chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the shot had shingles on leg/ suspected vaccination failure; Shingles on legs; Hurt; 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.   The patient's past medical history included shingles (had 3 years ago prior to the reporting, it was severe case had horrible pain and it was lasted a year).   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: Got the shot had shingles on leg/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on legs) and pain (Verbatim: Hurt). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine but he or she thought he or she again experienced shingles on his or her legs it was not as bad but it hurts. The patient stated that he or she going to try aloe vera as a treatment. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
fever 102 degrees, headache, chills, nausea, fatigue, loss of appetite, 48 hours tylenol
POTS; dizziness; fatigue; headache; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 15-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. In 2011 following vaccination, the pt experienced Postural orthostatic tachycardia syndrome (POTS), dizziness, headache, and fatigue. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
This spontaneous case reported by a consumer, describes the occurrence of low-grade headache in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine), for COVID-19 immunization. No medical history reported. On Oct 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In October 2021, patient developed a low-grade headache. At the time of the report, low-grade headache: not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Narrative: 12/16/22 - Pt presented to ED with weakness this morning, vomiting (but only dry heaves), cough, scratchy throat, and one reported episode of minimal diarrhea yesterday. Pt notes scratchy throat and cough started yesterday. ED ASSESSMENTS: cough sore throat gbw episode of nausea orthostasis abnormal chest xray covid19+ PLAN: admission supportive care **Patient admitted to facility from 12/16 to 12/20/22 with principal diagnosis = acute RT UL PE, COVID infection. Additional diagnosis include: Acute hypoxic respiratory failure due to COVID & PE; Orthostatic hypotension r/t covid; HTN; and HLD. ** HOSPITAL COURSE: Acute COVID 19 infection, pt was treated w remdesivir and decadron burst. was in isolation and symptomatic treatments applied. At time of dc pt was afebrile, w/o cough. He also had Acute RUL PE provoked by covid, was started on apixaban and will need to cont meidcation for 3 months and follwo w anticoag pharmacy, there was NO evidence of heart strain by CT, Echo will be deferred to COVID policy. Pt also had Acute hypoxic respiratory failure due to COVID, PE and was placed on O2 until resolution at dc. Pt had Orthostatic hypotension likely r/t covid as well, was hydrated, and taking po at time of dc this had resolved.
Please contact me to discuss neurological symptoms that persist post second Moderna Covid-19 vaccine.  There is not enough time on this survey before timing out to articulate the symptoms, signs, time course and overall adverse reaction. I am still struggling with GBS like symptoms.
Enlarged tender left anterior cervical node felt 10 min after injection. Markedly reduced in size by 20 min. We just kept him and watched him longer to make sure he was OK. Dr. then checked him again and released him.
Inadvertent administration of Vaxelis and Roteteq after TE; This spontaneous safety report, was received by the partner on 19-JUL-2023 and forwarded to company on 19-JUL-2023 and 20-JUL-2023, from a health professional on behalf of a physician.  A nine-month-old neonate experienced an inadvertent administration of Vaxelis and Rotateq after TE (temperature excursion). No symptoms were reported. No additional adverse event/product quality complaint.   Due to the nature of the event, the causality between the events "Inadvertent administration of Vaxelis and Roteteq after TE3" and Vaxelis was not applicable.  Companion Cases: MCM-005053, MCM-005054, MCM-005055, MCM-005056, MCM-005057.  No additional information is expected.
Passed out on my front porch-don't know what time. Friday morning when my son could not reach me by phone he came to my house and found me passed out on my front porch. First thing that I remember is being in the ambulance.  Spent 4 days at hospital. They have the records on what thy did.
PATIENT HAD AN IMMEDIATE ALLERGIC REACTION UNDE RTHE LEFT ARM, AWAY FRO THE SITE OF INJECTION
patient only received a partial dose of vaccine  due to the vaccine leaking during administration/ No AE; vaccine leaking during administration; while administering the vaccine the liquid running down the patient's arm from the injection site/No AE; Initial information was received on 24-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 11 years old female patient who on 24-Aug-2020 only received a partial dose of 0.5mL of first dose of vaccine  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U659AA and expiry date 21-May-2021) via intramuscular route in the left arm meant for prophylactic vaccination as the vaccine was leaking during administration and while administering the vaccine the liquid running down the patient's arm from the injection site (underdose, needle issue and exposure via skin contact)  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE (HPV VACCINE) for immunisation.  It was case of actual medication error due to vaccine underdose. it was also a case of needle leak and exposure via skin contact.   Case details:  Caller reported that the full amount of the vaccine was drawn into the syringe, needle was inserted into patients arm and while administering the vaccine she noticed the liquid running down the patient's arm from the injection site.   Caller unsure of the volume of the vaccine that the patient received.    At the time of report, no adverse event was reported.  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.
1 day of fever & chills 1 week of arm with red rash and itched for whole week (left arm - 2nd shot)
Child was coughing/wheezing, had hives on chest, arms, legs and bottom of neck. Tx was started with 1 3/4 tsp of Benadryl given at 10:05 A followed by Albuterol 0.083% at 10:05. Vitals were HR 129, O2 98%, BP 82/42, R 20. Decadron 8mg given, epinephrine 1/1000, 0.16 mg given SQ. 11:25 rechecked vitals BP 100/54, HR 120, O2 98, temp 98.8, R 22, epinephrine 1/1000 0.16 mg given SQ. 12:25 Vitals rechecked BP 102/52, HR 130, O2 98, temp 98.7, R 26. Pt remained under close observation and was clear to leave office.
I had the first vacination injected at the local Pharmacy. Had a stroke 48 hrs later. Was admitted to local Hospitol for weeks due to a stroke.
Was in presence of sick contact(partner) who was diagnosed with COVID. Initially had malaise and fatigue but developed acute onset weakness in legs followed by arms and is now paraplegic. COVID PCR +.Unique case of COVID infection presenting as Acute motor axonal neuropathy (variant of GBS) in a fully vaccinated but immunocompromised individual(DM1)
Mother reports fever on and off for 4 days, rash on face and decreased appetite since vaccine administration.
Mild heartburn onset about 5 hours after receiving injection. Over-the-counter antacid taken with crackers and water. Symptoms alleviated after about an hour.
Acute hypoxemic respiratory failure due to COVID-19; Pneumonia due to COVID-19
Patient received vaccines at about 11 AM. After returning to our office, I received a call at 3:45 PM from the coordinator at the school campus informing me that the student had been complaining of arm pain. He stated that the student thought the pain was extreme but it was manageable. At 4:15 PM I received another call from him. He informed me that an ambulance had been called to evaluate the student, since there was no medical personnel on campus. EMS came and evaluated the student. She was noted to have very bad pain to her left arm. EMS advised student to apply an ice pack and I confirmed with the informant that this was normal procedure. EMS did not advise any further medical attention and student was taken home by her sister. Informant told me that EMS was called because of the extreme pain student was feeling and because they were not sure if the level of pain was normal. I spoke with student/patient on 12/12/18 and she informed me that she was feeling much better. She stated that she was feeling better by 12/11/18, but still had some pain in her arm. She had not been seen by her doctor or received any further medical attention at this time. I advised patient to seek medical attention if she did not feel well again or if her pain increased.
Fever, worsening cough, chills, extreme fatigue and muscle pain for over 7 days. Returned to work after missing 9 days due to vaccine side effects, but cough and fatigue continued until August 6,2021 when we finally went to hospital ER with what we thought was bronchitis our maybe pneumonia. However, we were devastated when they diagnosed him with Stage C congestive heart failure! This was out of the blue. Other than a persistent mild cough which we thought was from smoking, he was healthy, normal weight, active and had no idea his heart was in danger. I watched him go from healthy to a man who was scared and dying over the course of a few weeks following his second vaccine dose. I don't care what conclusion is made, because I will always blame the vaccine. I saw it with my own eyes. Correlation isn't causation, but it would have to be one hell of a coincidence if the vaccine didn't trigger SOMETHING. His cardiologist dismissed my concerns over this, which is very disconcerting, and we have a new cardiologist that we can't see until February. Someone should document his case.
Received COVID vaccine on 1/23/2021 and 1/3/2021.   On 3/9/2021 had fever, body aches, diarrhea, headache, and nausea/vomiting.   Tested positive for COVID.
NEUROPATHY 5/5/2022 SEPTIC SHOCK  ACUTE NON ST ELEVATION MI 5/9/2022 SEPTIC SHOCK  NEUROPATHY 5/5/2022 LEFT KNEE ARTHROPLASTY FAILURE, SUBSEQ  ACUTE NON ST ELEVATION MI 5/9/2022 LEFT KNEE ARTHROPLASTY FAILURE, SUBSEQ  NEUROPATHY 5/5/2022 DM 2 W NEUROLOGICAL MANIFESTATION  ACUTE NON ST ELEVATION MI 5/9/2022 DM 2 W NEUROLOGICAL MANIFESTATION
pt exp extreme aching in arm; during the noc pt had high fever 103-104 & c/o muscles quivered in arms;had a 101+ fever for 24hr; arm sore 1wk
Same side as vaccine administered, face and arm have decreased sensation, moderate to severe joint pain, hand grip strength decreased, mild localized swelling around injection site, mild warmth around injection site, no redness noted.
After getting her first 2 covid vaccines she got covid back in Apr2021 or May2021; After getting her first 2 covid vaccines she got covid back in Apr2021 or May2021; Has been in severe flare up; Has a hard time walking; Stiffness in her ankle; This is a spontaneous report received from a contactable nurse and contactable consumer (patient). A non-pregnant 50-year-old female patient received BNT162b2 (covid-19 vaccine), first dose, via an unspecified route of administration on an unspecified date as single dose, second dose, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included BIOTIN, CITRACAL + D3, VITAMIN D2, PLAQUENIL, HYDROXZINE, AMLODIPINE BESYLATE, GABAPENTIN, CELEBREX, and MULTIVITAMIN. In 2021, after getting her first 2 covid vaccines she got covid back in Apr2021 or May2021 and she has been in a severe flare ever since then, has a hard time walking. Ready for a rit (uncertain what this means) was starting to get better still has stiffness in her ankle has a hard time walking. Improved but not resolved. The patient underwent lab tests and procedures which included COVID-19 Test positive, got covid in 2021. The outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and Covid 19 and suspect drug BNT162B2 cannot be excluded.
dizziness, raspy sensation.  pt. has history of food allergies;   resolved.
My son had a flu shot on 10/6/09 at his schoo in Texas.  When he came home(ny) for Thanksgiving weekend, he said he had a sore neck and severe headaches for weeks.  When he came back home back home for Christas break, he was very tired all the time.  When he returned to school in early January, he noticed numbness and tingling in his hands and feet.  He visited the school doctor, a private physicain, and eventually the emergency room.  His condition worstened to the point of complete paralysis.  Finally a neurologist diagnosed him with Guillain Barre syndrome where he was immediately hospitalized in the ICU.  He has been there for 11 days now.  He is going to be moved to a rehab facility tomorrow.
Got my 2nd shot on a Friday & was miserable for a week; This case was reported by a consumer via  interactive digital media and described the occurrence of feeling miserable in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th April 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced feeling miserable. On an unknown date, the outcome of the feeling miserable was recovered/resolved.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated that he/she got the shot on a Friday and was miserable for a week. The reporter stated that before getting these shots, it should be read what they can cause and only good for 4 years.
On 1/27/22 an hour after booster, developed hives on arms, then 2 hours after booster, body aches and then fever to 102 evening of 1/27/22.  Took cocktail of Benadryl 25 mg - 3 tabs, and Claritin 10mg, 1 tab in the AM of booster.  Evening of booster took Benadryl 25 mg 4 tabs, and Claritin 10 mg 1 tab (as directed by primary physician).  Also took Aleve one dose and Tylenol one dose treatment of fever. Symptoms resolved by 1/29/22 and back to work on 1/31/22.
Resident physician ordered incorrect vaccine preparation and dose was given to the patient. The patient needed both DTaP and IPV, so Kinrix was ordered. Kinrix is only approved for use in patients ages 4-6 years. The patient was 3.5 years old.
I had what has been dubbed "Covid arm," one week (almost to the minute) after the injection, with intense itching, a large rash, and swelling around the injection site. The area also felt very warm to the touch. The intense symptoms lasted 24-36 hours, and gradually subsided over the next few days. One week later (that is, two weeks after the injection), the symptoms were gone.  I'm reporting this to add to your database, though I don't consider this an adverse reaction. It seems to mean this means the vaccine and my immune system were forming a very strong alliance!
His appointment was at 10:30 am by noon his arm was completely swollen to the size of a tennis ball. It was hard and red, complained about feeling lightheaded and having a headache. I gave him the Benadryl around 5:30 when I got off work. before that he had taken some Motrin because that was all we had at home. He is still complaining say his stomach hurts and he feels dehydrated.
I've started experiencing a change in my menstrual cycle.; experienced spotting for 10 days and now my period is late; experienced spotting for 10 days and now my period is late; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 18-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 18-Year) in left arm on 09Apr2021 at 11:30 AM as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered in left arm on 17Mar2021 at 12:30 PM for COVID-19 immunization. No known allergies were reported. The patient received no other vaccine in four weeks; and no other medications in two weeks. The patient had COVID test type post vaccination (Nasal Swab). The patient not tested COVID prior vaccination. On 18Apr2021 the patient experienced a change in her menstrual cycle; experienced spotting for 10 days and her period was late. The patient reported that "she had started experiencing a change in her menstrual cycle. This is the first change she had ever experienced with it, so it was relatively out of the norm. She experienced spotting for 10 days and till then her period was late." The patient received no treatment for the adverse events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 22Apr2021. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccine was administered without complications. approx 5 mins after vaccine was given, patient reported feeling light headed, feeling like they were going to pass out. Patient was laying down, eyes open but was lethargic, still responding but slow to respond. HR was 47BPM however patient reported he was a runner and normally had a low HR. Blood pressure was 66/44 , patient was pale and diaphoretic. Pt was conscious the whole time, was put in supine position, cold compress applied. Patient denied chills, shortness of breath, difficulty breathing, nausea, chest pain. Pt was monitored, given oral fluids, and within 15 mins after event, vitals returned to baseline, HR remained bradycardic less than 60, no additional treatment was given and patient left after observation around 8:00pm.
The mother described the baby as being limp, sleeping most of the time, not responding to mother as usual and refusing to feed for 1 1/2 days, post vax.
Narrative:  Patient contacted telephone triage nurse today requesting appt with provider. Patient states he had his second covid vaccine on 4/20/2021, "And I still feel horrible." Patient is c/o intermittent headaches (none today), sinus pressure/congestion, "clear drainage", cough/chest congestion, "Mainly clear phlegm, but don't look." +Sore throat, fatigue, body aches. Some increased wheezing - pmh: COPD, using inhaler as directed, "helps." No chest pain with cough or deep inspiration. +Intermittent chills. No leg swelling. Patient also coincidentally mentions "both hands are mildly swollen the past 10 days, since I received the vaccine." Urinating well, "I'm staying hydrated, urinating fine, urine looks normal." No facial or abdominal swelling. spO2 = 96% room air. B/P: 142/98, pulse 91. Temp 97.3. Patient's biggest concern is fatigue, "I just feel so worn out, not getting better." Patient is interested in obtaining a covid test today, number has been provided - states he will call now.
3 months after 2nd vaccination of COVID-19 Pfizer diagnosed with Type 1 Diabetes