chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Did not feel well/but worse; She went to ER because her vagina was black; Her stomach was on fire,but worse; Had some sores on her vagina/but worse; She got sick/but worse; Fever/but worse; Throwing up/but worse; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well/but worse), VAGINAL DISORDER (She went to ER because her vagina was black), DYSPEPSIA (Her stomach was on fire,but worse), VULVOVAGINAL PAIN (Had some sores on her vagina/but worse) and ILLNESS (She got sick/but worse) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MALAISE (Did not feel well/but worse), VAGINAL DISORDER (She went to ER because her vagina was black), DYSPEPSIA (Her stomach was on fire,but worse), VULVOVAGINAL PAIN (Had some sores on her vagina/but worse), ILLNESS (She got sick/but worse), PYREXIA (Fever/but worse) and VOMITING (Throwing up/but worse). At the time of the report, MALAISE (Did not feel well/but worse), VAGINAL DISORDER (She went to ER because her vagina was black), DYSPEPSIA (Her stomach was on fire,but worse), VULVOVAGINAL PAIN (Had some sores on her vagina/but worse), ILLNESS (She got sick/but worse), PYREXIA (Fever/but worse) and VOMITING (Throwing up/but worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Herpes simplex test: came back false (Negative) came back false.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The patient had same symptoms from  1st dose but worse. The patient went to ER, because the vagina was black and took Herpes Tests and all came back false.   This case was linked to MOD-2022-443828 (Patient Link).
After 1st vaccine, had "gout flare-up" the same evening, lasting several weeks, into dose #2 and beyond.  Pt states she did have a history of gout in her past. (? on when, eleveated uric acid 8.4 noted on patient's chart on 1-20-2020.)  This episode started in right foot, moved to left foot several weeks later. States she does not feel dose #2 (2-2-21) made issue worse, as the issue was already present at that time.  Pt was prescribed indomethacin, allopurinol, ketorolac tablets. Pt states  pain did not really let up until several weeks later, and only has been tolerable and nearly resolved for past 1-2 weeks.
Right deltoid, (R) arm, (R) forearm severely swollen red warm with dry scaly itchy red rash. Fever T100.1
1 mo after Varivax, dx with shingles, extremely severe case. Lesions all over L chest, hip, buttocks. Treated by traiteut. At somte time brother had (groin) shingles but not much time spent with him. Dx by family practice.
Got hives on June 17 which seem to go away after taking Zyrtec for 7 days , but got hives back today 6/27/2021  Worried about taking second shot
Herpes Zoster in a previously vaccinated patient. Painful unilateral rash and headaches. Given treatment for illness.
The patient is a 35 y.o. female with history of POTS, Chiari malformation type I, and mast cell disorder, BIBM to the Emergency Department with flu-like symptoms following the Johnson&Johnson Covid vaccination. Patient received her vaccination mid-day yesterday and by yesterday evening she developed generalized myalgias, palpitations, HA, and chest pressure "like something is sitting on my chest." She specifies though that her chest pressure is "not bad enough that I need an inhaler." She notes that throughout the night she had a fever of 102 and woke up this morning with a heart rate of 148 prompting her ED visit. Patient is also nauseated, but denies any vomiting. She reports taking zyrtec, ketotifen, and cromolyn sodium at 0600 this morning. Patient is allergic to Benadryl. Patient notes that she received saline infusions in home a couple times a week for her history of POTS.
Bruises ranging in size from a quarter to a baseball from my hips down. Also, feeling extremely cold despite the house being 76 degrees.
Shakes, severe chills, temp 101.4 extreme fatigue and malaise. Headache, body aches, not smell or taste.  Tylenol, fluids Motrin, rest shower and than heated blanket set to high to try and get warm
Pt. co of feeling flushed and feeling funny. Patient was flushed and b/p 142/80 r arm. Pt observed 10 mins and she sated that she was feeling worse and scared . No noted shortness of breath. B/p rechecked 110/80.
Redness, itchy, inflamed not eating, drinking, listless, nausea, weak, equilibrium off on 3rd day seizure, She continues to have these symptoms including redness, itchy, and all above symptoms.
Soreness of the arm a few hours after. The following day there was a large circular hard and hot red raised lump near where the shot was administered. Very uncomfortable when touched and while sleeping. Symptoms have not yet gone away or gotten better. It has been 3 days so far after the vaccine.
Patient called the clinic on 9/30 with complaints of 2 two weeks of muscle pain in left arm (opposite arm) which occasionally radiates to chest. She describes that after the vaccination she had some muscle aches, nausea and stomach cramping the day after the vaccination which she related to standard symptoms.  About two days after the vaccination, the Muscle aches / pain began and is consistent in her right arm.  She has been taking Ibuprofen 800 mg q6h and a muscle relaxant to control the pain. Patient unable to get appointment with primary physician and was referred to an immediate care.
No adverse event occurred, wrong vaccine administered. Patient was to receive booster of adult pfizer and received pediatric pfizer
Headache. Neck stiffness, all over body aches, chills, abdominal pain, fever, faint.
I started experiencing cough and runny nose around 3rd week of august.  I had a positive pregnancy on aug 28.  The symptoms came back in Sept and got worsen.  At first I thought is just seasonal allergy. I develop shortness of breath, backpain and chest congestion aside from the coughing and runny nose and nasal congestion. I thought its covid related by I was tested 2x and still negative. On the night of 10/03, I started experiencing left inguinal pain and on 10/04, my left leg is swollen and I had hard time walking. I was rushed to ER and I was diagnosed with DVT and Pulmonary Embolism. Doctors and specialist cannot determine the exact cause since Im a healthy and active person without any family history of clotting disorder. The only changes happened is that I received 2  covid vaccine in april and in may, and I got pregnant.
Patient states that his left arm from his elbow down was numb yesterday (9/14). It is still not 100% today  (9/15) but he has more feeling in it today than yesterday.
Swelling of eyes, face, throat, sore throat, cough, swollen sinus.  Took Benadryl, next day needed ER.
03/28/07 Pt. developed red rash all over;itching;14x10 cm red macular rash at injection site on left leg;large erythemous patches on chest, back and abdomen;ears red- given benadryl and clarinex
Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, PRAVASTATIN and GABAPENTIN for an unknown indication.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.
Second one for the first couple days my arm just hurt; body aches; dehydrated; headache; This is a spontaneous report from a contactable consumer (patient herself) from a Pfizer sponsored program support. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0217), via an unspecified route of administration, administered in Arm Left on 25Jun2021 at 09:30, as single dose for covid-19 immunisation. The patient medical history and concomitant medications reported as none. Patient's family history reported as none and no relevant test was performed. Patient's historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 04Jun2021 at 09:30 as single dose for covid-19 immunisation and experienced no reaction. Patient's History of all previous immunization with Pfizer vaccine reported as none, prior vaccinations patient received only first dose of covid-19 vaccine. No additional vaccines administered on same date. Patient reported she is experienced headache on an unspecified date in Jun2021 and body aches on 30Jun2021 at 03:00. In her area of the country, they are having extreme heat and she isn't sure if her symptoms are from being dehydrated on 30Jun2021 or if they are from the vaccine. First vaccine I had nothing. Second one for the first couple days on 30Jun2021 at 03:00 my arm just hurt and today the headache started. Patient was wondering if it possible 5 days later to have effects from the vaccine. She could feel it in her sleep, and she woke up with a headache. She is not sure start date of headache is 29Jun2021 or 30Jun2021what time it was started it was in the middle of the night. Events not required visit to Physician Office or Emergency Room. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as not recovered.  Information on batch/lot numbers are available. Further information has been requested.   .
with a prescription from her HCP for GARDASIL 9. At that time the patient was 52 years old; No additional AE information was provided; received the second dose of GARDASIL 9 on an unspecified date in January 2023; patient received her first dose of GARDASIL 9 on April 21, 2022; This spontaneous report was received from pharmacist (who is also the pharmacy manager) and refers to a currently 52-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-APR-2022 the 51-year-old (also reported as 52, conflicting information) patient came to the pharmacy with a prescription from her health care professional (HCP) for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Product prescribing issue). On the same date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). In January 2023 the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). The pharmacist reported he did not have the lot/expiration dates of the vaccines because they were currently in storage. No additional adverse event information was provided.
a dose of Quadracel administered to a 4 month old patient, no AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case from the physician (pediatrician).  This case involves a four month old male patient who was vaccinated with a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (vial, lot C5655AA and expiration date 26-Nov-2021) via an intramuscular route in the left thigh for prophylactic vaccination on 20-Aug-2020 (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient had concomitantly vaccinated with a dose of HIB VACCINE (HIB) for prophylactic vaccination on 20-Aug-2020.  It was an actual medication error case due to inappropriate age at vaccine administration (latency was same day).  No adverse event reported at the time of reporting.  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 Directive and Module VI of the 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.
pt given 1st Hep B vax 330PM approx 30mins later states became dizzy, nauseous, & vomited once;
Joint pain in got severe in knee, feet hands, neck and jaw and mid back. Treated with Leflunomide, Prednisone, Humara.
This is a spontaneous report from a contactable consumer (mother) via the DTC First Connect Line. A 4-year-old male patient received a dose of PREVNAR13 on 19MAR2012. Relevant medical history was none, but the patient recently was on continuous positive airway pressure (CPAP) machine (date not specified). Concomitant medication included IBUPROFEN at one and a half teaspoons thee times a day orally from an unknown date and discontinued on 21MAR2012. The patient previously received polio-vaccine and MMR on an unknown dates. On 19MAR2012, the patient experienced an "irritable" leg (leg discomfort). On 22MAY2012, the patient developed leg swelling. No therapeutic measures were taken in response to the events. The patient had not yet recovered from leg swelling. The outcome for leg discomfort was unknown. Follow-up (17MAY2012) Follow-up attempts completed. No further information expected.
I hurt like heck and I was in bed for a day, the day after dose 2, I went to my Cardiologist on 06/29/2021 and am now being treated for AFIB-he gave me Metoprlol-ER.
Recv'd Hep B # 1 during a mild viral illness 9/27/99.Now complains of chronic fatigue & low grade fevers-negative medical workup to date.(2 1/2 mos of symptoms)
TEMP 102.4 X 1 DAY, THEN <100 X 2 DAYS.
1130AM 18MAR93 (1hr p/vax) pt screamed off & on w/high pitched scream for 5 1/2 hrs; had t102.4; MD called was told to give DPH; pt slept 3 hrs then was crabby x 1 day;
Chest pain two days after receiving vaccine. Labs obtained were troponin elevated to 21.8 BNP 230, diagnosis of myocarditis. Troponin levels are down trending. Echocardiogram obtained and plan for cardiac MRI. EKG obtained overall unremarkable.
Sudden onset of Urticaria from the neck down with itching., approx. 24 hours later.  Treated with hydroxyzine.
throat sore; Like sick; All body hurts; Horrible headache; fever; soreness arm; very shaky; dizzy; cold; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (soreness arm), TREMOR (very shaky), DIZZINESS (dizzy), NASOPHARYNGITIS (cold) and OROPHARYNGEAL PAIN (throat sore) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included TMJ syndrome.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness arm), TREMOR (very shaky), DIZZINESS (dizzy), NASOPHARYNGITIS (cold) and PYREXIA (fever). On 17-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (throat sore), ILLNESS (Like sick), PAIN (All body hurts) and HEADACHE (Horrible headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness arm), TREMOR (very shaky), DIZZINESS (dizzy), NASOPHARYNGITIS (cold), OROPHARYNGEAL PAIN (throat sore), ILLNESS (Like sick), PAIN (All body hurts), PYREXIA (fever) and HEADACHE (Horrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Pain medication for TMJ syndrome.
vissual issues, double vision, out of visual alignment per ophthalmologist, not resolved at second dose
10/2017-Pain and itching in injection shot noticed immediately. As of today, April 10, 2018, pain and itching has increased. On and off limited range of motion noticed December 2017, until current. The limited range of motion is ongoing everyday at this point and causes severe pain.
Vaccinated with FLUC 10/2/14 at 4pm; pt reports awaking with pain, swelling, bruising and headache.
After this patient received his first Pfizer COVID vaccine, the Health Agency contacted the clinic because they have the patients DOB listed as one date and not as his mom reported when she initially made the appointment.  The Immunization database picked up this discrepancy.  The second dose wasn't administered as the patient is not eligible based on his age.
This 2 month old female presents today with chief complaint of skin eruption. Patient seen after office hours at 10:20 PM at the clinic. Child received Pediarix, Hib and Prevnar at 6 PM today. Allergic reaction.
throwing up; Being hot all night; Feeling out of it; Sore Arm; Fever; Migraine; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, migraine, feeling hot and feeling abnormal. On 11th July 2020, the patient experienced vomiting. On 12th July 2020, the outcome of the pain in arm, fever, migraine, vomiting, feeling hot and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the pain in arm, vomiting, feeling hot and feeling abnormal to be related to Shingrix. The reporter considered the fever and migraine to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine and later that night she developed symptoms of sore arm, fever, migraine, throwing up, being hot all night and feeling out of it.   This case has been linked with case US2020AMR202822, reported by same reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202822:husband's case
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 16-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 144, and 144 hours, with the lowest recorded temperature of 34, and 33 degrees Fahrenheit (1.11, and 0.55 degrees Celsius) respectively. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Myalgia, Arthralgia, Fever, CoughWheeze, R ARM PAIN, BONE, BODY ACHES, FATIGUE, FEVER 101.0, SHORTNESS OF BREATH, DRY NON PROD COUGH Narrative:  prescription for zithromax but instructed to hold off on taking it for a few days. she has not taken this medication at this time client has hx of asthma and uses albuterol
Pt was inadvertently given a Kinrix instead of a Hep A at 19 months of age. No signs or symptoms of reaction after injection was given. Parent was contacted and returned for Hep A in opposite thigh.
Right arm swollen (patient stated 2-3 times size of left arm). Patient was instructed to put ice on arm and take some Benadryl.
Tinnitus - continuous ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus - continuous ringing in ears) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced TINNITUS (Tinnitus - continuous ringing in ears). At the time of the report, TINNITUS (Tinnitus - continuous ringing in ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication was provided by the reporter no treatment information was provided by the patient
Hands and face turned red; Hands and face itchy; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161) via an unspecified route of administration in the left arm on 15Apr2021 at 13:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021 at 13:30, 24 hours after injection, the patient's hands and face turned red and itchy. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with BENADRYL every (q) 6 hours which was prescribed when the patient called the doctor. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hands and face turned red and hands and face itchy were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.