chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; fatigue; headache; This is a spontaneous report from a contactable nurse, the patient. This 36-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3240) via intramuscular route in the left deltoid on 11Jan2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK5730, Expiry Date: 31Mar2021) via unspecified route in the left arm on 21Dec2020 at 14:00 (at the age of 36-years-old) and experienced extreme/severe fatigue, headache, sore throat, lightheaded, felt run down, felt out of sorts/ feeling unwell, bizarre feeling/felt really bad, soreness around injection site/sore arm, and wondered if being on Stelera made the symptoms from the COVID vaccine worse. On 12Jan2021 at 02:00, the patient experienced body aches, fatigue and headaches, all worse with second vaccine. The symptoms started approximately 12 hours post vaccine. The patient reported that the second dose reaction was much worse but shorter in duration. The body aches, fatigue and headaches did not require a visit to the emergency room and the patient was not admitted to the hospital. The body aches, fatigue and headaches did require a phone visit to the physician's office. There was no treatment required for body aches, fatigue and headaches. The clinical outcome of body aches, fatigue and headaches was recovered on an unspecified date
Received second dose 2 months after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 2 months after first dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 2 months after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 2 months after first dose) outcome was unknown. No concomitant medications were reported. Treatment information was not provided. Reporter did not allow further contact
PATIENT REPORTED ARM NUMBNESS IN THE AFTERNOON AFTER THE VACCINE WAS GIVEN IN THE ARM. AS THE DAY PROGRESSED THE FACE, THROAT AND LIPS STARTED TO SWELL. PATIENT WENT TO URGENT CARE AND RECIEVED BENADRYL INJECTION. ACCORDING TO PATIENT THIS IMPROVED SYMPTOMS BUT FACE STILL FEELS STIFF AS OF TODAY 8/19. SHE WAS ENCOURGED TO FILL THE RX GIVEN TO HER FROM URGENT CARE MD FOR ORAL STERIODS.
A lot of brain fog; Dizziness; Joint pain; Trouble sleeping; Confusion; Fatigue; 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 63-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 01, Age: 63 Years), when the patient was 63 years old, for Covid-19 immunization, reaction(s): "Joint pain", "Dizziness", "Brain fog", "Headache". The following information was reported: FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "unknown", described as "A lot of brain fog"; DIZZINESS (non-serious) with onset Feb2021, outcome "unknown", described as "Dizziness"; ARTHRALGIA (non-serious) with onset Feb2021, outcome "unknown", described as "Joint pain"; INSOMNIA (non-serious) with onset Feb2021, outcome "unknown", described as "Trouble sleeping"; CONFUSIONAL STATE (non-serious) with onset Feb2021, outcome "unknown", described as "Confusion"; FATIGUE (non-serious) with onset Feb2021, outcome "unknown", described as "Fatigue".  Additional information: The patient received his 3rd (Booster) dose of Pfizer Coronavirus vaccines on 31Aug2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; Lot that had been expired, administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Lot that had been expired, administered to patient) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Lot that had been expired, administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Lot that had been expired, administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Lot that had been expired, administered to patient).    NDCID number was reported as 80777027398.  Patient age was reported as 40 years and 01 month.  Concomitant product use was not provided by the reporter.  Reportedly, the number of patients at facility that received this Moderna vaccine between 08-Apr-2022 and 15-Dec-2022. Additionally, In the second list, reporter discovered a past lot that had also been expired and administered to patients with batch number as 065F21A.  Treatment information was not provided.
Took Vivotif with hot coffee; Spontaneous report received on 13DEC2019.  A 56-year-old female consumer reported that she "took Vivotif with hot coffee" (PT: Product administration error), while being on Vivotif for typhoid prophylaxis. On an unknown date in June, the consumer took all four doses of Vivotif and drank coffee each time within 10 minutes after taking Vivotif. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif with hot coffee (Product administration error). Vivotif should be taken with cold or lukewarm water. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took Vivotif with hot coffee (Product administration error). Vivotif should be taken with cold or lukewarm water. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Patient received Under dilted dose of Pfizer 5-11 covid vaccine. No adverse effects reported at this time.
given an expired vaccine TENIVAC to a patient 2 weeks ago, with no reported adverse event; Initial information received on 01-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a patient of unknown gender and age who was given an expired vaccine tenivac to a patient 2 weeks ago, with no reported adverse event while receiving vaccine Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (dose, route, strength, formulation, frequency, batch lot number: unknown), expiry date: 15-May-2022 in unknown administration site as immunization.  On an unknown date the patient developed a non-serious event given an expired vaccine tenivac to a patient 2 weeks ago, with no reported adverse event (expired product administered) (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a nurse concerning a 15 year old female with no medical history and no known allergies who on 23-OCT-2007 was vaccinated IM with the first 0.5 ml dose of GARDASIL. On 04-JAN-2008 the patient was vaccinated with IM with the second 0.5 ml dose of GARDASIL (Lot # 658563/1063U) and on an unspecified date was vaccinated IM with the third 0.5 ml dose of GARDASIL (Lot # 65863/1063U). Concomitant therapy included birth control shot. The patient cried with the second dose but did not have severe pain. After the third dose, the patient experienced severe pain radiating to her shoulder and elbow. She was doubled over in pain. She was treated at home with an ice pack and TYLENOL. At the time of reporting, patient was recovering. Unknown medical attention was sought in the office. No product quality complaint was involved. Additional information has been requested.
On day 8 after receiving vaccine my left arm started itching around site and is red and a little puffy.
Suddenly, post vax, multiple erythematous nodules, shown on the injection sites. Then pt had maculopapular rashes spray rapidly from head to toes, then urticaria was noticed. He had loss of muscle tone and response good to Decadron, Epinephrine and Diphenhydramine.
Shot administered, immediate painful within 1 hour swelling occurred, became tired. Next day throat felt "funny" went to physician and started on ZYRTEC 2 x 10 mg now 1 BID. No fever.
Increasing pain after 2-3 days. Shoulder mobility restricted with inability to lift/move over head. Strange circular bruise patter on right shoulder. Aleve started on third day provided significant relief. Doctor's office instructed me to continue Aleve and report if condition doesn't improve or worsens. It is now Day 4 with mild pain with movement after continuing Aleve. Still restricted ability to lift over my head.
6 hours after the vaccine my Tinnitus  increased to volume of 8 out of 10 for 3 hours. After 3 hours went to normal 2 out of 10.  on March 25th it went back up to 8 out of 10 , remains today.
During the first 5 minutes of the 15 minute observation period, I noticed tingling at the base of my palms. After the 15 minutes had elapsed, I went to out to my car and after taking a photograph of myself, I noticed that my forehead was red and splotchy, palms still tingly. I decided to sit in my car for another 15 to monitor how I was feeling. During this time, I noticed tingling under my chin and in my upper neck. After a total of 40 minutes had elapsed since my vaccination and after my symptoms had not worsened, I decided to head home on a route that had a hospital I could stop at if necessary. Fortunately, the tingling didn't get any worse on the way home. It is worth noting that I did not eat before getting the vaccine and that I have received botox injections in my forehead (5 months ago now). I plan to mention these  strange side effects at my next appointment.
Slight rash on face, onset began 06/25, ten days post vax. Upon exam it appeared as scattered pox marks on face and body. She was happy and playful despite rash and appeared to be feeling well at time of examination.
Migraine - started 3 days after receiving vaccine (received vaccine on 3/5/21; migraine started 3/8/21). My migraines occur every 30-40 days ... this migraine started 17 days after my last migraine.
About an hour after getting the vaccine in my left arm, I felt a tingling feeling in my left hand and all fingers, like "pins and needles."  This lasted throughout the day and evening and subsided the next morning. Additionally, the area around the injection site was slightly swollen/puffy, which lasted about 2 days.
Within hours of vaccination, pt developed mild itching over his entire body, severe scalp itching and headache. Pt recovered after approximately 2 weeks.
RASH DEVELOPED ON BUTTOCKS, ARMS, LEGS. STILL PRESENT THIS DAY BUT NOT AS PRONOUNCED DOCTOR PRESCRIBED STEROID MEDPAK
Swelling, redness, hot to touch at injection site. Symptoms started 12-18 hrs after admin. Treating with cephalexin suspension 250 mg/5ml (7.5 ml PO BID X 7 days) . Diagnosed with cellulitis of left lower limb.
Severe muscle cramps then fainting. Low blood pressure (80/60) and heart rate (<50 bpm)
Tested positive for covid-19; Tested positive for covid-19; This is a spontaneous report from a contactable consumer (patient) via female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN) via unspecified route of administration on 14Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient tested positive for COVID-19 on 29Mar2021.There was no PQC reported. On 06Apr2021, patient was scheduled for 2nd dose. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
swelling on the injection site; The area is red and warm to touch; It also itched in the beginning but is now light pink.; The area is red and warm to touch; Initial information received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA128665 and 2023SA130929.  This case involves a 17 years old female patient who experienced swelling on the injection site, the area is red and warm to touch, it also itched in the beginning but is now light pink while receiving vaccine Yellow Fever Vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 14-Apr-2023, the patient received at dose 0.5 ml at standard strength of suspect Yellow Fever Vaccine(lot: UJ782AA, Expiry date: 17-Feb-2024) via subcutaneous route in unknown administration site for Prophylactic Vaccination (Immunization).  On an unknown date the patient developed swelling on the injection site (vaccination site swelling), the area is red and warm to touch (vaccination site erythema) & (vaccination site warmth) and it also itched in the beginning but is now light pink. (pruritus) (unknown latency) following the administration of Yellow Fever Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
No adverse event; Dose 1 Janssen, Dose 2 (booster) Moderna 0.5ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Dose 1 Janssen, Dose 2 (booster) Moderna 0.5ml) and NO ADVERSE EVENT (No adverse event) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Denied allergies to medication, food and other products  The patient had not been diagnosed or tested positive for COVID-19. No chronic and acute illness at the time of vaccination and one month prior.  Previously administered products included for Drug use for unknown indication: Janssen (Dose 1) on 13-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen. Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) for an unknown indication.    On 07-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Dose 1 Janssen, Dose 2 (booster) Moderna 0.5ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Dose 1 Janssen, Dose 2 (booster) Moderna 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Dose 1 Janssen, Dose 2 (booster) Moderna 0.5ml).    No prescriptions, over the counter medications, dietary supplements or herbal medicines being taken at the time of vaccination and or at the time of adverse event.  Treatment information was not provided.  This case was reported for 10th patient out of 20 patients.   This case was linked to MOD-2022-665504 (Patient Link).
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 12-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Severe chills, body aches, weakness and malaise. Severe pain at injection site and all through L arm that effected ROM and strength.   All signs and symptoms that I described lasted 48 hours.
mom stated child had a little fever AM 15JAN97;didn't act sick;acted like had a little cold;gave APAP that afternoon;7PM temp got higher & started jerking;taken to ER adm to hosp;pt exp eye rolling back;resp 32;perihilar pneumonia,feb sz
Approximately 60 seconds prior to emergency, patient felt a sense of panic (first time ever).  Stated to me (wife) "I feel like I am having a panic attack" as we walked on to a parking garage elevator at 12:30 pm on 1.22.21.  As I turned to push the button to go down, leaned against the wall of the elevator. His eyes fluttered and back, he was a little pale.  When I turned around, again, he fainted and fell face down on the elevator floor.  He never stopped breathing and had no convulsions.  He was out for less than 30 seconds. When he came to, he got up by himself with minimal assist from me (911 was already on their way).  He did not remember saying that he felt like he was having a panic attack; but he remember the fear/panic he felt just prior to.  He was oriented x3.  I had him smile, stick his tongue out and speak to make sure it was not a TIA or stroke and there were no symptoms of that.  His bladder did release.  He went by ambulance to the ER (we were on a mini vacation to celebrate his birthday). They did a CAT scan, checked his blood sugar twice, EKG twice, complete blood work panels and urinalysis  All tests were either normal or negative.  They found nothing.  His BP was normal for the first 30 minutes at the hospital, then increased.  But has been normal ever since (he checks it daily). Absolutely no other symptoms since that episode.  He met with our PCP on 1.29.21 as a follow-up and she directed us to complete this form. She has ordered a consult with a Neurologist and that is scheduled for 3.10.21.  His second shot for the vaccine is due on 2.9.21.
sickle cell crisis; This is a spontaneous report received from a contactable consumer (patient herself). A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 12Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 6 or 7 days later after receiving the first dose of the Pfizer Covid vaccine, the patient started to experience a sickle cell crisis which was continuing and had not resolved. The patient wanted guidance and also wanted to know if she should get the second dose. Outcome of the event was not recovered.  Information related to the lot/batch number has been requested.
LEG CRAMPS; SHORTNESS OF BREATH; FEELING SLEEPY; DIZZINESS; HEAVY HEAD; VISION NOT NORMAL; NAUSEA; FEELING VERY TIRED; FEVER; MUSCLE PAINS; BODY ACHES; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced muscle pains. On 09-APR-2021, the subject experienced fever. On 16-APR-2021, the subject experienced dizziness. On 16-APR-2021, the subject experienced heavy head. On 16-APR-2021, the subject experienced vision not normal. On 16-APR-2021, the subject experienced shortness of breath. On 16-APR-2021, the subject experienced feeling sleepy. On 16-APR-2021, the subject experienced nausea. On 16-APR-2021, the subject experienced feeling very tired. On 18-APR-2021, the subject experienced leg cramps. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No Information (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, muscle pains, and fever on 11-APR-2021, and leg cramps on 18-APR-2021, and had not recovered from nausea, dizziness, feeling very tired, heavy head, vision not normal, shortness of breath, and feeling sleepy. This report was non-serious.
Headache; Dizzy when standing; arm pain; fever; This is a spontaneous report from a non-contactable consumer (patient).   A 25-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL3247), via an unspecified route of administration, in right arm on 10Feb2021 at 10:45 (at the age of 25 years old) as a dose 2 single for COVID-19 immunization. Patient had medical history of shellfish allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC). Patient doesnt had a COVID prior vaccination. Patient had not tested to COVID post vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247) in left arm on 20Jan2021 at 10:45 as a dose 1 single for covid-19 immunization. On 11Feb2021 the patient experienced headache, dizzy when standing, arm pain and fever. The patient did not receive any treatment for the events. The outcome of the events was recovered on unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Erythema 9x11cm left deltoid.  No induration, slight warmth, slight tenderness.