chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second Shot Received 38 days after the first shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Shot Received 38 days after the first shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Shot Received 38 days after the first shot). On 11-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Shot Received 38 days after the first shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
13:45 Pt c/o nausea, shaking, and clammy.  BP 150/88, HR 74, RR 201, SO2 98% T:98 Pt reports eating prior.  Water given to pt.  First COVID19 dose administered 12/23/2020.  Pt. reports having no reaction to 1st dose. 13:55 BP 142/80, faint 14:04 Pt. reports nausea resolved.  Denies feeling shaking/clammy.  Pt. reports having a co-worker bring her to the vaccination site.   14:08 BP 140/74, HR 68, SO2 99% RA, Pt reports her normal BP ranges 110-115/70-80s.  Pt left vaccination site at 14:14.  Dr. notified of above at 14:20, encouraged pt.to call PCP.  Educated Pt. to contract her PCP prior to her leaving vaccination site.
Dizziness, Headache, Myalgia, Fever, CoughWheeze, Diarrhea, NauseaVomiting, loss of taste/smell, sore throat, chills, fatigue, decreased appetite Narrative:  symptoms persist on and off (GI effects only 3-4 days) for over 1 week. Day 8 from vaccination and still experiencing fatigue on/off and headaches. Recently diagnosed with cancer and underwent radiation therapy in Dec 2020. Has similar reaction with influenza vaccine. Reports getting COVID tested but was negative.
second vaccine past the recommended 2-6 month window; rash on her left shoulder/ rash has now spread and dispersed all over her body and on both sides; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 0.5ml, in left arm on November 2021).   On 13th July 2022, the patient received the 2nd dose of Shingrix .5 ml. On 13th July 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In July 2022, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Aug-2022 Reporter's comment: The patient received Shingrix vaccine in left arm. The patient stated that about a week after her second shingrix vaccine, she started with a rash on her left shoulder.  The rash had now spread and dispersed all over her body and on both sides.  It was not painful or vesicular in nature.  The patient also reported that she got her second vaccine past the recommended 2-6 month window.  The patient did not consent to follow-up. The follow-up for Healthcare professional was denied.
This case was reported in a literature article and described the occurrence of anaphylaxis in a 62-year-old female subject who received Tdap vaccine. This case refers to patient 6 in the literature article. Previously experienced adverse reactions included hives (after sulfa and cephalexin). On an unknown date, less than an hour after receiving Tdap vaccine and hepatitis vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included vomiting, flushing, shortness of breath, nausea and abdominal pain. The subject was treated with epinephrine, antihistamine, H2 blocker, Steroid (Unspecified), oxygen, ASA, Nitroglycerin and morphine sulfate controlled release. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included vomiting (recovered/resolved), flushing (recovered/resolved), shortness of breath (recovered/resolved), nausea (recovered/resolved) and abdominal pain (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, vomiting, flushing, shortness of breath, nausea and abdominal pain may have been caused by Tdap vaccine and hepatitis vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 62-year-old female patient who had received unspecified Tdap vaccine (manufacturer unknown) and an unspecified hepatitis vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with hives after sulfa and cephalexin. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified Tdap vaccine and an unspecified hepatitis vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, within 30 minutes and less than 1 hour after the vaccination, the patient developed flushing, shortness of breath, nausea, vomiting and abdominal pain. This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by parenteral antihistamine and, parenteral H2-blocker, parenteral steroid, oxygen, aspirin, nitroglycerin and morphine sulfate controlled-release. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Information has been received from a nurse practitioner concerning a 2-3 year old female pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed a mild case of chickenpox with 5-6 lesions on the chest after being exposed to another child with chickenpox. Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved.  Additional information is not expected.
Good afternoon.   I just spoke with Dr. and Dr. about a probable med error with a COVID-19 vaccine that occurred this week. The patient in question. Please see below for a timeline of events:  o 12/28/2022  Vaccine prepared and delivered to unit for administration. o 12/29/2022  Vaccine order expires; upon review, order was never acknowledged by nursing in database; medication error form initiated. I followed up with nurses on the unit regarding this vaccine. Neither nursing or pharmacy technician could find the vaccine on the unit. Nurses had no record of vaccine being administered on database or in paper vaccine record. Nurse on unit followed up with patient, who stated that h
Patient became nauseous & itching within a few minutes of vaccination.  Gave patient diphenhydramine and monitored her.  Took off the bandage because she had an adhesive allergy issue.  Her arm quit itching after a few minutes.  Nausea became a little better.
Acute  intertribal hemorrhage; Stroke; Starting getting confused; Had a fall; Brain bleeding, brain hemorrhage; Induced coma; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Acute  intertribal hemorrhage), CEREBROVASCULAR ACCIDENT (Stroke), CONFUSIONAL STATE (Starting getting confused), FALL (Had a fall), HAEMORRHAGE (Brain bleeding, brain hemorrhage) and COMA (Induced coma) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) Dosage form. On 24-Mar-2021, the patient experienced COMA (Induced coma) (seriousness criterion medically significant). On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Acute  intertribal hemorrhage) (seriousness criterion death), CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), CONFUSIONAL STATE (Starting getting confused) (seriousness criterion medically significant), FALL (Had a fall) (seriousness criterion medically significant) and HAEMORRHAGE (Brain bleeding, brain hemorrhage) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was intra cerebral hemorrhage. At the time of death, CEREBROVASCULAR ACCIDENT (Stroke), CONFUSIONAL STATE (Starting getting confused), FALL (Had a fall), HAEMORRHAGE (Brain bleeding, brain hemorrhage) and COMA (Induced coma) outcome was unknown. Not Provided          Concomitant medication not provided. No treatment information/hospitalization information provided.  This case concerns death of a 79-year-old male patient who expired from acute intertribal hemorrhage after receiving mRNA-1273 vaccine.  three days after vaccine administration, the patient developed confusion and fell with subsequent events ensuing.  Based on the available information causal association between the event if confusion leading to fall and product use cannot be excluded.  The other events are assessed as directly related to the fall and unlikely due to product use.; Sender's Comments: This case concerns death of a 79-year-old male patient who expired from acute intertribal hemorrhage after receiving mRNA-1273 vaccine.  three days after vaccine administration, the patient developed confusion and fell with subsequent events ensuing.  Based on the available information causal association between the event if confusion leading to fall and product use cannot be excluded.  The other events are assessed as directly related to the fall and unlikely due to product use.; Reported Cause(s) of Death: intra cerebral hemorrhage
Information has been received from a physician concerning a female who was vaccinated with Gardasil vaccine (yeast) (dose and date not provided) as part of a clinical trial she was involved with. Subsequently "the physician reported that the patient had received the Gardasil vaccine (yeast) in the trial and was experiencing "dysplasia syn 2 due to one of the strains of the HPV virus, either 16 or 18." No lot number was provided. The patient sought unspecified medical attention. Additional information has been requested.
sore arm at injections site, chills, headache, body aches, nausea, flu like symptoms, sore throat, fatigue.
Severe vertigo, some muscle aches and malaise. No fever. Vertigo and malaise has lasted more than 10 days. Muscle aches are improved.
went almost two years between first and second shingrix shot; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose almost 2 years ago, from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-Apr-2022 Reporter's Comments:  The reporter was a consumer and went almost two years between first and second shingrix shot.  The reporter asked if that was okay. Additional Supportive Information:  The case was self-reported by the patient. The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The follow-up would not possible as no contact details were available.
Positive for Covid-19 on June 26, 2022 (symptoms starting on June 24, 2022)
Reaction to the arm muscle, below shot spot red; Reaction to the arm muscle, below shot spot red; hot arm muscle; Initial information received on 27-Dec-2022 regarding an unsolicited valid  non-serious social media case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced reaction to the arm muscle, below shot spot red, reaction to the arm muscle, below shot spot red and hot arm muscle while receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT WITH PRESERVATIVE. 5ML MULTIDOSE VIAL].  It is unknown if the patient had any medical history, concomitant disease, or risk factor. The patient's medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (strength, formulation, dose, expiry date, batch number, route: unknown) via unknown route in unknown administration site for Flu.  On an unknown date the patient developed a non-serious reaction to the arm muscle, below shot spot red (vaccination site rash), (vaccination site erythema) and hot arm muscle (vaccination site warmth) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Pt received first dose of Pfizer on 04/08/21, however when she came for her second dose, she received the Janssen vaccine. Pt was called to let her know of the error and we discussed prior testing that has been done on this vaccine sequence. She reported feeling body aches and malaise today 5/7/21.
approx 3yrs p/ vax pt exp approx 25 lesions located on torso, head & a few on arms.
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (Merck) (route, lot number and expiration date were not provided). Then on an unknown date, the patient was vaccinated with the second dose of VARIVAX (Merck) (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On an unknown date, the patient got an antibody test negative as the patient had an unspecified blood test for varicella antibody titers and tested seronegative for varicella immunity. It was unknown if the patient sought medical attention. The outcome of antibody test negative was unknown. The pharmacist did not rate the relationship of the event to VARIVAX (Merck). Additional information has been requested.
25Nov85 nl annual gyn exam;5Dec85 dx:flu;9Dec85 sinusitis,bronchopneumonia& hosp,11Dec85 bronchitis,colitis,pyelonephritis;30Oct86 chr back pain w/degenerative changes on xray;dx:DM II,paresthesia hands,sx cont w/CTS,TOS,back pain;dx:fibrom
Tender knot at the site of injection; sore at the site of injection; Red knot at the site of injection; Itchy knot at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Tender knot at the site of injection), VACCINATION SITE PAIN (sore at the site of injection), VACCINATION SITE ERYTHEMA (Red knot at the site of injection) and VACCINATION SITE PRURITUS (Itchy knot at the site of injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE MASS (Tender knot at the site of injection), VACCINATION SITE PAIN (sore at the site of injection), VACCINATION SITE ERYTHEMA (Red knot at the site of injection) and VACCINATION SITE PRURITUS (Itchy knot at the site of injection). At the time of the report, VACCINATION SITE MASS (Tender knot at the site of injection), VACCINATION SITE PAIN (sore at the site of injection), VACCINATION SITE ERYTHEMA (Red knot at the site of injection) and VACCINATION SITE PRURITUS (Itchy knot at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Friday January the 15 2021, at 5:00 PM, patient stated to have itchiness on left arm, Saturday 16, patient stated to have red little balls on left arm, PT states that she used hydrocortisone, and that calmed the itching.
soreness in the arm; started to itch on the side of the site where patient got the shot; started to itch on the side of the site where patient got the shot, and; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), VACCINATION SITE PRURITUS (started to itch on the side of the site where patient got the shot) and VACCINATION SITE ERYTHEMA (started to itch on the side of the site where patient got the shot, and) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PRURITUS (started to itch on the side of the site where patient got the shot) and VACCINATION SITE ERYTHEMA (started to itch on the side of the site where patient got the shot, and). On 23-Oct-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm). On 27-Oct-2021, PAIN IN EXTREMITY (soreness in the arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (started to itch on the side of the site where patient got the shot) had not resolved and VACCINATION SITE ERYTHEMA (started to itch on the side of the site where patient got the shot, and) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported after receiving first shot, patient had soreness in the arm which lasted for about 4 days.  On 5th or 6th day it was started to itch and redness appeared on injection site. Redness gone after 5 day but itching persist.  concomitant medications include vitamins supplements. treatment to the events not reported.
Localized redness, mild swelling, body aches chills and site was warm to touch. Received on 6/22/15. Redness presented 5-6 hrs after. Still present on 6/25/15. Advised home treatment/monitoring for now will T/M PRN.
Headache 12PM, chills, body pain 4PM, fever 5:30PM,  shortness of breath, slight cough due to airway constriction 5:30PM.  Plenty of fluids, sleep-night sweats, woke up better. Head & neck pain  and body ache. No chills/fever.
pt recvd vax & had optic neuritis w/ blindness & optic nerve damage;
Slight fever after a vaccine, after a booster dose (COVID-19 vaccine); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 90-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Slight fever after a vaccine, after a booster dose (COVID-19 vaccine)". Therapeutic measures were not taken as a result of pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediate pain in forearm of left arm.  Shot administered in deltoid in that arm.  Pain has not subsided and has expanded further including tendonitis and muscle pain.
redness, pain, burning sensation, slight swelling, and itchiness started to injection site 3 days after injection.
This spontaneous report was received from a mother of patient refers to her son of unknown age. Concurrent conditions and medical history was not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) injection (dose, route, lot number were not reported). Concomitant medications were not reported. On an unknown date, the patient lost movement in his leg (hospitalization) after receiving VARIVAX (Merck). On an unknown date, the patient was taken to an unspecified hospital (duration/location unknown) where an unspecified health care professional said this was a side effect of VARIVAX (Merck). Also reported the patient received therapy and has regained most usage of his leg but he can't verbalize (medically significant) if he was in pain or having difficulty with the limb. The outcome of the events was unknown. Causality was not assessed by the reporter. Upon internal review the event of can't verbalize was considered to be medically significant. Additional information has been requested.
face a little warm; a little red; after a week, I noticed a lump on my neck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (face a little warm), ERYTHEMA (a little red) and NECK MASS (after a week, I noticed a lump on my neck) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (face a little warm), ERYTHEMA (a little red) and NECK MASS (after a week, I noticed a lump on my neck). At the time of the report, FEELING HOT (face a little warm) and ERYTHEMA (a little red) outcome was unknown and NECK MASS (after a week, I noticed a lump on my neck) was resolving.        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. Patient went to his doctor to do an ultrasound, but it wasn't anything.   This case was linked to MOD-2021-356657, MOD-2021-356658 (Patient Link).
No adverse reaction, the vaccine was expired by 6 days at the time, i spoke with the family same day and again 2/21/23 and patient is fine, Vaccine administered on 2/17/23, exp date of vaccine was 2/11/23
Hospitalization: 1/15/2023 - 1/20/2023 (5 days) Presentation to the ED: sepsis, change in mental status. Coming from Health and Rehabilitation Center.  COVID + date: 1/15/2023 Treatment: No indication for steroid or remdsivir.  Discharge to: SNF  FJ1611 11/30/2021 FD7218 FD7218