chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy rash continued to spread to my entire abdomen; Hypersensitivity reaction; Itchy is the arm of the shot than it proceeded to all over; Rash in her stomach and other arm; Itch started the next day; a red rash appeared on my left arm surrounding the needle mark; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash continued to spread to my entire abdomen), HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itchy is the arm of the shot than it proceeded to all over), RASH (Rash in her stomach and other arm) and VACCINATION SITE PRURITUS (Itch started the next day) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis since 2015 and Spinal stenosis since 2015. Concomitant products included FUROSEMIDE for Edema, LISINOPRIL for Hypertension, METOPROLOL for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE RASH (a red rash appeared on my left arm surrounding the needle mark). On 06-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itch started the next day). On 07-Apr-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itchy is the arm of the shot than it proceeded to all over) and RASH (Rash in her stomach and other arm). On an unknown date, the patient experienced RASH PRURITIC (Itchy rash continued to spread to my entire abdomen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and HYDROCORTISONE (topical) for Itchy rash, at an unspecified dose and frequency. On 19-Apr-2021, HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itchy is the arm of the shot than it proceeded to all over), RASH (Rash in her stomach and other arm), VACCINATION SITE PRURITUS (Itch started the next day) and VACCINATION SITE RASH (a red rash appeared on my left arm surrounding the needle mark) had resolved. At the time of the report, RASH PRURITIC (Itchy rash continued to spread to my entire abdomen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes: Antihistamines   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-May-2021, contains significant information.Added Patient demographics, medical history, Concomitant medications, new event was added, event outcome was added.
12/23/2020 I started expecting the congestion  on 12/25/2020 I lost taste and smell & I felt out of breath and also had diarrhea.  12/26/2020 a doctor called me I express my symptoms he ordered a test for covid & I tested positive. On Saturday 01/02/2020 visited the ER to get help to breath
Really bad cluster headache on righthand side of head; High blood pressure; Racing pulse rate; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 17Mar2021 at 11:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), bromocriptine (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and amitriptyline (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 24Feb2021 at 15:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID -19 prior to vaccination and since the vaccination, the patient had not been tested for COVID -19. On 18Mar2021 at 02:00, the patient experienced really bad cluster headache on right hand side of head, fever, chills, high blood pressure and racing pulse rate. The patient did not receive any treatment for reported events. The clinical outcome of the events really bad cluster headache on right hand side of head, fever, chills, high blood pressure and racing pulse rate were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Systemic: Weakness-Mild
Potentiating drug interaction; didn't get her shot, she didn'tthink it was worth the risk; her fingers are killing her; This spontaneous case was reported by a consumer and describes the occurrence of POTENTIATING DRUG INTERACTION (Potentiating drug interaction), PRODUCT DOSE OMISSION ISSUE (didn't get her shot, she didn'tthink it was worth the risk) and PAIN IN EXTREMITY (her fingers are killing her) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POTENTIATING DRUG INTERACTION (Potentiating drug interaction), PRODUCT DOSE OMISSION ISSUE (didn't get her shot, she didn'tthink it was worth the risk) and PAIN IN EXTREMITY (her fingers are killing her). At the time of the report, POTENTIATING DRUG INTERACTION (Potentiating drug interaction), PRODUCT DOSE OMISSION ISSUE (didn't get her shot, she didn'tthink it was worth the risk) and PAIN IN EXTREMITY (her fingers are killing her) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO concomitant medication details were provided. No treatment medication details were provided.
Severe fatigue, bone pain, fever,  cough, sore throat., larangytis, phlem.
Redness, sewlling of (L) upper arm nausea and fever 102 degrees. Provider determined the area was an infection.
pt recv 4th dose of vax & devel localized redness @ inj site;also noted stiffness rt posterior neck, inc until AM of 7MAY97;seen in ER w/torticollis like a dystonic rxn & rash;pruritic;
Red and sore shoulder; Pain at the top of shoulder/sore shoulder; lot of pain when trying to lift his arm and it hurt extremely bad; This is a spontaneous report received from a contactable consumer or other non hcp. An 83-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9262) via an unspecified route of administration in Arm Left on 02Feb2021 (age at vaccination 83years old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not re-ported. The patient had a historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL1284) via an unspecified route of administration in Arm Left on 13Jan2021 (age at vaccination 83years old) as single dose for covid-19 immunisation. On 27Mar2021 the patient experienced red and sore shoulder, pain at the top of shoulder/sore shoulder, lot of pain when trying to lift his arm and it hurt extremely bad. Additional information reported as he was calling about the Pfizer covid19 vaccine. He received the first vaccine on 13Jan2021, and the second vaccine on 02Feb2021. On Saturday he started to have pain right at the top of his shoulder and it is kind of red and real sore. It has gotten worse. He was wondering since his last shot was 02Feb2021, whether this could be a result of the vaccination. He has been treating the symptoms with Aleve, which his doctor had prescribed for other pains. He took the first pill on Sunday. He also tried heat, ice, and pain-relieving cream; he does not know the name. He experienced a lot of pain when trying to lift his arm and it hurt extremely bad. He explains the area is not extremely red. He weighs around 150 pounds, but weight could vary a pound or two. The patient received treatment for the adverse events. The clinical outcome of the events was not recovered. Therapeutic measures were taken as a result of red and sore shoulder, pain at the top of shoulder/sore shoulder, lot of pain when trying to lift his arm and it hurt extremely bad.  No follow-up attempts are possible. No further information is expected.
Shortly after administration of vaccine in left deltoid, she began to develop a severe headache which radiated down her back. Developed cold chills. No nausea. Injection site had dime-sized area of redness with minimal induration, 1 day after administration. Subjective fever.
discomfort; flu symptoms; acute chest pain; discomfort in the chest area/chest is still tight; pain in left leg /leg is still sore; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (discomfort), INFLUENZA (flu symptoms), CHEST PAIN (acute chest pain), CHEST DISCOMFORT (discomfort in the chest area/chest is still tight) and PAIN IN EXTREMITY (pain in left leg /leg is still sore) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Singles vaccine in 2022 and Singles vaccine in 2022. Past adverse reactions to the above products included No adverse event with Singles vaccine and Singles vaccine. Concurrent medical conditions included Sinusitis, Acid reflux (esophageal) and Seasonal allergy.    On 03-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Jan-2023, the patient experienced DISCOMFORT (discomfort), INFLUENZA (flu symptoms), CHEST PAIN (acute chest pain), CHEST DISCOMFORT (discomfort in the chest area/chest is still tight) and PAIN IN EXTREMITY (pain in left leg /leg is still sore). The patient was treated with IBUPROFEN (IBUPAR [IBUPROFEN]) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency. At the time of the report, DISCOMFORT (discomfort), INFLUENZA (flu symptoms) and CHEST PAIN (acute chest pain) was resolving and CHEST DISCOMFORT (discomfort in the chest area/chest is still tight) and PAIN IN EXTREMITY (pain in left leg /leg is still sore) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient was slowly feeling better and feels like health had been compromised. Patient got two shingles shots 2 months ago.
AFTER THE ADMINISTRATION OF THE VACCINE HPV GARDASIL 9 TO THE PATIENT; SHE BEGINS HAVING  NAUSEAS, WANT O VOMIT AND VERBALIZE OF HAVING A LITTLE HEADACHE. I RECOMMEND TO THE MOTHER TO KEEP WATCHING HER DAUGHTER DURING THE DAY AND IF IT PERSIST VISIT AN EMERGENCY ROOM AS SOON AS POSSIBLE.
This spontaneous report as received from a physician via an unspecified reporter through a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 05-JUN-2015, the patient was vaccinated with VAQTA "25U/.5ML 10x1(ped), lot # J000985 with expiration date 21-SEP-2015 (route of administration unknown), which was stored at 32 F (0 Celsius Degrees) for 48 hours. The storage criteria and the type of excursion was refrigerator (R) and the vaccine status was reported as "in excursion". There were no concomitant therapies and adverse effects reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Redness & warmth at/below injection site extending approx 3" around & below site. Reaction occurred 3 days after vaccine administered.
I experienced blood clots, also had bilateral leg pain and lower back pain. I currently in the hospital.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.   On 19-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Pain, tooth aches. Couldn't raise arm for 12 days. Arthritis, rheumatism. Has carpal tunnel syndrome.
Injection site reaction, redness at site and progressing down arm. Warm. Pain at injection site.
On December 10th Patient was seen at Emergency Room for seizure like activity (4 Days after receiving the two immunizations listed above). Head Ct with contrast and blood work all negative and Patient was discharged the following day. She was seen for follow up at PCP's office on 12/11/2018 and additional testing was ordered (Brian MRI and EEG)  to find the cause of seizure activity. MD is unsure if two events are related but felt it needed to be brought to your attention.
Narrative:  Patient completed his Moderna vaccination series on 3/8/2021. He presented to ED on 10/17/2021 with a chief complaint of fever. He tested positive for COVID-19. He was in acute on chronic renal failure. He was initially diagnosed with bacterial pneumonia and treated with broad spectrum antibiotics. CTA revealed ground glass opacities and COVID directed therapy was initiated on 10/20/2021. He was not a candidate for remdesivir due to renal failure. He was not a candidate for tocilizumab due to severe pancytopenia (ANC 200). He completed 10 days of dexamethasone. He had a prolonged hospitalization complicated by pancytopenia RUL nodules and bacterial pneumonia. He was discharged hom on 11/9/2021.
One day after MMR immunization, pt reports discomfort in her arm near injection site. PT applied cold packs and icy hot, which helped. Discomfort subsided after 1 week. Reported to nurse 05/23/2005.
On my first shot my arm just hurt; This is a spontaneous report from a contactable consumer. This 22-year-old male consumer (patient) reported for himself that:  A 22-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 22Mar2021 13:30 (at the age of 22 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing (No). There were no concomitant medications. It was reported that other vaccine in four weeks was no. Other medications in two weeks was no. COVID prior vaccination was no. COVID tested post vaccination was no. Patient had no known allergies. No Other medical history. The patient experienced on my first shot my arm just hurt on an unspecified date. Therapeutic measure were taken as no as a result of event. The outcome of event was recovered.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with (Oka-Merck) PROQUAD which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 4 year old (also reported as age 5, units not provided) female patient (child). On 25-MAR-2014 at 4:21 pm, the patient might have been immunized with a dose of (Oka-Merck) PROQUAD lot number J0155596, expiration date 05-JUN-2015, in the left thigh (dose number, route and dose were not reported) which was not stored at the inappropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
1 of 4 pts vax from the same lot who exp an adverse event; pt vax w/OPV/MMR 10SEP94 & 12SEP parent reported that pt had not been feeling well cranky & crabby since 11SEP; no fever; no MD visit or med prescribed;
Unable to feel hands and feet, couldn't walk, essentially became paralyzed.  In hospital for 3 1/2 wees.
Patient presented to OV with siblings. Had all vaccines separated and on metal trays for all 3 patients.  Verified name and dob. Then accidentally pulled a TRUMENBA from the older siblings tray and administered to the 11 year old.
patient was adminitered vaccine which was exposed at below 30-32 F for one hour due to opening and closing of refrigerator door/No AE; Initial information was received on 19-Jun-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to cases 2020SA161064, 2020SA161182, 2020SA161183, 2020SA161184 and 2020SA161203 (same reporter).  This case involves a six month and twenty days old male patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was exposed at below 30-32 Fahrenheit for one hour due to opening and closing of refrigerator door (product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  On 10-Jun-2020, the patient received 0.5 ml third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ015AAA and expiry date 26-OCT-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of reporting, no adverse event was reported.  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.
BREAK OUT IN HIVES ON BACK AND STOMACH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy, and other pre-existing medical conditions included the patient did not have any other allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the patient experienced hives on back and subtle small pink dry patches on stomach shoulder and neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives on back and subtle small pink dry patches on stomach shoulder and neck. This report was non-serious.
03/27/23 presents to ED for "shortness of breath". PMHx of "breast cancer, atrial flutter, ulcerative colitis, Mycobacterium complex"
Right arm and hand are numb from shoulder to tips of fingers. Pain in left-side under rib cage near heart area.
Pt developed erythema on left thigh, with induration that lasted 36 hours.
The patient has reported severe arm soreness for the last 6 days, large red spot at the inject site that has grown, but the inject site is not warm to the touch and is not  itching. I have sent the patient to her PCP to be evaluated