chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bruising to all areas injected; dents and rock bubbles/bumps inside her mouth beneath the upper and lower lips; dents and rock bubbles/bumps inside her mouth beneath the upper and lower lips; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer (patient) reported that.  A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; hyaluronic acid (RESTYLANE), sublingual from 17Jun2021 (Batch/Lot number was not reported) to an unspecified date, at 2 mL for an unspecified indication. Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported. As per reporter it was reported that Reference is made to the Guidelines for Post-marketing Re-porting of Adverse Drug Experiences (Docket No.-#) dated Mar1992, requires Reports in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant. In accordance with the guideline, we are forwarding the be-low information related to an adverse drug experience received by withheld. Should you require further information concerning this report, please contact the reporter. It was reported that Reported Adverse Event: Patient was injected with 2mL Restylane withheld to the chin/between my chin and bottom lip, upper lip, and both the top and bottom lips 17Jun2021. Patient developed bruising to all areas injected and dents and rock bubbles/bumps inside her mouth beneath the upper and lower lips 17Jun2021. Patient contacted HCP and was advised not to apply ice, saying that ice would not be necessary. No further treatment information was provided by HCP. In the past patient has been injected with Restylane withheld as well as about 20 different fillers (patient did not wish to specify names of other fillers from the past). It was reported that Patient has not had any toxins in the past. It was reported that She had her COVID-19 vaccine (Pfizer; 1st dose Jan2021 and 2nd dose Feb2021). Patient has not had any other vaccines and dental procedures in the past 6-12 months, and she has not had any illness the month prior to her treatment. The outcome of events was unknown.  Information on batch/lot number has been requested.
Day 1 stomach aches; Day 2 big red mark 4x4 hard and painful went to pharmacy, was told by the administrator of vaccine it is the skin not the shot and not to do anything it will go away; Day 3 some temperatures 99. Did nothing no treatment as instructions; Day 16 mark was still 3x3 red swollen and painful called primary the triage nurse told me it is a local reaction use ice to treat; Day 24  it is still visible no longer painful but skin is peeling on the injection site.
Normal immune reaction: fever, chills, headache Abnormal immune reactions developed immediately including tinnitus in left ear, brain zaps or head rushes constantly throughout the day and night with and without dizziness and tingling and swelling in extremities.  This has not resolved six weeks post-vaccine.  Developed chest pain, vivid dreams, and head pressure/pain.  I've seen an ENT specialist and the Neurologist who are calling these long-haul autoimmune reactions.  It feels as if my nervous system is in overdrive and inflamed.  It is debilitating and is inhibiting my daily life.  I am a healthy 44-year-old woman who was in great health prior to this vaccine.
Rapid heartbeat but not tachycardic (>90 beats per minute but not over 100). No pain was experienced.
Pain; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Pain). The outcome of the pain was recovered/resolved (duration 2 days).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 15-MAR-2023 The case was received from the patient interactive digital media. The patient got 1st Shingles shot and only 2 days he/she felt the pain. The follow-up could not be possible as no contact details were available.
Case previously recorded as MA2009-4395.  Initial case report received from a nurse via agency on 16 NOV 2009.  A patient 3-year-old female was vaccinated with 0.5mL FLUVIRIN 2009/2010 (batch no. 102045P1) i.m. on 14 NOV 2009.  No adverse event was reported.  Wrong age (off label use) is unexpected after vaccination with S-OIV FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008317.
Vaccine was diluted with sterile water instead of the recommended normal saline.  No adverse effects reported.
Patient woke up morning of 3/25/10 and lower lip is swollen. No other c/o or s/s. FNC to 1) come to MCHD 2) See PCP or 3) Go to ER today for evaluation. Pt called clinic on 4-1-10 & told me she went to ER 3/25 & was told swollen lip due to spider bite.
pt reported racing heart / palpitations.  s/p valve (mechanical)replacement for brady arrythmias.  She schedule for pacemaker insertion.  Hr-96 slightly irregular- decrease 66 mins.   B/P 132/82;  SPO2 87% - increase to 97%
reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks; intense pain in reproductive organs; Bloating; now growths (possibly cervical polyps); dull achy sore pain where the shot was administered; tingliess in her fingers on that arm; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown, NDC 59267100002) via an unspecified route of administration at left arm on 13Apr2021 12:00 (40-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included depression and ADHD. Concomitant medications in two weeks included dextroamphetamine hydrochloride; alprazolam; sertraline hydrochloride (ZOLOFT); hydroxyzine hydrochloride (VISTARIL). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 23Mar2021 11:00 (40-year-old at time of vaccination) for COVID-19 immunization. Patient did not receive any other vaccines within 4weeks prior to the COVID vaccine. Event start date was reported as 14Apr2021 15:00. Patient has had a dull achy sore pain where the shot was administered ever since she received the last shot. She also has tingliess in her fingers on that arm. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for these adverse events. The patient also reported intense pain in reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks. Bloating and now growths (possibly cervical polyps)- visting OBGYN for follow up. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The case was serious, medically significant. No therapeutic measures were taken as a result of the event "dull achy sore pain where the shot was administered" and "tingliess in her fingers on that arm". The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initially, suffered a severe migraine.  I believed that I was having a stroke.  It was followed by vertigo, blurred and double vision, and dizziness.
Information was received on 08-AUG-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX (dosage and lot#/expiration not reported) in June 2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of herpes zoster. On or about 25-JUN-2016, patient was treated by physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 13-NOV-2014 (conflicting date as prior to diagnosis date), patient was treated by physician at a clinic for ongoing and worsening symptoms of herpes zoster infections. On or about 12-DEC-2011 (conflicting date as prior to vaccination and diagnosis date), patient received subsequent treatment by physician for ongoing symptoms of shingles that were uncontrolled by previous prescriptions and treatment attempts. Patient has been prescribed valacyclovir (VALTREX) and acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and  will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
After vaccination, patient complained of dizziness and loss of vision. Patient?s eyes rolled back and patient had brief seizure activity with jerking motions lasting a few seconds.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 25-APR-2018, the patient received an expired dose of VAQTA lot # N005605, expiration date on 08-APR-2018, intramuscularly, for prophylaxis. For the patient, that dose would be considered her second dose but it was not stated when the first dose was administered. No adverse effects were reported.
swelling, tenderness, pain, puffiness , redness, started about 4 hours after injection
Six hours post vaccine administered IM in right deltoid, Mom observed hives and swelling in right axilla, Increased arm and shoulder, Symptoms resolved gradually over the next 2 days.
Information has been received from a registered nurse concerning a teenage female who on unspecified date was vaccinated with a dose GARDASIL. After receiving GARDASIL, the patient was lightheaded. The outcome of the patient was not reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (doses administered past the published expiry date) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Oct 12, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 12, 2021, patient experienced administered expired product (doses administered past the published expiry date). On Oct 12, 2021, administered expired product (doses administered past the published expiry date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, the vaccine was removed from  freezer on Oct 12, 2021.
Pt got vaccinated with MCV4 (MENACTRA) 3/24/09, returned 3 days later with swelling and pruritus of injection site.  She was treated with Benadryl.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 29-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 28 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8737), in left arm, on 18Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 14Dec2021 as dose 3 (booster), single (Lot number: FJ1620), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Smoking" (unspecified if ongoing); "known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: known allergies: Sulfa antibiotics. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Negative; (Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid for Covid-19 anti viral treatment from 20Aug2023 to 24Aug2023.
Tested positive for COVID-19 on August 14, 2023,  patient expired on August 20, 2023.
hives; Tremors; Swollen face; This is a spontaneous Pfizer product safety information report form from a contactable consumer (patient's mother). A 16-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 30Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included prednisone (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 05Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. After the second shot, on an unspecified date in 2021, the patient had severe hives has went to the urgent care, her primary doctor and also, the emergency room as this has been so severe. She has hives all over her body, her face was swollen, and she has tremors. She was not responding to the usual course of an Antihistamine and Prednisone. The reporter thought the tremors might be form the Prednisone but was not sure. The patient was miserable and would like someone to call her back with some suggestions to help. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt inadvertently recv vax 14FEB99 & MOC states that pt appetite has increased since vax;
Pt c/o pain in (R) arm one day after injection - slight pinpoint rash - no redness or swelling noted. Saw Dr.
On Sunday night of this week she started running a fever that lasted for 36 hours. The highest fever was 102 .6. the lowest fever was about 101.1. This is 17 days after her vaccine.  I did take her to her pediatrician to be tested for COVID-19  the results were negative. During that time I was giving her Tylenol and Motrin to keep her under 100 degrees.  On the 07/12/2022 the fever broke that morning.
Patient experience tightness in her chest, pain in her chest and back, SOB, and heart was racing.  Symptoms occurred around the time the patient got off of work and was continuing when she came to the pharmacy an hour later.
I started running a fever, and I had pain in my lower left abdomen. It was hard to go to the bathroom. This was caused by the diverticulitis. I had an event with it about 25 years ago. It just came back which caused this event. My doctor gave me 2 weeks of antibiotics to get my white count down. The doctor said I had a blockage. The doctor wanted to do a colonoscopy on me but couldn't so they tried to do a barium x-ray but that didn't work either. I saw a surgeon on a Tuesday and had surgery on that Thursday. I was in the hospital for 5 days. Now I have an ostomy bag. I didn't have any pain after surgery. I was prescribed an antibiotic and a hydrocodone. I am very tired, but my doctor said that is what happens when someone has an abdominal infection.
Pt describes a severe centrally location headache, lasting more than; This is a spontaneous report from a contactable other healthcare professional. A 70-years-old non-pregnant female patient received bnt162b2 (Pfizer COVID 19, Solution for injection, Lot Number: EL3246), via an unspecified route of administration on 17Mar2021 (at the age of 70-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of bnt162b2 (COVID VACCINE) on 24Feb2021 (at the age of 69-years-old) for Covid-19 Immunization and had no adverse reaction. Patient describes a severe centrally location headache, lasting more than a month. The patient admits to having mammogram 5 days after vaccine date 17Mar2021, believes it to be related. The patient underwent lab tests and procedures which included mammogram was believes it to be related on 22Mar2021. The event resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment for adverse event. The outcome of event was resolved on 2021.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 18 year old female with asthma and no drug allergy who on 14-NOV-2007 was intramuscularly vaccinated with her first dose of GARDASIL 0.5 ml. (site of administration not reported; Lot number 658282/0929U). On 29-MAY-2008, the patient was intramuscularly vaccinated with her second dose of GARDASIL 0.5 ml. (site of administration not reported; Lot number 659441/1446U). Concomitant therapy included FLOVENT, ZYRTEC, ADVAIR and albuterol. The physician reported that the patient was pregnant. She was 9 weeks gestation on 05-AUG-2008. The patient sought medical attention and was seen. Her last menstrual period was 25-MAY-2008 and her estimated due date was 01-MAR-2009. The pregnancy test was performed and the result was positive. The outcome of the patient was unknown. Follow up information has been received from the pediatrician reported that she did not have any additional information on this patient. She last saw the patient in August 2008. At that time the patient was planning to go for obstetrical care at  hospital. Follow up information has been received from a physician concerning the 18 year old female with asthma, oesophageal acid reflux, anaemia, migraine, juvenile rheumatoid arthritis, hypersensitivity, gastrooesophageal reflux disease and iron deficiency anaemia and a history of papilloedema and pseudotumor cerebri who on 14-NOV-2007 and 29-MAY-2008 was vaccinated with the first and second doses of GARDASIL. Concomitant therapy included FLOVENT, ZYRTEC, ADVAIR, albuterol, PEPCID AC, influenza virus vaccine (unspecified), iron (unspecified), TYLENOL and vitamins (unspecified). On an unspecified date the patient developed bacterial vaginitis and was treated with FLAGYL. On 23-JUL-2008 ultrasound was performed with the result of intrauterine pregnancy. On an unspecified date serum alpha-fetoprotein test was performed with the result of negative. On 08-OCT-2008 the other ultrasound was performed with the result of 20 weeks intrauterine pregnancy. On 18-FEB-2009 the patient delivered a normal, healthy male baby weighing 7 pounds 4 ounces with no congenital anomalies. Apgar score is 8. There was not complication during pregnancy and labor/delivery, and not diagnostic test, infections. Additional information is not expected.
I had immediate pain with the first dose. Within 24-48 hrs I experienced sever pain, headache, nausea, diarrhea, loss of appetite. The fatigue tapered off after about a week, but did not fully resolve, I attributed the signs and symptoms to an immune response.. I received my second dose of Moderna on 2\7\21. The reaction was significantly more intense, the body pain( not aches, this was racking pain) was bad enough that I nearly called an ambulance. After 12 hours of pain, I slept for almost an entire day, and was exhausted for a week. Depression and apathy made activities of life almost impossible.  I do have fibromyalgia, and its like the worst never ending flare. The fatigue won't break. Depression and mental fog will not lift either. I will discuss with my doctor what,if anything, can be done. But it just really hit me this morning that I'm not getting better.
Approximately 16 hours post injection - Severe aches & pains, chills, fever, cramping, disorientation, fatigue, vaginal bleeding 6 days post injection (received shot on day 5 of menstrual cycle)
Case had a cough for several weeks before it worsened, on 10/02/2021. Case was taken to the hospital. She was admitted on 10/02/2021 until released on 10/05/2021.
two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days; two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) and EXPIRED PRODUCT ADMINISTERED (two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) and EXPIRED PRODUCT ADMINISTERED (two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days). At the time of the report, PRODUCT STORAGE ERROR (two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) and EXPIRED PRODUCT ADMINISTERED (two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date the vials were initially stored in the refrigerator: 02Jul2021 Date the vials were moved from freezer to refrigeration storage: 02Jul2021. No concomitant medication was reported No treatment medication was reported   This case was linked to MOD-2021-279492 (Patient Link).
Second shot of SHINGRIX. First shot had no reaction. Second shot caused histamine reaction approximately 24 hours later. Patient said she had been outside in the heat all day when the reaction was noted. The injection site was red and warm to touch. Patient used ice packs over night and it lessened the size of the redness area. Patient is allergic to BENADRYL. She may try using a different antihistamine and continue to use icing the area.