chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site puffy; injection site arm red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection site puffy) and VACCINATION SITE ERYTHEMA (injection site arm red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE INDURATION (injection site puffy) and VACCINATION SITE ERYTHEMA (injection site arm red). At the time of the report, VACCINATION SITE INDURATION (injection site puffy) and VACCINATION SITE ERYTHEMA (injection site arm red) outcome was unknown.            No concomitant medication was reported No treatment medication was reported Action taken with the mRNA-1273 vaccine in response to the events was not applicable
Fever; Cold; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 47 years old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown) via an unspecified route of administration in the left arm on 26Apr2021 at 14:00, (at the age of 47 years old) as a single dose of COVID-19 immunisation. The patient had no medical history. Concomitant medications include TYNALOL from unknown date for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown) (at the age of 47 years old), via an unspecified route of administration in the left arm on 07Apr2021 at 17:00, as a single dose of COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 at 19:00 the patient experienced fever, cold and dizziness. The clinical outcome of fever, cold and dizziness was not recovered.   No follow-up attempts are possible needed ; information about lot number cannot be obtained.
Pt received her vaccine at 1:18pm in RD, at 1:32pm Pt notified RN that she had numbness in her mouth, back of the tongue, and periorbital. She then reported a tingling sensation. Staff monitored & Paramedic assessed VS & noted that she was hypertensive. She requested a juice & drank without difficulty. Shortly after, around 1:55pm, she reported arm numbness bilaterally. AMR was summoned & the Paramedic continued to monitor (1:56pm). AMR arrived at 2:12pm & left with the patient at 2:18pm. She reported global numbness & tingling to AMR staff as she was leaving via gurney with them.
Complained of numbness to tongue, lips, face, complained of swelling to throat and difficulty breathing. FU: 30 minutes after vaccination she felt chest pain, her vital signs, monitored every 30 minutes, were okay. Oxymetry was normal. An ambulance was called, 0.3 cc epinephrine were administered but patients symptom continued to progress. Patient was sent to ER, from where she was released after 4-5 hours.
It was reported in a published article, five cases of postmeningitic deafness secondary to pneumococcal disease despite having received appropriate pneumococcal vaccinations. The 10 year old female patient was asplenic, a known risk factor for invasive pneumococcal disease. She had experienced pneumococcal meningitis 6 years earlier but recovered without complication. Preventive measures for meningitis included vaccination with a dose of PNEUMOVAX 23 (manufacturer unknown), appropriate to the patient's age and medical condition. The patient's meningitis reoccurred despite vaccination with PNEUMOVAX 23 five years later and daily oral penicillin. Profound deafness was diagnosed by using standard behavioral audiologic test methods on the fourth day of hospitalization. A three-dimensional SSFP MRI test that was performed six days after meningitis showed dramatically diminished T2 signal intensity within the turns of the cochlea, bilaterally. Surgical findings after twelve days of meningitis in the scala tympani of these ears revealed significant soft tissue; right ear: soft tissue filling basal turn, left ear: 4 mm of soft tissue. The patient underwent cochlear implementation (CI), bilaterally, between 01-DEC-2005 and 30-NOV-2007. The physicians relied on ABR/ASSR and imaging results alone to determine CI candidacy; the use of these techniques enabled the patient to undergo expedited evaluation for CI candidacy. An aggressive approach was used to optimize the likelihood of full electrode insertion in both ears, since the patient belonged to a population known to be at risk for progressive ossification. Pertinent medical history including pneumococcal vaccination status, results of auditory brainstem response (ABR)/ASSR testing and 3D SSFP MRI, degree of scala tympani obstruction, and achievement of electrode insertion constituted the mail focus of review. Bilateral cochlear implantation is of special importance in children with postmeningitic deafness. Despite complete electrode insertion, the patient was using only one device. The patient indicated that use of the processor in one of their ears was not useful despite multiple reprogramming sessions. Significant damage to the cochlear nerve by meningitis was suspected to be the underlying cause of these apparent ear differences. The preferred ear was not predictable preoperatively on the basis of imaging, audiologic testing, or intraoperative findings. Had only one ear undergone implantation and the second ear been addressed later, the obstruction found at the later surgery might have been more difficult to address. Conclusions: Pneumococcal vaccination had reduced but not eliminated childhood deafness secondary to pneumococcal disease. Auditory steady-state response testing and 3-dimensional steady-state free precession imaging are modalities that expedite candidacy evaluation of this population. Early bilateral simultaneous implantation increases the likelihood of binaural hearing and ensures implantation of the better ear in this population of children whose course is often complicated by formation of scar tissue and ossification within the cochlea. Additional information has been requested.
Headache  FATIGUE; BRAIN FOG' INJECTION SITE REACTION Narrative:
This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Since September 2014 (reported as "at the beginning of September 2014") the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose and indication were not reported). No symptoms reported. Additional information has been requested.
All was fine until she woke up the next morning.  Flu like symptoms; dizzy, glassy eyed, sweaty, somewhat disoriented, tired.
Sat 12-19-20 red spot around injection site, Mon 12/21/20 it feels warm and itching the redness is larger PT states she has taken Benadryl for symptoms
~1730 on 1/26/21, Pt reports they developed left hand pruritus which then progressed into urticaria on both arms- at this time taking Diphenhydramine 50mg po. Within 10min, urticaria throughout the entire body. During trip to ED, tongue developed itch and lips became swollen but denies any respiratory symptom involvement. ED course= IM Epi, IV Methylprednisolone, and famotidine. Next morning, Pt currently has slight pruritus but nothing further.
I called after one week and was advised to get a teledoc insurance company. I sent in a picture of my symptoms, he believed I had shingles, close to my eyes and I went to the ER. They did eye tests on me that the shingles was not in my eyes, and did standard triage protocols. The day after my vaccine I had bad episode of tachycardia which subsided one day and a half. For the most part my symptoms have resolved.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 67-year-old male patient who received HAV (Havrix 1440 adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. In October 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 06-OCT-2022 Reporter's Comments: The reporter stated that the patient received an expired dose of Havrix which was expired on 30th September 2022. The reporter gave consent to follow up. Additional Supportive Information: A patient received an expire dose of Havrix which led to expired vaccine used. This case had been linked with US2022143251 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022143251:Same reporter
Patient experienced "dire pain" at the injection site for two days.  Patient then went to urgent care on 6/2/23.  Per the urgent care provider: The inejction should have been in the deltoid, and this was given about halfway to the elbow, consequently leading to this highly adverse reaction.  Urgent care provider, who prescribed patient Cephalexin 500mg on 6/2/23.  Patient picked up this prescription at this pharmacy on 6/3/23 at 9:08 AM.
administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 035C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 12-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 12-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Day of headache (Sun), that night sore arm, and next day some sleepiness, but that doesn't concern me.  What does it Thurs (~Day5) afternoon, it felt like my tongue was getting "thick" and pressing my back teeth, then I noticed that the lymph node on the left side of my throat began to really swell.  It got really enlarged by Friday evening (~ Day 6) to the point that I wondered if I had tonsillitis - no pus/not strep.  But being only on the left side (same as shot) and not both, I figured that it could be a reaction.  Called my after-hours doctor on Sat who confirmed that this did sound very much like a reaction (not much to be found online) and nothing to be too concerned about unless it didn't resolve in a few days.  Swelling went down significantly by Sat. a.m. and was back to normal by Sun (Day 8).
2nd dose given one week from the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given one week from the 1st dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milligram. On 31-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 31-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given one week from the 1st dose). On 31-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given one week from the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.
URTICARIA/ITCHY FEELING ALL OVER HIS BODY/HIVES/RED, RAISED BUMPS THAT WAS ALL OVER ARMS, LEGS, BACK, AND BUTTOCKS/ RASH; SORE ARM WHERE GOT THE SHOT; FELT TIRED; This spontaneous report received from a patient concerned a 53 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 allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the subject experienced sore arm where got the shot. On 05-MAR-2021, the subject experienced felt tired. On 12-APR-2021, the subject experienced urticaria/itchy feeling all over his body/hives/red, raised bumps that was all over arms, legs, back, and buttocks/ rash.  Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, cetirizine hydrochloride, fexofenadine hydrochloride, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm where got the shot, and felt tired on 08-MAR-2021, and had not recovered from urticaria/itchy feeling all over his body/hives/red, raised bumps that was all over arms, legs, back, and buttocks/ rash. This report was non-serious.
PATIENT CAME IN FOR VERY FIRST MODERNA VACCINE IN ALL OF HISTORY.  PATIENT SCHEDULED FOR COVID VACCINE. ADMINISTERED  0.5MLS OF BIVALENT BOOSTER IM TO PATIENT'S LEFT DELTOID MUSCLE. ASKED TO STAY FOR OBSERVATION FOR 15 MINUTES.   LEAVING WORK, THE PATIENT WAS GOING THROUGH MY MIND AND AS SOON AS I GOT HOME I BEGAN RESEARCHING THE APPROPRIATENESS OF GIVING 0.5MLS BIVALENT AS FIRST DOSE. BEGAN RESEARCHING AND FOUND THIS WAS THE INCORRECT FORMULATION PER STANDARD GUIDELINES. IMMEDIATELY CONTACTED CLINICAL ADVISOR, MODERNA AND SUBSEQUENTLY THE CDC TO FIND RECOMMENDATIONS TO RESOLVE. CURRENTLY WAITING FOR MODERNA ADVANCED CLINICAL TEAM TO ADVISE FOR RESOLUTION.
The patient was given expired J&J vaccine doses. The vial was punctured at 9:40AM and expired correspondingly at 3:40PM.The respective time the shot was given outside this window was 4:54 PM.
Is it ok to wait an extra week to get the 2nd dose? It would be a month plus a week; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Is it ok to wait an extra week to get the 2nd dose? It would be a month plus a week) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Is it ok to wait an extra week to get the 2nd dose? It would be a month plus a week). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Is it ok to wait an extra week to get the 2nd dose? It would be a month plus a week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It has been one month and a week since first dose.  No concomitant medication were provided  Treatment medication was not provided
Patient initially stated that she felt dizzy and her head hurt to which her husband sat her down and came to get us. When we arrived she was very weak and having trouble responding but coherent. Gave her some water and an ice pack. Injection site was unremarkable, tongue and lips appeared to have no swelling. She slowly progressed and eventually said she needed to lay in the floor so we we eased her down and propped up her legs. She started to complain of her chest hurting and having trouble breathing slightly before we sat her down and she stated that again after we got her down and then she became unresponsive. We administered one Epinephrine 0.3 mg injection and within 30 seconds she became very alert and said she was feeling better. EMS arrived and took over from there.
Left arm with 6cm erythema & 4cm induration with small vesicles.  No fever no derep us duratation ROM-pulse ok.
Fever of 102.7F. Motrin given at that time and continued with Motrin X 48 hours. On 1/21/01, red rash (mainly on neck and stomach and then the back. Back had bumps. Right leg had fluid filled-yellowish.
Information has been received from a lawyer regarding a case in litigation concerning an approximately 62 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In March 2017, at approximately 62 years of age, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a healthcare provider. On an unknown date in 2017, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to himself and economic losses. Additional information has been requested.
1/14/11 swelling & redness at injection site (right deltoid). Approx. 8 cm in diameter of redness & swelling. Child treated for cellulitis 1/15/11 with BACTRIM. Symptoms resolved by 1/17/11.
The pt experienced a ringing in her ears "one day after the third dose, the ringing disappeared, but sometimes reappears. The ringing in the right ear has been constant for 4-5 years since vaccination." The pt noted she has seen several specialists. Additionally the pt reported "initially had antibodies determined through titer after the series but now have no detectable level." Additional information has been requested.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: body shaking, body sweats and chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: pt experienced severe fatigue that has not resolved. she experienced breakouts in chills and shakiness
pt recv vax & exp sore throat on onset, fever, dry cough-deep from chest & cont, mucous buildup in throat, inj area swelled, turned red, hurts still hurts as of this date 22OCT96;
Right arm pain. Right arm temperature extremely warm. Oral fever 103 degrees F. Malaise. Headache. Swollen lymph nodes right arm.
Fever; Shaking; Lower back pain; This is a spontaneous report from a contactable consumer (reported for an adult male patient). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 25Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient been tested for COVID-19. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On 25Feb2021, the patient experienced fever, shaking and lower back pain. It was unknown whether the treatment was given for the events. The outcome of the events was resolved on an unspecified date in 2021.  Health authority comment: Reporter's response: yes the patient mentioned it to me directly in conversation on the Sunday on 28Feb2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing in a female patient who received (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced difficulty breathing and rash. On an unknown date, the outcome of the difficulty breathing and rash were unknown. It was unknown if the reporter considered the difficulty breathing and rash to be related to dTpa vaccine. Additional details were reported as follows: This case was reported by a consumer via Media. The age at vaccination was not reported. The patient was given a DPT shot after a car crash. The patient was told it was a tetanus shot. The patient broke out in a horrible rash on her chest and experienced breathing problems. The patient stated, that stuff was poison.
Vaccinated 9/28/02. Day later with fever for 1-2 days. Fever went away on 10/13/02. Noted to have few scattered erythematous papules--pruritic by 10/14. Elevated lesions on neck, trunk, vesicular with clear clusters and some open lesions.
Rash all over body. Started after given flu mist. In afternoon -itchy bumps. No cough, fever or wheezing.
I started with constantly trying to clear my throat. This started on Monday. By Tuesday November 15, I felt like a cold was starting or it was allergy related or due to a seasonal change. I took CLARITIN. By Tuesday night, my throat felt infected and sore. I took a COVID-19 home test on Tuesday, and it was negative. On Wednesday, I felt like I needed to take a nap by afternoon and the clearing of the throat became a cough with clear mucus. I completed another COVID-19 home on Wednesday, and it was positive. I took another test, and it came back positive as well. I emailed my doctor and asked if he could prescribe the anti-viral treatment due to past issues with cold. I took the first dose on Thursday. My symptoms come and go. This morning I had a raspy voice with lots of mucus that is still clear. I still have the cough and at night I get a slight chill but that has gotten better. Sometimes I am congested and sometimes I have a runny nose. My doctor did not advise me to take any additional test outside of the rapid home test to confirm. I feel a little bit foggier where I forget what I have gone in a room searching for more often than prior to this.
Localized allergic reaction. Itchy, red, hot to touch over injection site. Mild pain. No ROM restrictions. Growing in size on 2/1/21.