chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 20-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included no previous pregnancies.  Prior to becoming pregnant the subject had not been using contraception.  On 29 August 2011 at 13:30 the subject received a booster dose of Boostrix (.5 unknown units, intramuscular, right deltoid), and experienced vaccine exposure during the second trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 24 weeks gestation at the time of vaccination.  Date of last menstrual period was 24 February 2011 and estimated delivery date was 16 December 2011.  Prenatal testing including ultrasound on 31 August 2011 had revealed no evidence of a defect.  There were no adverse events at the time of reporting.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound performed on 31 August 2011 revealed no evidence of a defect.
Started out itching at site within 5 min. of administration. Then developed soreness, redness, warmth and edema within 30 min. I took Phenergan 12.5mg and Motrin 800mg 1 hour after vaccine administration. I repeated Phenergan 6.25mg 5 hours after vaccine administration. Took Motrin 800mg at 08:00 AM on 10/4/12. Arm remains sore, red, and hard to touch. Also have itching over entire arm, but no visible rash on remainder of arm.
Patient received flu shot on 12/8/14, he came to pharmacy on 1/17 and said his arm is weak since he got the shot. he has difficulty picking up stuff.
Patient reported severe pain on the right side of his body and radiating down his leg starting 1 week after administration of the vaccine. After the second dose it got much worse.
Pt recv vax on 8/25/98; on 8/26/98 pt exp foaming at the mouth, unable to speak, unresponsive; pt to E.R.
Erythema, warm arm-shoulder to elbow, started 2 hrs p/inject; better by the next day;
No further AE; Medical assistant calls to report TE yesterday 7/25/2023.; This spontaneous report was received from a medical assistantand refers to a 22-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, one time, lot #x004813, expiration date: 28-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion on 25-JUL-2023, before administration to a patient. Temperature excursion took place in 50.5 Farenheit (F) for 54 hours 15 minutes (Product storage error). No additional adverse event was reported.
Headache, aches, fever, 10 hours after, dizziness 2 days after and now two weeks later, still dizzy at times.wake up spinning
Right bicep area - red rash-like patch of skin approx 1"x2". Pt states it is not causing discomfort/pain, or itchiness. States arm has "regular" pain from receiving vaccines
Fairly severe pain at injection site - beginning approx an hour or so after shot, increasing and lasting for about 3 days, although it did diminish in severity somewhat after about 36 hours.  Ibuprofen relieved most pain.  Also, redness about 3" X 4" at injection site started 2nd day and lasted until end of 3rd day.  Itching started when redness disappeared.  Still minor soreness at site after 3rd day.
altered mental status, fever over 40C, myocarditis, rhabdomyelitis.
This spontaneous report was received from a pharmacist regarding a 70 year old female patient. Pertinent Medical history and drug reactions/Allergies were none. On 09-DEC-2013 the patient was vaccinated with first dose of PNEUMOVAX23 lot # J004332; expiry: 26-AUG-2013, dose: 0.5 ml (millilitres), intramuscular. Concomitant therapies included lisinopril (manufacturer unknown). On 09-DEC-2013, the patient experienced the arm in which PNEUMOVAX was injected was really sore and she woke up and was unable to go back to sleep. It was reported that the patient when she went to bed on the evening of 09-DEC-2013 the arm in which PNEUMOVAX was injected was really sore, and at 3:00 am on 09-DEC-2013 her arm was in so much pain that she woke up and was unable to go back to sleep. The pharmacist recommended that the patient use a hot pack or a cold pack on the affected arm and use TYLENOL (manufacturer unknown) or ibuprofen (manufacturer unknown). The patient sought medical attention and called the pharmacist. The outcome of the events was reported as not resolved. Additional information has been requested.
no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 03-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 64-year-old female patient who received SHINGRIX. The patient's past medical history included thyroid gland cancer (thyroid removed) and mononucleosis. On 18th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 18th April 2018, several hours after receiving SHINGRIX, the patient experienced feeling unwell, influenza-like symptoms, fever, general body pain, pain of skin, hypersensation skin, headache, photophobia, fatigue, abdominal discomfort, difficulty breathing and cough. On an unknown date, the outcome of the feeling unwell, general body pain, pain of skin and hypersensation skin were unknown and the outcome of the influenza-like symptoms was recovering/resolving and the outcome of the fever, headache, photophobia, fatigue, abdominal discomfort and difficulty breathing were recovered/resolved and the outcome of the cough was unchanged. It was unknown if the reporter considered the feeling unwell, general body pain, pain of skin and hypersensation skin to be related to SHINGRIX. The reporter considered the influenza-like symptoms, fever, headache, photophobia, fatigue, abdominal discomfort, difficulty breathing and cough to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. At 10:00, the patient received SHINGRIX vaccine in left arm. Around 8:00 pm that evening the patient was not feeling well and started to feel worse during then night. The patient had flu-like symptoms which included, low-grade fever, body aches, skin sensitivity (her skin hurt when it touched the bed sheets), headache, bright light bothered her eyes, and extremely fatigued. The patient also felt sick to her stomach and found it hard to breath. On 19th April 2018, she was unable to get out of bed that day due to these symptoms. On the day of reporting, the patient was feeling a lot better but still felt fatigued and wiped out. She said her eyes do not look good because she was still not feeling well. She also started coughing on the same day. The reporter gave permission for her physician to be contacted.
Presented to ED w/SOB, cough, congestion; admitted for COVID-19 pna, acute resp failure; tx w/ O2 therapy, abx, remdesivir, steroids, mag, zinc; dc'd home on baseline O2 therapy
Dizziness, light headed, intense spinning vertigo on May 4, 2021 about 25 days after injection.   Ongoing vision and balance/vertigo issues.  Ringing in both ears.
Soreness in arm at the injection site; Chills; Fever; Sweating; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on an unknown date refer case US2020004313).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, chills, fever and sweating. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, chills, fever and sweating were unknown.   It was unknown if the reporter considered the injection site pain, chills, fever and sweating to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. It was reported that the patient had soreness in her arm at the injection site for both the first and second vaccine. The patient had chills, fever, and sweating. The reporter did not consent to follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; ASTELIN [AZELASTINE HYDROCHLORIDE]; IBUPROFEN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid as Treatment of COVID-19 from 15Dec2022 to 20Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt developed chest pain/shortness of breath by 4/20, proceeded to local Hospital  ER by 4/21 w/ N-STEMI on EKG w/ elevated troponin >8000, ECHO with global hypokinesis and mod-severe AR,, Chest CTA neg for PA/PNA. Emergent cardiac catheterization negative for CAD,  Transferred to another Hospital 4/22 where cardiac MRI confirmed acute edema. he was monitored by Dr's team for 10 days with improvement in LV function and reduction to near normal troponin level. Workup neg for eosinophilic carditis. Discharged home by 5/1 w/ rest precautions and adjustments made to his BP medications. Now followed by local cardiologist Dr.
suddenly had severe dizziness the next day.  Had trouble walking and extremely weak.  Had the usual muscle pain and feeling blah.  I was asked to report this by health dept due to this being an atypical response.  I have never reacted to a vaccine before.
No adverse effect reported; patient inadvertently received an expired dose of Varivax; This spontaneous report was received from a lab technician and refers to a patient of unspecified age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. The patient's concomitant therapies included Merck sterile diluent.  On 26-MAR-2019, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dosage form, lot#N008828, expiration date 16-MAR-2019 (anatomical location was not provided) for prophylaxis. No adverse effects were reported.
like a bruise at the injection site; it feels different but , not hurt, no itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (like a bruise at the injection site) and FEELING ABNORMAL (it feels different but , not hurt, no itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (past medical history not provided). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and LOVASTATIN for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced INJECTION SITE BRUISING (like a bruise at the injection site) and FEELING ABNORMAL (it feels different but , not hurt, no itchy). At the time of the report, INJECTION SITE BRUISING (like a bruise at the injection site) and FEELING ABNORMAL (it feels different but , not hurt, no itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information as not reported.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-FEB-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
mild soreness at vaccination site (Right deltoid, note form says Left Deltoid).  2 days later, developed "closing of throat" sensation, followed by Laryngitis same day.  Next day, voice was all but gone, and coughing up yellow mucus.
Arm had swelling/Arm still touchy/Swollen arm; Spent all day in bed; Couldn't move; Painful/ Tender; Hardness at injection site; Chills; Body ache; Headache; Fever; Very tired and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm had swelling/Arm still touchy/Swollen arm), BEDRIDDEN (Spent all day in bed), HYPOKINESIA (Couldn't move), PAIN (Painful/ Tender) and VACCINATION SITE INDURATION (Hardness at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VALSARTAN, ATORVASTATIN, HYDROCHLOROTHIAZIDE (HCT) and ALPRAZOLAM (XANAX) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm had swelling/Arm still touchy/Swollen arm), BEDRIDDEN (Spent all day in bed), HYPOKINESIA (Couldn't move), PAIN (Painful/ Tender), VACCINATION SITE INDURATION (Hardness at injection site) and FATIGUE (Very tired and fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 11-Feb-2021, CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Fever) had resolved. On 15-Feb-2021, PERIPHERAL SWELLING (Arm had swelling/Arm still touchy/Swollen arm) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. At the time of the report, BEDRIDDEN (Spent all day in bed), HYPOKINESIA (Couldn't move) and PAIN (Painful/ Tender) outcome was unknown and FATIGUE (Very tired and fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100.2 (High) Fever (100.2).         This case was linked to MOD-2021-250759 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26 Apr 2021 and patient's e-mail address updated. On 09-Jul-2021: Follow up received on 09 Jul 2021 included updates in the reported events.
Patient had the PNEUMOVAX on 9/17 and was hospitalized 9/18 with fever/sepsis. There was no obvious fever source. He had significant leukocytosis on admission. After he was in the hospital one day he started to develop a tender, red patch of skin on his left upper arm which was the site of his PNEUMOVAX. Dx- cellulitis related to the injection.
Moderna COVID-19 Vaccine EUA.  Red circle on skin two days post injection on same arm, a few inches down and to the right of injection site.  Initial circle was about 2 inches in diameter.  Rash did not itch but was sore to the touch.  Rash peaked at about day six, having spread intermittently down the arm toward the elbow and around to the inside in patches. Each patch was sore to the touch, and also felt slightly warm. Eventual area about  six by four inches.  It began lightening in color and soreness at eight days. The soreness is leaving as the redness fades.  Hydrocortisone creams relieves the minor itching.  There has not been any fever or muscle pain other than the first couple of days after the injection.
I had fever, congestion and slow heart rate. I also had a cough, chills and sore throat. This lasted for about a week. I still have the bradycardia and the cough. I tested positive on Jan 15th for COVID-19.
pt recv vax 30AUG97 & exp a sudden onset of sunburn like generalized body rash w/associated itching;pt recv 2nd dose of vax & 3-4wk later sudden onset of severe itching over entire body;also exp perioral edema w/gross swelling,resp distress
Bell's Palsy (House-Brackmann grade IV) developed on 4/4/21, 17 days after administration of the first Pfizer Covid=19 dose.   Pt was started the next day (today) on prednisone and valacyclovir.
woke up not feeling good;  a few hours later headache and dizzy; dizziness increased; driving and hard to keep eyes open; feeling overall sick and getting very hot; threw up quickly three times water only nothing in my stomach.  Got home and went to bed and slept for a few hours.  Woke up and felt better.   Headache and fatique so rested the day; next day felt better with headache and rested.  Third-day slight headache but felt much better.
Information has been reported in a study. The report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide vaccine (PPSV23) brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 31-JAN-2014. This spontaneous report as received from a other health professional refers to 5 patients. The median age of the patients was 69 years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced death. The outcome of death was reported as fatal. The cause of death was reported as other infectious. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases 1406USA003857 (respiratory disorder), 1406USA003863 (Unknown), 1406USA003859 (other non infectious disorder), 1406USA003860 (gastrointestinal), 1406USA003861 (Neurological), 1406USA003862 (Undetermined) and 1406USA003351 (Cardiovascular). Additional information has been requested.
About 10 hours after receiving hep B vaccine had episode of "gasping for air". Lasted about 1 hour. Did feel warm at that time, then irritable. Seen following day had some nasal congestion otherwise normal.
Knots to both legs, red splotches red to torso and legs. irritability X15-20 minutes. Tactile warmth.
Patient was vaccinated with the Janssen COVID-19 vaccine.  He was not eligible to receive it as he is minor. Patient did not report having an adverse reaction.
Pt received vaccine at an in-school clinic and returned to class. Within 10 mins of receiving vaccine. Pt was sitting at desk when he reported feeling light headed and believes that he passed out. Pt fell to floor from sitting position and the teacher reported that he quickly recovered and could report what had taken place. Event was over within minutes. Teacher reported that pt. slightly jerkes/twitched just before falling from desk has bump on (L) side of pt head treated and cool pack. Pt rested for one hour, then went home. Pt reported feeling fine.
Information has been received from the authors in a literature article as stated above. A two-year- old boy presented with a three-day history of fever and headache and a one-day history of periorbital edema, erythema, and a progressive vesicular rash on the right face. His pediatrician initially diagnosed bilateral otitis media and prescribed amoxicillin/clavulanic acid for 10 days. The next day, he developed a vesicular, pinkish-red rash with swelling over the right eye and forehead, accompanied by fatigue, decreased oral intake, and intermittent abdominal pain. He was admitted for presumed meningitis and herpes zoster infection. There was no clinical suspicion for immunodeficiency. While there was no known previous exposure to chickenpox, the boy had received a single dose of varicella vaccine (manufacturer unknown) at 12 months of age. Physical exam revealed scattered pinkish-red vesicles and papules on the right forehead, glabella, and superior eyelid. The lesions respected the midline, extending to the nasal bridge and right frontoparietal scalp in a V1 distribution. The right superior eyelid had near-confluent erythema and edema with sharp demarcation at the right lateral canthus; subsequent ophthalmological examination revealed an otherwise normal eye. Right anterior cervical lymphadenopathy was present. Labs revealed an elevated serum white blood cell count with increased polymorphonuclear leukocytes, pleocytosis, and positive varicella polymerase chain reaction (PCR) on cerebrospinal fluid (CSF) analysis; and positive varicella PCR directly from a skin scraping. Herpes simplex virus and enterovirus CR of CSF were both negative. The patient was treated with intravenous acyclovir (60mg/kg/day) for 10 days with total clearance of his skin lesions and symptoms. Herpes zoster is a rare diagnosis in children with a reported decreasing incidence since the advent of the varicella vaccine. Upon internal review the event Meningitis was determined to be medically significant. Additional information has been requested
Ten days post vaxs, this pt developed "20 small papules and lesions and a couple of small pustules on the face and neck. He presented with a fever of 102. The following day the physician dxed him with "atypical varicella." He recovered.
patient presented to emergency department on 11/16/21 with shortness of breath, lightheaded, cough and fever. pt said he was diagnosed with covid-19 on 11/9/21 patient was admitted for further management of pre-syncope patient was found to be covid-19 positive on 11/16/21 after swab test again on 11/16/21 patient did require treatment for symptoms associated with covid-19 infection. treatment included dexamethasone and remdesivir.  patient was discharged to home on 11/29/21