chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left eye is constantly twitching; muscle spasm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FL0007) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "left eye is constantly twitching"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "muscle spasm". Therapeutic measures were not taken as a result of muscle twitching, muscle spasms.  Additional information: Reporter stated, "I am first of all I am not sure whether to call this number. Actually, what happened to that I had a concern about what happened after, I had my booster shot and my son first shot. We think we had the same thing that happened which was little bit odd on both of us." When asked if you both had the shot: Reporter stated, "Yes, I have been fully vaccinated with the first booster and my son had his first shot."  When asked want to anything about it: Reporter stated, "Is this normal to all of this sudden like your left eye is constantly twitching or had like muscle spasm in your body." Reporter stated, "It was also due to the fact that I had the lung surgery right before COVID (Intent Medical history) and I mean, I have been in a breakout and I had my surgery and my lung is constantly spasm (Further clarification unknown, hence Ae captured as conservatively). So, I am kind of concerned about that." Reporter was informed about Pfizer Medical information department and was provided with the Number as (Withheld) (Option 3) and was informed about the timings as 8 AM-8 PM Monday To Friday (EST). Expiration Date: Reporter stated, "It doesn't have an expiration date." Other medical condition: Reporter stated, "No he does not." Other Medications: Reporter stated, "No." Lab test: Reporter stated, "No." Treatment: Reporter stated, "No, he did not." Vaccination Facility type: Reporter stated, "It was the pharmacy." Prior Vaccination (Within Four week) Reporter stated, "No, I did not." When probed for any further help: Reporter  further stated, "No, that was just it, I was just wonder if this is one normal to have like that muscle spasm you know in your body and because your eye or same eye your both of your eye constantly twitching and it has still not stopped. It was his on the (incomplete sentence) and my was like 12Dec2021 his first one when he got the vaccine, the 11th had their second dose (Further clarification unknown) and I will called his pediatrician to double check and I am waiting to call my doctor just to double check."  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200036315 Same reporter, same drug, different patient;US-PFIZER INC-202200036095 Same product and event, different patient
Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX (Lot #664653/1337Y). Subsequently the patient died. The cause of death was unknown. A priority lot check has been initiated. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions. drug reactions/allergies and concomitant medications were not reported. On unspecified dates since 10-FEB-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M037019, expiration date:04-NOV-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of - 1.7 Celsius degrees for 4 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013313: US-009507513-1703USA013314: US-009507513-1703USA013315:
Slightly sore 1st day followed by itchy (similar to reaction to 1st vaccination, but itchy sensation took week to develop on initial vaccination. Second week, knot developed distal to deltoid. Suspect pharmacist injected slightly below ideal sight.
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported to have numbness and tingling from her left arm, start from elbow to little finger. Did not happen at the first shot. Advised her to talk to PCP if it's still happening after 1-2 days and if it's getting worse.
pt recvd vax JUN92 & devel urine urobilinogen; liver function tests were nl; no further details were provided;
Mild dizziness, slight fever, touch of diarrhea. Went to bed early. Woke up and dizziness was much worse. Also had more diarrhea. Felt like vertigo. Hard to maintain balance. Dizziness has lasted over 24 hours so far. Took 2 aspirin and am going to bed. Having been drinking water all day (over 4 liters).
had his second shot on 21Apr2021 and was in the hospital for chest pains/pressure on April 23-25, diagnosed with Myocarditis,; Myocarditis; had his second shot on 21Apr2021 and was in the hospital for chest pains/pressure on April 23-25, diagnosed with Myocarditis,; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0162), via an unspecified route of administration in left arm on 21Apr2021 (at the age of 17-year-old) and as single dose for COVID-19 immunisation. Medical history reported as none, patient had no known allergies. Concomitant medication included escitalopram, dose: 10 mg taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8732), via an unspecified route of administration in Arm Left on 31Mar2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported that patient received Escitalopram 10 mg within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and patient did not test for COVID-19 since the vaccination. It was reported that patient had his second shot on 21Apr 2021 and was in the hospital for chest pains/pressure on April 23-25, diagnosed with Myocarditis. The patient was hospitalized for the events for 2 days on 23Apr2021 to 25Apr2021. On 24Apr2021, the patient underwent lab tests and procedures which included blood test for covid test and result with negative. Patient received treatment for events with 10+ ekg's or so, ibuprofen. The outcome of the events was recovered on an unspecified date in 2021.
Woke up and my arm was super, super tender and hot; it started swelling through the course of the day - 10 days after. It was confined to the upper arm. That lasted about 3 days. The doctor put me on antibiotics as a precaution - Amoxicillin.
started with pain in left elbow, started to swell over next 3 days with swelling moving down forearm.  warm to touch.   pharmacist suggested it sounded like cellulitis - suggested ice and take benedryl.   As I am out of state from general physician, I checked in via video visit.  since not moving up arm...  believe shot was not administered correctly!   16 days later, my elbow still in pain and am unable to fully extend my arm.
This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
15 mins after giving DTaP, IPV & MMR, patient started wheezing.  Treatments 1 ORAPRED 30mg PO given, 2 BENADRYL 12.5mg PO given, 3 2, albuterol neb treatments given.  9/26/08 REviewed ER medical records of 8/4/2008. FINAL DX: allergic reaction Records reveal patient experienced wheezing, vomiting, itching, papular facial rash immediately after injections in PCP office.  Tx in office w/benadryl, steroids & nebs.  In ER, sleepy but improved.  Tx w/IV Benadryl & pepcid.  Responded well & d/c to home.
Bell's palsy  12/8/06 Received records from provider which reveal patient experienced right facial weakness approx 24 hours s/p flu vax.  Weak right eye closure & smile was asymmetrical.  Treated w/anti viral & steroids.  Clinic visit of 11/20 revealed facial weakness unchanged but able to close right eye.  Treatment continued. Final Dx: Right Bells Palsy.
This is a spontaneous report from Non-Clinical-Study-Program from a contactable consumer. A 7-months-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were unknown. In Mar2013 the patient experienced pneumonia and was hospitalized for 4 days. Therapeutic measures were taken as a result of the event included unspecified antibiotics. The patient recovered after several weeks. Follow-up (18FEB2014): Follow-up attempts completed. No further information expected.
sepsis; fever of 100F; severe shaking; body aches; chills; Initial information and additional formation received on 03-Oct-2019 regarding an unsolicited valid serious case received from a nurse.  This case is linked to cases 2019SA276202 and 2019SA276197 (same reporter).  This case involves a 76 years old female patient who diagnosed with sepsis (Sepsis), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant medication   On 02-Oct-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ268AB via intramuscular route in the left deltoid.  On an unknown date, the patient was diagnosed with a serious sepsis associated with symptoms with fever of 100f (pyrexia), severe shaking (tremor), body aches (pain) and chills (chills) within 45 minutes following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant. The patient was hospitalized for these events on 02-Oct-2019 was still hospitalized at the time of reporting.  Relevant laboratory test results included: Body temperature - On an unknown date: 100 F [100]  Final diagnosis was sepsis.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the events.; Sender's Comments: Patient was diagnosed with sepsis with associated symptoms after vaccination with FLUZONE HIGH DOSE. Time to onset is too short to be compatible with the role of vaccine. Moreover, further information including patient's medical history, lab data suggesting the etiology for sepsis is not provided. Based on available information the role of vaccine cannot be assessed.
Was pink at the injection site; Very itchy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Was pink at the injection site) and VACCINATION SITE PRURITUS (Very itchy at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Was pink at the injection site) and VACCINATION SITE PRURITUS (Very itchy at the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Was pink at the injection site) and VACCINATION SITE PRURITUS (Very itchy at the injection site) outcome was unknown. Not Provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Two days after vaccine, my right leg started having painful Edema swelling. Since I have the blood clotting disorder Factor V Leiden, I went to the hospital, I had an Ultrasound performed on my legs, clots were found in my femur. Also had an Ultrasound of my Carotid Artery, zero plaque was found. My doctor doubled my dosage of Eliquis for 1 week to 20mg a day, then decreased it back to 10mg. Also started taking Valsartan 40mg and Crestor 5mg.
Redness around where they gave her the shot and it's hot like she has a fever right there; Redness around where they gave her the shot and it's hot like she has a fever right there; This is a spontaneous report received from contactable reporter (Consumer). An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 22Mar2021 (Batch/Lot number: unknown) at the age of 88 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication(s) included: NOVOLOG taken for diabetes mellitus. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "Redness around where they gave her the shot and it's hot like she has a fever right there". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth.  No follow-up attempts are possible. No further information is expected.
Arm swelling and erythema to "twice its diameter" (per ED notes) without fever and only with minimal pain, resolved with NSAID administration.
Within 5 minutes of giving patient her vaccination patient broke out into a  macule rash mainly on her forehead and upper R cheek. oxygen sat level at 100% room air,  158 for pulse.  Slightly lethargic & sleepy but no acute distress noted, no difficulty breathing or SOB noted.
1 year patient received kinrix; Extra hep-b that came from the 3rd Pediarix administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17-FEB-2024) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis.   Previously administered products included Engerix-B (1st dose received on 24th March 2022) and Pediarix (1st dose received on 1st June 2022). Concomitant products included PEDIARIX.   On 11-OCT-2022, the patient received the 3rd dose of Pediarix. On 20-JUL-2023, the patient received the 4th dose of Kinrix. On 11-OCT-2022, an unknown time after receiving Pediarix and not applicable after receiving Kinrix, the patient experienced extra dose administered (Verbatim: Extra hep-b that came from the 3rd Pediarix administration). On 20-JUL-2023, the patient experienced inappropriate age at vaccine administration (Verbatim: 1 year patient received kinrix).  The outcome of the extra dose administered and inappropriate age at vaccine administration were 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: 25-SEP-2023 The patient received 3rd dose of Pediarix, which led to extra dose administered for hepatitis B antigen. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up via email.
Pt presented to the clinic on 10/13/2014 describing symptoms of fatigue, pain, soreness, and flu like symptoms following vaccination.
Flu like symptoms, fever, chills, stiffness in multiple joints.  Stayed in bed for two and a half days before feeling strong enough to get up.  OTC meds.  Did not relate the event to the H1N1 vaccine at the time.
Monovalent was drawn and given as booster dose, mistaken for pfizer covid bivlanet
This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (pains on their left shoulders (injection site).) and ARTHRALGIA (having pain in other joints - right shoulder and the knees. For his wife - she complains about the pain too) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Pollen allergy.    On 30-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pains on their left shoulders (injection site).) and ARTHRALGIA (having pain in other joints - right shoulder and the knees. For his wife - she complains about the pain too). At the time of the report, VACCINATION SITE PAIN (pains on their left shoulders (injection site).) and ARTHRALGIA (having pain in other joints - right shoulder and the knees. For his wife - she complains about the pain too) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Patient received 1st booster dose on 25-Oct-2021, lot number 014F21A. The patient and husband got the 2nd booster dose of the Moderna Covid- 19 vaccine, they have been experiencing pains on their left shoulders (injection site). Patient complains about the pain too. Patient husband stated that they never got sick before they got the shot. No treatment information was provided by the reporter.
Red rash in the back of my left leg and swollen lymph node in my left leg groin area.
7/30/09 temp 101, febrile sz, seen by pmd, dx with viral illness.  2nd sz 7/31, still fever, seen in ED, no workup, dx viral, sent home.
COVID+ 1/15/2023.  Vaccination status - Pfizer x4 + Pfizer BIVALENT x1 PRIOR VAERS SUBMISSION -  VAERS 929214   BRIEF OVERVIEW: Discharge Provider: M* Primary Care Provider: DO Admission Date: 1/15/2023 Discharge Date: 01/18/2023 Presenting Problem: COVID Active Hospital Problems   Diagnosis Date Noted POA ? CRP elevated 01/17/2023 Unknown ? COVID 01/15/2023 Unknown ? Influenza 01/15/2023 Unknown ? Type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin 02/23/2022 Yes ? Status post heart transplant    DETAILS OF HOSPITAL STAY: HOSPITAL COURSE: This patient is a 59 yo M with PMH of heart transplant 5/9/19, DM2, HTN, dyslipidemia and paralyzed vocal cord who was admitted to the heart transplant team on 1/15/23 after testing positive for COVID and Influenza A. He was started on Tamiflu and Remdesivir (for total of 4 doses). ID was consulted. He did not require antibiotics. He was not hypoxemic. He was seen by medical services for management of his diabetes His immunosuppression goals were not changed, but his doses were adjusted to keep him toward the lower end of goal. He was medically ready for discharge on 1/18/23. Consults: Infectious disease Medical Services
Since the 1st Covid vaccine on 3/16/2021, i have lost most of my smell and taste, had a mild sore throat and constantly smell smoke.
Tremendous headache; sore arm; exhaustion. My arm was sore somewhat from when the moment I got my vaccine. My headache started around 5:30-6:30 pm but was terrible from 6:40 pm for almost exactly 24 hours to the minute. I was so tired I laid around all day and slept from 8:30pm until 3:50am, when I woke up in a lot of pain and aches in my head. I?d also sweated through my pjs and sheets. Once I got back to sleep at around 5:30am, I slept until around 9:00am. I still felt very tired and had a very bad headache until around 4pm I took some Ibuprofen which helped with the aches somewhat. Then at around 6:40pm I had a moment where all the sudden I could open my eyes more & could handle light (I?d shut all windows and turned off all lights when my headache began).  Storms were coming in so I started to feel a sinus headache which I think was coming from that, so I took Sudafed and Ibuprofen at around 8:30pm.
Information has been received from a doctor of pharmacy concerning a patient "over 60 years of age", who on 27-OCT-2010 was vaccinated with VARIVAX (Merck) (Lot # unknown) instead of ZOSTAVAX (Merck). No adverse event was reported. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available.
Next day I had severe shoulder pain in left and down my back, fever, and diarreha.
Vaccinated with shingles 11-7-12. Thursday reports HA and body aches that lasted two weeks. Treated with TYLENOL, which didn't do much for HA. At site swelling and redness 3" diameter. Itching also. As of 11-20-12 still some itching.
Immediate reaction after receiving  first dose to Anthrax in left arm. Bleeding, nodule, and tingling down arm.  Four hours late; complained of weakness, nausea, light-headiness, and  flushed in face. Site of injection present with nodule over deltoid muscle with tender to the touch complaint and still had tingling going down the left arm. Denied Shortness of breath, itchiness (anywhere), fever, or loss of consciousness. v/s are within normal limits. The facility is not a treatment facility and cannot provider any treatment other then life-threatening conditions. she was referred to seek care at the nearest emergency room or urgent care clinic. She was escorted with her direct line supervisor.
Mother reports (R) upper arm was red and itchy. Taken to Emergency Department-9 cm rash on (R) arm. Rash was "warm, tender, erythematous and indurated". Clinical impression: allergic reaction (Rx KEFLEX 500 Q 8 x 7 days).
Patient only had muffin and coffee that day early in am. Had some arm pain after shot no other reaction.  Did go home felt some nausea . Did not throw up.  Did not eat anything rest of day until around 11:30 pm . Felt much more nauseated and stomach cramping. Said she felt light headed and then had what appears to be vasovagal with brief passing out and then revived and with sweats.  Was not confused . Did not loose continence.  Was completely coherent after event. Went to ER to be checked out. In ER was found to have UTI and given some Rochephin . Had severe face and body swelling reaction requiring benadryl.  Was observed and sent home after several hours. It was assumed that ER had reported this although it was felt by ER and us that this was vasovagal from not eating and nausea and UTI on top of that.  Did not feel was secondary to vaccine  . ER did not feel it was either. However while probably unrelated we felt should document it.