chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old patient who received a dose of ADACEL (lot number, expiry date, dose, route and site of administration were not reported) on 16-Oct-2017 also received a 0.5 mL second dose of same vaccine lot C5446AA via intramuscular route in the left deltoid on 21-Jun-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL: and MENACTRA. It was a case of actual medication error due to Inappropriate schedule of vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Excoriated face; nose cheeks forehead and chin .. today also neck, chest and right shoulder. 4/22/2021
Patient had in 24 hrs pain in left arm, red, tender, swelling locally. Also had fevers to 102, chills, nausea, fatigue.
This patient received a vaccine that was expired. It had been  put in the fridge on 4/28/21 so it was good until 5/28/21, with the expiration of 11/09/21. They received it on 7/20/21. The patient reported chills, muscle aches, and fatigue.
Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I lost my sense of smell which lasted about 1.5 week and my arm was sore, heavy and red at the injection site.  The soreness and the feeling of heaviness ended the next day but the redness stayed for about 5 days and changed to a bruise which then stayed for about 1 another week.  On the 29th I was given a COVID-19 test which came back positive. I noticed when I lay flat I cough alot but when I prop myself up I dont.
Paresthesia in hands, feet and legs, high d dimer from blood test at 5 and 9 days after first jab, at 12 days was almost normal, diarrhoea the week following the injection. I underwent also neurological examination, electromyography, electrocardiogram, which were all negative.
I started to feel extreme tiredness, fluttering heart, and numb feeling of inner left arm after three to four days of the shot. These symptoms lasted for weeks, and then I started to feel better. After two months, these only happen occasionally. However, until today, I am still not fully recovered to be able to do exercise at the same intense level as I used to before the vaccination). I also had some chills after a couple days of the shot, but that went away within a week.
2 red blotches in my right armpit; swollen lymph nodes; Itchy; rash; This last week it has been really bad; everything irritates it; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (2 red blotches in my right armpit), LYMPHADENOPATHY (swollen lymph nodes), PRURITUS (Itchy), RASH (rash) and MALAISE (This last week it has been really bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 RASH MACULAR (2 red blotches in my right armpit), LYMPHADENOPATHY (swollen lymph nodes), PRURITUS (Itchy), RASH (rash), MALAISE (This last week it has been really bad) and SKIN IRRITATION (everything irritates it). At the time of the report, RASH MACULAR (2 red blotches in my right armpit), LYMPHADENOPATHY (swollen lymph nodes), PRURITUS (Itchy), RASH (rash), MALAISE (This last week it has been really bad) and SKIN IRRITATION (everything irritates it) outcome was unknown.        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 and treatment medications were not provided.
very severe rhinorrhea & very severe urticaria-very itchy, blotchy, red & hot w/in 15min of vax-all sx resolved w/in 24hr w/DPH;severe allergic rxn no hx of prev allergies;
administered with only the AS01B adjuvant of Shingrix.; administered with only the AS01B adjuvant of Shingrix.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 7C483, expiry date 14th November 2022) for prophylaxis.   On 16th September 2021, the patient received Shingrix. On 16th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient was administered with only the AS01B adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This is one of four cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206994:same reporter US-GLAXOSMITHKLINE-US2021206993:same reporter US-GLAXOSMITHKLINE-US2021206990:same reporter
KINRIX given to patient at 4 month well check but is not recommended in children under the age or 4 yrs.
Nausea; Migraines; Usual fatigue; Injection site pain after the second shot; This is a spontaneous report from a contactable consumer. A 35-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06May2021 (at the age of 35-years-old) as a 1ST DOSE, single dose for COVID-19 immunisation. The patient's medical history was not reported, and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation. On an unspecified date in May2021, the patient experienced usual fatigue and injection site pain after the second shot. On 16May2021, she experienced nausea and migraines. The consumer reported that "starting on 16May2021 she started experiencing worsen fatigue, nausea and migraines. These have not resolved since. It was further reported that event took place after use of product". The outcome of events usual fatigue, nausea and migraines was not recovered whereas the outcome of event injection site pain after the second shot was unknown.
enlarged lymph node in the left armpit; dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 06Dec2021 10:00 (Lot number: FH8027) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 09Mar2021, when the patient was 51 years old, for COVID-19 Immunization; Comirnaty (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 30Mar2021, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 10:00, outcome "unknown", described as "dose number=3"; LYMPHADENOPATHY (non-serious) with onset 07Dec2021 07:00, outcome "not recovered", described as "enlarged lymph node in the left armpit". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.  Follow-Up (17Dec2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a registered nurse concerning a 11 year old female who on 09/15/2001 was vaccinated with a third dose of hep b vaccine recombinant IM in the arm. On 09/15/2001, the pt experienced a localized reaction which involved a large area of the injection site and below which was quiet inflammed. The pt was treated with hiphendydramino hydrochloride and warm compresses. Additional info has been received from a registered nurse. The nurse reported that the pt had a large induration around, above and below the injection site. No further info is expected.
Dramatic facial swelling that persisted despite the use of Benadryl every 6 hours for 2-3 days.  Eyes were nearly swelled shut, red and watery.  Low energy and low appetite.  Fever of 103.5 on 10/10/2011.  Fever of 101.5 on 10/11/2011.  10/11/2011 - 10/12/2011 patient was clearly ill, moving slowly, very emotionaly labile.  He began clapping hands "tic" and vocal tic of "Hmm".  Began having trouble holding a pencil and writing.  He became uncoordinated- tripped and falling, bumping into things.  He complained of sudden, sharp, pain in knee, elbow, knuckle.  Hmm and clapping tics became more frequent 10/13/2011 - 10/16/2011.  A lot of movement, some movement appeared to be involuntary.  Movement stopped when he slept.  Low appetite but very high energy.  He complained of headache, neck pain, and that his left cheek felt "spacy".  He began describing sensations with colors.  10/18/2011- 10/21/2011 overflow movements, poor concentration and memory.  A few bouts of walking on his tip toes noticed both by parents and teacher at school.  Dragging of right leg when tired when walking or running.  A feeling of being "struck by lightening" in his chest.  In handwriting with new letter reversals.  Patient was given Cephalexin 250 mg/ 5 ml 4x/ day for 10 days on 10/13/2011.  Patient continued to experience hyperactivity, extra movements, emotional lability, sensory abnormalities, deteriorated fine motor skills for at least 7 months.  His handwriting has never fully recovered.
This spontaneous report as received from a registered nurse (RN) refers to a patient of unknown gender and age. The patient was respectively vaccinated with the first and second dose of RECOMBIVAX HB vial, (therapy type, lot number, route and dose were not provided) on 19-APR-2003 and 17-JUN-2005. There were no known adverse effects. Additional information has been requested.
She had episodes of shortness of breathe - no cough - no pain. She had swollen lymph nodes under left arm. She also stated that she had syncope.
Had severe functional neurologic disorder 6 weeks after the second dose of Pfizer vaccination. It went away after several months. Just had a booster shot yesterday and I have the same symptoms again. Freezing gait. Difficulty swallowing. The symptoms are severe. The first episode I didn't know what it was. I was hospitalized for several days and doctors thought I had Parkinson's or Progressive Supranuclear Palsy. But after a tertiary neurological consult I was diagnosed with functional gait disorder. Symptoms got better after a month or so and taking Lexapro. I had the booster shot yesterday and today the symptoms have returned. Freezing gait and anxiety. It just started but is clearly from the vaccination. I read of other reports of functional neurological disorders following the vaccination. MRI and all radiology studies were normal. Hopefully this will go away as it did the first time. It's terrible.
Swelling, redness, induration and soreness to whole upper arm now resolving.  Started day of shot.  Currently ~6 cm diameter patch remains 3 days after shot.  Mom mentions today had similar after last DTaP on leg.
headache radiating  to teeth with eyes bulging and blurred vision. muscle aches  radiating from shoulder down to the back. Aferbile with chills
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Mar2023 at 11:00 as dose 6 (booster), single (Lot number: GL0447) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: yes" (unspecified if ongoing), notes: known allergies: yes, Other medical history: yes. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for "Positive for COVID-19 on a home test three days after receiving the Pfizer COVID-19 booster on 19Jan2023." of "PFIZERBIONTECH COVID-19 VACCINE INJECTABLE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot "GL0447". A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The investigative process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  Clinical course: Patient received other medications in two weeks; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.
Unexplained crying, fussiness, irritable over 24 hours. Face with edema around eyes and cheeks. Localized erythema and swelling on right leg. "Infant not acting like himself" per Mom.
Pt seen next day in office with large area of erythema, itching, redness, swelling and pain
Muscle still aches - 5 days after shot. when administered no issues - no redness or swelling.
Patient reported itching at 30 minutes with dose 1 given on 10/25/21. Today itching started at 0430 where 50mg of Benadryl was given. the patient started complaining of throat swelling. The patient was brought down the hall to the attached urgent care where 2 doses of epi were given.
chest pain; herpes zoster; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis.        On an unknown date the patient experienced herpes zoster and chest pain.  As a direct and proximate result, Plaintiff's symptoms have resulted in physical limitations not present prior. Plaintiffs also experience mental and emotional distress due to resulting physical limitations and seriousness of Plaintiffs' condition. Plaintiffs sustained severe, serious, progressive, incurable, and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of chest pain and herpes zoster was assessed as not recovered.   The reporter considered herpes zoster and chest pain to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, the events herpes zoster and chest pain were considered as disabling due to "severe and permanent injuries".
Information has been received from a physician concerning a 4 year old male who on 22-APR-2008 was vaccinated into the thigh with a second dose of  VARIVAX (Oka/Merck) (Lot # 659735/1785U). The physician reported that after vaccination, the patient developed redness at the injection site. On an unspecified date the patient recovered from redness at the injection site. The patient sought medical attention, he was seen in the physician office. Additional information has been requested. This is one of several reports from the same source.
A volunteer (vaccinator) who was being trained by a nurse injected the vaccine very high in the shoulder - approximately  1 inch below the acromion process. Pain in the area of the injection site and shoulder began 3 hours after the injection. Pain was exacerbated by active motion of the arm, especially abduction. The pain resolved over 48- 60 hours. There were no other symptoms from the vaccination- there was  no fever, fatigue, nausea, chills, adenopathy, etc. The concern is that the injection was clearly not in the proper location and I have questions about the efficacy of the 2nd dose that was administered and the efficacy of the overall vaccination series because of this. I contacted the Health Department and reported this. They instructed me to also submit it to Vaers.
Breakthrough case admission after 2 vaccines Pfizer 1/26/21 lot# El9261;  Pfizer 2/17/21 lot# EL9265
PT REPORTED TO HAVING RECIEVED A SINGLE DOSE OF MODERNA IN MAY OF 2021. HE STATED A DOCTOR TOLD HIM HE'LL HAVE TO RESTART THE SERIES, SO HE OPTED FOR A SINGLE DOSE OF JANSSEN.  HE SAT IN OBSERVATION FOR 15 MINS, ADMINISTRATION OF VACCINE WAS WELL TOLERATED. PROVIDED EDUCATION ON S/S OF ANAPHLAXIS SHOCK, WHEN TO GO TO THE HOSPITAL, AND POTENTIAL REACTIONS FROM VACCINE.
Client reports sore left arm, unable to move; client states movement is improving now. Swollen face the next day. Arm is severely swollen, and redness over deltoid site and down arm nearing elbow. Also reports night sweats and feeling only cold day of vaccination.
Tachycardia, shortness of breath, chest pain, chest tightness, GI reflux, elevated D-dimer, nausea, fatigue, weakness
reports that the patient called her over and informed her that he was experiencing left head pain and the he had a bump there that was not there before and he just felt after he had received his vaccine (5/19/21 at 1102am)." escorted pt to triage area and stayed with pt until ARNP was able to assist him 3-5 minutes later.reports that pt was unable to concentrate or answer questions appropriately when she spoke with him. pt sitting upright with both arms on knees, appears to be in pain. pt reports the same situation to  ARNP as what was reported to.  Vitals obtained 1110: 119/76 BP,  75HR, 98%. pt A&OX3, Pt denies a hx of DM2, HTN, and anxiety. Lesion on L forehead was appreciated and was erythematic along with his L cheek. pt denies any previous trauma or bug bites this AM states " I came home, took a shower and then came to get my shot." visual acuity test performed and PERRLA present and pt able to follow without issue. B.F.A.S.T. completed to r/o stroke symptoms and it was negative. Lesion on L side of head continued to grow and pt's L eye visually was closing (or getting smaller). pt then reports that L side of face began to be numb and L arm with pain. he then agreed to be seen at ED; EMS called at 1115. Second set of vitals obtained 121/86 BP, 75 HR, 95%. pt given 2 tabs of benadryl at 1122.  EMS arrived at 1130 and pt left with them.
LUMPS AT SITE OF INJECTION; INFLAMMATION AT SITE OF INJECTION; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced lumps at site of injection, and inflammation at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lumps at site of injection and inflammation at site of injection was not reported. This report was non-serious.
Experienced a vasovagal response about 30 minutes after receiving the vaccine. I felt it coming on and knew I needed to elevate my legs above my heart but could not at the time, so I sat down and put my head down. I had intense cold sweats and loss of vision for about 2 minutes until my blood flow returned to my head. I was then able to get to a recliner to elevate my legs with assistance. The entire episode lasted approximately 30 minutes. I was able to stand and walk after this time without dizziness. I contacted my doctor today 12/21/20  and he advised I report this episode.
Pt received Pediatric dose of covid vaccine rather than age appropriate dose. Guidance from facility documents states Age appropriate dose should be given immediately.
This case was reported by a nurse via call center representative and described the occurrence of hearing loss bilateral in a 76-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2RG54, expiry date 30th June 2017). On 21st September 2016, the patient received FLUARIX QUADRIVALENT. On 23rd September 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced hearing loss bilateral (serious criteria disability and GSK medically significant) and sensorineural hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss bilateral and sensorineural hearing loss were not recovered/not resolved. The reporter considered the hearing loss bilateral and sensorineural hearing loss to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient had no medical history of hearing loss, no precipitating event and no concomitant medication in her chart according to the reporter. The patient received FLUARIX QUADRIVALENT on the left arm. On 23rd September 2016, at 5:00 am, the patient noticed the sudden onset hearing loss. The patient stated that the hearing in the right ear sounded like tunnel hearing and no hearing in the left ear. The physician documented sensory neural hearing loss. The patient was not hospitalized and the event was not assessed as life threatening.
Full contents of vial administered to patient, estimated to be >0.25mL. No adverse effects noted following 15 minute monitoring period.