chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When patient scratch it, it becomes red; intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs.; started getting intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs. When patient scratch it, it becomes red.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs.), PRURITUS (started getting intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs. When patient scratch it, it becomes red.) and ERYTHEMA (When patient scratch it, it becomes red) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056H21A, 002C21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, the patient experienced URTICARIA (intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs.) and PRURITUS (started getting intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs. When patient scratch it, it becomes red.). On an unknown date, the patient experienced ERYTHEMA (When patient scratch it, it becomes red). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE (topical) at an unspecified dose and frequency. At the time of the report, URTICARIA (intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs.), PRURITUS (started getting intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs. When patient scratch it, it becomes red.) and ERYTHEMA (When patient scratch it, it becomes red) had not resolved.            Patient was not under any concomitant or regular medications. Patient had no allergies. Patient does not have a history relating to the adverse events occurred.   This case was linked to MOD-2022-481401, MOD-2022-481416 (Patient Link).
titers are low; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced therapeutic response decreased (Verbatim: titers are low). The outcome of the therapeutic response decreased was unknown.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter was an Office staff member. The reporter stated that the physicians at the practice routinely check Hepatitis B titers and if the titers were low, they give a booster dose or redo the entire series. The reporter did not consent to follow up.
Barely Walk; Slight Headache; severe pain in right knee; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Barely Walk), HEADACHE (Slight Headache) and ARTHRALGIA (severe pain in right knee) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Pulmonary osteoarthropathy hypertrophic on 11-Aug-2020 and Total knee replacement on 15-Jan-2021. Concurrent medical conditions included Drug allergy (Amlodipine, Nifedipine, tramadol , oxazepane,azetimide), Hypertension, Migraine, Obesity, Obstructive sleep apnea syndrome and Type 2 diabetes mellitus. Concomitant products included VITAMINS NOS, LEVOTHYROXINE SODIUM (SYNTHROID), ASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, LEVOTHYROXINE, VITAMINS NOS (MVI [VITAMINS NOS]), OMEPRAZOLE and MACROGOL 3350 (MIRALAX) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced ARTHRALGIA (severe pain in right knee). On 12-Apr-2021, the patient experienced HEADACHE (Slight Headache). On an unknown date, the patient experienced MOBILITY DECREASED (Barely Walk). The patient was treated with PREDNISONE at an unspecified dose and frequency; CELECOXIB (CELEBREX) at an unspecified dose and frequency; LIDOCAINE at a dose of 5% patch and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-May-2021, ARTHRALGIA (severe pain in right knee) had resolved. At the time of the report, MOBILITY DECREASED (Barely Walk) and HEADACHE (Slight Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Blood test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pain resolved after receiving an  intra-articular corticosteroid injection on 14-MAY-2021. Fulminant response to the injection would support intra-articular soft tissue inflammation as the source of pain. The source of the intra-articular soft tissue inflammation was not clear.   This case was linked to MOD-2021-097825 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: ADR received on 07-JUN-2021 contains Allergies, past medical history updated. additional concomitant medications updated. Outcome for event of right knee pain updated.
c/o headache after receiving vaccine.  138/74, O2Sat 97%. 9:15am Pt. stated that he is feeling better.  EMS recommended that if patient still feels symptoms to contact 911 or primary care physician.
chills, fever, sweating, all over aches, weakness, loss of appetite, nausea, tired but difficulty sleeping, heart racing at times, sensitivity to light, hard to do anything for long (sleep, read, watch TV...)...tough to focus. Pain at injection site, too. Came on about 6.50 hours after getting the 2nd dose. Started with tingles and increased pain in injected arm. Worsened through the night. In middle of night was freezing but my back was completely sweaty and sheets covered in sweat. Was miserable like that through the next day. Was better the day after, and better again day 3, but now on day three still have dull headache, difficulty focusing, am exhausted, and have nausea despite pushing fluids, taking ibuprofen, and resting. Pain in left armpit (injected arm) started yesterday and still have it.
Participant reported warm feeling & had rash on left arm/ no epi administered/ after monitoring participant for several minutes, symptoms decreased.
pt recv vax & w/in 2min 5-6cm area of redness;ice applied MD notified
Started with fever of >101, body aches, chills, headache around 1am. Fever relieved with Tylenol at 7am. Body aches lessened, chills continued, headache lessened. Started again with fever, body aches, chills around 4pm. Took Tylenol again. Symptoms lessened. Felt better following morning, symptoms resided. Also very sore upper left arm x4 days
pt brought in @ 930 for shots was behind getting 6mos shot @ 10 mos; mom called office stating pt is having a sz; instructed mom to take pt to ER immed;
patient got so sick; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a patient (unknown age) who got so sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s) concomitant therapy and family history were not provided. Patient's vaccine included Influenza vaccine for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got so sick which kept him down for 3 days (illness) on the same day (an hours after) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
PT CALLED TODAY, SAID SHE HAS RUNNY NOSE, WHEEZING, GETTING OUT OF BREATH, MUCUS, STARTED FEELING THIS ON FRIDAY 09/29/2023
Patient states he slept for 36 hours after receiving second dose moderna and is still two days later experiencing massive body aches and pains as well as mild fever.
Fever within 12 hours lasted three days up to 103 degrees, shivering, severe headache, body and back aches, lethargic  Arm swollen, red, painful and itchy at injection site for one week after
Local indurated, erythemators reaction @ MMR site, occuring 1 wk with immun. administr. Ice, MOTRIN, topical steroids recommended.
woke up in the middle of night; bad sinus infection, but she doesn't feel sick nor is her nose plugged; smell a burning smell, like if food was burning.; voice seems different; cannot smell; cannot taste anything from vinegar, salty and sweets.; her eyes are itchy, but she states that she has allergies; 101.6 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (woke up in the middle of night), SINUSITIS (bad sinus infection, but she doesn't feel sick nor is her nose plugged), PAROSMIA (smell a burning smell, like if food was burning.), DYSPHONIA (voice seems different) and ANOSMIA (cannot smell) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced SLEEP DISORDER (woke up in the middle of night), SINUSITIS (bad sinus infection, but she doesn't feel sick nor is her nose plugged), PAROSMIA (smell a burning smell, like if food was burning.), DYSPHONIA (voice seems different), ANOSMIA (cannot smell), AGEUSIA (cannot taste anything from vinegar, salty and sweets.), PRURITUS (her eyes are itchy, but she states that she has allergies) and PYREXIA (101.6 degrees Fahrenheit). At the time of the report, SLEEP DISORDER (woke up in the middle of night), SINUSITIS (bad sinus infection, but she doesn't feel sick nor is her nose plugged), PAROSMIA (smell a burning smell, like if food was burning.), DYSPHONIA (voice seems different), PRURITUS (her eyes are itchy, but she states that she has allergies) and PYREXIA (101.6 degrees Fahrenheit) outcome was unknown and ANOSMIA (cannot smell) and AGEUSIA (cannot taste anything from vinegar, salty and sweets.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) High.         Treatment medication included acetaminophen for fever.   Concomitant product use was not reported.   This case was linked to MOD-2021-052484 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Updated email address of the patient. Updated the event outcome for cannot smell and cannot taste from unknown to not recovered.
SWELLING OF LEGS; SWELLING FROM BOTTOM TO TOP OF KNEE; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced swelling of legs. On 2021, the subject experienced swelling from bottom to top of knee. Laboratory data included: Diagnostic ultrasound (NR: not provided) swelling from bottom to top of knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling of legs and swelling from bottom to top of knee was not reported. This report was non-serious. This report was associated with a product quality complaint:  The suspected product quality complaint has been confirmed to be void (does not meet criteria) based on the PQC evaluation/investigation performed.
8MAY lethargy, difficult to arouse from sleep, 7MAY irritable afebrile; adm to hosp PM of 8MAY92 IV fluid for hydration was the only tx fever of 100 to 101 R devel day 4 in hosp;
had little pimples on her face; allergy/ allergy that her daughter had because of the Pfizer covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 14-year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 21Jan2022 (Batch/Lot number: unknown) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DESOGESTREL taken for dysmenorrhoea. The following information was reported: ACNE (non-serious) with onset 22Jan2022, outcome "recovering", described as "had little pimples on her face"; ALLERGY TO VACCINE (non-serious) with onset 22Jan2022, outcome "recovering", described as "allergy/ allergy that her daughter had because of the Pfizer covid vaccine". Therapeutic measures were taken as a result of acne, allergy to vaccine.  Additional information: The reporter stated that the patient had the reaction like she had little pimples on her face. This started the second day after the vaccine. This event happened for about 4 days and then the patient took Benadryl and then it improved. Also stated that an allergy that her daughter had because of the Pfizer covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
shaking/chills, fever, cough, post nasal drainage, symptoms started Sat night around 10 pm, came on very suddenly. Reports having fever this morning, around 100.7F. He is fully vaccinate starting 11/30/21
a patient was given high dose fluzone that is not in the recommended age range and the patient is pregnant/No AE; a patient was given high dose fluzone that is not in the recommended age range and the patient is pregnant/No AE; a patient was given high dose fluzone that is not in the recommended age range and the patient is pregnant/No AE; a patient was given high dose fluzone that is not in the recommended age range and the patient is pregnant/No AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves female patient of an unknown age who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site on an unknown date, while she was pregnant.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of vaccine exposure during pregnancy. The patient was pregnant when she received vaccine.  It was also the case of actual medication error due to inappropriate age at vaccine administration, product use in unapproved population and overdose.  Caller says that a patient was given high dose fluzone that is not in the recommended age range and the patient is pregnant.  At the time of report, no adverse event was reported.  Pregnancy outcome was unknown at the time of report.  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 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.  Information on the batch number was requested.  List of documents held by sender- none.
NORMAL ARM PAIN HOWEVER THE FOLLOWING WAS FELT REAL TIRED BARELY ABLE TO STAY AWAKE
pt recvd vax & w/in 24hrs pt presented to MD because exp local erythema & shoulder to elbow pain;MD stated a concern w/lot of vax involved in report;pt also exp swelling from shoulder to elbow & fever;
Roughly 15 minutes later, pt became pale and light-headed, and began to lean over on his mother. He was A & O, with radial pulses 1+. He was placed on an examination table with knees up. Blood pressure was 80s/40s. He was given some juice while lying down, and roughly 15 minutes later, his pulses were stronger and he felt less light-headed. BP was then 90/50. He continued to lay down for another 15 minutes, drinking juice, and continued to feel less light-headed, although his blood pressure remained roughly 90/50. He then sat up for 15 minutes, followed by standing up, and felt baseline the entire time. His BP continued to stay 90s/50s-60s, but he had 2+ pulses, his color had returned, and he did not have anymore light-headedness.
Rash on hands, severe psoriasis flair up on elbows and left eyelid, welts on eyelid, forehead and elbows, intense itch on the scalp.
At least one month after shot it was still red in the area. Soreness/pain in upper left arm when trying to use, lift, sleep on left side. Use ice or heat pack to help relieve pain. Pain pills do not help. Pain or sore ever since shot given; some days light some days heavy pain. Use right arm at times to lift left arm.
Client developed swelling of eyes (lower lid Bid) and c/o eyes itching. No visible rash or wheals. No edema at injection site.
Approx. 8 hours after the injection I became nauseated but did not vomit. Rolling waves of nausea and stomach cramps continued every few minutes throughout the night. I made several trips to the bathroom but did not vomit or have diarrhea. I also experienced teeth-chattering chills for approx. 1 hour beginning around 2a.m. My arm was also swollen, sore, and warm to the touch in an area approx. 4.5 inches diameter around the injection site. The following morning I had a headache (extremely rare for me) and was excessively fatigued and lethargic throughout the day. I was able to eat a piece of toast around 2pm  (24 hours after the injection) and was able to eat toast with provolone cheese on it by 7pm.  The nausea had completely remitted by that evening, but the extreme fatigue continued . I went to bed around 10pm and slept through the night and woke up the next day symptom-free except for the continued soreness and swollen area around the injection site. It is now approx. 55 hours post-injection and the injection site is still noticeably swollen, warm to the touch, and sore, but less so than yesterday. ( I also had an adverse event following the first dose of the Shingrix vaccine, characterized by 12 hours of teeth-chattering chills that began 24 hours after the injection.)
States throat and glands began swelling about 24 hours after receiving a MMR vaccine. Difficulty swallowing and eating. No fever but complains of throat burning and pain or hurting in chest area.
This is a spontaneous report from a contactable Consumer via Pfizer sales representative. A 68-year-old female patient received first dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got shot and 3 days later, she woke up without any prior ax and felt like she had a full blown case of bronchitis (continuously coughing) without any other symptoms. Just a horrendous cough. Then 2 days later she went to a minute close mic and the Physician Assistant said she had a 101 fever and diagnosed her with pneumonia in both lungs. She got a Z pack and gave her albuterol and some OTC cough medicine, she continued to call and 3 days later went back to the doctor for a follow up (but she was still coughing). The MD said her lungs were clear and that she didn't have pneumonia or bronchitis, and then he said that she had a inflammatory response to the vaccine. The outcome of the coughing was not recovered, while the rest events was unknown.
(L) arm was red, swollen, indurated bl. and very tender, no fever. It's a local reaction to DTAP.
pt to ER on 8SEP95 w/redness, swelling, tender area rt upper arm extending over the elbow w/2-3 blistered area; no axillary lymphadenitis-was given DPH & instructed to apply cold packs; f/u 9SEP95 @ ofc dx poss rxn to MMR vs cellulitis
Patient presented to our office on 8/20/2015 with symptoms gastroenteritis with HCV, lab results, revealed extremely elevated ALT/AST further testing labs and Hep A.
This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown demographics. On an unknown date these patients were vaccinated with doses of PEDVAXHIB (dose, frequency, therapy route, lot # and expiry date unspecified) which were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event was unknown. Reporting pharmacist considered the event to be not related to PEDVAXHIB. This is one of several reports received from the same source (MARRS # 1502USA002011 and MARRS # 1502USA002297). Additional information has been requested.
Two weeks after Pfizer vx, my heartbeat started increasing from around 68 to 106 (approx). Has permenent stayed at over 100 BPM.
Nurse administered vaccine to pt while father was holding them. After injection of the needle, nurse started to push plunger however pt moved his arm away. Pt received less than half dose, some vaccine content plunged out of syringe and last of vaccine content still remained in syringe. In accordance to CDC guidelines, OK to repeat dose immediately. Upon pt education with father, father OK'd us to repeat dose. Repeat dose successful.
Patient received first dose of COVID-19 vaccine. Within a few minutes after vaccination, patient reported feeling lightheaded with blurred vision and rapid heart rate. Patient drank some juice and sat for an additional 10 minutes; patient reported she felt better and opted to leave. Suspected vasovagal reaction.
Felt fine until 5pm the day of the vaccine.  Then had to turn the heat on( was 70 outside) and electric blanket on high.  Terrible headache and what felt like a fever, and serious chills.  Felt worse than I had in years.  Woke up to sheets being soaking wet, and terrible headache, tooth pain and injection site pain.  Woke up feeling a bit better.  Two days later feeling shortness of breath, light headedness, and dizzy.  Quite a bit of anxiety. Could be due to vaccine sites shut down or the actual vaccine..  4th day since the vaccine and still not felling myself.