chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with a red tongue few hours after the vaccine, and approx. 6 hours after vaccine, began with hives. Family called our physician on call, who recommended BENADRYL.
Swelling and redness locally at left thigh injection site about 5cm in diameter on 8/9/01.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE PULMONARY EMBOLISM RIGHT FACIAL MUSCLE WEAKNESS 1/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Metallic taste in mouth; Metallic taste in mouth and smell in nose; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW01710) via an unspecified route of administration in the left arm on 22Apr2021 at 10:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 at 10:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Apr2021 at 08:00, the patient experienced metallic taste in mouth and smell in nose. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event metallic taste in mouth and smell in nose was recovered on an unknown date in 2021 at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Developed hyperventilating, itchy/red chest, "catch" in throat; able to breathe easily. No tongue swelling. No SOB. Took OTC meds on own. No hives noted. Irritated cough. Refused to be seen in ER, though agreed to go if worsened.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown dates, the patients received doses of improperly stored (Merck) VARIVAX (lot #K008818 with expiration date on 19-JUN-2016; lot #L001331 with expiration date on 13-JAN-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt experienced tightness in the chest /w chills & muscle ache but no fever the same day /p receiving Typhoid Vaccine. Later in the day the pt reported that the tightness in his chest was diminshing
rash is hot,rash is getting bigger,rash is red,rash does not itch; rash is red; fever; chills; Rash on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (rash is hot,rash is getting bigger,rash is red,rash does not itch), RASH ERYTHEMATOUS (rash is red), INJECTION SITE RASH (Rash on arm of injection), PYREXIA (fever) and CHILLS (chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INJECTION SITE RASH (Rash on arm of injection). On 10-Apr-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 12-Apr-2021, the patient experienced INJECTION SITE WARMTH (rash is hot,rash is getting bigger,rash is red,rash does not itch) and RASH ERYTHEMATOUS (rash is red). At the time of the report, INJECTION SITE WARMTH (rash is hot,rash is getting bigger,rash is red,rash does not itch), RASH ERYTHEMATOUS (rash is red), INJECTION SITE RASH (Rash on arm of injection), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No concomitant and treatment medications were reported.
A little sore in the arm where the shot was; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 05-Aug-2022. Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had his/her first vaccine 3 days prior to the reporting. The patient received Shingles vaccine on an unknown arm. The only reaction experienced by the patient was a little sore in the arm where the shot was given.  The patient had to return in 2 to 6 months for the second dose.  The patient was very glad, he/she got it to reduce the chances of catching shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Wrong vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EW0178) 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) at an unspecified dose. On 15-Jun-2021 at 4:20 PM, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong vaccine administered). On 15-Jun-2021, WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not listed.  Treatment Information was not provided by the Reporter .   Reporter did not allow further contact
Arm sore; Slight headache; This is a spontaneous report from a Pfizer sponsored program, Pfizer, received from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER COVID-19 VACCINE, solution for injection Batch/Lot number and Exp Date: not reported), via unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced minor symptoms like sore arm and slight headache on an unknown date, a day after she got the vaccine. Outcome of the events were unknown.  Information about lot/batch number has been requested.
"Moderna COVID?19 Vaccine EUA" :  I had fever, chills, headache, fatigue, body ache, sore arm, for one day, however, have had a constant headache and migraine since 2nd vaccine.  I have taken headache medicine  and went to med stop on 15 Apr 2021 and received a Toradol shot that only subdued the headache.  Took Imitrex 25 mg twice today and still have the headache.
sars-cov-2 test positive; sars-cov-2 test positive; Lips felt prickly; balance/dizziness; foot fell asleep and the feeling progressed up the right side of her body to her fingertips by the next morning; Lasted for 2 weeks but she still had intermittent feeling of her foot being asleep and balance issues that made it hard to walk or look at a computer screen without getting dizzy; Lasted for 2 weeks but she still had intermittent feeling of her foot being asleep and balance issues that made it hard to walk or look at a computer screen without getting dizzy; This is a spontaneous report from a contactable nurse (patient). This 41-years-old female patient (non-pregnant) received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Right on 06Jan2021 09:00 (Lot Number: Elt9899) at age of 41-years-old as dose 1, single for COVID-19 immunization.  Medical history included Allergy. Concomitant medication included probiotics NOS. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Multivitamin and probiotics. The patient experienced Lips felt prickly, balance/dizziness, foot fell asleep and the feeling progressed up the right side of her body to her fingertips by the next morning. Lasted for 2 weeks but she still had intermittent feeling of her foot being asleep and balance issues that made it hard to walk or look at a computer screen without getting dizzy on 06Jan2021 09:30 AM. The events resulted in Doctor or other healthcare professional office/clinic visit except sars-cov-2 test positive. Treatment received for the events included allergy medication except sars-cov-2 test positive. The patient underwent lab tests and procedures which included sars-cov-2 test (Binax Now): positive on 21Sep2021 (Nasal Swab), sars-cov-2 test (NAA): negative on 14Feb2021 (Nasal Swab). The outcome of the event sars-cov-2 test positive was unknown, of other events was recovered with sequel. No covid prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 and events COVID-19 and drug ineffective cannot be fully excluded.
19 y/o pt received 2nd dose of Moderna vaccine 9/30/2022. Pt mother noted pt received Moderna Bivalent vaccine 10/3/2022 and was reported to clinic on 10/3/2022. Correct course of action confirmed with Moderna manufacturer and CDC. Pt received Monovalent 10/3/2022, as directed by CDC.
Pt. developed rash on face,back & chest on 11/24, after office hrs. Seen at ER that night & tx'd w/Hydroxyzine. Pt seen by MD on 11/26, still had rash and itching, no further tx. given. Pt. seen again 12/16, all sx's abated.
RASH ON FACE AND NECK WITH BURNING AND STINGING.  SWELLING OF FACE AND EYES.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2 NOS), on 15Oct2022 at 12:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 28Feb2023 to 04Mar2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial report received from a healthcare professional on 05 September 2013. A 30-year-old female patient had received an intramuscular first dose of ADACEL (Lot number C4432AB, anatomical site of vaccination was not reported) on 05 September 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 28 December 2012 and the expected date of delivery is 11 October 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. Treatment for infertility was not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: None.
This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 28-FEB-2017-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. A digital data logger was used.  No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001720: Original Case : 1706USA001714 US-009507513-1706USA001721: Original Case : 1706USA001714 US-009507513-1706USA001714: Original Case : 1706USA001714 US-009507513-1706USA001723: Original Case : 1706USA001714 US-009507513-1706USA001719: Original Case : 1706USA001714 US-009507513-1706USA001724: Original Case : 1706USA001714 US-009507513-1706USA001725: Original Case : 1706USA001714 US-009507513-1706USA001726: Original Case : 1706USA001714 US-009507513-1706USA001727: Original Case : 1706USA001714 US-009507513-1706USA001728: Original Case : 1706USA001714 US-009507513-1706USA001729: Original Case : 1706USA001714.
Administration arm sore, random temperature spikes, aching joints, breathing became difficult IE: settled in chest. Saw same doctor 05/09/2015, xray taken, admininstered antibiotics, prednisone and Symbicort.
1 day after, low grade fever/unsettled stomach/chills/dazed/fatigue 4 days after dizzy enough to hold onto walls/headache/red & sore eyes watery/debilitating 5-7 days dizziness has decreased, not debilitating but still there when bending over, looking up, moving fast, unsettled stomach decreased but comes in waves  still happening
Severe arm swelling immediately, bruising at injection site the next day, painful to touch.  No treatment except Tylenol, warm packs.
Moderna COVID-19 Vaccine. Site of vaccine is still very red, with a rash, and slightly swollen in the area of vaccination, down just past her elbow. Patient also describes intermittent headaches, nightly insomnia, chills, and a cold feeling daily since her vaccination in February.
The excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 C with no reported adverse event; the same vaccine had been administered to 2 patients with no reported adverse event; Initial information received on 15-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2-months-old male patient who was administered HIB (PRP/T) vaccine [ACT-HIB] post the excursion that lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3V (vero), tetanus vaccine toxoid (Pediarix); and pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 30-Aug-2023, suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (batch number: UJ834AA; expiry date: 23-Feb-2024), was packed in the refrigerator with ice packs, however the ice packs were placed right beside the thermometer, so the reading went below zero, although none of the vaccines were actually frozen. The excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 C with no reported adverse event (product storage error) (unknown latency).   On 06-Sep-2023, the patient received 0.5 mL dose of same suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (Frequency: once; Strength: standard) (batch number: UJ834AA; expiry date: 23-Feb-2024) via intramuscular route in the thigh NOS (not otherwise specify) for immunization post temperature excursion with no reported adverse event (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   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.
This spontaneous report as received from a pharmacist refers to a 72-year-old female patient. The patient did not have any known drug allergies. The patient's pertinent medical history was not reported. In 2015 (reported as "a year ago"), the patient was vaccinated with PREVNAR 13 with no adverse effects. On 07-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23 intramuscularly, in the arm, lot # M029680, expiration date 17-JAN-2018 (dose and frequency were not reported) for prevention of pneumococcal disease. On the same date, the patient was vaccinated with a dose of INFLUENZA VIRUS VACCINE (UNSPECIFIED) (reported as "Flu shot") in the opposite arm (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. Concomitant therapies included losartan potassium (manufacturer unknown), omeprazole, CYTOMEL (reported twice) and SYNTHROID. On 07-NOV-2016, the patient's arm that received the PNEUMOVAX23 had swelling and redness in "the whole arm from the shoulder to an inch above the elbow". On that day, the injection site was red and swollen of  "the size of a baseball". On 09-NOV-2016, the patient was vomiting and she "felt weak". On an unknown date in approximately November 2016, the patient was seen by an unknown healthcare provider and was treated with unspecified "topical steroids". The outcome of the events and the relatedness between the events and the suspect vaccines were not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA006698.
My first full menstrual cycle after the shot was abnormally and extremely long.  It was 39 days.  For the past 26 years of my life I always have a monthly period (except the two times I've been pregnant).  The last 3 years my cycle is usually only 21-25 days long, with an average of 24 days.  So obviously, a 39 day cycle is very abnormal for me.    I finally started bleeding after that abnormally long cycle on October 30.  I bled heavily for about 11 days (previously I only bled for 6-7 days, never longer).  I stopped bleeding for about 24 hours around November 11, then bled again, this time longer and heavier than before.    I've now been bleeding for 82 of the last 88 days.  YES YOU READ THAT RIGHT.  I'VE BEEN BLEEDING HEAVILY FOR NEARLY 3 MONTHS.    I bleed heavily.  I estimate that I'm losing 5-8 ounces of blood a day.  I arrive at this number using simple math.  I require 12-15 super plus tampons (each of which holds 12-15 grams of menstruation) a day which I often have to change every 30-90 minutes because they are so full the blood and clots leak out around them.    The clots I shed daily are anywhere from 1-3 inches in size.  I shed many a day.
Covid home test positive 28Dec2022 with symptoms; Covid home test positive 28Dec2022 with symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 12:00 as dose 6 (booster), single (Lot number: GH9693) at the age of 57 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE HCL, start date: 01Jan2021; DUPIXENT, start date: 07May2021; FAMOTIDINE, start date: 01Jan2021. Past drug history included: Bacitracin, reaction(s): "Known allergies: Bacitracin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Dec2022, outcome "not recovered" and all described as "Covid home test positive 28Dec2022 with symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2022) Positive, notes: Covid home test positive 28Dec2022 with symptoms; (06Jan2023) Negative, notes: improvement of symptoms by 06Jan2023 and Covid home tested negative; (08Jan2023) Positive, notes: Covid home tested positive 08Jan2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Covid home test positive 28Dec2022 with symptoms. Started Paxlovid 30Dec2022 to 04Jan2023 (lot number: GE3014) with improvement of symptoms by 06Jan2023 and Covid home tested negative. Symptoms returned 07Jan2023 and Covid home tested positive 08Jan2023.
This spontaneous report was received from a Certified Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Neither medical history nor concurrent conditions were reported. On 17-JUL-2015, 20-JUL-2015 and 21-JUL-2015, unspecified number of patients were vaccinated with an improperly stored VARIVAX (Merck) (lot # K021932, expiration date 10-NOV-2016). No adverse effects were reported. No product quality complaints were reported. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
About 5 minutes after the vaccine was administered, the patient reported tingling in the mouth, throat, and flushing and just "not feeling right". We were worried about anaphylaxis due to the mouth and throat involvement and decided to have paramedics come evaluate her. After they were called patient said she had not eaten much today. We were also concerned about hypoglycemia as a result, but the paramedics took her blood sugar upon arriving and it was normal. She decided to go with them to the ER to be evaluated. We have tried to follow up with the patient many times after the incident, but she hasn't responded.  We do not believe it resulted in a serious event as it seemed to be resolving while she was still here and never progressed to anaphylaxis to our knowledge.
Information has been received from the CDC concerning 4 children in one classroom who were vaccinated with varicella virus vaccine live. The children were exposed to a classmate (WAES00120576) who had developed chickenpox. Subsequently the 4 children also developed chickenpox. Additional pt (WAES01034330-01034331) had a similar experienced following exposure to varicella virus vaccine live. No further information is available.