chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: Bell's palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.     It was unknown if the company considered the bell's palsy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The reporter said that shingles shot gave her husband Bell's palsy.  These shots were worse than the actual disease. The reporter said do not do it. The follow-up would not possible as no contact details were available.
A provider used the vaccine after it was opened for 5 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Arm pain at injection site began a few hours after injection.  Fatigue began 18 hours after injection.
Swelling, warm, redness to left thigh after immunizations administered. Fine macules noted mid-thigh, blanching erythema. FNP prescribed KEFLEX and ibuprofen. Pt to f/u in one week.
Muscle/joint pain, fever with chills with general malaise that lasted several hours.  The onset of these symptoms was shortly after rollerblading for 10 miles.
Child developed pain, redness, heat, swelling of left arm 2 days s/p vaccination. Patient was seen at a local urgent care and prescribed KEFLEX x 7D and BENADRYL prn for what was felt to be a possible allergic reaction or possible cellulitis.
pt recv vax & temp started about 3PM 102-103;APAP & Motrin alternated q 3hr;that noc temp 104;Wednesday both thighs sl swollen-no redness;T101 during day by 4PM;temp up to 105;cont w/APAP & Motrin;no appetite;crabby;
Already are a tinnitus sufferer but about 6 weeks after the vaccine it got worse and the ringing much louder; This is a spontaneous report from a contactable consumer(patient). A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly of administration in Arm Right on 30Apr2021 15:45, at 62-year-old, as single dose (Batch/Lot number was not reported) for covid-19 immunisation.  The patient was not pregnant at the time of vaccine. Medical history included tinnitus sufferer and allergy to neosporin, non-organic eggs, and gabapentin. Concomitant medications included naproxen sodium, sumatriptan succinate (TREXIMET), bupropion hydrochloride (WELLBUTRIN) and topiramate. All concomitant drugs were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly of administration in Arm Right on 06Apr2021 03:00 pm, at 62-year-old, as single dose (Batch/Lot number was not reported) for covid-19 immunisation.  No other vaccine in four weeks. The patient had not got Covid prior vaccination and had not Covid tested post vaccination. The patient reported she already were a tinnitus sufferer but about 6 weeks (as reported) after the vaccine it got worse and the ringing much louder on 31May2021. The patient got no treatment and was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Approximately 10 minutes following injections, pruritis and urticarial rash developed.  Rx BENADRYL liquid 1 tsp.
Swelling size of child's football. Red, feverish, hard knot, itched, sore: it was like the pneumococcal shot that reacted left arm had flu shot the week before in same arm.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions or concomitant medications.   On or around 31-OCT-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
arm being swollen and arm was about the size of a golf ball; arm was warm to the touch; lump in arm; lightheaded; disoriented; bronciospasms; wheezing and dyspnea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded), DISORIENTATION (disoriented), BRONCHOSPASM (bronciospasms; wheezing and dyspnea), PERIPHERAL SWELLING (arm being swollen and arm was about the size of a golf ball) and SKIN WARM (arm was warm to the touch) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (lightheaded), DISORIENTATION (disoriented) and BRONCHOSPASM (bronciospasms; wheezing and dyspnea). On 11-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm being swollen and arm was about the size of a golf ball), SKIN WARM (arm was warm to the touch) and SKIN MASS (lump in arm). On 31-Mar-2021, BRONCHOSPASM (bronciospasms; wheezing and dyspnea) outcome was unknown. On 19-Apr-2021, PERIPHERAL SWELLING (arm being swollen and arm was about the size of a golf ball), SKIN WARM (arm was warm to the touch) and SKIN MASS (lump in arm) had resolved. At the time of the report, DIZZINESS (lightheaded) and DISORIENTATION (disoriented) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Inhaler as needed. Treatment information included Nebulizer at home and  In hospital: Ativan through IV and inhaled Lidocaine.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Added new events peripheral swelling, skin warm and skin mass.
I did not have an adverse reaction to the vaccine but contracted Covid 19. Tested positive 05/04/2022. I had about three negative test (PCR and home)  prior to the saliva test which confirmed the positive result. Nettie pot for my congestion and a lot of honey for sore throat to alleviate symptoms. I also took Advil for sinus relief. I felt better about thirteen days after testing positive.
Within 36 hours of vaccine, developed sore throat and upper respiratory infection that persisted for 10 days - 2 weeks.
Hospitalized 12JUL91; Onset 12JUL91 confirmed H. Influenza Type b p/2 HBCV vax;
Severe body aches, vomiting, sweating, chills, headache, generalized pain
Approximately 15 pt developed induration, swelling, redness and pain on the entire arm.
Rash on lower part of leg began the next day, raised, hypopigmented & linear streaks about 3-4 cm x 3-4 cm.
Tested Positive for Covid on July 12, 2022. Flu like sympthoms with head congestion, coughing, fever and headache until July 17, 2022. Fatigue continues
Pt said she felt dizzy and then passed out in the nurses office at school, landed flat on her face and had a possible seizure that lasted less than one minute.
Starting Jan 7, he has been experiencing fatigue and light-headedness, which gets worse if he stands up too fast.
4th shot 15 X 15 cm red raised lump of 3 cm, hot.
Patient received Twinrix vaccine. 1st dose given at 16 y/o (10/24/2006) and second dose given at age 17 (10/25/2007).  Vaccine approved for patients 18 years of age and older.
Lethargy, fevers, headaches, nausea and body aches lasted for about a day
crying at time of shot.  increased later to unconsolable crying and wailing within a few hours.  Never happened before with previous  vaccines in the past.  Onset of fever within hours of the shot that increased throughout the afternoon.  Nausea and aversion to food. Aversion to any soothing mechanisms.  The most alarming was that her receptive and expressive language was affected.  She went from knowing 10+ different signs in Sign Language and communicating nonverbally effectively with us for months, to losing this ability the day of the shot.  At first we thought she still wasn't feeling well from the shots but this carried on with so much confusion on her end and it took months and lots of work for her to relearn all what she lost.  In the work I do, I had never seen a setback like this in a healthy child who only showed developmental progress until this time.   It was a major setback in her communication and learning.  Stopped communicating with caregivers nonverbally, despite knowing and performing Sign Language for months.  Would only do one sign and looked confused.
This spontaneous report as received from a consumer refers to a 56 year old female patient. The patient is allergic to latex. No pertinent history. On 03-FEB-2014 the patient was vaccinated with ZOSTAVAX (one single injection, dosing information and route were not provided). Concomitant therapies included CELEBREX and "many other unspecified medications". On 03-FEB-2014 the patient experienced "bumpy rash as big as a softball", fever and pain at the injection site. The patient reported that the pain is getting worse and has not yet gone away. The patient did not seek medical attention. No treatment was given. The outcome of "bumpy rash as big as a softball", fever and pain at the injection site was reported as not recovered/not resolved. The causal relationship was not provided. Additional information has been requested.
I've had 2 shots but still contacted Covid; I've had 2 shots but still contacted Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A "27 (units not provided)" male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I've had 2 shots but still contacted Covid".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site, Left deltoid,  got swollen right after the shot was given at 10:35am on  2/25/2022.  injection site started itching and progresses to her entire arm. after 10 minutes patient reported to have itchiness in the back of her throat. Patient assessed, vital signs checked, within normal limits.  BP: 116/75  HR:80  injection site was iced and patient was transferred to emergency department for further evaluation.
05/10/2022 I woke up with a mild sore throat that went away. That afternoon, it came back along with nasal congestion, cough and I felt feverish. The next day I talked to Dr. who prescribed Paxlovid and an albuterol inhaler. I had a SAT monitor at home which was reading 90-92 percent. I was feeling more feverish. I picked up the Paxlovid but did not take it. On 5/12/2022 I had 101.5 temperature and started taking the Paxlovid on 5/13/2022. I could not get rid of the fever. Even though I was eating, I was losing weight. I felt tremendously better about 12 hours after I started taking Paxlovid and my fever was gone. I followed the CDC guidelines for isolation. I have recovered except for a tiny cough and a little more fatigued than I usually am.
site of injection is hard; site of injection is itchy; site of injection is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (site of injection is hard), VACCINATION SITE PRURITUS (site of injection is itchy) and VACCINATION SITE ERYTHEMA (site of injection is red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE INDURATION (site of injection is hard), VACCINATION SITE PRURITUS (site of injection is itchy) and VACCINATION SITE ERYTHEMA (site of injection is red). On 30-Mar-2021, VACCINATION SITE INDURATION (site of injection is hard), VACCINATION SITE PRURITUS (site of injection is itchy) and VACCINATION SITE ERYTHEMA (site of injection is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
horseness; This spontaneous case was reported by a patient and describes the occurrence of DYSPHONIA (horseness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPHONIA (horseness). At the time of the report, DYSPHONIA (horseness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not provided by reporter, No concomitant medications were provided by reporter.   Reporter did not allow further contact
Fatigue, Headache, sore injection site as of 2/5/2021@1324 PST.
Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; This is a spontaneous report from a contactable Nurse reporting for herself. A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EJ1685, via an unspecified route of administration on 22Dec2020 08:00 as a single dose in the left arm  (Dose number: 1) for COVID-19 vaccination.  The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There were no other vaccines received by the patient within 4 weeks prior to the COVID-19 vaccine. Medical history included diagnosed with COVID-19 on an unknown date prior to vaccination. There were no allergies to medications, food, or other products. Concomitant medication included atorvastatin (ATORVASTATIN), ethinylestradiol, norgestimate (TRI LO MILI), and vitamin D2 (VITAMIN D2).  On 24Dec2020 at 16:00, the patient experienced swelling and redness an inch belowinjection site, tenderness, site was warm to touch, and commented "it's 4 days already after vaccination date" (as of reporting on 26Dec2020). There was no treatment received for the events. The clinical outcome of the events swelling and redness an inch below injection site, tenderness, and site was warm to touch was not recovered. The patient was not COVID tested post vaccination.
Possible breakthrough case of COVID-19.  Symptoms began April 21, dry occasionally productive cough, sneezing, fatigue, trouble concentrating, fever over 104F, extreme night sweats. Fever controlled with Advil, Tylenol had little effect. Fever subsided evening of April 26, after 24 hours unmedicated fever free ended quarantine.
Breakthrough case admission after 3 vaccines Moderna 3/19/21 Lot# 045A21A;  MOderna 4/16/21 Lot# 016B21A;  Moderna 12/20/21Lot# 064H21A
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with her third dose of GARDASIL (lot# not reported). Subsequently, "right after the vaccine was given", the patient "fainted, her vision went black and she had memory loss" for a few seconds after her third shot of GARDASIL. The physician reported that the patient had no symptoms after the first and second dose of GARDASIL (dates of vaccination not reported). Subsequently, on an unknown date the patient was considered to have recovered from fainting, vision going black and memory loss. Upon internal review, "vision going black" was considered to be an other important medical event. Additional information has been requested.
Large red( 6?) warm , sore and itchy area  just below the injection site on the upper right arm. Presented itself about 45 minutes after Moderna COVID-19 Vaccine EUA . Today is 03/05/2021 and area is smaller in size ( about 3? ) but still red, sore, warm and itchy. Treatment with Benadryl topical cream
lt arm red, warm, soreness area 4cm diameter according to mom who is RN;red for 6 days w/itching treated w/heat & APAP;
No adverse effects reported; one patient received one dose of PROQUAD via the intramuscular route in the left thigh.; This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's historical conditions, previous drug reactions, allergies, concurrent condition and concomitant medications were not provided.      On 29-JUL-2019, the patient received one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S003861 and expiration date 08-AUG-2020) ) and recombinant human albumin (rHA) by intramuscular routed (incorrect route of product administration ) in the left thigh; as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were not provided). No adverse effects reported.  Lot number and expiration date were reported in the source document. But, when entering the lot number in MARRS the system automatically auto-populated the correct expiration date, which sometimes  may differs from the expiration date reported by the source.
loss of taste; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), HEADACHE (Headache) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced AGEUSIA (loss of taste), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, AGEUSIA (loss of taste), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
He had the flu and was having trouble breathing. He also had a fever, chest pain, and a terrible cough. He was prescribed Tamiflu. Now his airway is restricted anytime there is inflammation. We are still dealing with this at this time.
This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 61-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 19th June 2018, the patient received SHINGRIX. On 20th June 2018, 1 days after receiving SHINGRIX, the patient experienced malaise, headache, fever, dizziness, nausea and vomiting. On an unknown date, the outcome of the malaise, headache, fever, dizziness, nausea and vomiting were recovered/resolved. It was unknown if the reporter considered the malaise, headache, fever, dizziness, nausea and vomiting to be related to SHINGRIX. Additional details were provided as follows: This case was reported to the physician. The patient was administered SHINGRIX in the left arm. The patient reported that the next day after a SHINGRIX dose, she experienced malaise, fever, nausea, vomiting, dizziness, and headache. The symptoms lasted about 72 hours and then improved.
SORENESS ON LEFT ARM, WERE VACCINATION WAS ADMINISTRATED, CAN'T LIFT LEFT ARM AND PAIN BEEN ON 4 WEEKS SINCE VACCINATION.
Information has been received from a physician via a company representative concerning a female (age not reported) who, on an unspecified date, was vaccinated with a first dose o Gardasil (Lot # not reported). The physician reporeted that after the first dose, the patient experienced nausea, diarrhea and vomiting. The physician also reported that after the second dose of Gardasil, the patient experienced a sore throat and swollen glands. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received their first dose of Moderna Covid-19 vaccine and experienced a sore arm.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to INC.-MOD-2021-069676 (E2B Linked Report).; Sender's Comments:   INC.-MOD-2021-069676:
Warm, erythematous, tender area 2-3 inches below injection site that is progressively spreading.
Fatigued, weak, and a dizzy feeling later on. I felt fatigued and a little dizzy. It was like my chest was hurting so to speak. I went into my doctors office several days later to check-in.
8-1-07 25 mm x 20 mm red, indurated, heat and painful at injection site with body aches, HA. 8-2-07 c/o nausea, dizziness, induration decreased, still red at inj site. 8-3-07 induration decreased 10 x 15 mm: erythema 25 x 20-same. Still dizzy; nausea off/on