chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOST 25 PERCENT HEARING OF LEFT EAR/DISABLED ON THE LEFT SIDE/HEARING PROBLEMS; INNER EAR PAIN; BALANCE AFFECTED; HUMMING IN EARS/EARS SENSITIVE; This spontaneous report received from a patient and concerned a 58 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 1805018 and expiry 21-NOV-2021) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On unspecified date in end of MAR-2021, the patient experienced hearing problems within few weeks of vaccination, Patient reported that his ears became sensitive, he had a little inner ear pain, he started fighting with neighbors about hearing their AC unit and called police and they measured the meter. The police said he should go to the doctor to check his hearing. Patient saw ENT (Ear Nose Throat) doctor because it comes and goes and affected his balance, test was performed, and ENT doctor sent him to the audiologist. Patient lost 25 percent of hearing in left ear. He reported that he hears a constant humming noise and was sensitive to noises. He said it was annoying. Patient reported that he was disabled on the left side and it messed up his balance. Some days it was bad, especially if humid or exposed to noise. Patient reported that it was like the noise under the water (dose number in series 1). The patient received Moderna booster vaccine (dose number in series 2), (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported for prophylactic vaccination. No adverse events were reported following administration of Moderna vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inner ear pain, balance affected, humming in ears/ears sensitive, and lost 25 percent hearing of left ear/disabled on the left side/hearing problems. This report was non serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Patient called with a blue/purple bruise; it started getting darker with time; no other symptoms; bruise is black now 10/17/19; recommended patient contact physician as well - no concerns on physician end
Redness at site of injection - soreness, itching next day - 8/3/11 2.5 cm x 5 cm - contacted 8/10/11 still some redness. Has not had chickenpox that she can remember.
Headache, Sedation, Myalgia, Arthralgia & Fever Narrative:  Other Relevant History:
I started with a sore throat & runny nose so i spoke with doctor on telehealth call & went to urgent care & tested positive for Covid-19.
Rash; Itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and PRURITUS (Itching) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 RASH (Rash) and PRURITUS (Itching). At the time of the report, RASH (Rash) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No Treatment medicines were reported.   This case was linked to MOD-2021-067700 (Patient Link).
Red spot on 3/10 at injection site. Edema and redness began on 3/11.
Beginning greater than 24 hours but less than 48 hours after injection, patient reports shoulder pain with extension across line from injection site to spine, severe muscle pain lasting greater than 5 days, weakness of affected limb.
Pfizer-BioNTech COVID-19 Vaccine EUA. 12 hours after vaccine experienced chills, fever, nausea, headache. 15 hours after vaccine vomited. Fever, chills and headache persisted from 12-32 hours after vaccination. Lymphadenopathy with considerable swelling and tenderness evident in ipsilateral axillary and supraclavicular lymph nodes.
First day (04/17/2021) = Redness (spread throughout the day),  Itching,  Swollen, Warm to the touch. Second day (04/17/2021) = Redness (covered more surface area than the day before), Itching, Warm to the touch, Not swollen but area around the injection site feels more "firm" than the rest of my arm and aching from my shoulder to my elbow.
Patient came back 3 days after vaccine administration with a rash/bruise at the injection site. Patient said the rash is painful and about 1 1/2" in radius. Patient was advised by M.D to use cold compress.
normal flu like symptoms of achiness starting at 2:20am however what I was not expecting and I think abnormal was a contraction every 5 to 25 seconds in either my vaginal canal or urethra canal. It work me up. It was not painful but just unsettling that it was a constant contraction every 5 to 25 seconds. It was strong enough to wake me up. It lasted until about 5am. I did get up once to go to the bathroom and the contractions stopped when I was moving but resumed when I went back to bed. After I fell back asleep, I woke up and the contractions stopped and my aches also were almost gone. It is now 2:18 pm and the contractions never came back. I have never felt this sensation before and found it to be odd, disruptive to my sleep and unsettling.
Received vaccine on 10/22/07, next day complained of severe headache, ears felt blocked, nausea and vomiting.
Five days after first dose, my 10 year old daughter is having up to 15 ice pick headaches a day. Cleared by neuro but clearly vaccine related. Please advise and look into this.
diffuse erythematous macular papular rash 2 days p/vax;also fever to 103.8;
The day after I got the shingles shot, I experience severe pain in my right hip.  This lasted for a few days and then I got a very painful shingles rash on my right hip.  This lasted for 3 weeks.
Patient presented to the clinic c/o right arm soreness,  pain,  and weakness after Janssen vaccine, decreased RUE ROM, headaches, fatigue, weakness, nausea, vomiting x 1 episode, dizziness. Pt was recommended to have a COVID test on 04/15/2021 and resulted negative
ADACEL given 2/24/11 approximately 1pm; right arm pain (swelling, soreness) starting Friday. Rash (morbilliform) on right deltoid, biceps area. Fever over weekend. Complained of neck pain & stiffness.
Initial unsolicited case received from a nurse on 31 Oct 2017. This case is linked with the cases 2017SA214850, 2017SA214851, 2017SA214853, 2017SA214841 same reporter. This case involves a female patient (age reported as from 30 years to 90 years who was vaccinated with 0.5 ml one dose of FLUZONE QUADRIVALENT (Batch number: UT5899LA, expiry date, dose in series and site of administration were not reported) via intramuscular route on an unknown date. Patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe arm pain and arm pain was so severe that it was difficult to the patient to move her arm. Relevant lab tests were not reported. As a corrective treatment the patient received TYLENOL which did not help reduce the pain and was also given oxycodone. As of 31 Oct 2017, the outcome of the events was reported as recovering. List of documents held by sender: none.
Obesity, impaired fasting glucose, chronic low back, elevated liver function tests, health maintenance, osteoarthrosis, fibromyalgia, acute gastritis, burning sensation (chest), depression, Acid reflux, bone ache, joints ache, loss of concentration, high cholesterol, low hemoglobin, low hematocrit, low MCV, low MCH, low PLT, hair loss, headaches, memory bad, anxious, angry, irritable, pain legs back knee, Charlie horse, insomnia, weight gain, allergies.
Information has been received from a health professional concerning an adolescent female who in 1995 was vaccianted with a dose of varicella virus vaccine live. On 5/25/2005 the patient presented with chickenpox with more than 50 vesicular lesions. She was treated with OTC calamine lotion. No product quality complaint was involved. No other information was provided. The patients brother experienced chicken pox following vaccination with varicella virus vaccine live (WAES0505USA03010). Additional information has been requested.
Vaccine was administered on 5/12 in the right deltoid muscle. Pt reports that on 5/15 she had a large bump at the vaccine site that was slightly red and warm to touch. On 5/18 Pt reports that the bump decreased in size and the redness increased. On 5/19 Pt presented to clinic with a red, warm to touch area 2.5 in X 2.0 in at the injection site. At the center of the area was a white circular area, 0.5 in diameter, that was a hard bump with palpation. Pt denied any pain at the injection site and stated "it is more itchy that painful". The red area was outlined in pen. Per the Pt the redness did not go outside on the pen outline. On 5/23 the Pt presented to the clinic for a another recheck. The injection site was no longer red, with palpation the bump decreased in size to approximately 0.4 mm.
pt recvd vax & pt reported that an elongated brown 6-7 inc spot devel @ the inject site; reaction abated w/in 1 wk;
HX OF MELANOMA R ARM REMOVAL ALONG WITH LYMPHNODES , LEFT ARM WITH LOTS OF SCAR TISSUES, AND REQUESTED FOR INJECTION IN L THIGH. VACCINE GIVEN IN L THIGH AS REQUESTED.
Day 5 after injection:  Pain in armpit area Day 7 after injection:  itchy, reddness, swollen area around injection site.  Day 8 after injection:  Reddness around injection site grew to about 3-4 inches down arm.  Pain diminishing in armpit area/almost gone Treating with benadryl and tylenol.
Patient reported he felt dizzy and had mouth/tongue numbness and tingling. HR 130's, RR 25, o2 sat 100%. Patient then laid himself on floor and was in and out of consciousness. He maintained pulse and breathing. Patient taken to Emergency Room. He appeared to have 3 syncopal episodes while in route to Emergency Room. In the ER, symptoms resolved. Patient denied anxiety deteremined to be vasovagal response.
Patient presented to the ED on 3/9/2021 for post-surgery pain. The patient was not admitted. Per EUA, all hospitalizations/ED visits must be reported after a recently receiving a vaccine. This ED visit does not seem related to the vaccine.
p/vax pt became dizzy,  hot, sweaty approx 1/2hr p/vax;c/o pain @ inj site that radiated down to inner aspect of arm;to ER;
Several hours after my shot ( Wednesday Apr 7 )I started to feel very nauseous, it lasted until Saturday Apr 10 , Friday I woke up with back pain ( I thought it was just from swimming all day) but as the day went own it became worse , to the point I couldn?t even walk , I drove home from work in tears thinking I did something to my back, after calling a doctor through my insurance company they advised me it was ? just ? a side effect of my vaccine and it could last up to two weeks.  Also on Saturday Apr 10 in the evening I started to itch all over my neck and left arm/shoulder and when I looked in the mirror I had small bumps everywhere ( that I still have today , but looks to going away slowly.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 2, single (Batch/Lot number: unknown), on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 29Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Indication: Covid-19 immunization; (07Jun2022) Positive, notes: Tested positive for COVID19 with an at home rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Anti-viral details included product for COVID 19 Treatment (Brand: Pfizer), treatment start date was on 24May2022 and treatment stop date was on 29May2022. Tested positive for COVID19 with an at home rapid antigen test because I woke with a headache, stuffy nose and laryngitis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
14 year old daughter took her shot today; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old daughter took her shot today) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old daughter took her shot today). On 01-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old daughter took her shot today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
Fever, body aches, nausea/vomiting beginning six hours after SHINGRIX administration.
sore left arm; body aches; headache; fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore left arm), MYALGIA (body aches), HEADACHE (headache) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A, 001C21A, 039C21A and 033K21-2A) for COVID-19 prophylaxis.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Dysequilibrium, Autoimmune disorder (Autoimmune disorder after being bitten by a Deer tick in 2005.) since 2005, Lyme disease (Lyme Disease with MS symptoms) and Blood pressure abnormal (on Blood Pressure Medication).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore left arm), MYALGIA (body aches), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore left arm) and MYALGIA (body aches) outcome was unknown and HEADACHE (headache) and FATIGUE (fatigue) was resolving.            Patient was on unspecified blood pressure medication. Patient had a sore left arm, body aches, headache, and fatigue after first, second, third and fourth doses of the Moderna vaccine. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-744170 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744170:PFS case
Swelling in lips/face difficult to breath from nose and rash.  Mother treated with BENADRYL, swelling went down.  No breathing problems.  No more rash.
Cellulitis- treated with Avelax and Omnicef-resolved after 6 days
itching, redness, and burning of left arm given Benadryl 25mg PO x 1 and symptoms resolved within 10-15 minutes
The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023; No adverse event; Pharmacist states they administered the Moderna bivalent 2 days after the 30-day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist states they administered the Moderna bivalent 2 days after the 30-day BUD), PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: COVID-19 Vaccine Moderna on 27-Sep-2021. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine Moderna.    On 16-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 16-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist states they administered the Moderna bivalent 2 days after the 30-day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist states they administered the Moderna bivalent 2 days after the 30-day BUD), PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist states they administered the Moderna bivalent 2 days after the 30-day BUD) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 14-Jul-2023. The vial did not undergo temperature excursions.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737983 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737983:Same Reporter
1st dose 2011, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 48-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose back in 2011).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments: The registered pharmacist reported that the patient never finished series of Twinrix (nnever received 2nd and 3rd doses). The reporter inquired for Twinrix, did the patient need to restart series, or any guidance on administering 2nd and 3rd doses. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Same evening after vaccination began with red area around injection site. On 2/10/12 area was larger - redder and warm to touch. Diagnosed with cellulitis and treated with KEFLEX.
Nurse gave undiluted pediatric Pfizer vaccine. 0.2 ml. Child had no immediate reaction. Notified medical director and parent. Advised to given ibuprofen and contact facility or PCP if any adverse reaction occurs.
Confirmed case of covid 19; Confirmed case of covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 1, single (Lot number: FE3590) and in Dec2021 as dose 2, single (Lot number: FH8027) at the age of 13 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination. Covid tested post vaccination was reported as yes. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Confirmed case of covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive.  No follow-up attempts are possible. No further information is expected.
DAD STATES PATIENT DEVELOPED RASH AROUND NECK AND MOUTH APPROXIMATELY 7-8 HOURS AFTER RECEIVING SHOT.  HE ISSUED BENADRYL. PATIENT HAS HAD REOCCURING RASH ALL WEEK BUT IT IS SUBSIDING AND GETTING SMALLER.  BENADRYL HAS BEEN GIVEN ABOUT 2-3 TIMES THIS WEEK.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Shingrix (batch number DD43M, expiry date March 2019) for prophylaxis. On 8th September 2018, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 8th September 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 9th September 2018, the patient experienced injection site erythema. On 11th September 2018, the outcome of the injection site erythema was recovered/resolved. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema to be related to Shingrix. Additional details were reported as follows: The healthcare professional stated the patient was inadvertently administered Shingrix vaccine subcutaneously instead of the indicated intramuscular, which led to incorrect route of vaccine administration. A red injection site reaction developed the day after vaccination. This case has been linked with US2018165485, reported by same reporter.