chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I'm running a fever, 101F; I'm starting to feel like crap; This is a spontaneous report from a contactable consumer or other non hcp (female consumer).   A female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration on 22Mar2021 as 2nd dose, single for covid-19 immunisation. Historical Vaccine was a female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration on unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications.  The patient experienced I'm running a fever, 101f, I'm starting to feel like crap on 22Mar2021.  The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 22Mar2021. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch cannot be obtained.
This spontaneous report as received from a 66 year old male patient who was a pharmacist via company representative referred to himself. In June 2012 the patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, route and duration were unspecified). In November 2012 (exact date unspecified) he developed a chicken pox like rash on both arms that was itchy (when scratched it became irritated). The chicken pox rash resolved after a couple of weeks(date unspecified). Patient did not seek medical attention. No treatment was given for the events. The relationship was not provided. Additional information has been requested.
Same day - blurred vision that went away shortly after experiencing.  Headache, tired, very swollen at site of injection, diarrhea, chills, temp of 101.
8/12/21 Cyst in right breast expanded within body; huge painful red lump continued to grow (7 days) until drained.   8/19/21 The night of the draining, necrosis of the skin the size of a quarter occurred near, but not on, drainage site. Took 2 different antibiotics (Bactria, Clindamycin)  before results showed no infection.  Muprocion ointment and 24 hour bandages.  Hydrogen peroxide soaks.
Patient received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number ms5hc, expiry date 8th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose on 25th March 2019).   On 12th May 2022, the patient received the 3rd dose of Shingrix. On 12th May 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.       Additional Information: GSK Receipt Date: 12-May-2022 Reporter's Comments: The pharmacist reported that the patient received a 3rd dose of Shingrix . No adverse event was reported . The reporter consented to follow up.  Additional Supportive Information: The patient received 3rd dose of shingrix which led to extra dose administered.
Information has been received from a physician concerning an approximately 50 year old "about 50" male patient with a history of depression and no drug reactions or allergies who on 14-SEP-2010, was vaccinated SQ with a dose of VARIVAX (Merck) (Lot# not reported). On 30-SEP-2010, the patient began to have fever, malaise and then a rash on the chest, upper arms, and back. Lab diagnostics studies were not performed. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow-up information was received on 14-OCT-2010, from a physician who stated that at that time the patient was extremely itchy and the patient would need medical attention. Additional information has been requested.
Nausea, threw up at 1 AM, dizziness, elevated temperture, 99.2, 99.4, arn - no pain
Red rash all over my body with hives that were itching uncontrollably. Anytime I was touch my body or a red rash/whelp would appear. I felt nauseated, had chest pain and felt fatigued. This occurred at all times of the day and night  and was worse when I wore loose clothing.
the patient was administered a dose ofMMRII by intramuscular injection on 3/27/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.      On 27-MAR-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S013539, expiration date 02-MAY-2021; strength and dose were unknown) by intramuscular injection for prophylaxis (PT: incorrect route of product administration).  Other suspect therapies included sterile diluent (STERILE DILUENT) (dose details were not provided).
Swollen, redness, itchy reaction around injection site.  Measures about 2in by 2in in size
Swollen uvula, sore throat, fatigue and chills. I have experienced a swollen uvula about 20 years ago as an allergic reaction after eating a nut.
Patient experienced syncope and possibly a brief seizure about 5 minutes after receiving the vaccine. Patient was sitting down and fortunately did not fall. Patient regained consciousness quickly and remained sitting down until EMS arrived. Patient was able to walk himself to the ambulance and was taken to hospital for further evaluation.
patient received Moderna for dose 1 and Pfizer dose 2. She did not inform anyone that she had previously received a dose of COVID vaccine when asked
Extreme fatigue & nausea.  Slept for approximately 22 hours.  Felt nauseous anytime he woke up.
HUGE WELTS ON MY LEFT ARM.  THAT IS WHERE THE FLU VACCINE WAS ADMINISTERED.  THE WELTS ARE STILL THERE AS OF 12/12/2022
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), in Aug2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 16Dec2022 to 20Dec2022. Clinical course: Now Day 16 after start of symptoms and still have COVID Symptoms - runny nose, sneeze, cough, sore throat and also some bleeding from throat.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BLOOD CLOTS IN LEGS; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots in legs and it was reported as " same here blood clots in my legs " The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20230103607- Blood clot in legs-Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
My ears began ringing within 15 seconds of the first COVID vaccine and have not stopped.  The ringing is constant but the pitch and volume change.  Today it is so bad I sought how to report. Sometimes the ringing is a dull ring, sometime a loud ring.  Sometimes it's high pitched and sometimes it's a fast signing and sometimes a slow ringing.
Skin swelling around left deltoid area; shooting migraine headache causing pain around his left eye and pain runs down on his spine down to lower back; feels lethargic, but doesn't hinder his daily activities.
Flushed and anxious Txment: Water            Extended observation- Felt mostly recovered Vitals taken                        at 1:47 pm - Rtw No allergy review recommended  Received inject #2 1/16/21 (1/16/21) In supine position 3                                           problems/adverse events
Information has been received from a lawyer concerning an approximately 11 year old female patient who on 03/29/90 was vaccinated with one dose of MMR live. In approximately 2000 the patient was diagnosed with subacute sclerosing panencephalitis and was hospitalized. No further information is available.
Had a terrible outbreak of mouth ulcers (canker sores); There were many large ones in mouth/ throat and were very painful; These were many large ones in my mouth/throat and were very painful; UTI; It felt like the immune system had completely shut down/been weakened; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 05May2021 at 14:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to the vaccination, the patient was diagnosed with COVID-19), mouth ulcer and urinary tract infection (UTI). The patient had no known allergies. Concomitant medications included birth control pills daily (unspecified) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. On 06May2021, within a day of receiving the vaccine, the patient had experienced a terrible outbreak of mouth ulcers (canker sores). The patient reported that she rarely got mouth ulcers, might be one time, once or twice a year. These were many large ones in her mouth, throat and were very painful. The patient never had an outbreak like that before. The patient also developed a urinary tract infection (UTI) within a day of receiving the vaccine and reported that she rarely ever got a UTI and it was usually from wearing a bathing suit too long or a specific reason. Both of these reactions were out of the blue and the patient could not think of any other reasons that they would have occurred other than receiving this vaccine. The patient felt like her immune system had completely shut down or weakened for those reactions to occur. The events resulted in doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which included treatment with prescription medications and mouthwash (unspecified). On 06May2021, the patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) and the result was negative. The clinical outcome of the events outbreak of mouth ulcers (canker sores), throat ulcers, large ones in mouth, throat and were very painful, urinary tract infection (UTI) and felt like immune system had completely shut down/been weakened was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
About 2 mins after receiving vaccines she became pale, sweaty, and c/o being tired. Placed on exam table with legs elevated. She recovered after 2-4 min.
Patient contacted the pharmacy today to let us know she was still experiencing arm pain after receiving her vaccines on March 20, 2019. She described it as a throbbing arm pain where it is sometimes difficult to lift up her arm for daily activities. We recommended the patient follow up with an MD for treatment.
Noticed onset of pain and swelling of upper arm with pustules at injection site, swollen lymph nodes in R supraclavicular area the morning after administration of vaccine. Pt presented to health services 2 days after vaccination. Tx: CEPHALEXIN and NSAIDS.
Half of head became very numb; Drooping eye lid; Earache; Sharp pain in head on right side; Pressure behind eye; Tongue weakness in back of tongue on right side; bell's palsy; This is a spontaneous report from two contactable other health care professionals one of the (patient). A 47-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0183), via intramuscular, administered in Deltoid Left on 20May2021 10:20 (age at the vaccination 47-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included been dealing with tinnitus for over a year and hypertension from 12Jul2017 and ongoing. There were no concomitant medications. The patient previously took flush from alcohol and experienced known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient experienced bell's palsy on 20May2021 13:00, half of head became very numb, drooping eye lid, earache, sharp pain in head on right side, pressure behind eye, tongue weakness in back of tongue on right side on 20May2021 03:30 PM. Patient received treatment of Prednisone for the event Bell's palsy. Patient visit physician office for this event. Patient did not receive treatment for other events. The outcome of the event bell's palsy was recovering and not recovered for another events.  Follow up attempts are needed; further information has been requested.; Sender's Comments: Based on available information, a possible contributory role of the suspect product, BNT162B2 vaccine, cannot be excluded for the reported event Bell's palsy due to close temporal relationship. The case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt came into pharmacy @ 11 am on 11/23/2019. They went to the customer service desk stating they were having  a reaction to shots she got on tues 11/19/2019. The patient did not allow the Pharmacist on duty talk to her because she left and went to urgent care. No other information is known because they did did not actually report to urgent care
Patient has a history of obesity and diabetes. Notably, she recently arrived from another country (Unknown date of when she moved) and currently lives with her son. She was seen on 4/25/23 in the ED for wheezing, shortness of breath, chest pain, and chest pressure that has been ongoing for about 5 months. Over the past week, her symptoms have been worsening. On arrival to the ED, she was noted to have oxygen saturations in the low 90's and subsequently was placed on 2L O2 via nasal cannula. Additionally, a COVID PCR test performed in the ED resulted positive. She was admitted 4/25/23 - 4/30/23. Discharge diagnoses included acute hypoxia due to COVID-19 with recurrent reactive airway disease. During admission, the patient was able to be weaned to room air. She has received the primary COVID vaccine series, however the lot number for the vaccine is unknown.
The patient, with PMH significant for asthma, present to ED with concerns for an allergic reaction after her 2nd COVID vaccine. She received the vaccine at approximately 0730, and shortly afterward developed itchiness to her eyebrows, ear canals, and upper neck. She is also feeling like she is dyspneic and wheezing, so used her levalbuterol inhaler with relief. She experienced similar itchiness with the 1st vaccine, and had premedicated herself with antihistamine.  The patient remained asymptomatic throughout her observation period and was discharged.
On 4-11-21 at approximately 5 pm, I fainted while in the bathroom at home.
Dizziness, Diarrhea, NauseaVomiting, chills, fatigue Narrative:
arm felt sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm felt sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm felt sore). On 16-Jan-2021, PAIN IN EXTREMITY (arm felt sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment reported was none for adverse event.   This case was linked to MOD-2021-034426 (Patient Link).
within 15 minutes of receiving the vaccine I started to become itchy.  My face started itching. I left the clinic without saying anything by the time I got home from the clinic another 10 minutes I was itchy all over and my throat started to feel funny.  I immediately took Benadryl  I went to urgent care where they said it was an allergic reaction but did not give me steroids. I continued to itch and have a weird feeling in my throat I then went to my family Dr. where I had hives, extreme itching and they prescribed me steroids.  I did my first round of steroids where I seemed to be getting better.  I finished the steroids and within a day I was back to having hives as well as extreme itching and a very itchy throat again.  Later that day I went to the ER and was put on a second round of steroids., I have finished the 2nd round, I am still itchy not terribly though as of now.
At the injection site, patient instantly had what appear to be a hematoma or quarter sized  bump. The size reduced to a nickel size in 15 minutes. The injection shot bled down to patient's upper elbow. The bleed stopped once Band-Aid was applied.
very sick; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), CHILLS (chills) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick), CHILLS (chills) and PYREXIA (fever). At the time of the report, ILLNESS (very sick), CHILLS (chills) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.    Reporter did not allow further contact; Reporter'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.
BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: MD Admission Date: 6/1/2022 Discharge Date: Jun 6, 2022  PRESENTING PROBLEM: Sepsis [A41.9] AKI (acute kidney injury) [N17.9] Sepsis with acute organ dysfunction without septic shock, due to unspecified organism, unspecified type  [A41.9, R65.20] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 67 year old man who recently had radical prostatectomy with LN dissection for stage IV prostate cancer 6 weeks prior to admission. He had left PCN placed recently for hydronephrosis and right PCN placed for urinary diversion after bladder leak was discovered. Recently tx for E coli uti with ciproflocacin as well.    He presented this time with severe sepsis with aki and left flank pain found to have left PCN tube malpositioned and incidentally covid +. He has hx of copd and has been on 3L oxygen since prior discharge during surgery admission.    He was started on broad spectrum antibiotics and urology and IR were consulted. IR repositioned the left PCN and converted both tubes to nephroureteral tubes for better diversion. Urology had no further reccs.    He also had recent DVT and PE so he was maintained on heparin gtt while home eliquis was held. He required 1 u prbcs for hgb < 7 but had no active bleeding.    IR noted ascites and placed a drain into peritoneal fluid as well.    He grew enterococcus on blood cultures and antibiotics changed to add vancomcin and ultimately de escalated to ampicillin with planned amoxicillin on discharge per ID. Echo was negative for vegetations.    His aki resolved and home lasix was resumed.    PT recommended home discharge which was arranged.
INFLAMMATION; PAIN; PATIENT JUST WANTED TO SLEEP; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (PATIENT JUST WANTED TO SLEEP), INFLAMMATION (INFLAMMATION) and PAIN (PAIN) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced SOMNOLENCE (PATIENT JUST WANTED TO SLEEP). On an unknown date, the patient experienced INFLAMMATION (INFLAMMATION) and PAIN (PAIN). At the time of the report, SOMNOLENCE (PATIENT JUST WANTED TO SLEEP) outcome was unknown and INFLAMMATION (INFLAMMATION) and PAIN (PAIN) had not resolved.            No concomitant products were reported.  On unknown dates, the patient experienced inflammation and pain. In 2021, the patient experienced patient just wanted to sleep. moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. on 03-Feb-2021, she received 1st dose covid-19 vaccine manufactured by moderna. on 03-Mar-2021, she received 2nd dose covid-19 vaccine manufactured by moderna. In 2021, she received moderna booster.  Causality for humira (adalimumab) the reporter's causality for the event(s) of patient just wanted to sleep and inflammation was not provided. The reporter's causality for the event(s) of pain with humira(adalimumab) was a reasonable possibility.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.