chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after getting the shot, I started to experienced bad external tremors. I had to concentrate to even take a sip of water. I still have tremors now.
Pt was seen on 11/04/05 and was given the poly valent Pneumovax 23. The shot was given subcutaneous in the left thigh. On 11/09/05 the patient presented with a coin (dollars size swelled area. The patient had no fever or other symptoms.
Patient received the first dose of Moderna on 2/3/21 but never received the second dose. When patient reported to the ED for a infected ankle MD wanted to administer the second dose of COVID vaccine. MD accidentally ordered Janssen vaccine instead of Moderna. Error was not caught by pharmacy nor nursing. No patient harm reported.
Tingles in lip and numbness and the next day body aches, couldn?t get up from bed and had to call into work.  As of today mild body aches.
Rash; I have it all over my mid-section, my back, my upper legs and it's very itchy; It's very itchy; This is a spontaneous report from a contactable consumer. This consumer (patient) of unspecified gender and age reported that he/she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 02Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unknown date in 2021 about a week after the second dose patient started breaking out rash, had it all over his/her mid-section, back and upper legs. It was very itchy and patient went to doctors, dermatologist and nobody knew what it was. Patient wanted to know how to get rid of it and mentioned that he/she did not have any problem until he/she got the second shot. The event outcome was unknown.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Pt recv vax on 10/27/98; on same day pt exp red, hot, itchy, sore swollen LA x 2 day w/ headache 3 day
None stated 1/2/09-records received for DOS 12/2/08-C/O rash on left side of back.DX: Chickenpox. Reaction to varicella vaccine. 12/8/08-lesions are now scabbed over.
This case was reported by a nurse and described the occurrence of wrong vaccine administered in an infant patient who received FLUARIX Quadrivalent 2014-2015).  On an unknown date, the patient received FLUARIX Quadrivalent 2014/2015 season .5ml. On an unknown date, an unknown time after receiving FLUARIX Quadrivalent 2014-2015 season, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration.  On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the wrong vaccine administered and inappropriate age at vaccine administration to be related to FLUARIX Quadrivalent 2014-2015 season.   Additional information received: There were 2 patients that were inadvertently administered the 0.5 ml dose of FLUARIX QIV who were less than 3 yo. The nurse only had patient specific and lot specific information for ony 1 of the two patients at the moment.
Tested positive for Covid after more than a month of 2nd vaccine (Rapid & PCR tests); Tested positive for Covid after more than a month of 2nd vaccine (Rapid & PCR tests); This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 12Feb2021 (Batch/Lot Number: EL9266) as SINGLE DOSE for COVID-19 immunization. Medical history included Penicillin allergy from an unknown date. The patient has no COVID history prior vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL9266), on 22Jan2021, on left arm, for COVID-19 immunization. The patient tested positive for COVID after more than a month of 2nd vaccine (Rapid & PCR tests) on 17Mar2021. The patient did not receive treatment for the event. The patient underwent lab tests and procedures which included Nasal Swab (Rapid and PCR): positive on 17Mar2021 and 18Mar2021, respectively. The patient was recovering from the event.
Pt states that 3 hours after leaving pharmacy, she started getting chills, fever of 100, severe headache, weakness, fatigue, chest tightness, trouble breathing, arm pain, and later on large red blotches on her arm, not at the injection site but farther down her arm. Pt went to the ER.  Pt followed up with a dermatologist, dermatologist diagnosed her as having severe adverse reactions to the vaccine, as well as an allergic reaction to the vaccine.
Pt. reported a red, raised, circular (approximately 2 inch in diameter) area of rash with heat and hardness about 2 inches below injection site on left arm. Advised to take BENADRYL & seek medical attention if no improvement.
started out as a lump on the injection site. it was hot and lumpy and itched very much.  Then the next day it disappeared and a bigger lump and rash started lower than the injection site. extremely tired, feeling exhausted, very light headed and feel weak.  All 7-9 days afer initial vaccine.
Starting getting hives at 7:00 am this morning; itchy lasting until the time of this VAERS (10:45am).  Called MD who didn't think it was the flu shot, but instructed patient to contact pharmacy.
dry cough; productive cough; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration at the right arm on 12Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medication included ascorbic acid (VIT C). Historical vaccine included first dose of bnt162b2 (lot number: EF5730, expiry date not reported) in the left arm on 22Dec2020 08:00 at single dose for COVID-19 immunization. The patient experienced dry cough that turned into a productive cough on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 01Feb2021. Therapeutic measures were taken as a result of the events that included dexamethasone injection and Zithromax. Clinical outcome of the events was recovered with sequelae on an unspecified date.
large red splotches  and soreness on arm  surrounding injection site.  did not occur until almost two weeks after injection.  Very low soreness and no fever.  Was taken aback because was not made aware of a delayed reaction to first short.
Pain on left arm; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received first dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL3247), dose 1 via an un-specified route of administration, administered in Arm Left on 01Mar2021 11:45 as dose 1, single for covid-19 immunisation (at the age of 37-year-old). Medical history included None. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. On 01Mar2021 15:00 PM patient experienced pain on left arm. The treatment was not received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Within 12 hours developed a sore arm at site of injection, by 24 hours had worsening soreness, difficulty raising arm.  Improved at 72 hours and resolved at 96.
bodyache; fever; chills; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (bodyache), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and #040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient experienced PAIN (bodyache), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN (bodyache), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia (97-99): Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-034402 (Patient Link).
I got hives on my neck, face , and abdomen. My neck became very swollen and was hard to turn. I also had a really large swollen spot under my right arm. The swollen area continued under my right breast.
Sx started 7/16/17 with Fever, Rash, Headache, Fatigue or malaise, Stiff neck, Altered mental status, Seizures, drowsiness and confusion. Pt was hospitalized at Hospital 6/19/17-6/23/17 and was diagnosed with LaCrosse Encephalitis and Jamestown Canyon Virus disease.
Left arm felt hot and tingling to my fingertips.  Achy, Fever of 103F, chills, tired for 2 days.
Expired vaccine administered due to how the expiration date is printed on box. Led to confusion on part of immunizer.
1/1 To ED by EMS for shortness of breath. Patient reports feeling more short of breath for the last 4-5 days. Per family, he did have recent Covid exposure. Occasional cough. Reports decreased appetite. EMS was called, oxygen saturation 66% on room air, placed on oxygen and brought to the emergency department. 1/2 CT thorax: Extensive bilateral pulmonary opacities, right greater than left, suspicious for multifocal pneumonia superimposed upon chronic changes. Advanced coronary artery atherosclerotic calcifications. Included portions of the upper abdomen demonstrate cirrhosis. On decadron. 1/3 Place has poor prognosis, DNR Comfort and Palliative Care  1/4 Pt expired
Patient developed shortness of breath, cough, malaise starting the evening of her vaccination. Symptoms gradually progressed over the course of the next month, admitted to the hospital for 1 week and given steroids, antibiotics, and antifungals for bilateral pulmonary infiltrates. Some improvement in symptoms and imaging but then had worsening with discontinuation of steroids. Repeat imaging in January 2022 showed worsening infiltrates, underwent bronchoscopy with biopsies consistent with organizing pneumonia.
Chills, body and muscle aches, fever and imnsomnia.  felt like a train ran over my body
The patient fainted a few minutes after given the vaccine. The patient was pale and needed to stay in a flat position. The EMT was called and the patient was not  taken to the hospital. The patient was feeling better after 30 minutes. The patient stated that she sometimes faints when giving blood.
Dizziness, NauseaVomiting, HYPERtension, LIGHTHEADENESS, CHEST TIGHTNESS  Narrative:  CXRAY, EKG
body aches; cough; big sore in my nose; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), COUGH (cough), RHINALGIA (big sore in my nose) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D14M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 26-Apr-2020. Concurrent medical conditions included Hypertension and High cholesterol.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced MYALGIA (body aches), COUGH (cough), RHINALGIA (big sore in my nose) and CHILLS (chills). At the time of the report, MYALGIA (body aches), COUGH (cough), RHINALGIA (big sore in my nose) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2020, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure medicine and cholesterol medicine.  Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Non-significant information received on 23-JUL-2021. reporter email updated.
Same day mouth and throat swelling, rash appeared several days later, not getting betting with steroids, Benadryl. Petechial rash diarrhea several days later.
Pt had adverse reaction of dizziness and lightheadedness. Vitals where obtained. Pt was monitored in clinic 15 mins post reaction. Pt. states feeling better. Pt reassessed prior to leaving clinic and vitals rechecked.  Pt instructed to follow up with PCP if symptoms worsen. Pt and parent verbalized understanding. Pt accompanied home with parent.
First shot I was very sick; just felt yukky; Achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (First shot I was very sick), FEELING ABNORMAL (just felt yukky), PAIN (Achy) and FATIGUE (tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (First shot I was very sick), FEELING ABNORMAL (just felt yukky), PAIN (Achy) and FATIGUE (tired). At the time of the report, ILLNESS (First shot I was very sick), FEELING ABNORMAL (just felt yukky), PAIN (Achy) and FATIGUE (tired) outcome was unknown.            This case was linked to MOD-2021-162385 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-162385:2nd dose case
Back tightened within 2-3 hours of receiving the booster shot vaccination. Fever and chills within 24 hours of receiving the booster shot.
s/s began w/mild HA & nausea 1 day following vax; s/s persisted w/ea addtl dose & intensified following 4th capsule on 14JUL92 plus fever 100.5, loss of appetite & diarrhea on the 15th; sleeping alot;
Blood blister under left nares 5 days. Used ABREVVA. Eventually dried up.
Systemic: Black raised bruise with red spots around it on the inner thigh-Mild, Additional Details: patient woke up with black raised bruise with red spots around it on inner thigh. Unsure if it is related. Advised her to contact her doctor.
patient was administered IPOL on 10 Nov 2020 that expired the day before with no AE; Initial information regarding an unsolicited non-valid serious case was received from a pharmacist via Agency and transmitted to Sanofi on 10-Nov-2020.  This case involves a 49 years old male patient who was administered ipv (vero) [Ipol] at a dose of 0.5 ml once in left deltoid (lot number: P1E701M and expiration date: 09-Nov-2020) for prophylactic vaccination on 10-Nov-2020 that expired the day before (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine polysacch vi (Typhim Vi); and pneumococcal vaccine conj 13v (crm197) (Prevnar 13).  This was an actual medication error case due to the event expired vaccine used.  At the time of report, no adverse event was reported.  No laboratory data 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.
Injection site red and sore, redness size of an orange, the area is hard and itchy
He woke up this morning with pain in his front chest; pain in his leg/pain in my front shin; tight muscles/tense muscles; losing sleep because of the pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1 0.3 ml, single (Lot number: HG2649) at the age of 59 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "upset stomach" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for abdominal discomfort. Vaccination history included: covid-19 vaccine Janssen (DOSE 1, SINGLE, Batch/lot number: 202A21A), administration date: 08Apr2021, for COVID-19 immunisation; covid-19 vaccine Janssen (DOSE 2 (BOOSTER), SINGLE, Batch/lot number: 213D21A), administration date: 08Dec2021, for COVID-19 immunisation. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 07Oct2023, outcome "unknown", described as "tight muscles/tense muscles"; SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (non-serious) with onset Oct2023, outcome "unknown", described as "losing sleep because of the pain"; PAIN IN EXTREMITY (non-serious) with onset 18Oct2023, outcome "unknown", described as "pain in his leg/pain in my front shin"; CHEST PAIN (non-serious) with onset 19Oct2023, outcome "unknown", described as "He woke up this morning with pain in his front chest". The events "tight muscles/tense muscles", "pain in his leg/pain in my front shin", "he woke up this morning with pain in his front chest" and "losing sleep because of the pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle tightness, pain in extremity, chest pain, sleep disorder due to a general medical condition.  Additional information: The patient got the shot late afternoon Friday. Saturday he had tight muscles just below his shoulder blades on both sides in his back. Throughout the week he started getting "a muscular thing" on his lower ribs just below his chest in the front. He was losing sleep because of the pain. He think it was from the vaccine. Last night his legs were really bothering him. He woke up with pain in his front chest. It tends to come and go. He knows its muscular because he can use a foam roller to roll on and it loosens up his muscles. He tried cold and heat: hot tub, ice packs, hot showers to loosen up his muscles but the roller gave him the most relief. X-rays have also been taken of his chest.
That same type of swelling happened the following day directly at the injection site with minor muscle and joint pain and fatigue. Heat pad applied to lower the swelling./Left forearm swelling; joint pain; minor muscle and joint pain; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm on 12Jan2021 at 15:45 at single dose for COVID-19 immunization. Medical history included shellfish allergy. There were no concomitant medications. The patient previously received his first dose of BNT162B2 intramuscularly on left arm on 22Dec2020 at 09:00 AM for COVID-19 immunization, two weeks later a mass grew within the muscle at the forearm region. No ecchymosis with minor pain. Heat pad applied to lower the swelling. After the second shot on unknown date in Jan2021, same type of swelling happened the following day directly at the injection site with minor muscle and joint pain and fatigue. Heat pad applied to lower the swelling. There has been significant relief with just rest and applications of heat to both locations. Left forearm swelling is almost completely gone. The outcome of event vaccination site swelling was recovered on unknown date in Jan2021. The outcome of rest events was unknown.  Information on the Lot/Batch number has been requested.
Extremely sore shoulder. Unable to lift shoulder up or right to left. Large localized swelling- constant aching. Soreness & discomfort at time of immunization (10/8/10) & continues to present. No treatment provided.
R lateral thigh 3" x 2 1/2 region, redness and swollen around. HC 2.5% and Keflex, Motrin.
Oval Rash Spot that is 95% resolved in 3 days.  Note a little itching and discomfort upon touching site. Also noted a runny nose and congestion a few days after injection.  Took Benadryl which helped the runny nose.
Tested positive for Covid 19 after learning her husband had tested positive.  No symptoms to report.
I63.9 ACUTE STROKE DUE TO OCCLUSION OF UNSPECIFIED ARTERY 2/11/2022 BLADDER CANCER, UNSPECIFIED SITE I95.9 HYPOTENSION 2/3/2022 BLADDER CANCER, UNSPECIFIED SITE J96.00 ACUTE RESPIRATORY FAILURE 2/22/2022 BLADDER CANCER, UNSPECIFIED SITE I63.9 ACUTE STROKE DUE TO OCCLUSION OF UNSPECIFIED ARTERY 2/11/2022 SEPTIC SHOCK I95.9 HYPOTENSION 2/3/2022 SEPTIC SHOCK J96.00 ACUTE RESPIRATORY FAILURE 2/22/2022 SEPTIC SHOCK I63.9 ACUTE STROKE DUE TO OCCLUSION OF UNSPECIFIED ARTERY 2/11/2022 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 2/3/2022 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 2/22/2022 ATHEROSCLEROSIS OF AORTA I63.9 ACUTE STROKE DUE TO OCCLUSION OF UNSPECIFIED ARTERY 2/11/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I95.9 HYPOTENSION 2/3/2022 NONTRAUMATIC ACUTE KIDNEY INJURY J96.00 ACUTE RESPIRATORY FAILURE 2/22/2022 NONTRAUMATIC ACUTE KIDNEY INJURY
Maculopapular rash on upper extremities bilaterally with pruritis, treated with Zyrtec and topical cortisone resulted in resolution over several weeks.
erythematous, itchy area surrounding the inj site;saw on 4MAR96 & treated w/ATB & cortisone cream;rash still itchy w/flat redness;