chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 12 hours after the vaccine i started to get very bad chills and body aches and also fever that reached 102. Every bone in the body felt like it was cracking. This lasted about 24 hours. I was also sweating a lot. The sweating at night lasted 3 days. I have the dry mouth and tongue with a thick layer of saliva and the mouth is swollen. I also have very dry eyes and nose/throat. These also are the after side effects of covid which i had in mid jan that i was getting better from. After taking the vaccine the symptoms of swollen mouth and thick saliva including dry eyes flared up again. Today is day number 6 after the vaccine and its a little better but not much.
Bedridden; fatigue / bad reaction; This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and bedridden. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the bedridden was unknown.   The reporter considered the fatigue and bedridden to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had severe fatigue lasting a month after the second dose of Shingrix, leaving her bed ridden. The patient and staff felt it was due to the second dose of Shingrix. The reporter enquired whether a patient who had bad reaction to Shingrix could then get the flu vaccine at a later visit or not. No other shots were receive. The reporter consented to follow up.
Information has been received from a certified medical assistant concerning a 59 year old male who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The reporter indicated that the pt developed an erythematous site reaction and a fever after vaccination. The reporter also asked if this would be a "contraindication for a dose five years from now." Unspecified medical attention was sought. Additional info has been requested.
Pt recvd vax on 27AUG91 & c/o h/a, fever, redness, area hot & raised approx 3" diameter; hard to breathe;
called health system call center on 4/30/21 reporting she received dose 2 on 4/21/21. has been having left arm pain since recieving vaccine. had mild relief with Prn tylenol.  Patient was scheduled for urgent care visit for additional evaluation.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Medium, Systemic: Fever-Medium
This spontaneous report was received from a pharmacist via field employee and refers to a patient of unknown age and gender. On an unknown date reported as "a few weeks ago" the patient was vaccinated with ZOSTAVAX (Lot number, expiry date, route and dose not provided). On an unknown date also reported as "3 days later" the patient developed shingles. The patient recovered from shingles " in a few days" on unknown date. The relatedness between ZOSTAVAX and shingles was not provided. Additional information has been requested.
Extreme pain, erythema, heat and induration distal to injection site (13x13 cm).  Onset slowly increasing within 4 hours of injection. Currently 16+ hours post injection
One hour after receiving the COVID Pfizer vaccine, I experienced tightness in my throat.  The tightness lasted about one hour, then I began with all over muscle shaking, which lasted about five hours.  I had chills with the shaking, and sat on the sofa with a blanket and heater until the symptoms resided.
04/25/05- Mom RTC here to report reaction. Took child to MD for redness, itching, limping, pain. Starting 04/24/05 received Hep A 1, PCV 7 4, on 04/23/05 IM LL. No problems breathing or redness any other areas. Observed site 04/26/05, still swollen, red, improved per mom, child is walking with no limping.
Within 2 hours of injection, developed pain in shoulder, shoulder blade and neck. Within 48 hours of injection, could not use arm. Severe pain in shoulder, shoulder blade area, neck and down arm to wrist. Could not move arm- described as 'frozen'. This level of pain and dysfunction lasted two days and since, pain is less in wrist to elbow. Some improvement in function of arm but still pain in deltoid and bicep of arm. Not totally functional 4 days later. Encouraged patient to seek medical evaluation.
Information has been received from a physician concerning her 4 year old grandson who on 12/3/98 was vaccinated with a dose of varicella virus vaccine live. On 12/20/01 the patient developed a mild case of chicken pox. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint. The physician also indicated that 3 other children experienced chicken pox after being vaccinated with a dose of varicella virus vaccine live. Additional information has been requested.
Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) in a 50-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.   It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.  No treatment medications were reported.
Information has been received from a consumer via Market Research referring to her/his friend's daughter, a 13 year old female patient. It was reported the patient was healthy. On an unknown date in 2000 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, lot # and expiration date were unknown). On an unknown date the patient experienced pain which lasted a week and she was in bed for a week after GARDASIL injection. Therapy with GARDASIL was reported as interrupted and the patient did not get the second dose. The outcome of pain was reported as recovered/resolved on an unknown date in 2000, and it did not appear again. The reporter considered pain to be related to GARDASIL. It was reported none of the other friends chose to take GARDASIL because of these stated events. The reporter considered the event was serious due to the patient was in bed for a week. This is one of two cases received from the same reporter. Additional information has been requested.
After recieving 4th Anthrax on 20 May 2004 member had episode of tachycardia and diaphoresis that  lasted for 2 1/2-3 hrs then resolved. Pulse was 113 b/p 153/89. Denied CP or SOB. Symptoms began approx 4 hrs after shot. Member did come to clinic but was told he needed to go to PCP or ER for treatment as this is not a treatment facility. Member did not seek care despite advice to do so.   Only problems with 3 previous Anthrax doses was headache which pt treated effectively with tylenol. Previous 3 doses were all in year 2000.
Approx. 2 days after vaccination patient experienced pain, soreness and stiffness in arm where vaccine was given. Approx 2 weeks following. Pt saw pcp who referred her orthopedic dr. Ortho prescribed anti-inflamatory, x-ray and physical therapy.
Had all the symptoms the first few days (May 15-18) and recovered: diarrhea; body aches; chills. Felt like it was over until today, May 24th (9 days from 2nd injection). I woke up at 5 am this morning not feeling well-rested. I felt body aches, exhaustion, coughing, chest was on fire and my fever got up to 102.5F. Acetaminophen took the fever back down to 100F. I still feel drained and have muscle aches with back pain.
fever of 99.4 developed day 7; Headaches/strong recurring headaches past three nights/headaches always around temple areas; This is a spontaneous report from a contactable consumer (mother).   A 14-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 13May2021 11:30 (Batch/Lot Number: ER8735) as DOSE 1, SINGLE (at the age of 14 years) for covid-19 immunisation.  Medical history included seasonal pollen allergies from an unknown date, ongoing food allergy, ongoing Allergy to tree nuts, Cashew, pistachio, ongoing oral food allergy from an unknown date, ongoing seasonal allergy Pollen allergy -Rhinitis ongoing -pollen, adenotonsillectomy from an unknown date, removed tonsil adenoids at age 8 , anaphylactic shock from an unknown date, carries an epinephrine injector always, rhinitis from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for seasonal allergy from an unspecified start date and ongoing.  The patient experienced headaches/strong recurring headaches past three nights/headaches always around temple areas (reported as disability, medically significant) on 16May2021 20:00 with outcome of recovered, fever of 99.4 developed day 7 on 20May2021 with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: 99.4   on 20May2021, body temperature: 101.5   on 04Jun2021.  Therapeutic measures were taken as a result of headaches/strong recurring headaches past three nights/headaches always around temple area.  Headaches are nightly and require Tylenol and ibuprofen at night to sleep, strong recurring headaches past three nights which seem to subside in the morning. 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, patient has not been tested for COVID-19.  No follow-up attempts possible. No further information expected.
Developed a red rash about the size of the palm of my hand that itched really bad and also was painful.  This is day 7 and is still red, itchy and painful.
increased contact site reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (increased contact site reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TDAP (The patient received a T-dap shot first and then approximately 2 weeks later the patient received the Moderna COVID-19 vaccine.).    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 VACCINATION SITE REACTION (increased contact site reaction). At the time of the report, VACCINATION SITE REACTION (increased contact site reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up information received contained non-significant information.
extreme elevation in bp     195/132  then dropped to 95/55  and an un responsive period of more than 2 minutes.  Breathing did not stop, but unable to gain consciousness for 2+ minutes.
This spontaneous report was received from a healthcare worker (also reported as a radiology tech/vaccine coordinator) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in October 2016 (reported as "between 06-OCT-2016 and 21-OCT-2016"), the unspecified numbers of patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # L026602 and expiration date 19-OCT-2017) and (lot # L036301 and expiration date 20-DEC-2017) (dose and anatomical location were not reported). No adverse effects were reported. Excursion details: Temperature/Time: -0.1 C for 8 hours and 15 minutes. No previous excursions. This information was from a digital data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Fever, Rash,  First symptom was generalized itching,then fever, fatigue, no appetite and shooting pain right side of chest. Still having tingling and itching over body Narrative:
No symptoms or treatment, reporting due to patient being under the age of 12 years old at the time vaccine was administrated
This spontaneous case reported by a consumer, describes the occurrence of ear pain (sore arm, chills, earache), pain in extremity (sore arm, chills, earache), headache and chills (Sore arm, chills, earache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 01314209) for COVID-19 immunization. No medical history reported. On Mar 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 9, 2021, patient experienced ear pain (sore arm, chills, earache), pain in extremity (sore arm, chills, earache), headache and chills (sore arm, chills, earache). At the time of the report, ear pain (sore arm, chills, earache), pain in extremity (sore arm, chills, earache), headache and chills (sore arm, chills, earache) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
spinal cord injury with huge inflammation, somehow it moved outside my body into air; spinal cord injury with huge inflammation, somehow it moved outside my body into air; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPINAL CORD INJURY (life threatening), MYELITIS (life threatening), outcome "unknown" and all described as "spinal cord injury with huge inflammation, somehow it moved outside my body into air". Clinical course: Patient reported, "I need help!!! Your shot has created a monster of an out of controlled substance outside my body!! I have a spinal cord injury with huge inflammation., somehow it moved outside my body into air!!! I can't explain in a text !! I need someone to call me ASAP!! Or I'm going to hv to call the news!! I can't get help with drs! I'm not crazy I can prove that & a lie detective !!! Plz plz some one call me Your think tank dept, Scientist or someone with brains This is going to kill me if I don't get".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Severe 90 % hearing loss of the right ear which started the morning after the vaccine. Distorted sound in the right ear which has not improved in 3 weeks!
11/18/2019 HEADACHE, MUSCLE ACHES 11/19/2019 RASH TO CHEST, BACK ABDOMEN, NECK
Bleeding after having blood drawn for labs and after second covid vaccine dose. Bruising & bleeding after applying Dexcom G6 CGM.  I have taken baby aspirin for years and had to stop after receiving vaccination due to bruising & bleeding. This did not happen prior to receiving the vaccination. 6
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm), vaccination site bruising (bruising around injection site), pain (aches), lethargy (feels lethargic) and vaccination site swelling (swollen at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 032N20A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 6, 2021, patient experienced pain in extremity (sore arm). On Mar 19, 2021, patient experienced vaccination site bruising (bruising around injection site), pain (aches), lethargy (feels lethargic), vaccination site swelling (swollen at the injection site), chills, fatigue (tired) and vaccination site pain (arm hurt at injection site). At the time of the report, pain in extremity (sore arm), vaccination site bruising (bruising around injection site), pain (aches), lethargy (feels lethargic), vaccination site swelling (swollen at the injection site), chills, fatigue (tired) and vaccination site pain (arm hurt at injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported.
Patient received a PREVNAR 13 (right arm) and FLUZONE HD (left arm) shot on 11/20/17 and returned today on 11/25 with concern over swelling in right arm approx. light swelling 4in in diameter and a smaller 1in diameter slight forming indentation. She reports no symptoms such as pain, fever or itching, and only the site of the swelling and indentation. She was recommended to see her physician and in the meantime to take an anti-inflammatory/fever reducer which she was already taking ALEVE, and antihistamines. This is not an administration error. The pharmacist who had administered the shots, she clearly remembers the vaccines were appropriately stored/refrigerated and used sterile needles. Patient reports that she has a lot of allergies and is aware of signs of allergic reactions such as hives, swelling of throat and to seek emergency medical attention.
Adverse Event: redness and swelling 4in width x 4in height injection site 2in from shoulder medial redness and swelling extending 2.25 in anterior lateral; 2in posterior lateral induration of dense tissue 2.5in medial Treatment: ibuprofen (12.5 ml of childrens) every 6-8 hours and benadryl every 6 hours (12.5ml of children's) ice pack to area 15 min 5-6 times a day monitor for more redness, swelling, pain, can't move arm, red streaks down arm, drainage from site, or fever (100.4 or greater)
yesterday she was not feeling well; severe gall bladder pain; feeling kind of having hot flashes' during that night; abdominal distress; had some pain at the sight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Irritable bowel syndrome" (ongoing), notes: Irritable bowel syndrome manages with diet and supplements, currently her bowel is irritated, diagnosed 7-8 years or so.; "gallbladder issues diagnosed" (unspecified if ongoing), notes: gallbladder issues diagnosed about a year and a half ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot: EP6955), administration date: 17Mar2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Lot: EW0153), administration date: 08Apr2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (1st Booster), Lot: FH8020), administration date: 22Oct2021, when the patient was 58-year-old, for Covid-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 27Apr2022, outcome "unknown", described as "abdominal distress"; HOT FLUSH (non-serious) with onset 27Apr2022, outcome "unknown", described as "feeling kind of having hot flashes' during that night"; INJECTION SITE PAIN (non-serious) with onset 27Apr2022, outcome "unknown", described as "had some pain at the sight"; BILIARY COLIC (non-serious) with onset 27Apr2022, outcome "not recovered", described as "severe gall bladder pain"; MALAISE (non-serious) with onset 28Apr2022, outcome "unknown", described as "yesterday she was not feeling well". The events "severe gall bladder pain", "feeling kind of having hot flashes' during that night", "abdominal distress", "had some pain at the sight" and "yesterday she was not feeling well" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: caller states Patient has already been had this gallbladder ejection frequency issue prior to the vaccines, states has been working with acupuncturist to help in an attempt to avoid having surgery. Patient had gall bladder pain and sometimes it was not there and sometimes its maybe 0-3 pain and then sometimes, like this morning, Patient has surging acute pain. Patient received Covid-19 vaccine within Pharmacy In A Grocery Store facility type. Patient did not received vaccine In military facility. Patient does not require to visit emergency room. Patient had not prior vaccination within 4 weeks of first administration date of the suspect vaccine.
Pt c/o dizziness, nausea, feeling very warm. She was very clammy to touch and shaking uncontrollably. Her BP was 110/70 laying down and 120/78 sitting up, 122/88 standing. Pt was given juice and crackers and remained in room until pt could stand without dizziness. She also c/o her throat feeling tight.