chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started to feel tired I had lots of cough and concession and was tired. The doctor gave me prescription albuterol, and PAXLOVID. This was the 8th of November and within 3 days I started to feel better. In a complete week I was back to my normal self.
Pt received  immunizations on 03/31/2005: by 04/01/05 @ right arm, mom noted rash on body- later that day the rash increased, with fever and c/o breathing difficulties. Pt seen @ ER
24 hrs after booster jab, was at work on computer and out of nowhere,  started profusely sweating, sharp pain up left side of nostril, over left eye and left side of head behind ear. Couldn't walk in straight line was very disorientated and dizzy, unsteady on feet. Managed to get a lift home and immediately vomitted upon entering house.  This came over me in waves over the last 48hrs and still suffering now.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.    This case was linked to MOD-2021-395985 (Patient Link).
Information has been received from a woman in a physician's office concerning a 12 year old white female who on 23MAY1995, was vaccinated with a dose of varicella virus vaccine live. It was reported that on 15AUG2003, the pt developed chickenpox. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
COVID-19 Vaccine Approx 4 hrs after vaccine felt a period of brief lightheadedness. Approx 7 hrs after vaccine had severe diarrhea that lasted 48 hrs in addition to flu type symptoms (fever 100.5, headache, chills) Left Arm pain radiating to elbow, unable to raise arm.
Long lasting period of 28 days. Spotting for 9 days after and 3 days before. Cramps, dizziness, headaches. Extremely heavy flow.
ON ARRIVAL TO OBSERVATION AREA SEVERAL MINUTES POST VACCINATION, PATIENT OBSERVED AS PALE AND COMPLAINED OF FEELING FAINT. NP HELPED HIM TO THE FLOOR TO SIT. TRANSPORTED TO TRIAGE 1 VIA WHEELCHAIR. DR. ON SITE WITH PARAMEDICS.  THIS REPORTING NP ALSO ONSITE WITH NP FROM OBSERVATION AREA. PATIENT'S MOTHER ALSO IN TRIAGE AREA FOR DURATION OF ASSESSMENT AND STABILIZATION. VITAL SIGNS TAKEN AND OBSERVED WIDENED PULSE PRESSURE INITIALLY. PATIENT REMAINED FULL ALERT AFTER 10 MINUTES. hE WAS OFFERED ORAL FLUIDS INCLUDING WATER AND APPLE JUICE.  PATIENT WAS RELEASED TO LEAVE FOLLOWING SITTING UP FROM GUERNEY WITH FEET DANGLING THEN GRADUALLY STANDING FOR A MINUTE OR SO BEFORE BEING RELEASED TO LEAVE WITH HIS MOTHER WITH HIM. HE WAS ADVISED REGARDING VASO VAGAL REACTION TO INJECTION AND THAT WE WILL TAKE PRECAUTION WITH SECOND DOSE OF COVID-19 VACCINE.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 48 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 11:00 (Lot number: FF8841) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm left, administration date 01Dec2021 (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: EL3248, Route of Administration: Intramuscular, Anatomical Location: Left arm, Time of Administration: 11:00), administration date: 16Mar2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL3247, Route of Administration: Intramuscular, Anatomical Location: Left arm, Time of Administration: 10:00), administration date: 23Feb2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 11:00, outcome "unknown", described as "Dose received 3/dose number = 3"; PAIN (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "Body pain"; HEADACHE (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "Left arm pain"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 01Dec2021, outcome "unknown" and all described as "Product use for unapproved combination". Therapeutic measures were not taken as a result of pain, headache, pain in extremity. Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No follow-up attempts are possible. No further information is expected.
extreme vertigo; nausea; diarrhea; lethargy; Headache; she described as brain fog; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EN6207) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing), notes: 12years ago; "Multiple Sclerosis" (ongoing). Concomitant medication(s) included: ACETAMINOPHEN taken for headache (ongoing); ASPIRIN (E.C.) taken for headache (ongoing); CAFFEINE taken for headache (ongoing). Past drug history included: Penicillin for known allergy. Vaccination history included: Bnt162b2 (product=COVID 19, brand=pfizerbioNTech covid19,, lot number=EN6200,, administration date=17Feb2021,, administration time=02:00 PM,, vaccine location=Left arm,, dose number=1), administration date: 17Feb2021, when the patient was 73 years old, for Covid-19 Immunization, reaction(s): "Fatigue". The following information was reported: VERTIGO (non-serious) with onset 18Mar2021, outcome "recovering", described as "extreme vertigo"; NAUSEA (non-serious) with onset 18Mar2021, outcome "recovered" (19Mar2021), described as "nausea"; DIARRHOEA (non-serious) with onset 18Mar2021, outcome "recovering", described as "diarrhea"; LETHARGY (non-serious) with onset 18Mar2021, outcome "recovering", described as "lethargy"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "she described as brain fog"; FATIGUE (non-serious) with onset 17Feb2021, outcome "unknown", described as "fatigue". Therapeutic measures were not taken as a result of vertigo, nausea, diarrhoea, lethargy.  Additional information: The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Prior Vaccinations (within 4 weeks) include Pfizer Covid-19 vaccine, first dose. Adverse events did not require a visit to Emergency Room/Physician Office.AE(s) following prior vaccinations, Relevant Tests were reported as None.  No follow-up attempts are possible. No further information is expected.
This is a 33 y/o male that received revaccination of smallpox vaccine on 14 July 2003.  One week following vaccination he developed persistent chest pain for approximately 4-5 days.  He described the pain as a daily mid- sternal "pulling pressure".  The pain progressed to a sharp sensation and worsened with moving, bending or leaning over.  He associated the pain with physical activities at work and did not seek evaluation.   The same week he had a dental procedure performed.  Following his dental procedure he went down to the ER to wait for his ride.  While he was waiting in the emergency room he passed out.  He was monitored in the Emergency room for two hours and then transferred to a hospital for further evaluation.  He was admitted for one week.  He underwent several diagnostic and laboratory test and  was diagnosed with myocarditis by a cardiologist.  He was discharged after one week and instructed not to deploy until further evaluation and follow-up that was scheduled for 13 August 2003.   In August 2003, he was deployed before his cardiology follow-up appt.  During his deployment, he experienced episodes of chest pain.  On 4 October 2003, he was airvac for evaluation of chest pain.  He was seen by cardiologist, and hospitalized for one week.  He was then transferred.  A repeat echocardiogram, EKG, and MRI were done.   He is currently on convalescence leave. He continues to experience mild dull chest  "aches".  He denies SOB, fatigue, nausea, myalgia/arthralgias. 60-day follow up received on 01/22/04: "It is unknown if the pt recovered from the adverse events."
Vaccine administered at approximately 10:45 AM At 10:50 AM patient said her sight was blurry and fading out and eventually said she could not see.  This was within a two minute span.  During that two minute span she began fainting (dropping to the point that she had to be carry walked to lay down)  Dr. listened to her heart, took her pulse and the nurse took her blood pressure.  She was communicating the entire time.  She rested for about 5 to ten minutes before we left the doctor's office.
Less than five minutes of receiving vaccine: Eyes rolling back, feeling of fainting, tinnitus, blue lips, blue fingers, really hot,  Thirty minutes after receiving the vaccine: bad chills/shakes/shivers/teeth chattering, diarrhea, confusion
tiredness; low grade fever; body aches; This case was reported by a consumer and described the occurrence of tiredness in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced tiredness, low grade fever and general body pain. On an unknown date, the outcome of the tiredness, low grade fever and general body pain were unknown.   It was unknown if the reporter considered the tiredness, low grade fever and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received a dose of Shingrix last night of reporting date and was experiencing low grade fever, body aches and tiredness. The reporter inquired if those events caused by the vaccine.
After 2nd dose, slept for most of day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 23Feb2021 09:00 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN. Vaccination history included: Bnt162b2 (Dose 1; administration time: 01:30 PM; vaccine location: Left arm), administration date: 04Feb2021, when the patient was 55 years old, for COVID-19 immunisation, reaction(s): "Very sore arm for approx. 48 hours". The following information was reported: HYPERSOMNIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "After 2nd dose, slept for most of day". Therapeutic measures were not taken as a result of hypersomnia. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness and redness after shot. A couple hours later developed firmness and redness below the injection site. The area was itchy and hurt at the touch and was about an inch in diameter.  On April 29th, at around 3:30 pm arm started hurting, itching and started getting chills. Took Tylenol and drank electrolytes to keep hydrated. After the chills happened I noticed temperature started rising and had  to leave work. Had fever, chills, soreness and itchiness all night. The morning of April 30th no fever nor soreness but around 10 am temperature spiked from 98.7 to 100.7. Took 2 Tylenol pill ands temperature decreased.
A couple of hours after my fist dose Moderna vaccine, my left arm began to hurt, I also developed headaches, body aches and left arm swelling. At 1am-2am, I could not move my left arm and my fever was 103.3F. I contacted urgent care who told me to take Ibuprofen as pain medication.  My symptoms did decrease although I still have today difficulty sleeping and sweat at night which I did not have before the vaccine.
This spontaneous pregnancy report as received from a 34 year old female consumer with no drug reactions/allergies refers to herself. On 13-SEP-2013 the patient was vaccinated with a dose of M-M-R II, injection, (dose and route unspecified). Other suspect vaccines administered on the same day included an unspecified varicella vaccine (manufacturer unknown), an unspecified tuberculosis vaccine (manufacturer unknown) (dose and route unknown). Concomitant medication included TDAP (manufacturer unknown). The patient then became pregnant on an unspecified date "within 3 months" following the vaccination date. The LMP was on 10-SEP-2013 and EDD was on 17-JUN-2014. The pregnancy outcome was pending. No lab diagnostics studies performed. The patient sought medical attention via spoke with an unspecified physician. No treatment was given. No adverse experience was reported other than becoming pregnancy. The patient also reported that, according to an unspecified physician, sometimes exposure to unspecified vaccinations during pregnancy was "good for the (unborn) babies' immune systems". Additional information has been requested.
Per NP note, "This is a 31 y.o. female presenting to the emergency department with a chief complaint of intermittent headaches onset five days ago s/p Johnson and Johnson vaccination. The patient's headaches are localized to the right front side of her head and are described as severe and "throbbing". She notes that these headaches are nothing like she has experienced before. Associated symptoms include dizziness. The patient was instructed to come here by her nursing school, who is concerned she may be at risk of CVA due to the recent vaccination. The patient got a notification from CVS warning about risks of the vaccine which prompted her concern as well. The patient denies any facial changes, fever, sore throat, cough, nausea, vomiting, diarrhea, urinary complaints, abdominal pain, shortness of breath, or chest pain. The patient has no other symptom complaints at this time."
Mom states baby went limp after shots (immediately) then approx 3 hrs later went limp again and was transported by EMS to hospital. Spent 23hrs in hospital with normal EEG and labs. Went home recovered.  8/17/07 Received hospital medical records which reveal patient experienced a near syncopal episode, pale, limp unresponsive.  Sent from PCP office to ER for BP check & then released to home.  Second episode of unresponsiveness/limpness occured & returned to ER.  Admitted 7/31-8/1/07 for observation.  No further spells in hospital FINAL DX: AE after a vax. 9/4/07 Received vax records from PCP which confirms RO dose & lot # as reported.
Started feeling chilled in afternoon with fever starting in evening. Up to 103.8 over next few days. Remains between 101-to 102.8 with Tylenol and flu meds. Diarrhea started today 10/18/2010. No vomiting to date.
Pt developed itching on left thigh at injection site on 11/19/14 pt had onset of redness and swelling of left thigh with localized blisters and sloughed skin. Prescribed KEFLEX x 7 days for possible infection and BENADRYL PRN for itching.
NONE pt died 28JUN93 death dx SIDS; focal superficial hemorrhage of visceral surface of lungs w/focal low grade acute & chronic inflammation; hyperemia of liver; poss low grade resp tract infect of poss viral orgin;
Fever; general body aches; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 15 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 12Jan2022 20:00 (Lot number: FJ1614) at the age of 15 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION HCL XL; AMPHETAMINE. Vaccination history included: Cormirnaty (Dose Number: 2, Batch/Lot No: EW0186, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 04Jun2021, for COVID-19 Immunization; Cormirnaty (Dose Number: 1, Batch/Lot No: EW0186, Location of injection: Arm Right, Vaccine Administration Time: 04:30 PM), administration date: 14May2021, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Jan2022 21:00, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 13Jan2022 21:00, outcome "recovering", described as "general body aches"; HEADACHE (non-serious) with onset 13Jan2022 21:00, outcome "recovering", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, headache.  Additional information:Patient had no vaccination within 4 weeks of vaccination. Prior to vaccination patient had not been diagnosed with COVID-19. Patient had not been tested for vaccination since vaccination. There were no known allergies. Follow-up attempts are completed. No further information is expected.
PATIENT REFERS NUMBNESS IN MOUTH, TONGUE AND LEFT SIDE OF THE BODY.
This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in an 18 year old male subject who was vaccinated with Engerix B for prophylaxis.  On an unspecified date the subject received 3rd dose of Engerix B in an unknown deltoid to complete the three dose series.  On an unspecified date following completion of the Engerix B series, the subject had a negative titer.  The reporter suspected a possible quality issue with the vaccine.  At the time of reporting the outcome of the events was unspecified.
This spontaneous report was received from a nurse via company representative concerning to a male patient of approximately 11 years old. The patient's historical conditions, concurrent condition and concomitant medications were not provided. In Fall 2018, the patient received a dose of unidentified Merck GARDASIL 9 or GARDASIL (strength, route of administration, anatomic location, lot number and expiration date were not provided) as prophylaxis. On an unspecified date, the patient experienced stroke. The patient sought for medical attention from unspecified healthcare provider and he received unspecified medical treatment on unspecified date. The nurse also reported that the patient had a speech impediment. The outcome of cerebrovascular accident was reported as not recovered. The causality assessment between the events and unidentified Merck GARDASIL 9 or GARDASIL was not provided. Upon internal review, cerebrovascular accident was determined to be a medically significant event and the speech disorder to be significant disability.
Immediately after receiving the shot I had redness at the site of injection. I also felt tired about 6 hours later, like if you don't get enough sleep the night before. The next day, around the 22 hour mark post-shot, I began to feel very ill. I had chills, the worst headache of my life, a mild fever, a huge red spot on my arm, body aches, exhaustion, and soreness in the arm where I received the shot. This lasted at least until 10:00 PM when I went to bed. If this is what the flu feels like, I never want to get it! The next morning most symptoms were gone, although I still felt a little tired and my arm was still sore. The redness at the injection site lasted about 4 days and the soreness lasted 3 days total.
4/5/2021  Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening without incident. She was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Felt dizzy after her 15 minutes, kept her additional 15 minutes, gave her juice and checked her vital signs, BP 133/79, P 83, O2 99%, she states she feels much better after drinking juice.   Pt was instructed to call 911 with any severe reactions post vaccine: o Difficulty breathing  o Swelling of face and throat  o A fast heartbeat  o A bad rash all over body  o Dizziness and weakness    Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/5/2021  7:05 PM
10 days after vaccine, 3 cm erythematous raised rash with central clearing around vaccine injection site. Severe pain, inflammation.
arm is red; arm is warm; rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is red), FEELING HOT (arm is warm) and INJECTION SITE RASH (rash at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included hives (7 years ago and recently returned a month or two prior to report (and before vaccination)). Concurrent medical conditions included Asthma, Hypertension and Hypothyroidism. Concomitant products included MOMETASONE FUROATE (ASMANEX) for Asthma, LEVOTHYROXINE, TRIAMTERENE, METOPROLOL, VITAMIN D3, POTASSIUM CHLORIDE and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Feb-2021, the patient experienced INJECTION SITE RASH (rash at injection site). On 22-Feb-2021, the patient experienced ERYTHEMA (arm is red) and FEELING HOT (arm is warm). At the time of the report, ERYTHEMA (arm is red), FEELING HOT (arm is warm) and INJECTION SITE RASH (rash at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.