chrisvoncsefalvay/vaers-outcomes huggingface dataset:
erroneously received an overdose entire undiluted vial of Pfizer Covid 19/No diluent, resulting in higher than authorized dose; erroneously received an overdose entire undiluted vial of Pfizer Covid 19/No diluent, resulting in higher than authorized dose; This is a spontaneous report from a contactable pharmacist. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE (at the age of 48 years) for covid-19 immunisation. The patient medical history and concomitant medications. The patient erroneously received an overdose entire undiluted vial of Pfizer Covid 19. No diluent, resulting in higher than authorized dose (i.e., 0.3 ml of undiluted vaccine administered). Administration error occurred on 06Aug2021.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded.
Swollen lymph node started under my right arm in my armpit beginning of July then cough chest tightness and pain swelling in my limbs and lymph node then lymph node in my left armpit swelling along with nausea and diarrhea
fatigue, brain fog, dizziness, body aches, pain at injection site, no appetite, feeling hot
Cough; post nasal drip; UTI; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), UPPER-AIRWAY COUGH SYNDROME (post nasal drip) and URINARY TRACT INFECTION (UTI) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), UPPER-AIRWAY COUGH SYNDROME (post nasal drip) and URINARY TRACT INFECTION (UTI). At the time of the report, COUGH (Cough), UPPER-AIRWAY COUGH SYNDROME (post nasal drip) and URINARY TRACT INFECTION (UTI) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Antibiotics for UTI. No relevant concomitant medications were reported.
Itching at insertion site changing to redness. Large area the size of my palm raised and warm to the touch with mild discomfort?
Local reaction in left deltoid 2 days after vaccination 2 in induration with redness, heat, feverish all over. 2-3 weeks later, intense heat on  shoulder, elbow,wrist joints, decreases ROM, pain.
Generalized pain, (L) arm pain, swelling, and hot flashes. Duration from 04/07/2021 at 3:00 pm to currently (04/08/2021 11:30 am)
1st dose on 31Oct2019, ate for the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31st October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 6-Jul-2022 Reporter's comment: The pharmacist reported that the patient was late for the 2nd dose. The reporter consented to follow-up via email. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
second dose was still not given,; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The age at vaccination was not applicable. Pharmacist reported that till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.  The reporter did not consented to follow-up.
No adverse reaction. 9-13-22 Pfizer Prim was administered this was the 1st in the series.  10-5-22 Pfizer Bivalent was administered instead of the 2nd Pfizer in the series.  10-5-22 Poison control was notified. The patient was notified. No problem at this time. No adverse reaction noted. P. Control stated this was good to use it to complete the series and when she is due for a booster she will be able to receive it.
Dizziness; lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and DIZZINESS (lightheaded) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (Dizziness) and DIZZINESS (lightheaded). At the time of the report, DIZZINESS (Dizziness) and DIZZINESS (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.   No relevant concomitant medications were reported. No treatment information was provided.
within 4 days after receiving vaccine, patient developed sudden onset of cough, shortness of breath and leg swelling with fatigue.  initially diagnosed with pneumonia and treated with doxycycline, but no improvement.  returned to ED and found to be in acute heart failure with ejection fraction of 20%.
I had flu like symptoms day of. A few days later respiratory issues persisted. Heavy cough, wheezing, difficulty breathing. Bronchitis like symptoms. I lost consciousness briefly twice due to coughing.
This spontaneous report as received from a health professional refers to a 13 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). The temperature excursion of the administered dose of vaccine was 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA. One week after first dose a mild rash appeared at the injection site area.
First dose 3/25/2021:  Symptoms began 22 hours after vaccine and lasted one day.  Fever 103, vomitting, headache, no appetite, dehydration, severe body aches, deep cough, fatigue and sore underarms,    Second dose 4/23/2021: Symptoms began 9 hours after vaccine  First day- Fever 105, vomitting, Severe headache, sensitive to light and sounds, severe baody aches, no appetite, deep cough, fatigue and sore unders.  Second day -  Fever 102, vomitting, Severe headache, sensitive to light and sounds, severe baody aches, no appetite, deep cough, fatigue and sore unders.  Third day- Fever gone. Left with fatigue and headache
Varicella vaccine breakthrough. Had 24 vesicles and pustules on torso. No fever.
Erythema and swelling left upper arm, pruritic per pt.  Area involved is from top of left arm to elbow.
Jan 23, 2021 - Afternoon - Was admitted to Urgent Care with chest pains, fatigue, shortness of breath, low oxygen levels. Diagnosed as having fluid surrounding heart and lungs - heart and lungs were tested and were fine but still experiencing shortness of breath and fatigue. Did not report it on my contract tracing monthly text questionnaire since I did not believe at the time it was related to the vaccine.
vial was not diluted stronger dose was given mom notified at 9am, advised to monitor mom stated injection site was ok
Patient noticed soreness in (L) arm this morning at site of varicella vaccine (given on 1/17/12). Arm noted to be warm, tender to touch with area of redness measuring 60 mm x 75 mm. No fever. No itching. Patient seen by NP who prescribed cortico-steroid cream.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 19-JAN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Patient had tonic-clonic seizure involving face and shoulders approximately 3 hours after receiving third hepatitis B vaccine. ER evaluation was negative. Event lasted less than 1 minute. Post-ictal for 15 minutes. No further treatment given. Temperature in ER was 104.
Huge red raised hives like rash on my arm 2 weeks after injection. super itchy and my arm is very painful. 4 inches x 3inches in size
She got her vaccine, she got very hot and sweaty within 10 minutes.  She was still filling out her form for the next vaccine.  She asked a paramedic some questions, and asked if anybody else had reported anybody get hot and sweaty and he directed her to go to the open door and drink some water and rest.  He asked if somebody could check her out, and came back again and asked again and they hooked her up to some electrodes and called the ambulance (somewhat foggy memory).  She was having a lot of palpitations which included PVC's, and possibly other heart arrhythmias at the same time.  He got to the hospital and could tell that she was going to the trauma room and they were waiting on her.  She had an Echocardiogram which showed that her left bundle branch was not working, her Troponin's were going up and went from very low  to high and then started trending down again.  She had a cardiac cath and was told that she had nothing wrong with her heart and had a heart of a child.   They mentioned Takotsubo's cardiomyopathy and wanted to do another in 6-8 weeks, which she had done and it is totally back to normal.   Her blood pressure was fluctuant between high and low. When she was discharged home on the 4th day she had severe diarrhea.   She was put on Plavix 75 mg, they upped her Metoprolol XL 25 mg to twice a day, they also gave her Lipitor to take briefly.  They took her off baby aspirin.     The recent echocardiogram was back to normal.    She was told she could not get the 2nd vaccine either.
I had an eye condition called uveitis, I was treated with a dilator and a steroid for 3 weeks. It usually is associated with an autoimmune disease which can be triggered by a vaccine.
Fever, Runny Nose,  Cough, Vomiting, and Diarrhea
she experienced a swollen right leg and abdomen after receiving the COVID-19 vaccine; she experienced a swollen right leg and abdomen after receiving the COVID-19 vaccine; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 41-year-old female patient received bnt162b2, via an unspecified route of administration on 17Dec2020 at a single dose for covid-19 immunization. The patient' medical history and concomitant medications were not reported. The patient experienced a swollen right leg and abdomen after receiving the covid-19 vaccine in Dec2020. Outcome of the events was recovered on an unknown date. Patient reported that she had follow-up with her doctor, received lab work that returned normal, and now has no more swelling.   No follow-up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected
No adversed effect at or near the time of vaccination.  Developed Covid-19 symptoms on the morning of 5/17/2022.   See item #21  On 5/18/2022, and online visit to  GP prescribed a 5 day series of Paxlovid which I completed on AM of 5/23/2002. Symptoms diminished over time and only a slight, occasional cough remains - which is likely due to post-nasal drip rather than lung congestion.
Soreness in Injection Arm; Slight Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in Injection Arm) and CHILLS (Slight Chills) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in Injection Arm) and CHILLS (Slight Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness in Injection Arm) and CHILLS (Slight Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment for the event included Ibuprofen
On the Friday which was the first day I felt overwhelming tired in the afternoon and had a little bit of a sore throat. On Saturday I had a little bit of a sore throat and runny nose and tested negative to COVID-19. Later that night I had a headache, painful cough, sore throat, muscle aches, and felt like  I had the flu. I felt feverish but didn't take my temperature. By Sunday all symptoms improved and my temperature was 99.4 and I tested positive at 7:30am but I was already feeling better. I called the Doctor that day and they prescribed the Paxlovid which I started around 11am. Monday I had a video visit with my Dr. and by that time I had a hoarse voice but felt fine and well enough to go to work. By the fourth day I tested negative.
Pt has history of a reaction with the 1st dose of COVID 19 Vaccine with c/o SOB 4 hours after receiving the primary dose of COVID 19 Vaccine, and hives x 4 days after vaccination.; Pt has history of a reaction with the 1st dose of COVID 19 Vaccine with c/o SOB 4 hours after receiving the primary dose of COVID 19 Vaccine, and hives x 4 days after vaccination.; This is a spontaneous report from a contactable other hcp.   A 21-years-old female patient received bnt162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, (Batch/Lot number was not reported)), via intramuscular on Jan2021 (at the age of 21 years-old) as, Single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included medroxyprogesterone acetate. It was unknown If COVID prior vaccination. Unknown If COVID tested post vaccination. Patient stated that she had received her Depo-Provera injection the day before vaccine. Pt given second (2nd) dose today4:50. at15:30 Pt denies any signs and symptoms and plan of care was to have patient's boyfriend come and pick up patient to ensure that she was with someone to ensure if she had onset of SOB she could have someone call or take her to receive follow up care. On Jan2021, the patient experienced pt has history of a reaction with the 1st dose of covid 19 vaccine with c/o sob 4 hours after receiving the primary dose of covid 19 vaccine, and hives x 4 days after vaccination. The patient had 5:20 pt still denies any s/sx of allergic reaction. Patient would take second dose on 18Feb2021 on 03.00 PM by intramuscular route with Lot no EN6198. The outcome of the event was recovered on an unspecified date.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Initial misuse case was received from a healthcare professional on 31 OCT 2013. Cases were received on 21 March 2014. A 3-year-old patient whose demographic details, medical history and concomitant medication were not reported received a 0.25 ml dose of FLUZONE on unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received an incorrect dose of vaccine. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
Unilateral tinnitus (right ear) on 16May21 at 21:00 turned into bilateral tinnitus on 17May2021 at 07:00 (~12kHz tone and slight ~4kHz tone both in both ears).; Sleep was interrupted; Slight dizziness; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the arm left on 13May2021 at 12:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A-DAY) for unspecified indication since unspecified date within two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took prednisone (MANUFACTURER UNKNOWN), asprin (MANUFACTURER UNKNOWN); both were taken for unspecified indication since an unspecified date and experienced drug allergy. The patient experienced unilateral tinnitus (right ear) on 16May21 at 21:00 turned into bilateral tinnitus on 17May2021 at 07:00; it was (~12kHz tone and slight ~4kHz tone both in both ears). On 16May2021 at 21:00, the patient's sleep was interrupted and had slight dizziness accompanied the unilateral tinnitus only. The events resulted in doctor or other healthcare professional office/clinic visit. It was reported that, the patient had primary care visit on 25May2021. Therapeutic measures were not taken as a result of events. On 27May2021, the patient underwent audiogram, tympanometry and the results were unknown. The events bilateral tinnitus and sleep interrupted was persisted. The event resulted in ENT visit on 10Jun2021 . The clinical outcome of the event unilateral tinnitus , sleep was interrupted; slight dizziness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a four years old male patient who was vaccinated with 0.5 ml dose of QUADRACEL (lot no C5497AA and Exp. Date 17 Jul 2010) via intramuscular route in the right thigh on 23-Aug-2018. The patients medical history was not reported. Previously patient received QUADRAEL from a well-child visit in Feb 2018. Concomitant medications included PROQUAD for Immunization. It was an actual medication error due to drug administered to patient of inappropriate age. it was reported that quadracel was early to male patient due to missing immunization records. It was unknown whether the patient had any adverse event (No known reports of symptoms or need for treatment). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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 sender: none.
Large hard swelling, red & hot - began within the hour - still present & sore 30 hours later. Dull headache. 7 x 7 cm 30 hours later.
got covid after being boosted; got covid after being boosted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: FA6780) as dose number unknown (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got covid after being boosted". Clinical course Reporter husband's brother and his wife also got covid after being boosted. No further details, she doesn't know if they would want to report. Declines to complete a report for her husband's bother and his wife. PC also filed on Reports 1, 2, and 3, of 4. Is there a product complaint to report? Yes. Description of Product Complaint: Description of complaint: Got covid after being boosted with the covid-19 vaccine. Not provide Product strength and count size dispensed. Not provide Additional lot numbers.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200469651 same reporter/drug/AE, different patient
Numbness in mouth, lips and moving toward back of the throat and up sinuses. headache and fatigue These symptoms were present 4 hours after 2nd Pfizer vaccine- treatment was steroid shot and benadryl tablets these symptoms reappeared 2 weeks after 2nd shot.  treating with benadryl tablets and symptoms mildly improving
Dizzy; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that after received Shingles vaccine he/she experienced dizzy. The patient wanted to know why he/she experienced dizzy after received Shingles vaccine shot. Additional supportive information: Follow-up would not possible as no contact details were available.
Patient is a 57 y.o. female who received the Janssen COVID vaccine Lot# 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate   of observation: Dizziness  Patient was treated/managed as follows:    Pt given Gatorade Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car by staff