chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She mentioned that her son is having a high fever (102degreesF) after the 2nd dose.; This is a spontaneous report received from contactable consumer (parent) from Pfizer sponsored program. A male patient had received the second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, lot number and expiry date were not reported) via an unspecified route of administration, on 23Apr2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had previously received first dose of vaccine on 02Apr2021. Caller reported that her son who already received both first and second dose of the Pfizer Covid-19 vaccine respectively. On an unspecified date in Apr2021 she mentioned that her son was having a high fever (102degrees F) after the second dose. She wanted to know the threshold of the body temperature for this type of adverse event. The clinical outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Information has been received regarding a case in litigation concerning a female patient who was vaccinated with a first, second and third dose of hepatitis B vaccine recombinant on 23 OCT 1992, 29 DEC 1992, and 11 JUN 1993. Concomitant therapy included a first and second dose of MMR vaccine on 30 DEC 1993 and 26 SEPT 1997; a first, second and third and fourth dose of HIB conjugate vaccine on 23 OCT 1992, 29 DEC 1992, 06 MAR 1993 and 30 DEC 1993; a first, second, third, fourth and fifth dose of poliovirus vaccine on 23 OCT 1992, 29 DEC 1992, 05 MAR 1993, 30 DEC 1993 and 26 SEPT 1997; a first, second, third, fourth and fifth dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid on 23 OCT 1992, 29 DEC 1992, 05 MAR 1993, 30 DEC 1993, and 26 SEPT 1997. It is alleged that these injections contained toxic mercury in the form of thimerosal and were given to the patient between 3 months of age and two years of age. It is alleged that the patient has been diagnosed with neurological injuries, including disintegrative (or regressive, late onset, degenerative) autism. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested. MMR II has ben changed to concomitant therapy from secondary suspect therapy.
High fever, chills, night sweats, HA, pruritic rash on neck, upper shoulders, spreading down chest, back, arms & thighs.
Pfizer on 2/28 and 3/21. Positive on 9/8
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Concurrent conditions and medical history were not provided. On 01-AUG-2015, the patient was vaccinated with an unspecified improperly stored dose of GARDASIL, injection, lot # K006124 and expiration date 02-FEB-2017 (route of administration and anatomical location were not reported). There was not concomitant medication reported. No adverse effect reported. This is one of three cases from the same reporter. Additional information has been requested.
Vomiting /headache/numbNess and tingling in all four extremities/ hyponatremia
Swollen lymph nodes on left side; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes on left side) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on left side). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes on left side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other Medications: back pain medicine. No treatment information was provided.   This case was linked to MOD-2021-034245 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Reporter's email address information added; Sender's Comments:  MOD-2021-034245:
Left upper arm pain, radiating to under arm, pain with raising her arm Pain all over body in muscles and joints, though had pain in same joints prior to Rheumatology visit where immunizations were given.  Headache, migraine, had been having these for 10 days prior but worse the night of the vaccines
Intense nausea, fatigue, headache, aches and pains, and diarrhea from about 4 am  on May 4th to about noon on May 5th.
Extream fatigue/inability to stay awake, nausea/throwing up even trinng to drink water, fever 104+ then dropping to 95 degrees an back up, extreme hot and cold flashes(sweating while having goose bumps), migraines an knub feeling doing anything about past out, above lasted 36 hours, afterwards still extreme fatigue even walking up stairs loose energy/breath like im going to pass out, numb feeling, loss of appetite etc which has continued to today.
In June 2021, I experienced changes in my menstrual cycle and increase in migraines that I had previously suffered. My menstrual cycle was delayed by 45 days and then symptoms changed completely when no other variable had changed in my life. Due to the increase in migraines, I had to reach out for treatment to address these changes.
Patient only received the adjuvant; Patient only received the adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-Jan-2023 Reporter's Comment: The reporter stated the patient float pool MA did not reconstitute the vaccine correctly and the patient only received the adjuvant suspension.  The reporter stated GlaxoSmithKline had a program to replace Shingrix due to a medication error. The reporter consented to follow up. Additional supportive Information: The patient only received the adjuvant suspension, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Left leg feels crampy; Fingers feel a little bit numb; Pain in left arm; Left arm to feel tired / Fingers feel tired; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Left leg feels crampy), HYPOAESTHESIA (Fingers feel a little bit numb), PAIN IN EXTREMITY (Pain in left arm) and FATIGUE (Left arm to feel tired / Fingers feel tired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), ROSUVASTATIN, LOSARTAN, METOPROLOL, OMEPRAZOLE and TRAZODONE for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Left leg feels crampy), HYPOAESTHESIA (Fingers feel a little bit numb), PAIN IN EXTREMITY (Pain in left arm) and FATIGUE (Left arm to feel tired / Fingers feel tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Left leg feels crampy), HYPOAESTHESIA (Fingers feel a little bit numb), PAIN IN EXTREMITY (Pain in left arm) and FATIGUE (Left arm to feel tired / Fingers feel tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a female healthcare worker of unknown age, refers to herself. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patient was vaccinated with M-M-R II, as a child, (dose, frequency and route of administration not provided). Healthcare worker reported her titers showed low antibodies for MMR. The outcome of the event was not resolved. Causality assessment was not provided. No product quality complaint (PQC) was involved. No additional information was reported. Additional information is not expected, as the patient declined to answer questions.
ACUTE NON ST ELEVATION MI 1/1/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Moderna Covid-19 Vaccine EUA :Injection site reaction. Started with mild itching the same afternoon. I woke up at 1 am this morning to find the area around the injection site, 6 inches in diameter, red, hot and swollen, area firm to touch. Benadryl had no effect. Will be taking 5 mg prednisone p.o., and also icing down next.
nausea, sweats, weakness and feeling "out of it" for approx. 1 hour following
Knot in arm, very sore arm, severe headache, fatigue, chills, fever, nauseous  all on first night after shot.  All gone by next morning with the exception of the headache, which is not as severe now.
Pt recv vax on 1/10/98; subsequently pt exp a rash.  On 1/12/98 pt exp injection site rxn of pain &swelling.
experienced Covid-19 like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced Covid-19 like symptoms) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse drug effect (no medical history found).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (experienced Covid-19 like symptoms). At the time of the report, VACCINATION COMPLICATION (experienced Covid-19 like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided
Pt c/o low grade temp, swelling of glands in neck & under arm & fatigue; sx appeared on 5APR92 most severely though pt already c/o fatigue on the eve of 4APR92 & the swollen lymph glands;
Patient experienced visual disturbances, and turned pale, was dizzy and sweating profusely. This lasted about 5-7 mins or maybe less. Called 911 cause it seemed like the patient had momentarily passed out.
I had sudden chest pains and could not breath felt as if i was having a heart attack.   It lasted about 1 hour and 50 minutes and then it gradually went away.
17 y/o male presented to ED (6/21) after experiencing "chest pain" with exercise (playing basketball).   This occurred 5 days after receiving his 3rd dose of his Pfizer vaccine (6/16). He received a 3rd dose at the recommendation of his PMD after being informed that his 2nd dose was expired at the time when he had received it on 6/7 Following this vaccination he "slept for 18-20 hours" and had subjective fevers which self-resolved after 24 hours. He developed dyspnea, acute onset of R-sided/mid chest pain and the sensation that his heart was racing. He presented to the ED and was admitted to the PICU for monitoring. Labs revealed elevated troponin (240 ng/L) which downtrended to 89 ng/L by 6/23. Concern for myocarditis vs pericarditis in setting of recent Pfizer COVID-19 vaccine; started on ibuprofen 400mg PO q6h.
shaking; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shaking). At the time of the report, TREMOR (shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment reported.   This case was linked to MOD21-151493 (Patient Link).
Unusual and extremely heavy Menstrual cycle with many clots.  The menstrual cycle was heaviest and has had most clots that I have ever experienced.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, an unspecified number of patients were administered improperly stored doses of PROQUAD (Merck) injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Information has been received from a healthcare professional via Pfizer (case # 2016382414) referring to a female patient of unknown age. The patient's medical history included fibromyalgia, chronic fatigue/malaise, mild hypertension, anxiety, asthma (mild), high cholesterol, migraines/stress headaches, lower lumbar spine (LS)  pain, sleep apnea, hysterectomy, biopsy breast, cervical spinal fusion, carpal tunnel release, radial tunnel release, lumbar vertebral fracture L1, ischemic colitis, colonoscopy, spinal cord stimulator (SCS) implant, implant removed, allergy to PNEUMOVAX 23 (MARRS# 1609USA002894). The patient's historical drug included cortisone. On unknown date in December 2012 the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date the patient had reactions to the vaccine of ZOSTAVAX. The outcome was unknown. The causality was related. This is one of several reports received from the same reporter concerning the same patient. Additional information has been requested. Sender's Comments: US-009507513-1609USA000051: US-009507513-1609USA002894: MERCK 1609USA002895:Mfr number.
Onset of diarrhea after injection. (with 24 hr) Still having same discomfort so question if really related
Pt recv vax on 10/9/98; on same day pt exp body aches,joint pain,chills, sweats,nausea; tx=Tylenol; pt imp approx 2 day
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" 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 drug ineffective, covid-19.  Clinical course: Symptoms returned and tested positive for Covid after 4 days, symptom free after 5 day paxlovid treatment.
Delayed reaction to the first shot of Moderna COVID-19 vaccine with symptoms beginning 6 days after the first dose. No visible signs of redness or rash. Symptoms include dry, itchy skin, pruritus. Patient describes a hot, burning sensation of skin similar to the feeling of bad sunburn without redness. This affects both arms, shoulders, chest and has moved to neck and face. No visible redness or rash however skin is visibly dry.  Other symptoms include paresthesia and numbness in forearms, hands and feet, general chills, horripilation and fatigue. Symptoms worsen in the evening and episodically occur 3-4 days a week, gradually worsening over a couple days.
Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA177766, 2018SA177771 and 2018SA177772. This case involves a female patient (age reported as 16-20 years) who experienced redness, swelling and lump at injection site, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that the patient did not receive any other vaccine on the date of administration. On 25-Jun-2018, the patient received a dose of ADACEL lot C5541AA, expiry date: 13-Nov-2020) via intramuscular route in the deltoid NOS. On an unknown date, the patient developed a non-serious redness, swelling and lump at injection site, following the administration of ADACEL. Relevant tests were not reported. Final diagnosis was lump at injection site and redness, swelling at injection site. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: none.
Appx 8 hours after injection site became so painful bi could not use my arm and my finger tips are tinglin, BOTH EVENTS ARE STILL OCCURRING.  I have this issue but normally only in the morning.  .  Today my stomach began having hard cramps when I woke. In general I feel like I have the old fashioned file weak, tired and s headache residing in the front of my head.
When the vaccination was given, a large portion of the liquid squirted out of the back of the syringe. Therefore we were not sure how much was actually administered to the patient. We then administered a 2nd dose in the opposite right arm. Patient waited 15 minutes before leaving,
4/10/21 awoke 0600 with severe headache, injection site sore along with entire upper arm, aching muscles in both shoulders and neck, severe dizziness, eye "fatigue" and burning, feeling of "fog head" (difficulty concentrating)
Breakthrough case of COVID 19, started 8/10/22, tested positive on home test. Moderate case. Exhaustion, fever, headache, muscle ache. Sick for about a week, tested negative on the 13th day. Headache and fatigue continue to present day, seeing personal physician for Long Covid, no treatment except OTC pain relief acetaminophen/ibuprofen for head/muscle aches.
12/01/05 24 hours post injection progressive increase rash started at site left arm over entire body nonpruritic nonbillform maculopapular ( arms, body, legs ) - resolved within few days no meds
G47.33 OBSTRUCTIVE SLEEP APNEA 11/11/2022 ACUTE FEMALE PELVIC PAIN
3 hours post vax, pt developed swelling in both legs, soreness and redness especially in left thigh. Infant cried and screamed, fell asleep for brief periods of time but essentially inconsolable, and pt also experienced decrease in appetite. No fever was noted but pt was taking Tylenol.
patient presented to emergency department on 9/15/21 with cough. patient was admitted for further management of covid-19 pneumonia and atrial fibrillation patient was diagnosed with covid-19 6 days prior to coming to the emergency department patient did receive treatment for symptoms associated with covid-19 infection. treatment included remdesivir  and examethasone patient was discharged to rehab facility on 10/13/21
Felt dizzy as soon as first injection; fast heartbeat; nervous; Muscle ache; Arm hurts; chill on chest up and down; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 07Oct2021 (Lot number: FC3184) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney replacement transplant" (unspecified if ongoing), notes: Years ago; "Known allergies: Penicillin" (unspecified if ongoing). Family history included: "heart disease" (unspecified if ongoing), notes: 2 Family members died of Heart Disease. The patient took concomitant medications. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin". The following information was reported: DIZZINESS (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "Felt dizzy as soon as first injection"; HEART RATE INCREASED (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "fast heartbeat"; NERVOUSNESS (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "nervous"; MYALGIA (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "Muscle ache"; PAIN IN EXTREMITY (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "Arm hurts"; CHILLS (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "chill on chest up and down". The events "felt dizzy as soon as first injection", "fast heartbeat", "nervous", "muscle ache", "arm hurts" and "chill on chest up and down" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, heart rate increased, nervousness, myalgia, pain in extremity, chills. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient receive other medications within 2 weeks of vaccination. Patient had bathed in rubbing alcohol.  No follow-up attempts are possible. No further information is expected.
App. 10 minutes after Hepatitis A vacc., employee developed numbness in her legs, progressing to her arms, and then tightness in her throat. Epi-Pen .3 mg, Benadryl 25 mg P.O. and 3 liters 02 per nasal cannula. 911 was called and transported to hospital. ( employee also received an intradermal PPD skin test 3 minutes prior)
Infant began with inconsolable crying when at ER found to have temperature 103.8. CXR, Lab, and UA were reported as normal by mother. Given Motrin and discharge home. Returned to another ER at 4PM with behavior changes, staring and local erythema to right thigh was noted. 4/12/12 Erythema now 10mm X35 mm on lateral thigh. Temp 98.8 and infant happy and smiling.
Narrative:  Reported unusual headache that caused patient to wake up several times throughout the night, resolved by morning.