chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lump the size of a baseball under his armpit and it feels squishy, not hard; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101706140.  A 37 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Nov2021 14:30 (Lot number: FJ8762) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EN6201), administration date: 10Feb2021, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2, Lot: EN6200), administration date: 28Feb2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 14:30, outcome "unknown", described as "Booster"; AXILLARY MASS (non-serious) with onset 01Dec2021, outcome "not recovered", described as "lump the size of a baseball under his armpit and it feels squishy, not hard".  Follow-up attempts are completed. No further information is expected.
nauseated; Body aches; Sore arm at injection site; very persistent headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (very persistent headache), NAUSEA (nauseated), MYALGIA (Body aches) and VACCINATION SITE PAIN (Sore arm at injection site) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Body aches) and VACCINATION SITE PAIN (Sore arm at injection site). On 10-Mar-2021, the patient experienced NAUSEA (nauseated). In March 2021, the patient experienced HEADACHE (very persistent headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 07-Mar-2021, MYALGIA (Body aches) and VACCINATION SITE PAIN (Sore arm at injection site) had resolved. At the time of the report, HEADACHE (very persistent headache) and NAUSEA (nauseated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Left thigh local reaction=> moderate swelling, mild erthema, local inflamatory response with low grade temps x2 days. Fever 102'99'.
Tachycardia; tinnitus in both ears; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 23Mar2021 (reported Age at Vaccination was 55 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: EN6202) on 02Mar2021 (at 55 years old) as single dose for COVID-19 immunisation, No reaction on previous exposure to vaccine. Caller states he is experiencing since 10May2021, tinnitus in both ears, states he found out that it is being reported that people are experiencing this side effect after the Pfizer Covid vaccine so he wants to report it. States he got the first dose of the Pfizer vaccine on 02Mar2021 and second dose on 23Mar2021. States the tinnitus started on 10May2021, states it first got a little better but over the last couple of days it has gotten worse. States when he had the second vaccine, 9 minutes after the second dose he had tachycardia they rushed him to the ED (emergency department) and they kept him there for 2 hours, did an EKG and he seemed to be doing okay, states the next evening it happened again, ambulance came to his home the next evening, had a  rapid heart beat again, took him to the same hospital, the ED and they let him go in a few hours later and it completely resolved and has not happened again. States he got injections in both his left and right arms, does not clarify which injection went in which arm. The patient was hospitalized for Tachycardia on unknown date. Emergency room visit for Tachycardia. The outcome of the event Tachycardia was recovered on 24Mar2021, for other event was not recovered.  information on the lot/batch number has been requested.
Information has been received from a other health professional referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-JAN-2016 the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L025738 with expiration date 14-AUG-2017, lot # L044707 with expiration date 06-OCT-201, lot # L025738 with expiration date 14-AUG-2017, dose and route were unknown). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe headache, severe stomach ache, temp of 100 degrees, chills, muscle aches
Lt post cervical node; afebrile; tachycardia (120-130min); few shoddy ort tonsillar nodes detected; rx warm packs & APAP
24 hours post injection Pt. c/o pain at injection site (L Deltoid). Gradually increased to sore shoulder. Tx. NSAID, and Physical Therapy
Severe vomiting and diarrhea, & dry heaves, which ruptured blood vessels under eyes & bruising under eyes for over 12 hours.  Luckily it let up before having to take him in to the Emergency Room for treatment to stop the vomiting & diarrhea.
03/19/2021 wife had severe stomach pain, went to urgent care, referred to hospital for cat-scan, admitted to hospital for observation and tests, tests inconclusive, Monday, 03/22/2021 @ 02:42 wife declared dead.
I had no reaction for the first 8 day.  I woke up on the 9th day with itchy arm. When I looked at the are it was red, felt hot to touch at the injection site and was swollen. This lasted 2 days (day 9 and 10). On day 11, it appeared to be going away and my are looked mostly normal on 2/17, I noticed the knot in my arm had disappeared by I thin had a large read ring shaped rash that covered the entire width of my arm. It feel irritated and is warm but not painful. No other symptoms.
This spontaneous report was received from a Registered Nurse, referring to two patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. It was reported that improperly stored doses of VARIVAX (Merck) Lot # L029466 with expiration date on 06-AUG-2017 and Lot # L024367 with expiration date on 08-SEP-2017, (dose and route were not reported), were given to the patients on 04-APR-2016. It was unspecified which of the above lots the patients received. No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
2" area of redness around injection site on (R) arm. Harder spot in center. Offered BENADRYL 25mg (pt. declined) offered ice/hot bag pt accepted. Pt. reports not painful. Physician notified 1/5/15.
Vertigo and lightheaded ness starting 4 days after receiving vaccine; Vertigo and lightheaded ness starting 4 days after receiving vaccine; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Apr2021 at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included colon cancer, asthma and fibromyalgia. The patient had known allergies to azithromycin (ZITHROMAX). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, 4 days after vaccination, the patient experienced vertigo and light-headedness. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo and light-headedness was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On Monday Sept. 19 I had my annual flu shot, and the "mild problems" - aches, headache, fever, and a dry wheezing cough - that "usually" last two days continued beyond that point. By the fourth day the aches and headaches were gone but the fever and cough continued. The cough is best described as a dry wheezing asthmatic cough that came in uncontrollable bursts. I have never had asthma. I have had bronchitis and pneumonia but never a dry wheezing cough like this unaccompanied by any congestion in my chest. The coughing left my ribs sore and with a feeling that my brain had been rattling against my skull. The fever was in the 101 to 103 degree range and like the cough persisted without abatement for 10 days. I managed the fever with ADVIL. On th 11th day I went to the doctor who confirmed that I did not have bronchitis or pneumonia but was unable to identify the cause of the persistent cough and fever. I was prescribed a 5-day course of antibiotics and a cough suppressant. By the fourth day the fever ended. The cough has gradually gotten better, but as of today, October 13, still persists in a mild form.
1st shot made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (happened around 2017 before covid), blister (had blisters from the right side of back, up neck to around right ear), pruritus (itched) and pain (hurt a little).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient previously had shingles happened around 2017 before covid and she had not gotten the shingles shots yet and reported no, the vaccination or covid had nothing to do with it. The patient reported that like the other lady, her case was rather mild and had blisters from the right side of back, up neck to around right ear. It itched and hurt a little, but nowhere near what these other people were describing. The patient went to the doctor and took her medications later it cleared up. The patient got the first Shingles shot which made her sick. The patient reported that her doctor told her that might just want pass on the second shot. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Patient experienced one week of diarrhea, abdominal pain, fatigue, and cough for 2 weeks. She came to ED on 7/31/2021 and tested positive COVID PCR. She was hospitalized on 7/31/2021. She also stated her husband is currently hospitalized for Covid.  Note: patient completed the series of COVID19 Pfizer vaccines in Feb, 2021.  8/4/21: patient discharged.
When receiving the vaccine I felt a pain run down my arm, within minutes my left hand went numb.    Weeks later my hand still feels like I have carpal tunnel and my outer hand, ring finger and little finger get tingly, burning painful sensation.
After receiving her shot, the patient was walking the store aisles when she felt weak and dizzy. She was helped to a seat by a nurse and a paramedic who happened to be walking in the aisles at the same time. she responded fairly well to a mental state exam and was asked if she has a history of  illness or chronic health conditions to which she replied no. Out of an abundance of caution the paramedics were called in to further evaluate her vital signs. they offered to take her to a nearby hospital to which she reluctantly agreed.
I've had recurring massive nose bleeds, the first on 10/7.  I've had another 4 since that date, 3 Emergency Room visits because the bleeding will not stop.  Last massive nose bleed was 12/9, ER doctor packed my left nostril, that hurt like hell, packing stayed in my nostril for 5 days and was seen by ENT doctor who removed it and said my nostril looked like hamburger.  Used Afrin for 4 days and put vaseline inside both nostrils until I was seen again by ENT doc.  Saw ENT doc again 1/5, he still couldn't tell me anything and prescribed a staff infection ointment that I used until today in both nostrils, 1/14.  My nose feels a bit better but all the other abnormal symptoms remain; i.e., congestion, stuffiness, unable to breathe most of the time through my nose, inability to sleep soundly, pressure behind eyes and in nose, etc.  For the record I've not ever had a nosebleed in my life.  The nose bleeds, blood runs down my throat while my nose is clamped, clots come out of my throat and nose, it's gross.  I'm anxious waiting for the next one since they come on with no warning and anxious about why this is happening.  The good news is I haven't had another nosebleed since 12/9 and I have another appointment with a different ENT doctor for a second opinion Monday, 1/17, at 3 pm.  I'm requesting an MRI and bloodwork done - CBC, PT, PTT, INR, and bleeding and clotting for starters at the recommendation of a friend that's in the medical field.
No additional adverse effects were reported; patient received and expired dose of PEDVAX HIB; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 03-DEC-2019, the patient was vaccinated with an expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), 0.5 milliliter, once, lot # R034340 and expiration date 23-NOV-2019 was an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) (route and anatomical location were not provided) for prophylaxis. No additional adverse effects were reported.
Severe headaches after shot, both 1st and second shots, I never had headaches like this before? slowly disappearing
Patient was scheduled for second dose at appropriate interval 28 days from first dose 3/30 to come back on 4/27. Patient presented 4/13 on day 14 since she thought the next appointment was 2 weeks, not 4 weeks. Patient bypassed the screening process and this was not caught by registration or vaccination. Patient was called after the error was discovered and her primary care provider was also informed of the situation.
Chills, body aches, headache, strong fatigue, soreness injection site  lasting ~36hours
Next day after given Influenza seasonal vaccine 2017 weakness in lifting full water glass shaky hands. This is when I first noticed symptoms of Parkinson's Disease.
Itching, pain, and swelling at injection site which has gotten worse on day 2 than day 1.  Also constant pain and swelling under armpit of left arm.  Headache, back and neck pain, and chills with cold sweats.
after the injection I became lightheaded and my blood rose to 155/94. after a hour both my pressure and lightheadness went away. on 1/1 I felt fatigue at work and the injection site began to hurt. On 1/2 I stood home and was still fatigue and had some tension in my neck area. On 1/3 began to feel better no pain at the injection site, no longer fatique, and no tension on my neck.
Myalgias, chills, headache, fatigue and fever 100.8 F
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 52-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 (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients.  No Treatment medication reported.
Flu like symptoms: joint pain, nausea, vomiting, diarrhea, body-ache, fatigue
I got my injection at 11:00 am. At 6:00 pm, I started to have body aches, chills, nausea, fever, and  headache. Went on for a day.
chest pressure; back pressure; pain in hardware; puking; migraines; nausea; fever; injection site pain; tired; muscles pain; chills; joint pain; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date was not reported) via an unspecified route of administration, administered in arm right on 05May2021 17:30 (at the age of 43 years old) as dose, 2 single for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing, Hyperglycemic, renal disorder from an unknown date and unknown if ongoing, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing, limb discomfort from an When probed for other medical condition, consumer stated, I had hard legs (not clarified), multiple allergies from an unknown date, and unknown if ongoing, known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date was not reported) via an unspecified route of administration, administered in arm right on 14Apr2021 17:30 (at the age of 43 years old) as dose, 1 single for COVID-19 immunization. On 05May2021 17:30, patient experienced chest pressure, back pressure, pain in hardware, puking, migraines, nausea, fever, injection site pain, tired, muscles pain, chill, joint pain, and feeling unwell. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccine in four weeks. The patient took other medications a bunch in two weeks. Adverse events resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 25Apr2021. The outcome of the events was not recovered.  Information about the Lot/batch number has been requested.
Incorrect vaccine was given for childs age group. Pfizer vaccine for ages 12years and older was given to this 8 year old. This submission is to report the vaccine error, no adverse reaction noted at this time.
04/08/23 presents to EC ED for "altered mental status, fatigue". PMHx of "hypertension, Alzheimer's, A-fib on Xarelto"
pt devel shingles exactly 7 days p/vax;pt suspect was given chicken pox vax by accident/mistake instead of rubella;
This spontaneous report was received from a pharmacist via a field employee regarding a female patient of "around 50 years of age". No information about medical history, drug reactions and allergies was specified. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, dose, route not reported) vial 19400 plaque forming unit (PFU). No concomitant medications were reported. The field employee reported that the pharmacist reported to her that the patient developed rash, redness, and swelling after ZOSTAVAX was administered. The patient sought medical attention with the pharmacist. There was no product quality complaint. VZVIP pack was faxed to pharmacist. Field employee reports that the pharmacist reported to her the patient has recovered from the above adverse events at an unspecified date. The causality of the event was not specified by the reporter. Additional information has been requested.
Pt c/o tickle in throat, throat itching, anxious, tingling, lump in troat 5 min. post injection. 1351 epinephrine 0.3mg IM left V.L. 1354 Benadrly 50mg IM right deltoid. O2 @ 2L via NC.  transported to E.D. via guerney to triage.