chrisvoncsefalvay/vaers-outcomes huggingface dataset:
third toe of right foot, with some slight swellingand redness; third toe of right foot, with some slight swellingand redness; Itchy; Sensitive to touch; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included drospirenone; ethinylestradiol betadex clathrate (YAZ) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 10Mar2021 at 13:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 08:00, the patient thought she might be developing COVID toes which was started on the third toe of her right foot, with some slight swelling and redness. It was itchy but sensitive to touch. The patient thought it was a bug bite, but now it was starting to develop on the same toe of her left foot. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events third toe of right foot, with some slight swelling and redness, itchy and sensitive to touch was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
approx 4 inch are redness and warmth around vaccine site, increaseing in size approx 1 inch each day. subj temp gen malaise
After getting vaccinated with GARDASIL, patient within seconds just passed out in front of nurse and landed face down on concrete floor and while she was unconscious was having jerking body movements while at the same time was having heavy bleeding of nose and mouth..doctor was called immediately performed first aid with cold ice compresses and lay her down on floor until she regained consciousness again. But she was still having chills and headaches and dizziness and was unaware of what had happened to her and why is she still on floor, but all she kept complaing the most was the pain and discomfort of her nose, she also stated that she feels pain in her front teeth as well and still having headache.  Doctor sent us to another hospital to have a cat scan done, and then sent to ENT specialist to get her nose checked, and he said based on CAT scan nose is broken and dented towards the side she fell off to the floor..but since its a big swelling he gave her appointment to come back on Friday 10/05/2012. And will also set up procedure/surgery date for patient. Even now she was told to put ice packs around face area for 15 minutes, but even at home she is sad and crying because of the incident and she is still in shock and traumatized.
received 1st primary series dose 8 months ago, never received 2nd primary series dose; she didn't receive the second primary series dose because she "didn't want it"; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (received 1st primary series dose 8 months ago, never received 2nd primary series dose) and PRODUCT DOSE OMISSION ISSUE (she didn't receive the second primary series dose because she "didn't want it") in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (received 1st primary series dose 8 months ago, never received 2nd primary series dose) and PRODUCT DOSE OMISSION ISSUE (she didn't receive the second primary series dose because she "didn't want it"). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (received 1st primary series dose 8 months ago, never received 2nd primary series dose) and PRODUCT DOSE OMISSION ISSUE (she didn't receive the second primary series dose because she "didn't want it") outcome was unknown.            No concomitant drug information was provided.  The reporter wants to know if it was okay to receive the second dose now.  No treatment drug information was provided.   Reporter did not allow further contact
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Severe, Additional Details: Influenza shot given high than usual on left arm in deltoid. Patient states she could feel "needle penetrating and breaking through". Patient felt resistance from needle injection.
3.5 inch x 1/2cm circular urticarial swelling on (R) triceps. Mild tenderness and erythema. Symptoms started today. Cold compresses TID.
Psoriasis; Bilateral rash / rash; This case was reported by a consumer via sales rep and described the occurrence of psoriasis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, 1 month after receiving Shingrix, the patient experienced psoriasis and rash. The patient was treated with dermatologicals nos (Lotion). On an unknown date, the outcome of the psoriasis and rash were not recovered/not resolved.   The reporter considered the psoriasis and rash to be possibly related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient stated that 1 month after 2nd dose she experienced bilateral rash that was later diagnosed as psoriasis.  The reporter was still treating 3 years later with medication and lotions.  The reporter felt rash was related to vaccine.
day p/shot given pt was getting ready for school in AM c/o bad h/a then passe out;mom revived pt, fed pt breakfast & pt felt fine;saw MD  had ECHO-dx innocent heart murmur;
no additional AE; A pharmacist reported that an improperly stored VARIVAX vaccine was administered to a patient.; This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions and allergies were not provided.   On 27-JUL-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, to prevent varicella infection (lot number W011622 which has been verified to be valid, expiration date reported and validated as 06-APR-2024). Lot number A011622 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX). (dose, route of administration, and anatomical site of injection were not provided). The administered dose of the vaccine was stored at a temperature of 5.67 degrees Fahrenheit (F), during a time frame of 3 hours and 45 minutes. There was a previous temperature excursion reported as 7.81 F, during a time frame of 1 hour and 5 seconds (product storage error). No additional adverse events were reported in the patient.
Headache, Myalgia, Arthralgia, Tachycardia, fever=101.5, large (8x4 cm) wheal at injection site Narrative:
Swollen painful axillary lymph node, malaise, constant headache, nausea for several days; Swollen painful axillary lymph node, malaise, constant headache, nausea for several days; Swollen painful axillary lymph node, malaise, constant headache, nausea for several days; Swollen painful axillary lymph node, malaise, constant headache, nausea for several days; Swollen painful axillary lymph node, malaise, constant headache, nausea for several days; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the left arm on 18Dec2020 at 09:00 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included celiac disease and hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID) and paroxetine hydrochloride (PAXIL). Past drug history included known allergies: minocycle, tetracycline and acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020, the patient experienced swollen painful axillary lymph node, malaise, constant headache, nausea for several days. No treatment was provided for the events swollen painful axillary lymph node, malaise, constant headache, nausea. The outcome of the events swollen painful axillary lymph node, malaise, constant headache, nausea was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Alopecia Areta; This is a spontaneous report from a contactable consumer reporting for a male patient (son). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced "alopecia areta". The reporter stated that after COVID Vaccine the son developed Alopecia Areta. Just want to hear from Pfizer all about that. The reporter was also asking whether the vaccine trigger auto immune response. The outcome of the event was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Patient received COVID-19 vaccine (Janseen on 6/23/21). We were having a vaccination event at the facility on 7/13/21, where patient was. Patient walked into the vaccination area and requested to be vaccinated against COVID-19. I had checked Vaccine Information System but because I did not have the correct spelling of her name, I could not pull her name up in the system. I asked her if she had a vaccine card and she denied it. After giving her the COVID vaccine, I got the information from that she had been vaccinated against COVID on 6/23/2021. Patient was notified as well as my supervisors. I followed up with patient for several days and patient did not report any adverse events.
Pfizer COVID-19 BioNTech  0.2mL administered without reconstitution. Provider/medical director at the facility notified immediately of vaccine error. Patient was kept in office for monitoring. Provider notified mother of vaccine error. All questions answered and mother will contact provider if needed.
DAY 9 - Redness/bump/sore at administration site (prior to day 9 no redness, arm was sore the first two days)
bladder infection; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 08Apr2021 10:45 (Batch/Lot Number: Ew0153), at the age of 52 years old, as single dose for covid-19 immunisation. Medical history included haemolytic anaemia from an unknown date and unknown if ongoing. Concomitant medication included amoxicillin taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. On 08Apr2021, by 15:00, the patient felt genital burning. The next morning by 11:00 (09Apr2021), she saw blood in urine and saw that she has a bladder infection. The patient undwerwent Covid test post vaccination (Nasal Swab) on 22Mar2021 with negative result. The event was reported as non-serious. The patient received nitrofurantoin as treatment for events. Outcome of the event was unknown.
pain in lower back that would move to the front starting 4 days after the shot. Dizziness, nausea, faintness, lightheadedness, palpitation and feeling there is a cloud in my brain starting 4 days after
pt recv vax 17MAY94 & pt exp mild swelling @ inj site;No further details were provided;
Patient presented to the ED ~ 14 hours post dose.  Chest discomfort, dyspnea, fatigue, and malaise.  Had prolonged covid hospitalization April-May.  Had some sinus tachycardia between 110 and 117.  Administered methylprednisolone 40 mg IV.  Was discharged from the ED with no outpatient prescriptions.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) after seizure with nausea, vomiting, and diarrhea. Patient diagnosed with c. difficile infection and hypertensive emergency, administered antiepileptics, antibiotics, anti-emetics, and IV fluids. Patient admitted to the hospital, symptoms and seizures resolved, vital signs improved, and discharged to home medically stable. Seizures and hypertensive emergency attributed to inability to take oral medications due to vomiting.
Engerix-B administered to patient on 4/14/2023 and 5/12/2023
Daughter has had a red, itchy rash behind ears, face, neck, arms and legs.
Bruise at injection site day 1 and 2 after vaccination on 10/20/16. 10 days after still has yellow purplish bruise. No treatment, patient will keep us informed if condition worsens.
Mother is the vaccinee. BABY DIED; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer in social media via a company representative concerned multiple patients of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was pregnant at the time of vaccination. The patient was gravida1. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had vaccine exposure during pregnancy and baby died. The date of the patient's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in a spontaneous abortion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine exposure during pregnancy and baby died was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220251162-Covid-19 vaccine ad26.cov2.s-Baby died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20220251162-Covid-19 vaccine ad26.cov2.s-Vaccine exposure during pregnancy. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
pt recv vax 8MAR97 &9MAR97 pt devel atypical rash that started on arm, spread to trunk, & then to upper legs;rash consisted of little, red  itchy spots;
Woke up at 5 am on 3-1-2021, feeling like my lips were very dry, and my upper lip was swollen.  Within 1-2 hrs, both my upper and lower lips felt swollen, and tingling/numbness, and felt very dry.  Look only minimally swollen, but feel swollen inside.  Look very dry and using chap stick to moisten every hour.  This has not resolved at all by 3-4-21, at which time I filed this report.
1) Immunizations given 09/24/2003; 2) 10/03/2003: Fever for 2 days 103 right (Tylenol/Motrin given alternately every 4 hours). 3) 10/05/2003: Rash developed-tiny red bumps all over body; 4) 10/05/2003- Runny nose; 5) Child will have ER check physical symptoms as reported.  No other untoward symptoms reported.
Patient had 4 seizures within 72 hours after receiving the vaccination. This is increased frequency compared to regular amount of seizures.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19". Patient received paxlovid for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sweating When Veteran returned to receive his 2nd Pfizer COVID-19 vaccine on 3/15/21, he reported that he had a mild reaction on the day of his first vaccine (2/23/21). Approximately 15 minutes after the vaccine, he experienced sweating, nausea, and one episode of vomiting. After drinking some water, the symptoms self-resolved within 3-5 minutes.
patient with immediate syncope with vaccination lasting less than 5 seconds.  patient recovered with no recurrence.   concomitant nausea without emesis and HA
This spontaneous report as received from a consumer refers to herself a 74 year female with a medical history of thyroid disorder, blood cholesterol increased and drug allergies ("many allergies if there is a 1% chance of a side effect, I will be in the 1% that gets it"). On 04-OCT-2016 the patient was vaccinated with PNEUMOVAX 23, route of administration "with a syringe". This was the first time she had ever been vaccinated with PNEUMOVAX 23. Concomitant therapies included ZOCOR, unspecified thyroid medication, Diazepam and LEXAPRO. On 04-OCT-2016, within hours of receiving the vaccine, she began to feel soreness in her arm. She lost her appetite and felt queasy after that. Three days later her arm was very sore and she started taking extra strength TYLENOL for the pain. She then got a sore throat, felt tired and was "headachy". The patient reported feeling better and was almost back to normal (date not specified). Additional information is not expected.
Got every bit of flu symptoms; Had 99 something fever; Had headache; Started feeling dizzy / had about 10 episodes of dizzy spells; Had chills / chills were really bad; Throat closed; Difficult breathing; The eye swollen up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficult breathing) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient had COVID around 20 Mar 2020.) on 20-Mar-2020.    On 22-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 DYSPNOEA (Difficult breathing) (seriousness criterion medically significant), EYE SWELLING (The eye swollen up), THROAT TIGHTNESS (Throat closed) and CHILLS (Had chills / chills were really bad). On 23-Feb-2021, the patient experienced DIZZINESS (Started feeling dizzy / had about 10 episodes of dizzy spells) and HEADACHE (Had headache). On 24-Feb-2021, the patient experienced INFLUENZA (Got every bit of flu symptoms). 24-Feb-2021, the patient experienced PYREXIA (Had 99 something fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat tightness, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficult breathing), EYE SWELLING (The eye swollen up), INFLUENZA (Got every bit of flu symptoms), THROAT TIGHTNESS (Throat closed), DIZZINESS (Started feeling dizzy / had about 10 episodes of dizzy spells), CHILLS (Had chills / chills were really bad), HEADACHE (Had headache) and PYREXIA (Had 99 something fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 99 (Inconclusive) 99. something Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided..  Treatment medications included a breathing treatment at the emergency room.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I recieved my flu and covid booster at noon and they next morning at 4:00 am I could not see.  I lost my prefrail vision.  I went to the er.  I have been to specialist.  The doctors have found no reason for the loss of sight.  I have had different opinions from the doctors on weather it was the covid shot or some freak medical event.  It is slowly improving I am still under dr care.
Nausea; Diarrhea; This spontaneous case was received on 22-Sep-2022 from other healthcare professional (nurse) via Regulatory Authority (reference number: SEQW22-03412) and concerned a patient of unspecified age and gender.  The patient's concurrent condition included dementia. The patient's past medical history included a stroke. The patient's concomitant medications included all the medication pertaining to the aftermath of a stroke.  On 20-Sep-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization against influenza disease caused by influenza virus subtypes A and types B. The batch number reported was AS1596C and expiry date 30-Jun-2023. The reporter stated that the vaccination went normal as always.   On 21-Sep-2022, during the night, 18 to 24 hours after receiving Flucelvax Quadrivalent, the patient developed nausea and diarrhea. The patient was given 7up and acid as a corrective treatment.   On the same date, the patient recovered from both events. As reported, the patient no longer had these symptoms.   The reporter did not provide causality assessment.  The case was assessed as non-serious.  This case is linked to the cases 202204734, 202204735, 202204736, 202204737, 202204738, 202204739 and 202204740 (the same reporter).  Company comment: The events of nausea and diarrhea are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of nausea and diarrhea are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.
Shortness of breath and chest pain after receiving the 2nd dose.  Patient given IV fluids and nsaids.  Diagnosis of Pericarditis
Janssen vial was punctured at 932 AM and dose was administered at 5:25PM.  Punctured vial was stored in fridge and would have been stable for 6 hours expiring at 332PM.  No adverse events reported.  I will follow up with patient for the next several days..