chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling in his arm; a little headache; This is a spontaneous report from a contactable consumer or other non hcp (parent). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling in his arm and a little headache on an unspecified date. It was reported that, my family member just got the vaccine yesterday, and all he had was swelling in his arm, and a little headache. Caller enquired what are the risks of the pfizer-biontech covid-19 vaccine. The outcome of the events was unknown.  Information on Lot/Batch number has been requested. Further information is expected.
Numb lips and swollen throat.  Breathing was OK but more difficult to swallow.
Headache, Fever, Fatigue, nasal congestion, chills Narrative:  The day after the vaccine was administered, patient reported a fever of 102 (F), headache, nasal congestion, chills, and fatigue. Over the course of 24 hours, took ibuprofen 600mg three times and acetaminophen 1000mg two times.
I came down with severe gastrointestinal issues days after my first shot that lasted from mid October (2021) to mid May (2022). The symptoms were similar to that of IBS. I would have a sudden urgency to go to the restroom, extreme bloating and pain, severe nausea, heavy GI bleeding, and excessive burping. I have never had anything even similar to this in the 25 years that I have been alive. The onset was fast and came on without warning. I lost weight because I couldn?t hold anything on my stomach and eventually was afraid of the pain caused by eating. I had to have a colonoscopy at 25 years old because the bleeding was so severe the last time. I had maybe one or two stomach aches at the end of may but I have not had any of these symptoms since then.  My periods are still completely out of whack. I used to not have periods because of my birth control. Since having the shots, I have a period every other month. A week or two before starting, my boobs grow a cup size larger and literally hurt to touch. I have numerous pregnancy symptoms leading up to the period as well. It is very strange and somewhat frightening.
Arrived w/ known COVID infection, hypoxia and hypotension. Fully vaccinated plus booster. Admitted for COVID pna. Received O2, zithromax, steroids, Merrem, Rocephin, vit c. DC to rehab.
Within a few days my son experienced a feeling that something wasn't right and very strange overall feeling specifically in the area of his heart.  He was never an anxious person and was looking forward to receiving his vaccine.  Within a few days the uneasy feeling  developed further and he started to get heart palpitations and fluttering. Additionally he felt some strange tightness and discomfort and didn't feel himself.
Migraine Nausea Vomiting Diarrhea Headache Dizzy Heart palpitations In a fog Extreme fatigue Muscle & joint pain  Loss of appetite Dry mouth Started 4/3/2021 @ 11:00 am Still continuing
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with VARIVAX (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 31 year old female patient. On 09-MAY-2014 at 11:21 am, the patient might have been immunized with a dose of VARIVAX (Merck) lot number J009165, expiration date 24-JUL-2015, in the right upper arm (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (massive hair loss/bare spots), MYALGIA (muscle pains in legs), PYREXIA (fever for 3 or 4 days) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced ALOPECIA (massive hair loss/bare spots), MYALGIA (muscle pains in legs), PYREXIA (fever for 3 or 4 days) and FATIGUE (fatigue). The patient was treated with ZINC at an unspecified dose and frequency and BIOTIN at an unspecified dose and frequency. At the time of the report, ALOPECIA (massive hair loss/bare spots), MYALGIA (muscle pains in legs) and FATIGUE (fatigue) outcome was unknown and PYREXIA (fever for 3 or 4 days) had resolved. This case was linked to MOD21-080679 (E2B Linked Report).; Sender's Comments: MOD21-080679:
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 19-AUG-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Extreme irritability x 48 hours after DTaP, Hib and IPOL given. Crying, not relieved by sleep, attempts at feeding, Tylenol. Pt recovered after 48 hours.
Left arm pain from wrist through shoulder to upper left side of back.; Left arm pain from wrist through shoulder to upper left side of back.; Swollen & painful lymph nodes under left arm towards left breast and left side below arm; Swollen & painful lymph nodes under left arm towards left breast and left side below arm; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 10Apr2021, as a single dose for COVID-19 immunisation. Medical history included celiac disease. The patient did not have any allergies to medications, food, or other products. Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole (ESOMEPRAZOLE) and ibuprofen (MANUFACTURER UNKNOWN); all taken for unknown indications since anunknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed not with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 20Mar2021 as a single dose for COVID-19 immunisation. On 11Apr2021 at 19:00,  the patient reported that she felt pain in the left arm from wrist through shoulder to upper left side of back and swollen & painful lymph nodes under left arm towards her left breast and left side below her arm. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event left arm pain from wrist through shoulder to upper left side of back, swollen lymph nodes and painful lymph nodes under the left arm were not recovered at the time of this report.  No follow-up attempts are possible; No further information is expected.
BODY ACHE; BODY WARM TO TOUCH NO FEVER; SORE THROAT; LIGHT SENSITIVITY; SHARP POKY PAIN ON THE ABDOMEN; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2018ZIA, expiry: not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced body warm to touch no fever. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced light sensitivity. On APR-2021, the subject experienced sharp poky pain on the abdomen. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body ache, fatigue, body warm to touch no fever, sore throat, light sensitivity, and sharp poky pain on the abdomen. This report was non-serious.
almost fainted; localised tingling; Vaccination site warmth; lightheaded; racing heart; shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (almost fainted), PARAESTHESIA (localised tingling), VACCINATION SITE WARMTH (Vaccination site warmth), DIZZINESS (lightheaded) and HEART RATE INCREASED (racing heart) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PRESYNCOPE (almost fainted), PARAESTHESIA (localised tingling), VACCINATION SITE WARMTH (Vaccination site warmth), DIZZINESS (lightheaded), HEART RATE INCREASED (racing heart) and TREMOR (shaking). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 17-Apr-2021, PRESYNCOPE (almost fainted), PARAESTHESIA (localised tingling), VACCINATION SITE WARMTH (Vaccination site warmth), DIZZINESS (lightheaded), HEART RATE INCREASED (racing heart) and TREMOR (shaking) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided   This case was linked to US-MODERNATX, INC.-MOD-2021-083578 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083578:Cluster case for people
Vaccination on patient under 18 y/o; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination on patient under 18 y/o) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history reported.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination on patient under 18 y/o). On 12-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination on patient under 18 y/o) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was doing well and did not experience an adverse reaction to the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Reporters details, patient demographics and event information updated.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
As patient  walking over to observation LPN noted patient run into floor sign patient complained of difficulty seeing, pupil dilated approx.  4-5mm unsteady gait.  Patient assisted to EMS room per w/c  provided water and peanut butter crackers.  Patient skin tone to face returning as color was pale at time of reaction.  After lying on cot for approx. 30 minutes patient reports feeling much better.  Per father with patient patient didn't eat much for breakfast before coming in for vaccine. Left with parent.
back pain; Pneumonia in right lung; Shortness of breath and couldn't breath; Malaise; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia in right lung) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020 and Pneumonia (Patient had Covid about an year ago and it gave them pneumonia.) in 2020. Concomitant products included THYROID for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache). On 07-May-2021, the patient experienced PNEUMONIA (Pneumonia in right lung) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath and couldn't breath). On an unknown date, the patient experienced BACK PAIN (back pain). On 06-May-2021, MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, PNEUMONIA (Pneumonia in right lung), DYSPNOEA (Shortness of breath and couldn't breath) and BACK PAIN (back pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Blood analysis were good. On an unknown date, Scan: abnormal (abnormal) Found pneumonia in right lung.         The patient was treated with doxycycline for five days and received antibiotics in the hospital.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Developed a headache 9 hours after I received vaccine. It's been 2 weeks and the headache has not subsided. It has been a persistent migraine feeling that is affecting my work and overall day to day activities.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
metastatic breast cancer; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as DOSE 2, SINGLE and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. A potential AE has been reported to the Pfizer Clinical Trials Contact Center. The caller (patient) stated that she has received both doses of the Pfizer vaccine. Caller has metastatic breast cancer and she is getting ready to start stage 4 of her treatment. She will be taking an immunosuppressant drug. No other additional information was provided. Outcome of the event was unknown.  No follow-up attempts are possible; information about the batch/lor number cannot be obtained. No further information is expected.
Information was received for this unsolicited report on 09 February 2015 from a consumer who is the patient's mother. This reporter also reported two other events, one for her husband and one for herself. These cases are captured in 2014SA172624 and 2015SA017179. A female patient, with an unknown medical history, age and date of birth not reported was vaccinated at a pediatrician's office on an unknown date with Influenza vaccine, manufacturer, batch, route and site of administration were not reported. The patient was seen at the ER last night (08 February 2015) and was swabbed and has the Flu now too. The reporter was not sure which vaccine she received. She will report  it once she finds out. Laboratory test was not provided. The patient outcome is unknown. Documents held by sender: None.
Patient  was given the Pfizer 12 and up bivalent on 10/20/22. The patient is 11 days away from turning 12 years old.
Left ear feels numb; Side of face feels numb; Numbness in lips, lips still feel numb; lips felt swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips felt swollen), HYPOAESTHESIA ORAL (Numbness in lips, lips still feel numb), HYPOAESTHESIA (Side of face feels numb) and HYPOAESTHESIA (Left ear feels numb) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concomitant products included PITAVASTATIN CALCIUM (LIVALO) and VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced LIP SWELLING (lips felt swollen) and HYPOAESTHESIA ORAL (Numbness in lips, lips still feel numb). On 12-Feb-2021, the patient experienced HYPOAESTHESIA (Side of face feels numb) and HYPOAESTHESIA (Left ear feels numb). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN EXTRA) for Adverse event, at a dose of UNK dosage form. At the time of the report, LIP SWELLING (lips felt swollen), HYPOAESTHESIA (Side of face feels numb) and HYPOAESTHESIA (Left ear feels numb) outcome was unknown and HYPOAESTHESIA ORAL (Numbness in lips, lips still feel numb) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
With in 5 minutes flushed, heat through out my body, light headed or brief dizziness. Hyper feeling tingling in my hands. High BP and heart rate 181/101 HR 115. Not swelling throat but trying to breath deep enough.   day 2 eve BP now 150-160
PATIENT WITH HISTORY OF THROAT TIGHTENING WITH DOSE 1 OF COVID-19 PFIZER VACCINE 3 WEEKS AGO. VACCINE # 2 GIVEN TODAY IN TRIAGE 2 AS PRECAUTION.  VS: 133/93 HEART RATE 71, PULSE OX 99% ROOM AIR DR. AT BEDSIDE. PATIENT REPORTED THROAT TICKLE AND TIGHTENING AT 10:23 AM. ZYRTEC 10 MG ORAL CHEWABEL TAB GIVEN TIMES 1 DOSE WITH BOTTLE OF WATER. DISCHARGED AT 10:35 WITH  SYMPTOM RESOLUTION.
confused; drained of energy; I can't recall info that I should know; can't do two things at once; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confused), ASTHENIA (drained of energy), MEMORY IMPAIRMENT (I can't recall info that I should know) and DISTURBANCE IN ATTENTION (can't do two things at once) in a patient of an unknown age and gender 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, the patient experienced CONFUSIONAL STATE (confused), ASTHENIA (drained of energy), MEMORY IMPAIRMENT (I can't recall info that I should know) and DISTURBANCE IN ATTENTION (can't do two things at once). At the time of the report, CONFUSIONAL STATE (confused), ASTHENIA (drained of energy), MEMORY IMPAIRMENT (I can't recall info that I should know) and DISTURBANCE IN ATTENTION (can't do two things at once) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Treatment of COVID-19/ Pfizer / BioNTech 12-NOV-2021; Treatment of COVID-19/ Pfizer / BioNTech 12-NOV-2021; 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 male patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 24Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE, start date: Jan2008, stop date: Jun2022; ROSUVASTATIN, start date: Apr2021, stop date: Jun2022. The following information was reported: DRUG INEFFCETIVE ant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/ Pfizer / BioNTech 12-NOV-2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Negative, notes: Covid symptoms resolved and negative rapid antigen test on Day 6; (26May2022) Positive, notes: positive rapid antigen test on Day 8; (01Jun2022) Positive, notes: positive rapid antigen test on Day 8 thru Day 14 and continuing. Therapeutic measures were taken as a result of drug ineefctive , covid-19.  Clinical course: Patient received Covid-19 treatment from 19May2022 to 24May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received two doses 4/16/21 first dose, second dose 5/14/21. Patient did not report prior vaccines. patient did not report any reaction after moderna.