chrisvoncsefalvay/vaers-outcomes huggingface dataset:
join pain; bones were hurting; couldn't move; This is a spontaneous report from a contactable consumer (Patient) in response to Non-Health Care Professional letter sent in cross-reference case.  A 32-year-old unspecified gender patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN6208) via intramuscularly, administered in left arm on 17Mar2021 at 17:00 as dose 2, single for COVID-19 immunization. The patient medical history included anxiety. The concomitant medication included sertraline (MANUFACTURER UNKNOWN) for anxiety from Mar2020 to Feb2021. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198; Expiration date: 30Jun2021), via intramuscularly, administered in left arm on 24Feb2021 as a dose 1, single for COVID-19 immunization and experienced cough, mild rash on left cheek, body ache, chills and sore throat, dizzy. On an unspecified date, the patient experienced join pain, bones were hurting and couldn't move.  The patient stated that after the second dose joint pain and bones were hurting to the point and couldn't move. No relevant tests conducted. The outcome for all the reported events was unknown.  No follow-up attempts are possible. No further information is expected.
Client's mother reports that muscles went "wack".  States started with (R) shoulder, then (L) shoulder to neck and then to arms and legs.  Client felt like was paralyzed; couldn't move .  Muscle spasms, shaking all over. Client went to ER and at time of visit had a temperature of 103; client given Motrin and temperature dropped to 99.9.  Mother reports blood work done was "OK".  Mother states was told that this was an inflammatory syndrome from vaccine.
Hives and heartburn. The first few days were most severe. Taking prednisone 20mg eliminated symptoms until stopped taking after 5 days. Heartburn and hives returned. Heartburn went away in a few days thereafter. Hives turned into dermatographia and itchiness, which has lasted since. Antihistamines reduce itchiness.
Sore arm after shot. Very sweaty while sleeping throughout the night. The following day woke to arm being more sore. Started to feel nausea and tired. Around 10:30am the day after shot I begin feeling waves of accelerated heart rate, chills, hot flashes, nausea. Eventually went to the ER where I was treated for multiple waves of a panic attack. Given ativin.
Mother called & stated right after pt received vaccine he c/o gen. malaise, temp increased, chills, dizziness & SOB that night.
Itchy rash just near injection site on left arm 6 days after second dose; Itchy rash just near injection site on left arm 6 days after second dose; This is a spontaneous report from a non-contactable other hcp (Patient). A 40-year-old non pregnant female patient received of second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 29Jan2021 (age at vaccination: 40-Year-old) as single dose for covid-19 immunization. Medical history included hypertension, hashimotos thyroiditis. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported, levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported, bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported, curcuma longa (TURMERIC [CURCUMA LONGA]) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08-JAN-2021 for covid-19 immunization. No known allergies. No Covid prior to vaccination. On 04Feb2021 at 16:00 The patient experienced itchy rash just near injection site on left arm 6 days after second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome for the event was not resolved.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Approximately three hours following vaccination c/o itching on neck, cheeks and chest areas.  Also reports accompanied by red,raised rash.  Symptoms progressively improved and subsided after approximately five days.
Arm was very sore the evening of injection and lasted two days. Then redness appeared and continued to increase. Area is very warm to touch and the size of an orange.
With the second one, she just had her arm get red and inflamed; With the second one, she just had her arm get red and inflamed; difficulty breathing; light headed; rope around my neck; Dizzy; This is a spontaneous report from a contactable consumer. This 61-year-old female consumer(patient) reported that: A 61-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular, administered in left arm on 30Jan2021 (at the age of 61-years-old) as DOSE 2, SINGLE for covid-19 immunization. Vaccination facility type: Nursing home/Senior living facility. Medical history included allergic reaction from an unknown date and unknown if ongoing. Concomitant medication(s) included methylprednisolone (MEDROL) taken for hypersensitivity from 19Oct2021 to 25Oct2021; cortisone (CORTISONE) taken for allergic reaction from 18Oct2021 to 18Oct2021; methylprednisolone acetate (MEDROL [METHYLPREDNISOLONE ACETATE]) taken for allergic reaction from 27Oct2021 to 02Nov2021 and amoxicillin, clavulanate potassium (AUGMENTIN [AMOXICILLIN; CLAVULANATE POTASSIUM]) taken for allergic reaction from 27Oct2021 to 02Nov2021. Prior vaccination, the patient had not received any other vaccine within four weeks. The patient had previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EK5730), via intramuscular, administered in right arm on 09Jan2021 (at the age of 61-years-old) as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, the patient experienced with the second one, she just had her arm get red and inflamed, difficulty breathing, light-headed, rope around my neck and dizzy. It was reported that, 1st vaccine fine 2nd vaccine arm red swollen booster. The patient had difficulty breathing, light-headed and dizzy. It felt like there was a rope around her neck. Went to family Doctor. Dr. said it was a severe allergic reaction. He gave a shot of cortisone a prescription for Medrol 4mg (methyl prednisone) went back to Dr. on 27Oct2021 because symptoms were better but not gone. He prescribed another Medrol pack and Augmentin 875 mg. Did a chest x ray which was good. On 27Oct2021, the patient underwent lab tests and procedures which included X-ray result was good. The patient required to visit Physician office for the adverse events. The patient had received treatment for the adverse events. The outcome of events was recovering at the time of this report.  Follow-up attempts are completed. No further information is expected
Significant dizziness, stumbling, lightheaded, unsteady.   Booster - States that ever since receiving the COVID booster shot on Friday, when he takes his daily medications that include meds for HTN, patient becomes dizzy and stumbles when walking but has not fallen. States that it is a lightheaded feeling, not a spinning/tilting. Is drinking plenty of water per patient and urinating often.  Got the covid 3rd dose on Friday at 1 and now everyday at 9am when he takes his meds he starts getting dizzy and can't walk straight, sick to stomach, nausea. Hasn't taken meds yet today and is okay so far.  Blood pressures were normal on checks.
Pfizer-BioNTech COVID-19 Vaccine EUA  Symptoms included mild headache, chills, mild muscle aches, loss of appetite. Lasted approximately 24 hours.  Note: I contracted Covid in July of last year and fully recovered.
Narrative:  Unknown if patient passing away was due to COVID vaccine however, it is being reported as a Vaccine Adverse Drug Reaction as the patient passed away within 42 days of receiving the vaccination.
Information has been received from a registered nurse concerning an 8 year old white female who on 17APR1996 was vaccinated with a dose of varicella virus vaccine live. It was noted that the vaccination was given by another health care provider. There was no known illness at the time of vaccination. The reporter indicated that on 28NOV2003 the patient presented at her practice with a mild case of chickenpox. A prescription drug was not required. A product quality complaint was not involved. Follow up information was received from a registered nurse which indicated that on 28NOV2003 at 1:00 pm. the patient  presented with a varicella rash at the office seven and a half years after receiving the vaccine. The patient subsequently recovered. No further information is expected.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not Provided). The reporter is the patient. A 14 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 01Nov2021 (Batch/Lot number: unknown) to 10Jan2022 at 40 mg (unknown (40 mg,1 in 2 wk.)) for juvenile idiopathic arthritis. Relevant medical history included: "Migraine", start date: 2019 (unspecified if ongoing); "Depression", start date: 2020 (unspecified if ongoing); "Juvenile Idiopathic Arthritis" (unspecified if ongoing); "Gastritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Attention Deficit" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE (ongoing); NEURONTIN (ongoing); FOLIC ACID (ongoing). Vaccination history included: Bnt162b2 (1st dose, Route: Intramuscular), administration date: 21Jun2021, for COVID-19 immunization; Bnt162b2 (2nd dose, Route: Intramuscular), administration date: 14Jul2021, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (hospitalization) with onset 14Feb2022, outcome "not recovered", described as "Feeling dazed"; VACCINATION COMPLICATION (hospitalization) with onset 12Feb2022, outcome "recovered" (Feb2022), described as "Vaccination adverse reaction"; BLINDNESS (medically significant) with onset 14Feb2022, outcome "recovered" (14Feb2022), described as "Vision loss". The patient was hospitalized for feeling abnormal, vaccination complication (start date: 15Feb2022). The patient underwent the following laboratory tests and procedures: magnetic resonance imaging head: (17Feb2022) unknown result. The action taken for adalimumab was dosage permanently withdrawn on 10Jan2022.Clinical information: The reporter's causality for the event(s) of dazed and vision loss with Humira 40mg/0.4ml (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of reaction to Covid-19 vaccine was not provided. Regulatory Authority opinion is that there is no reasonable possibility that the events of dazed, vision loss and reaction to Covid-19 vaccine are related to Humira 40mg/0.4ml (adalimumab). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on limited information in the case , a possible causal association between All the reported events Feeling abnormal, Vaccination complication, Blindness,   and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient received expired vaccine. DH and Pfizer recommend revaccination. Patient was contacted to schedule an appointment. Will schedule soon.
soreness in arm Narrative: Patient reports soreness in arm after vaccination. Symptom is minimal and he is still experiencing symptom.
Hives all over face and all over both sides of her neck, up to her hairline and also at her jawline; It resembles acne; Red and raised bumps, not itchy; Red and raised bumps, not itchy; rash all over face and all over both sides of her neck, up to her hairline and also at her jawline/ rash has progressively gotten worse; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives all over face and all over both sides of her neck, up to her hairline and also at her jawline), ACNE (It resembles acne), SWELLING (Red and raised bumps, not itchy), ERYTHEMA (Red and raised bumps, not itchy) and RASH (rash all over face and all over both sides of her neck, up to her hairline and also at her jawline/ rash has progressively gotten worse) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LO LOESTRIN FE) for Birth control.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced URTICARIA (Hives all over face and all over both sides of her neck, up to her hairline and also at her jawline), ACNE (It resembles acne), SWELLING (Red and raised bumps, not itchy), ERYTHEMA (Red and raised bumps, not itchy) and RASH (rash all over face and all over both sides of her neck, up to her hairline and also at her jawline/ rash has progressively gotten worse). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over face and all over both sides of her neck, up to her hairline and also at her jawline), ACNE (It resembles acne), SWELLING (Red and raised bumps, not itchy), ERYTHEMA (Red and raised bumps, not itchy) and RASH (rash all over face and all over both sides of her neck, up to her hairline and also at her jawline/ rash has progressively gotten worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
UNDERDOSED AND RECEIVED 0.3ML OF VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2132D21A, expiry: UNKNOWN) dose was not reported, administered on 03-DEC-2021 for prophylactic vaccination (Dose series number : 1). No concomitant medications were reported. On 03-DEC-2021, the patient experienced underdosed and received 0.3ml of vaccine. On 03-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the underdosed and received 0.3ml of vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211209986.
patient didn't receive the 2nd dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient didn't receive the 2nd dose of the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient didn't receive the 2nd dose of the Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient didn't receive the 2nd dose of the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received PPSV23 and reported feeling flush. The patient was instructed to sit in the IMZ booth so that we could monitor her for any further reaction. After sitting she reported feeling better immediately. We had her remain seated for an additional 20 minutes, she then left to continue her shopping in the store. She said she felt fine when she left and would return if any issues arose.
Within minutes of vaccines administered, while child crying, bilateral lower extremities became flushed and swollen. Confluent redness from thighs distally. No hives or rash elsewhere, no associate wheezing. Benadryl .3ml given with instantaneous resolution.
9/9/16 3:00 pm, 1 hour after injection swollen, red painful, warm, 3cm. Txt today with steroids , antihistamine.
patient reported being pale, sweaty, blurry vision, and ringing in the ears 5-10 minutes after receiving vaccine.  Patient checked in to ER and was treated, monitored, and onserved for an hour and half without any futher adverse reactions noted
Patient passed out in the chair within seconds of receiving the first dose of the Pfizer covid vaccine. I steadied him in the chair until he came back to, approx 20-30 seconds. When he awoke he said he felt nauseous, hot and sweaty. I provided him with a water and had him stay seated until he felt he could stand up, approx 10 minutes. He then left with his father, who was with him the entire time.
This is a spontaneous report from a contactable physician. A 69-years-old female patient was allergic to pneumococcal vaccines, cefazolin, DEMEROL, erythromycin, indomethacin, lidocaine, CIPRO XR, CIPRO, DARVON, INDOCIN, PROCAINE, moxifloxacin, NITROFURANTOIN MONO/MAC, PROPOXYPHENE and procaine. Relevant medical history included sulfonamide allergy and adhesive tape allergy. The patient's concomitant medications were not reported. The action taken with all suspect drugs in response to the event and the outcome of the event were unknown. Follow-up (24Jan2017): Follow-up attempts are completed. No further information is expected. Follow-up (16Jan2019): This is a follow-up report combining information from duplicate reports 2018388022, 2018529712 and 2016580139. The current and all subsequent follow-up information will be reported under manufacturer report number 2016580139. New information from a contactable consumer and a contactable nurse includes: medical history and suspect drugs. The information on the batch number has been requested. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein), cefazolin, erythromycin, indomethacin and lidocaine in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein), cefazolin, erythromycin, indomethacin and lidocaine has submitted the same report to the regulatory authorities.
Information has been received from a physician concerning an 18 year old female patient who on 22-JAN-2009 was vaccinated with her first dose of GARDASIL. On 09-APR-2009 the patient was vaccinated with her second dose of GARDASIL. The patient developed a headache, vomiting and achiness after receiving her second dose of vaccine. It was also reported that the patient had a similar response when she received her first dose of vaccine. The patient had sought unspecified medical attention. The symptoms following the second dose resolved "after a couple of days" in April 2009. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (dose, lot #, expiration date and route of administration were not reported). There were no adverse symptoms reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there was no consent for further contact.
Patient called and stated she had extreme pain in the arm that extends down to the elbow since receiving her vaccine on Sunday. She has tingling in the fingers and felt the vaccine was very high on the arm. Bump/lump has appeared as well in the armpit region of the patient. Pain started a few hours after injection of the vaccine.
12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed headache, 3pm developed nausea, vomiting and dizziness, flushing of skin. Rapid Response called at 3:52pm and patient sent to Emergency Room at 4pm.  VS on arrival were BP 144/105, HR 146, RR 22, T 97.9, O2 sat on Room air 98%.  ED treatment included IV of 0.9NS (1L), EKG, IV Zofran 4mg, IV Benadryl 25 mg, IV Ativan 0.5mg, IV Compazine 10mg. Also had CT head.
Received expired vaccine, vaccine expired on 4-17-22, Moderna contacted,  and this was the report "Analysis of the vials associated with your storage excursion is complete. The vaccine administered on April 19, 20, 21, 2022 from lot number 016J21-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
started to wheeze while sitting and watching TV; then kept getting worse by next day and in evening could not breathe, had to use inhalers to breathe, kept getting worse, went to DR got prednisone tx; got worse following week, more breathing problems, coughing, sore throat, drainage, allergies activated...
Had varicella vaccine in 1999. Seen on 5/16/05 in our office and diagnosed with varicella by doctor. Exposed to chicken pox at school 3 weeks prior to visit. Had 25 lesions on trunk, arms, some with small central vesicle, a few crusted. No fever.
Sore arm.  About 3 hours after getting the shot, I started getting aches, feeling cold, and tired.  The next morning my joints ached and I had a sore throat.  I took a couple of Ibuprofen (200 mg each) and about an hour later, my aches started going away.  By 8 pm the next day, I didn't have many side effects.
This spontaneous report was received from a nurse refers to a 18 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored VARIVAX Lot # H014074 (dose, route and frequency were not reported). The nurse reported that on 24-OCT-2013, VARIVAX was stored for -13.9 C for 8 hours.On 29-OCT-2013, the VARIVAX was stored for -12.8 C for 4 hours. On 14-NOV-2013, the VARIVAX was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the VARIVAX was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the VARIVAX was stored for -13.8 C for a total of 5 hours. Since the overall average for VARIVAX was below -15 C, these cumulative excursions of -11.4 C for 20 hours is supported. No adverse event has been reported. No further information was provided. This case is linked to the case 1405USA015833, 1405USA015834, 1405USA015835, 1405USA015836, 1405USA015838, 1405USA015839, 1405USA015840, 1405USA015841, 1405USA015842 and 1405USA008798 (same reporter link). Additional information has been requested.
Pt. described having tingling, muscle twitching, in (R) side of face, trouble closing (R) eye, blurred vision in (R) eye and tingling on his tongue.