chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 15 year-old patient was administered PROQUAD.; This spontaneous report was received from a physician referring to a 15 years old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reaction or allergy and concomitant therapy was provided.   On 14-AUG-2020, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (1 dosage form, lot # S035110, expiration date 03-MAY-2021, strength and route were not provided) for prophylaxis (inappropriate age at vaccine administration).
Weakness and dizziness.  Patient collapsed while walking from POD to Observation.  O2 sat 99%, BP 91/61, HR 72, Patient did not hit head or lose consciousness.  No CP, SOB,  Hadn't had anything to eat today.  Given water and food.  Symptoms resolved.
Gave bivalent covid pfizer booster instead of pfizer covid dose 2 of primary series
Over the next week to week and a half after my vaccine, I experienced a rather sharp chest pain. It would go away for short periods of time but kept coming back with no obvious trigger.
Patient is a 69 y.o. male with a history of Non-Hodgkin Lymphoma, DVT (off anticoagulation), HTN, Anemia who presented to Hospital 2/22/2023 with several hours of weakness, fatigue, cough, fever, and mechanical fall from which he was unable to stand after due to weakness. In ED: SARS-CoV-2 positive. Admitted due to hypoxia with evidence of Covid-19 pneumonia. Symptoms improved with decadron/remdesivir and supportive care. Did require low flow O2 for discharge.    1. COVID-19 pneumonia : Patient with fever cough fatigue and generalized weakness since 2/22/23 (0 days prior to admission). SARS-CoV-2 positive on 2/22/23. Patient is vaccinated.  CTPA 2/23/23: mild ground glass opacities bases, no PE. Dexamethasone 6mg PO x10 days (last dose 3/3/23). Started remdesivir IV x5 days (last dose 2/25/23 given planned discharge). Symptoms improved overall.  2. Acute hypoxic respiratory failure: Patient not on oxygen at home but requiring 2 L oxygen through nasal cannula.  Likely secondary to COVID.  Received steroid and remdesivir as above and supportive treatment. Required O2 for home-going (1L). Further weaning in outptient setting.  3. Mechanical Fall: No loss of consciousness, no head strike. PT/OT followed, patient and spouse declined HHC.    4. Mantle Cell Lymphoma: Followed by Dr. (Oncology), daignosed 3/2021, stage IV with marrow and splenic involvement on bendamustine and Rituximab. Last chemo ~10/2022, next dose rituxan due 2/24/23, will need to reschedule and follow up outpatient.  5. Chronic DVT: Diagnosed 3/2021. Venous duplex 5/2021 chronic left femoral to gastrocnemius venous thrombosis. Patient taken off Xarelto ~10/2022. 6. Chronic Iron Def Anemia: baseline Hgb ~10-12. Hgb of 12 (MCV 98) in ED.  7. Chronic Thrombocytopenia: baseline plt count ~100-200k. Plt of 106k in ED. Suspect due to lymphoma. Monitored. 8. Hypertension: by history, not on medications prior to admission. Monitored.  9. Osteoarthritis: Followed by Orthopedics s/p left knee steroid injection 1/17/23. Monitored. 10. Chronic Encephalopathy: Followed by Dr. (Neurology). Admitted to Facility 11/2022 for hallucinations and metabolic encephalopathy, negative workup, eventually resolved. Continued home Seroquel taper.
Client received her first Pfizer shot (Lot# EW0182 EXP 08/31/21) from RN at 18:40. RN stated within 20-30 seconds after administering shot, client's eyes rolled back, and she began to pass out.  The client's friend was also in the room.  RN stated that she and the friend grabbed the client, held her, and she started responding to their voices within 15 seconds.  RN stated she simultaneously called for help.  2nd RN ran down the hallway to grab EMT  and 3rd RN called 911.  From the Lead's room, Lead RN and  Co-Lead RN observed 2nd RN running down the hallway.  Leads proceeded to the hallway and observed a cluster of individuals at vaccination station 5.  Lead RN & Co-Lead RN  arrived at station 5 at 18:42. Leads observed client conscious and sitting in a chair.  Thirty seconds later EMT  arrived.  Leads observed client was pale in color.  Client stated she got dizzy, and her eyes got blurry within seconds after the shot was administered.  Client stated she was hot and sweaty, but was not experiencing SOB or trouble breathing.  Client was alert and oriented times 4.  Co-Lead RN opened the window.  RN  put a wet towel on client's forehead and client was transferred to a zero-gravity chair.  Client stated she had eaten and drank plenty food and fluids earlier in the day.  At 18:48 client stated she was feeling better.  EMT took vitals at 18:50. (BP:  82/54 HR: 42).  RN took client's pulse again and stated HR:  76.  Client stated she has no known allergies and takes no medications other than birth control.  Client also stated she used to take medication for anxiety, but stopped taking the medication 6 months ago.  Firefighter EMTs arrived at 18:54 took vitals (BP:  106/74 O2: 99 HR 68) and performed a 12-lead ECG.  At this time client stated that she has never given blood because she starts to pass out when she sees blood.  She also stated that she passed out 9 months prior when she saw her sister's blood drawn at the hospital.  At 18:58 client's color was coming back.  She stated she was no longer dizzy and felt better, but was now cold because the window was open, and her jacket had been taken off to perform the ECG.  RN closed the window.  Firefighters took vitals again at 19:00 with client sitting (BP: 104/70 O2: 99 HR:  70) and standing at 19:01 (BP:  106/70 O2:  99 HR:  72).  Client stated she felt much better.  Client declined transport to hospital.  Lead RN provided client with a Pfizer fact sheet and educated client on the common side effects vs the adverse effects of the Pfizer vaccine.  Lead RN instructed her to contact her HCP if the common side effects persisted beyond 2-3 days and to go to urgent care or the ER if she experienced any adverse effects.  Lead RN also instructed client to call 911 if she experienced any respiratory issues once she was home.  RN walked client to observation room for additional 15-minute surveillance.  Client walked with a steady gait.
3/26/03: Pt states left arm has red circle size of baseball around injection site, hard as rock. Right arm had little red knot at injection site. MD said it was reaction to shots.
Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reactions/allergies reported. Since 15SEP2015, doses of improperly stored ROTATEQ (lot # K019370 with 16NOV2016, dose, frequency and route were unknown) were administered to an unspecified number of patients. No concomitant therapy was reported. No adverse experience was reported. Additional information has been requested.
swelling; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated he had a long conversation with someone yesterday regarding the large under swelling he had after receiving the Pfizer COVID-19 vaccine. He wanted to know if this was common with the vaccine. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
fast heartbeat; dizziness; weakness; slow thinking; very tired; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265), via an unspecified route of administration in the left arm on 08Feb2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. Medical history included cardiac pacemaker insertion because of chronotropic incompetence. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included vitamins and zolpidem tartrate (AMBIEN), both were taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 18Jan2021 14:00 as a single dose for COVID-19 immunization and experienced sweating, chills and tired. On an unspecified date in Feb2021 after receiving the second dose, the patient experienced fast heartbeat, dizziness, weakness, very tired and slow thinking. No treatment was received for the adverse events. The clinical outcome of the fast heartbeat, dizziness, weakness, very tired and slow thinking was unknown.
Patient had redness and tenderness at the site on injection. The site was red, approximately 2 inch in diameter, oblong in shape, and raised. The patient states she feels fine. The other pharmacist on duty, and I advised the patient to contact her doctor. The patient stated that she would. I will follow-up with patient on Monday.
Knumbness and tingling in fingers and toes. Both feet knumb. Large swollen lump under armpit on same arm as injection.
Chest pain, jaw pain, headache, kidney pain,. chest pain every 5-7 breaths,  pressure on her chest, Pain was in the center of her chest.  Jaw pain was bilateral and headache was on the left and unrelieved with advil. She also reported difficulty thinking.
Information has been received from a physician concerning an over 60-year old female who on an unspecified date was vaccinated with a 0.65mL dose of ZOSTAVAX (Merck) (LOT# not reported).  It was reported that 5 days after vaccination.  The patient developed a case of shingles on her neck.  The patient sought an unspecified medical attention.  The outcome was not recovered.  Additional information has been requested.
No adverse event; Patient was given the incorrect dosage of a Moderna bivalent.This was their second dose following a previous dose of the Moderna Monovalent product/. Was given a dose from the presentation with the dark pink cap at a dosage of 0.25mL.; off label use; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was given the incorrect dosage of a Moderna bivalent.This was their second dose following a previous dose of the Moderna Monovalent product/. Was given a dose from the presentation with the dark pink cap at a dosage of 0.25mL.), OFF LABEL USE (off label use) and NO ADVERSE EVENT (No adverse event) in a 40-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was given the incorrect dosage of a Moderna bivalent.This was their second dose following a previous dose of the Moderna Monovalent product/. Was given a dose from the presentation with the dark pink cap at a dosage of 0.25mL.) and OFF LABEL USE (off label use). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was given the incorrect dosage of a Moderna bivalent.This was their second dose following a previous dose of the Moderna Monovalent product/. Was given a dose from the presentation with the dark pink cap at a dosage of 0.25mL.), OFF LABEL USE (off label use) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient was given the incorrect dosage of a Moderna bivalent.This was their second dose following a previous dose of the Moderna Monovalent product/. Was given a dose from the presentation with the dark pink cap at a dosage of 0.25mL.) and OFF LABEL USE (off label use).    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received Moderna Monovalent vaccine as first dose.  No concomitant medications was reported.  No symptoms was reported.  No treatment medications was reported.
sore arm; 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 63-year-old male patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 2, single (Lot number: PE3590) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Pfizer LOT number FE3590), administration date: 28Oct2021, when the patient was 63-year-old, for Covid-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300284611 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300075974 same reporter/patient/product, different dose/AE;
Pt recvd shots 11AM; approx 5Pm spiked t105 couldn't hold head up or sit; seen by MD did lab & CXR to r/o other eitology; told to cont APAP; temp lasted approx 5-6 days at 104;
On June 1, he began to have a high fever (up to 103.1° F) and later developed into Gingivostomatitis. He has had several sores in his mouth that have caused diarrhea, bad breath, blood on his gums, little appetite, etc.
significant left thigh swelling-site of DTAP;lethargic mom describes as just passing out, very sleepy x 48hr;very irritable, strange cry, difficult to console x 48hr;
Dizziness, headache, blurred vision associated with elevated blood pressure. Pressure consistently spiking around 165/80. Appointment with primary care physician on 15Feb2022. Began increased dose of Lisinopril (40mg) effective 16Feb2022. Symptoms continue. Physician follow-up again on 01Mar2022.
Immediate swelling at injection site. Soreness and swelling for 2 days after. 4 days later and there is a large bruise around injection site and even larger area around that is hard and swollen.
Employee received COVID vaccine on 12/21/20-Pfizer/Lot#EJ1685 then received 2nd dose on 1/12/21 Pfizer/Lot#EJ13302.  Employee had an asymptomatic  screening test on 3/17/21 which was positive.  Employee had traveled on 2/25/21 and returned home on 3/1/21. Her husband developed symptoms on 3/12/21 and tested positive for COVID.
Information has been received from a physician concerning an approximately 10 week old healthy female with no medical history or allergies who on 05 Sep 2006 was vaccinated with the first dose of Rotateq. The physician reported that in September 2006 the patient developed abdominal pains. The patient subsequently presented with evidence of malabsorption and mucous in stool. Stool tests performed showed no blood and no white blood cells (WBCs) in the stool. Protein fecal substance was high at 1,000 and pH was 7.0, The patient  was on amino acids (Nutramigen) and was gaining weight appropriately. At the time of this report, the patient's events persisted. Additional information has been requested.
Pressure in rectal area which escalated to pain; Pressure in rectal area which escalated to pain; This is a spontaneous report from a contactable consumer (the patient). A 65-year-old male patient received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 18Feb2021 13:00 (at the age of 65-year-old) as single dose for COVID-19 immunization. The patient did not have any medical history, any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021 17:30, the patient experienced pressure in rectal area which escalated to pain. No treatment was received for the adverse events. The clinical outcome of the pressure in rectal area which escalated to pain was resolving.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
This is a spontaneous report from a non-contactable consumer, the patient. A 57-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 16:00 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), FLONASE as allergy medication on an unknown date for unknown indications. Patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not have any allergies to medications, food, or other products. On 18Mar2021 at 10:00, the patient experienced body pain, vertigo, nausea, fever, chills, brain fog, severe fatigue, headache and coughing. Patient did not receive any treatment for the events. The clinical outcome of the events body pain, vertigo, nausea, fever, chills, severe fatigue, headache and coughing was resolving at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained.
bump around the injection site / bump is oval in shape; Physical appearance of injection site resembles the skin of an oragne; feels like a chemical burn; Warm to touch; Slightly painful; Red and raised area around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (bump around the injection site / bump is oval in shape), VACCINATION SITE REACTION (Physical appearance of injection site resembles the skin of an oragne), CHEMICAL BURN (feels like a chemical burn), FEELING HOT (Warm to touch) and PAIN (Slightly painful) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0221321a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder, Allergy NOS and Mucous discharge. Concomitant products included CHLORPHENIRAMINE MALEATE for Allergy NOS, GUAIFENESIN (MUCINEX) for Mucous discharge, LEVOTHYROXINE for Thyroid disorder.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced VACCINATION SITE MASS (bump around the injection site / bump is oval in shape), VACCINATION SITE REACTION (Physical appearance of injection site resembles the skin of an oragne), CHEMICAL BURN (feels like a chemical burn), FEELING HOT (Warm to touch), PAIN (Slightly painful) and VACCINATION SITE ERYTHEMA (Red and raised area around injection site). At the time of the report, VACCINATION SITE MASS (bump around the injection site / bump is oval in shape), VACCINATION SITE REACTION (Physical appearance of injection site resembles the skin of an oragne), CHEMICAL BURN (feels like a chemical burn), FEELING HOT (Warm to touch), PAIN (Slightly painful) and VACCINATION SITE ERYTHEMA (Red and raised area around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Fever up to 103.9 Chills Muscle aches Headache Nausea and vomiting
Breakthrough PE; This is a spontaneous report received from a contactable reporter(s) (Physician) from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2022-013982 (Company).  This spontaneous case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (breakthrough PE) in 70-year-old male patient who received apixaban (Eliquis) for Cerebrovascular accident prophylaxis. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 prophylaxis. On an unknown date, the patient started Eliquis (Oral), 5 milligram twice a day and Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced PULMONARY EMBOLISM (seriousness criterion medically significant). The action taken with Eliquis(Oral) was unknown. At the time of the report, PULMONARY EMBOLISM outcome was unknown. The strength of apixaban was 5 mg. Rep reported that patient experienced a break through PE after receiving vaccination for Covid (date unknown). For Eliquis(Oral), the reporter did not provide any causality assessments.  Apixaban (Eliquis) is under agreement with a Company.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Cpmpany medical evaluation comment: This 70-year-old patient had pulmonary embolism after receiving apixaban therapy and COVID-19 vaccination. Elderly age and underlying thromboembolic susceptibility are risk factors for the reported event, hence considered not related to apixaban. Pfizer comment: Based on the information provided, a contributory role of the suspect product Covid-19 Vaccine to the reported pulmonary embolism cannot be excluded. It was noted that patient experienced a break through PE after receiving vaccination for Covid. Vaccination date and event onset dates were not provided. Case will be reassessed upon receipt of additional information. 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.
He has a rash that appeared on left side of abdomen/chest. Slight fever and swelling.
Four-year-old patient was inadvertently given pediatric Pfizer BioNTech which is indicated for ages 5-11.