chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Reported Total amount of time the vial was exposed to room temperature range (8 degree  to 25 degree C= 46 degree to 77 degree F) and 24-48 hours. Reported Date the vial was initially stored in the refrigerator was 08FEB2022 Removed from the fridge on 09FEB2022  Treatment medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2022: Follow up received includes non significant information
The vaccine received expired on 3/18/22.  A stability study has been requested from Moderna.  The patient reports zero adverse events from the booster.
Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves Adult patient who had mild reaction, while he/she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced reaction allergic (NOS). (Other relevant tests included no lab data). Final diagnosis was mild reaction. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for mild reaction. List of documents held by sender: none.
told pt to wait 15 minutes on the chair but her mother and she went shopping and while walking she didn't feel well and pass out and hit head on the floor.  She could stand by herself and sit down the chair.  She said she felt ok but hurt her back head a little bit while we were waiting  911 staff.  Meanwhile we gave ice on the head.
This is a spontaneous report from a contactable consumer or other non- health care professional and health care professional. A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734) via an unspecified route of administration administered in left arm on 03Apr2021 12:45 as single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) and high blood pressure. The patient's concomitant medications were not reported. Previously patient received vaccine first dose of BNT162B2, the lot number was E in left arm on 13Mar2021 at 12:45 for COVID-19 immunization. The patient experienced shingles on 14Apr2021. The event was assessed as non-serious. Therapeutic measures were taken as a result of shingles with valacyclovir. The adverse events resulted in physician office visit. The vaccination facility type was reported as pharmacy. The patient taking COVID 19 vaccine because she did not want to get COVID. The outcome of the event was reported as recovering. No follow-up attempts are needed. No further information is expected.
COVID arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (COVID arm). At the time of the report, VACCINATION COMPLICATION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
body ache; muscle ache; swollen lymph nodes; joint ache; fatigue; soreness; redness; hot to touch on the area of the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (body ache), MYALGIA (muscle ache), LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (joint ache) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.).    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body ache), MYALGIA (muscle ache), LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (joint ache), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE WARMTH (hot to touch on the area of the injection). At the time of the report, PAIN (body ache), MYALGIA (muscle ache), LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (joint ache), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE WARMTH (hot to touch on the area of the injection) outcome was unknown.            No concomitant medications were provided. Treatment medications included paracetamol. Action taken with mRNA-1273 in response to the events was not Applicable.
Arm hurt immediately after receiving injection. Pt. went to ER & sent home. Pt saw Dr. Monday, and admitted her to hospital.
This case was reported by a physician via sales rep and described the occurrence of numbness in hand in a 79-year-old patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced numbness in hand, muscle pain and tingling of extremity. On an unknown date, the outcome of the numbness in hand, muscle pain and tingling of extremity were not recovered/not resolved. It was unknown if the reporter considered the numbness in hand, muscle pain and tingling of extremity to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported the patient was seen by him after receiving SHINGRIX vaccine. The patient experienced numbness and tingling of both hands, and general muscle aches.
Patient became dizzy, lightheaded and felt faint within 2-3 minutes following injection. After being seated, patient continued to feel faint but did not lose consciousness. Patient slowly recovered over the next 10-20 minutes.
April 7, 2021: 1st Pfizer vaccine dose August 19, 2021: 2nd Pfizer vaccine dose October 2021: pain begins in left hip, never stops June 2022: pain in hip diagnosed as multiple myeloma. Treatment not yet started.
Redness, swelling, aching, arm felt hot, the next morning after injection at injection site.
Case number PHEH2014US021124, is an initial spontaneous report from a health care professional received on 16 Oct 2014. This report refers to male patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date after vaccination, he experienced diarrhea. The outcome of the event diarrhea was reported as condition improved. Seriousness of the event was reported as non serious and causality was not reported.
Recipient complained of a burning sensation at the injections site (left deltoid) within 5 minutes of receiving the Moderna vaccine.    10:20AM  HR - 101   BP - 113/94  Pulse oximeter - 99%    10:23 am  HR99  BP 117/84    Recipient reported history of COVID and lost sense of tast and smell and has not completely resolved to date.    10:25am - Recipient reports feeling better.  Vital signs remain stable - HR101 and BP 114/82 at 10:35am.    Recipient also reported a sense of lock jaw during this period of time that resolved.
This second dose of the vaccine is believed to have caused a full SLE (lupus) Flare. Those symptoms included extreme fatigue, body aches, joint pain, leg weakness that required the use of a cane, overall body weakness, cognitive issues including mental confusion (not a typical symptom of my flares), forgetfulness, and forgetting how to do common tasks (not a typical symptom of my flares). I was unable to drive for much of this time due to confusion and weakness/poor response time (not a typical lupus flare symptom for me). As these symptoms continued to worsen, (rheumatologist) ordered the first prednisone taper from 3/24/2021 - 3/29/2021. This made no progress so a second taper was started on March 31 - April 5, 2021. The symptoms persisted and continued to worsen so a higher dose was given. The doctor ordered that I stop the taper and begin Prednisone at 30 mg starting 4/04/21 through 4/12/21. Then beginning 4/13/21 - 4/15/21 I was taking 20mg of prednisone. Lastly 10mg of prednisone beginning 4/16/21 through 4/18/21.
admitted to hospital with confusion, encephalopathy, respiratory failure; intubated in the ED; positive test for COVID; transferred to ICU; placed on steroids and vasopressors; pt's condition continued to deteriorate and she was placed on DNR; she passed away in the hospital
Fever (TMax 102.7), chills, body aches, diffuse myalgia, fatigue. Appeared within 24 hours of vaccination.
RN vaccinated client and within 30 seconds noticed client started moving to the side. RN held client at chair, RN responded while two other RNs set up anti-gravity chair. Between all nurses, lifted client and laid in chair. PHN joined, client oriented to self and situation, pale, diaphoretic. Vitals at 1412: blood pressure 100/60 pulse 76, oxygen 97%. Client stated feeling dizzy, denied headache, blurry vision, nausea, shortness of breath, chest pain. Client given water and juice. Father present stated no reaction to first vaccine, allergies to peanuts and seafood. Vitals at 1414: blood pressure 106/70, pulse 79, oxygen 98%. Client alert and oriented x4, stated felt dizzy but did not lose consciousness. Per client same thing happened years ago when having blood drawn. Father informed we would observe for 30 mins. 1417: blood pressure 108/72, pulse 81, oxygen 98%. Client stated feeling better. Vitals at 1422: blood pressure 106/74, pulse 79, oxygen 97%. Client stated symptoms resolved. Alert and oriented x4, color normal for ethnicity. Per Father, client's blood pressure is on the lower end. Vitals at 1427: blood pressure 100/70, pulse 85, oxygen 99%. No complaints. Vitals at 1437: blood pressure 100/70, pulse 85, oxygen 98%. Per client feeling fine, everything resolved. Client and Father given ER precautions and advised to follow up with provider. Last vitals before client leaving blood pressure 106/78, pulse 87, oxygen 97%. Client able to stand up with no complaints. Client left facility with steady gait at 1444.44.
Patient received Pneumovax right deltoid. Within 8 hours, developed chills, high fever, some right arm pain without swelling or erythema. Symptoms lasted 12 hours; right arm pain persists less than 24 hours.
5 cm red swelling of (L) upper arm with pain and no itching and no warmth.
This case was reported by a healthcare professional (also the subject's colleague) via a representative and described the occurrence of fever in a female subject aged 40 - 49 years old who was vaccinated with BOOSTRIX (Glaxosmithkline). On an unspecified date the subject received 1st dose of BOSSTRX (details unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced fever. At the time of reporting the outcome of the event was unspecified.
Tinnitus, unresolved.  Neuropathy in right foot.  Resolved: joint pain, headache, fatigue.
Massive swollen arm at injection sight that is warm to the touch and is red and hurts to the touch. Body hurts all over and headache.
Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Rash/lesions that is painful, itching, weaping-Severe, Additional Details: Rash started about 4 days after the shot. Initally rash started on back, but spread to sides, arms, legs. Rash was initally itchy. Became painful, itchy, 'ugly' and weaping lesions formed. Patient has tried antihistamines (hydroxyzine, allegra), creams (triamcinolone, mupirocin). Nothing has helped and he states that this shot has changed his life.
Headache, congested head, runny nose, started sneezing. Went home and laid down. Her arm was very sore for about a week. Also had  the pic line in her right arm as mentioned in medications.
Warmth, redness, pain at site of vaccination.  Generalized malaise, fatigue, body aches and pains (quite severe).  Fevers.
fever; Her body is not like as before. She is like a sick patient; She has some nausea sort of; This is a spontaneous report from a contactable consumer (patient's husband). A 40-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. It was reported that the patient had the vaccine second shot 10 days back (Feb2021). She still has a little bit of fever going on and off. Her body was not like as before. She was like a sick patient. She had some nausea sort of. They wanted to know whether everyone in that lot have the same issue. Outcome of the fever was not recovered and other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
injection site itchy; not feeling well; headache/ slight headche; nausea; fever 100.5; pain at injection site; could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DEFICIT (could not sleep), MALAISE (not feeling well), HEADACHE (headache/ slight headche), NAUSEA (nausea) and PYREXIA (fever 100.5) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced SLEEP DEFICIT (could not sleep). On 11-May-2021, the patient experienced HEADACHE (headache/ slight headche), NAUSEA (nausea), PYREXIA (fever 100.5) and VACCINATION SITE PAIN (pain at injection site). On 12-May-2021, the patient experienced MALAISE (not feeling well). On 13-May-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchy). On 13-May-2021, SLEEP DEFICIT (could not sleep), MALAISE (not feeling well), HEADACHE (headache/ slight headche), NAUSEA (nausea), PYREXIA (fever 100.5), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE PRURITUS (injection site itchy) had resolved.            Treatment information was not provided. Concomitant product use was not provided. Lab data was not provided.   This case was linked to MOD-2021-089116 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-MAY-2021 and does not contain any new information
little discomfort felt in the deltoid from the shot; This is a spontaneous report from a non-contactable consumer (patient, Pfizer employee). A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date in 2020 at a single dose in deltoid for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced little discomfort felt in the deltoid from the shot on an unspecified date. The outcome of event was unknown.    No follow-up attempts are possible, information about lot/batch cannot be obtained. No further information is expected.
pt received 5-11 year old dose of pfizer of 0.2ml instead of 12 and older dose of 0.3ml. No adverse reactions noted.
complaining of chest hurting, wheezing , heart beat was fine BP was 190911 was called for ambulance and client was taken to hospital unknown whether vaccine was cause.
Pt had lung biopsy scheduled for 8/17 at hospital due to breathing issues for several months and order of Pulmonary Dr from chest xray in April. Only symptoms cough and fatigue other than the breathing difficulty which has been ongoing. Pt has Crohn's disease and hypertension and has been diagnosed with interstitial Lung Disease.
pt recvd vax;exp a febrile illness w/ pharyngitis & weakness;sx cont 2-3 days & resolved;
Acute cholecystitis due to biliary calculus. ED visit and hospital admission. This visit is within 6 weeks of receiving the COVID vaccine.
Patient had MMR2 on 11/20/07, found out today that she is pregnant.
She was also vaccinated with varicella on 10/25/07, She is very healthy and each occurrence happened after the vaccinations. First vaccine high fevers after about 2-3wks after vaccine of 102 to 104.0 no other symptoms lasted about 2weeks. Taken to MD and evaluated.  This second vaccine again a reaction at about 2weeks starting May 11th high fevers again ranging from 102.5 to 103.4 as of date but with chills,weakness when fever rises, and night sweats. This time fevers were better controlled with alt tynenol q6hs and ibuprofen q6hs. If this fevers are this high, it is a concern of mine for children that may be immunosuppressed or younger to get this vaccine due to the reaction. I'm sure it was the vaccine, it was the only common thing that she received at the time. Please evaluate and do more research regarding this fevers. No rash, no blisters. I'm a nurse and will continue to monitor my daughter for further symptoms. thank you.
Case number PHEH2015US001686, is an initial spontaneous report from a nurse received on 21 Jan 2015. This report refers to a 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: X14082) without being reconstituted with MenA intramuscularly on 19 Jan 2015. No adverse event was reported following the administration error.
Nerve pain on her back. It is in the same spot where she had previously had shingles pain
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients might have been vaccinated with PNEUMOVAX 23 (dose, lot and expiry date were not reported) that have been expose to unsupported temperature excursions. No adverse effect was reported. This is 3 of 3 reports from same reporter. Additional information has been requested.
Gave 7 vaccines that were expired today from the same vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 7 vaccines that were expired today from the same vial) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 7 vaccines that were expired today from the same vial). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Gave 7 vaccines that were expired today from the same vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Excessive headache, excessive vaccine location soreness, excessive entire body soreness, excessive tiredness. Symptoms lasted approximately 30 hours
On 8/8/2021 Admitted to Covid Unit. She started having illness last Thursday with body aches as well as headache. She is status post splenectomy. She thinks she had possible infection from her husband. Patient started having fever and chills on the weekend before admission. Tested positive for COVID-19 on 8/8/21. Patient previously vaccinated with Pfizer COVID-19 vaccine. First Dose: 02/16/2021 Lot Number EN6200 and Second Dose: 03/09/2021 Lot Number EN6206. On 8/10/2021: discharged. At the time of interview, she feels somewhat better, still has body aches. Did not have any further fever. Available records in Cerner have been reviewed.  Patient denied any chest pain, shortness of breath, or diaphoresis. She denies any diarrheal illness. She did not have any nausea or vomiting. Lantus, nortriptyline, protonix, pravachol, and Coumadin.
flu-like symptoms such as nausea, fatigue, and aches; This is a spontaneous report received from a contactable reporter (Other HCP).  A 56-year-old female patient (not pregnant) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), on 28Aug2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), on 28Aug2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing); "Allergies: Cream cheese" (unspecified if ongoing). Concomitant medications (in two weeks) included: TRULICITY (manufacturer: Eli Lily), start date: 17Aug2023; METFORMIN, start date: 14Aug2023; FAMOTIDINE TEVA, start date: 14Aug2023; RAMIPRIL ZYDUS, start date: 14Aug2023; ROSUVASTATIN GLENMARK, start date: 14Aug2023. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 29Aug2023 at 07:30, outcome "not recovered", described as "flu-like symptoms such as nausea, fatigue, and aches". Therapeutic measures were not taken as a result of influenza like illness. Additional information: The vaccine was administered at the pharmacy or drug store. There was no other vaccine in four weeks. Upon follow up on 30Aug2023, the reporter was confirmed to be in direct contact with the reporter.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
NL/YG cellulitis on left upper arm with fever, chills.  Resolved with ibuprofen, ice and rest over next 48-72 hours.