chrisvoncsefalvay/vaers-outcomes huggingface dataset:
adverse reaction-Right leg DVT and bilateral pulmonary emboli. Symptoms- right leg pain and shortness of breath Time- over 3 weeks Treatment- anticoagulant Outcome- dischrged from hospital. Still on medications for 6 months to a year
administered with the vaccine which has been stored in the refrigerator for more than 30 days; stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided. HCP claimed that the vaccines did not experience temperature excursion while in the refrigerator. They would like to seek guidance as to how to proceed in this situation like whether they should give an extra dose or not? Crosslinked with MOD21-122955, MOD21-122993, MOD21-122994, MOD21-122995, MOD21-122996, MOD21-122998, MOD21-122999, MOD21-123000, MOD21-123001, MOD21-123002, MOD21-123003, MOD21-123004, MOD21-123005, MOD21-123006, MOD21-123007, MOD21-123008 and MOD21-123009.   This case was linked to MOD-2021-265450 (Patient Link).   Reporter did not allow further contact
Hives began on the right arm 3 days after vaccination.  The next morning (day 4) the hives/welts had spread all over but would come and go mostly where her clothes would rub or where there  was any kind of heat (like under arm area).  The hives eventually moved down to her feet on day 7.  The patient is still reporting hand sensitivity/itching if exposed to heat. The patient was prescribed pepcid, steroid shot, and prednisone taper.  She is also using topical hydrocortisone cream.  The steroid injection has helped with symptom management per the patient.  (patient is also getting allergy injections and had received her allergy injection about 3 weeks before her covid vaccine)
Patient received 0.2ml of the vaccine diluted with 1.3ml of normal saline.
Headache, UrticariaPruritus, facial tingling and allodynia, shooting pain into right eye and teeth Narrative:  self treated with rx gabapentin 200mg once then 100mg qhs for 4 nights
Left upper arm redness, swelling, warmth 4cm x 4cm - area at injection site.
Severe vertigo approximately 5 days after; On 2nd shot: Migraine headaches on day 2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 (Lot number: E0102) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: ER2613, Vaccine location: Left arm), administration date: 21Mar2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious) with onset 12Apr2021, outcome "unknown", described as "On 2nd shot: Migraine headaches on day 2"; VERTIGO (non-serious) with onset 15Apr2021, outcome "unknown", described as "Severe vertigo approximately 5 days after". The events "on 2nd shot: migraine headaches on day 2" and "severe vertigo approximately 5 days after" were evaluated at the physician office visit.  Additional Information: On 3rd shot: Tinnitus in the right ear, still ongoing after 1 week  No follow-up attempts are possible. No further information is expected.
I swear of ulcerative colitis at my booster third shot; booster third shot has been administered; booster third shot has been administered; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: en0171) via an unspecified route of administration on 18Aug2021 (age at vaccination 44-years-old) as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as dose 1, single and dose 2 single for covid-19 immunization. On 19Aug2021, the patient stated that she swear of ulcerative colitis at her booster third shot. On 18Aug2021, the patient administered booster third shot. The outcome of the event of ulcerative colitis was unknown.   No follow-up attempts are possible. No further information is expected.
4 days after vaccination he developed a small red swollen area size of a quarter, by day 6-7 it was dark red raised, painful and the size of a softball.
pharmacist did not visually inspect the syringe prior to administration; she did not realize the syringe was empty until she had stuck the patient with the needle with no reported adverse event; Initial information received on 26-Oct-2023 regarding an unsolicited valid non-serious case received via consumer/non-hcp.  This case involves a 47 years old female patient and reporter reported pharmacist did not visually inspect the syringe prior to administration; she did not realize the syringe was empty until she had stuck the patient with the needle with no reported adverse event after receiving influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Oct-2023, the patient received an unknown dose of suspect influenza quadrival A-B vaccine, Suspension for injection (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for Immunization and pharmacist did not visually inspect the syringe prior to administration; she did not realize the syringe was empty until she had stuck the patient with the needle with no reported adverse event (product administration error) (latency: same day).  It was reported, The pharmacist had already stuck the patient with the needle, when they noticed that there was no solution inside of the syringe. The patient notes that the syringe looked intact, and there was no leaking during administration; the syringe was already empty at the time of administration. The patient reports that the pharmacist had to get out a different FLUZONE QIV NP pre-filled syringe to complete the dose. The patient notes that she is fine, but wanted to report the even    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.
A nursing assistant reported temperature excursion for vaccines that were administered to patients after excursion occurred; This spontaneous report was received from a nursing assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 03-AUG-2020, the patient was vaccinated with improperly stored dose of VARIVAX 1 dose (dosage regimen and route of administration were not reported) lot # T000341, expiration date 05-JAN-2022, for prophylaxis. The improperly stored dose experienced a temperature of -10.2 degree Celsius for 1 hour and 53 minutes. There was no previous temperature excursion. The call was because a digital data logger. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2009USA000117: US-009507513-2008USA014705: US-009507513-2008USA014798: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000132: US-009507513-2008USA014757: US-009507513-2008USA014767: US-009507513-2008USA014697: US-009507513-2008USA014803: US-009507513-2008USA014820: US-009507513-2008USA014825: US-009507513-2008USA014869: US-009507513-2008USA014871: US-009507513-2008USA014937: US-009507513-2008USA015018: US-009507513-2009USA000112: US-009507513-2008USA014803:AE Case # 01697206 US-009507513-2009USA000113:
No additional AEs were reported; a patient received an improperly stored vaccine today; temperature: 34F; This spontaneous report was received from a medical assistant referring to a 8-week-old male patient. Information about patient's medical history, concomitant medications, concurrent conditions and drug reactions/ allergies was not provided.  On 14-APR-2022, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) dose of 2 mL, administered orally, lot number: 1837116, expiration date: 24-MAR-2023 (dose number and formulation was not reported) for prophylaxis (product storage error). A physician also reported that on the same day, the patent received diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) (manufacturer unknown) dose of 0.5 mL, lot number: B4722, hib vaccine conj (tet tox) (ACTHIB) (manufacturer unknown) dose of 0.5 mL, lot number: UJ604AAA and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (manufacturer unknown) dose of 0.5 mL, lot number: EX1980 (dose number, formulation, route of administration, anatomical location and expiration date was not reported for all of the vaccines) for prophylaxis. No other information provided. No additional adverse events (AEs) or product quality complaint (PQC) reported (no adverse event).  The administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion of 66 degrees Fahrenheit for 15 hours and 10 minutes. It was reported that there were no previous temperature excursions. It was unknown, whether a digital data logger was involved.
pt rcvd vax; 2hrs later pt had seizure apnea 2 min presented to ER w/ cyanosis & postictal; adm 30 mg suppository;
Woke up next morning with 102 fever that would only come down to 100 with Tylenol and cold compress. Also had intense headache and joint pains. Decreased appetite and could only eat sweets and dairy. All lasting 3 days.
Pt recvd 3 doses series of Recombivax in Oct89, Nov89, & APR90, followed by 3 doses of Engerix-B given 8SEP90 & 13DEC90 & 6MAR91 respectively; No Antibody response;
5SEP95 was awakened by itching; later in AM devel gen urticaria & intense itching; also had swelling of wrists & dorsum of hands & fingers; no diff breathing;
Have been having shortness of breath heart palpitations on annoy limp notes swollen on the left arm slight upper chest pain and under the arm and back headaches  My stress anxiety has increased....
Patient was to receive a booster dose of Moderna (previous two-dose series had been Moderna). Pfizer was administered instead as the booster.
Vomiting; diarrhea; fever; chills; extreme stomach cramps; This is a spontaneous report from a non-contactable consumer or other non-hcp (Patient).   A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: En6202) via an unspecified route of administration (Age at vaccination 36-year) in Left Arm on 05Mar2021 14:15 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not received any other vaccine in four weeks. Patient does not have covid prior vaccination. On 07Mar2021 06:00 the patient experienced vomiting, diarrhea, fever, chills and extreme stomach cramps. The seriousness of all the event was reported as non-serious. Patient not covid tested post vaccination. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Cellulitis - Red, swollen, hot to touch no D/C noted L leg > R leg  L thigh oval shaped  2 1/2 x 1 3/4 inch & R thigh round 1 inch area.
Chills, Headache, Body Ache, beginning about 12 hours after vaccination and lasting 6 hours.
Symptoms started about 8 days after vaccinated. Symptoms include hands and feet tingling, dizziness, syncope, fatigue. Has had several episodes of syncope and low blood sugar.
Sever swollen hives on face, head, neck, and torso. Itching. Went to ER, they gave a injection of dose of Pepsid and told her to take claritin and pepcid daily. Said it should clear up. She has been doing that now her eyes are itching and body again, plus has a sever sore throat now.
Patient showed up at pharmacy 2 days after immunization with a huge migrating bruise on Left arm. Started at vaccination site and was migrating down to fingers. Grew approximately 5 inches since the morning and was rotating around elbow.  Pharmacist advised patient to seek medical attention ASAP.
arm soreness/Left upper arm injection site soreness; My arm hurts and there is a little discomfort/when discomfort started; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2021 16:00 (Lot number: EN6205) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing), notes: Diagnosed 12-15 years ago., does take oral medication for diabetes; "High Cholesterol" (unspecified if ongoing), notes: Diagnosed 15 years ago. The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Mar2021 16:00, outcome "not recovered", described as "arm soreness/Left upper arm injection site soreness"; VACCINATION SITE DISCOMFORT (non-serious) with onset 17Mar2021 16:00, outcome "not recovered", described as "My arm hurts and there is a little discomfort/when discomfort started". Therapeutic measures were taken as a result of vaccination site pain, vaccination site discomfort. Additional information: The patient takes oral medication for diabetes (unspecified). Patient had no previous history of immunization with the Pfizer vaccine considered as suspect and had no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks) and no adverse event following prior vaccinations. Patient took Excedrin this morning and it did work, took 2 of 500 mg capsules.   No follow-up attempts are possible. No further information is expected.
patient had her test done on 29Jan2021 and it came back positive for COVID; patient had her test done on 29Jan2021 and it came back positive for COVID; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 12Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history included the patient had a handicap. Concomitant medications were not reported. The patient who lived in a group home had her first dose of the Pfizer COVID-19 Vaccine on 12Jan2021. She was then exposed to someone who was positive for COVID within the group home. The patient went to live with her mother (reporter). The patient had her test done on 29Jan2021 and it came back positive for COVID (also reported that the patient tested positive last 31Jan2021). Therefore, she could not go and get her second scheduled Pfizer COVID vaccine. The nurse who oversaw the group home house scheduled the second dose for 23Feb2021 which was six weeks since the first dose. The reporter was inquiring to find out if that was okay and if it would still work. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 29Jan2021. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
felt slight swelling in upper lip; prickly tingly feeling in my face that caused some itching; periodically, really bad itching on hand or foot like two mosquito bites/ Tingling caused face itching; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (felt slight swelling in upper lip), PARAESTHESIA (prickly tingly feeling in my face that caused some itching) and PRURITUS (periodically, really bad itching on hand or foot like two mosquito bites/ Tingling caused face itching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LIP SWELLING (felt slight swelling in upper lip), PARAESTHESIA (prickly tingly feeling in my face that caused some itching) and PRURITUS (periodically, really bad itching on hand or foot like two mosquito bites/ Tingling caused face itching). On 12-Mar-2021, LIP SWELLING (felt slight swelling in upper lip), PARAESTHESIA (prickly tingly feeling in my face that caused some itching) and PRURITUS (periodically, really bad itching on hand or foot like two mosquito bites/ Tingling caused face itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatments were reported.
Started with chills and fever approx 5 hrs after injection.  Controlled with Tylenol.  The following morning was afebrile but was having soreness at injection site.  Took ibuprofen Tuesday am prior to work.  As the day progressed I began to experience more cold chills and by the time I got home from work my fever was 101.7, continued with chills, but also experienced malaise, body and head ache, mild nausea. Took tylenol again at about 5 pm.    Repeated temp approx. 1015 pm last night 100.1, took additional ibuprofen and temp this am was 98.8 and felt better but still with mild HA, body aches and fatigue.
term expired vials were used to provide 38 doses; Sore arm; some identified common side effects after the vaccine (ex: sore arm, etc.); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.) ) and EXPIRED PRODUCT ADMINISTERED (term expired vials were used to provide 38 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (term expired vials were used to provide 38 doses). In November 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.) ). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (term expired vials were used to provide 38 doses) had resolved. In November 2021, PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.) ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No vial went any temperature excursions.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. Till 19-Nov-2021, there were no adverse reactions to the vaccine.  As of 19 Nov 2021, there were no adverse reactions to the vaccine reported by the list below. We spoke with some that received the vaccine during these dates and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: The additional information included suspect administration date. On 19-Nov-2021: Follow-up information included about patients details On 19-Nov-2021: Significant FU appended (Second reporter Information was updated)
PATIENT RECEIVED VACCINE THAT WAS OUT OF RANGE OF THE STORAGE CRITERIA. NO STABILITY INFORMATION AVAILABLE TO DETERMINE THE VALIDITY OF THE VACCINE ADMINISTERED.
Chill , fever aches,pain,headache,weak joint pain numbness in feet  could hold my eyes open and stayed in bed 2 days couldn?t do anything except use bathroom taste off  3D day weak but up short periods diarrhea (hope tomorrow better)
I had an endoscopy and a colonoscopy. The endoscopy - November 11 - it showed severe Esophagitis. I was diagnosed with that. From the colonoscopy: It showed things, too. I was diagnosed as Diverticula, polyp and hemorrhoid. They prescribed just for the Esophagitis - Omeprazole (Prilosec 40 mg). I have not yet started on that. I have had swallowing issues, cough and pain on swallowing. I have had rectal bleeding - it started after my booster shot. Flu shot - I had that after this vaccine on the 29th of October. I had it at doctor office, I think I had it on the left arm.
Joint and muscle aches, approx. 24 hours  Chills, approx. 2 hours  Exhaustion, approx. 36 hours
This spontaneous report was received from a pharmacist, concerning an male patient on his seventy's. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unspecified date in January 2019 (reported as "a couple weeks ago"), the patient was vaccinated with PNEUMOVAX 23 1 injection for prophylaxis, route of administration reported as injection (strength, frequency, lot number and expiration date were not reported). On an unspecified date in January 2019, the patient experienced more injection-site swelling than usually sees for patients receiving that vaccine. At the time of reporting, the outcome of injection-site swelling was unknown. The causal relationship between the vaccination with PNEUMOVAX 23 and the event was not provided by the reporting pharmacist. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1901USA012214.