chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a practice manger via company representative referring to a patient of unknown age and gender. On 16-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Within a couple of months, I developed an irregular heartbeat. Doctors could not get it regulated. Felt like elephant on my chest. Went to ER, then PCP.  ER did an EKG and MRI. PCP sent me to associate who put in a pacemaker.
Stated felt a "drugged" feeling. Thick tongue and slurred speech.  Seen by PMD in the clinic office.
low grade fever 4-5 hrs after shot, chills, fatigue;  30 hrs after shot - cramping in hands and back, chills, nausea, vomiting (once), headache,  fatigue; 48 hrs after shot - fatigue but other symptoms subsides
Swollen arm at injection spot. About the size of a cutie orange. Feels very hot and itchy. This is a week and 2 days after injection. Headache and achy all over.
74 yo F with history of renal transplant on immunosuppresssion, IDDM, a-fib/flutter on apixaban, sick sinus syndrome s/p PM presents with acute onset of headache, cough, SOB, and generalized weakness.  Symptoms started about 3 days ago.  Associated with chills and diaphoeresis.  Denies fevers.  Cough has been dry, non-productive.  No N/V/D, no dysuria.  Her husband recently had a cold, but otherwise no sick contacts.  She had a renal transplant at the end of May and is currently on MMF, Tacrolimus, and 5mg Prednisone daily.  She received her first two shots of COVID prior to her transplant and got a booster shot in August (all Pfizer). Recently admitted here in October for ESBL E. Coli UTI for which she completed 30 days of Ertapenem at home and reports having two follow-up negative UAs.  Denies any recent lower urinary tract symptoms.      In the ED, she was hypoxic to 83% and had low-grade fever to 100.2F.  ABG 7.45/36/63/93% on 3L.  Labs notable for leukopenia, stable normocytic anemia, BUN/Cr 22/1.5 (improved from last labs), glucose 188, pro-BNP 1078.  Found to be COVID positive and CXR with bilateral patchy opacities consistent with early PNA.  Hospitalist consulted for admission.   PT IS AN IN-PATIENT AT THIS TIME.
Moderna vaccine was inadvertently administered past the 30 day use by date.  Moderna company contacted and case ID was given. No reports of any signs or symptoms given at this time.
Swollen and painful  lymph nodes-- right arm pit and breast (vaccine was given in right arm). Swelling and pain has lasted 3 days so far and has not lessened.  Small circular rash developed 3 days after shot, on right arm at crook of elbow. On fourth day it had not grown.
pt recv vax & devel redness on face, legs, arms since 3JAN98 w/T102, loss of appetite;states redness resembles whelps;pt referred to PMD;pt saw MD 3JAN98 & told had ear infect & cold not sure about rxn to vax;
Patient was admitted on 02/08/22 for abdominal pain and bloody bowel movements. This is not considered a breakthrough case
partial dose of the vaccine was administered; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced partial dose of the vaccine was administered.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   The physician reported a partial dose of the vaccine was administered. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, experienced partial dose of the vaccine was administered, was considered resolved on an unknown date.; Reporter's Comments: This case concerns a patient of an unknown age and gender. The patient's medical history and concomitant medications were not provided. The patient experienced a non serious event of partial dose of the vaccine was administered. The event occurred on the same day the first dose of the mRNA-127 was administered, with no reported AEs.
I have MS and have been in remission for 5 years. I now have a new lesion on my brain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: AUBAGIO; OMEPRAZOLE; ZOLOFT; SIMVASTATIN; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose 2; Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Aug2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (Dose 1; Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Apr2021, when the patient was 49 years old, for COVID-19 Immunization. The following information was reported: CENTRAL NERVOUS SYSTEM LESION (non-serious) with onset Apr2022, outcome "recovering", described as "I have MS and have been in remission for 5 years. I now have a new lesion on my brain". The events "i have ms and have been in remission for 5 years. i now have a new lesion on my brain" required physician office visit. Therapeutic measures were taken as a result of central nervous system lesion.  Additional information: The patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. Other medications in two weeks inlcuded Aubagio, omerprozole, zoloft, simvistatin, c, d. No covid prior vaccination and no covid tested post vaccination. It was reported that, the patient took dose 3 on Jan2022 at 10:00 AM. Therapeutic measures included stronger MS medicine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediately rapid pulse; feeling of dizziness; joint pain; heaviness in chest/pressure in face/sinuses/neck throat and chest area, feeling jittery; plus headache; weakness; pressure in face/sinuses/neck throat and chest area, feeling jittery; skin itching; pressure in face/sinuses/neck throat and chest area, feeling jittery; This is spontaneous report from a contactable consumer (patient) reported for herself. A 55-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Mar2021 at 18:45 pm (age at vaccination was 55 years) as dose 1, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient previous took MMR vaccine and had a strong allergic reaction as a child. The patient did not receive any other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Mar2021 at 18:45 pm, the patient experienced immediately rapid pulse, feeling of dizziness, joint pain, heaviness in chest. Continued to next day, plus headache, weakness, pressure in face/sinuses/neck throat and chest area, feeling jittery, skin itching. No treatment was received for the adverse events. The patient underwent lab test which included heart rate: immediately rapid pulse on 02Mar2021. The case was reported as non-serious. The outcome of the events was not resolved.   No follow-up attempts are possible. No further information is expected.
choking, sweating, eyes rolled back in head; temp p/cool water applied 102R; unresponsive until grandma applied cool water & pt vomited large amount of formula; taken to ER; referred to pvt MD;
wheals devel on face w/in 20-30 mins of DTP; no other sx; rash faded in 25 mins; hives returned later in the afternoon resolved w/single dose of DPH;
Quarter sized raised reaction at the injection site, plus a rash, warm to the touch on stomach, back and groin and under arms.
sudden sore throat; quickly escalated to a tightness in the throat and escalating further super difficulty swallowing and talking lasting several hours.
LOWER PROGESTERONE LEVELS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prevention of covid-19. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced lower progesterone levels. Laboratory data (dates unspecified) included: In vitro fertilization (NR: not provided) UNKNOWN. Treatment medications (dates unspecified) included: progesterone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 11-MAR-2021, and had not recovered from lower progesterone levels. This report was non-serious.
Narrative: Patient states that he had an injection site reaction and a headache for one day. Symptoms has resolved.  Other Relevant Hx: Symptoms:  Headache & injection site reaction Treatment:
Extremely loud ear ringing/pain/pressure;  headache and pressure; constant thirst;  nausea (nausea ended 10/09/2021);  blurry vision that shifted from eye to eye (vision issues ended 10/10/2021);  lightheadedness (this ended 10/08/2021);  fatigue;  weight loss(6 lbs. by 10/03/2021);  pain and skin irritation in injected arm that radiates down arm and into shoulder (this began 10/09/2021); Was told by a nurse to take Zyrtec-D 9/25/2021 to help with ear and head issues. Was given a shot & 6 day dose of methylPREDNISolone 9/26/2021 to fix the ear issues. These did not relieve the adverse issues. All issues that do not have an end date are still ongoing
Confirmed Breakthrough   COVID-19 (Pfizer) 1  01/19/2021 Pfizer EL3248   COVID-19 (Pfizer) 2 02/12/2021 Pfizer EM9810   COVID-19 (Pfizer) 3 11/17/2021 Pfizer EW0172
Pt. immediately develop itching, swelling & redness at injection site, pt c/o oral numbness provider provided BENADRYL 50mg PO, DECADRON 8 mg IM.
Grand Mal Seizure; Urinary Tract Infection; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (Grand Mal Seizure) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (Grand Mal Seizure) (seriousness criterion medically significant) and URINARY TRACT INFECTION (Urinary Tract Infection). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (Grand Mal Seizure) and URINARY TRACT INFECTION (Urinary Tract Infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medication were provided No Concomitant medication were provided Unknown lab tests done resulted in UTI (Urinary tract infection) Company Comment : Based on the current available information which state that the patient does not have any prior history of seizures and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality for the event of generalised tonic-clonic seizure  of is possibly related. Due to lack of any plausible mechanism connecting mRNA-1273 and occurrence of urinary tract infection, causality for the event of urinary tract infection is assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Follow up received on 04-SEP-2021 contains No new information. However, updated reporter type to Non-Health Professional, missed in earlier step.; Sender's Comments: Based on the current available information which state that the patient does not have any prior history of seizures and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality for the event of generalised tonic-clonic seizure  of is possibly related. Due to lack of any plausible mechanism connecting mRNA-1273 and occurrence of urinary tract infection, causality for the event of urinary tract infection is assessed as unlikely related to mRNA-1273.
-Within 12 hours of receiving Moderna vaccine, patient reports racing heartbeat/tachycardia (resolved within 48-72 hours) -Within 12 hours of receiving Moderna vaccine, patient started having itching on legs which progressed to itchy, red rash on thighs, back, torso, arms, and neck (rash has been getting worse); rash burns from itching. Has been taking Benadryl + Prednisone
diagnosed with COVID-19 after receiving the first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with COVID-19 after receiving the first dose of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced COVID-19 (diagnosed with COVID-19 after receiving the first dose of vaccine). At the time of the report, COVID-19 (diagnosed with COVID-19 after receiving the first dose of vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided.
Pulmonary Embolus; Significantly hypoxic; fatigue; shortness of breath; blood clots/The clots are old, not acute; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Lot number: EN6201) at the age of 77 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing). Patient did not have any known allergies. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, lot number=EL9261, vaccine location: Right arm), administration date: 05Feb2021, when the patient was 77-year-old, for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, disability, medically significant, life threatening), outcome "recovering", described as "Pulmonary Embolus"; HYPOXIA (hospitalization, disability, medically significant, life threatening), outcome "recovering", described as "Significantly hypoxic"; FATIGUE (hospitalization, disability, life threatening), outcome "recovering"; DYSPNOEA (hospitalization, disability, life threatening), outcome "recovering", described as "shortness of breath"; THROMBOSIS (hospitalization, disability, medically significant, life threatening), outcome "recovering", described as "blood clots/The clots are old, not acute". The patient was hospitalized for pulmonary embolism, hypoxia, fatigue, dyspnoea, thrombosis (start date: 22Sep2022, discharge date: 26Sep2022, hospitalization duration: 4 day(s)). The events "pulmonary embolus", "significantly hypoxic", "fatigue", "shortness of breath" and "blood clots/the clots are old, not acute" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism, hypoxia, fatigue, dyspnoea, thrombosis.  Clinical Course: The patient did not have covid Prior vaccination. The patient was not tested with covid post vaccination. Patient did not receive any other vaccine in four weeks. The patient had Pulmonary Embolus, bilateral pulmonary embolic disease, albeit relatively small clot burden. Significantly hypoxic. The clots are old, not acute. Recognized a slow decline after receiving Covid Vaccine. Fatigue, shortness of breath for well over a year. Shortness of breath worsened throughout the year and months. Room air oxygen was 70%. No risk factors at all for blood clots, except for Pfizer vaccine. The patient went to emergency room on 22Sep2022. Admitted from PE in both lungs and severe Hypoxia. Flown to a hirer level of care on 24Sep2022. Release to recover at home on 26Sep2022. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. The patient took Heparin, O2, Blood Thinners and Air Lifted as the treatment of the events.
Patient had 5 days of bruising and left leg swelling prior to presenting to the emergency department 3/26/21, where she was found to have an extensive occlusive DVT of left lower extremity as well as thrombocytopenia of 15,000.  That evening she was taken to the Cath Lab and had an IVC filter placed. The next day patient began to have paresthesias and discoloration of the right lower extremity.  Ultrasound showed high-grade occlusion of the right proximal superficial femoral artery.  Patient was pre-treated with platelets and  taken back to Cath Lab emergently.  In addition to the right SFA there is also thrombotic occlusion of bilateral iliacs.  Patient had bilateral thrombectomy and bilateral common iliac stent placement. The following day developed gross hematuria.
feeling weak; falling; is not talking coherently mostly; measure of her blood sugar and it was 300 mg/dl; This is a spontaneous report from a contactable consumer (patient daughter). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Apr2021 as SINGLE DOSE for covid-19 immunization. Medical history included: reporter recalls: that her mother had covid 19 over 3 months ago and she had almost the same symptoms although that time it was more GI problems like diarrhea. She mentions that her mother is also diabetic. The patient's concomitant medications were not reported. In Apr2021 after the vaccination patient experienced some side effects as the patient was feeling weak, falling sometimes and was not talking coherently mostly when asked questions. It was also reported that they took a measure of her blood sugar and it was 300 mg/dl. In Apr2021 the patient underwent lab tests and procedures which included blood glucose: 300 mg/dl. The outcome of events was unknown.  Reporter asked since her mother had side effects after the first dose of the vaccine, should she get the second dose. Response: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Information has been received from a health professional concerning an 8 year old female who on 21-OCT-2008 received the second dose of VARIVAX (Merck), subcutaneously in the right lower arm (lot# 661536/0954X). On 21-OCT-2008 the patient experienced painful at injection site, a 3 inch x 5 inch welt at injection site and swelling. At the time of the report, the outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Woke up day after shot with a rash widespread over the body and some puffiness to her eyes. Urticaria.
Information has been received from a nurse practitioner concerning a 22 year old female with no drug reactions or allergies who on 22-May-2009 was vaccinated with the second dose of GARDASIL. Concomitant therapy included ZYRTEC, DETROL, FLONASE and hormonal contraceptives (Unspecified). Subsequently on an unspecified date the patient experienced a bald spot. The patient did not seek medical attention. At the time of this report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
1st vaccination was Moderna back on 12/24/2020. Another employee was misinformed about the length of time between injections and proceeded to give the client a Pfizer vaccine. She said she was advised that if the client exceeded a certain number of days between vaccinations, the client would be considered non-vaccinated. Client did not exhibit any signs or symptoms.
Swelling of thigh at site of vax, 11 1/2 x 9 1/2cm. Red, warm, tender. New onset central area with increased warmth, swelling given antibiotics for possible infection of central area.
BlurredVision, Headache, Myalgia, fatigue, jaw pain Narrative:  1/14 - fatigue 1/15 - tension of both sides of her jaw, body aches, headache, blurred vision. Symptoms lasted throughout 1/15. 1/16 symptoms resolved.