chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One week after 4 month check, presented to office with unusual movements for several days. Quickly recognized as infantile spasms in the office. Admitted for treatment. EEG showed hypsarrhythmia. Started on steroids. Remains on anticonvulsants with seizures controlled by significant developmental delay.  9/17/09 PCP records received. In for 4 month WCC. Returned shortly after with c/o muscle tightening, stiffening, shaking, head thrown back with eye deviation. Quiet after.  Episodes noted during PE with horizontal nystagmus, head turns to Left.  In between-normal.  DX: Epilepsy, Infantile Spasms w/o intractable epilepsy. Tx: prednisone. At 6 and 9 month check developmental milestones not being met. Neurodevelopmental consult 4/13/09 with following dx:  Static encephalopathy.  Global developmental delay. Seizure d/o-infantile spasms. Hearing impairment.  Cortical dysplasia-gray matter heterotopia.  Oral defensiveness. Hypotonia. Hypohydrosis and heat intolerance. Adrenal suppression 2' to ACTH and steroids. Increased spasms in 5/2009. Recent cochlear implant. Increase in seizures after meningitis and other vaccines.  9/22/09 Hospital records received, multiple consults, DOS 8/8/09 to 2/9/09 with the following additional information: Assessment: Central Nervous System Heterotopia. Patient spits up formula. Dry cough. Fever. Upper airway congestion. Tachypnea. Upper respiratory infection, pneumonia.   10/13/09 ICD-9 Codes received: 749.22 Cleft lip and palate unilateral incomplete, 381.3 Other chronic nonsuppurative otitis media, 345.60 Infantile Spasms without mention of intractable seizures, 754.0 Congenital deformity of skull face and jaw, 486 Pneumonia unspecified organism, 742.4 Other brain anomaly, 276.51 Dehydration.
Bld press (120's norm) to 172 - 36 hrs. Severe headache. Dizziness. Atrial Fib-skip beats. Neuropathy-incr. Allergies-ZYRTEC. None wheezing.
A week or 2 after the vaccine started getting shortness of breath. I checked my oxygen on this meter I have, and it showed that my oxygen was dropping into the 80's. So, I contacted my doctor and he called and suggested I go to the ER, but I was afraid to go because of COVID-19. So, I put new batteries in my meter and my oxygen looked a little better, so I talked myself out of going even though my wife disagreed. A few days later I woke up in the middle of the night with chest pain and shortness of breath. I made an appt to see my doctor. He did a D-dimer test on me. Scheduled me for an MRA with contrast- multiple pulmonary emboli. He sent me straight to the ER, and I had to sit and wait for 7 hours and never saw a doctor. They ended admitting me right from the waiting room. They set me up and started heparin drip, and while I was there did an EKG- normal, bloodwork- normal, mildly anemic, ECG-normal. They could not figure out why I had pulmonary embolism. After 3 days, they released me to follow up with primary provider. He reviewed my results and referred me to Hematologist. Waiting on contact from them.
Partial dose of vaccine (less than 1/2 dose) was given in error and a repeat dose has been rescheduled per CDC guidelines.  Patient reported to RN that he had no adverse effects from vaccine, and will return for revaccination.
This spontaneous report as received from a health department registered nurse refers to a 12 years old female patient. The patient was vaccinated with expired GARDASIL (lot # (666595/0096Z), expired on 14-OCT-2012) on 22-OCT-2012. No adverse effects reported. Additional information has been requested.
Within 2 or 3 minutes after the injection she became very pale and clammy and said she didn't feel well at all.  Shaky, weak, a little dizzy. She said the back of her neck became suddenly very hot as well. Lasted for 15-20 min after injection.
On  11/4/22 began to have fever chills, and some chest tightness with shortness of breath,  went to ER on 11/5/22 and went into cardiac arrest was put on vent and transported to hospital.  Is still in hospital as of today, 11/9/22
Sore muscles after a few hours post vaccine. Around 10pm had a very hard time moving legs to get up. During the next day continued increased pain and stiffness in joints and numbness and tingling in face and arms nausea and mild dizziness
developed shingles eruption and nerve pain under left breast. Treated with Valtrex 1 gram TID x 7 days. Resolved. Second eruption May 2021 in same location. Same treatment, then placed on Valtrex 500mg prophylactic. Resolved. In June, same eruption below left breast, then shingles crossed midline under right breast. Same treatment, then placed on Valtrex 1 gram qd as prophylactic. On 08/17, new shingles eruption back of neck right side, crossed midline to left side. New eruptions under both sides of breast. Shingles on neck far worse in terms of number, nerve pain, and size. Placed again on Valtrex 1 gram TID and am still on this dose. Also placed on Metanx for post-herpetic neuralgia.
Sore throat/Soreness in throat; Congestion; Coughing; Sneezing but could be allergies per patient/Reported sneezing 5 times in a row which was expulsive; Swelling of the lymph nodes; Fatigued/tired; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat/Soreness in throat), NASAL CONGESTION (Congestion), COUGH (Coughing), SNEEZING (Sneezing but could be allergies per patient/Reported sneezing 5 times in a row which was expulsive) and LYMPHADENOPATHY (Swelling of the lymph nodes) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included LISINOPRIL, LORATADINE (CLARITINE), FLUOXETINE, LEVOTHYROXINE, ALOGLIPTIN, MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ZINC for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat/Soreness in throat), NASAL CONGESTION (Congestion), COUGH (Coughing), SNEEZING (Sneezing but could be allergies per patient/Reported sneezing 5 times in a row which was expulsive), LYMPHADENOPATHY (Swelling of the lymph nodes) and FATIGUE (Fatigued/tired). At the time of the report, OROPHARYNGEAL PAIN (Sore throat/Soreness in throat), NASAL CONGESTION (Congestion), COUGH (Coughing), SNEEZING (Sneezing but could be allergies per patient/Reported sneezing 5 times in a row which was expulsive), LYMPHADENOPATHY (Swelling of the lymph nodes) and FATIGUE (Fatigued/tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, SARS-CoV-2 test: negative (Negative) tested negative for the rapid test.         It was reported that patient called and stated that she is fully vaccinated and has been exposed to her 2 children who tested positive for covid and are sick with covid. She stated that both kids are wearing a mask in the house and remain upstairs for most of the time. She stated that one of the children was not vaccinated as they are 17 years old. She stated that she has 2 people in the house with the virus.  The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was Not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Non-Significant follow up appended
Body aches, fever, chills, swollen lymph node under arm where I recd the shot, headaches, neck pain,
About May first , two weeks after my second Vaccine shot, I started to feel pain in my left knee that I never had before , gradually pain increasing and became intense,  I did left hip replacement in 2018, did very well, I noticed when I press right the bottom part of the knee i feel pain, walking became difficult, i had to use cane when i never used cane when i had severe left hip osteoarthritis, standing on my feet became hard, bending left leg became painful, i started to take wobenzyme tablets , epsom salt bath, putting ice on the knee and solanpus, the pain almost was gone after couple of days but it returned and now feel pain even sitting, i contacted my holistic dr for natural treatment, my xray is mild arthritis both knees, my primary dr is not sure what the cause is when  i tell her for no reason i started to have this intense left knee pain, walking with cane after vaccination and never had any discomfort in my life. dr has ordered knee physical therapy only
Started with gas and some diarrhea.  Progressed by 9/15 to extreme fussiness, more frequent diarrhea, and lack of sleep.  (Baby was up the entire night.) By 9/16, diarrhea was more frequent, and baby also had reflux-like symptoms.  Another night of no sleep and lots of crying.  9/17, baby still has diarrhea and has also developed coughing and a mild rash on her back and chest.  Still extremely irritable.  Calling doctor tomorrow.
patient tested positive for COVID on 1/19/2022, having had symptoms the previous 4 days.  presented to the emergency department on 1/21/2022  from infusion center when she was found to be hypoxic.  She was sent to the infusion center because of a diagnosis of COVID-19.  She was going to get infusion but did not meet criteria because she was found to be hypoxic.  She was diagnosed with COVID-19 2 days ago triage tent.  She is reporting her symptoms been ongoing for 5 to 6 days.  Symptoms has been 5 to 6 days.  Describes symptoms as moderate.  She had increased shortness of breath over the last several days.  She denies associated symptoms of nausea, vomiting, no abdominal pain no hematuria no dysuria no diarrhea no other associated symptoms no modifying factors.  She is vaccinated with 2 COVID-19 vaccine, no booster.  Patient is dialysis Monday Wednesday Friday.  She did not do dialysis today as it was deferred to tomorrow with a diagnosis of COVID.  She was admitted to ICU, and expired 1/28/2022.
sneezing; coughing; nose ran like water all day; Not like a cold just this head stuff; This is a spontaneous report from a contactable consumer, the patient. A 64-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration, administered in arm left on 27Feb2021 14:45 as dose 1, single (at the age of 64-years-old) for covid-19 immunization. Medical history included nephrectomy on Jan2020 (dad kidney removed Jan2020), ongoing cancer (but doing amazing and all good) and allergies to caffeine, sulfa drugs, codeine and some blood pressure medications. Concomitant medications included calcium, magnesium, vitamin C [ASCORBIC ACID], omega oil and verapamil. On 28Feb2021, the patient experienced a sneezing, coughing, nose ran like water all day, not like a cold just this head stuff. It was reported that the patient had shot on Saturday afternoon, woke up at 03:00 (28Feb2021), could not stop sneezing and coughing, nose ran like water all day. The patient took antihistamine at 11:30pm woke up all good. Another episode a few days later and woke up 2am morning 09Mar2021 same as first episode. Could not get nose to stop running, violent sneezing. The patient did know if it was related to vaccine but never had this happened before. Not like a cold just this head stuff, otherwise patient felt great, but it was hard to do anything because she literally hangs over the sink and just let it run out of nose. The patient took flonaise and more antihistamine as a treatment for the events. The patient did not receive any other vaccine in four weeks. The events were resulted in doctor or other healthcare professional office/clinic visit. The patient had not covid prior to the vaccination and patient had not tested for covid post vaccination. The outcome of all events was not recovered.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 12:57 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 12:57 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 83.67.  Concomitant medication of the patient was not reported.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature of 29 degrees Fahrenheit at 09:00 AM, 35 degrees Fahrenheit at 10:00 AM and 11:00 AM respectively. These vials were moved to fridge on 02-Feb-2021 and 09-Feb-2021 and beyond use date for the vials was reported as 03-Mar-2021 and 10-Mar-29021. The vaccines moved to clinic on 05-Feb-2021 and 12-Feb-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2019SA010556 (same reporter). This case involves a 24 years old female patient who received vaccine MENACTRA. Expiry date: 14-Oct-2018 (lot number U5746AC) via unknown route in in the right arm, on 10-Jan-2019. The patients past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included INFLUENZA VACCIN. It was a case of actual medication error due to expired product administered. ( It was reported that expired doses of MENACTRA were administered) No reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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
Breakthrough case admission after two doses Pfizer 3/3/21 Lot# EN6202 Pfizer 3/24/21 Lot# ER8727
Redness at injection site (~4" by 6" stripe on her upper arm around injection site) - flu-like symptoms: fatigue, headache, body aches.
This study case was received from the investigator on 06 May 2010. A 20 year-old male subject with no significant medical history was vaccinated with ACAM2000 on 07 August 2009. Fifteen days post-vaccination on 27 August 2009, the subject was diagnosed with other and unspecified acute myocarditis (ICD-9 code 422.9) and the following day on 28 August 2009 a diagnosis of non-specific myocarditis (ICD-9 code 429.0) was reported. The subject had an abnormal troponin I (8.9) on 18 August 2009, an abnormal electrocardiogram on 18 August 2009, an abnormal echocardiogram on 19 August 2009 and a normal MRI of the heart on 01 September 2009. No other information was provided. The outcome of the subject was not reported. List of documents held by sender: None. Note: Additional Information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance study.
Dizziness, nausea, and sore arm. 15 minutes to 1/2 hour after flu shot.
Pt received her 1st injection of the series at the age of 17 versus the recommended age of 18 y/o.  Nurse called and spoke with mom to notify of the finding and to check in on pt.  Mom reported that pt experienced soreness at the site with mild swelling and a low grade temperature.  Mom reported that pt denied the suggestion of any medication and s/s resolved in less than 48 hours.  Mom reported that pt would be returning to health center as scheduled for second dose per CDC recommendation.
2 weeks after 2nd dose hives appeared over entire body. Throat began to close, received a Prednisone shot and 5-day dose of Prednisone. Hives reappeared after finishing prescribed meds. Was told to take 2 Allegra in the morning, 2 in the afternoon, and 2 in the evening. Hives reappeared after Booster dose of vaccination. (Arms, hands, legs, ankles, and the top area of the feet)
Aching joints. Shivering. Vomiting. Difficulty breathing. Decreased blood pressure (approximately 85/40). Increased white blood cell count.
Severe migraine headache and multiple joint pain until steroids Mar 21, now slight headach. Swollen face Mar 20, 21, 22.  Fatigue and brain fog for 10 days. Went to emergency room twice. Mar 18 and 21.
Dizzy spell lasting for about 1 minute while out gardening - so bad patient had to stay down on hands and knees on the ground for it pass.
Was out of it for 36 hours; Was throwing up; Had a fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was out of it for 36 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    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 LOSS OF CONSCIOUSNESS (Was out of it for 36 hours) (seriousness criterion medically significant), VOMITING (Was throwing up) and PYREXIA (Had a fever). At the time of the report, LOSS OF CONSCIOUSNESS (Was out of it for 36 hours), VOMITING (Was throwing up) and PYREXIA (Had a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Systemic: heart palpitations-Medium, Additional Details: pt experienced heart palpitations and skipping beat sensation and hs not gone away
Headache, nausea, dizziness, severe swelling on arm where vaccine administered, bruising, armpit swelled & turned black & blue under where vaccine administered, swelling still present 3 weeks later. Doctor gave steroid pack for treatment & also prescribed consistent icing of the site.
Developed left supraclavicular swelling, lymph node enlargement, mildly tender lymph nodes less than 48 hours after booster dose. Ipsilateral to vaccine site.
Dose administered >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0352CIA) for COVID-19 vaccination.   No Medical History information was reported.  On 21-Oct-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No relevant concomitant medications were reported.  Treatment information was unknown.  Patient height is given as 66 inches.  On 20-Oct-2021 at 07:40 AM, the vial was first punctured and on 21-Oct-2021, patient was administered with the vaccine from the vial. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 31 hours.  Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received contains significant information, patient details and suspect drug details updated
Shoulder and armpit pain approximately 2 weeks after receiving flu shot. Pain is better but not resolved at six months after receiving shot.
Age:  22 yrs   Date of Admission: 12/25/2021 Chief Complaint: Labor  Source of Information: Patient and Available medical record   History of Present Illness: This is a 22y.o. G1P0 at 40w0d dated by patient reported EDD.  Patient seen in L&D for contractions that started at 0200 this morning. Patient seen earlier tonight at different hospital and was sent home due to not making cervical change.Patient receives prenatal care unable to access any records. Patient denies any complications with this pregnancy. Based on records int the computer patient IGG positive for HSV-2, denied any history or prodromal symptoms at this time. Endorses hx of chlamydia back in march, states she was appropriately treated.  History At present (+)CTX, (+) FM, (-) LOF, (-) VB. Gestational Age(weeks days/7): 40      Method of Delivery: Vaginal, Spontaneous     Birth Weight: 2.95 kg (6 lb 8.1 oz)
A really bad pain in her left arm  where she got the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A really bad pain in her left arm  where she got the second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 045A21A) for COVID-19 vaccination.     No medical information history.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (A really bad pain in her left arm  where she got the second shot). At the time of the report, VACCINATION SITE PAIN (A really bad pain in her left arm  where she got the second shot) outcome was unknown.            No treatment medication provided. No concomitant medication provided.