chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LACK OF EFFECTIVENESS; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced lack of effectiveness with vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lack of effectiveness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments:  20210664590-COVID-19 VACCINE AD26.COV2.S- lack of effectiveness. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Large lump left side of base of neck/shoulder. Pain over clavicle on left side. Started 10/13/21. Tried Excedrin, motrin, acetaminophen for symptoms with no effect. Same side as vaccine administration. MD notified and aware, has not been seen at this time by MD.
The pt developed redness, swollen, and tenderness from thigh extending to knee 24 hrs after injection. No fever noted.
dizzy; racing heart; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and HEART RATE INCREASED (racing heart) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Drug allergy (bactrim).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy) and HEART RATE INCREASED (racing heart). At the time of the report, DIZZINESS (dizzy) and HEART RATE INCREASED (racing heart) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 76,90 (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provided No treatment details were provided
This is an observational study case, initially received from other health professional on 08-Nov-2018, concerning a 25-year-old adult female pregnant patient of body weight 131.4 lbs, height 63.3 inches and body mass index (BMI) 23.1, enrolled in a prospective observational safety study. The subject had no maternal and paternal history of major congenital malformations. The subject's obstetrical history included two previous full-term live births and had no birth defects occurred in previous pregnancies. The subject's last menstrual period (LMP) date was 26-Feb-2018. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's current condition included low platelets since 07-May-2018. On 25-Sep-2018, the subject received TDAP. The subject's concomitant medication included PNV for pregnancy. On 18-Jul-2018, anatomical scan was performed, and no major congenital malformation was noted. On 05-May-2018, haemoglobin electrophoresis was performed, and no major congenital malformation was noted. On 21-May-2018, Zika virus testing was performed, and no major congenital malformation was noted. On 23-Oct-2018, at gestation age of 34 weeks (third trimester), the subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF41708, dose, route of administration, anatomical location and expiry date: not reported). On an unspecified date, after vaccination, the subject developed chronic kidney stones. At the time of this report, the subject had not recovered from the event chronic kidney stones. The estimated date of delivery was reported as 03-Dec-2018.
Pt fainted after receiving 4 vaccines. She became alert 10-15 seconds later.
A report has been received from a Health Professional concerning an 11 year old, Female subject, who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on 12-Sep-2013. The reporter stated that patient was administered with full dose into one nostril on 12-Sep-2013. FLUMIST (intranasal) was discontinued on 12-Sep-2013. The outcome of the event of full dose into one nostril is unknown. The report was considered to be non-serious.
Right arm red, warm to touch, child c/o tenderness, slightly swollen 24-48 hours after vaccines administrated. Mom took him to MD, no treatment with antibiotics. Comfort measures only, DX was vaccine reaction.
Patient came down with a low grade fever and a very sore arm. She noticed a rash that began centralized at the injection site but then started moving down her arm to her elbow.
Chronic headaches; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in left arm on 02Apr2021 at 11:30 (at an age of 51-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0171) via an unspecified route route of administration in left arm on 28Apr2021 at 11:30 (at an age of 51-year-old) as single dose for COVID-19 immunisation. Medical history included allergy towards some antibiotics (not specified). Concomitant medication included diclofenac (MANUFACTURER UNKNOWN), multivitamins (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and cannabidiol (CBD) oil (MANUFACTURER UNKNOWN) . The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021, in the few days following vaccination, the patient experienced chronic headaches. The patient had headaches as side effect of vaccine and was continuing to have bad headaches daily 8 days after second dose. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event of chronic headaches was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter (other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 13:00 as dose 5 (booster), single (batch/lot number: GH9694) at the age of 65 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (batch/lot number: EL3247), on 01Feb2021 as dose 2, single (batch/lot number: EL9264), on 17Aug2021 as dose 3 (booster), single (batch/lot number: F97485) and on 31Mar2022 as dose 4 (booster), single (batch/lot number: FK97485) for covid-19 immunization. The patient's relevant medical history included: "lupus" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "penicillin allergies" (unspecified if ongoing); "sulfa allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Pavlovid with treatment start date 29Dec2022 and treatment stop date 02Jan2023.; Sender's Comments: Based on the known the information available the Causal relation between the events Vaccination failure, Covid 19 and suspect drug cannot be excluded completely
Roughly two weeks after 2nd dose I began suffering severe GI issues lasting several days at a time. These issues would come and go in cycles averaging 2-3 weeks in between bouts. Severe gut pain, lots of gas, bloating and diarrhea. This continued into the present day, however it has diminished quite a bit. At the current time I am experiencing cycles of uncomfortable bloating and gas, but not so much the diarrhea and wrenching gut pain. Nothing else changed in my diet or daily routine when this all started. The only new thing in my life was the vaccine.
It?s been nearly a week and I I am continuously having high-grade fever terrible headache hives all over her legs and arms and now I have recently developed a dry cough
At the end of April I started having pains in my stomach and started with diarreha for about 48 hours. The pain got worst so I ended up in the ER. I was diagnosed with unspecific internal bleeding in my pelvic area. I had surgery on 05/20/2021 for a D&C. On 07/06/2021 for test results and official diagnosis.
Patient reports pain on right side & traveling to neck. Patient has taken ALEVE & going to MD today (9/23) & will report s/sx there at office.
Initial unsolicited report received from a Nurse on 23-Jan-2015. A 21 years old female patient, had received a dose of MENACTRA via intramuscular route in the right deltoid (Batch number 44798AA, expiry date unknown), ADACEL via intramuscular route in the left deltoid (batch number 44971AA, expiry date unknown) and FLUZONE via intramuscular route in the right deltoid (batch number 41231AA, expiry date unknown) on 22-Jan-2015 at 07:30 p.m. There was no pre-existing physician diagnosed allergies, birth defects, medical conditions and no illness at the time of vaccination. The concomitant medications included antibiotics which were stopped on 21-Jan-2015. On 23-Jan-2015, at 11.30 a.m., the patient experienced sore throat, achy legs/arm muscle pain and body temperature of 101.5 degree Fahrenheit. There were no lab investigations and corrective treatment was not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none. Follow up information received from a  physician on 05-Mar-2015. It was reported that the patient had received the first dose of all three vaccines MENACTRA, ADACEL and FLUZONE. The patient had not received any other vaccination prior to these three vaccines and dose not have any illness at the time of vaccination. The patient's family had not experienced any adverse event after any vaccinations. The patient had received antibiotics as corrective treatment and stopped the treatment on 21 Jan 2015. At the time of this report the patient was recovered from adverse events. Documents held by sender: none.
6 months baby girl-red hives on body, rubbing eyes. (Taken to ER 11:30 am) EMT gave 9 mg BENADRYL.
Mild tenderness in abdomen was found before vaccination 3/20/2020. After it did not get better, doctor scheduled CT scan morning of 4/11/2020. CT scan found acute appendicitis. Laparoscopic appendectomy was done afternoon 4/11/2020 on unruptured appendix. Recovery from surgery was typical without complications.  (Note: No one believes the vaccine had anything to do with the appendicitis; reporting to VAERS in case there is a possible trend.)
Covid injection #3 "booster":  expected side effects 12 hours after injection:  headache, muscle pain, sweating, nausea side effect day 3-current day 5 after injection:  injection site pain, bright red, hard lump, heat, itching. 4 inch diameter area right deltoid
Red rash from injection site to below elbow; itching down to hand by 2 hrs post injection. Itching stopped after 24 hrs.
PATIENT RECIEVED PFIZER BIVALENT BOOSTER IN SEPETERM 9, 2022. PATIENT CAME TO PHARMACY AND REQUESTED A PFIZER BOOSTER, VERIFIED IT HAD BEEN 2 MONTHS SINCE LAST BOOSTER BUT DID NOT VERIFY IF IT WAS MONVALENT OR BIVALENT BOOSTER. PATIENT RECIEVED BOOSTER TODAY 11/22/22. MENTIONED HER RECIEVED A BOOSTER AND SEPETEMBER AND WANTED TO KNOW THE DIFFERENCE. LOOKED AT HIS PROFILE AND REALIZED HE RECIEVED ANOTHER PFIZER BOOSTER.
Legs began to swell with large knots on both legs at the injection site, lasting a few weeks. She began running a fever which lasted about a week. She would no longer speak, hold eye contact, clap, wave, give hugs and kisses, play with her siblings, etc. She would just sit and stare or play alone. She would no longer respond to her name or any sounds to get her attention.  She was tested on August 2017 and in less than 10 minutes they were able to diagnose her with autism spectrum disorder. She has been in therapy over a year now and is still non verbal.
big mosquito bites 10PM-worsened by 12AM- itching more rash in am, totally covered w/rash & itching; 12PM 2 capsules DPH & Cortisone cream;
About 30 minutes after injection felt brain fog and had a hard time finding words; About 30 minutes after injection felt brain fog and had a hard time finding words; It's like we were having to concentrate more than usual to do routine stuff; This is a spontaneous report from a contactable consumer (patient himself).  A 44-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number Ej1685), intramuscular on the left arm, as first single dose on 20Dec2020 (at 06:30) for COVID-19 immunisation. The patient did not have a relevant medical history. No relevant concomitant medications were provided. About 30 minutes after injection felt brain fog and had a hard time finding words. Another nurse that got vaccinated at the same time felt the same way. It's like we were having to concentrate more than usual to do routine stuff. The patient was not treated for the events.  The patient did not perform COVID test before vaccination but after vaccination Nasal Swab, Rapid PCR, was Negative. He was recovering from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020504556 same drug, same event and different patient
Patient received a TENIVAC vaccine and a PNEUMOVAX 23 vaccine yesterday in office. This morning she came into the office complaining of right deltoid pain, swelling and redness, dizziness, chest tightness, and nausea. Only the arm which the PNEUMOVAX was given in had the local reaction. No adverse reaction in the left arm where Td was given.
About 12 hours after the 2nd Covid vaccine shot, I started throwing up. At first, once, then progressed to vomiting every 30 minutes, fever, soreness, and extreme headache. I went to ER  and finally saw an Er doctor-he gave me fluids and zofran-then sent me home?about 6 hours later, the same symptoms and went to a different ER because I would not have to wait 3 hours to see dr. They gave me fluids, phengran, and toradol w/tylenol. He kept me long enough to make sure it had passed. The intense headache continued thru the 13 but finally better today. It was horrible.
This spontaneous report as received from a health professional via Pfizer refers to a 16 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with HPV vaccine (manufacturer unknown) (strength, dose, route and site of administration, lot # and expiry date were not reported). Other suspect therapies included TRUMENBA, 0.5 ml (strength, route and site of administration, lot # and expiry date were not reported) and MENACTRA (strength, dose, route and site of administration, lot # and expiry date were not reported). On an unknown date, after the use of the vaccines, the patient passed out for a few seconds. The outcome of the event was unknown. The relatedness between the event and the suspect therapies was not provided. Additional information has been requested.
This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from an office manager concerning a 12 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. On 14-NOV-2007, was vaccinated with the second dose of GARDASIL and is sick. Specific symptoms unspecified. Patient contacted the office by phone and is coming into the office tomorrow (18-JUL-2008). At the time of reporting the patient had not recovered. Follow-up information was received from the physician who reported that the sickness was allergies that were not relative to vaccine. The patient's sibling also had an adverse experienced after vaccination with GARDASIL. (WAES # 0807USA03685). No further information is available.
pt devel a prickly rash @ the inject sit eon both legs on 2 occasions w/in 2 days p/receiving DTP/HIBTITER;
Returned to clinic for evaluation of tender red area on back of left arm.  Arm noted to have area of erythema (3 cm x 1.5 cm), induration, warmth and tenderness to palpation, afebrile. Given antibiotics.  Pt. presented in the Emergency Room 10/2/10 at 12:19 am with redness and warmth extending 2 cm beyond previously drawn line, T 39.4.
Presents with red area on inner (L) leg at injection site of MMRV given 1 week ago 5/23/14, Center is raised and white w/darker red at edge of center. Pink surrounding area warm to touch and itchy. Pain last night but denies today after shot was pink area has gotten worse since 5/2.14. Afebrile, active, behaving normal. Redness about 60 mm across. Advised treat symptoms and monitor for infection, fever etc. Spoke w/mother 6/2/14, redness, swelling, heat all decreased, child behaves normal, afebrile.
Hives turned into large itchy blotches of pink the next day; Splotchy hives on injection arm up to neck; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Nov2021 at 13:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and triamterene (MANUFACTURER UNKNOWN), both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 15:30 (at the age of 44-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 15:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 07Nov2021 at 20:00, the patient experienced splotchy hives on injection arm up to neck after 55 hours of administration. Hives turned into large itchy blotches of pink the next day. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event splotchy hives on injection arm up to neck, hives turned into large itchy blotches of pink the next day was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Moderna  vaccine 3/4/21, 4/1/21  CHIEF COMPLAINT COVID Infection   HISTORY OF PRESENT ILLNESS The patient  is a 74 y.o. female  With the following background:   -Recurrent diffuse large B-cell lymphoma(Dx 2011, recurrence 2019, status post chemotherapy, after longus bone marrow of marrow transplant 2019 and splenectomy 2020, currently on rituximab therapy -obstructive sleep apnea -hyperlipidemia -osteoporosis -Vaccinated with Moderna   Patient is visiting for follow-up appointments as part of executive Medicine.  She reports that she developed symptoms on Tuesday 9th of November.  She reported symptoms of cough productive of yellow sputum and severe fatigue she also reported so
The pt experienced an unknown adverse event. Follow-up was received from a physician which indicated "no side effect unusual has ever occurred in my practice so far, so no report needed at this point". No further information is available.
Received 2nd dose of vaccine at 3:30pm. The following morning woke up with a migraine and low grade fever. By 3:30 (24 hours later), had 102 fever, body aches, chills, painful to breathe deeply and nausea throughout the night. Slept as much as possible. Following day temp was in 99-100 range all day. Body aches and bad headache continued. Today, normal temp, but body aches, headache, and total exhaustion continue.
One week after first shot, a genital herpes outbreak, followed by a second, third and fourth in March, April, May, all four weeks apart. I normally have a single outbreak every one or two years.
Information has been received from a physician concerning a female who on an unspecified date "about a month ago," approximately June 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient experienced mild blisters at injection site. Unspecified medical attention was sought.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
nauseated (with no vomiting); fever; diarrhea; achy; This is a spontaneous report from a contactable consumer (patient himself). A 49-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration on an unknown date 2021 (Batch/Lot number was not reported, Solution for injection) as single dose for covid-19 immunisation; dupilumab (DUPIXENT), subcutaneous from an unknown date Jan2021 (Batch/Lot number was not reported; Expiration Date: 30Jul2022) to an unspecified date, at 300 mg, every other week for chronic rhinosinusitis with nasal polyps. The patient medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC, 10 mg) at 10 mg, budesonide (PULMICORT) at 0.5 mg, fluoxetine hcl at 10 mg and salbutamol sulfate (ALBUTEROL SULFATE HFA) taken for an unspecified indication. The patient previously took aspirin for allergy (At the time of the event, the patient had ongoing allergy with aspirin). Historical vaccine included bnt162b2, dose 1 via an unspecified route of administration on an unknown date 2021 (Batch/Lot Number: Unknown) as single for covid-19 immunisation. The patient reported that he received his second dose of the Pfizer covid vaccine on Saturday (unspecified date in 2021) and on Sunday (unspecified date in 2021), he started to feel nauseated (with no vomiting), fever, diarrhea and achy. He was fine now. It was unknown if the patient experienced any additional symptoms/events. The patient stated that his sinuses was clear today than normal. The action taken in response to the events for dupilumab was unknown. The outcome of the events was resolving.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Body aches, Awakening Shortness of Air around 0345, became cold quickly, unable to get warm, started to shake and shiver, then was super hot, began to have some sort of out of body phenomenon or hallucination, felt like was about to pass out but was able to sit up and check temperature and discovered a temperature of 103.5 at around 0600. Was able to take Tylenol around 0630 and take shower. Remained weak and exhausted until 1000hours on 1/27. Left arm has pain around injection site.