chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up in the morning eight days after receiving Dose #1 to find my upper arm all around the injection site (about a 2" x 4" area) covered in a raised, red, itchy rash--much like poison ivy-type rash. I started applying OTC 1% hydrocortisone cream three times a day and the rash is slowly going away but has not completely cleared up yet.   Please note: This is not interfering with my daily activities, but I wanted to report it as a possibly unusual side effect to be added to the information base about the vaccine (assuming a few others may have had it as well).
pt had a positive COVID test on 8/20/21 and again 9/7/21; was treated with monoclonal antibodies; pt entered Hospital on 9/21/22 with GI bleed; pt had a massive right MCA stroke and was moved to inpatient hospice status; was then transferred to Hospice where she passed away; death certificate and med records sent to vaers website per VAERS request -
This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and PRURITUS (Itching on left arm/ progressed to both arms, leg, stomach, face.) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. Concurrent medical conditions included Acid reflux (oesophageal). On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and PRURITUS (Itching on left arm/ progressed to both arms, leg, stomach, face.). The patient was treated with HYDROCORTISONE for Itching and Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash) and PRURITUS (Itching on left arm/ progressed to both arms, leg, stomach, face.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.This case was linked to MOD-2021-154555 (Patient Link).
Itching all over my body - arms legs back.  Extreme itching hen starched causes swelling and/or hives.
Extreme swelling with erythema, pain, discomfort, low grade fever, acute diarrhea. Note: New address. Follow up on 05/05/04: "I do not know the information you are asking for. Please call or write the doctor to find out the vaccine lot numbers."
Breakthrough COVID infection in fully vaccinated patient. Positive date 08/05/2021.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 10-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2018, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 72 hours and the lowest recorded temperature reported was 33 Fahrenheit (F) (0.555555556 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Approximately 5-10 seconds after leaving clinic, Pt turned white, stated to mom "my eyes feel funny", had tonic clonic movements of arms, vomited x 3; mom held him, gave him a pepsi and he fully recovered.
The expiration date was incorrect in the refrigerator, and the patient received an expired dose of Pfizer COVID-19 vaccine.
Area of vaccination become red and inflamed. Patient reported to pharmacist on Friday 5/25/12 if normal Pharmacist told pt. reaction to vaccine on 5/26/12, Pt. treated by doctor for cellulitis Pharmacist contacted pt. on 5/29 patient doing fine.
This spontaneous report was received from a physician, via a company representative, referring to a female patient of about 1 year-old. The patient's relevant medical history, drug  reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with M-M-R II, subcutaneously, for prophylaxis (strength, dosage schedule, lot number and expiration date were not reported). On an unknown date, two weeks after vaccination, the patient developed measles-like rash on the abdomen area. It was unknown by the reporter whether the patient received treatment to the aforementioned event or if any laboratory tests were carried out. The reporter informed that the patient visited the physician's office on an unknown date. The patient fully recovered of measles-like rash on an unspecified date. The relatedness between M-M-R II and measles-like rash was not reported.
Muscle aches and pains and extreme fatigue the day after.  Resolved by the day after that.  Am  96 hours out from vaccine and still have red arm and some slight swelling at injection site and some pain, slight though.  Still feels a tad warm.
Presented to ED about an hour after vaccination with chest pain, SOB, and palpitations.
Patient was provided booster outside of recommendations: <six months from second dose and not immunocompromised
Arm hurts when she lays on it; cannot get my hand up past face; left arm was sore right away and lasted a couple of months; pain started to move down left arm all the way down to her wrist; left arm was sore right away; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts when she lays on it), MOBILITY DECREASED (cannot get my hand up past face), MYALGIA (left arm was sore right away and lasted a couple of months), ARTHRALGIA (pain started to move down left arm all the way down to her wrist) and VACCINATION SITE PAIN (left arm was sore right away) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Restless leg syndrome.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts when she lays on it), MOBILITY DECREASED (cannot get my hand up past face), MYALGIA (left arm was sore right away and lasted a couple of months), ARTHRALGIA (pain started to move down left arm all the way down to her wrist) and VACCINATION SITE PAIN (left arm was sore right away). At the time of the report, PAIN IN EXTREMITY (Arm hurts when she lays on it), MOBILITY DECREASED (cannot get my hand up past face), MYALGIA (left arm was sore right away and lasted a couple of months) and ARTHRALGIA (pain started to move down left arm all the way down to her wrist) outcome was unknown and VACCINATION SITE PAIN (left arm was sore right away) had resolved.            Concomitant drug included medication for restless leg syndrome. Treatment medications were not provided.  It was reported that patient receive vaccine on left shoulder.
"real stiff"; like having bronchitis; arms sore; brought him down a little; neck sore; like someone is sitting on his chest/a feeling of pressure on his chest; nose has been "clogged up"; having problems breathing/breathing easier; shoulders sore; "real sore"/whole body is sore/like he has been beat all over; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS ("real stiff"), BRONCHITIS (like having bronchitis), PAIN IN EXTREMITY (arms sore), MALAISE (brought him down a little) and NECK PAIN (neck sore) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A, 017B21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis and Ragweed allergy.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced MUSCULOSKELETAL STIFFNESS ("real stiff"), BRONCHITIS (like having bronchitis), PAIN IN EXTREMITY (arms sore), MALAISE (brought him down a little), NECK PAIN (neck sore), CHEST DISCOMFORT (like someone is sitting on his chest/a feeling of pressure on his chest), NASAL CONGESTION (nose has been "clogged up"), DYSPNOEA (having problems breathing/breathing easier), ARTHRALGIA (shoulders sore) and MYALGIA ("real sore"/whole body is sore/like he has been beat all over). On 03-Dec-2021, DYSPNOEA (having problems breathing/breathing easier) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS ("real stiff"), BRONCHITIS (like having bronchitis), PAIN IN EXTREMITY (arms sore), MALAISE (brought him down a little), NECK PAIN (neck sore), CHEST DISCOMFORT (like someone is sitting on his chest/a feeling of pressure on his chest), NASAL CONGESTION (nose has been "clogged up"), ARTHRALGIA (shoulders sore) and MYALGIA ("real sore"/whole body is sore/like he has been beat all over) outcome was unknown.            Concomitant medication was not provided.  Treatment medication include blood thinner (40 mg daily), inhaler.   This case was linked to MOD-2021-404563 (Patient Link).
Numbness in extremities, feeling of crawling all over body, muscle spasms, ringing in ears.
Client received her COVID Moderna Booster dose lot # 035C21A exp. 12.30.21 on 12.09.21. At 1257, client reported to EMT that she was feeling ?lightheadedness,? and he transported client to the anti-gravity chair in a semi-fowler position. PHN came to assist with the client. Client denied shortness of breath (SOB). At 1300, EMT took client?s vitals: BP 108/746, HR 66, R 17, O2 Sat. 99%, and client was alert and oriented x 4. At 1305, EMT took client?s vitals: BP 110/70, HR 72, O2 Sat. 99%, and client ate the crackers and juice provided by EMT. Client told she didn?t eat anything today. Client denied SOB or any other anaphylactic signs and symptoms. She denied any history of allergy or taking any medications. At 1328, EMT took client?s vitals: BP 110/76, HR 76, O2 Sat. 99%, and client said her ?lightheadedness? was 2/10. At 1330, client reported she was ?feeling better? and denied any ?lightheadedness? or any other symptoms. At 1330, PHN educated client on adverse reactions and when to seek EMS. At 1335, client declined to have her last vitals taken and left the vaccination site with a steady gait.
This spontaneous report as received from a pharmacist refers to a 82 years old female patient with no medical history and no drug reactions/allergies. The patient was vaccinated subcutaneously with ZOSTAVAX on 07-JAN-2009. No other co-suspects were reported. No concomitant medications were reported. The patient developed shingles twice this year (2012) after receiving ZOSTAVAX. No treatment information was reported. The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
I was exposed to a known Covid positive person on January 2, 2021 and started showing symptoms on January 9, 2021.
pt recvd vax & had hives on upper arm where shot was given & also on wrist; wrist was swollen; 10MAY93 pt called said put aloe vera on hives did not see MD; had t100 & pains in neck;
swelling of lt latissimus dorsi & lt axilla w/tenderness & sl erythema;no  inc heat or induration;inj site is tender w/node lt axilla;
Case number PHEH2015US023409, is an initial spontaneous report from a pharmacist received on 10 Nov 2015. This report refers to an 89 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date after vaccination the patient experienced swelling in the arm of injection site and a rash. The outcome of the events was unknown. Seriousness and causality of the events were not reported.
Back of head swelled same day. Sore throat at day 2 and stopped up nose at day 5.
This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient was a neighbor of the reporter. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter mentioned that the patient had experienced a headache following the SHINGRIX shot. No additional details were reported. This case is linked with US2018172507, reported by the same reporter.
Presented to ED with hypertension, BP 198/71, HR 88, RR 20, SpO2 99%, hyponatremia (126) and hyperkalemia (5.6). She remained saturating adequately on room air and all inflammatory markers did not show evidence of active disease; thus, ID has recommended not to offer COVID therapeutic protocol
Vertigo, dizziness, imbalance lasting now over 3 weeks.  Constant light-headedness, and dizziness upon lifting head.
Mild pain and tenderness near injection site; Mild pain and tenderness near injection site; mild chills; mild fatigue; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Nov2021 10:00 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 033B21A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 20May2021, when the patient was 53 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 007C21A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 22Apr2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 10:00, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 28Nov2021, outcome "recovered" (2021) and all described as "Mild pain and tenderness near injection site"; CHILLS (non-serious) with onset 28Nov2021, outcome "recovered" (2021), described as "mild chills"; FATIGUE (non-serious) with onset 28Nov2021, outcome "recovered" (2021), described as "mild fatigue". Therapeutic measures were taken as a result of vaccination site pain, vaccination site pain, chills, fatigue. The lot number for bnt162b2 was not provided and will be requested during follow up.  Adverse event treatment: OTC Advil. No covid prior vaccination. No covid tested post vaccination.
Onset  ~1.5 hours following dose of significant muscular tightness of bilateral cspine paraspinals and severe fatigue that lasted ~36 hours.
3 pregnancies, 2 live births, pregnancy#3 due January 15 2022
10JUN92 230PM resp distress, color bluish, temp elevated; 02 placed, resp tx given, suctioned, APAP given for temp sudafed given no effect; 730PM resp & cardiac arrest, no code;
High and irregular heart rate (Atrial fibrilla_on) on 06/02/2021, the AFib episode was on around one hour than it subcided. The frequency of irregular heat beat increasing from then. On August 28th 2021, the irreular heart beat was last in 48h and again after 3 days later which was last in 24 hours. My cordiologist monitering the condition and trying to control iregular heart beat by medications metoprolol and Atenolol.
she had complaints of fever; This is a spontaneous report from a contactable consumer or other non-HCP (patient mother) via Medical Information Team. A 22-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 22-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced complaints of fever on an unspecified date. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient is a 65 year old female with a PMH significant for asthma, htn, Metastatic/stage IV C( pT4a, pN0, pM1c) moderately-differentiated mucinous adenocarcinoma of the appendix (grade 2), KRAS mutation positive, BRAF negative, MMR protein intact, with abundant mucin, peritoneal carcinomatosis; cytoreductive surgery with debulking of peritoneal implants,  peritoneal stripping, cholecystectomy, hyperthermic intraperitoneal chemotherapy with mitomycin C on 9/27/19, followed by exploratory laparotomy with abdominal washout, primary repair of perforated small bowel 10/2/19, with disease progression, on palliative modified FOLFOX 6 since 8/31/2020 who presents for sob, cough x 2 wks getting progressively worse. States home oxygen sensor dropping to mid 80's and extememely sob. Had 2nd Covid vaccine early March. Sx began about 2wks ago with +ve covid testing, fevers, diarrhea. That has since improved.
General weakness - sudden paralysis. Vision problems - headaches. Tingling, numbness - muscle pain. Unsteady gait.
BLOOD CLOT TO HEART; BLOOD CLOT TO LUNGS; This spontaneous report received from a consumer and concerned a patient of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 14-DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-DEC-2021, the patient experienced blood clot to heart and lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot to heart and blood clot to lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211235366-  covid-19 vaccine ad26.cov2.s- Blood clot to heart, Blood clot to lungs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
tingling lips; swelling sensation in throat; sore arm; headache; chills and fever; chills and fever; achy; arm tired; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 09:00, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021 at 09:00, as a single dose for COVID-19 immunisation. 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 13Apr2021, the patient experienced tingling lips, swelling sensation in throat, sore arm, headache, chills and fever, achy and arm tired. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tingling lips, swelling sensation in throat, sore arm, headache, chills and fever, achy and arm tired was recovering at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax;pt ill w/ v & d;devel T of 103;seen by MD for eval;mom felt rxn to polio vax;T nl on 31jan96 in pm;
A non-serious spontaneous report of administration to pregnant female was received from a health professional concerning an adult female. Neither relevant past medical history, obstetrical history nor concomitant medications were reported for this patient. The patient who is 16 weeks pregnant received FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable and the event is considered to be resolved.
Covid pneumonia; Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a contactable physician and a contactable consumer (company representative). An 83-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in January 2021 as DOSE 1, SINGLE; and dose 2 via an unspecified route of administration on an unknown date in January 2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history included prostate cancer (currently undergoing radiation for prostate cancer. It was not sure if the patient was undergoing radiation therapy at time of vaccine). The patient's concomitant medications were not reported. The patient had both Pfizer vaccines in January2021. On an unknown date, the patient was tested positive for covid. On an unknown date, the patient progressed to Covid pneumonia. The patient was hospitalized for covid pneumonia (covid-19 pneumonia) from 08Aug2021 over the weekend. Events took place after use of product. The patient on an unknown date underwent Covid test which was positive. The patient was treated with Z PACK and steroid and put in isolation. The outcome of tested positive for Covid and Covid pneumonia was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported lack of efficacy  events  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