chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, pain, inflammation that started the night of injection day. Doctor gave her antibiotic because it looked like cellulitis. Was given at back of arm instead of deltoid.
fatigue, achy, headache, swollen arn and limbs, face and throat swollen, tan skin, cough
This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated improperly stored doses of PROQUAD from lot# N002325 with expiry: 19-JUL-2018 and lot# M042502 with expiry 17-APR-2018 (dosing details not reported) for prophylaxis. Concomitant included sterile diluent (MERCK STERILE DILUENT). The vaccine stored at  9 degree Celsius to 8 degree Celsius for 38 minutes. The vaccine had no previous temperature excursion and the excursion was detected by data logger.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA003217:
Tightness in throat, throat swelling, tachycardia. Treated with epinephrine IM x 1, benadryl, famotidine, methylprednisolone,
Information has been received from a nurse referring to multiple patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not provided. On  multiple unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M010671, expiration date: 02-JUN-2018; lot # M020926, expiration date: 11-AUG-2018; dose and route were unknown) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature excursion of 35.6 Fahrenheit five times (7 hours each time). There was no previous temperature excursion. Additional information has been requested.
6/28/21 - J&J vaccine administered in right arm 6/29/21  - left calf cramp notice first thing in the morning, assume potassium issue, took supplement - no change 6/30/21 - intermittent numbness left calf, cramping still present 6/30/21 - MD Visit to walk in clinic - ultrasound - for DVT - results negative - doctor diagnosis - likely pulled muscle - ordered prescription for cyclobenzaprine (FLEXERIL) 10 mg tablet 7/1- 7/6 - cramping spread to ball of foot, hamstring, and quad, all left leg. occasional short stinging like bee, on outside of calf, numbness and pins and needles intermittently - flexeril results no benefit 7/7/21 - Visit to PA -D-Dimer test .27 (>.50 indicates blood clot) negative DVT ultrasound.  Summary -  Ultrasound of legs negative for DVT.  Leg cramps likely due to to recent vaccination.  Please call the office if there is no improvement after taking ibuprofen as instructed.
Systemic Lupus began in July 2021, stroke Nov 2021, dvt nov 2021
Initial and follow up information has been received from a physician concerning a 5 month old white with no pre-existing allergies, birth defects, or medical conditions reported. On 03-JAN-2006, at approximately 3 PM, the patient was vaccinated into the right thigh with the first dose of PedvaxHIB (Lot#65226/0655R). It was reported that the patient's mother had requested to wait and vaccinate the patient at his 5 month visit. It was reported that the patient was well at the time of vaccination and did not receive any other concomitant vaccines on the day of the vaccination with PedvaxHIB. On 03-JAN-2006, at approximately 6 or 7 PM, the patient developed "inconsolable crying" and was "not as responsive to mother when crying". It was further noted that the patient had a "thigh hard" and was "sore at injection site" (previously reported that the child developed an "unusually severe reaction" involving "high fevers", "inconsolable crying" and "red lumps at the injection site". On 10-JAN-2006, (also reported as the patient "one week later, was still not sleeping as well'). There were no signs or symptoms of illness and the patient was "still not as responsive". The patient's mother reported that the patient was "not himself" and more fussy" for 2 to 3 weeks after the vaccination. At the time of this report, the patient had recovered from the events (date unknown). It was noted that a twin brother had a similar experience following vaccination with PedvaxHIB (WAES#0601USA01930). The physician checked with parents of other children vaccinated with this lot number and they were fine. A lot check of concern has been requested. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no pen Quarantines registered that there were no open Quarantines registered against this lot/fill. Additional information has been requested.
Became light headed, pale, lost consciousness. Patient felt like he was going through a time-warp. He described twitching. This started immediately after vaccines were given. Pt rested about 5 minutes - his head was raised (pt was in an exam table). He was talking and interacting. He became pale and his head was lowered. He had generalized twitching for about 5 seconds.
Patient presented to the ED and was subsequently hospitalized for severe sepsis without septic shock within 6 weeks of receiving covid vaccination.
pt recvd vax 29aug94; LT leg was lump; no redness or discomfort; WM soaking was recommended; father called on 11oct94, reported lump to be 1/2 the size; 28oct94 limp still present( size of small egg & hard); advised to see MD;  ? abscess;
really high blood pressure; could not get up; a reaction to the vaccine at the site of injection with a rash; Nauseous; Passed out; Light Headed/dizzy; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, PRAMIPEXOLE HCL for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Light Headed/dizzy). On 28-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Light Headed/dizzy), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information was not provided  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-248557 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Both her hands are in pain; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were unknown), via an unspecified route of administration on 19Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, patient experienced both her hands are in pain. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Localized pink papule left deltoid lump beneath skin approx. 2cm x 2cm left deltoid area. Mild tenderness no redness no warmth. 4-15-19
CHEST PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chest pain was not reported. This report was non-serious.
Severe Urticaria / Hives; Dermatographia; Feels awful; Extremely itchy hives on various body parts that worsen if i scratch them and then spread; Patient back was currently covered with still healing scars from sores that looked like bug bites; Sores that looked like bug bites; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Severe Urticaria / Hives), MECHANICAL URTICARIA (Dermatographia), FEELING ABNORMAL (Feels awful), PRURITUS (Extremely itchy hives on various body parts that worsen if i scratch them and then spread) and SCAR (Patient back was currently covered with still healing scars from sores that looked like bug bites) in a  patient of an unknown age and gender 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced URTICARIA (Severe Urticaria / Hives), MECHANICAL URTICARIA (Dermatographia), FEELING ABNORMAL (Feels awful), PRURITUS (Extremely itchy hives on various body parts that worsen if i scratch them and then spread), SCAR (Patient back was currently covered with still healing scars from sores that looked like bug bites) and BLISTER (Sores that looked like bug bites). At the time of the report, URTICARIA (Severe Urticaria / Hives), MECHANICAL URTICARIA (Dermatographia), FEELING ABNORMAL (Feels awful), PRURITUS (Extremely itchy hives on various body parts that worsen if i scratch them and then spread), SCAR (Patient back was currently covered with still healing scars from sores that looked like bug bites) and BLISTER (Sores that looked like bug bites) had not resolved.            No concomitant medication were reported. Treatment included daily Antihistamines that control itching. Without antihistamines patient get extremely itchy hives on various body parts that worsen if patient scratch them and then spread. Patient has been and was still, honestly, a torturous experience. .
My lips swelled significantly about 30 hours after the shot. They had the cosmetic filler injected into them in late February and have also been tattooed with permanent makeup. They feel hot, dry, and tight and have doubled in size. I also experienced experienced extreme pain in my bones, muscles aches, exhaustion, and irritability the first 36 hours after the shot. Those symptoms have resolved but my lips are still swollen.
Fatigue, Muscle Aches, Itching on the toe areas, Redeness, Forehead
Case number PHEH2015US019222 is an initial spontaneous report from a health care professional on 29 Sep 2015. This report refers to a patient of an unknown age and gender. The patient was vaccinated with FLUCELVAX (batch number: not reported) on an unknown date. It was reported that accidentally the patient again received one more dose of FLUCELVAX (batch number: not reported) on the date before reporting. No adverse event reported following this medication error (inappropriate schedule of vaccine administered).
tc from father states pt  cried, could not console, fever, red, took to ER; MD stated local react gave meds father not sure what name of meds were RUT red, swollen, looked like wasp sting;
Patient complained of edema and redness on her left arm at the injection site. Patient given KIFLEX 500 mg, BENADRYL 75 mg and nebulizer treatment.
Fever, headache, nausea, vomiting, diarrhea, aches, chills , left arm very sore, dizzy.
10 days after I received the Moderna booster, I experienced an extreme skin reaction with very itchy hives everywhere on my body.
Within 24 hours of getting the shot, patient felt flush, fatigued, nauseous, along with diarrhea. In addition to these, patient also had pressure in both ears. 72 hours after the shot was administered, most of the side effects had subsided. The pressure in the ears continued along with a constant, loud and deep humming tone. As this report is being filled out, 12 days after the injection, patient is still complains of ear pressure, loss of hearing, and the load tone.
Body aches, not just in injection site, dizziness, nausea, fainting. Lasted 30 hours after beginning of symptoms
Dizziness, NauseaVomiting, lethargy, no appetite, slept 18 hours Narrative:
received dose reconstituted by using saline; received dose reconstituted by using saline; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number 3G33K, expiry date 10th July 2023) for prophylaxis.   On 27th May 2022, the patient received the 2nd dose of Shingrix. On 27th May 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 31-MAY-2022 Reporter's comment: The pharmacist reported that the patient had received (not completely sure if that was the date) a 2nd dose of Shingrix that was reconstituted by using normal saline. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via email. Additional Supportive Information: The patient had received a 2nd dose of Shingrix that was reconstituted by using normal saline which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
9:45am a 14 year old patient reported not feeling well, vital signs taken BP: 76/50, HR 60, then dropped to 50s, 02 sat at 98% room air. Then patient became unresponsive with that 2 minutes, still with pulse of 52, Benadryl 50mg IM given to right arm, within 2 minutes patient became responsive and with color came back to her face. Ambulance came within 6 minutes, patient became responsive and vital signs stable. Report given to the ambulance. Patient and mom and sister went in the ambulance in stable condition.
Severe bloody nose lasting from 30 to 60 minutes. Inflammation. Lymph node swelling
This case was reported by the grandmother of a consumer and described the occurrence of seizure in a 11-year-old female subject who was vaccinated with Pediarix, GlaxoSmithKline. A physician or other health care professional has not verified this report. In August 2007 the subject received unspecified dose of Pediarix (unknown). On 25 August 2007, after vaccination with Pediarix, the subject experienced her first seizure. The subject had other seizures on 28 August 2007 and 26 September 2007. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved.
This spontaneous report was received from a Licensed Practical Nurse, concerning a patient of unknown age and gender. On an unknown date, a dose of VARIVAX (Merck), 1350U, (total dose, route, lot number and expiry date were not provided) which was exposed to 6 degrees F for possibly 66 hours, was administered to an unspecified patient. Co-suspect therapy and concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
low blood pressure; pale and diaphoretic; pale and diaphoretic; Pain injection site; nausea and feeling faint; nausea and feeling faint; This is a spontaneous report from a contactable nurse and a contactable consumer. A 44-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3247, Expiration Date: 31May2021), via an unspecified route of administration on 19Jan2021 at 14:00 at 0.3 mL, single on deltoid left for covid-19 immunisation.  Medical history included panic attack.  There were no concomitant medications. Patient received the vaccine on 19Jan2021 at around 14:00 in her left deltoid. Pain at injection site started at 14:10 on day of injection, patient came to observation area with pain at injection site, nausea and feeling faint. After that, the nurse in observation area took blood pressure (BP) at 14:12 and blood pressure was 88/60 and pulse was 78 and O2 sat 88 on room air, pale and diaphoretic at this time. Treatment: patient legs elevated, offered juice and water. Patient was able to swallow. Nurse in observation placed call to 911 at this time. 14:17 BP rechecked 118/82 and pulse was 78 and Sat 98% and starting to feel better. 14:20, blood pressure was taken again 120/84 pulse 80 and O2 Sat 98%, patient was returned to upright position and stated they felt so much better, cancelled EMS (Emergency Medical Services). Patient stated at this time that she had a history of panic attacks and she felt that she worked herself thinking about the vaccine. Did call doctor in charge of clinic and checked out the patient. Checked on patient the following day and stated that she was fine and going back to work. Outcome of the events was resolved.
Sore, hot arm; nausea; some vomiting; horrible headache; fatigue; sleep tired; achy; on 03/19/2021 my heart rate was around 180
Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (Body aches) 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 CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
PATIENT WITH C/O BRUISING OF EXTREMITIES 1-2 DAYS POST 2ND COVID DOSE
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), on 01Nov2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Ectopic pregnancy", start date: 1974 (unspecified if ongoing); "Fibroid removal", start date: 1980 (unspecified if ongoing), notes: Fibroid removal; "Fibroid removal", start date: 1984 (unspecified if ongoing), notes: Fibroid removal. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Time: 02:00 PM, Anatomical site of injection: Left arm, Route of injection: Intramuscular), administration date: 17Feb2021, for COVID-19 Immunization; BNT162b2 (Dose: 02, Time: 02:30 PM, Anatomical site of injection: Left arm, Route of injection: Intramuscular), administration date: 10Mar2021, for COVID-19 Immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 2022, outcome "recovering", described as "Lower back spasm"; CONSTIPATION (non-serious), outcome "unknown". The event "lower back spasm" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle spasms. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
FACIAL FLUSHING WITH HOT FACE; BODY ACHES; hOT AND COLD FEELING OVERALL; This is a spontaneous report from a contactable nurse, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 15:45 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and allergic to tetanus. Concomitant medications included olmesartan (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication and hydrochlorothiazide (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 26Feb2021 at 14:30(at the age of 71-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 09:30, the patient experienced facial flushing with hot face, body aches, hot and cold feeling overall with no fever. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events facial flushing with hot face, body aches, cold and hot feeling were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
On 08/08/2021 injected the vaccine from the vial that was punctured at noon on 08/07/2021. Product was expired per manufacturer guidelines. Pharmacist notified patient of incident while patient was here. Patient was calm as he explained that we would need to probably repeat his first dose in several days after monitoring any side effects from today expired dose
itchy throat and puffy itchy eyes a couple of hours later,  Benadryl used, then EpiPen later as itching  got worse and lip-tingling got started,  pounding headache, bruised and very sore arm: took Motrin
1 hour after taking vaccine, noticed blood vessel in left eye burst, BP systolic 180, swelling at left arm and pain, and nausea. BP came back to normal 3rd day. Nausea lasted for 2 days. Swelling came down the night of 2nd day.
24 hour after vaccination patient experienced hot flashes and dizziness that lasted on and off for three consecutive days. On the third day patient experience bilateral lower leg cramps and muscle tightness in both calves, patient also experience the same cramps and muscles tightness lower left abdomen. Symptoms resolved after three day with slight residual tight experienced in lower left calf muscle