chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a  registered nurse, concerning a female patient who was vaccinated with the third dose of Gardasil (date unspecified). There was no concomitant medication. The patient developed "little bumps" that developed about 2 days after the vaccination, "mostly near the arm and neck." The nurse reported that bumps did not appear to be hives, but that some of the bumps "appeared to be vesicles." The nurse stated that the vesicles resolved "several days later." The patient sought unspecified medical attention. Additional information has been requested.
flu like symptoms 36+ hours after dose.  Described as sweating, chest congestion, mild fatique, body aches.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Visual Changes/Disturbances-Severe
The day after vaccine patient conplained of pain at site and developed small area of redness, which grew overnight to 7 cm diameter urticarial lesion around the site of injection.
Information has been received from a physician, that was informed by a patient, that someone else experienced temporary blindness within one or two days after receiving the second 0.5 ml dose of GARDASIL. The pt was reported to be female between 16 and 18 years old. No further information was provided. The physician was not the treating physician of this patient and does not wish to be contacted regarding this case. The reporting physician considered temporary blindness to be disabling. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Information has been received fro a physician concerning 15 children who were vaccinated PO with the first 2.0 ml dose of Rotateq after 32 weeks of age. Medical attention was not sought. It was noted that the children only received the first dose in the series. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Patient was put into Irregular Heart rhythm 3 hours post vaccine; This is a spontaneous report from a contactable other healthcare professional (HCP). A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el8982) Intramuscular on 29Jan2021 03:15 PM at single dose for covid-19 immunisation. Medical history included atrial fibrillation, prostate CA and dyslipidemia. No known allergies. No COVID prior vaccination. Concomitant medications were not reported. no other vaccine in four weeks. Patient was put into irregular heart rhythm 3 hours post vaccine on 29Jan2021 06: 15 PM, resulted in Life threatening illness (immediate risk of death from the event). Treatment included medication. No COVID tested post vaccination. Patient was recovered from the event on unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of  arrhythmia  due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient with medical history included atrial fibrillation and dyslipidemia.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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.
"vaccine arm" at exactly day 8 after injection. Over that next 24 hours it got worse a large circle about the size of a baseball around injection site. It was warm and itchy.  after 36 hours it began to fade and at the end of 48 hours it's almost visibly gone, just the itching remains.
Pt was here for 2nd Covid Moderna vaccination.  Pt received Pfizer 2nd dose instead of Moderna .  Dr.      was notified was instructed to let patient know that the CDC says that it is safe.  Called patient let her know what happened . That we do not need to revaccinate.   Pt  said she was feeling find No adverse reactions noted  other then being tired.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE SWELLING (Swelling on injection site arm) and VACCINATION SITE ERYTHEMA (Redness on injection site arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to sulfa) and Asthma.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE SWELLING (Swelling on injection site arm) and VACCINATION SITE ERYTHEMA (Redness on injection site arm). At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE SWELLING (Swelling on injection site arm) and VACCINATION SITE ERYTHEMA (Redness on injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
A male pt was vaccinated on 8/30/00 with 1 ml Rabipur for the 1st time. Simultaneously, he received a booster vaccination with Revaxis (tetanus toxoid). On 9/6/00, he received the 2nd vaccination with 1 ml Rabipur and on 9/25/00, the pt suffered from bilateral tinnitus. It was mentioned that the pt also had a vaccination against Japanese-encephalitis in the past. Preliminary assessment; No seriousness criterion given. Causality; unrelated.
I tested positive on Feb 15, 2023, I had fever, chills, nausea, stuffiness, cough, I was prescribed PAXLOVID, I took 2 doses, 2 in the morning and 2 at the night, and I was vomiting, I discontinued it. The cough lasted for several weeks, 14 days later I tested negative for Covid-19.
Excess bruising and pain at the injection site starting after receiving the injection, the patient noticed the brusing on monday after receiving the shot on saturday (roughly two days after the administration), bruising could have started earlier, but the patient didn't notice until then. The patient describes the pain and discomfort as a 3/10 on the pain scale.
This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No relevant concomitant medications were reported. Vaccine was moved from freezer to refrigerator on 12/02/22. Of the ten vials in question 43 injections were given and 7 doses were wasted. No treatment medication reported.  This case contains information for the 20th of 43 adult patients described by the reporter.
dizziness; tiredness; headaches; body pains; muscle aches and pain; chills; fever; nausea; some vomiting; rapid heart beats; breathing problems; Soreness in arm; This is a spontaneous report from a contactable consumer or other non hcp (patient himself) via medical information team and Pfizer- sponsored program  Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on 17Mar2021 16:30, as dose 1, single for COVID-19 immunization. Medical history included Seasonal asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 19Mar2021, the patient experienced tiredness, headaches, body pains, muscle aches and pain, chills, fever, nausea, some vomiting, rapid heartbeats, breathing problems, on an unspecified date in Mar2021, experienced soreness in arm and on an unspecified date, experienced dizziness. The caller went to work Thursday and Friday and there were no problems. Friday night it started going downhill. The patient underwent lab tests and procedures which included body temperature: 102 on unspecified date in Mar2021 and it came down to 98. The outcome for tiredness, body pains, chills, fever, nausea, some vomiting, rapid heartbeats, breathing problems, soreness in arm and dizziness was unknown. The outcome of events headaches, muscle aches and pain were not recovered. The outcome for fever was recovered on unspecified date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021316682 same reporter/drug/event, diff patients
teeth chattering; A spontaneous report (United States) was received from a 18 years old female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced teeth chattering.  The patient's medical history included allergies (unspecified). Concomitant medications included treatment (unspecified medication) to treat allergies.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced teeth chattering.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, teeth chattering was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
contracted chicken pox on 29MAR97 had varivax vaccine on 29MAY96;
Patient was due for Dtap #4. Instead of administering Dtap (Infanrix) a dose of Dtap + Hep B + IPV (PEDIARIX) was administered. Results in an extra dose of IPV and Hepatitis B.
Starting at 4am the morning after I received my booster vaccine I woke in a cold sweat with fever-like symptoms. The entire following day I have felt nauseous, muscle aches, abdominal pain, headaches, and feverish.
Information has been received from a medical assistant concerning a patient who in a approximately Oct 2002, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641116/1160L). Approximately 24 hours later, the patient presented to the doctor's office with a large red welt at the injection site that extended from the deltoid to the elbow. A similar adverse experience occurred in a second patient (WAES0210USA01670) and the reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the evaluation and research and was released. Aditional information has been requested.
Rash all over body x 2 days. Fever x 2 days. (99.0-100.3).  Other (cough, coryza, conjunctivitis) none listed. Meds: Adovax and Calomine lotion.
Admission Date: 3/20/2023 Discharge Date: 3/23/2023  PRESENTING PROBLEM: Sepsis Bacterial lobar pneumonia  Urinary tract infection with hematuria, site unspecified  Altered mental status, unspecified altered mental status type  Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present  COVID-19    HOSPITAL COURSE: Patient is a 68 y.o. man with DM2, HTN, hyperlipidemia, and metastatic RCC (with metastases to the bones, skin, likely lungs) receiving treatment with axitinib/nivolumab now admitted with altered mental status likely in the setting of infection.   In the ED was found to be febrile, altered mental status, hyponatremia, hyperlipidemia, AHRF and be COVID positive.  Furthermore he was found to be tachycardic tachypneic with no leukocytosis.  CXR significant for R lower lobe pneumonia.  He was started on Zosyn and vancomycin in the emergency department.   During his hospital course his infectious workup was negative for MRSA, strep, Legionella, influenza A/B and respiratory panel film array. His sepsis and altered mental status had resolved after 2 L of IV fluids.  Per his CAP, the abx was switched to ceftriaxone for targeted coverage. He was  transitioned to Augmentin prior to SAR discharge to complete 5 day course. Per patient's COVID status he remained asymptomatic and satting 100% on room air.  He was treated with remdesivir for 3 days. On his arrival to the medicine floor patient was found to have pressure injuries. Type 1 to coccyx and patient offloading of pressure was prioritized. Type 2 to urethra likely secondary to chronic foley. Photos were uploaded to media tab. Patient denied any pain to these locations.   Patient discharged in stable condition back to his SAR facility. With plan for close PCP follow up.
6PM noted shoulder of arm where MMR given was extremely swollen (site of inject an 6" area surrounding site hot to touch & painful; pt had low grade temp; APAP given;
hives on her chest, neck and back / hives spread to arm, legs and thigs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on her chest, neck and back / hives spread to arm, legs and thigs) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 022M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, METOPROLOL and HYDROCHLOROTHIAZIDE, LISINOPRIL (ZESTORETIC) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives on her chest, neck and back / hives spread to arm, legs and thigs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of UNK dosage form and METHYLPREDNISOLONE (MEDROL DOSEPAK) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on her chest, neck and back / hives spread to arm, legs and thigs) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Concomitant medications were provided
Pain at inject site; Myalgia at the injection site; This is a spontaneous report from a contactable physician (patient). This 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration in left arm on 09Jan2021 at 09:30AM as a 1ST DOSE, SINGLE for COVID-19 immunization. The patient had no medical history and family history. The patient's concomitant medications were not reported. The patient did not receive other vaccinations with 4 weeks of COVID-19 vaccine. The patient did not undergo any lab test. On 09Jan2021, the patient experienced injection site pain and myalgia for three days. The patient did not require a visit to physician or ER (emergency room). The outcome of the event was resolved on 12Jan2021. The reporter assessed the events injection site pain and myalgia as related.  Follow-up attempts are completed. No further information is expected.
broke out in an intense wave of itchiness on my skin; then broke out in a swath of hives; causes skin to become raised; skin becomes very red; skin becomes very red and irritated; Rash; slightly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (broke out in an intense wave of itchiness on my skin), URTICARIA (then broke out in a swath of hives), SWELLING (causes skin to become raised), ERYTHEMA (skin becomes very red) and SKIN IRRITATION (skin becomes very red and irritated) in a male patient of an unknown age 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 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2022, the patient experienced PRURITUS (broke out in an intense wave of itchiness on my skin). In January 2022, the patient experienced URTICARIA (then broke out in a swath of hives), SWELLING (causes skin to become raised), ERYTHEMA (skin becomes very red), SKIN IRRITATION (skin becomes very red and irritated), RASH (Rash) and MYALGIA (slightly sore arm). At the time of the report, PRURITUS (broke out in an intense wave of itchiness on my skin), URTICARIA (then broke out in a swath of hives), SWELLING (causes skin to become raised), ERYTHEMA (skin becomes very red), SKIN IRRITATION (skin becomes very red and irritated), RASH (Rash) and MYALGIA (slightly sore arm) outcome was unknown.            No Adverse response to the first and second dose. No Treatment information was provided. No Concomitant medication was provided.   This case was linked to MOD-2022-454732 (Patient Link).
Lightheaded, dizziness, nausea; BP-138/92 O2Sat 98 P-86.
Arm became very stiff & dvlped a high fever.Also dvlped sore throat & other cold symptoms.
Pulmonary embolism diagnosed on 10/22/2022. Symptoms began on 10/21/2022 with pain in left side of chest. Mild symptoms the day before. The pain became severe at 1:00am on 10/22/2023 and I went to the Emergency Room at the Hospital. Current on Eliquis. No reoccurrence.
tingling in arm; muscle soreness; chills; fever; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), PARAESTHESIA (tingling in arm), MYALGIA (muscle soreness), CHILLS (chills) and PYREXIA (fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047a21a and 036B21a) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced ILLNESS (felt sick), CHILLS (chills) and PYREXIA (fever). On 28-Apr-2021, the patient experienced PARAESTHESIA (tingling in arm) and MYALGIA (muscle soreness). At the time of the report, ILLNESS (felt sick), PARAESTHESIA (tingling in arm), MYALGIA (muscle soreness), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
9 hours after vaccine: chills, fever, headache, nausea and body ache for 12 hours.  Treated with Tylenol and Zofran.  Second night fever occurred again and was again treated with Tylenol.
Swollen Painful Lymph nodes in L armpit; Swollen Painful Lymph nodes in L armpit; This is a spontaneous report received from a contactable other hcp (patient). A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 28Jan2021 (at the age of 25-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). The patient had allergy towards Promethazine HCL. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3246), via an unspecified route of administration, administered in left arm on 09Jan2021 as a single dose for COVID-19 immunization. On 11Feb2021, the patient experienced swollen painful lymph nodes in L armpit. No treatment was received for the event. The patient was not diagnosed with COVID-19, prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was reported as recovering.    Follow-up attempts are completed. No further information is expected.
The patient is 11 years old and was given a Pfizer Bivalent vaccine intended for those 12 and older.  The patient's mother was informd.
This is a spontaneous report from a contactable nurse. A 20-year-old female patient of an unspecified race and ethnicity received the second dose of TRUMENBA (lot M77282, exp.date 30Jun2017) via intramuscular route in the right deltoid at 19 years on 30Sep2016 15:03 at 0.5 ml single for immunisation. On 30Sep2016 15:03, the patient also received MENVEO on the right arm, and on unknown date the fifth dose of influenza vaccine (lot UI684AD, manufacturer Sanofi Pasteur) via intramuscular route on the left arm. Relevant medical history included abdominal pain (problem stress related) from 30Nov2012 to Apr2013. Concomitant medication included amoxicillin, at 500 mg, 3x/day, for sinusitis. Illness at time of vaccination included sinusitis. The patient had received the first dose of TRUMENBA on unknown date in Jul2016 and had experienced swelling and pain in Aug2016. On unknown date the patient experienced cellulitis, arm hurt, swelling arm, redness, hurts to move it, warm to touch, headache. The patient received AUGMENTIN for cellulitis. The events required an emergency room. The patient was not admitted to hospital. The outcome of the events was reported as unknown. Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
Burning eyes Extreme muscle and joint pain through body  Feeling rapid heart rate  Whole body throbbing   Treatment: rest, warm epsom bath, Tylenol and ibuprofen