chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After Meningococcal conjugate vaccine 4-valent IM shot she reported headache immediately after reaching home in about 30-40 minutes. Headaches were continues along with chest pain and swollen lymph nodes for over a week. After that chest pain reduced and went away. She continued to have swollen nodes on and off very hard. Her headaches developed into on and off migraines every day. She is continuing to have the headaches almost every day. Severity level changes.
HEART BEATING FAST; SLIGHT REACTION OF DIZZY/LIGHTHEADED; KIND OF LIKE THE FLU WHEN IT'S COMING ON/FELT TERRIBLE(FELT LIKE HAD FLU); ACHY ALL OVER; SWEATY HANDS; DID NOT SLEEP; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non-smoker, seasonal allergies, allergy to sulpha antibiotic, and autoimmune condition, and other pre-existing medical conditions included: No drug abuse or illicit drug usage. The patient was previously treated with measles vaccine/mumps vaccine/rubella vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included loratadine for seasonal allergy, and gabapentin. On 06-APR-2021, the patient experienced heart beating fast. On 06-APR-2021, the patient experienced slight reaction of dizzy/lightheaded. On 06-APR-2021, the patient experienced kind of like the flu when it's coming on/felt terrible (felt like had flu). On 06-APR-2021, the patient experienced achy all over. On 06-APR-2021, the patient experienced sweaty hands. On 06-APR-2021, the patient experienced did not sleep. On 06-APR-2021, the patient experienced chills. On 06-APR-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) Normal, and Heart rate high (NR: not provided) heart was beating fast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beating fast, slight reaction of dizzy/lightheaded, and sweaty hands on 06-APR-2021, and kind of like the flu when it's coming on/felt terrible(felt like had flu), achy all over, did not sleep, chills, and headache on 07-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20211144902.
After receiving tdap states developed fever in evening with fatigue. Did not take actual temperature. Developed redness/tenderness swelling left deltoid. Had body aches. Began to feel better today - states no fever or body aches at present. 3/23/12 afebrile erythema deltoid no induration.
Vaccination site red and sore evening of administration.  Next day pain and redness increased with swelling. Pt. was febrile. MD visit on 7/12/13, prescribed Keflex 500 mg TID for 7 days.
Both upper and lower legs swollen; Had trouble bending his leg; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Both upper and lower legs swollen) and LIMB DISCOMFORT (Had trouble bending his leg) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Both upper and lower legs swollen) and LIMB DISCOMFORT (Had trouble bending his leg). At the time of the report, PERIPHERAL SWELLING (Both upper and lower legs swollen) and LIMB DISCOMFORT (Had trouble bending his leg) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
W/in few hrs p/receiving inject, lt arm became red, swollen & tender; Nauseated by 9JUN91, inject site was real hot, real red, real hard in area 5" down; Seen by MD was told cellulitis given ATB;
Headache/migraine, fatigue/exhaustion, sore arm with movement and touch, warm/flushing from the neck up, swollen upper 1/3 of arm
Headache, itching and swelling of the tongue and roof of the mouth. Onset 11:15am. 50mg oral Benadryl given, vital signs monitored. Progressed to nausea, dizziness and SOB. One IM EpiPen injection in the right thigh. First responder called and transferred patient via wheelchair to Emergency Room after rapid deployment team evaluation.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy, ACETAMINOPHEN for Symptomatic treatment.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced MYALGIA (muscle pain). At the time of the report, MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO treatment information was provided.
pt recv vax 30NOV98 & parent reported fever x 3 days & itching rash on head, neck & trunk x 8-10 days;skin on hands peeled;parent did not seek medical treatment for child;
About 10 min after administered, I felt lightheaded, hot, and nauseated.
Patient was mistakenly given the adult dose of the vaccine (30mcg) instead of the 5-11 year dose (10mcg) no adverse outcome, patient tolerated fine
A little bit of a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (A little bit of a cold) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Flu shot). Past adverse reactions to the above products included No adverse event with Flu shot.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (A little bit of a cold). At the time of the report, NASOPHARYNGITIS (A little bit of a cold) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Patient received shot and left the room and then passed out in the waiting area, hit head on the ground.
From initial information received on 11/15/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 90 year old male patient received FLUZONE, lot number U1458AA, administered IM in the left arm on 10/20/04. Two weeks later on 11/4/04, the patient developed a full body rash. He was hospitalized for two days. He was seen by a dermatologist and an allergist and prescribed Zyrtec, Singulair and Prednisone. It is unknown if the patient recovered from this event.
Patient was hyperventilating after shot. Passed out for about a minute and came to. EMS was called BP 120/72 and hr 110. Patient refused going to hospital.
sheet of paper it stated received 0.5 mL but should be 0.7 mL with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 71-year-old male patient who reported sheet of paper stated received 0.5 ml but should be 0.7 ml of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA425178, 2022SA424555.   On 11-Oct-2022, the patient received a dose of suspect Fluzone High-Dose Quadrivalent vaccine received dose 0.5 ml instead should be 0.7ml (lot: UJ900AA, expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for immunization with no reported adverse event (incorrect dose administered) same day latency.   Patient stated that the prefilled syringes appeared orange, when the consumer asked about the color, the pharmacist stated that it was just the needle cover on the syringes. Consumer asked if they should receive another influenza vaccine this year. The consumer states that he would like to be contacted regarding this event. When the consumer asked the pharmacist about the volume being incorrect the pharmacist replied, I made an error.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
I have also had similar pain in my feet.; I am having pain in my hands and fingers.; I am having pain in my hands and fingers.; I have never had arthritis but I have the symptoms of this; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jul2021 12:00 (Lot number: EL0087) at the age of 59 years as dose 1, single and administered in arm left, administration date 27Aug2021 12:00 (Lot number: EW0217) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "I have also had similar pain in my feet."; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "I am having pain in my hands and fingers."; ARTHRITIS (non-serious), outcome "not recovered", described as "I have never had arthritis but I have the symptoms of this". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pain in extremity, pain in extremity, arthritis.  Additional information: Vaccination facility: Hospital. No other vaccine in four weeks. No Covid prior vaccination. patient tested for covid on 22Jul2021 (Nasal Swab) and result was Negative. had no Known allergies. It was reported having pain in hands and fingers. he have never had arthritis but he have the symptoms of this. he have also had similar pain in feet. Never had these symptoms prior to vaccination for Covid.   No follow-up attempts are possible. No further information is expected.
DIZZYNESS AT STANDING AFTER 15 MINUTE POST VACCINATION OBSERVATION TIME.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.   Patient called and informed of advers event, no adverse events noted.
Patient came to our office on 11/30/04 with complaints of swelling lesions and history of chicken pox exposure. Doctor diagnosed as Varicella lesions, scabbing.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A patient of unspecified age, race and gender received TRUMENBA on an unspecified date at 0.5 ml single for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a mild rash on the arm and peeling of the skin on the hand, both on an unspecified date with unknown outcome.
had to get another shoulder surgery today because the shoulder got infected post-first surgery; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative. An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "shoulder surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTHRITIS INFECTIVE (medically significant) with onset Dec2021, outcome "unknown", described as "had to get another shoulder surgery today because the shoulder got infected post-first surgery". Not positive on vaccine status of individual (believe Adult age), but reporting anyway. Patient had shoulder surgery and had to get another shoulder surgery today (29Dec2021) because the shoulder got infected post-first surgery. Need for surgery identified believe on 29Dec2021. Had to have a tube put in so that antibiotics could be administered post-surgery via syringe at home. Will stay overnight post-surgery. Therapeutic measures were taken as a result of arthritis infective included antibiotics. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event infective arthritis  and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient developed new onset hemolytic anemia. No other causative etiology has been discovered via laboratory evaluation and bone marrow biopsy.
Patient immediately began to feel tired. He also developed a headache and a low-grade fever (99.0F) within 2 hours of receiving immunization. Patient felt better later in the evening of 8/12/08.
Booster; chronic spontaneous urticaria; severely impacted my life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown Manufacturer, DOSE 01), for Covid-19 immunization; Covid-19 vaccine (Unknown Manufacturer, DOSE 02), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; CHRONIC SPONTANEOUS URTICARIA (non-serious), outcome "unknown", described as "chronic spontaneous urticaria"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "severely impacted my life".  Additional information: It was stated that after receiving booster shot patient have developed chronic spontaneous urticaria and it was very very disruptive and has severely impacted life now.   The lot number for bnt162b2 was not provided and will be requested during follow up.
The vial was initially stored in refrigerator on 03-Apr-2023 and was administered to patient on 09-May-2023; No adverse event; HCP is reporting that a dose was administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 03-Apr-2023 and was administered to patient on 09-May-2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 03-Apr-2023 and was administered to patient on 09-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 03-Apr-2023 and was administered to patient on 09-May-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 03-Apr-2023 and was administered to patient on 09-May-2023).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. It was reported that it was the 2nd Bivalent dose for the patient. Treatment medications were not provided.
No additional AE information; temperature excursion; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 22-JAN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin)   (PROQUAD) lot # S027465, expiration date of 02-MAR-2021, 0.5 milliliter  for prophylaxis  (strength, dose, route, frequency, and anatomical location were not provided).   The vaccine was exposed to multiple temperature excursions since 01-NOV-2020 through the end of February 2021.  The call was made due to a digital data logger. No additional adverse effect reported.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2103USA000947: US-009507513-2103USA000942: US-009507513-2103USA000993: US-009507513-2103USA001343:
Doses administered to patients 18 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Pink injection site; COVID arm 8 days after first shot; Soreness at the injection site; Swollen injection site; A spontaneous report was received from a consumer concerning a 71 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  covid arm 8 days after first shot, pink injection site with a pink line running out of it and going down to the arm pit, soreness at the injection site, swollen injection site.  The patient's medical history was not provided. Concomitant medications reported were Rapaflo, Lovastatin, Gabapentin  drug used for unknown indication.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch:  Batch number not provided) for prophylaxis of COVID-19 infection. On 10 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch:  Batch number not provided) in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, COVID arm 8 days after first shot. Pink injection site with a pink line running out of it and going down to the arm pit. On 10 Feb 2021, the patient experienced the  soreness at the injection site and  swollen injection site.  No treatment information was provided.    No relevant laboratory details were included  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, covid arm was unknown.The outcome of event, pink injection site with a pink line running out of it and going down to the arm pit was unknown.The outcome of events, soreness at the injection site and swollen injection site was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a nurse practitioner refers to a 14 years old patient of unknown gender. No information on patient's medical history or concurrent conditions were provided. On 09-JAN-2015, the patient was vaccinated with a dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.