chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 29-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UI981AB and expiry date: 16-Mar-2019) via intramuscular route in the left arm on 29-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because FLUZONE HD given to a pediatric Patient. No AE symptoms were reported. 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 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. List of documents held by the sender: None.
slurred speech; Right arm and right leg weakness; TIA; Fever; Weakness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8737), via an unspecified route of administration in right arm on 16Apr2021 16:00 as 2nd dose, single for COVID-19 immunization. Medical history included hypertension (Htn) and non-insulin dependent diabetes mellitus (Niddm). Concomitant medications included amlodipine and vitamins nos (MULTIVITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8730) in the left arm on 26Mar2021. The patient experienced slurred speech, right arm and right leg weakness, transient ischaemic attack (TIA), fever, and weakness, all on 18Apr2021 08:00. The events resulted to ER visit (Emergency room/department or urgent care) and patient was hospitalized for 2 days. Therapeutic measures were taken as a result of the events and reportedly included treatment with blood thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered with sequel. Events seriousness was hospitalization and disability.  Information on lot/batch number was available. Additional information has been requested.
Gran mal seizure on 5/18/01. Unconscious for 45 minutes with oxygen and artificial respiration necessary. Child transported to emergency room by ambulance. Child admitted for observation. Stay of 1 day and diagnosed with right sided brain anomaly; EEG abnormal. Consult with doctor (pediatric neurologist in hospital). Prognosis: 50% chance seizures will recur. Residual encephalopathy noted by parent. 18 year old sibling had a similar event at about the same age.
irregular heart beat/a women at the pharmacy tapped her shoulder and told her she had received the vaccine too and experienced the same thing as the caller.; pulse rate was high/a women at the pharmacy tapped her shoulder and told her she had received the vaccine too and experienced the same thing as the caller.; would wake up in the middle of the night with her heart pounding like crazy/a woman stopped her and said she had COVID with the same symptoms; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, 04Mar2021 at single dose for COVID-19 immunization. The patient medical history included heart attack, Covid-19, concomitant medication was not reported. Patient experienced after two days irregular heart beat, wake up in the middle of the night with her heart pounding like crazy, pulse rate was high/a women at the pharmacy tapped her shoulder and told her she had received the vaccine too and experienced the same thing as the caller, wake up in the middle of the night with her heart pounding like crazy. The outcome of event was unknown.  Information on the lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021297868 same drug/event, different patient;US-PFIZER INC-2021294406 same drug/event, different patient
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) with lot number: L007230, expiry date: 03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous case, initially received from other non-health professional (consumer) on 30-Oct-2018, concerns a male patient of an unspecified age. The patient's medical history and concomitant medications were unknown. On an unspecified date, the patient was administered influenza vaccine, [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: unknown, trade name and manufacturer: not reported]. On an unspecified date, after vaccination, the patient developed a reaction which he recognized as a sulphite sensitivity. The treatment associated with an event was unknown. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serious and considered the causality of the event as related to the suspect vaccine.
Strong reaction; Felt a little lightheaded; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Strong reaction) and DIZZINESS (Felt a little lightheaded) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION COMPLICATION (Strong reaction) and DIZZINESS (Felt a little lightheaded). At the time of the report, VACCINATION COMPLICATION (Strong reaction) and DIZZINESS (Felt a little lightheaded) outcome was unknown.        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.   Concomitant medication was not reported. Treatment includes Gatorade and water. Nurse reported that she received her first Moderna vaccine at the end of January 2021 and had a strong reaction on the same day.  She felt a little lightheaded the same day of her shot.    This case was linked to MOD-2021-408590 (Patient Link).
MMR vaccine administered 3/21/06 due to a negative rubeola titer.  Volunteer called on 4/3/06 to report a rash on her upper body.  She said she had a fever the night before.
No adverse event; administer the vaccine to two patients on 20Jul2022, after leaving  it at a room temperature on the 19Jul2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the vaccine to two patients on 20Jul2022, after leaving  it at a room temperature on the 19Jul2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the vaccine to two patients on 20Jul2022, after leaving  it at a room temperature on the 19Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the vaccine to two patients on 20Jul2022, after leaving  it at a room temperature on the 19Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administer the vaccine to two patients on 20Jul2022, after leaving  it at a room temperature on the 19Jul2022).    Th e patient was a pediatric patient. Number of doses or vials 2 doses. The vial was initially stored in the refrigerator was unknown. The vial was first punctured on 19 Jul 2022 at 9.45 am. The vial was stored in room temperature post puncture. The vial was exposed to room temperature range for 24 hours.  No concomitant medications was reported. No treatment medications was reported.
after receiving the vaccine,  the patient was leaving the store and fainted.  He was helped to a sitting position by store staff and given water and crackers.  He left after approximately 15 minutes.
gen vesicular rash began same day as vaccine; all over body, reddened halos w/scab formation in centers;appears like chickenpox;some areas still visable w/severe itching;
Patient received vaccines on 9/24/19. Patient presented to pharmacy on 9/26/19 with red swollen right arm, bruising around injection site, extremely swollen and red near elbow,  with upper arm being warm to the touch. Advised patient to use cool packs and to watch for any change in condition. Will follow up with patient as well. Patient instructed to follow up with doctor in 2 days if not improved or sooner if it gets worse. Patient reported trying Benadryl with no effect. Patient reported no pain just the swelling and redness.
This spontaneous report was received from a medical assistant and refers to a 4-month-old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with PROQUAD injection, lot # N022973 with expiration date on 19-FEB-2019 (dose and route of administration) for prophylaxis. No adverse effects were reported.
OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a pharmacist concerned a 17 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 08-APR-2021, the subject experienced product administered to subject of inappropriate age. On an unspecified date, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
On Friday, November 12, 2021 patient came for a COVID-19 Moderna booster dose. He received his first and second dose of Sinovac vaccine in April 2021 in another country. During assessment questions, client denied any allergic reaction to previous vaccines and no chronic medical history.  Submitted medical consult via text to vaccine operations lead who consulted with the doctor, and approved for patient to receive Moderna booster dose with 30-minute observation. The patient received the COVID-19 Moderna vaccine (batch/lot# 066F21A) at approximately 2:00 pm in right arm. Client was educated by RN on signs/symptoms of adverse reactions and when to go to the ED/call MD. Client experienced no adverse reaction while waiting in observation area and left vaccination site with a steady gait at approximately 2:30 pm.
expired dose of ACTHIB was administered to ONE patient with no AE; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from a physician via Medical information (MI) number: 00787391.      This case involves a 18-month- old patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).   The Patient's concomitant medications include DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), INFLUENZA VACCINE (INFLUENZA) for prophylactic vaccination respectively.   The patient's medical history, past medical treatments vaccinations and family history were not provided.  On 27-Sep-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE[ACT-HIB] (lot number: UJ391AAA and expiration date 10-Aug-2021) via intramuscular route in unknown administration site for prophylactic vaccination.   It was a case of an actual medication error due to expired product administered (latency same day).    It was reported "Physician called to report that an expired dose of ACTHIB was administered to ONE patient. The caller would like to know whether the dose is valid or whether it should be re-administered".  At the time of reporting, no adverse event was reported.   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.
COAGULOPATHY, UNSPECIFIED TYPE 4/18/2023 PERICARDIAL EFFUSION ACUTE PERICARDITIS, UNSPECIFIED 3/24/2023 PERICARDIAL EFFUSION COAGULOPATHY, UNSPECIFIED TYPE 4/18/2023 ATRIAL FIBRILLATION, PAROXYSMAL ACUTE PERICARDITIS, UNSPECIFIED 3/24/2023 ATRIAL FIBRILLATION, PAROXYSMAL COAGULOPATHY, UNSPECIFIED TYPE 4/18/2023 PERINEUM ABSCESS ACUTE PERICARDITIS, UNSPECIFIED 3/24/2023 PERINEUM ABSCESS
Was administered covid vaccine J&J  on left arm felt a burning sensation just after it which i knew it normal you just got a vaccine. Walked to the observatory area where we are supposed to wait 15min until you are released to go. Well less than 10 min in the observation area that?s when i started to feel un well my body started sweating excessively and thats when i felt numbness on my right side of my head with a tingling sensation couldn?t hear with my right ear and i freaked out when i started to get blurred vision thats when i knew something was wrong i got up to ask for water once i got up i felt like i was going to faint and felt really dizzy. Once i got to the lady that was there in the observation area  she was shocked at how i looked she told me to go sit down and brought me water as she called the ambulance. Once i was sitting down and was brought water i drank like more than half of the water and the numbness was going down from my right side of my head but still had blurred vision and just felt disoriented and not my self. The ambulance took me to the ER once i got there i felt a little better but still disoriented and dizzy. So disoriented that i left the hospital with me actually realizing i had to stay there to get checked because they kept saying i was fine.
COVID-19; COVID-19; 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 male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 23Oct2023, outcome "unknown" and all described as "COVID-19". Clinical course: Patient and his wife had taken all of the COVID-19 vaccines produced by Pfizer. They took the most current vaccine two weeks ago. Two days ago they contracted COVID-19 and were surprised to have contracted the virus with the current vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300349536 same reporter/vaccine/event, different patient;
Moderna COVID-19 Vaccine EUA Starting on third day after vaccination:  pain and swelling in joints; pain and swelling of left jaw and face; difficulty opening mouth/eating due to pain and swelling of left jaw; intermittent earache in left ear  Earlier more typical reactions first and second day after vaccine:  pain and swelling at injection site; elevated temperature which responded to Tylenol; chills.
arm stiff hot achy itchy since 2/10/2021 headache stiff neck
16x29 cm area of tender swelling and erythema and warmth (R) medial arm-humerus-forearm-started within 30 minutes of immunization.
5 hours after injection: 102 degree tempreture, vomoting, headache. 12 hours after injection tempreture 98.8.  24 to 72 hours after injection on and off chills and overall exhaustion.
1 hour after injection, experienced hot flashes, itchiness, burning feelings , sweating. 2 hours after injection expeirenced throat swelling and a light headedness, along with other symptoms from previous. Second day same symptoms with kidney pain. Not seen by dr on 10/21/04. Medical records from 08/17/05 include allergic reaction and nephritis.
pt exp lightheadedness & devel a funny taste in mouth immed p/recvd flu vax; on f/u pt reported that had devel labyrinthitis which lasted for 1 wk;
WITHIN 2 MINUTES OF GETTING THE SECOND DOSE OF MODERNA COVID VACCINE, PATIENT FAINTED ON HIS WIFE'S ARMS. SHE PUT HIM ON NEAR BY CHAIR AND CALLED OUT TO THE PHARMACY. WE CALLED 911 RIGHT AWAY. I STOOD BY HIM. HE LOOKED PALE, DOSING OFF, I WAS ASKING HIM QUESTIONS AND HE WAS ABLE TO ANSWER FEW WORDS AND DOSE OFF AGAIN, HE FELT HOT, AND HE ASKED HIS WIFE WHAT HAPPENED AND SHE SAID HE FAINTED, AND HE REPETEADLY HAVING SAME FAINTING EPISODE WHILE SITTING, HE WAS ABLE TO DRINK WATER FROM WATER BOTTLE. I TOLD HIM TO REMOVE HIS FACE MASK FOR BETTER BREATHING. I TRIED TO CHECK HIS PULSE BUT IT WAS VERY VERY SLOW. PARAMEDICS CAME AND HE IS FEELING BETTER BY THE TIME THEY CAME. HE WAS ABLE TO COMMUNICATE ALOT BETTER WITH THEM. THEY MEASURED HIS BP AND GLUCOSE, GLUCOSE WAS 91 AND BP WAS LOW HIS FIRST TIME AROUND AND SECOND TIME WAS NORMAL BUT HAD LOW HEART RATES. HE REFUSED TO GO TO THE HOSPITAL. HE FELT LIKE HE HAD A HEADACHE AND HOT. WIFE WAS BY HIS SIDE. PARAMADICS WALKED HIM DOWN TO THEIR CAR AND ADVISED THEM TO GO TO NEAREST HOSPITAL IF NOTICE ANYTHING.
ED visit: Sore throat and temperature of 105F at home and 39.7C. Feeling "jittery", dazed, occipital paresthesias, intention tremor (which exam confirmed) and myalgias. Discontinue Sudafed. DX: Exudative pharyngitis and given Ceftin, Tylenol, Motrin.
I had laryngitis, stuffy nose, a headache with a fever 102F. I also had achy bones, sore muscles and diharra in the beginning.
On 8/6/08 - mother noticed small red bumps and redness to site of injection.  Has since spread to arm-upper only.  Areas 1st appeared AM now fading.
Per System, patient received 2 doses of Pfizer COVID-19 vaccines on 7/26/2021 and 8/16/2021 and was subsequently diagnosed with COVID-19 at our hospital on 12/27/2021
Within seconds after giving IM injections, broke out in blotchy and purple rash with raised pink hives only on legs. Lesions faded without treatment.
numbness in toes; minor weakness in legs; minor low back aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in toes), MUSCULAR WEAKNESS (minor weakness in legs) and BACK PAIN (minor low back aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced HYPOAESTHESIA (numbness in toes), MUSCULAR WEAKNESS (minor weakness in legs) and BACK PAIN (minor low back aches). At the time of the report, HYPOAESTHESIA (numbness in toes), MUSCULAR WEAKNESS (minor weakness in legs) and BACK PAIN (minor low back aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
pt had a positive COVID test at outside ED (Hospital) on 9/25/22 and was dc'd to home; pt back to hospital 10/4/22 with nausea, productive cough; given dexamethasone and azithromycin; O2 supplementation; had bloody BM requiring transfusion; pt's status improved; stable to dc to home on 10/11/22; pt passed away at home
T100.8 tympanic-large reddened, hard, swollen area lt upper thigh--warm to touch;also had T100.3 tympanic on day of immun secondary to dx of LOM;
MODERNA COVID VACCINE DOSE 3 GIVEN 12/1/21, LOT #076C21A; pt had a positive COVID test on 7/3/22; O2 via NC; isolation unit; given Mucinex, Zinc, Vitamin D, Eliquis; 7/5/22 family changed pt's status to DNR with comfort measures; pt passed away in nursing home
HAD A COLD IN MY NOSE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced had a cold in my nose, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had a cold in my nose and headache was not reported. This report was non-serious.