chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a consumer concerning her 12-month-old Caucasian daughter who on 19-JUL-2006 was vaccinated with a dose of Varivax. There was no concomitant medication. On 19-JUL2006 the patient developed a fever of 103.9 and began "behaving really cranky". Unspecified medical attention was sought. It was noted that the fever was intermittent for approximately one month without other signs or symptoms and was eventually diagnosed with a UTI and ureteral reflux. No laboratory or diagnostic tests were reported. The reporter noted that the fever was probably unrelated to the vaccine but coincidentally began at the same time. No outcome was reported. No product quality complaint was involved. Additional information is not expected.
COVID-19 breakthrough. It started on the 2nd. I had a persistent dry hacking cough. The next day it got worse and I had to stay home from work. I went to get tested for COVID-19 and tested positive. I started to feel better by Friday. I hacked up some stuff so my doctor prescribed me a antibiotic, levofloxacin. I have also lost my sense of smell and the cough is pretty much gone.
When putting my son in the car, approximate 15 minutes after he was vaccinated, we noticed a few mosquito-like bumps on his leg, right at the site of the shot.  Over the course of the next several hours, the hives spread all over his body, outward, first on his chest then his face; first on his thighs then down to his feet.  They also became increasingly itchy and painful, peaking at around 5pm.  At the advice of our doctor, gave dose of Benadryl every few hours, which helped calm things down, but the hives continued to come and go for the next 2 days.
Fever, headache, nausea, joint pain, unusual tiredness/weakness, aching muscles, muscle weakness, bad stomach ache.  2/18/09 Received vaccine records & PCP medical records of FINAL DX: viral syndrome & vaccine allergic reaction Records reveal patient experienced left arm pain s/p vaccination w/fever, HA, facial swelling, difficulty swallowing, gen aching, nausea, & seen in ER 2/6/09.  Tx w/IVF & meds, imiproved & d/c to home.  Missed 3 days of school.
Patient presented to local facility on 1/10 with rapid heart rate. Patient woke up diaphoretic and  was also very fatigued.  Upon getting out of bed, patient felt slightly off balance; she attributes this to 50 mg Benadryl at night prior to sleep.  She usually takes Benadryl at night.  She experience limping pain in her chest as of her heart was beating very fast.    She was mildly short of breath.  No nausea, vomiting patient never experiences before.  No H/O SVT a or any other arrhythmias.  Unknown if there is family history of arrhythmias.  She has been vaccinated against COVID-19.  Patient was diagnosed with COVID-19 infection and 11/2020 and has had a cough/chronic nasal congestion since then.  She was not hospitalized at that time.  Patient is not smoker.   No illicit drug use.  No cannabis use.  No caffeine, stimulant, energy drink use.  No thyroid disease.  No history of VTE.  No herbal medications/over-the-counter medication/pseudoephedrine use Noted the patient's HR was in the 210 and gave adenosine 6 mg which converted the patient to sinus rhythm.  Patient also received ASA.  At that time, patient had chest pain/pressure.  Patient did have negative stress test in 2015 (it was ordered at the time when she was having MS symptoms).  No fever, chills.  Patient is complaining of more runny nose and worsening dry cough at the moment.  No sore throat, AP, LH, paresthesias, headache, LE swelling.  Patient was tired 1 day PTA.    Patient was admitted with SVT/ Sepsis 2/2 COVID-19 infection.  Patient given IV magnesium.  After discussing with the patient, patient received monoclonal antibodies. Remdesivir initiated. Patient asked to hold off on OCP (which is being used for ovarian cysts and not for contraception) for few days and to discuss with PCP 1 to resume a since she is hypercoagulable with current infection with COVID-19.  Patient is being discharged in stable condition.
Information has been received concerning a case in litigation, via medical records, concerning an approx 2 year old male with an unremarkable neonatal course and no known drug allergies with a family history of demyelinating process (brother)revealed via MRI who on 1/28/1989 was vaccinated with the first dose of MMR II 9lot 631641/0917J) was given on 9/3/1999. In approx Oct 1989, the pt was noted to have speech delay as he was no longer saying distinct words and could only be heard to utter jargon in a sing song manner. He was also noted to have stopped developing. In approx April 1990, a diagnosis of autism was made. on 5/10/1992 the pt was hospitalized in a pediatric ward for reactive air way disease, developmental delays and to rule out pervasive developmental delay. At that time, the pt was noted to have poor speech with a vocabulary of approx 15 words. He was evaluated by a developmental pediatrician who noted that the pt appeared to be showing very stereotypical behavior consistent with Pervasive developmental delay (PPD), in particular, autism, The physician noted that the pt had a severe verbal and non verbal communication disorder with some deviant social interactions. In additional, the pt had chromosomes which were also sent for fragile X, which were negative, High resolution chromosomes that were done revealed that the pt was a 46 xy normal male by chromosome appearance. The pt also had a normal EEG and audiological evaluation. A speech evaluation concluded that the pt had a severe speech delay pattern. Discharge diagnosis included PPD, probably moderate to severe mental retardation and reactive airway disease. On 7/10/1992, the pt was seen by a developmental pediatrician who confirmed a diagnosis of PPD, but was unclear of the specific etiology of the pts developmental difficulties. On 9/15/1992 and MRI of the brain was normal. On 3/19/2001, the pt developed a seizure disorder for which he was hospitalized. ON 3/20/01, a cranial CT scan was normal (no mass lesion and fluid space normal). The pt was also noted to have ADHD and neurobehavioral problems for which he was treated with multiple medications. As of 7/12/2001, the pt was becoming more violent, screaming all the time and hitting family members especially his mother, he had learned some single word slight vocabulary and spelling and numbers, but continued to converse in a single words at best and his verbal reasoning was rudimentary at best. The pt was currently taking lorazepam (Ativan) 4mg BID, divalproex NA (Depakote) 500 mg in the morning and clonidine 2 mg at night. Upon internal review, autism and moderate to severe mental retardation were determined to be an other important medical events (OMIC). Medical records received on 9/12/06 contained the following adverse experienced reactive airway disease requiring hospitalization. Ethmoideral and sphnoid sinus disease, revealed via cranial CT scan. No further information is available. All available medical records will be provided upon request.
Fever for 5 nights, fussiness for 9 days, gastrointestinal pain and distress for 9 days, problems feeding for more than one week post vaccination.
6-27-02 1st PNEUMOVAX - 0 reachon 1-6-09 2nd PNEUMOVAX - tenderness, redness from site to elbow (Lt), hardness @ site local RXN only - no systemic SX or a injec edema hives etc. Update pt was seen earlier 1-7-09 but returned later evening with increased swelling but no sytemic c/o's. Advised to continue BENADRYL/ice. No further contact after 1/7/09 noted.
Chills, extreme fatigue, elevated resting heart rate (105bpm), shortness of breath but normal SPO2 (98%), Fever
At noon 5/23/12 began with headache, jts aching, diarrhea, muscles aches, extreme fatigue. At 600 pm fever 100 degrees, went to bed at 730 pm awakened intermittently with chills, fever. At 900 am after speaking to clinic took ADVIL - noticed redness, swelling (L) lower arm.
c/o sharp chest pain which radiating to L lower chest and body ache since J&J shot yesterday 1700. denies took any meds.
Fevers, aches, chills, general malaise sore, red swollen arm since vaccine -treated with prednisone.
Horrible nightmares; Sweating; Sore arm for 3 days; Feeling of unreality; Headaches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 36 years old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ew0171), via an unspecified route of administration in the left arm on 26Apr2021 at 16:45 (at the age of 36-years-old), as a first single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included Suboxone (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 27Apr2021 at 13:00, the patient experienced horrible nightmares, sweating, sore arm for 3 days, feeling of unreality, headaches, and chills. The clinical outcome of horrible nightmares, sweating, sore arm, feeling of unreality, headaches, and chills was recovering.   No follow-up attempts are possible. No further information is expected.
Ringing in ears. I told my primary care physician about it. She said it was allergy related. I say it?s vaccine reported.
Caller has not had very much of an appetite; muscle aches all over; little rash on the lower left arm; low grade fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Caller has not had very much of an appetite), MYALGIA (muscle aches all over), RASH (little rash on the lower left arm), PYREXIA (low grade fever) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031278) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Dose Number: 5 and Batch/Lot No: 062D22A) on 21-Oct-2022; for Drug use for unknown indication: CALCIUM (Vitamins like Calcium) and VITAMINS NOS (Vitamins like Calcium). Past adverse reactions to the above products included No adverse event with CALCIUM, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) and VITAMINS NOS.    On 08-Oct-2023 at 12:30 PM, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 08-Oct-2023, the patient experienced DECREASED APPETITE (Caller has not had very much of an appetite), MYALGIA (muscle aches all over), RASH (little rash on the lower left arm), PYREXIA (low grade fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Caller has not had very much of an appetite), MYALGIA (muscle aches all over), RASH (little rash on the lower left arm), PYREXIA (low grade fever) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2023, Body temperature: around 100.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745657 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745657:same patient, different dose
Pt got TWINRIX. Developed aby to HAV only but not HBV after proper dosing. Has happened to other patients. Is HBV vaccine part not effective?
Hospitalized after 1st dose; second dose of the Moderna COVID-19 Vaccine on today, 14May2021; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Hospitalized after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the Moderna COVID-19 Vaccine on today, 14May2021). On an unknown date, the patient experienced HOSPITALISATION (Hospitalized after 1st dose) (seriousness criterion hospitalization). On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the Moderna COVID-19 Vaccine on today, 14May2021) had resolved. At the time of the report, HOSPITALISATION (Hospitalized after 1st dose) outcome was unknown.            No relevant concomitant medications were reported. The caller reported that both he and his mother received the first dose on 31-Mar-2021. His mother was then hospitalized due to unspecified reason. Due to the hospitalization, his mother missed her second dose. The caller then took her to receive her second dose on 14-May-2021. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.  Company comment: Very limited information regarding this event has been provided at this time. However, This report refers to a case of (inappropriate schedule of product administration) for mRNA-1273, lot #  unknown, with no associated AEs.; Sender's Comments: Very limited information regarding this event has been provided at this time. However, This report refers to a case of (inappropriate schedule of product administration) for mRNA-1273, lot #  unknown, with no associated AEs.
the patient "experienced diarrhea that started on 07/01/2019 and lasted for 4 weeks, until 07/22/2019, which also had blood and mucus in it."; the patient "experienced diarrhea that started on 07/01/2019 and lasted for 4 weeks, until 07/22/2019, which also had blood and mucus in it."; was then administered the 2nd dose of ROTATEQ (unknown lot/exp date) in the series on 06/28/2019; Information has been received from a nurse prescriber via a field employee, referring to a 4 months old female patient. The patient had no concomitant medications, no pertinent medical history and no drug reactions or allergies.  On 11-APR-2019, the patient was administered the first dose in the series of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, lot # and expiration date were unknown) orally for routine vaccination with no adverse symptoms. On 28-JUN-2019, the patient was administered the second dose in the series of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, lot # and expiration date were unknown) orally for routine vaccination (Inappropriate schedule of vaccine administered).  On 01-JUL-2019, the patient started experiencing diarrhea and lasted for 4 weeks, until 22-JUL-2019, which also had blood and mucus in it. Parent of the patient contacted the reporter. There was no treatment given for the events. On an unknown date, stool cultures were completed and the results were negative. The outcome of the events was recovered. The causality between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.   Upon internal review, diarrhea had blood in it was determined to be medically significant.
Interchange of vaccine products; She has COVID-19; She has COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "vocal cord's problems" (unspecified if ongoing); "pouch in her esophagus" (unspecified if ongoing); "she cannot swallow big pills" (unspecified if ongoing); "Polio" (unspecified if ongoing); "bulbar polio" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She has COVID-19". Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Noticed that face was swelling on both sides about 4 days after the shot / Today is 8 days later, and look like a chipmunk/ The swollen area is a bit tender to the touch; Noticed that face was swelling on both sides about 4 days after the shot / Today is 8 days later, and look like a chipmunk; Day after shot, "I" was exhausted; Day after shot, was exhausted and muscles were very achy; The patient received a third/booster dose; The patient received a third/booster dose; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Sep2021 at 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and morbid obesity. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications within two weeks of vaccination which was reported as several, but nothing new. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Mar2021 at 15:00 (at the age of 60-years-old) and also previously received the second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 15:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 29Sep2021, day after the shot, the patient was exhausted and muscles were very achy. On 02Oct2021 at 14:00, about 4 days after the shot, the patient noticed that her face began to swell on both sides, was not sure if the swelling had started earlier. On 06Oct2021, 8 days later, the patient "looked like a chipmunk", and the swollen area was a bit tender to the touch. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with mild prednisone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events exhausted and muscles were very achy and face began to swell on both sides, 8 days later, the patient "looked like a chipmunk", and the swollen area was a bit tender to the touch was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
About 7 days after vaccination I began experience intense itching all over my body.  Not at the vaccine site but all over.  Skin hypersensitivity.  It was very intense.  I saw my Dr and then a Dermatolgoist and they recommended taking an antihistamine.  I have been taking Allegra for the last 9 months.
Swelling and erythema on left thigh with lymphedema practically covering all left thigh. Erythema recovering at left gluteal area.
rash/itchiness on the arm that received the injection; rash/itchiness on the arm that received the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (rash/itchiness on the arm that received the injection) and VACCINATION SITE RASH (rash/itchiness on the arm that received the injection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (rash/itchiness on the arm that received the injection) and VACCINATION SITE RASH (rash/itchiness on the arm that received the injection). The patient was treated with CORTISONE for Vaccination site rash and Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (rash/itchiness on the arm that received the injection) and VACCINATION SITE RASH (rash/itchiness on the arm that received the injection) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
I have received two Pfizer COVID 19 vaccinations in March of 2021 and a Moderna COVID 19 booster in November of 2021.  I received the two Pfizer shots in my upper left arm and experience the expected soreness in my arm for about 2-3 days each time. However, after that time period, I continued to experience sharp pain in my arm and muscle weakness off/on for the next few months with an inability to move my left arm above my head or behind to my back without experiencing severe pain.  When I received the Moderna booster, I asked to get in my right arm. I am now experiencing the same issue in the right arm with a sharp pain that comes and goes but is noticeable enough that it keeps me up at night. Meanwhile, almost a year after receipt of my original Pfizer vaccine the pain in my left arm is noticeably less.  I read about Parsonage-Turner syndrome following COVID-19 Vaccination in two patients and thought to report my experience here as well, though I have no laboratory or imaging results to share/confirm.
Pneumonia; High BP; Fall; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster); Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: PNEUMONIA (medically significant), outcome "unknown"; HYPERTENSION (non-serious), outcome "recovered", described as "High BP"; FALL (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Therapeutic measures were taken as a result of hypertension.  Clinical course: Patient was in good to excellent health, high BP controlled with Lisinopril, plus oral HRT. Patient had pneumonia in second grade, patient not had flu shot since last fall, and had both COVID Shots and two boosters.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.