chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Cancer".  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Fever, NauseaVomiting, FATIGUE Narrative:  STAYED HOME FROM WORK
Redness approx lg egg size, edema, pain warm to touch, initial itch.
Headache; chills; pain in  joints (shoulders, elbows, hips); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: otherwise good health. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 13Oct2023 at 18:00, outcome "recovered" (14Oct2023 at 06:00); CHILLS (non-serious) with onset 13Oct2023 at 18:00, outcome "recovered" (14Oct2023 at 06:00); ARTHRALGIA (non-serious) with onset 13Oct2023 at 18:00, outcome "recovered" (14Oct2023 at 06:00), described as "pain in  joints (shoulders, elbows, hips)". Therapeutic measures were not taken as a result of headache, chills, arthralgia. Additional information: No other vaccine in four weeks. The patient experienced headache; chills; pain in joints (shoulders, elbows, hips), all lasted about 12 hours post-vaccine injection. No covid prior to vaccination. Not tested for covid post vaccination. No known allergies.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
I had a telehealth appointment with a doctor. He did an exam over the phone. I was told that I have shingles. I was prescribed a medication for it.
Aching right arm pain with tensed upper arm muscle as well as a  clear demarcated red rash about the size of my hand. Rash is hot to touch, but not raised. Started 24 hours ago and is continuing with these symptoms. Nothing notable  occurred before pain and rash came on.  Taking NSAIDs for pain and will be taking Benadryl at night in hopes of clearing up the rash.
Information has been received from a licensed practical nurse concerning a 21 year old female with penicillin allergy who on 29-MAY-2008 was vaccinated with a first dose of 0.5 ml GARDASIL via a subcutaneous route. There were no concomitant medications. On 29-MAY-2008, after receiving her first dose she felt lightheaded, the injection site became red and swollen, pain radiated down to her pinky and she felt "tingles" on the left side of her face. She sought unspecified medical attention from the nurse. At the time of the report the patient was recovering. Additional information has been requested.
No adverse event occurred; The patient received a dose of GARDASIL 9, but the product expired; This spontaneous report was received from medical assistant referring  to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 10-NOV-2022, the patient was vaccinated with an expired  dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot number s028738, with an expiration date: 03-APR-2022 (strength, dose, anatomical site injection, route of administration  were not provided) (expired product administered). No adverse event occurred.
Patient received her vaccine at the community center.  2 hours later at her home she became lightheaded and dizzy with nausea.  She stated she almost passed out (fainted) but didn't.  Called her mother to let her know.  The next day (5/27/2021) she woke up feeling fatigued with headache, dizziness, body chills and fever (temp 99.5).  Later that day her headache had gotten worse, she took Ibuprofen with no relief .  She went to pharmacy on the following Tuesday pm and got some Sudafed.  She called the health department and was advised to call her physician.  The doctor office sent her to Urgent Care on 6/3/2021.  She was diagnosed with Strep Throat and she received a shot for her headache and a Z-pack antibiotic for the strep  throat.  She has improved. following the treatment.
Onset of diarrhea 4 days after 1st dose of Rotateq, profuse, presented 12-24 hours later with dehydration (10%) 2/25/09-records received for DOS 2/9-2/14/09-DC DX:Metabolic acidosis and dehydration requiring subspeciality care in intensive care unit management. Day before admission developed sudden onset of profuse water, frequent stools and 10% weight loss. 3/16/09-records received for DOS 2/14/09-Transferred from another facility-one week history of bloody diarrhea and weight loss and metabolic acidosis. Heart murmur detected echo showed small VSD but otherwise normal.
Approximately 06/06/14 pt developed asymptomatic papules on the dorsal side of hands, elbows and knees.
A week after 2nd dose, I broke out in red circular somewhat itchy marks and oval welts ranging from small to about an 1" in diameter or length on arms,legs, back, chest.; This is a spontaneous report received from a contactable consumer, the patient. An 82-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the right arm on 13Mar2021 at 09:30 (at the age of 82-years-old), as a single dose for COVID-19 immunisation. Medical history included occasional sciatica and some hearing loss. The patient did not have any known allergies to food, medications, or other products. The patient did not receive any other vaccine 4 weeks prior to COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the right arm on an unspecified date in Feb2021 at 09:30 (at the age of 82-years-old), 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. On 21Mar2021 at 17:00, the patient broke out in red circular somewhat itchy marks and oval welts ranging from small to about an 1" in diameter of length on arms, legs, back and chest. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures included treatment with BENADRYL and calamine lotion (MANUFACTURER UNKNOWN). The clinical outcome of welts was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2013US001278 is an initial, spontaneous report combining follow-up information received from a physician on 14 Jan 2013: This report refers to a 67-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on to left upper arm on an unknown date in Nov 2011. The reporter stated that 24 hours after vaccination, she experienced a rash that covered most of her upper left arm surrounding the area of injection. The rash was warm, burning and was believed to be cellulitis. It was reported that the patient was now reluctant to receive vaccine again. The outcome of the event was not reported. No further information was provided.
2 days p/receiving MMR had stiffening of joints of hands, elbows, & knees; also had red, bumpy, splotch areas; seen by MD 20AUG; 10SEP92 no more spots or aching joints;
cramping in legs,; coughing; headaches; Constant  pain in the left shoulder; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration in the left arm on 08Mar2021 at 11:00 (at the age of 59-years-old) as a 0.3 ml single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient had received unspecified other medications within 2 weeks prior to the COVID-19 vaccine as concomitant medications. The patient had known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Mar2021 at 12.00, the patient experienced constant pain in the left shoulder, cramping in legs, coughing and headaches. On 11Mar2021, the patient had nasal swab test and resulted negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The therapeutic measure was taken as a result of events and included treatment with Tylenol. The clinical outcome of the events pain in the left shoulder, cramping in legs, coughing and headaches were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Three (so far) episodes of VERY severe nosebleeds lasting up to 30 minutes. Not normal for me.
had the Pfizer Covid19 primary series and 1st booster vaccines/ tested positive for Covid; had the Pfizer Covid19 primary series and 1st booster vaccines/ tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Sep2022 as unk, single (Batch/Lot number: unknown) for 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 Sep2022, outcome "unknown" and all described as "had the Pfizer Covid19 primary series and 1st booster vaccines/ tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: she and her 80 year old husband both tested positive for Covid last Tuesday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: It was reported that, caller was a 78 year old female patient and states that she and her 80 year old husband both tested positive for Covid last Tuesday and started taking Paxlovid yesterday. Caller states that she and her husband have had the Pfizer Covid19 primary series and 1st booster vaccines and had the flu shot last Wednesday.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201198148 Same vaccine/event, different patient;
Nothing has been. Done.  Warm to touch, very tender red circle is about the size of a grapefruit.
Dose error Patient aged 16 yrs Moderna Vaccine product not indicated for use in persons under age 18 yrs
soreness in elbow of the arm where injection was given; soreness in muscle of the arm where injection was given; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness in muscle of the arm where injection was given) and PAIN IN EXTREMITY (soreness in elbow of the arm where injection was given) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (soreness in muscle of the arm where injection was given) and PAIN IN EXTREMITY (soreness in elbow of the arm where injection was given). At the time of the report, MYALGIA (soreness in muscle of the arm where injection was given) and PAIN IN EXTREMITY (soreness in elbow of the arm where injection was given) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided.
Initial information received on 18 November 2013 from a consumer who is the patient. A female patient, age not reported had FLUZONE HD vaccine, batch, route and site of administration not reported, in September 2013. The patient had no ill effects at the time of the vaccine. Concomitant medications and medical history were not reported. On October 1st the patient had a corneal transplant. The patient began experiencing problems with rejection on an unspecified date. The patient was seen by a physician on an unspecified date. The patient outcome was not reported. No further details were available at the time of this report. Documents held by sender: None.
Fifteen mins after receiving vaccine, I had a numb feeling in left jaw and lower teeth which spread to the arm and then hand.  It was not severe, rather it felt like the after effects of having a dental numbing shot.  About 20 minutes later I could feel it in my hip and left leg.  The numbness subsided after about an hour.   After that I felt a little tired with sore muscles everywhere.  This is the same feeling as when the flu is coming on.  That evening at approximately 9:00PM I became sick with high fever of 102 with uncontrollable shaking related to the fever .  After a hot shower which calmed the shaking and 2 Motrin I was able to sleep and by morning the fever was broken.   I felt hungover upon awakening with a headache.  Two more Motrin and feeling much better, just tired after a long night.   I had not expected these side effects and when I searched the expected side effects and didn't see these symptoms I thought I should report it.   Prior to taking the vaccine, my husband and I were in deep quarantine for the birth of our granddaughter for 3 weeks.  The first time out among other people was at the vaccine facility.  It is highly unlikely that I could have been exposed to an illness before the vaccine.  And, it was immediately upon receiving the vaccine that I began to feel symptoms.  I am 100% positive my illness overnight was due to the vaccine.
BODY ACHE; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient have no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 04:00, the subject experienced body ache. On 06-APR-2021 04:00, the subject experienced chills. On 06-APR-2021 04:00, the subject experienced headache. On 06-APR-2021 04:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and headache, and the outcome of body ache and chills was not reported. This report was non-serious.
I'm not feeling too good; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I'm not feeling too good) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I'm not feeling too good). At the time of the report, ILLNESS (I'm not feeling too good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Tinnitus and hearing loss in right ear.    Stuffed sinus.  Headache.  Mussel ache.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 20-year-old female patient who received FLUARIX QUADRIVALENT. On 1st November 2017, the patient received FLUARIX QUADRIVALENT (intramuscular). On 1st November 2017, 45 min after receiving FLUARIX QUADRIVALENT, the patient experienced injection site itching, injection site extravasation and injection site injury. On an unknown date, the outcome of the injection site itching, injection site extravasation and injection site injury were unknown. It was unknown if the reporter considered the injection site itching, injection site extravasation and injection site injury to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient called the pharmacist to report that, 45 minutes after vaccination, she started to experience itchiness at the injection site. After she scratched it, there was oozing of clear to colorless liquid from the injection site.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 20-AUG-2014 the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular (lot # not reported) that underwent a temperature excursion. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Patient started sweating and acted like overheated. she mentioned she has anxiety issues and she didn't have breakfast either.
Headache, Myalgia, Diarrhea, night sweats Narrative:
Local erythema, warmth, 5x5cm and 3x3 area on (L) outer arm. Deltoid area.
INITIAL SYMPTOMS INCLUDED ITCHING, REDNESS, BUMPS, TINGLING TO LEFT EAR. PROGRESSED TO RIGHT EAR JAN.01 2021 WITH "SKIN FLAKING" TO BOTH EARS. JAN  01 2021, EYE IRRITATION, ITCHING TO FACE AND EYES, "FEELS DRY AND IRRITATED". SYMPTOMS OPNGOING AT TIME OF REPORT. PT  ABLE TO RETURN TO WORK.
she felt like her heart was cold; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: CL0142), via an unspecified route of administration in left arm on 09Jan2021 at single dose for COVID-19 immunization. Medical history included stage 3 kidney disease and high blood pressure from an unknown date and unknown if ongoing. The patient was asking, "Does the vaccine stay cold in your body? Since the vaccine has to be kept at such a cold temperature in storage when it is injected does it have to stay cold. Is it ok to take the medicine that the doctor has given me along with the vaccine, should I stop or hold some of my medicine?" Is it normal to have a "cold feeling in her heart after getting the vaccine?" The patient stated that she felt like her heart was cold on 12Jan2021 so "I put my hand there to keep it warm". She stated, "Is this normal after getting the vaccine? The patient received her first vaccine dose on Saturday and yesterday she felt like her heart was cold. The patient saw her primary care in Dec2020 for her annual check up and they recommended that she get the vaccine. She is only on her normal medications. She called her doctor to ask if any of her medications could have reacted with the vaccine, but they said to take her medication like usual. The patient stated, "this feeling lasted about an hour." The outcome of the event was recovered on 12Jan2021. No treatment was given to the patient for the event.
patient felt dizzy and then blacked out. he also had aches and pains and was cold and hot and had nausea and diarrhea
I started my menstrual cycle after 22 days and was very heavy. Every cycle after has been early and very heavy with clots. For reference my cycles have always been at least 30 days in-between or more. Regular flow the first few days and taper off after that. My cycles now are substantial and last for at least 7 days or more. Heavy every day with no taper off.
Patient said he wasn't feeling well immediately after the injection. Patient began sweating and passed out. Patient then convulsed. 911 was immediately called. While awaiting EMS, patient woke up, and was alert and oriented. EMS responded and did not transport to ER. Family came and picked up patient. EMS advised to call doctor.
Pediatric dose to an adult; Pediatric Engerix administered to an adult; This case was reported by a physician via call center representative and described the occurrence of underdose in a 34-year-old male patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B with an associated reaction of therapy non-responder (received 1st series on an unknown date and the patient did not respond to first series, refer case US2022AMR022533) and Engerix B (received 1st two doses of Engerix B of second series on an unknown date).   On 4th February 2022, the patient received the 3rd dose of Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 4th February 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR022533  Additional details were provided as follows: Medical doctor stated that a pediatric dose of Engerix B was administered to an adult patient, which led to underdose and adult use of a child product. The reporter stated that this was 3rd dose of second series due to which patient repeating the whole series because patient did not respond to first series. The reporter wanted to know how to proceed with Engerix B series. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR022533:Same patient, different series