chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My most recent period (which came on the day of my second dose, 5/10 , prior to the dose). The blood flow is more than I remember seeing in the past. Everything seemed stronger - pre period symptoms; Feeling sick; Fatigue; Lymph nodes in neck enlarged; Emotional; Lightheaded; Feeling off; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 07Apr2021 at 20:45 (at the age of 39-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10May2021 (at the age of 39-years-old) as single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took amoxicillin and experienced allergy to the medication. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 10May2021, the patient experienced her most recent period (which came on the day of the second dose on 10May2021, prior to the dose) began with feeling like she was getting sick - fatigue, lymph nodes in her neck enlarged, emotional, lightheaded and feeling "off". She did not attribute to period because it was only 25 days since the last one, and she usually do not feel like she was getting sick. The blood flow was more than she remembered seeing in the past. Everything seemed stronger, pre-period symptoms and the flow of the period. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, most recent period (which came on the day of the second dose on 10May2021, prior to the dose) began with feeling like she was getting sick - fatigue, lymph nodes in her neck enlarged, emotional, lightheaded, feeling "off", the blood flow was more than she remembered seeing in the past and everything seemed stronger, pre-period symptoms and the flow of the period was unknown at the time of the reports.  No follow-up attempts are needed. No further information is expected.
Received my second vaccine on 10/14/2021 and began having left leg pains on 11/01/2021. Was officially diagnosed with DVT?s in my left leg on 11/07/2021. Clots then traveled to my lungs on 11/08/2021.
It was found that a box of 10 MENVEO vaccines were not reconstituted correctly so the patient only received half of the dose. Once discovered agency was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK).
Intense itchiness on scalp, back, groin, arms, and beard every evening.
may have received an incomplete dose; Patient may have received an incomplete dose because the vial leaked during administration.; A spontaneous report was received from a pharmacist concerning  a 31-year-old, female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced accidental underdose and syringe connection issue.   The patient's medical history and concomitant medications were not reported.  On 27-Jan-2021 the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) for prophylaxis of COVID-19 infection.  On 27-Jan-2021, the patient experienced an accidental underdose as the vial leaked during administration.  No Laboratory details provided.  No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the events, accidental underdose and syringe connection issue, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of Accidental underdose and Device connection issue for mRNA-1273 (lot/batch: 028L20A) with no associated AEs.
Initial report received on 4/4/06 from a health care professional. A 19 year old male pt with a history of drug allergies to Advair, penicillin and Biaxin, had received his 1st dose of Menactra, IM, in the left deltoid, on 8/16/05. Two months later, the pt experienced a rash that began bilaterally on his fingers and spread up his arms to his axillary area. The rash was also present in the groin area. The rash appeared as "thousands of tiny pink spots". Over the past eight months, the rash has occurred off and on. The pt was treated with steroids and all blood work, "ASO (Anti-Streptolysin O) test, and skin punch test were negative. The pt has not recovered from the events.
Bleeding ulcer; A spontaneous report was received from a consumer who was a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced bleeding ulcers.  The patient's medical history was not provided by the reporter.  Concomitant medication use was not provided.   On 05-Feb-2021, the patient received the first of two planned doses of mRNA-1273 (lot: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 05-Mar-2021, the patient experienced bleeding ulcers and had to go to emergency room.    No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, bleeding ulcers, was considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Breakthrough case admission after three vaccines mOderna 3/11/21 Lot# 010A21A;  Moderna 4/8/21 Lot# 025B21A;  Moderna 11/15/21 Lot# 051F21A
Malaise, fever to 100.5, anorexia, chills, no fever today, some malaise in morning clearing up now, classic mild flu like symptoms
Comparison of intensity of adverse events per dose; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The age group was captured as adult as per Shingrix indication.  The registered pharmacist reported that most patients who do get the second dose of Shingrix, the adverse events were not as bad as with dose 1 but sometimes just as bad and sometimes worse. No further details were provided by registered pharmacist. The reporter gave permission to follow up. For tolerance for 2nd dose, refer linked case US2019146733.
The father states the pt was given Tylenol as soon as they returned home from the clinic. The pt acted fine. Within 6 hours her temp "shot" up and she had a seizure. Was taken to the ER and admitted to the hospital for observation. She was on an IV and was in the hospital 1 day. She is home now and is acting like she feels ok now. MD thinks it is due to DTAP.
Pt's mom reports inconsolable crying lasting approximately 12 hours. Accompanied by fever.
Diagnosed with polymyalgia rheumatica; myalgia; This case was reported by a pharmacist via call center representative and described the occurrence of polymyalgia rheumatica in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant) and myalgia. The patient was treated with prednisone. On an unknown date, the outcome of the polymyalgia rheumatica and myalgia were unknown.   It was unknown if the reporter considered the polymyalgia rheumatica and myalgia to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in left arm. The patient was diagnosed with polymyalgia rheumatica. Additional information was not provided. The reporter consented to follow up. This case has been linked with case US2019215233, reported by same reporter.
w/in 12hr of vax site of inj swelled to round raised area-site was red & hot to touch as well as very sore to touch;diff using rt hand could not close fits or fingers;soreness in joints, wrist, shoulder x 4/5 days;call MD
My blood work showed the THC was elevated. 5 months before it was normal. And after I got my vaccine I got COVID in January and in April my THC was high. Vitamin D levels were high as well.
Myalgia, Diarrhea, chills, fatigue Narrative: Symptoms/Complaints-extreme body aches, fatigue, and chills day 1 & 2 after vaccine administration and severe abdominal pain with multiple episodes of watery diarrhea on day 4 after vaccine.
no adverse effects, But I was notified by Dept of health that vaccine had expired on 9/30/2022, as it was transferred to me by them from another facility,.At time of transfer, i have in writing and was told verbally that the doses expired on 11/08/2022, so this was not an oversight on my part as i trusted what was written on the  envelope and what I was told verbally. I contacted pfizer, who have sent me a letter saying that stability data DOES support the use of that product on that date. I am also contacting patient to inform him of what happened.
a dose of TYPHIM VI was given to a patient which was expired/ No AE; Initial information received on 25-Jun-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Agency number: 00656790).  This case involves a 20 year old female patient who received an expired 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] lot number: R2A252M, Expiration date: 11-May-2021, Frequency: once, Strength: standard via intramuscular route in the left arm on 24-Jun-2021 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It was an actual medication error due to expired vaccine used (latency: same day).  Description: HCP (Healthcare Professional) stated she noticed it when entering in the system. HCP wanted to know if the consumer needed to be revaccinated or they covered. Do patient need to be revaccinate and what do we need to do. Pharmacy visit on 24-Jun-2021.  Adverse Event (AE) symptoms or no AE.  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.
Patient with a nut allergy, tongue became tingly 20-30 minutes following vaccine.  Patient was given 50 mg of diphenhydramine and was able to transport home with his wife.
R  arm began to get aching same day and then yesterday  a week later he developed gout or CPPD R elbow and whole arm hurting. Never had ho gout
This spontaneous report as received from a medical assistant refers to a 12-month-old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX 0.5ml, intramuscular (lot # J006358, expiry 23-MAY-2015) that was stored inappropriately. The medical assistant stated that was a power outage on 12-APR-2014 and (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
having a blood sugar problem; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on 16Apr2021 (at an unspecified age) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had her first dose of the vaccine 16Apr2021 and wanted to set up an appointment for her second dose of the vaccine. It had been longer than 21 days since the first dose of the vaccine. She was scheduled to have the second dose 07May2021 but was hospitalized and was having medical issues. Her hospitalization occurred after her first dose of the vaccine. Her husband called the paramedics because she was having a blood sugar problem on an unspecified date. She stated this event had nothing to do with the vaccine. The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: There is no sufficient evidence that the reported blood sugar problem, although temporally related, may be related to administration of BNT162B2. Of note, medical history and concomitant medications were not provided to determine pre-existing risk factors or conditions that may have led to the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Infantile spasms, seizures, brain damage and developmental delay. My daughter was hospitalized for diarrhea and stomach cramps on 1/23/01. We were not sure what was wrong with her so we took her to the ER. She had also been sick for a few weeks. It was discovered, after being admitted to the hospital and several test later, that she had infantile spasms. Her 2nd negative reaction occurred a few months after being dx'd with infantile spasms. We were encouraged to immunize her and within 5 minutes of receiving 4 immunizations, on 3/27/01, the seizures came back worst than ever. Her development ceased and the seizures are no where close to being under control. The 60 day follow-up states that she has seizures and she is developmentally delayed.
Patient came to health department on 1-6-2020 to have tb skin test results read. She showed me her back of the left arm. Reddness noted there it measured 50 x 28 mm. I drew out line with a marker. I asked her to apply Ice packs and take Ibuprofen. I followed up with a phone call today (1-9-2020) & she said she was okay now.
Chills 5 hours after shot; uncontrollable chills  Fever of 104.7 15 hours after shot  Low grade fever around 101 for the following four days  Nausea and vomiting 24 hours after shot
This spontaneous report was received from a nurse referring to herself, a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-DEC-2016, the patient was vaccinated with a dose of GARDASIL or a dose of GARDASIL 9, the reporter could not specify which, for prophylaxis, intramuscularly, on her triceps instead of in her deltoid (dose, strength, lot/batch number and expiration date were not reported). On 15-DEC-2016, a few hours after vaccination with GARDASIL or GARDASIL 9, the patient arm felt weird (Limb discomfort) and then that feeling went away. The reporter could not specify the date when the weird feeling resolved. The outcome of arm felt weird (feeling abnormal) was reported as resolved on an unspecified date in December 2016.  The relationship between GARDASIL or GARDASIL 9 and limb discomfort was not reported. Additional information has been requested.
Extreme vertigo starting 36 hours after 2nd dose.; Nausea caused by verigo; Lasting about 36 hours followed by tiredness and weakness.; Lasting about 36 hours followed by tiredness and weakness.; This is a spontaneous report from a contactable consumer, the patient. A 70-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 on 08Mar2021 at 15:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, osteoporosis, irritable bowel, and penicillin allergy. The patient  had received concomitant medication within two weeks of vaccination which was not specified. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) and experienced drug allergy. 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 vaccination. On 10Mar2021 at 04:00, the patient experienced extreme vertigo starting 36 hours after second dose. The patient experienced nausea caused by vertigo lasting about 36 hours followed by tiredness and weakness on an unknown date in Mar2021. Therapeutic measures were taken as a result of adverse events and included treatment with motion sickness pills and vertigo exercises. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme vertigo starting 36 hours after second dose, nausea caused by vertigo lasting about 36 hours followed by tiredness and weakness were resolved with sequelae on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Since day after 2nd vaccine dose pt felt ill with malaise and progressive dyspnea on exertion. Until he presented to urgent care. with complaints of shortness of breath at night and on exertion.  Symptoms started 2 months ago 24 hours after he got Covid vaccine.  Since his symptoms has remained persistent he cames to the ED.  Further work-up shows congestive heart failure and cardiomegaly.  Clinical diagnosis is myocarditis.  He will be admitted for further evaluation. ECHO LVEF 10% dilated global cardiomyopathy
Mild, constant, and persistent tinnitus in left ear upon waking.  Approximately 2kHz tone without interruption or changes.
Starting within an hour the site of the shot started getting red, hard, hot and painful to the touch.  Each day since (4 days now) the area has grown larger, is not symmetrical, and is still hard, red, hot, and painful.  On day 4 the area is still hard, hot, and painful and has now taken on a blueish tint.
Received 2nd vaccine on 2/12/21 and on 2/13/21 starting having diarrhea, nausea, vomiting, and chills.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 05-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# and expiration date not reported), at the age of 51, via an unspecified route of administration, right arm, on Mar 7, 2021, at 02:15, single dose, for COVID-19 immunization. Medical history included allergy to gluten, wheat and yeast. There were no concomitant medications. Prior to vaccination, patient was not diagnosed with COVID-19; and did not receive any vaccines within four weeks. Patient was not pregnant. The patient experienced pain in right eye and eyelid became swollen on Mar 7, 2021, 15:00. The events resulted in doctor or other healthcare professional office/clinic visit. It was reported that eyelid became swollen, continued pain in right eye. Eyelid swollen 15 hours following vaccine and pain still in eye. Patient will call ophthalmologist in the morning. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the event. The outcome of events not resolved. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 13:30 as dose 1, single (Lot number: ER8727), in left arm, on 14Apr2021 at 10:00 as dose 2, single (Lot number: EW0153), in left arm, on 11Oct2021 at 17:30 as dose 3 (booster), single (Lot number: Fh8020), in left arm and on 16Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma-reactive airways" (unspecified if ongoing), notes: Asthma-reactive airways; "Known Allergies: Eggplant" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; TOPIRAMATE; PROGESTERONE; ESTRADIOL. Past drug history included: Phenergan, reaction(s): "Known allergies: Phenergan", notes: Phenergen; Morphine, reaction(s): "Known allergies: Morphine", notes: Morpheme; Demerol, reaction(s): "Known allergies: Demerol"; Codeine, reaction(s): "Known allergies: codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Positive, notes: Testing positive with home test still (20Jul2022); (06Jul2022) Positive, notes: Tested positive on 06Jul2022(symptomatic for several days prior to positive test). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Tested positive on 06Jul2022 (symptomatic for several days prior to positive test). First dose in evening on 06Jul2022. Felt better (15Jul2022) then on 186Jul2022 got fever, chills, sweats, congestion, scratchy throat, exhaustion, diarrhea. Never checked if patient  tested negative ever but testing positive with home test still (20Jul2022). Fever gone but still congested, very tired, general malaise, sweats. During this time, my lingering cough/lungs have continued to clear well, though. The patient received Paxlovid from 05Jul2022 to 11Jul2022 for treatment of COVID 19.