ache in her thigh muscle and lower back."; ASTHENIA (non-serious), MALAISE (non-serious) all with onset 03Apr2021, outcome "not recovered" and all described as "Caller started to feel weak and not that well yesterday until today."; NAUSEA (non-serious) with onset 04Apr2021, outcome "not recovered", described as "Caller also experienced a little bit of nausea just this morning.".  Additional information: Patient completed the vaccination series on 30Mar2021. She experienced stomach ache, ache in her thigh muscle and lower back. She started to feel weak and not that well yesterday until today and also experienced a little bit of nausea just this morning. She stated that it is the fifth day of side effects. She wants to know how long these side effects will last and if it is related to the COVID-19 vaccine. Medical Information: Medical questions addressed by this program forwarded/referred to Medical Information.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tingling of tongue.  No swelling, no rash.  BP 176/80, T 96/1, P 80, O2Sat 96. Patient recovered and was sent home.  EMS checked vitals BP 164/80, P 64.
Co-administered with tetanus and rabies shot; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DRUG INTERACTION (Co-administered with tetanus and rabies shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cat bite since 11-Mar-2021. Concomitant products included TETANUS VACCINE TOXOID (TETANUS) from 11-Mar-2021 to 11-Mar-2021, RABIES VACCINE (RABIES VACCIN) from 11-Mar-2021 to an unknown date and ANTIBIOTICS from 11-Mar-2021 to an unknown date for Animal bite.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DRUG INTERACTION (Co-administered with tetanus and rabies shot). At the time of the report, DRUG INTERACTION (Co-administered with tetanus and rabies shot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After being administered the second dose of the COVID vaccine, the patient reported to the nurse that she was bit by a cat before coming to her appointment and was at urgent care, where she received a tetanus shot and was started on an antibiotic. Also, the patient's doctor's office found out that one hour after the patient received her COVID vaccine, she went to the Emergency Room, as she still had pain from the cat bite. There, she was given the "3 series" rabies shot.  Treatment information was not reported.
Chest pain w/1-day hospitalization, post testing  showed excess fluid around heart. Cardiologist diagnosis of Pericarditis.
Circular rash on torso and neck area, one hour after shots given. Referred her to her PCP for treatment.
p/vax pt devel lt sided tonic-clonic sz activity;taken to ER & recv IV ativan x 3 & loaded w/med w/no further sz activity noted;neuro consulted;all lab workup negative;neuro felt unnecessary to cont anticonvulsant;
SI am a diabetic  on Lantus 20 units daily I noticed sudden drop  in blood sugars  I did not not pay attention until this continued into second day despite decreasing my dose by 50 % My blood sugars dipped to 68 ,72  This continued into 3rd day post vaccination.Sugars eventually stabilized and Day 4 was fine after my usual dose of meds I wanted to report possible hypoglycemia post vaccine. I did not experience any hypoglycemia after first dose of Covid vaccine
Fever, could not stand up. Called EMTs taken to hospital. Kept overnight. MRI performed. They wanted to keep her another night and to another MRI, but she signed herself out. Dr stated he could find nothing wrong with her.
Patient began with pain at the site and then a few hours later, there was redness at the site.  The area has gotten a little larger per her description.
In the middle of the night 05/31-06/01, I woke up with a nasty cough and when my husband left for work at 4 a.m. he noticed that I was warm to the touch. When I got up that morning, I was not feeling well, so I called my employer who is also my physician and informed him that my temperature was 100.1 and I was having body aches. I did go in to be tested for Covid that morning and I was positive. I have began a round of Paxlovid antiviral medication. I'm still having body aches and am coughing but overall, I would say it isn't too bad.
miscarriage; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration on 05Mar2021 15:30 (at the age of 30 years old) as a 2ND DOSE, SINGLE, for COVID-19 immunisation. Medical history included COVID prior to vaccination. The patient has no allergies to medications, food or other products. Concomitant medications included prenatal vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. LMP was on 20Jan2021. The patient experienced miscarriage on 09Apr2021. The mother was 11 Weeks pregnant (also reported as 8 weeks 1 day) at the onset of the event. The mother was due to deliver on 17Nov2021.  The event resulted in Doctor or other healthcare professional office/clinic visit. Unspecified treatment was received in response to the event. The outcome of the event was unknown. The patient has not been tested for COVID since the vaccination.   Information about lot/batch number has been requested.  Follow-up (07May2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Miscarriage. 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 agency, as appropriate.
Muscle and joint pain from approx 6hrs after to 36hrs after injection, chills for about 1 hr at approx 12 hrs after injection, fever peaking at 102F at approx 24hrs after injection, nausea approx 16 hrs after injection, diarrhea at approx 16 hrs after injection, headache from approx 6-24hrs after injection.
I am anaphylactic survivor.  I felt it instantly after the shot: pain up my neck, left side of my back & shoulders, then few minutes later metallic taste in mouth,  then nose was stinging, then runny nose and then a few mins later shortness of breath.  Told my family about it and they said it was probably side affect, minor/seasonal allergies and that I could take Claritin-D 24-hr.  It appeared to have minimized the  shortness of breath, which comes & goes every few (15 or 30) mins, but still runny nose. I took for 3 days.  When I stopped taking Claritin-D 24-hr on Wed in the AM, in the afternoon, started to have difficulty breathing  and runny nose.  But it was stronger,  shallow breathing.  So I took Claritin-D 24-hr again but it wasn't working that well, so, took Benedryl at night as well. Then I took an additional Benedryl.  I still have the symptoms but manageable with the allergy meds.