chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm 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) and on 28Apr2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "TIA" (unspecified if ongoing); "colon cancer" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Epinephrine, reaction(s): "Known allergies: epinephrine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient received Paxlovid from 28Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient alerted nurse in observation that she  felt cold and clammy. nurse observed patient looking conscious but lethargic. Nurse immediately called for emergency medical assistance. patient then complained of n/v and proceeded to vomit. EMS arrived on scene and evaluated patient and patient refused to be transported to the hospital and stated she was nervous and felt ok.
RASH ALL OVER BODY; STINGING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination on left deltoid. . No concomitant medications were reported. On MAR-2021, the subject experienced stinging. On 11-MAR-2021, the subject experienced rash all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash all over body, and the outcome of stinging was not reported. This report was non-serious.
Paresthesia. Pins and needles through out body. Bruising with no pain at the site of injection
Within two days of receiving my second Pfizer dose I began experiencing menstrual spotting and by 4/27/2021, my period started. It was 7 days early and I am *never* early?my cycle has been 28-30 days like clockwork since I started menstruating in 1993. My flow has been much heavier and I have had a lot of large clots which is very unusual for me.
Had headache, congestive, fatigue, some diarrhea, and stomach pain. These lasted for about 7 days. On Jan 26 was tested positive for Covid-19 test.
Redness at injection site, warm to touch. Treated with KEFLEX. Pt had allergic reaction to antibiotic KEFLEX. Changed to clindamycin 300mg on 3/5/11 at ER. Redness improving since changing med.
Can I use steroids to treat my side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Can I use steroids to treat my side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Can I use steroids to treat my side effects). At the time of the report, VACCINATION COMPLICATION (Can I use steroids to treat my side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided
Patient initially stood up and walked around the pharmacy after the vaccine administration. After a few minutes, she felt dizzy and had to sit down. Patient was under observation for 30 minutes.
PT EXPERIENCED A SYNCOPAL EPISODE IMMEDIATELY AFTER RECIEVING SECOND DOSE OF PFIZER VACCINE. PT IMMEDIATELY PLACED IN COT, VITAL SIGNS ASSESED AND STABLE, FR NOTIFIED. PT PLACED IN TRENDELENBURG AND ASSESSED BY FR. PT SITTING UPRIGHT, STATES SHE FEELS BETTER AND SIGNS REFUSAL TO GO WITH FR TO HOSPITAL. PT SENT HOME WITH FAMILY MEMBERS, AMBULATES TO CAR.
Tiredness and bodyaches. I slept enough hours last night that I have no reason to be as tired as I am and my body feels like someone hit me with a baseball bat all over. Even my hands and feet feel some soreness.
pt had onset of severe body ache & flushing x 1 1/2hr the evening of the vax;pt very weak the next day;also c/o heart palpitations;
Patient without past medical history presented to ED with BG 760. Patient diagnosed with type 2 diabetes.
This spontaneous report was received from a nurse, regarding a 15 years old female patient. The patient's medical history or concurrent conditions were not reported. The patient had no any drug reaction / allergy. On 11-JUL-2018 the patient was vaccinated with 1 dose of GARDASIL 9 for prophylaxis (reported as "vaccination for HPV") (strength, anatomical location and route of administration were not reported). Lot number R000303, expiration date: 29-AUG-2020. Other suspect vaccines included Hepatitis A Vaccine, Inactivated (manufacturer unknown) (Dosage, route of administration, Lot number and expiration date were not provided). Concomitant therapies included melatonin and LEXAPRO. On 11-JUL-2018 the patient experienced syncope; it was stated from the reporter that she gave the GARDASIL 9 immediately after giving the patient Hepatitis A Vaccine, Inactivated (manufacturer unknown). Right after the patient received the GARDASIL 9 dose, the patient fainted for a couple of seconds to a minute (syncope). The patient received medical attention for the event, she layed down and recovered quickly and stayed in the office for observation for 20 to 30 minutes, but no additional side effects happened. An unspecified treatment was given for the adverse event. On 11-JUL-2018, the patient was recovered from the event. The causal relationship between the syncope and the vaccination with HPV GARDASIL 9 and Hepatitis A Vaccine, Inactivated (manufacturer unknown) was not reported.
infant had shots app 11 days ago now with redness to right thigh at site of shot and child with low grade fever and fussiness today mom noted  small blisters to back abd and now arms   parents worried                                   a rash is noted that is diffuse in location;  the color is mainly pink;  it is best characterized as vesicular;  at site of injection red raised lump with 3 vesicles   no erythema  no warmth  no fluctuance                                         PLAN  rxn to varicella  no secondary infection noted  course of disease discussed with parents  follow up if increase pain, cont fever, poor po intake
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: About 2 minutes after receiving the vaccine the patient was complaing about being hot (flushed) with sweating. Patient asked for a glass of water. When getting the patient water my technician said she saw the patients eyes roll to the back of his head and that he was going to pass out. I went out to the patient and helped him to the ground and had him lay flat on his back with his feet elevated. After 3-4 minutes the patient was feeling better. Patient never lost consciousness.
Chills - started within an hour Sore muscles and joints - 2 hours Palpitations - 12 hours Fever - 24 hours Rash - 48 hours
Ringing in ears, high blood pressure 165/95, hives, face itchy   Took Benadryl
After receiving my third dose, I experienced sore throat, cough, itchy/watery eyes and sinus pressure. I never had a fever, but my whole body would get super hot. I became a little short of breath and had chest tightness. I'm still experiencing squeezing around my heart, occasionally, since my first dose. My second dose it became a bit worse and it's still here after my third dose. I have also experienced wheezing, feeling groggy and have had a lot of drainage.
Approximately 12 hours after receiving the second dose, I experienced severe aches, rapid heartbeat, headache, and swelling of my lips. All symptoms except lip swelling improved 24 hours later after taking Tylenol.
swelling in her throat area; Shaking; Dizziness; Low grad fever; Body ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swelling in her throat area), TREMOR (Shaking), DIZZINESS (Dizziness), PYREXIA (Low grad fever) and MYALGIA (Body ache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had COVID 3 months ago). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METFORMIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PHARYNGEAL SWELLING (swelling in her throat area), TREMOR (Shaking), DIZZINESS (Dizziness), PYREXIA (Low grad fever), MYALGIA (Body ache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (swelling in her throat area), TREMOR (Shaking), DIZZINESS (Dizziness), PYREXIA (Low grad fever), MYALGIA (Body ache) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that some of the symptoms from the vaccine were similar to that of the COVID symptoms
very sick; 104 fever; pretty severe reactions; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (pretty severe reactions), ILLNESS (very sick) and PYREXIA (104 fever) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced ADVERSE REACTION (pretty severe reactions). On an unknown date, the patient experienced ILLNESS (very sick) and PYREXIA (104 fever). At the time of the report, ADVERSE REACTION (pretty severe reactions), ILLNESS (very sick) and PYREXIA (104 fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021089752 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Consumer declined to provide email and declined further follow upAR onset date and other events added; Sender's Comments:  MOD-2021089752:Crosslinked, Father's case
Administered HPV 9 Lot number L006547 into the patients right deltoid. Pt appeared fine and talked freely to her sister for 1-2 minutes after receiving the injection, while sitting on the exam table.  Pt stated she felt fine and moved from the exam table to the chair approximately 5-10 steps away.  Pt continued talking for a short time possiblly 1 minute then stated she did not feel well.  Pt's head fell back and eyes rolled back, pt was unresponsive to touch or sound. Her face turned red and pt began to drool. Her body became stiff and rigid.  With assisstance was able to maneuver pt to a sitting position on the floor.  Pt seemed to be awake at this time, however, not talking or oriented. Pupils were dilated. Lowered pt to a supine position on the floor with both legs lifted pt came to and was quickly oriented.  Her coloring then became very pale and she became diaphoretic and shaky. Placed a cool moist towel on her forehead and continued to talk to the pt.  Pt remained on the floor for approximately 10 min then was able to sit up and drink gatorade and eat crackers.  Remained in sitting position on the floor for another 5-7 minutes before standing up.  Pt was still shaky but was feeling better.
Shots given 5/23/03. Mother knew for sure something was wrong on 6/10. Went to doctor; had noticed a cutting of the eyes about two weeks prior to seeing doctor but didn't realize it was seizure activity. Put in hospital 6/16; EEG came back abnormal. The medical record states congenital brain anomaly. A 60 day follow up report received 10/24/2003 adds: Still having seizures. Abnormal structural development of front left lobe of brain. Being treated currently with ATCH.
I have never been pregnant before this. We confirmed a positive pregnancy after conceiving via in vitro fertilization. It was confirmed on November 23rd 2021 from a blood draw for HCG. The due date was August 2nd 2022. HcG blood tests were also done on  November 29th and December 6th, 13th, and 20th. Ultrasounds were done on December 6th and December 20th. A heartbeat was seen on the December 20th ultrasound. On December 30th another ultrasound was performed and no heartbeat was seen. A repeat ultrasound was done on January 4th and it was confirmed that the pregnancy was no longer viable. A D&C procedure was done on January 7th, and some of the tissues were sent for genetic testing, and am currently awaiting results.
Low grade fever, body aches more than 30 hours, spent the day on the couch, feeling lousy.
Rash developed a few days after vaccinations. Looks like diffusely - spread red bumps with itching. Treat supportively with calamine lotion and BENADRYL PRN, itching.
This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as "Flumist" and administered intranasally.  There were no other adverse events other than "bad taste."
Patient states that after receiving the 3rd dose of Moderna 01/04/2022, started experiencing symptoms 01/05/2022 of headaches, muscle aches, joint aches, fatigue, pain on the left side/injection site, and redness/feverish at the injection site. No noted Primary visit/communications. Joint pain still continuing as a symptom.
Patient was admitted on 1/5/2022 for a left laparoscopic hand-assisted nephrectomy after receiving third dose of  Pfizer given 12/30/2021
Bruising on feet, back and arms; Vomitting; This spontaneous case was reported by a patient and describes the occurrence of VOMITING (Vomitting) and CONTUSION (Bruising on feet, back and arms) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced VOMITING (Vomitting). On an unknown date, the patient experienced CONTUSION (Bruising on feet, back and arms). At the time of the report, VOMITING (Vomitting) and CONTUSION (Bruising on feet, back and arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Whole body tremor/spasmed (seizure) starting with arms and legs with head nodding. Afterwards, screaming more, low grade continuous grunting instead of previous "talking" with intonations. Fussy eating. Lack of eye contact compared to before, smiles/laughs less if at all. Bottom lip sucked in.
For a few days following the first dose of the vaccine, I experienced extreme pain and limited mobility in my upper left arm and shoulder. I visited my primary care physician, who advised a course of high dose ibuprofen to reduce any inflammation that might be occurring as a result of the vaccination. This provided some relief, but I still experienced limited mobility in my upper left arm and shoulder. MY PCP then advised on a 6-day steroid treatment - this, again, provided much relief and increased mobility but a few days following the completion of the steroid pack, the pain and decreased mobility returned. I was then recommended to an orthopedist, who upon review of an x-ray, recommended physical therapy. I am now in physical therapy two days a week.   Upon return for my second vaccine, i expressed my concerns about my first dose and she advised it seemed as if the first dose was given too high in the arm.
WOKE UP AT 2-3 AM WITH  EXTRA ACHINESS FROM NECK DOWN; CHILLS AT 2-3 AM; FEVER; This spontaneous report received from a patient concerned an adult female. 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 not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 16:00 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced woke up at 2-3 am with extra achiness from neck down. On 14-MAR-2021, the subject experienced chills at 2-3 am. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from woke up at 2-3 am with extra achiness from neck down, and chills at 2-3 am on MAR-2021, and the outcome of fever was not reported. This report was non-serious.
The day after vaccination I woke up and was nauseous. I was in class online at 2:15 and I vomited one time. I was nauseous the rest of the day  and I felt dizzy. My upper arm  near the vaccinate injection site I have these red rashes(streaks of the red rashes looks I was whipped or something).  They are kind of itchy.  The red spots appeared last night and they are still today.  Today I feel okay I just feel a little weak, yesterday I couldn't hardly eat.
First one didn't hurt any more than any other shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: First one didn't hurt any more than any other shot). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that his/her doctor told him/her that the modern Shingles vaccine is a two shot series, taken 90 days, but not more than 180 days apart. The patient reported that the first shot of Shingrix did not hurt any more than any other shot and that he/she received the first dose a day before reporting. The patient stated that all know what vaccines are like. The follow-up could not be possible as no contact details were available.
Suspected vaccination failure; Had them not fun even after I had a shot; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Received Pfizer vaccine on 4-3-2021 before we administer the Moderna.  The patient did not tell the staff until in observation.
LOCALIZED REACTION - AREA OF WARMTH, REDNESS & SLIGHT EDEMA APPROX 6.5CM IN DIAMETER RIGHT DELTOID @ FLU VACCINE INJECTION SITE. PATIENT DENIED PAIN, RASH, HIVES, BREATHING PROBLEMS.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-JUL-2015, the patient received improperly stored PROQUAD (Merck) (lot # L002213, expiration date: 21-JUL-2016) dose and route were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, Myalgia, Fever, Fatigue, Chills, Left arm swelling Narrative:
patient was given ADACEL SC instead of IM, no advesre event; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown demographic who was vaccinated with a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] via subcutaneous route instead of intramuscular route on an unknown date (batch number, expiration date and dosing details not reported).  The medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate route of vaccination.  No adverse event reported at the time of reporting.  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 Directive and Module VI of the 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 on the batch number was requested.