chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was received from a health care professional on 10 October 2007. Additional information was received from a newspaper article. An 18-year-old female patient received a meningococcal vaccine (name, manufacturer, and lot number not reported) on an unspecified date. The patient, who was a college freshman, travelled on 05 October 2007 to visit her family for the weekend. She reportedly felt "slightly ill" upon her arrival, and subsequently took an aspirin and went to bed, awakening at 1:30pm the following afternoon 'appearing refreshed". She became feverish again that night, and awoke at 1:00am the morning of 07 October 2007 with chills and a severe headache, complaining that "my head is about to explode". She was taken to a local hospital, where a CAT scan of the brain revealed meningococcal disease in her brain and brain stem. She was immediately transferred to another hospital, and died that evening of 07 October 2007 due to complications of meningitis. The health department noted that "lab tests have not yet confirmed the strain of meningitis" but that it was "likely the type not prevented by the vaccination". Past medical history and concomitant medications were unknown: it was not known if the patient was ill at the time of vaccination.  10/18/07 Patient name received from FDA.  10/18/07 Received death certificate from funeral home which states COD as brain death due to cerebral herniation and meningoencephalitis.  10/26/07 Received vax record from pcp which indicates patient received HPV & Menactra on 5/10/2007.  VAERS database updated w/same. Vax record indicates patient also received 2nd dose of HPV 6/13/2007, Lot # 0523U, left arm.  11/27/07 Reviewed hospital medical records which reveal patient experienced HA, fever & neck pain x 1 day.  Had come home from college 10/5 & developed chills next day. Seen in outlying ER where LP showed high pressure, grossly purulent CSF growing meningococcus.  Intubated & IV antibiotics started & transferred to higher level of care.  Neurosurgery & ID consults done.  Pupils dilated & nonreactive.  Diffuse cerebral edema leading to brain herniation & death.  12/4/07 Reviewed ER medical records which reveal patient seen 10/7/2007.  Patient experienced pale, nausea, fever, chills, HA, neck stiffness, back ache & photophobia.  Temp in ER max 104.7  Became nonresponsive w/posturing in ER.  Intubated.  Started on IV antibiotics & transferred to higher level of care.
chills, fever of 101.6 with Tylenol on board, headache, chest tightness, nausea, malaise
very dizzy; Nausea off and on; off balance focusing; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (very dizzy), NAUSEA (Nausea off and on) and DISTURBANCE IN ATTENTION (off balance focusing) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced DIZZINESS (very dizzy), NAUSEA (Nausea off and on) and DISTURBANCE IN ATTENTION (off balance focusing). On 30-Dec-2020, DIZZINESS (very dizzy) had resolved. At the time of the report, NAUSEA (Nausea off and on) and DISTURBANCE IN ATTENTION (off balance focusing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided; Reporter'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
Development of mild disease from a live vaccine. Redness and tenderness at injection site. Warm to touch. No fever. Spots appearing on torso and arms. Referred to Personal Physician for definitive diagnosis.
Pt called to return to hospital for covid testing as her husband tested positive.  Dry cough and nasal congestion.
Muscle very sore the evening of and more so the next morning (11/3/23), then 11/4/23, it was very itchy and there were multiple vesicles at the site.  Very red, hard, itchy and many vesicles.  They were scratched and popped, then scabbed over.  Scabby, itchy, dull ache still present as of 11/7/23.
Chest palpitations; difficulty breathing; fatigue; This is a spontaneous report from a contactable consumer or other non hcp.     A 57-years-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: ER8727; Expiration date: 20Jul2021), via an unspecified route of administration, administered in Arm Left on 09Jun2021 09:00AM (at the age of 57-year-old) as, 0.3ML single for covid-19 immunisation.  Medical history included diabetes mellitus from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, apnoea from an unknown date and unknown if ongoing.   The patient's concomitant medications were not reported.  It was reported that patient did not administered any other vaccine in four weeks. It was reported that other vaccine in two weeks was reported as yes. It was reported that covid prior vaccination was no. Covid tested post vaccination was no. Patient had known allergies. The patient experienced chest palpitations, difficulty breathing, fatigue on 01Jul2021.  Therapeutic measures were taken with inhalers, ekg as a result of chest palpitations, difficulty breathing, fatigue. The outcome of events was not resolved.   Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Menactra booster dose was given at 14 years age with no reported adverse event; Initial information received on 01-Feb-2022 regarding an unsolicited valid non-serious case was received from the health professional.  This case involves a 14 years old female patient to whom meningococcal a-c-y-w135 (d conj) vaccine (Menactra) booster dose was given at 14 years age with no reported adverse event.  The patient's past medical history, medical treatment(s), and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 01-Feb-2022, the patient received a booster dose of suspect meningococcal a-c-y-w135 (d conj) vaccine at 0.5 ml total (lot number: U6951AA) via intramuscular route in right deltoid for immunization (product administered to patient of inappropriate age) (latency: same day). Reportedly, the patient was inadvertently administered a booster dose of meningococcal a-c-y-w135 (d conj) vaccine too early. Healthcare professional asked if there was any special to watch for in terms of safety or if there was any information on the validity of a dose given early and in response to the information provided in the "Booster Dose" SRD, whether it means in this case that the child could get the Menactra booster dose "when the child reaches at least the minimum age" or since this inadvertent dose was given at 14, would the patient have to wait 3 years until age 17 before getting a Menactra booster, since "the repeat dose should be spaced after the invalid dose by the recommended minimum interval." HCP stated that she had spoken to the patient's mother about three hours after the inadvertently dose, and the patient was fine and not experiencing any issues so far.  Action taken with meningococcal a-c-y-w135 (d conj) vaccine was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
This spontaneous report as received from a consumer reporting on himself: a 65 year old male patient. He had no pertinent medical history. No concurrent conditions were reported. The patient has had drug reaction/allergy to NIASPAN. On 23-JUN-2014 the patient was vaccinated with PNEUMOVAX 23 injection, dose 2, for prevention of pneumonia; lot#, expiration date not reported. Concomitant therapies included CRESTOR 20mg, Lisinopril (manufacturer unknown), COREG, PRILOSEC and ASPIRIN 81 mg. On 24-JUN-2014 the patient's arm (below the injection site) started to become red and swell. The next day, on 25-JUN-2014, the redness and swelling continued down the patient's arm and stopped right above the wrist. The patient saw his physician, on an unknown date, and was given unspecified steroid shot and an unspecified antibiotic shot. The patient was also prescribed cephalexin 500mg and prednisone 20mg. At the time of the report the patient was recovering after the physician started him on the treatment. It was also reported that the patient has had PNEUMOVAX 23 on an unspecified date (reported as "over 5 years ago") and did not have any adverse experience. Relatedness between use the PNEUMOVAX 23 and the adverse events was not reported. Additional information has been requested.
Headache, Myalgia, Fever, chills, photosensitivity, fatigue
skin rash on both arms 5 minutes after vaccination, throat tightening sx's, globus sensation, headache and palpitations 5-15 minute after vaccine administration.  8 hours later, sensation of chest burning, throat burning and dyspnea; watery eyes and facial warmth.  Associated facial erythema and eyes rolling in head X 5 minutes.   Had alternating cold and warmth sensation - now still.  Sx's continued - especially globus sensation.  + abdominal pain continued for few days.  One week later, patient with dyspnea.  + eye dryness.
Pt denied allergies. TD given in left deltoid with reaction approx 20 mins later RTC and stated felt dizzy and c/o sweating, tightness in chest with nausea, appeared anxious, Pt put in supine position on table. BP 120/80, P82, Ct still c/o nausea. but no tightness of chest, no SOB ever noted 2:45 pt left in wheelchair to car with fiance driving. Pt instructed to go to ER if needed.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jun2023 at 15:00 as dose number unknown, single (Lot number: GL0087), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "MGUS" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid treatment from 21Aug2023 to 26Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288164 same patient, different drug/event;
12 hrs after IM I started to feel malaise, lethargy and had body aches. I continued with these symptoms for about 12 hrs. During the 12hrs I also had severe injection site pain and muscle soreness, chills, sweats and felt as if I had a low grade fever (did not check temp). Towards the end I had a headache. After 12 hrs I was fine. I have no residual side effect from the IM which was 12 days ago.
ARM WHERE INJECTION WAS RECEIVED SORE APPROXIMATELY 3 WEEKS LATER.
Nurse administered 0.5 cc of Tdap to client.  Expiration date was checked before administration of vaccine but still was not realized til entered into grits.  Vaccine expired on 5/2/09 but was given on 5/4/09.  Reported to supv.  No report of reaction.
no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 31-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
redness, swelling, itching, growing lump ONE WEEK AFTER vaccine was administered.
Patient has completed Moderna COVID-19 series on  2/16/2021 and 3/9/2021 and then tested positive for COVID-19 infection on 5/20/2021. Possible breakthrough case.
This spontaneous report was received from a health care worker (certified medical assistant) refers to patients of unknown age and gender. The patients medical history and concurrent conditions were not specified. The reporter stated that, multiple unspecified patients received improperly stored doses of ROTATEQ orally (lot # L004466, expiry date 02-AUG-2016, dose, strength, dose number, vaccination site not provided) on unspecified dates. Concomitant medications were not specified. Additionally 7 doses of ROTATEQ were administered to these patients on unspecified dates. No adverse effects were reported. The vaccines were exposed to temperature of 50.03 F for a time period of 48 hours. There was no previous temperature excursions. No additional information was provided. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Headache, moderate to severe, gradually worsening over several hours Fatigue, moderate to severe, gradually worsening over several hours Ache in neck and shoulders, moderate Nausea, mild
Patient noted to have a fingertip sized depression in (L) upper arm approximately 1 mo? after vaccine (suspect Fat Necrosis). (No change in physical finding).
swollen lymph nodes; Joint Pain; Weakness; Explosive headache; Muscle pain; fever for 1.5 days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HEADACHE (Explosive headache), MYALGIA (Muscle pain), PYREXIA (fever for 1.5 days) and LYMPHADENOPATHY (swollen lymph nodes) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 10-Nov-2023, the patient experienced ASTHENIA (Weakness), HEADACHE (Explosive headache), MYALGIA (Muscle pain), PYREXIA (fever for 1.5 days) and ARTHRALGIA (Joint Pain). On 13-Nov-2023, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). On 11-Nov-2023, ASTHENIA (Weakness), HEADACHE (Explosive headache), MYALGIA (Muscle pain), PYREXIA (fever for 1.5 days) and ARTHRALGIA (Joint Pain) had resolved. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) was resolving.            Concomitant medication was not reported.  It was reported that the patient had explosive headache, weakness, joint and muscle pain, fever for 1.5 days, 4 days later, swollen lymph nodes.   Treatment medication was not reported.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; COULD NOT MOVE ARM; LEFT ARM PAIN; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. 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: 201A21N, expiry: UNKNOWN) dose was not reported, 1 total, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure, suspected covid-19 infection which further explained as the patient did not undergo clinical testing for diagnostic confirmation. The patient experienced fever, cough, and body aches. The reporter also noted that after initially received the vaccination patient developed a headache that lasted for 2 months and left arm pain such that he could not move his arm for 2 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm pain, headache and the outcome of suspected covid-19 infection, suspected clinical vaccination failure and could not move arm was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number 90000213691. This case, from the same reporter is linked to 20220139528 and 20220139639.; Sender's Comments: V0-20220139854-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
I received the H1N1 injectable vaccine on Tuesday, Oct. 20th. I requested the injectable due to my recently being diagnosed with Interstitial Cystitis. I felt OK Tuesday evening, went to bed at 21:00. I woke up at 05:00 Wednesday with a bad headache. Because of the medications I was on for my I.C. (ELMIRON 100 mg tid and ELAVIL 30 mg qd and PYRIDIUM prn) I could not take anything for the headache. I got to work at 08:30 and continued to work with the headache getting progressively worse. At 14:30, I left for a GYN appointment. While driving I became nauseated and had to pull over to vomit x 2. I decided I was not in any shape for the GYN visit and instead drove to my home. I cancelled the GYN visit and called someone to alert her of my illness. We discussed whether or not it was related to the vaccine, as both headache and nausea were listed on the handout as possible side effects. I had no further vomiting, but continued with a severe headache until I fell asleep about 20:30 with a hot pack on my neck. We discussed that I would call her cell phone and leave a message, and I would call my own physician if I was not better Thursday morning. I woke up at 05:15 Thursday and the headache was gone. I have had no further symptoms since. I am not sure if it was related to the vaccine, as it may have been in combination with my I.C. I did not have this reaction with the seasonal flu shot I had received  09/22.
Patient reported dizziness at 13:20. Vitals WDL. Patient placed in recumbant position. Patient stated she felt much better.
Seven days after vaccine administered I experienced an itchy area of about 3" x 3" around the injection site. The area was hot to touch, felt bruised and developed a bumpy rash. Today, which is two days later, the reaction is subsiding.
Pt was to receive 0.25 ml booster dose Sars-2-COVID, instead received 0.50ml dose. Nausea for 24-36 hours. Better now.
I had a fever bring my temperature lower than normal.  I experienced uncontrollable shaking, dry mouth, headaches, body pains, and sweating intensely. These symptoms hit with no warning. One second I was putting a Christmas tree up and the next thing I know I was crawling to the couch asking my wife for blankets. Thank God I wasn't driving or away from home... This terrible feeling lasted for 48 hours and I have to admit it was MUCH WORSE than any symptoms I received from having COVID-19. I wanted to go to the emergency room but didn't want an ambulance to pick me up or leave the couch with the shaking. My wife was very scared for my life.   After 6 days I'm still feeling weaker than normal and I have a slight ache in my left leg that won't go away.
Pain and swelling around injection site; Fever; Chills; Headache; Body aches - Lasted about 8 hours
I got Covid-19 twice. I had stuffy nose and cough. First time the symptom lasted for about a week. The second time lasted for about 2 weeks. On 03/03/2021 and 01/07/2022 was tested positive for Covid-19.
Rapid heartrate (120s), shortness of breath, and palpitations started within 24 hours of second vaccination. Went to Urgent Care on Friday, ECG completed. Urgent care sent patient to ER to be evaluated further. ER physician states rapid heartrate and symptoms likely due to the vaccine.
During A Employee Health Clinic for Staff on 4.2.2021.  We had three people either no show or cancel.  Instead of just wasting the doses we called anyone we could think of that could make it in before 1500. 1500 was when the vaccine was no longer within the 6 hour reconstitution period. I was the person who called my sister and she brought my niece with her. I believed her to be 18 but she is only 16 1/2 and the Shot was given already, before this was noticed. She waited the 15 minutes had no issues and went home with her Mother.  The only side effects noted to me was a sore arm and a slight Head Ache.
About a week after shot, pt started experiencing extreme muscle fatigue/weakness/paralysis & also overall fatigue. It has lasted 3 months. She had just started getting slightly better over last 3 weeks. Couldn't perform normal daily functions.
3.5 cm circular diameter erythema, warmth, no induration. Vacc site (L) deltoid. Pt given 400mg po Ibuprofen and 10mL of 12.5mg/5mL BENADRYL on 4/21/13 at 1535. Wrong vaccine administered 4/19/13 by MA. DTaP given should have been Tdap.
pt recv vax; exp fever, flu-like sx & blisters around genital area & mouth;