chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIZZINESS; ALL OVER BODY ACHE; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified health issues, and other pre-existing medical conditions included the patient had no health history that would relate to the vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, batch number: 1805022, and 1005022 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced all over body ache. On 16-MAR-2021, the subject experienced sore arm. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, all over body ache, and headache on 17-MAR-2021, and had not recovered from sore arm. This report was non-serious.
Patient was erroneously administered an undiluted vial of COVID-19 vaccine. This error was caught within 10 minutes of administration and patient was called to return to the pharmacy. At the time, he had no adverse effects, but was monitored for approximately 1 hour. He was provided water and instructed to stay hydrated, apply ice to the injection site and take Tylenol and ibuprofen as needed for any reactions he may expect. After doing research, it was found that he would likely experience heightened side effect from the vaccine, but nothing has happened. He was instructed on how to treat any side effects and to contact me should any concerns arrise.
Arm swollen, itchy , red, hot, and painful. No treatment. Swelling decreased after day #3.
6th July: injection in the morning by the afternoon arm is sore. Took 600mg Advil afternoon and 800mg at bedtime. Restless night waking frequently with arm neck and sinus pain.  7th July morning took 800mg Advil by afternoon arm is heavy like I can hardly lift it and pain now radiating to finger tips and down my legs from buttock like severe sciatic nerve pain. Manage to sleep for 3 hrs in the afternoon by evening pain worsening. 6.30pm felt cold even though 29C outside  pain still severe and feels heavy to breath. 7.30 pm hot shower and to bed cramping in arm to finger tips, under breast, severe pain down from buttock to the soles of my feet and scalp tingling. 8.00pm my legs arm and head feel on fire. 8th July morning less cramping and arm still heavy but feel slightly improved from yesterday, sinus pain, neck stiff and breathing still heavy but not as bad. 9th July symptoms improving slowly.
Hepatitis A vaccine Influenza vaccine Developed likely ADEM (acute disseminated meningoencephalitis) From Admission Note: Patient was in his usual state of health until the evening of 2/21 when he started with retching, abdominal pain, back arching, NBNB vomiting, diarrhea. Yesterday, 2/22, he continued to have a few episodes of NBNB emesis and diarrhea. The family called the PCP, who recommended supportive care at home. This morning at 7:30am (2/23) he woke up from sleep and was crying, had a small mucous vomit, then had a 15min seizure (bruxism and teeth chattering, eye deviation up and right, whole body shivering/shaking, minimally responsive). Otherwise he was recently well, fully vaccinated, no sick contacts, no fevers. No toxin exposures. Had vaccines a few weeks ago, had an elevated lead level of 9 planned to follow with the PCP. No recent traumas. He recently spent the last 5 months away from home and returned a few weeks ago. No FH of seizures or neurologic conditions. The family called EMS, per report the shaking seemed to have subsided by EMS arrival however patient was post-ictal. He was transported to hospital. There he had stable VS, irritable. He had a non-con CT that was reportedly normal. Labs with WBC 18, otherwise CBC normal, BMP normal, LFTs normal, no blood culture. Received 20cc/kg of NS. He was transferred to another hospital for ongoing care. In the ED, he was slightly post-ictal and not encephalopathy, responsive, apprehensive with caregivers, nonfocal neuro exam except for mild ataxia (vs peripheral IV in foot). He was tolerating PO. Abdominal US in ED was also negative. He also had a spot EEG which showed some possible L temporal slowing, non-epileptogenic. He was admitted to the floor for monitoring for unprovoked seizure. On the floor this afternoon, he has been slightly "sleepy" but interactive and arousable with a non-focal exam. Around 5:30pm today, he had a 15 min seizure (R eye deviation, unresponsive, intermittent whining sounds, bruxism, shaking, lip tremulousness). He had emesis with desat to 87% placed on the non-rebreather. Treated with 0.1mg/kg ativan with resolution of the seizures. Afterwards was post-ictal with some upper extremity posturing and overall rigidity and hypertonicity. He gradually recovered. By 6:30pm had R gaze preference but minimal residual rigidity. He had a full brain MRI which showed multiple areas of T2 hyperintense signal encephalitis/meningitis. He was admitted to PICU for monitoring and ongoing care, LP, acyclovir, antibiotics, and workup as per plan. His infectious studies including HSV PCR have been negative to date. He is receiving treatment with high dose IV steroids for presumed ADEM.
severe ARDS and pulmonary fibrosis; severe ARDS and pulmonary fibrosis; presented to the hospital on 26Feb with severe resp distress; This is a spontaneous report from a contactable Other healthcare professional (HCP). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Right on 18Feb2021 16:00 (Lot Number: EN6203) (at 67-year-old) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Store. Medical history included Malignant neoplasm of sigmoid colon, hypertension (HTN). Concomitant medications included tamsulosin; tipiracil hydrochloride/trifluridine (LONSURF), hydrochlorothiazide/lisinopril (ZESTORETIC), docusate sodium (COLACE), hyoscyamine sulfate (LEVSIN/SL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162B2 (Lot number: AL9265) at 27Jan2021 12:30 PM, Intramuscular at right arm for covid-19 immunization. Patient received 2nd vaccine on 18Feb2021 and presented to the hospital on 26Feb2021 with severe respiratory distress. Currently intubated/paralyzed with severe Acute respiratory distress syndrome (ARDS) and pulmonary fibrosis. Unknown if any correlation, Adverse event start date was on 26Feb2021. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Adverse event treatment included: Intubation/paralytics. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: A contributory role of BNT162B2 to events respiratory distress, Acute respiratory distress syndrome (ARDS) and pulmonary fibrosis cannot be excluded based on temporal association. 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 reports severe arm swelling and pain on upper arm that the injection was administered. Patient has tried ibuprofen and Benadryl with no symptom improvement.
Had minimal reaction at time of 1st vaccine.  Rash, elevated heart rate, itching.  No reaction at time of 2nd vaccine.  Broke out in shingles in July Approximately  5 months after 2nd vaccine given. Due to my immune disorder took over one month and two rounds of prescribed antibiotics for symptoms to subside.  Painful to touch, rash, numbness and chicken pox like outbreak on upper torso, back and only under my right armpit.
Weakness all over body, itching at site of injection, feeling of "heaviness and light headed". Light headed feeling 15-20 minutes after influenza vaccine.
Pt called and reported a red upper arm. I told her to ice the area and if it did not improve within 24-48 hours to seek medical attention as it could be an infection.
localized reaction: left leg became very hard, red, swollen and very warm to touch.  the red area was about 4inches x 3inches
Severe chills for 5 hours (95.2 degrees); Followed by 4 hours of fever (102.7 degrees); repeated for 2 more periods of 8 hours; Severe achiness; Lack of ability to concentrate; Dose number=5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 17:30 as dose 5 (booster), single (Lot number: CRH9694) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: SIMVASTATIN; TRAZODONE. Past drug history included: Levofloxacin, reaction(s): "Known allergies: levofloxacin", notes: Known allergies: levofloxacin. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer"), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03; Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 04; Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 30Sep2022 at 17:30, outcome "unknown", described as "Dose number=5"; PYREXIA (non-serious) with onset 30Sep2022 at 20:45, outcome "not recovered", described as "Followed by 4 hours of fever (102.7 degrees); repeated for 2 more periods of 8 hours"; DISTURBANCE IN ATTENTION (non-serious) with onset 30Sep2022 at 20:45, outcome "not recovered", described as "Lack of ability to concentrate"; PAIN (non-serious) with onset 30Sep2022 at 20:45, outcome "not recovered", described as "Severe achiness"; CHILLS (non-serious) with onset 30Sep2022 at 20:45, outcome "not recovered", described as "Severe chills for 5 hours (95.2 degrees)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, pain, disturbance in attention.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No; Reported Event: 4 hours after injection \severe chills for 5 hours (95.2 degrees), followed by 4 hours of fever (102.7 degrees); repeated for 2 more periods of 8 hours; severe achiness & lack of ability to concentrate. Prior to vaccination, was the patient diagnosed with COVID-19:No. Since the vaccination, has the patient been tested for COVID-19?:No
A non-serious spontaneous report of nose bleed has been received from a health professional concerning an female older than five years of age, subsequent to FLUMIST. Medical history includes nose bleed. No concomitant medication was reported for this patient. On an unknown date in Nov-2010, the patient received FLUMIST for Flu prevention via intranasal route. Some time during the night on the same day of FLUMIST vaccination, the patient experienced nose bleed twice. The outcome of the event nose bleed was resolved.
reflects the wrong lot numbers and we can not figure out which patient's records are wrong; Circumstance or information capable of leading to medication error; The patients have not reported any adverse reactions; This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, 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 TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions). At the time of the report, TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (The patients have not reported any adverse reactions) to be not related. No further causality assessments were provided for TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    This case contains information for the 7th out of 16 adult patients described by the reporter. No concomitant information was reported. Reporter states, "16 Patients Vaccination Cards reflects the wrong lot numbers and cannot figure out which patient's records are wrong. All patients received the correct vaccine and bivalent dose. The error only involves documentation. They administered Bivalent boosters from Bivalent Lot numbers: 061F22A and AS7170B. They wrote AS7170B on all 26 patient's vaccination cards. Cannot distinguish which patients. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696236 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696236:CASE
large welt in area of vax & very warm for @ least a wk period of time;
Pt developed confusion, apasia 3 days after flu shot. Was hospitalized for 4 days with negative w/up-diagnosis was encephalopathy possibly due to flu shot 12/26/07-records received for DOS 10/7-10/12/07-Metabolic encephalopathy of unknown case as well as some underlying dementia. Presented to ED with confusion which started day before. Difficulty with finding words and not completely making sense. Speech garbled.  On date of admission unable to walk. Fever.
Pain (moderate), Swelling (moderate), Redness (severe), Chills (severe), Fever (Max 102.8F), Headache (moderate) Tirdness (moderate) all 1 day after shot
The injection site is swelling; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (The injection site is swelling ) and PYREXIA (Fever) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (The injection site is swelling ) and PYREXIA (Fever). At the time of the report, VACCINATION SITE SWELLING (The injection site is swelling ) and PYREXIA (Fever) outcome was unknown.        No relevant concomitant medication was reported. The treatment information was not provided.; 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.
Cold sore outbreak on lip; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 09:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included oral birth control (MANUFACTURER UNKNOWN), taken from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 12:00, the patient experienced cold sore outbreak on lip. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event cold sore outbreak on lip was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe headache, stomach and back pain, lower back pain for 4 days. Will go to see private physician.
Headache, Myalgia, PAIN IN THE LEFT AXILLA TO UPPER FOREARM; Narrative:
3 months after receiving vaccines child developed balance issues. Would not walk, sleeping more, appetite decreased.
Service member received his 7th Anthrax vaccination at 1330 on Nov 6, 2010. Around 1800 that night he began to experience headaches, muscle and body aches and pains, weakness, chills, diarrhea, injection site hot and red. Went to his provider the next day for treatment of the symptoms.
Information has been received from a RN concerning a pt who was vaccinated with varicella virus vaccine live. The RN reported that on 12Apr2003 the pt's 7 month old younger brother who had not been vaccinated because of his age came down with chickenpox. Subsequently two weeks later, reported as 26Apr2003, the pt, who had been vaccinated, "broke out with a moderate case of chicken pox". Unspecified medical attention was sought. The reporter mentioned that two other siblings also "broke out with a moderate case of chicken pox" following vaccination with varicella virus vaccine live. Additional information has been requested.
she had her booster a week ago today and is still unable to function; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 12:00 (Batch/Lot number: unknown) at the age of 23 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "tourette syndrome" (unspecified if ongoing); "mild case /anxiety" (unspecified if ongoing); "depression under control with meds" (unspecified if ongoing); "Allergies:penicillin" (unspecified if ongoing); "trunk rash" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Product=COVID 19, Brand=Pfizer, Lot unknown=True, Lot unknown reason=Not available/provided to reporter at the time of report completion,, Administration date=Apr2021), administration date: Apr2021, for Covid-19 Immunization; Bnt162b2 (DOSE 2, Product=COVID 19, Brand=Pfizer, Lot unknown= True, Lot unknown reason=Not available/provided to reporter at the time of report completion,, Administration date= =May2021,), administration date: May2021, for Covid-19 immunization; Bnt162b2, for Covid-19 Immunization, reaction(s): "severe nausea", "vomiting"; Bnt162b2, for Covid-19 immunization, reaction(s): "Unable to keep any food / drink down". The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "unknown", described as "booster"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "she had her booster a week ago today and is still unable to function". The event "she had her booster a week ago today and is still unable to function" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of loss of personal independence in daily activities.  Additional Information: The patient did not receive any vaccine prior to Covid vaccine. The patient did not test positive for Covid post vaccination. Adverse event was treated with IV fluids and anti-nausea medicines.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a healthcare worker and concerns an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with oral ROTATEQ (Lot# L02086, expiry: 09-FEB-2017; Lot# L035510, expiry: 13-MAY-2017) (route, dose and strength were not reported) that was improperly stored at 46.7 Fahrenheit for 14 hours and 40 minutes. No adverse effects were reported. There was no prior temperature excursions noted. This is one of the two cases from the same reporter. Additional information has been requested.
Chills; heart racing; Vomiting; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration in the left arm on 23Jan2021 15:15 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. No known allergies. The patient is not pregnant. No other vaccine in four weeks and no other medications in two weeks. The patient had no COVID prior vaccination and not tested with COVID test post vaccination. The patient experienced chills, heart racing, and vomiting, 4 hours after vaccination on 23Jan2021 19:15. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Redness of neck; Had COVID arm; Itching neck; Chills; Confusion; Redness of face; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness of neck), RASH ERYTHEMATOUS (Had COVID arm), PRURITUS (Itching neck), CHILLS (Chills) and CONFUSIONAL STATE (Confusion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness of neck), RASH ERYTHEMATOUS (Had COVID arm), PRURITUS (Itching neck), CHILLS (Chills), CONFUSIONAL STATE (Confusion) and ERYTHEMA (Redness of face). At the time of the report, ERYTHEMA (Redness of neck), RASH ERYTHEMATOUS (Had COVID arm), PRURITUS (Itching neck), CHILLS (Chills), CONFUSIONAL STATE (Confusion) and ERYTHEMA (Redness of face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment information was provided.