chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her arm was tender; can barely move her arm,; Brain fog; Constipation; dizziness; she has pain in the arm that is almost unbearable; she has chills; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Her arm was tender), MOBILITY DECREASED (can barely move her arm,), FEELING ABNORMAL (Brain fog), CONSTIPATION (Constipation) and DIZZINESS (dizziness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dairy intolerance (Dairy allergy), Allergy to animal dander and Seasonal allergy. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) for Allergy, MULTIVITAMIN FOR WOMEN for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced TENDERNESS (Her arm was tender), MOBILITY DECREASED (can barely move her arm,), FEELING ABNORMAL (Brain fog), CONSTIPATION (Constipation), DIZZINESS (dizziness), VACCINATION SITE PAIN (she has pain in the arm that is almost unbearable), CHILLS (she has chills), NAUSEA (nausea) and FATIGUE (fatigue). On 30-Apr-2021, TENDERNESS (Her arm was tender), MOBILITY DECREASED (can barely move her arm,), FEELING ABNORMAL (Brain fog), CONSTIPATION (Constipation), DIZZINESS (dizziness), VACCINATION SITE PAIN (she has pain in the arm that is almost unbearable), CHILLS (she has chills), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-204090 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up information received on 03-JUN-2021include the following new information, Dose 1 and 2 details, patient demographics, medical history and new events added.
11:02 Patient reported tingling  and swelling of lips. Denies any other symptoms such as swelling of her throat. She declined an epi pen and accepted Liquid Benadryl. She was monitored one on one with a nurse until 11:59, when she stated that she was back to normal and denied any further treatment. During her observation, her BP, P, and 02 was monitored and was WNL for her.  Respirations normal and pulse steady. She stated that her P runs high (over 100) and her BP has been running high as well. She was just her doctors office, 2/3/2021. She said her 02 was in the high 80s during her visit. During observation, her 02 ranged primarily in the mid to high 90s on RA. She was talking a lot and her 02 did drop into the 80s, when she stopped talking to rest and take in deep breaths, it increased back into the 90s. Patient's initial BP was 128/92 and it got down to 118/80 during observation. She denied ever feeling short of breath during the observation period. She was flushed and she suggested it was due to wearing her mask. She was in cooler room for observation, where she was able to remove her mask for a better assessment and for comfort. Thee flushness diminished. She was encourage to get a ride home versus driving. Her pcp will be made aware.
9/18 HEADACHE, LIGHT MENSTRUAL BLEEDING 9/19 HEADACHE, LIGHT TO MODERATE MENSTRUAL BLEEDING Rx Paracetamol 1 GRAM + IBUPROFEN 200 MG 9/20 MODERATE TO HEAVY MENSTRUAL BLEEDING 9/21 HEAVY MENSTRUAL BLEEDING
red inflammation; rash; itchiness at site of injection; fever at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ADMINISTRATION SITE INFLAMMATION (red inflammation), RASH (rash), VACCINATION SITE PRURITUS (itchiness at site of injection) and PYREXIA (fever at site of injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001R21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Glaucoma since an unknown date. Concurrent medical conditions included Blood pressure high. Concomitant products included HYDROCHLOROTHIAZID for Blood pressure high, ATORVASTATIN for Cholesterol, DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (COSOPT) and BIMATOPROST (LUMIGAN) for Glaucoma.   On 17-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 1 dosage form. On 17-Mar-2021, the patient experienced ADMINISTRATION SITE INFLAMMATION (red inflammation), RASH (rash), VACCINATION SITE PRURITUS (itchiness at site of injection) and PYREXIA (fever at site of injection). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, ADMINISTRATION SITE INFLAMMATION (red inflammation), RASH (rash), VACCINATION SITE PRURITUS (itchiness at site of injection) and PYREXIA (fever at site of injection) had resolved.            Patient used Ice for treatment.   This case was linked to MOD-2021-015718 (Patient Link).
Patient called 4/7 to advise us of an outpatient treatment for a blood clot on 4/4/21. In hindsight, he is questioning whether there is an association between his COVID vaccine series and the clot. He recieved his 1st dose (reported above) on 3/13/21. Symptoms (gradually progressive redness, irritation, swelling) began approximately 3/28/21, but were not recognized as a blood clot at the time. He received his second dose on 4/3/21 (Lot EW0150) in the right deltoid muscle. He reported to the ED for treatment on 4/4/21 with continued worsening of symptoms. So far, his treatment is going well with no lasting deficits and continuing followup treatment.
Within 1 1/2 to 2 mins after receiving vaccine pt states starting having an anaphylaxis reaction. Immediately transported to the emergency department. Pt had audible wheezes and stridor noted.  Patient was given  EPI pen her rt outer thigh. IV started. Pt started having relief within 30 seconds. Wheezing and stridor was decreasing. Pt was also started on a racemic epi neb. Pt placed on monitor and oxygen monitor. One hour later the symptoms of feeling "throat was swelling off" returned and EPI 3 mg given and another racemic treatment given. Treated with solumederol, Benadryl and Pepcid. Patient was admitted to the hospital where she remained overnight with no additional symptoms.She was released next day.
Repeated vomiting over a five or six-hour period, dizziness, aches, feeling unwell.  The vomiting stopped by 7:00 AM Saturday, 19 Mar. 2021, but I felt quite sick for a few days.  I don't yet feel my normal self.
Facial Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Facial Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Facial Rash). At the time of the report, RASH (Facial Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 20-OCT-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic (by an unspecified healthcare professional) for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient was diagnosed with shingles and developed difficulties with breathing, including shortness of breath.  Thereafter, the patient presented to a hospital cardiology clinic and was diagnosed as suffering from nonischemic cardiomyopathy.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The event of Nonischemic cardiomyopathy was determined to be medically significant. Additional information has been requested.
8NOV96 devel fever (did not take temp), felt woozy arm pain @ site of inj;all resolved in 2 days;also devel bilat rash in armpits, rt armpit also swollen & red, lt rash only;lateral pain in armpits R>L;
pt returned to the pharmacy after having immunizations on sunday, she showed her arm it was red and swollen at the lower end above the elbow below the injection site nearer the lateral arm and toward the elbow. She states the pharmacist administered bothinjections at the same site in the same inject safe barrier. I told her I would report to VAERS as she has not had a reaction to a vaccination previously, i suggested benadryl if she fears allergic reaction. i checked her hx pt got prevnar 13 on 10/7/2018 pneumaovax delivered 9/30. 1 week early . pt rash went down after benadryl administration 10/1/2019
After vaccine was administered, it was later discovered that the medication had been out of the deep freezer for longer than the recommended 70 days, even though it was not past it's expiration date. Pzifer ultimately determined that it should be considered not a valid dose since it was out of the deep freezer for longer than the recommended period of time.
12/17/2020  VERY ORGANIZED. AFTERNOON/EVENING SORE ARM.  12/18/2020  WORKING IN ER WEARING M95 MASK AND MASK OVER PER EMPLOYER, TO WEAR WHOLE SHIFT. 9:30 NOTICED A 'FLOATER' IN RIGHT EYE, SHAPE OF A CLOUD., 10-12 WAS QUITE LARGE.  11AM NOTICED BLIND AREA IN EYE, DECIDED TO NOTIFY OPTOMETRY. EXAMINED BY DR. HEMORRAGE IN RIGHT EYE, COTTON WOOL SPOTS IN BOTH EYES. F/UP IN 1 MONTH WITH OPTOMETRY.  FLU SHOT 10/2020
Lymphedema; Arm began to swell/6 weeks later arm swelling was noticed/whole left arm was 1 inch thicker than right arm and hand/SWELLING MAY HAVE BEEN THERE BUT NOT NOTICED BY ME/SWELLING IS NOT PAINFUL/swelling remains 1 inch larger than right arm; This spontaneous case was reported by a physician and describes the occurrence of LYMPHOEDEMA (Lymphedema) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Renal insufficiency and Artificial cardiac pacemaker user.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced LYMPHOEDEMA (Lymphedema) with PERIPHERAL SWELLING (Arm began to swell/6 weeks later arm swelling was noticed/whole left arm was 1 inch thicker than right arm and hand/SWELLING MAY HAVE BEEN THERE BUT NOT NOTICED BY ME/SWELLING IS NOT PAINFUL/swelling remains 1 inch larger than right arm). At the time of the report, LYMPHOEDEMA (Lymphedema) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative negative (Negative) Negative. On an unknown date, Ultrasound Doppler: negative negative (Negative) Arterial doppler study (Negative) and negative negative (Negative) Negative. On an unknown date, X-ray: negative negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient consulted pacemaker cardiologist and he said that he had occasionally seen arm swelling after insertion of pacemaker, though usually shortly after insertion.  Patient visited lymphedema clinic in MAY 2021 and have been managing lymphedema since. No concomitant medication details were reported. No treatment medication details was reported   This case was linked to MOD-2021-086256 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up received on 02JUN-2021.No new information added. On 04-Jun-2021: Follow up received on 04-JUN-2021.patient details and lad data updated. new events added.
Chills,; Cold sweat; Body aches; Headache; Injection site soreness; Dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 14:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control pill (MANUFACTURE UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and pantoprazole (MANUFACTURER UNKNOWN); all taken for unknown indication, from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 05Feb2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Feb2021 at 05:00 the patient experienced chills, cold sweat, body aches, headache, injection site soreness, dizziness. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with paracetamol (ACETAMINOPHEN) at home. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, cold sweat, body aches, headache, injection site soreness, dizziness was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Common Variable Immunodeficiency" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 05Sep2022 to 10Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Wheal 3x5 cm at injection site at 48 hours. No resp. distress. Rx with antihistamine.
Feeling a little sluggish; fever; Very nauseous; Loss of balance; overall pain; Could not sleep; No appetite; Full blown flu symptoms all night; Injection site pain; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (overall pain), INSOMNIA (Could not sleep), DECREASED APPETITE (No appetite), BALANCE DISORDER (Loss of balance) and SLUGGISHNESS (Feeling a little sluggish) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (overall pain), INSOMNIA (Could not sleep), DECREASED APPETITE (No appetite), INFLUENZA LIKE ILLNESS (Full blown flu symptoms all night), VACCINATION SITE PAIN (Injection site pain) and MYALGIA (muscle aches). On 25-Feb-2021, the patient experienced BALANCE DISORDER (Loss of balance), PYREXIA (fever) and NAUSEA (Very nauseous). On 26-Feb-2021, the patient experienced SLUGGISHNESS (Feeling a little sluggish). At the time of the report, PAIN (overall pain), INSOMNIA (Could not sleep), DECREASED APPETITE (No appetite), BALANCE DISORDER (Loss of balance), SLUGGISHNESS (Feeling a little sluggish), INFLUENZA LIKE ILLNESS (Full blown flu symptoms all night), VACCINATION SITE PAIN (Injection site pain), MYALGIA (muscle aches), PYREXIA (fever) and NAUSEA (Very nauseous) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7 (High) high.         Concomitant medications were not reported. Treatment information was not reported.
Dose administered  from a vial that was more than 30 days on the fridge; vial that spent more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered  from a vial that was more than 30 days on the fridge) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered  from a vial that was more than 30 days on the fridge). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered  from a vial that was more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Facility administered by error a dose from a vial that spent more than 30 days on the fridge(since 19Aug2021). No concomitant medication information were provided. No treatment medications were reported.   This case was linked to MOD-2021-326226, MOD-2021-326432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow-up received contains- Patient demographic- ethnicity, contains vaccination facility information, Updated dose number.
PATIENT RECEIVED PNEUMOVAX 23 IN LEFT ARM, PT STATED 2 HOURS AFTER RECEIVING IMZ HIS ARM SWELLED AND WAS HOT TO TOUCH.  HE SAID HE TOOK BENADRYL AND IBUPROFEN. HE WENT TO URGENT CARE ON 10/10/19
Dizziness/nausea (felt like might pass out or vomit), felt like heart was pounding although Apple Watch did not detect significantly elevated heart rate, hot flash/broke out into a sweat. Symptoms began a few minutes after injection and lasted about 10 minutes. No medical treatment was received or required.
Fever up to 103 three days. Redness left arm 7" x 4"  soreness upper arm and under arm
Achy all over, slight temp no higher than 98.7 and moderate headache.
PT received 0.5 cc of anthrax vaccine in left deltoid SQ, at 12 p.m. At 5:30 p.m. PT noticed his face, back, and chest had large red patches.
5/14/10 - Localized pain, swelling, fever at administration site. 5/15/10 - Increased swelling/pain, itchy, urticaria at site (L) shoulder pain - took TYLENOL - no help. 5/17/10 - Sx relieved.
Positive COVID test; Positive COVID test; Is pregnant: Yes Gestational period: 20; This is a spontaneous report from a contactable consumer. A 31-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration in Aug2021 at single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration on 28Aug2021 at single dose for COVID-19 immunisation. The patient was pregnant at the time of vaccination (gestational period: 20 weeks). The patient had no known allergies. Relevant medical history was none. Concomitant medications were not reported. The patient had no COVID prior vaccination but was tested post vaccination. On 04Nov2021 the patient started having symptoms of congestion, sore throat, cough, loss of taste resulting in doctor or other healthcare professional office/clinic visit. The patient had positive nasal swab on 05Nov2021. Vaccination failure/COVID-19 was resolving, outcome for exposure during pregnancy was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
HARD RED AREA 24 HRS AFTER VACCINATION MEASURED 70MM LATERALLY. TREATMENT WARM COMPRESS AND TYLENOL.
Clinician prepared vial with 1.3ml Normal Saline diluent rather than 1.8ml Normal Saline. Pt reported having heel pain a few days st vaccination. Lasted approx 2 days & resolved on it' own.  Afer 5-6 days he began to experience headache, neck/jaw & temple pain. Took Ibuprofen PRN for 1 week with little effect. Symptoms lasted approx 1.5 weeks. Stated on 1/31/21 he felt better and refused MD appointment
I got really sick last time; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got really sick last time".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.