chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/26/24 - metallic taste in mouth - lasted 3 days - resolved 10/27/23 - pain to touch and redness 2 mm below injection site - pain and redness increased 10/28/23 - pain woke me up night of 10/27 - 10/28 10/28/23 - induration 2 mm below injection site  and pain to light touch 10/29/23 - measured area of redness - 18mm x 14mm - marked area of induration - 14mm x 12mm, tried to apply topical triamcinolone cream but too painful to touch - pain was still localized to the area of induration with decreasing but still noticeable topical pain over red area.  11/1/23 - was able to use topical triamcinolone cream (Rx from my PCP) - no systemic symptoms 11/1/23 - unable to sleep due to "achy" pain with intermittent sharp pain (positional) and used a Lidoderm 5% patch at night over shoulder/top of deltoid area - it seemed to help - did that for 3 nights to sleep (on at night/off during the day) 11/3/23- pain was increasing while induration was decreasing - 11/3/23 induration was 6mm x 3 mm- but pain was not skin, it was deltoid from tuberosity to clavicle 11/9/23 - pain increasing but also muscle weakness - took 800 mg Ibuprofen and it helped a little but it was affecting my ability to type, write, dress, etc. 11/9 - 11/15/23 - increased muscle weakness, pain and guarding   11/15/23 - Spoke to pharmacist and PCP and made the decision to report to Pfizer and FDA
Redness; itchiness; rash not at sight of injection but on chest, whole trunk, and arms; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (itchiness) and RASH (rash not at sight of injection but on chest, whole trunk, and arms) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX (Had large hive reaction.) in November 2020. Concurrent medical conditions included Osteopenia since 22-May-2008, Cholesterol high since 2017, Hypothyroidism since 22-May-2006, Hair dye sensitivity and Allergy to chemicals (Had a sudden reacton of very red inflames eyes to preservative in contact lens solution  confirmed by opthomological specialist in 1988.). Concomitant products included IBANDRONATE SODIUM for Bone loss, ROSUVASTATIN for Cholesterol blood increased, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, CALCIUM, MAGNESIUM (CALCIUM + MAGNESIUM) for an unknown indication.    On 04-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021 at 12:30 PM, the patient experienced ERYTHEMA (Redness), PRURITUS (itchiness) and RASH (rash not at sight of injection but on chest, whole trunk, and arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), PRURITUS (itchiness) and RASH (rash not at sight of injection but on chest, whole trunk, and arms) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Added reporter alternate contact, updated medical history and concomitant medications. Action taken updated from unknown to withdrawn and dechallenge positive, updated event outcome as recovered from unknown.
This spontaneous report was received from a female patient of unknown age reporting on herself. Information regarding the patient's pertinent medical history and concomitant drugs was not provided. The patient was allergic to sulfites. On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown), reported as "shingles vaccine, (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 06-MAY-2019, the patient was diagnosed with bronchiectasis. The outcome of bronchiectasis, as well as, the causality between the event and therapy with zoster vaccine live (manufacturer unknown) were unknown. Upon internal review the event bronchiectasis was considered to be medically significant.
The patient received the vaccination at 12:15pm on 6/10 and reported back to pharmacy around  1:20pm with a skin reaction of hives and no respiratory distress. Pt was administered diphenhydramine  50mg and monitored by rph for approximately 1 hour. At the time the hives had decreased substantially  but were still present and there was not further progress of adverse event. The patient was referred to  primary care md and declined to have us call emergency number. The patient left shortly after this time without  informing rx staff. We tried to follow up with patient three times on 6/11 and the number on file was  not connected and rang busy each time. It is unknown if pt followed up with md as directed.
a little out of it the day after the second shot; but she got really exhausted; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional via Medical Staff. This consumer reported similar events for daughter and lot of people. This is the 2nd of 2 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced a little out of it the day after the second shot and got really exhausted. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021726880 similar report from same reporter
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Mild, Additional Details: Patient complained of heat on the arm and neck of the left side (side of vaccination). EMS contacted but patient refused treatment. Patient recovered and left under his own power.
46 year old female with no past medical history or allergies to medications.  She received her first Moderna COVID-19 vaccine and reported dizziness and nausea afterwards.  She denied any trouble breathing, facial swelling, rashes, vomiting or difficulty swallowing.  She denied taking any medications after the first dose of the vaccine.  She received her second dose of Moderna COVID-19 vaccine on 3/8/21 and approximately 30 minutes after the dose complained of dizziness, nausea and throat tingling.  Her vital signs were stable (HR 76, RR 18, SpO2 97%RA, BP 132/81).  Her oropharynx was clear, no lip/tongue or posterior oropharynx swelling.  She spoke in clear sentences, no respiratory distress, respirations are unlabored.  She was given Benadryl 50mg orally and advised not to drive home.  She was given strict allergic reaction/angioedema/anaphylaxis education and go to ED if any symptoms persist/worsen.
tested Covid-19 positive; tested Covid-19 positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested Covid-19 positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information information provided a causal association between reported events Drug ineffective, covid-19 and suspect BNT162B2 cannot be excluded. case will be assessed once new information becomes available.
Hospitalization for abdominal pain on dates 8/14/2023- 8/19/2023. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Started off as a few hives and patches. Subsequently spread over my entire body. It was pretty severe. I had 3 weeks of calls with my PCP but I was not seen. They put me on over the counter medications but they did not work. I was eventually seen on week 4 by a dermatologist. They started me on steroids and the first course did not work. So we got a second course. I ended up requiring 6 weeks of steroids. I gained 40 pounds. I went to the allergist after.
Patient presented to the ER with complaints of chest pressure, syncope, dizziness, and dehydration on 9/11/21 (2 days after the COVID vaccine).  He had low blood pressure initially that recovered to normal limits after receiving IV fluids and discharged home in stable condition with plans to follow-up with cardiology for an Echo.  He returned to ER on 9/15/21 and diagnosed with a GI bleed and admitted to the hospital for 2 days.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 at 13:00 as dose 1, single (Lot number: EL0142), in left arm, on 23Jan2021 at 13:00 as dose 2, single (Lot number: EL3248), in left arm and on 18Aug2021 at 13:00 as dose 3 (booster), single (Lot number: EW0168) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Jun2022 at 13:00 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), on 27Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Vit D deficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: have continued to test positive 3 additional times by rapid antigen test; (unspecified date) Positive, notes: have continued to test positive 3 additional times by rapid antigen test; (unspecified date) Positive, notes: have continued to test positive 3 additional times by rapid antigen test; (18Jul2022) Positive, notes: I tested positive for Covid 18Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient had no known allergies. I am an immunocompromised physician due to treatment for MS (Gilenya). I am vaccinated with 2 boosters (Pfizer and Moderna), resulting in no significant antibody response, proven by participation in a multistate study. I underwent prophylactic Evusheld administration, with last dose given 27Apr2022. I contracted Covid-19 with symptoms starting 08Jul2022. I began Paxlovid on day 4, and took it 12Jul2022 to 17Jul2022. I tested positive for Covid 18Jul2022, and have continued to test positive 3 additional times by rapid antigen test. I believe that my case falls into the category of treatment failure rather than Paxlovid rebound, since I never had a negative test following cessation of treatment.; 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 drug BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Developed blanching, erythematous rash on cheeks, neck and upper chest, 15 minutes, post vax. Almost resolved by 45 minutes after vaccine.
Sore arthritic feeling in knuckles on both hands, right ankle and both right and left wrists.
Pt recv vax on 4/9/99; immediately post vax pt exp slumping & unresponsive to voice &touch x 60 sec, lt hand jerking, diaphoretic/ ashen color
Strange taste, tingling and numbness in face, throat and tongue. Sore throat and chest congestion. All within 15 minutes of the shot. This happened on both the first and second shot. Severe headache with the first moderna vaccine.
Client reporting flushing in face for last hr. since vaccine was given. B/P = 160/100. BENADRYL was given 25mg (2 tablets) q 4-6 hrs. Additional 2 tabs were given to client to take after 4 hrs if symptom is not improved.
Severe runny nose, severe headache, stomach sick. Fever, no sleep, body hurt. Blood sugars were high.
I got my shot at around 2:50PM on 04/29/2021. I started experiencing symptoms at around 12 hours (3am)after the shot. Basically chills, fever, headache, and just overall body cramps. Overall just felt super dizzy and could barely walk due to the dizziness and fatigue. About an hour later, I had trouble breathing and started hyperventilating. My body started cramping up all over to the point where I couldn?t move any part of my body and my entire body was tingly and it felt like I was having a heart attack but I believe it might have been a panic attack. I have not had many symptoms to vaccines in the past. Only meningitis B
N/A-No adverse event  Client was given 0.5ml dose of Moderna as a booster dose.
Day 1 Tdap vaccine in left deltoid causing soreness and slight pain in shoulder. Day 2 slightly more painful and hard to raise arm above head. Day 3 to present (day 13) severe pain when attempting to use arm, very limited range of motion. On day 3 began taking Ibuprofen which helped to decrease the pain. Today is day 13 and the pain is still very bad and I'm continuing to take Ibuprofen.
Patient administered moderna covid vaccine while temperature excursion was ongoing; Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that because their facility had not been able to download the digital data logger, they have been put on at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment was made. There have been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download are for the months of DEC2021, JAN2022, and FEB2022. She says that they were filling out a temperature excursion assessment at the time and she was calling in to report the same. It was further confirmed that patients have been administered doses while the temperature excursion assessment was ongoing. No details on how many patients were impacted or any information on the patients. No adverse reactions were reported by any patients.  No concomitant medication were reported.
got a heavy period maybe 4 times in the month after the Covid 19 vaccine; This is a spontaneous report from a contactable female consumer. This consumer is reporting for 3 Patients. This one of the 3 reports (Sister's friend) A female patient of an unspecified age received BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as UNKNOWN ,SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Her sister's friend who is a nurse and works in the hospital got a heavy period maybe 4 times in the month after the Covid 19 vaccine on an unspecified date. Outcome of the event is unknown.  Additional information is requested.
Bruise at injection site, pain in arm, mild neck pain. No treatment. Symptoms went away after two days.
Rash beginning in arm the shot was given in. It has spread to the other arm and below both armpits. Itchy spots have popped up on both legs, but not rashed.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Shortly after administration pt began to sweat and fainted. Pt regained conciousness after 3 seconds and then remained under observation of the rph until pt was confident they would be able to make it home on their own. #4 benadryl was given to take home but instructed to take if symptoms came back.
Great soreness at the injection site for 48 hrs. Significant rash on chest, stomach and arms for 72 hours.
Patient was dizzy, pale, hot, sweating.  Arms started twitching. Laid her on the floor with legs up. Gave her Ice pack, after few seconds symptoms started getting better, called store management and 911.  She was conscious when paramedics took her to the hospital.
Patient (pt) suffered from mild irritation at the injection site immediately after the injection that resolved without treatment.  In the subsequent weeks since vaccination, pt has intermittent events of right leg/hip pain associated with limping.  Events have occurred about one time per week since vaccination and typically lasted about 1 day, but pt has 3 days of ongoing pain and limping with the right leg.  Pt was seen in clinic by provider (myself) yesterday (10/19/21).  Assessment included full normal range of motion (ROM) for the left leg/hip and right knee but reduced ROM of the right hip.  Pt was limited to 90 degree flexion of the right hip on exam.   Pt had notable stiff leg limping gait in clinic, as well.  No pain medications have been attempted by mother.  Mother stated that pt seems to be walking better today (10/20/21) but is still limping.  Physical therapy referral was started at clinic visit yesterday but pt has not been assessed by specialist yet.
This spontaneous report was received from the patient mother refers to her son as a 12 year old male patient. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose and lot# were not reported) intramuscular. Other suspect therapies included GARDASIL (dose, route and lot# were not reported) as the product GARDASIL or GARDASIL 9 was unspecified. The sequence of GARDASIL shots was unspecified. On an unknown date, the patient developed autoimmune disease called vitiligo. Patient sought medical attention. The reporter reported that the pediatrician referred the patient to a dermatologist for treatment. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of vitiligo was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
I was diagnosed with COVID-19 on 19-May-2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I was diagnosed with COVID-19 on 19-May-2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified and Drug allergy (unknown drug allergy). Concomitant products included METOPROLOL from 29-Nov-2021 to an unknown date for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced COVID-19 (I was diagnosed with COVID-19 on 19-May-2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 25-May-2022, COVID-19 (I was diagnosed with COVID-19 on 19-May-2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) tested negative on an antigen test. On 30-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient was diagnosed with COVID-19 on 19-May-2022 and started taking Paxlovid on 20-May-2022. Patient cleared all symptoms on 25-May-2022 and released from isolation on 28-May -2022 and tested negative on an antigen test. Two days later on 30-May-2022, COVID symptoms started again and tested positive on antigen test. The device date was reported as 06-Jun-2022. Pfizer have permission to contact about this report but does not have permission to contact the patient's healthcare provider.  Company comment: This spontaneous case concerns a 60-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 20-may-2022 to 25-may-2022.After 5 days patient symptoms subsided released from isolation after 3 days and 2 days later covid symptoms started again tested positive on antigen test. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 20-may-2022 to 25-may-2022.After 5 days patient symptoms subsided released from isolation after 3 days and 2 days later covid symptoms started again tested positive on antigen test. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.