chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from the mother of a 11 month old male patient with allergies to peanuts. On 15-MAY-2000 the patient was vaccinated with the first dose of (Merck) VARIVAX (lot # 631476/1004J, EXP date 10-DEC-2000). On 08-AUG-2008 the patient was vaccinated with the second dose of (Merck) VARIVAX  (lot # reported as 05284 or 0528Y). On an unknown date in 2011 the patient experienced severe reaction to sulfa and was hospitalized. Patient sought unspecified medical attention. There was no lab diagnostics performed. At the time of report, the status of patient was unknown. Additional information has been requested.
I had problems with breathing; headache; went into itching; fever with chills; fever with chills; fatigue (slept all day Sat); body aches; balance issues; This is a spontaneous report from a contactable consumer reported for himself.   A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number: EN6108) via an unspecified route of administration in arm left on 05Mar2021 09:45 AM as 2nd dose, single dose for COVID-19 immunisation. The patient medical history included afib, mouth cancer and known allergies were codeine. The patient's concomitant medications included glucosamine (GLUCOSAMINE), apixaban (ELIQUIS), tamsulosin (TAMSULOSIN), and multivitamin. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number:  L9264) via an unspecified route of administration in arm left on 12Feb2021 09:45 AM as 1st dose, single dose for COVID-19 immunisation. No other vaccine in four weeks. No treatment received for adverse event, no covid prior vaccination, did not tested covid post vaccination. On 05Mar2021, 01:15 PM patient experienced headache, went into itching, fever with chills, body aches and fatigue (slept all day Sat). Wake up every hour during the night to use the bathroom, felt like throwing up, once but nothing happened. Had balance issues. Sunday evening through Tues had problems with breathing. The clinical outcome of the event was resolving.  No follow up attempts are possible. No further information is expected
This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 44-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jun2021 at 15:00 (Lot number: EW0217) at the age of 44 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes and "Penicillin allergy" (unspecified if ongoing), notes: Known allergy: Penicillin. Concomitant medications included: LISINOPRIL and SIMVASTATIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0171, Anatomical Location: Right arm, Administration time :15:45, Route of Administration: Unspecified), administration date: 20May2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: CHEST DISCOMFORT (non-serious) with onset 10Jun2021 at 23:15, outcome "recovered", described as "Extreme tightness in chest"; PYREXIA (non-serious) with onset 10Jun2021 at 23:15, outcome "recovered", described as "Fever"; CHILLS (non-serious) with onset 10Jun2021 at 23:15, outcome "recovered", described as "Chills"; FATIGUE (non-serious) with onset 10Jun2021 at 23:15, outcome "recovered", described as "Fatigue". Therapeutic measures were not taken as a result of chest discomfort, pyrexia, chills and fatigue.   Additional Information: Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. 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.
12 days post Moderna Covid-19 Vaccine on 1/18  I noticed on my right arm near where the vaccine was administered that my arm was red, itching, and warm to the touch. This started 1/18 afternoon. The area affected is about the size of a golf ball. I took ibuprofen and Benadryl which helped, also iced the area. 1/19 area is slightly smaller today, still red and itchy, but is not warm to the touch today.
Breakthrough case admission after three doses Pfizer 1/27/21 Lot# EL9265 Pfizer 2/17/21 Lot# EL9267 Pfizer 9/1/21 Lot# FC3183
This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 05-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a Nurse Practitioner via company representative refers to a 1 year old pediatric female patient. ON 13-SEP-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # H019521, expiry date 24-OCT-2014) injection (dose, strength and route were unspecified). Other suspect therapies included M-M-R II (lot # H018181, expiry date 10-MAY-2014) (dose, route, strength and indication not reported) and VAQTA (lot # J002347, expiry date 09-APR-2015) (dose, route, strength and indication not reported) both vaccinated on 13-SEP-2013. On approximately 27-SEP-2013 (two weeks later), the patient experienced "a crop of vesicles," at the VARIVAX (Merck) injection site. The patient was prescribed an unspecified anti-viral cream, which was applied to the site. After an unspecified period of time, the rash disappeared. The same patient experienced a second event on 10-FEB-2014. At this time "a shingles-like rash" in the "T2 Dermatome region," appeared. In this instance the patient again applied an unspecified anti-viral cream, along with BENADRYL and unspecified use of CLARITIN. It was reported that the "second" rash was "still present, but improving." The therapy was reported as not reintroduced. The patient requested physician appointment to seek medical attention. Additional information has been requested.
Extreme muscle and nerve pain, fever of 102 degrees, dizziness, fatigue, headache, tinnitus, swelling and numbness of hands, arm and armpit pain, swelling of arm and armpit area spreading to the ribs and hand.
I had extremely mild, no aches, and cold like symptoms. I had fatigue, little so throat, and a little cough. I went to a wedding, they were testing for COVID-19 and my test came up positive. I went urgent care and tested positive there again. They prescribed me PAXLOVID.
delayed onset difficulty breathing; delayed onset dizziness; delayed onset weakness; confusion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (delayed onset difficulty breathing), DIZZINESS (delayed onset dizziness), ASTHENIA (delayed onset weakness) and CONFUSIONAL STATE (confusion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025220A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DYSPNOEA (delayed onset difficulty breathing), DIZZINESS (delayed onset dizziness), ASTHENIA (delayed onset weakness) and CONFUSIONAL STATE (confusion). At the time of the report, DYSPNOEA (delayed onset difficulty breathing), DIZZINESS (delayed onset dizziness), ASTHENIA (delayed onset weakness) and CONFUSIONAL STATE (confusion) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Heart rate: (High) fast heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
pt recv vax 30SEP95 & 4MAR96 pt was seen to r/o allergy;6MAR96 a mild case of breakthrough chicken pox, which consisted of 5-10 lesions, was dx;chicken pox occurred primarily on the pt chest & back;no further details were provided;
Information has been received from a consumer concerning her 24 month old white son with no history or allergies who on 05-NOV-2004 was vaccinated in the left arm with a first dose of Varivax (lot # 648309/0277P). There was no concomitant medication and no illness at the time of vaccination. ON 15-NOV-2004, 10 to 14 days later, the patient experienced a fever of 101F and 13 chickenpox lesions on face, scalp and trunk. Treatment included Neosporin to the facial lesion. No labs or diagnostic studies were performed. The patient recovered on 19-NOV-2004. Medical attention was sought. No product quality complaint was involved. Follow up information was received from the physician who reported that on 18-NOV-2004 the patient developed multiple vesicles with surrounding erythema on the trunk and extremities. The patient also had a fever, by history. He reported that the patient recovered on 21-NOV-2004. Additional information is not expected.
After getting this vaccine I was feeling dizzy , having headache ,tachycardia,  fatigue,  and body aches during 4 days
Information has been received from a nurse concerning a 15 year old male with no specified drug reactions/allergies or medical history, on an unspecified day in 1998 was vaccinated with VARIVAX (Merck) (dose, route and lot number unspecified). The nurse reported "the patient developed a mild case of chicken pox (amount of lesions was unknown) last week (approximately on 22-MAY-2009). At the time of the report the outcome of the patient was unspecified. The patient sought medical attention at the physician's office. Additional information has been requested.
48 hours after shot was taken flu like symptoms appeared. No fever. Headache, body aches, severe congestion, coughing, extreme fatigue, shaky hands, brain fog. Six days after shot, Wednesday 04/21/21, I woke up with vertigo and could not think clearly. It was primarily the right side of my head did not feel right. Vision blurred, pressure behind right eye and slight vertigo coming from the right side of my head. My brain was very foggy.  Body did not feel present. These symptoms lasted from 11:30a on 04/21/21 to 10:30p 04/21/21 . Same day 04/21/21 my menstrual cycle started 15 days early. My last menstrual cycle ended on 04/02/21. I have been regular my whole life. Every 30 days is my cycle. I have cramps, menstrual blood is different looking, brighter.
fever/feeling feverish; nausea; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever/feeling feverish) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever/feeling feverish) and NAUSEA (nausea). At the time of the report, PYREXIA (fever/feeling feverish) and NAUSEA (nausea) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Patient wanted to report negative side effects of the Moderna COVID19 vaccine. Patient only received 2 doses. The caller discarded his vaccination card -1st dose when it was available, and 2nd dose when it was available. Following vaccination with the Moderna COVID19 immediately after the 2nd dose within a day patient experienced fever, nausea and feeling feverish. The duration of the symptoms: The symptoms never went away. The two weeks experiencing bad fever nauseas made the patient to take a magnesium Zn supplement and only with that did it subside and furthermore still had to take the supplement because if it stop taking them within 3 days his symptoms begin again.
Very sore arm later that day and throughout the next two days. Headache on 12/3 and 12/4 Nausea 12/4 Constant urination 12/3 into 12/4 Fatique 12/3 and 12/4
Information has been received from a health professional, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with a history of papilloma viral infection who on 06-APR-2009 was vaccinated a dose of GARDASIL during pregnancy.  The Estimated date of the patient's last menstrual period was 02-MAR-2009 and the estimated delivery date was 07-DEC-2009.  The patient sought medical attention at the practice and had not experienced any known symptoms.  Follow-up information has been received from a nurse.  She stated that dose of GARDASIL that the patient received was not given at this office.  Follow-up information has been received from the nurse.  It was reported that on 16-OCT-2009, the patient delivered a normal, male baby via preterm forceps delivery at 32 weeks and 3 days of pregnancy.  The baby's weight was 1910 grams, Apgar score was 7/9.  The baby's experience has been captured in WAES # 0904USA03198B1.  No further information has been requested.
8/10/07 1030 Patient reports pain at injection site, assessment revealed left deltoid lead with hardened area, urticaria, erythema at site. Patient reports no other symptoms. Patient instructed to take oral Benadryl as directed on package - as well as topical Benadryl cream. May take Motrin or Tylenol for pain.
PATIENT REPORTED SWOLLEN CLAVICULAR GLAND ON THE LEFT SIDE OF THE BODY. STARTED 1 DAY AFTER VACCINE, GETTING BETTER ABOUT 5 DAYS AFTER VACCINE.
After receiving vaccines and application of Band-Aids, infant's bilateral legs developed areas of erythema. Band-Aids removed and erythema resolved.
I started having constant headache with slight breathlessness 5 days later. The breathlessness is better now but the headache is still there on the 8th day after vaccination.
half after the shot patient was pregnant 7 months besides; flu; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case via social media, consumer or non-health care professional (Patient).  This case involves adult female patient who experienced flu (influenza) after the INFLUENZA VACCINE [Flu shot] maternal exposure before pregnancy.  Data regarding this pregnancy were received prospectively.  The date of last menstrual period was not reported.  The estimated due date was not reported.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 1957, the patient developed a non-serious flu (influenza) a month and a half following the administration of INFLUENZA VACCINE.  It was the case of vaccine exposure before pregnancy (maternal exposure before pregnancy) [Latency : unknown].  It was reported that, that was patients first in 1957 and last one after that and never had the flu since.   Pregnancy outcome was unknown at the time of report.  It was unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  At the time of reporting, the event outcome reported as unknown for influenza.  Information on the batch number was requested.
Information has been received from a certified medical assistant concerning an unspecified number of patients who on unknown date, were vaccinated with the second or third dose of GARDASIL (dose, route, lot number not reported) late (dates unspecified). No adverse reactions reported. Telephone follow-up information has been received from the medical assistant. No further information was available at that time. Additional information has been requested.
Chills, fever, body aches, headache, and fatigue / rotated ibuprofen and Tylenol / side effects lasted from 10:30 PM on Feb. 24 to 4:00 PM on Feb. 25
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Batch/Lot number: unknown), on 07Mar2021 as dose 2, single (Batch/Lot number: unknown), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hip joint replacement" (unspecified if ongoing); "congenital dysplasia" (unspecified if ongoing); "Cervicalgia" (unspecified if ongoing); "Essential hypertension" (unspecified if ongoing); "known allergies: pollen" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Sep2022) Positive, notes: diagnosed with covid 19 with antigen test at home; (24Sep2022) Negative, notes: at home antigen test; (26Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Started Paxlovid 17Sep22 through 22Sep2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 and BNT162B2 OMI BA.4-5 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 and BNT162B2 OMI BA.4-5 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Moderna Dose 1 5/6/21 (017C21A) Moderna Dose 2 6/3/21 (022B21A) COVID Positive 2/2/22  2/2/22: History is obtained from patient as well as by personal review of records.  I also reviewed records from Hospitals. Patient is 63-year-old was previously hospitalized at outside hospital from 1/24/22-  to 1/28/22.  She was treated for possible sepsis, possible cholangitis.  She received IV Zosyn during hospitalization and was discharged on Augmentin.  Patient was seen by Dr., infectious diseases specialist during last hospitalization.   She reports having intermittent fevers, cough, right upper quadrant pain, generalized weakness for 3 weeks. Patient was advised by primary care provider to go to emergency department.  She remained afebrile after arrival in emergency department.  Leukocytosis has resolved. Transaminase levels have gone up.  She had AST level of 50 and ALT level of 19 towards the end of her last hospitalization.  Now AST level has gone up to 125. Patient also complained of non productive cough.  Three weeks ago she had an episode of confusion which has resolved.   She tested positive for COVID-19.  CT scan of chest showed bilateral pneumonia.  CT scan of abdomen showed chronic changes which are being further evaluated with MRCP.  2/8/22: Patient is a 63-year-old female with history of chronic pain syndrome, depression, dm, HTN, and chronic lymphedema who was admitted on 2/3/2022 with bilateral COVID pneumonia, elevated AST, elevated lactate, tachycardia, abdominal pain, nausea and vomiting.  She was admitted to the medical floor and the general surgeon was consulted.  A diagnostic workup to place and it was determined that the patient has a remnant gallbladder from her previous cholecystectomy.  It was determined she does not have acute cholecystitis, and Dr. signed off. He will follow-up with her in 6 weeks to re-evaluate.  The patient likely developed superimposed bacterial pneumonia and was started on Remdesivir, Solu-Medrol, and Levaquin. Her blood cultures have shown no growth.  The patient has continued to require 4L of supplemental oxygen at rest and 6L with activity.  The patient is requesting to go home today.  Home O2 walk was performed, to the best of the patient's ability physically, and it was determined that she will need to go home with 4 L of oxygen at rest and 6 L with activity.  The patient today reports that she is feeling much better.  She denies shortness of breath, chest pain, palpitations.
13 1/2 x 7 1/2 cm erythema left deltoid.
Pain in all joint; arthritis-like symptoms every morning since receiving vaccine. Right shoulder still very painful, 24 hours a day.
A physician reported the occurrence of limb swelling in a child of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received the fifth injection of Infanrix (lot DTPA541E9). Subsequently, the subject developed significant limb swelling. As of 4/29/03, the outcome of the limb swelling was unknown. Comment: The reporter indicated that eight subjects experienced significant limb swelling after receiving Infanrix lot DTPA54E9. However, these subjects are not presently identifiable.
She did get a little nauseated; she had a reaction; She tried to receive the second dose today, but the pharmacy turned her away; A week after the first dose, swollen lymph node under my armpit/lymph node stayed about 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she had a reaction), NAUSEA (She did get a little nauseated), LYMPHADENOPATHY (A week after the first dose, swollen lymph node under my armpit/lymph node stayed about 3 weeks) and PRODUCT DOSE OMISSION ISSUE (She tried to receive the second dose today, but the pharmacy turned her away) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) 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. In January 2021, the patient experienced LYMPHADENOPATHY (A week after the first dose, swollen lymph node under my armpit/lymph node stayed about 3 weeks). On 27-Aug-2021, the patient experienced VACCINATION COMPLICATION (she had a reaction) and PRODUCT DOSE OMISSION ISSUE (She tried to receive the second dose today, but the pharmacy turned her away). On an unknown date, the patient experienced NAUSEA (She did get a little nauseated). In February 2021, LYMPHADENOPATHY (A week after the first dose, swollen lymph node under my armpit/lymph node stayed about 3 weeks) had resolved. On 27-Aug-2021, PRODUCT DOSE OMISSION ISSUE (She tried to receive the second dose today, but the pharmacy turned her away) had resolved. At the time of the report, VACCINATION COMPLICATION (she had a reaction) and NAUSEA (She did get a little nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.