chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy; arm is red; 3 knots behind her neck; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchy), ERYTHEMA (arm is red) and NECK MASS (3 knots behind her neck) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 01-Apr-2021, the patient experienced PRURITUS (itchy), ERYTHEMA (arm is red) and NECK MASS (3 knots behind her neck). At the time of the report, PRURITUS (itchy), ERYTHEMA (arm is red) and NECK MASS (3 knots behind her neck) outcome was unknown. Not Provided          No concomitant and treatment medicine has been reported by reporter   This case was linked to US-MODERNATX, INC.-MOD-2021-079282 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079282:Case for first dose
Classic "COVID Arm": Red, raised welt, about 4" diameter, itchy. Presented exactly one week after shot.
He had the same issue; lower back pain problem; This is a spontaneous report from a contactable consumer (patient's brother). A male patient of an unspecified age received first dose of bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced he had the same issue, lower back pain problem on an unspecified date. Last week in the process of to get his pants over his mother's house and his brother was already in there and he has had both shots and they asked him if he had any back problem or anything was going on and he had the same issue but he didn't ask his wife because she got same shot. He spoke to his brother if he had done that and he had the same we are just talking about this and when they asked him at facility when he went to the second one, if he had any lower back pain problem and he said yes, so, they matched that he was having issues with his back so it's a possibility that it was due to the shot but was fine. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
POST VACCINE, PT REPORTED DIZZINESS, FELT LIKE SHE WAS GOING TO PASS OUT. BROUGHT TO OBS AND PLACED IN TRENDELENBERG, REPORTS RELIEF AFTER 10 MINS. VSS THROUGHOUT OBSERVATION. PER ON SITE MD, PT EXPERIENCED CLASSIC NON SYNCOPAL VASOVAGAL RESPONSE-RELIEVED. ESCORTED TO EXIT WITH NO ISSUES AT 1035. 1020 INITIAL BP 124/70 HR 70 SATS 100% RA 1030 SITTING BP 141/71 HR 74 SATS 99% ON RA 1035 STANDING BP 138/76 HR 80 SATS 98% RA
4 hours after administration patent experienced chills, nausea, shortness of breath, and pain arm. Symptoms cleared up within 5 hours and did not require medical attention.
Information has been received from a consumer concerning her 7 year old white daughter with no past medical history who on 04-Sep-1997 was vaccinated with a first dose in the left thigh (lot 622748/0422EE) of varicella virus vaccine live. It was also reported that the patient "had prior Varivax 9/1/1996". Concomitant therapy included multi-vitamins (unspecified). On 17-Dec-2003 the patient broke out in a varicella rash. On the morning of 18-Dec-2003 the mother counted about 35 chicken pox lesions. The child's doctor prescribed acyclovir for treatment. No product quality complaint was involved. Follow up information from a physician indicated that the patient had a mild rash consistent with varicella and that the patient recovered. No labs or diagnostic tests were done. Additional information has been requested.
Narrative:  COVID infection following COVID vaccine series 04/27, Pfizer, dose #1 05/18, Pfizer, dose #2 12/16 COVID swab, result: not detected 1/10 COVID swab, result: detected 1/10 pt cc: exposure: unknown
Cold Sore outbreak on lip. The last one I had was over 5 years ago. Then I had an outbreak 2 days after receiving the 1st Pfizer dose. I took Valtrex for the following 4 days to keep it at bay.
myo/pericarditis beginning Tuesday, 10/26 upon waking.   Left chest pain, midclavicular line around 4th-6th intercostal spaces, ~6-7/10 when moving, 0/10 when stationary. Pain increases when laying down.   ibuprofen PRN
Systemic: Dizziness / Lightheadness-Severe, Systemic: patient described altered taste and rapid heart rate and vision blurriness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: pt requested an ambulance due to altered vision - the patient did not exhibit symptoms that warranted benadryl or epinephrine
Pain and swelling in knees; Pain and swelling in knees; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 12Feb2021 a 12:00 PM (at the age of 65 years), as dose 1, single, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included estradiol (ESTROGEN), progesterone, esomeprazole magnesium (NEXIUM), and hyaluronate sodium (HYALURONIC) on 15Feb2021. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a doctor's office or urgent care facility. On 18Feb2021, the patient experienced pain and swelling in knees after receiving hyaluronic gel injections 3 days after vaccination. The events resulted in physician office visit. Treatment to the events included ibuprofen and cold compress. The patient has not been tested for COVID-19 post vaccination. The patient had not recovered from the events.  No follow-up attempts are required; information about lot or batch number cannot be obtained. No further information is expected.
Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 26 year old (also reported as 24 year old) female with no known allergy and Paroxysmal supraventricular tachycardia who on 29-AUG-2008 was vaccinated IM with a first dose of RECOMBIVAX HB vaccine 0.5 ML lot# 660951/0399X. On 29-SEP-2008 the patient received IM at 10:30 AM into left deltoid her second dose of RECOMBIVAX HB vaccine lot # 660951/0399X. Concomitant therapy included digoxin. In follow up report from the doctor's office it was reported that on 01-OCT-2008 (previously reported as on 30-SEP-2008) at 10:00 AM the patient developed flu-like symptoms after getting the second vaccination. Her upper left arm became swollen, red, hard, and warm. She also had pain at left deltoid site few days after the vaccination. She also experienced facial flushing. On 04-OCT-2008 patient recovered. No additional information was provided.
Bilateral foot warts (plantar warts) resolved; HPV vaccine for bilateral foot warts (plantar warts); .  This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 53 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, laser (PDL), sqaric acid, candida albicans, cimetidine, zinc (unspecified) and cidofovir. The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for bilateral foot warts (plantar warts) (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   On an unspecified date, the bilateral foot warts (plantar warts) resolved (drug effective for unapproved indication).   The patient's immune status was reported as none. The patient was followed up for treatment for 7 months.  The outcome of drug effective for unapproved indication was unknown.   The causal relationship between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.   Follow-up information was received via telephone call on 02-APR-2020.  A request was made for patient identifiers, events experienced and causal relationships.; Sender's Comments:  US-009507513-1912USA001729:
INTERNAL ITCHINESS; MILD CHILLS; FATIGUE; This spontaneous report received from a consumer concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. 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 09-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced fatigue. On 23-APR-2021, the subject experienced internal itchiness. On 23-APR-2021, the subject experienced mild chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 11-APR-2021, and was recovering from internal itchiness, and mild chills. This report was non-serious.
Pt recvd vax & later same day devel hives; also devel pruritus; skin involved became warm, then erythematous, then hives & itching occurred;Epstein-barr virus titer was sl elevated @ 180; localized heat followed by erythematous rash;
Right thigh with immediate 3cm erythema, warmth surrounding injection site, 1cm x .5cm white raised blob just distal to injection site. Child given 12.5mg Benadryl liquid. Within 20 minutes, erythema decreased but not resolved, no respiratory difficulties. Afebrile, able to move all extremities.
Patient had autoimmune appearing reaction with rash, iridocyclitis, DVT right femoral vein, thrombocytopenia, lymphadenopathy, aphthous ulcers, pharynigitis rheaumatology consultation, anticoagulation, ophthalmology care, hematology consultation, ENT consultation
He has been screaming and crying in his sleep.  Tossing and turning all night, not sleeping well at all.  He's upset, irritable and inconsolable.  He seems to have lost much of his appetite and is refusing food and milk.
THE NIGHT OF THE VACCINES, MOM STATES THAT THE PATIENT'S L THIGH BEGAN TO HAVE A REACTION. PT SEEN IN OUR URGENT CARE CLINIC ON 9/28: Left anterior thigh: moderate erythema approximately 6cm x 4cm with mild warmth and minimal induration without fluctuance; non-tender.
woke up with significant tinnitus in my right ear; woke up with tinnitus in right ear. Over the course of next day it went away from right but it still lingered overall and was aggravated. The days following, tinnitus settled back in left but is at the same aggravated levels it was back in 2014; the left ear feels stuffed up as do my sinuses; mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 07Apr2021 at 09:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included benign prostatic hyperplasia, mild tinnitus since 2014 and allergy to sulpha. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included silodosin (MANUFACTURER UNKNOWN) 8mg per day, for an unknown indication from an unknown date and unknown if ongoing. The patient previously received influenza vaccine (MANUFACTURER UNKNOWN) in the left arm on an unknown date for immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that he had mild tinnitus in left ear since 2014. The onset of that had coincided with a flu shot he had taken then on the left arm. Since then, the tinnitus had subsided to a tolerable level. On 07Apr2021, the patient experienced mild fatigue. He was fine through the day. On 08Apr2021 at 03:00, that night the patient woke up with significant tinnitus in his right ear. Over the course of the next day, it went away from the right ear but it still lingered overall and was aggravated. The days following, the tinnitus settled back in the left ear but is at the same aggravated levels it was back in 2014 and also the patient experienced the left ear feels stuffed up as do his sinuses. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild fatigue, significant tinnitus in right ear. Over the course of the next day, it went away from the right ear but it still lingered overall and was aggravated. The days following, the tinnitus settled back in the left ear but is at the same aggravated levels it was back in 2014 and left ear feels stuffed up as do his sinuses was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pfizer 3/15/21, 4/5/21. Positive on 1/29/22
New onset joint pain to distal joints (wrists, ankles); This is a spontaneous report from a contactable physician (patient). This 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscular, administered in Arm Left on 13Jan2021 14:00 (at the age of 25-year-old) (Batch/Lot Number: EK5730) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included Congenital spinal stenosis causing RUE pain and headache. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3246) on 22Dec2020 at 15:30 intramuscular in the left arm for COVID-19 immunisation; the patient was allergic to ranitidine hydrochloride (ZANTAC) and povidone iodine (BETADINE). Concomitant medications included gabapentin taken for an unspecified indication, start and stop date were not reported and ibuprofen, start and stop date were not reported, intermittent for headache. In Jan2021, the patient experienced new onset joint pain to distal joints (wrists, ankles), lasting almost 1 month since vaccination. Corrective treatments included OTC pain medication. The patient did not have COVID-19 prior to vaccination; the patient underwent nasal swab in Jan2021 with negative result. The patient had not recovered from the event.
Body aches, low gr. temp. aches into her buttocks area down back of post. thighs. She did have Covid infection in Sept 2020. Meds admin - NaCl 0.9% I.V. bolus. 500 ml. Tyl. + Hydrocodone 650/25 - Labs - UA. lactic acid, SARS antigen, BMP, CBC, CXR - revealed pneumonia - F/U with family practice on Monday. In addition to above - numbness from waist down to toes, loss of bowel + bladder. T-102.F. Unable to walk - this lasted for 17 hrs.
pt recv vax -soreness in arm & sl coughing woke up next day extremely ill-coughing;sneezing, flu sx, fever, chest congested, nasal congestion, very ill;
Got the shot still got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In JAN-2023, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient. A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 at 08:00 as dose 1, single (Lot number: EH9099), in left arm, on 08Jan2021 at 07:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Oct2021 at 14:00 as dose 3 (booster), single (Lot number: EL1284) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diverticulitis" (unspecified if ongoing), notes: other medical history: Diverticulitis; "childhood asthma" (unspecified if ongoing), notes: other medical history: childhood asthma. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jul2022) Positive, notes: Positive Covid test on 5th day after finishing Paxlovid; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included treatment with Paxlovid from 18Jul2022 to 21Jul2022. Patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.
Pain at the injection site lasted for 4 weeks.  Since the date of 1st dose I still continue to have residual pain of the entire left arm.  Pain is with rotation of the left arm especially rotation behind my back.  Some pain reaching above also.   Pain is worse at night.  Aching pain is constant.   I received my 2nd dose in my right arm with no side effects.
Heart pain and palpitations/flutter later that evening when I went to bed.  less severe fluttering and funny feeling in heart from time to time since then.  Today most severe and pro-longed heart fluttering since the night of the third vaccination shot.
Two weeks post vax, "fever and flat rash on body that comes and goes." Fever lasted 243 hours. Rash continued for 3 days. No other symptoms.
I started having symptoms on 10/30/2021 morning, I had slight fever, sniffles and some what fatigue for part of the day.
12/16 EVENING OF VACCINE, VERY SORE SHOULDER. LASTED 24 HOURS.  12/17 - 12/19 VERY FATIGUE, ACHY JOINTS.
4/28/21 Mom called to report that Patient received Pfizer covid vaccine on 4/10/21- approximately 4/12-4/13 patient noticed a rash on his feet and started to spread up to face. Mom reported she noticed bruising all over his arms approximately 6 between both arms. Patient was evaluated via virtual system 4/29/21 Patient denies  fever, congestion, sore throat, joint pain, headache, itchiness, or pain. Rash not raised, smooth to touch Labs ordered 4/30/21
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 22-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 9 September 2014, the subject received a dose of BOOSTRIX (intramuscular, administration site unknown). Her last menstrual period was on 24 December 2013 and estimated date of delivery on 10 October 2014. The subject was exposed to the vaccine during the third timester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 06 October 2014 from nurse: The VAERS details were provided. Some of the patient's details were updated. This has a normal conception pregnancy. Follow-up information received on 06 January 2015 from nurse: Concurrent medical conditinos included pollen allergy (z-pak). This was a normal conception. The subject received dTpa vaccine at week 35 4/7 of the pregnancy and during the third trimester of pregnancy. On 4th Octobet 2014 after 39 weeks, the subject gave birth to a [gender unknown] neonate via vaginal delivery. The pregnancy resulted in a live neonate with no apparent congenital anomaly. The neonate weighed 3900 grams (8lbs 10oz) at birth. The length, head circumference and Apgar score were unknown.
Sore throat/swollen glands started a week after receiving the COVID-19 vaccine. Swollen glands have been persistent for the past 3 days and have not improved at all.
Within 30 minutes after vaccine administration, patient become sweaty, felt like his heart rate and BP were elevated.  He was brought to Urgent Care where he was monitored  Rested and remained stable for 20 minutes.