chrisvoncsefalvay/vaers-outcomes huggingface dataset:
abscess on anal; sinus issues; flu like symptoms; trickle of blood at injection site; sometimes caused stinging; This spontaneous case was reported by a consumer and describes the occurrence of ANAL ABSCESS (abscess on anal) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAL ABSCESS (abscess on anal) (seriousness criterion medically significant), SINUS DISORDER (sinus issues), INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE HAEMORRHAGE (trickle of blood at injection site) and VACCINATION SITE PAIN (sometimes caused stinging). At the time of the report, ANAL ABSCESS (abscess on anal), SINUS DISORDER (sinus issues), INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE HAEMORRHAGE (trickle of blood at injection site) and VACCINATION SITE PAIN (sometimes caused stinging) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided. No treatment information was provided.  Company comment: This spontaneous case concerns a 65-year-old male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Anal abscess unknown days after receiving an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Medical judgement.; Sender's Comments: This spontaneous case concerns a 65-year-old male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Anal abscess unknown days after receiving an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Medical judgement.
Injection was performed on right deltoid. Began to feel weakness in left arm, throbbing headache, and numbness on left side of face approximately 2 hours post-administration. Symptoms lasted for approximately 7 hours and then subsided.
Parents state pt hard to arouse for 5" called 911; to ER by parents;
Tested positive for Covid-19 on January 19, 2021. 1st vaccine 4/6/2021 2nd vaccine 4/28/2021 ~ 3rd-4th week of May, developed adverse taste/smell.  NOTHING tastes/smells as it used to - very "chemical"-like smell/taste -- foods taste pungent. Visited Primary Care PA end of June 2021 - tested negative for COVID-19. When symptoms did not resolve over time, visited ENT specialist on Tuesday 8/31/21.  Prescribed 10 day course of Prednisone 10mg + Alpha Lipoic Acid.  No noted sinus inflammation.  No sinus pressure.  No sinus infection visually present. When symptoms did not resolve, visited ENT specialist for follow up appointment on 9/15/21.  No further course of action / resolution offered .... "hopefully" time will resolve
Allergic reaction at injection site. Area is red and swollen for several days; Allergic reaction at injection site. Area is red and swollen for several days; Allergic reaction at injection site. Area is red and swollen for several days; Allergic reaction at injection site. Area is red and swollen for several days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 09:30 (Lot number: FF2590) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 12Oct2021. Vaccination history included: Bnt162b2 (Dose 2;, Lot number: ER8737,, Dose administration time: 11:30 AM, Vaccine location: Left arm), administration date: 20Apr2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose 1;, Lot number: EN6204,, Dose administration time: 11:30 AM, Vaccine location: Left arm, ), administration date: 30Mar2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE REACTION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), HYPERSENSITIVITY (non-serious) all with onset 01Nov2021, outcome "recovering" and all described as "Allergic reaction at injection site. Area is red and swollen for several days". Therapeutic measures were not taken as a result of vaccination site reaction, vaccination site erythema, vaccination site swelling, hypersensitivity.  Additional information: Allergic reaction at injection site. Area is red and swollen for several days. This occurred just on the 3rd shot. Adverse events start date: 01Nov2021. If patient recovered: Recovering. If treatment ae: No. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. Other mediation in two weeks: No. Known allergies: No. Other medical history: No.  Follow-up attempts are completed. No further information is expected.
Syringe leaking in the vaccination area, he didn't feel anything going in; Syringe leak; A spontaneous report was received from a consumer 78-year-old, male patient concerning a patient who was participating in the mRNA-1273 Emergency Use Program and the syringe leaking in the vaccination area.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13-Jan-2021, Prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.  During his injection the syringe was leaking at the vaccination area. There was vaccine dripping down his arm and a puddle that formed on his chair.  He reported that he didn't feel anything going in.  No treatment information was provided.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event incorrect dose administered was unknown.  The reporter did not provide an assessment for the event.; Reporter's Comments: This report refers to a case of incorrect dose administered and syringe leak for mRNA-1273.  There were no reported adverse events associated with this case.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 67-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) for prophylaxis. On 15th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th April 2018, 1 days after receiving SHINGRIX, the patient experienced swelling arm and swelling of wrists. On an unknown date, the outcome of the swelling arm and swelling of wrists were recovered/resolved. It was unknown if the reporter considered the swelling arm and swelling of wrists to be related to SHINGRIX. Additional details were reported as follows: The patient experienced arm, wrist, and hand swelling which lasted for 3 to 4 days.
Patients COVID-19 Vaccine card showed patient received 1st dose of Moderna on May 13th, he was given the 2nd Moderna dose in June. Consent was given by patient. On investigation, he had received 1st dose in January from another facility. Patient is stable, denies any chills, ache or fever on assessment on 06/10/2021. Care team will continue to monitor. Dr notified
Sore arm; Have lot of discomfort in my chest and it's getting really hard to breath; Have lot of discomfort in my chest and it's getting really hard to breath; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on 24Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got the Pfizer vaccine on 24Aug2021 (yesterday, as reported) and on 25Aug2021 (today, as reported) patient had like you know the normal side effects like sore arm or whatever, but as the day go on patient had lot of discomfort in chest and it's getting really hard to breath. So patient was wondering if patient could see a doctor or just wait and see. The outcome of the event(s) was unknown.  Information on batch/lot number was requested.
Syncope; Information has been received from the US Food and Drug Administration (FDA) on 05-FEB-22.  This solicited report was received from a health care professional regarding a 26-year-old male patient.  The patient did not have any allergies to medications, food or other products. The patient did not have any other illnesses at the time of the vaccination and up to one month prior, or any chronic or long-standing health conditions. The patient was not taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at the time of the vaccination.   On 23-JAN-2020 10:43:00, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly on the right arm for prophylaxis (lot number reported as R0209, strength,dose and expiry date were not provided). Lot # R0209 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Lot # R0209 does not match any company product as confirmed by Lot Verification Team.  On the same day, the patient was also vaccinated with hepatitis a vaccine inact (HAVRIX) dose 1 administered intramuscularly  on the left arm(lot # reported as E22NT, strength, dose, formulation, expiry date, and indication were not provided), and with influenza vaccine inact split 4v (FLULAVAL QUADRIVALENT) dose 1 administered intramuscularly on the right arm (lot # reported as 55GY9,strength, dose, formulation, expiry date, and indication were not provided). The patient was vaccinated at a public health clinic.  On 23-JAN-2020 10:45:00, the patient experienced syncope. The event lasted only 1 minute. The patient's treatment included  juice, snack, ice pack and rest. The patient recovered with treatment withing 10 minutes. No medical tests or laboratory results were performed.   The action taken with the suspect vaccines and the causality assessment were not provided.  Follow-up information has been received from the healthcare professional on 18-FEB-2022.  The reporter stated that they were not able to identify the patient and they could not provide any further information.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 42-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN XL; ADVAIR; ALBUTEROL HFA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. From 15Jun2022 to 19Jun2022, the patient was treated with Paxlovid for the COVID-19. The had patient previously receive a COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
This spontaneous report as received, via field employee, from a physician refers to a 13 year old female patient. In approximately May 2012, reported as one year ago, the patient was vaccinated with GARDASIL (dose, lot number and expiration date were not reported) dose 1, intramuscular. In approximately May 2012, reported as one year ago, after receiving the first dose of GARDASIL, the patient experienced involuntary hand movements once a day, for an unspecified period of time. On an unspecified date, in approximately 2013, reported as recently at an unspecified timeframe, the patient received a second dose of GARDASIL, (dose, lot number and expiration date were not reported). On an unknown date, in approximately 2013, (72 hours after vaccination with second dose of GARDASIL) the patient experienced seizure. The patient sought medical attention with a neurologist visit (unspecified Health Care Professional (HCP)) and received unspecified treatment. The outcome of involuntary hand movements once a day and seizure was reported as recovering/resolving. Upon internal review the event seizure was considered as medically significant. Additional information has been requested.
Patient complained of drowsiness, heartburn, and esophageal pain. Mother gave daughter TUMS to relieve heartburn.
had half of his lung removed; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY RESECTION (had half of his lung removed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    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 PULMONARY RESECTION (had half of his lung removed). At the time of the report, PULMONARY RESECTION (had half of his lung removed) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient needed to receive a booster dose as he had cancer, received the Moderna COVID-19 vaccine and also had half of his lung removed.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: The follow up document contains no new information.
Funny taste in my mouth; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Funny taste in my mouth) and MYALGIA (Muscle aches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced MYALGIA (Muscle aches). On 03-Feb-2021, the patient experienced DYSGEUSIA (Funny taste in my mouth). At the time of the report, DYSGEUSIA (Funny taste in my mouth) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Patient was scheduled for his second dose of the vaccine on 03-Mar-2021.
Arm swelled down to her elbow; Arm had a rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled down to her elbow) and RASH (Arm had a rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swelled down to her elbow) and RASH (Arm had a rash). At the time of the report, PERIPHERAL SWELLING (Arm swelled down to her elbow) and RASH (Arm had a rash) outcome was unknown. Not Provided          No concomitant medications were reported No treatments were reported.  Moderna lot 025L20A Patient reported at her second Moderna vaccine shot that her arm swelled down to her elbow and arm had a rash. Patient reports that this lasted 1 week.
Fever, Rash, NauseaVomiting, body cramps, sore R arm Narrative:
Vaccine given at approx 4:10pm. Mother reports to nurse at approx 4:25 that child complaining "can't breathe". Child developed deep red facial flush, dry cough. He put hands to neck. Escorted to ER in building at 4:27. Triaged and treated by 4:35. Given Epinephrine, Prednisone, BENADRYL and albuterol inhalant. Discharged stable 6:05pm with meds and follow up to his allergist.
Fevers started the night of the vaccines 11/11/19 into the next morning. Patient was extra fussy through the night and next morning
Patient was given flu vaccine by LPN. Nurse left the room, patient was sitting on the exam table. Patient passed out. Dad was standing near the table and caught patient before he fell. Dad yelled out to the staff that patient had passed out. Nurses ran into the room. Patient was lying on the table, alert and oriented. Patient's blood pressure was normal, he was able to keep down fluids, observed in office for 15 minutes and was able to walk to his fathers vehicle without assistance.
Client received first dose of vaccine, five minutes later complained of feeling dizzy and nauseous.  Vital signs stable, client able to talk and answer questions.  Within 15 minutes client states she feels better, no longer dizzy or nauseous, vital signs stable.  Client walked out on her own with her friend, steady gait after 30 min of observation.
return of vertigo that had previously gone away.  vertigo is light but is almost always noticeable and occurs night and day.
Flu shot administered at 4:40 PM in treatment room. Patient did not appear to have adverse physical or mental reaction. He walked to the front desk (approx 25 ft) took out his wallet, paid a fee for his flu injection, and then fell backwards, appearing to faint. This was witnessed by a staff member. Roused quickly, checked by paramedics, dismissed to go home.
Pfizer / BioNTech / Treatment of COVID-19; Pfizer / BioNTech / Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech / Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (22Aug2022) Positive, notes: Reoccurrence of COVID on 22Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Additional information: Paxlovid was given as anti-viral treatment for COVID 19 from 18Jul2022 to 22Jul2022. Reoccurrence of COVID on 22Aug2022. Reoccurrence of COVID on 22Aug2022 at 06:00 AM. The event was not recovered. No known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sore Arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 10-years-old female patient received bnt162b2 (BNT162B2), administration date 08Nov2021 (Lot number: FK5618) at the age of 10 years as DOSE 1, SINGLE for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 11Oct2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Nov2021, outcome "recovered" (2021), described as "Sore Arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: The patient had other vaccine in four weeks. Other vaccine in 4 weeks product = Flu shot. Other medications the patient received within 2 weeks of vaccination: No. No treatment was received for adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient received PNEUMOVAX and FLUVIRIN. She developed redness and swelling at the site. By the second day, the swelling was down and no more pain or itching.
Patient reported jaws clicking and inability to close mouth. States jaws hurt. See PMD or try taking 600-800mg motrin/ibuprofen. If works repeat in 6 hours. No difficulty swallowing.
Pt had been playing outside w/other children; others came in house  pt found sleeping in lawn chair, difficult to arouse, slow to respond, ashen color; Improved in 15-20min; Then slept 10min, then appeared well; normal exam;
Pfizer vaccine administered 11.04.21 with second one 12.10.21. Covid-19 12.24.21. I week or so later Covid-19 pneumonia, follows by conjunctivitis, periorbital cellulitis, myositis, and possible optic neuritis. Currently in-patient with diagnosis 3rd nerve palsy and cranial nerve neuropathy. Severe systemic plan and unable to open or see out of the right eye. Thank you.
After administering vaccines, PT's right leg immediately began to swell and redness spread up the leg. Notified Dr of the reaction. Dr ordered 12.5 mg/5ml of Benadryl. Medication given and within 30 minutes, the swelling and redness diminished.
Was administered Kinrix instead of Dtap and polio separately. It is not licensed for his age nor the Dtap being #3 dose.. Mother was notified using interpreter.  He doesn't have any side effects as of 3pm 6/29/23. Mom was advised to call me at health department if he develops any symptoms.
I had a bruise on my arm for almost two weeks at the site of the shot. I started to feel cramping as if I was  getting ready to start my cycle on Sunday. They lasted almost two weeks every day and some days I needed to take Ibprofen because they were strong. I also had very sore and tender breasts and became bloated like I was going to start my cycle. I finished my cycle two days prior to getting the shot, so these symptoms are not normal at this time. I still have some cramping and off and on bloating. My breasts hurt off and on. I have started slightly spotting. I should not have my cycle until the end of the month. I told my doctor about these symptoms and she said they sound related and to report this.