chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluttering eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXCESSIVE EYE BLINKING (Fluttering eyes) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Previously administered products included for an unreported indication: FIORICET. Concurrent medical conditions included Migraine. Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET).  No treatment information was reported.  On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced EXCESSIVE EYE BLINKING (Fluttering eyes). At the time of the report, EXCESSIVE EYE BLINKING (Fluttering eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
experiencing episodic of atrial fibrillation to sinus beat like 2 to 1 or 3 to 1; Little bit of chest discomfort; shortness of breath; This spontaneous case was reported by a nurse and describes the occurrence of ATRIAL FIBRILLATION (experiencing episodic of atrial fibrillation to sinus beat like 2 to 1 or 3 to 1) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heartbeats irregular in 2017 and Cardiac ablation in 2017. Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (experiencing episodic of atrial fibrillation to sinus beat like 2 to 1 or 3 to 1) (seriousness criterion medically significant). The patient was treated with NAPROXEN (NAPROSYN [NAPROXEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, ATRIAL FIBRILLATION (experiencing episodic of atrial fibrillation to sinus beat like 2 to 1 or 3 to 1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Heart rate: heartbeat jumped up to 140-150 beats (Inconclusive) heartbeat jumped up to 140-150 beats.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ATRIAL FIBRILLATION (experiencing episodic of atrial fibrillation to sinus beat like 2 to 1 or 3 to 1) to be possibly related.    This case concerns a 66 year-old male patient with medical history of irregular heartbeat and cardiac ablation in 2017, who experienced the Serious Unexpected event of Atrial fibrillation and other non serious events. The event started 2 hours after the second dose of an unknown schedule of administration of Moderna COVID-19 Vaccine. Rechallenge for this event is Not applicable as no additional dosing will be given. Medical history of irregular heartbeat and cardiac ablation remains a confounder for this case. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Additional information has been requested.; Sender's Comments: This case concerns a 66 year-old male patient with medical history of irregular heartbeat and cardiac ablation in 2017, who experienced the Serious Unexpected event of Atrial fibrillation and other non serious events. The event started 2 hours after the second dose of an unknown schedule of administration of Moderna COVID-19 Vaccine. Rechallenge for this event is Not applicable as no additional dosing will be given. Medical history of irregular heartbeat and cardiac ablation remains a confounder for this case. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Additional information has been requested.
SORENESS TO RIGHT ARM; INJECTION SITE SORENESS; SORE THROAT (MILD); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sore throat (mild). On 12-MAR-2021, the subject experienced soreness to right arm. On 12-MAR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site soreness, sore throat (mild) and soreness to right arm was not reported. This report was non-serious.
Mom noticed spots on Left thigh 4-12-17 pm. Office visit 4-14-17:Left thigh with a red 2.5cm diameter area with mild induration, not warm, no drainage, nonfluctuant. Several healed over areas that look like small vesicles that had broken open and then healed over.
I had  same reaction on days 1-3 then it disappeared,  a week later I stared with the Sam symptoms again,  The site where I got the vaccine is red, warm and hard. It is itchy as well.
pt recv vax  2JUN97 & 3JUN97 woke up w/red rash/hives on back, stomach, legs & arms which comes & goes;very itchy;
she is still experiencing soreness to the injection site in the left arm where she got the shot; This is a spontaneous report from a contactable consumer (patient) via Medical information team.  A 85-years-old female patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265; Expiration Date: May2021) via an unspecified route of administration, administered in left arm on 29Jan2021 at 13:30 (at the age of 85 years old) as single dose for covid-19 immunisation. The patient's medical history included blood pressure high, A-Fib 3-4 years or longer was diagnosed with A-Fib, thyroid disorder since at least five years. The patient concomitant medications included digoxin 125mg tablet once a day for heart pill, methimazole 5mg once a day for thyroid pill, metoprolol tartrate 25mg tablet twice a day oral, spironolactone 25mg once a day as water pill, magnesium oxide (MAG OXIDE) 400mg tablet oral twice daily, apixaban (ELIQUIS) 5mg twice daily for blood thinner, vitamin d3, cobamamide (VITAMIN B12). The patient's historical vaccine included flu shot, pneumonia shot, and shingles shot. The patient did not receive any other vaccines within four weeks prior to the vaccination. No additional vaccines administered on same date of the suspect pfizer vaccine. On 29Jan2021, the patient experienced soreness at injection site, the upper left arm in the evening of the day she got the vaccine. The patient asked if it was normal, and should she get the second dose of vaccine if she is still sore. The outcome of the event was not recovered.
830 AM mom phones clinic stated pt had MMR/DTP/OPV & exp t104 R; pt taken to ER; 22JUN94 pt exp rash;
"You were seen in the emergency department for an allergic reaction after receiving her second COVID-19 vaccine. Patient given Benadryl in clinic that improved your symptoms. Patient augmented this with a steroid and Pepcid. Pt observed during periods of observations, than symptoms have resolved. I have discharge you home on similar medications. Please take these as directed. "
received the 1st dose of Shingrix "5 years ago" and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 5 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No symptoms reported. The reporter stated that, the patient did not know the extact date of 1st dose vaccination. The reporter consented to follow up.
SEVERE menstrual bleeding. Clots the size of grapefruits for 8 hours. No history of fibroids, or other uterine problems. Gravita 2, no complications noted. Remained in the restroom for 9 hours and was completely unable to abúltate due to SEVERE BLEEDING, cramping, and headache. 3 cycles complete now with clots in 2nd cycle baseball to softball sized. No significant bleeding past 2nd cycle.
This case was reported by a healthcare professional to a sales representative and described the occurrence of joint pain in a 48 year old female subject who was vaccinated with Twinrix for prophylaxis. There were no concurrent medications. On 19 October 2005 the subject received 1st dose of Twinrix in the right arm (lot AHABB030AA). On 19 October 2005, less than one day after vaccination with Twinrix, the subject experienced joint pain, vomiting, diarrhea and a "low grade temperature." The subject was seen at a physician's office. The events resolved on an unspecified date on or after 19 October 2005 and on or before 25 October 2005.
PT FELT DIFFICULT  BREATHING AFTER ABOUT 5-10 MINUTES AFTER GOT THE SHOT.  PATIENT FELT LIKE THROAT CLOSE UP AND SO GAVE ONE SHOT OF EPIPEN, PATIENT THEN FELT BETTER AFTER THAT.  THEN MEDICS SHOW UP, CHECKED VITAL SIGNS AND EVERY LOOKED GOOD.
child c/o itching under lt arm & on rt leg;mom noted red rash;denies any fever, chills, sore throat, cough, coryza;no camping  trips;not in daycare;
Sore throat; runny nose; fatigue; This is a spontaneous report from a contactable consumer (patient's mother).  A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, on 20Apr2021 for COVID -19 immunization and experienced fatigued/tiredness, headache, fever, sore throat, nasal congestion, "now sick at the urgent care", not been feeling well, flu symptoms, still coughing and has seasonal allergies. The patient's mother reported that the patient has been sick for 5 days following first dose. The patient experienced sore throat, runny nose and fatigue on an unspecified date. The patient's mother confirmed that events were previously reported. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Kinrix administered instead of Infanrix; Kinrix administred to a 18-month-old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14th April 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-Nov-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received Kinrix dose instead of Infanrix vaccine at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Initial case received from a nurse on 27 June 2011. It pertains to 1 of 2 patients who experienced an adverse event following ADACEL administration. The event for the other patient is captured in case number 2011-03810. An 11-year-old male patient, with a history of asthma and color blindness, was diagnosed with pertussis 8 months after receiving an intramuscular left arm injection of ADACEL (sanofi pasteur Ltd. lot number C3257, sanofi pasteur Inc. lot number U3042AA) on 11 October 2010. The patient also received a right arm intramuscular injection of MENACTRA (lot number U3333AA) on the same date. Concomitant medications included albuterol and EPI-PEN as needed. The patient presented to his physician on 14 June 2011 with a harsh cough without wheeze or fever. An initial pertussis smear on 15 June 2011 was negative; subsequent PCR on 20 June 2011 was positive for pertussis. Treatment included a nebulizer treatment. Outcome was not reported. Of note, the reporting nurse stated that she was aware of 3 patients who had been diagnosed with pertussis; however, only 2 of the 3 were identified as having received ADACEL. Documents held by sender: None.
On Saturday 1-16 I started having pain in my chest and back in go worse over time at about 8pm I went to the emergency room. After doing blood work, CT scan, Xray and a EKG they believed it was my gallbladder. I released and sent to follow  up with a surgeon. They surgeon ordered a hida scan the results came back that my gallbladder was working at a negative 13% and needs to be removed . Surgery scheduled for Feb. 11
The patient is not exhibiting any adverse symptoms; patient was supposed to received both VARIVAX and MMR II today (10/27/2020), but instead of MMR II, PROQUAD was administered; was supposed to received both VARIVAX and MMR II/ but instead ofMMR II, PROQUAD was administered; This spontaneous report has been received from a physician (also reported as a practice manager), referring to a 12 months old patient of unknown gender. The patient's current condition, concomitant medication and historical condition were unknown.  On 27-OCT-2020, the patient was supposed to receive both varicella virus vaccine live (oka/merck)(VARIVAX) (lot # SO38702 was evaluated and changed to the valid lot # S038702, expiration date: 01-DEC-2021; 1 injection) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, lot number and expiration date were unknown), but instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot# S031884 with expiration date: 07-APR-2021; 1 injection) was administered (wrong product administered and accidental overdose). The route and strength for all suspect vaccines were unknown. The indication for all suspect vaccines was prophylaxis. The patient was not exhibiting any adverse symptoms.
4-5 hours severe headache still continues after 3 days 12 hours muscle aches for 48 hours
This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 10Apr2021 at 14:45 (at the age of 56-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 01May2021 at 11:30 (at the age of 56-year-old); both as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) 0.05mg and unspecified vitamins; both for unspecified indication from an unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPIRIN) for unspecified indication from an unknown date and experienced drug allergy. On 25Apr2021 at 09:00, the patient experienced ringing in ears which developed over the last 3-4 weeks (as reported). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears developed over the last 3-4 weeks was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Headache started within 30 min of first shot, lasted about 36 hours. Took Tylenol.  Second shot 21 days apart.  Headache started within 30 min a lot worse after second dose.  Lasted a couple of days.
first Shingrix injection on 11/14/2019. She received the second Shingrix injection intramuscularly in unspecified deltoid on 3/5/2020; red spot coming up" over her eyebrow; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior outbreak of shingles previously 9 years ago above her eyebrow). Previously administered products included Shingrix (1st dose received on 14th November 2019).   On 5th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, immediately after receiving Shingrix, the patient experienced vesicular rash and red rash. On an unknown date, the outcome of the vesicular rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash and red rash to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient could be 62 years or 63 years of age. The reporter did not wish to provide her exact date of birth. The reporter was not able to locate a lot number on her paperwork from the pharmacy but did provide the pharmacy phone number, since they will have the lot number on file. Since receiving the shot of Shingrix in an unknown deltoid, the patient had noticed a red spot coming up over her eyebrow. She said she knew that it has to be shingles.  She showed it to the pharmacist where she got her Shingrix and the pharmacist said it looks like shingles. The reporter did not wish to provide her medical doctor contact information. Did not consent to follow-up.
pt recv vax;mom states pt has mild rash on stomach,upper back & arm 2aug95;3 days later, rash still present, advised to see MD;
Pt woke up 22hrs after receiving vaccine and experienced first time ever episode of vertigo, which caused her to collapse into the wall and lie on the floor. She could not lift her head without exacerbating symptoms - felt like she was falling/spinning and got nauseated. Pt had to receive treatment in ER same day for this.
Client was incorrectly administered wrong dose of Pfizer COVID vaccine.  Based on client age 12, she should have received the dose authorized for 12+, but in error was administered the pediatric Pfizer dose.
This spontaneous report as received from a licensed practical nurse refers to unknown number of patients of unknown age and gender. On 16-JUL-2014, improperly stored (Oka/Merck) PROQUAD lot # K004712 (injection, strength, dose, dose number, route and duration were unspecified) were administered to the unknown number of patients. No adverse symptoms reported. No further information provided. The outcome was unknown. This is one of the four reports that received from the same source. Additional information is not expected.
Booster; Developed vitiligo soon after 3rd dose of pfizer covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: 30145BA) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "type 1 diabetes" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "sjogrens" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG; CEVIMELINE; NP THYROID; LISINOPRIL; XIIDRA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729), administration date: 09Apr2021, when the patient was 63 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207), administration date: 19Mar2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Oct2021, outcome "unknown", described as "Booster"; VITILIGO (non-serious) with onset Oct2021, outcome "not recovered", described as "Developed vitiligo soon after 3rd dose of pfizer covid vaccine". The event "developed vitiligo soon after 3rd dose of pfizer covid vaccine" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vitiligo.  Additional information: The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event steroid creams. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies.
Metallic taste; Metallic smell; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 13Apr2021 at 17:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, prior to the vaccination. The patient did not have any known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6955) via an unspecified route of administration in the right arm on 23Mar2021 at 17:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient experienced metallic taste and metallic smell which was ongoing for 4 days. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event metallic taste and metallic smell was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
I had scratchy throat and left sore arm and felt very tired. I am currently pregnant on the 09-08-21 and 09-09-201 I noticed a decrease in movement within my baby.  Fetal heart monitor was used with a doppler and baby is okay. I had a check up today and an ultrasound comin g up next week.  EDD: 01/17/2022.   My left sore arm is not present today nor my scratchy throat.  I do not have lot# to provide.
Patient is not having an adverse reaction, I am reported because she was mistakenly given Pfizer for dose 2 when she was supposed to receive dose 2 of Moderna. Moderna was administered on 5/13/21.