chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered ACTHIB that expired on 26OCT2022 (with no reported adverse event); Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA046834, 2023SA046778, 2023SA046763, 2023SA046745, 2023SA045388 and 2023SA045123.  This case involves a 16 month old male patient who was administered HIB (PRP/T) vaccine [ACT-HIB] that expired on 26oct2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Immunisation.  On 10-Jan-2023, the patient received an expired 0.5 mL dose 4 of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot: UJ594AAA; expiry date: 26-Oct-2022) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered acthib that expired on 26oct2022 (with no reported adverse 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 guidelines. 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.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On 27th September 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reported lot number (PKNBY) for SHINGRIX did not exist and was updated to PK9BY, according to sales datasheet.
left arm was painful and pain is going towards hand; patient felt weakish; nausea is worse; patient felt kind of funny; left arm became swollen; left arm was tingling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (patient felt kind of funny), PERIPHERAL SWELLING (left arm became swollen), PARAESTHESIA (left arm was tingling), PAIN IN EXTREMITY (left arm was painful and pain is going towards hand) and ASTHENIA (patient felt weakish) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL and METOPROLOL for Blood pressure, GABAPENTIN for Pain back, TRAZODONE for Sleep difficult, DONEPEZIL HYDROCHLORIDE for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced FEELING ABNORMAL (patient felt kind of funny), PERIPHERAL SWELLING (left arm became swollen), PARAESTHESIA (left arm was tingling) and NAUSEA (nausea is worse). On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm was painful and pain is going towards hand) and ASTHENIA (patient felt weakish). At the time of the report, FEELING ABNORMAL (patient felt kind of funny), PERIPHERAL SWELLING (left arm became swollen), PARAESTHESIA (left arm was tingling), PAIN IN EXTREMITY (left arm was painful and pain is going towards hand), ASTHENIA (patient felt weakish) and NAUSEA (nausea is worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history reported.
Took flu shot lat Oct, 1 1/2 - 2 weeks later developed rash dark pink macule all over body, had fever and body aches. 11/27/06 rash still visible, skin reddening no itching. Family Doctor sent for test results, MD doesn't think related to shot. Unsure what it is. Rash is improving.
Arm a little sore; Rash at the injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm a little sore), INJECTION SITE RASH (Rash at the injection site) and INJECTION SITE PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042LWA and 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE PAIN (sore arm). On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm a little sore) and INJECTION SITE RASH (Rash at the injection site). On 23-Jan-2021, INJECTION SITE PAIN (sore arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm a little sore) and INJECTION SITE RASH (Rash at the injection site) outcome was unknown.
November 24 and potentially the day before I started to develop hives after physical touch or friction to skin. Initial hives on hands where nitrile gloves rub when removing between thumb and pointer finder on the top of my hand. Then area that had small itches and no hives prior to itching/scratching turned into red irritated hives by simply scratching an itch. Seams of pants and tags left welts or hives. Began to improve. Initially didn?t recognize that it worsened after COVID exposure end of December, but I never tested positive or had respiratory symptoms. Saw the dermatologist at a dermatology office. Recommended taking up to 60mg of Zyrtec daily. Started with 20 and not improvement and then 30mg. Took 40-50mg most days. Traveled out of area hoping time off and vacation would improve it. Worse or the same. Contacted allergist. Recommended reporting. Will add Pepcid to 40mg of Zyrtec and give more time.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 booster, single (Batch/Lot number: unknown) at the age of 67 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 1, single) and second regimen (Batch/Lot number: unknown) at single (dose 2, single) for Covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Gout" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Airborne, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant) with onset 12Jun2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "started Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: positive; negative; positive. Therapeutic measures were not taken as a result of Covid-19. Patient stated that she started Paxlovid on day 4 after testing positive for Covid. She took it 5 days. On day 11, she tested neg for Covid on rapid and PCR test. She had been testing everyday since with a rapid test. On the 6th day after she finished Paxlovid, she developed symptoms and tested positive for Covid. She had rebound Covid on my 6th day after treatment and she want that recorded. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Patient received second booster dose.  Treatment medications were not reported.
Day 3 sudden severe onset of nausea, followed by vomiting and chills. Day 4 nausea and weakness Day5 back to normal- just sore from vomiting
Reporter indicated that 28 pts recvd Engerix-B 8 pts have tested neg;
I tested positive/I am fully vaccinated and boosted all with Pfizer; I tested positive/I am fully vaccinated and boosted all with Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 13:15 as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "ashtma" (unspecified if ongoing); "copd stage 1" (unspecified if ongoing), notes: copd stage 1. There were no concomitant medications. Past drug history included: Sulfur, reaction(s): "known allergies: none that I am aware of besides sulfur", notes: known allergies: none that I am aware of besides sulfur. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I tested positive/I am fully vaccinated and boosted all with Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient started the 5 day course of paxlovid the night she tested positive which was 27Apr2022. She was fully vaccinated and boosted all with Pfizer. The only symptom she had was fatigue and possibly some muscle aches. She felt fine until Friday which was 8 days after testing positive and 5 days after completing the paxlovid in which she woke up with flu like symptoms. Stuffed nose and dry cough which turned into a productive cough with yellow thick mucus. Two days later on Sunday she woke up at 1:30 am itching my arms like crazy. Hives developed and were gone by morning. They came on again the next day at work in the afternoon on her lower body. She took Benadryl with no relief. They disappeared again for a whole 24 hours and then came back but mild. Its been 48 hours w/o eventually turned clear with a very stick texture. I am now 8 days past this event and am still having horrible congestion and still coughing up mucus which is causing air hunger upon any activity. Oxygen is still reading in the 90's.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
HIGH BLOOD PRESSURE; INCREASED HEART RATE; HEART PALPITATIONS; SHORTNESS OF BREATH; CHEST TIGHTNESS; TIRED; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressures, and increased heart rate, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced tired. On 08-MAR-2021, the subject experienced heart palpitations. On 08-MAR-2021, the subject experienced shortness of breath. On 08-MAR-2021, the subject experienced chest tightness. On 10-MAR-2021, the subject experienced high blood pressure. On 10-MAR-2021, the subject experienced increased heart rate. Laboratory data included: EKG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, heart palpitations, shortness of breath, chest tightness, high blood pressure, and increased heart rate. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Very confused 2 days after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Very confused 2 days after 2nd dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CONFUSIONAL STATE (Very confused 2 days after 2nd dose). At the time of the report, CONFUSIONAL STATE (Very confused 2 days after 2nd dose) outcome was unknown.            Patient doesn't remember doing certain things like going to bed, getting up, swimming or driving. Patient was still confused.
Went into emergency room on 5/5/2021. MRI came back with results of stroke. Has something to do with carotid artery. I don't know much else right now. The stroke effected the left side of his brain.. plaque can get in there? His right arm is still weak
Woke up at 3 am due to arm being sore, at 7:15 she had a temp of 101.8 lympthnodes in next are swollen and its hard for her to turn her neck due to pain.
The pt developed a fever on 4/25/01 through 4/26/01. The pt was drowsy also. The temp was 103.4 in the office.
Conjunctivitis of the eyes with swollen eyelids and pink inflammation of the inside portion of my eyes (towards my nose). This lasted for 5 days.
Redness over the left arm approximately 7 inches in length and 2 to 3  inches wide down arm toward elbow. Warm to the touch. Slight pain
Patient complains of tender, swelling, and erythema at pneumococcal injection site.  Cold pack was applied.  3 hours later site is painful, with redness and swelling of 7 cm.  Patient also has temperature of 99.5, chilling, and aching.  Diphenhydramine is administered.  One hour later, temperature if 100.5, physician examines & notes swelling of vaccination area, and orders cephalexin, acetaminophen, diphenhydramine, and ice.  The following day, the site appearance is stable & patient is dismissed on cephalexin.  Patient presents to our ED on 3/3/13 with worsening symptoms & is admitted with left leg cellulitis & is treated with IV vancomycin x 2 days combined with clindamycin IV x 4 days followed with po clindamycin to continue 7 more days at dismissal.
EXCESSIVE DROOLING/SLOBBERING; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes, lisinopril for high blood pressure, and tamsulosin. On JUN-2021, the subject experienced excessive drooling/slobbering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from excessive drooling/slobbering. This report was non-serious.
lethargic; felt tired; a little of fever; body aches; This spontaneous case was reported by a nurse and describes the occurrence of LETHARGY (lethargic), FATIGUE (felt tired), PYREXIA (a little of fever) and MYALGIA (body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Contrast media allergy (contrast dyes), Blood pressure high (no recent change in status such as improvement or worsening), Heart disease, unspecified (no recent change in status such as improvement or worsening) and Diabetes (no recent change in status such as improvement or worsening). Concomitant products included HYDROCHLOROTHIAZIDE, CLOPIDOGREL BISULFATE (PLAVIX), ESTROGENS CONJUGATED (PREMARIN), FLECAINIDE and DILTIAZEM for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced LETHARGY (lethargic), FATIGUE (felt tired), PYREXIA (a little of fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 13-Mar-2021, LETHARGY (lethargic), FATIGUE (felt tired), PYREXIA (a little of fever) and MYALGIA (body aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient never had COVID test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The adverse events did not cause patient to seek medical care.   This case was linked to MOD-2022-547355, MOD-2022-547429, MOD-2022-547432 (Patient Link).
Vomiting after 3rd shot; Fever 103 F after 3rd Shot / Fever goes up and down even without Tylenol; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 103 F after 3rd Shot / Fever goes up and down even without Tylenol) and VOMITING (Vomiting after 3rd shot) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A, 029L20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever 103 F after 3rd Shot / Fever goes up and down even without Tylenol). On 16-Dec-2021, the patient experienced VOMITING (Vomiting after 3rd shot). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 16-Dec-2021, VOMITING (Vomiting after 3rd shot) had resolved. At the time of the report, PYREXIA (Fever 103 F after 3rd Shot / Fever goes up and down even without Tylenol) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2021, Body temperature: 103 (High) 103 Fahrenheit.         Patient requested for half booster dose but healthcare professional (nurse) refused to give half doe due to patient medical history of cancer.  No relevant concomitant medications were reported.   This case was linked to MOD-2021-417464 (Patient Link).
Pt had vaccine on the 5th of Oct and on the 10th of Oct 2008 he started having shortness of breath and chest pains.  He went to his MD who referred him to MC where he went to the ER and was admitted overnight on telemetry with a diagnosis of Pericarditis.  He was discharged the next day with orders to report back on the 28th of Oct for an appointment with Cardiology clinic.  1/6/09 Additional f/u records received for DX of Pericarditis s/p smallpox vaccine.   Asymptomatic by 10/28/08. However developed occasional L sided chest pressure and tingling lasting 10-15 secs with slight SOB by 11/26/08. Dx as atypical chest pain.
Sore arm days 1-4 Joint and muscle aches days 2-4 Nausea and vomiting days 5-6 (on day 6 now, hopefully won't continue..)
shingles; died; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient that currently would be 76 years old. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2009, the patient (pt) was inoculated with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions by a pharmacist at the pharmacy.On an unknown date, the pt suffered from the following injuries resulting from pt's zoster vaccine live (ZOSTAVAX) use: shingles. Pt received unspecified treatment from a healthcare provider at a hospital. Pt died due to unknown reason on 24-AUG-2017. It was unknown if autopsy was performed. The outcome of shingles was unknown. The events were considered to be related to the suspect therapy.
Hair loss began within a few days of Gardasil.  This continued at a dramatic rate so that she has lost what mom believes to be up to 50% of her hair volume.  Has also had extreme fatigue and muscle soreness. 1/4/2010 PCP records for 8-11/2009, on 11/9/2009 patient with c/o's hair loss, fatigue, facial flushing
Pts  reports had a sore arm followed by tenderness 4/10 swelling and erythema of the injection site and warmth . Pt had influenza vaccine and pneumoccocal vaccine at the Medical Clinic, Lot # and Expiration date not on file
Multiple subsegmental pulmonary emboli, which turned into heart palpatations.. One emboli traveled to my brain and caused me to collapse at work, where I was taken by ambulance to Emergency Room.
About 45 minutes after the injection, my face became red, flushed and warm.  My lips, tongue and mouth began tingling.  I felt a little strange bur no other side affects.  I took a Benadryl and all symptoms were gone in about 15 minutes.  Then I felt fine.
Muscle aches, weakness, unable to bend down, difficulty getting out of bed, almost impossible to get up from low position. Extreme pain in left arm after period of inactivity. Difficulty getting in and out of vehicle, difficulty driving. Becoming progressively worse as time goes by.