chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had shingles / Suspected vaccination failure; I had shingles; got to were I couldn't walk; 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. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had shingles) and unable to walk (Verbatim: got to were I couldn't walk). The outcome of the vaccination failure was unknown and the outcome of the shingles and unable to walk were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and unable to walk to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and unable to walk to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-Jul-2023 This case was reported the patient via interactive digital media. The patient had already the shots. The patient had Shingles and got to were he/she could not walk. The patient asked to get the shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
This case was reported by a consumer via call center representative and described the occurrence of myoclonic jerks in a 59-year-old female patient who received Rabies vaccine. Previously administered products sulfa drugs with an associated reaction of urticarial (sulfa antibiotics caused hives). Concurrent medical conditions included arthritis. Concomitant products included CLARITIM, COREG, PREVACID and Cranberry pills. On 15th September 2015, the patient received Rabies vaccine. On an unknown date, less than a year after receiving Rabies vaccine, the patient experienced myoclonic jerks, anxiety, crawling sensation, neck swelling, neck pain, feeling abnormal and muscle twitching. Rabies vaccine was continued with no change. On an unknown date, the outcome of the myoclonic jerks, crawling sensation, neck swelling, neck pain, feeling abnormal and muscle twitching were unknown. It was unknown if the reporter considered the myoclonic jerks, anxiety, crawling sensation, neck swelling, neck pain, feeling abnormal and muscle twitching to be related to Rabies vaccine. Additional information was provided as follows: The patient was not actually bitten by a bat in her home. Her condition was getting worse. The patient was given 5 injection, but the physician was not sure what all 5 injections were and reported that she may have gotten a split dose of the RABAVERT and the HRIG with doses in both shoulders, both thighs and 1 shot in the buttocks.
What appeared to be blood blisters- one an inch from the injection site, and 4-5 more on back. Hives/rash on face, neck, and back. Sore throat, bloody noses (only when blowing nose), as well as the expected side effects- fever, headache, extreme joint pain.
COVID-19; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: TDAP (Route IM and Lot E55XZ) on 05-May-2021. Past adverse reactions to the above products included No adverse event with TDAP. Concurrent medical conditions included Drug allergy (Propofol). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) from 16-Oct-2020 to an unknown date for Allergy, CELECOXIB (CELEXA [CELECOXIB]) for Insomnia, VITAMIN C [ASCORBIC ACID] from 01-Feb-2022 to an unknown date, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 29-Dec-2020 to an unknown date and CENTRUM SILVER +50 from 14-Oct-2020 to an unknown date for Supplementation therapy.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2022, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On 21-Jan-2022, DRUG INEFFECTIVE (Lack of drug effect) had resolved. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.  Company comment: This is case of drug ineffective for this 53-year-old male patient with no relevant medical history, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 which occurred approximately 8 months after the administration of second dose. SARS-CoV-2 test result was positive; no further details regarding clinical course or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-503784 (Patient Link).; Sender's Comments: This is case of drug ineffective for this 53-year-old male patient with no relevant medical history, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 which occurred approximately 8 months after the administration of second dose. SARS-CoV-2 test result was positive; no further details regarding clinical course or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Taste buds are off; Feeling dizzy; Similar side effects as mine; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Taste buds are off), DIZZINESS (Feeling dizzy) and VACCINATION COMPLICATION (Similar side effects as mine) in a female patient of an unknown age 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 AGEUSIA (Taste buds are off), DIZZINESS (Feeling dizzy) and VACCINATION COMPLICATION (Similar side effects as mine). At the time of the report, AGEUSIA (Taste buds are off), DIZZINESS (Feeling dizzy) and VACCINATION COMPLICATION (Similar side effects as mine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Translation document received on 11-Sep-2021 contains no new information.
Within 2 minutes of getting my first dose of the Pfizer vaccine, my tongue became itchy and swollen, and my eyes became itchy.  I did not have trouble breathing .  The symptoms lasted most of the day and were gone by the next morning.  I did not experience similar symptoms after the second dose but got a bad headache  within 12 hours after the second dose.
About eight hours after vaccine administration, at about 4:00 AM, patient experienced sensation of throat constriction and inability to breathe deeply.  His voice was hoarse. He also complained of pain at the back of his neck and tightness at the base of the front of his neck and throat.  He was occasionally dizzy, especially on standing and walking.  He took 600mg ibuprofen and 25mg Benadryl at 5:00 AM.  This partially relieved symptoms, but drinking and eating were still uncomfortable.  At 11:00 he took another 25mg Benadryl, and was able to tolerate a dental exam.  At 3:00PM, he called his Primary Physician to report symptoms, and was instructed to go to the emergency room.  At the ED, he had continued symptoms of dizziness and throat tightness. He had blood drawn for CMP (all values within normal ranges  ), and had a light scope of the throat, which found no inflammation or obstruction. After administration of 1000mL of NSS per IV, he was discharged to home with instructions for care of sore throat, which was not one of his complaints.
Rt arm became very swollen, red, warm, very painful from below injection site to wrist.
Fever, chills, sweats, sore throat, body aches, stuffy head, and extremely weak.  Ate chicken noodle soup and took Tylenol on 11/7/2011.  Next day, 11/8/2011, still with fever, chills, and sweats.  Body pain, sore throat, very weak.  Took Thera Flu around the clock, ate popcicles and drink gingerale. Took Ibuprofen that night for extreme sore throat and stuffy head with headache. On 11/9/2011, felt better. Still took Thera Flu and Ibuprofen. Body aches and stuffy head.  Began to have a cough.
Nurse was administering a Covid booster to patient in his right deltoid. Just as she was finishing, there was a very clear snap sound and as I pulled back, the needle had broken clean off of the syringe. It was far enough into his arm that the provider decided to send him to the ED for further evaluation. The syringe used was VanishPoint Lot# G210415.
Started with difficulty breathing at 6pm.  by bedtime was having chills.  had joint stiffness starting about midnight.  By 6am, had diarrhea.  Had congestion in chest with large amt of mucus in lungs that continued until present.
I had a rash from my shoulder to my elbow, That called it Moderna arm. It was raised and bright red, it took two weeks for it to fade.
Parents came made appt for 3 persons and came in and received the shots after filling the paper works. They did not disclose that their son was not 18 years. After the paperwork was being data entered, we realized he was not yet 18 yrs. We contacted parents and verified that patient was doing ok with the 1 dose of moderna the following day of the shot.
Due to prior allergy history consisting of anaphylactic reaction to oxycodone, this patient was required to be observed for a minimum of 30 minutes post-vaccination. During that observation period the patient reported difficulty swallowing and the feeling that her throat was swelling. Emergency Department staff were notified, and following evaluation, decided to administer Epipen 0.3 mg IM, diphenhydramine, famotidine, and methylprednisolone.
Seen for well visit Friday and got HIB and PREVNAR, Friday night developed rash over body-has gotten progressively worse since Friday, seems itchy per day, no fever, no runny nose, no cough, no other symptoms, no new foods, not on any abx.
Nausea, headache, body aches that worsened as the day progressed.
got really sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick). At the time of the report, ILLNESS (got really sick) outcome was unknown.            Concomitant medication use was not provided by reporter. Treatment medication use was not provided by reporter. "My daughter and son-in-law both got really sick after the second vaccine does my husband and myself did not have any side effects does that mean the vaccine will not work" this was reported by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: No specific follow-up information recorded.
Patient received the first Pfizer shot on 8/4/21 the second was on 8/25/21. On 9/25/21 a seizure took place. Patient has NO history of seizures. On 10/23/21 patient had second seizure. The first seizure witnesses stated that she went into a swimming pool and then started seizing. The second seizure patient was at her birthday party at a bowling alley and mom noticed patient sitting down with her head turned over her right shoulder. Mom shouted patients name several times (no response from patient) and mom walked over to see patient, and eyes pulled over to the side. Patient's body started seizing, eyes rolled, patient making noises and foam coming out. This lasted about 1 1/2 minutes. Paramedics were called and patient was taken to Hospital and was kept under observation. Patient once again has no history of seizures and has always been healthy.  Notes: the first seizure on 09/25/21 was in the PM. Second seizure on 10/23/21 was in the PM.  Patient has an EEG scheduled on 11/2/21.
Pt awoke at 2 AM with swelling and itching on (R) shoulder, arm, and hand. Went to ER, received fluids and Benadryl.
hot to touch at injection site; itchy/area is a little itchy, red; a red mark at the injection site/red between 1 to 2 inches in diameter; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE PRURITUS (itchy/area is a little itchy, red), VACCINATION SITE PAIN (Pain in arm) and VACCINATION SITE ERYTHEMA (a red mark at the injection site/red between 1 to 2 inches in diameter) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE PAIN (Pain in arm). On 10-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE PRURITUS (itchy/area is a little itchy, red) and VACCINATION SITE ERYTHEMA (a red mark at the injection site/red between 1 to 2 inches in diameter). At the time of the report, VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE PRURITUS (itchy/area is a little itchy, red), VACCINATION SITE PAIN (Pain in arm) and VACCINATION SITE ERYTHEMA (a red mark at the injection site/red between 1 to 2 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.   Treatment information was not provided.
On the evening of my appointment around 7pm, I experienced fatigue and achiness. During my sleep, I had insomnia and very strange dreams - the achiness continued and progressed. In the morning of May 8 around 6am I got out of bed because I could no longer lay still. Around 7am nausea set in and I began vomiting. This lasted until about 11am. I remained in bed most of the day with body aches and fatigue. I did not eat anything until May 9 at 12:30pm. The evening of May 8 I slept well and woke up feeling OK - the achiness had subsided. As the day progressed, I mentally went downhill and became very foggy. The evening of May 9 I had strange dreams and hallucinations. May 10 the aches have subsided but mentally I'm very foggy.
Tested negative after 5 days on treatment. Now testing positive a week later; Tested negative after 5 days on treatment. Now testing positive a week later; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 19Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22May2022, outcome "not recovered" and all described as "Tested negative after 5 days on treatment. Now testing positive a week later". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were not taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalized for dyspnea, cough, fatigue, chills, and nasal congestion
2 weeks after second dose began experiencing continuous itchiness over most of my body and it still continues today; This is a spontaneous report from a contactable consumer, the patient. A 87-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266,) via an unspecified route of administration in the left arm on 16Feb2021 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (reported as high blood pressure). The patient did not have allergy to any medications, food, or other products. Concomitant medications taken within two weeks prior to the vaccination included lorazepam 1 milligram (MANUFACTURER UNKNOWN) up to four times per day and hydrochlorothiazide 6.25 milligram, bisoprolol fumarate 2.5 milligram (BISOPROLOL FUMARATE & HCTZ) one and a half per day; both from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267) via an unspecified route of administration in the left arm on 26Jan2021 at 09:30 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, two weeks after second dose, the patient  began experiencing continuous itchiness over most of her body and it still continued on the day of report. The patient reported she had been using the following medications for many years with no side effects: lorazepam 1 milligram up to four times per day., and bisoprololfumarate/ HCTZ tab 2.5/6.25 milligram, one and a half per day. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. The clinical outcome of the event two weeks after second dose began experiencing continuous itchiness over most of body and it still continued on the day of report was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Headache, Myalgia & NauseaVomiting  Narrative:  Other Relevant History:
Left arm swollen around injection site of ZOSTAVAX. She reported rash at different part of body the day after getting the vaccine. The upper arm was red, swollen and warm to touch on 12/12/15. Patient said the swelling has been going down steadily. She is using BENADRYL.
pt recv vax;crying immed p/ inject then turned blue approx 10 sec;CPR started,respiration returned;P 100;color pale;apnea monitor applied by MD;
Onset of high pitched inconsolable crying x several hours. No fever. No irritation at injection sites.
three weeks after first dose: extreme fatigue, brain fog,  inability to focus, confusion, dizziness, vertigo, headaches, blurred vision, sensitivity to light, loss of appetite, nausea, stiffness in back of the neck, tingling fingers and toes. Symptoms progressed in severity from Monday Oct 11 onwards with a peak on October 16th and 17th. Symptoms mostly faded by the 18th but continue to linger.
On the 4th day after the Moderna booster I woke up with a large bruise at the top of my left wrist.
Went in to check out patient, saw a swollen weal where MMR was given. Notified provider. Provider ordered .5 ml of Childrens BENADRYL and we put allergy itch relief cream on . Observed patient for 15 more min's. Advised. Left.
After receiving vaccine pt complained of blurred/black vision nausea 12/10/10 pt mother called to say pt experiencing back pain and site of injection pain.
pt recvd vax 11AM on 14APR92 & noted fine rash on face & rest of body @ 10PM 14APR92; also had puffy eyes; temp not taken; went to ER on 15APR PM given DPH;
10/29/18, two weeks after vaccination, patient contacted us to say that his arm was still sore and hurting. He noted that the injection was given towards the middle of the bicep, it was not higher or lower than others. Stating Bicep and shoulder soreness and he had visited his primary care. Name of physician not given to us.
This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot # N000326, expiry date: 14-OCT-2019; lot number: N004799, expiry date: 30-JUL-2018) for prophylaxis. Dosing details and route of administration were not reported. No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of -1°C or colder (-1C) for 11 hours 29 minutes. No previous temperature excursion were reported. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA006090: US-009507513-1708USA005593: US-009507513-1708USA006091: US-009507513-1708USA006088.
Started with a headache within 7 hours.  Woke up at 3 am on the 5th, within 15 hours with a terrible headache, chills, body aches to the point of it hurting to move and a fever of 102.4.  Took ibuprofen.  By the 10th at this time, a dull headache only.
pt recvd vax 25JAN94 in mid afternoon 26JAN93 early AM arm began swelling w/red streaks to elbow; no temp noticed; pt c/o discomfort but not inactive;