chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous case reported by a consumer (subsequently medically confirmed), describing the occurrence of vaccination site warmth (super hot-to-touch), discomfort (little discomfort), vaccination site induration (hardness), vaccination site pruritus (itching) and vaccination site erythema (bright pink) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 015M20A) for COVID-19 immunization. No medical history reported. On Feb 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 20, 2021, patient experienced vaccination site induration (hardness). On an unknown date, patient experienced vaccination site warmth (super hot-to-touch), discomfort (little discomfort), vaccination site pruritus (itching) and vaccination site erythema (bright pink). The patient treated with Benadryl 24-D (loratadine/pseudoephedrine hydrochloride) ongoing since an unknown date, 1 dosage form; and Tylenol (paracetamol) ongoing since an unknown date, 1 dosage form. At the time of the report, vaccination site warmth (super hot-to-touch), discomfort (discomfort), vaccination site induration (hardness), vaccination site pruritus (itching) and vaccination site erythema (bright pink): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication information  provided.
1 of 4 linked same reporter cases (other related cases: 1210USA012785, 1210USA013664 and 1210USA013665). This spontaneous report as received from a pharmacist refers to unspecified number of patients who on unknown dates were vaccinated with VAQTA. The patients might have been vaccinated with improperly stored of VAQTA but did not have any other information. No adverse effects reported at that time. The outcome of the event was unknown. Additional information is not expected.
unable to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9269, Expiration Date: 31May2021) at the age of 74 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "unable to walk".  Additional information: Reporter stated that got the first Pfizer Covid vaccine 06Feb2021, second one on 02Mar2021 and got the booster on 05Nov2021. About four weeks after the first vaccine she was unable to walk; has muscle weakness in left leg. Has been like that for 2.5 years. Was wondering if it was going to get any better. Has been to so many doctors, they do not know anything and are not talking as much.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300337515 Same patient/vaccine, different vaccine dose/event;US-PFIZER INC-202300348118 Same patient/vaccine, different vaccine dose/event;
Redness, swelling and painful to touch at site of injection. 11 1/2 cm x 5 cm. Treated with prednisone 20mg, 2 daily for 5 days.
Patient came in on 2/15/2013 to report redness at the site that spanned about 4 inches in diameter. No other symptoms.
Moderna COVID-19 Vaccine EUA. First dose. Soreness in the arm that continued for 48 hours.  Low grade fever for about 4-6 hours with occasional chills. Most significant adverse reaction was sleeplessness. It was like I was on a caffeine high. Did not even feel close to sleepy until 3:30 AM, about 12 hours after the shot. Normal bedtime is 10:30 pm.
massive rash; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 60-years-old non- pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration, administered in Arm Left on 19Mar2021 at 12:00 AM (Age at Vaccination: 60-years-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Facility type Vaccine was Pharmacy or Drug Store. The patient took no other vaccine in four weeks, had no Covid prior vaccination and was not Covid tested post vaccination. Medical history included cancer diagnosed on 18May2021 and unknown if ongoing, the patient had no known allergies. There were no other medications in two weeks. It was reported that the patient took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8734) via an unspecified route of administration, administered in Arm Left on 19Apr2021 at 12:00 AM (Age at Vaccination: 60-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. On 13Apr2021 at 12:00 AM, the patient experienced massive rash. The adverse event resulted in doctor or other healthcare professional office/clinic visit. For Adverse event treatment was done with steroids, doxyclicine. Outcome of event was not recovered.   Follow-up attempts are completed. No further information is expected.
This literature report (initial receipt 18-Nov-2011) concerns a 54-year old patient, who had a past medical history of elevated cholesterol, HTN (hypertension) and shrimp allergy. The patient received AFLURIA and developed facial diplegia 7 days later. The event outcome was not reported. Reporter's comments: The reporter considered the event to be possible in relation to the suspect drug.
Narrative:  Reported ongoing exhaustion and insomnia for ~2 months since receiving Moderna Covid vaccine booster.
From telephone contact received at manufacturer on 5/24/02, it was reported that a 5 year old male received Tripedia on 5/21/02. Patient was sent to Emergency Room on 5/22/02 to rule out cellulitis because of red, hot, and swollen deltoid at injection site. IV Nefrcilin given and blood work done.
After receiving Covid 19 shot, Pfizer, LOT# ER8734 in left arm and Pfizer, LOT# EW0161 in right arm, I am continuing to have severe upper arm and shoulder pain. The shots were given on 4/3/21 (Left arm) and 4/24/21 (right arm). The shots were given at store. The pain started about two months after the injections and continues until this day (08/29/22).
Initial and follow up information has been received through the pregnancy registry, from a physician and a medical assistant (MA), concerning a 19 year old caucasian female patient with asthma, who on 12-FEB-2007 was vaccinated IM in the right arm, with the first dose, 0.5ml, of Gardasil (Lot #655619/1427F).  There was no concomitant medication.  The MA reported that on 27-FEB-2007, the patient called the office to report she had performed a urine home pregnancy test that was positive.  On 19-MAR-2007, the patient visited the office and an ultrasound test also confirmed the pregnancy.  At that time, vitamin and mineral therapy with PRENATE ELITE was initiated on a daily basis.  The date of the LMP was 16-JAN-2007, with an estimated date of delivery on 23-OCT-2007.  Follow up information from the physician, indicated that from 19-JUL-2007 to 25-JUL-2007, the patient was treated for a urinary tract infection with nitrofurantoin (MACROBID), but she indicated there were no complications during the pregnancy.  Additional ultrasounds were performed on 29-MAY-2007 and 20-SEP-2007 (results not provided).  On 11-OCT-2007, at 38 weeks gestation, the pregnancy resulted in the uncomplicated delivery of a normal male infant (weight not provided).  Additional information is not expected.
High fever, 104.0 for the booster. Along with major body aches/then again after the booster, I was subject to a high fever,over 105; High fever, 104.0 for the booster. Along with major body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (High fever, 104.0 for the booster. Along with major body aches/then again after the booster, I was subject to a high fever,over 105) and PAIN (High fever, 104.0 for the booster. Along with major body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 5 milliliter. On 22-Jan-2022, the patient experienced PYREXIA (High fever, 104.0 for the booster. Along with major body aches/then again after the booster, I was subject to a high fever,over 105) (seriousness criterion medically significant) and PAIN (High fever, 104.0 for the booster. Along with major body aches) (seriousness criterion medically significant). On 23-Jan-2022, PYREXIA (High fever, 104.0 for the booster. Along with major body aches/then again after the booster, I was subject to a high fever,over 105) and PAIN (High fever, 104.0 for the booster. Along with major body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other medications not provided by the reporter. Patient Reduced body temperature by laying in a bathtub with water at 101 degree for extended periods.  Company comment: This case concerns a 57-year-old male patient with no prior medical history, who experienced serious, unexpected PYREXIA and PAIN one day after the third dose of mRNA-1273. Outcome had resolved on the following day. The reporter who is a health care professional, assessed the events as serious. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-458864.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2022: Follow up received and contains No new information.; Sender's Comments: This case concerns a 57-year-old male patient with no prior medical history, who experienced serious, unexpected PYREXIA and PAIN one day after the third dose of mRNA-1273. Outcome had resolved on the following day. The reporter who is a health care professional, assessed the events as serious. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pt recv vax on 10/20/98; on 11/13/98 pt exp whooping cough x 2 nights, body & teeth pain, flu-like sxs
ACHE; STIFFNESS\UNABLE TO STRAIGHTEN BOTH ELBOW; SWELLING; JOINT RANGE OF MOTION DECREASED; PAIN IN HAND; ARTHRITIC PAINS/JOINT PAIN/PAIN IN WRIST; SUSPECTED COVID-19; INTENTIONAL MISUSE IN PRODUCT USE DURATION; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose and frequency were not reported from an unspecified date to 26-JUL-2021, dose and frequency were not reported from 03-AUG-2021 to AUG-2021, and dose and frequency were not reported from 10-AUG-2021 for moderate to severe rheumatoid arthritis. Concomitant medications included methotrexate, and prednisone.  On JUL-2021, the patient experienced intentional misuse in product use duration. On 01-AUG-2021, the patient experienced suspected covid-19. On 21-AUG-2021, the patient experienced stiffness\unable to straighten both elbow. On 21-AUG-2021, the patient experienced swelling. On 21-AUG-2021, the patient experienced joint range of motion decreased. On 21-AUG-2021, the patient experienced pain in hand. On 21-AUG-2021, the patient experienced arthritic pains/joint pain/pain in wrist. On an unspecified date, the patient experienced ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with upadacitinib was withdrawn on AUG-2021. The patient was recovering from suspected covid-19, had not recovered from ache, stiffness\unable to straighten both elbow, swelling, pain in hand, joint range of motion decreased, and arthritic pains/joint pain/pain in wrist, and the outcome of intentional misuse in product use duration was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 24-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.).    The route of administration of suspect Moderna bivalent was reported as BI. Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Pfizer 5/13/21, 6/3/21, 12/28/21. Positive on 1/24/22
Large rash at vaccination site about 4 inches in diameter. Other patient's receiving this lot also reported rashes.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of covid-19. Adverse event After taking the full course of Paxlovid and testing negative, my symptoms (and positive antigen test results) returned on day +5 after taking the final dose (day 0). Anti viral details Product: COVID 19 Treatment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
4/9 4:25pm: runny nose, headache, stuffy sinuses/pain- went away after 15 minutes  4/9 11:06pm: woke up to speeding heart rate, labored breathing, thumb joint left hand hurts/pain, stomach nausea, racing in stomach, neck itchy, pin prickly hands and legs   4/10 4am: hand joints very stiff, can?t close hands, fingers extremely swollen and painful,  injection site - severe pain, thirsty, dehydrated  4/10 7am: neck severely itchy, hands feels like they?re going to explode from pressure- swelling and red with pain, severely dehydrated, coated tongue and disgusting taste in mouth, feel nauseous, multiple head spasms continuing at approximately 15 min intervals, scalp itchy, pain at injection site
I experienced a breakthrough case of COVID-19 with fever, body aches, fatigue, head  cold, chills, sinus congestion and I thought it was the Flu but I tested positive for COVID-19.
Received An Expired Dose; Initial Report Received on 17-Mar-2023  This spontaneous report was received from a nurse regarding a 26-year-old male patient who received an expired dose of HEPLISAV-B that was administered for "titers" that were 6.6.   Medical history included that the patient received a previous series of a hepatitis B vaccine (details not specified) and not had any previous allergic reactions or reaction to other vaccines.  Concomitant medications included Flomax (tamsulosin).   It was reported that on 10-Mar-2022, "titers" were drawn which resulted in a value of 6.6.  The reporter noted that the values should be 9.9 so they gave the dose of HEPLISAV-B.    On 17-Mar-2023, a dose of HEPLISAV-B (Lot # 935849 and expiration date 13-Jan-2023, NDC 43528-003-05), was administered in the right upper arm.    The nurse reported that she checked the expiration date on the box, and it was "really tiny" and thought it read 2025 and it actually read 2023.  There were no adverse reactions reported by the patient.    No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient returned to clinic 2 days later experiencing fever since vaccine administered. Vaccine sites (Left and Right deltoids) are red, swollen, warm, and painful.
Information has been received from a registered pharmacist concerning an adult male who, "many years ago", was vaccinated with a "complete dose" of RECOMBIVAX HB before undergoing dialysis. The patient subsequently had a kidney transplant and was on immunosuppressive therapy. He recently applied to work in the hospital and routine titers for hepatitis B were low. No adverse effects was noted. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report was received from a nurse concerning a male patient of unknown age. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 31-MAY-2018, the patient was vaccinated with the first dose of GARDASIL 9 (anatomical location, strength, dose, route, frequency, lot number and expiration date were not reported) for prophylaxis. On 29-NOV-2018, also reported as at the time of the call, the patient was in the office requesting a second dose of GARDASIL 9 to be administered early (approximately on 31-JUL-2018). Second dose was not administered.
as reported by mother, patient had low grade fever (100.8) and became lethargic, then started having seizure like activity.  Parents proceeded to ER, where he was diagnosed with influenza, most likely secondary to the vaccine.
Vaccinated on 11/2/15 - on 11/9/15 - mother noticed site of varicella to be dark red, warm to touch measuring - 3/4 inch by 5/8 inch (L) lateral thigh - child very playful and no temperature.
Vaccine given at approx. 1608, Patient developed full body itching, chest tightening, and tingling tongue approx. 8 minutes after the vaccine injection. Patient denies difficulty breathing or swallowing. Vitals taken: HR 88, BP 121/72, RR 20, SPO2 97% on RA. Diphenhydramine 50mg IM in left arm at 1627.. At 1700 tongue started tingling again with new hives on chest. At 1707 Hydrocortisone 100mg IM given in right ventrogluteal muscle.  At 1746 patient feels no tongue tingling or lip swelling and itching has subsided, Denies difficulty breathing or swallowing. Patient released home.
Expired Engerix-B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 49-year-old female patient who received HBV (Engerix B) (batch number LG5RN, expiry date 20th August 2022) for prophylaxis.   On 25th August 2022, the patient received the 3rd dose of Engerix B. On 25th August 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 25-AUG-2022 Reporter's comment: Medical Assistant(MA) reported that the patient was administered a dose of Engerix-B on 25th August 2022 which had an expiration date of 20th August 2022. At the time of reporting, the dose has not been repeated. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Engerix-B which was already expired, which led to expired vaccine used.
This spontaneous report was received from medical assistant refers to a 67 years old male patient. The patient's pertinent medical history included impaired fasting glucose, hypercholesterolaemia, hypertension and sleep apnea and was allergic to angiotensin-converting enzyme (ACE) inhibitors. On 04-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 (dose and frequency were not reported) (lot # K020214 and expiry date: 25-MAR-2016) intramuscularly. Concomitant therapies included losartan potassium (manufacturer unknown) and COREG. On 04-JUN-2015, the patient experienced pain in the injection site as well as not being able to lift the arm, fever, chills and nausea. The patient developed decreased range in arm motion. The patient sought medical attention and was treated with MEDROL dose pack/diclofenac. No lab data was reported. The outcome of the events was reported as not recovered. The relatedness of the events with PNEUMOVAX 23 was not reported. No product quality complaint (PQC) was reported for PNEUMOVAX 23. The reporting medical assistant considered the event, not being able to lift the arm to be serious as disability, as the event resulted in decreased range in arm motion. Additional information has been requested.
I experienced chills, fever, trouble swallowing, loss of taste/smell, mucus, runny nose and headache.
Soreness at injection site (shoulder) Redness and swelling - right bi-cep. Slight headache.
Post vax, Anthrax #4 (within 2-3 days) left peripheral 7th nerve palsy. Post vax, Anthrax #2 (within 2-3 days) left peripheral 7th nerve palsy.
The child developed inconsolable crying for 2 hrs the day after administration of vaccines (PEDIARIX, Hib, PCV, ROTARIX). He also had loose stools 2 to 3 times but no blood in stools. The symptoms resolved within 24 hrs with no intervention.
General malaise, body aches, low grade temperatures, syncope, nausea, chest pains.