chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Feb2021 at 11:00 as dose 2, single (Lot number: EN 6201), in left arm and on 30Sep2021 at 11:00 as dose 3 (booster), single (Lot number: 30155 BA), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) negative, notes: tested negative on successive days about 2 days after taking the full Paxlovid regimen; (03Jul2022) positive, notes: three days later. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: dose 1 vaccination lot number: BL or EL 9269 (hard to read).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008621, expiration date 04-MAR-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow-up.
Approx. 7 mins after rcig vaccine, pt. with LOC, seizure like activity , cyanosis, drooling, lasting approx 2-3 mins.
Pale, felt faint, very warm, chills, symptoms lasting 30 minutes.  Occurred 1/2 hour after injection.
Fever; Chills; Massive induration; Erythemia; Arm swelled up, it was huge / took over a week to resolve; Felt beaten down; Like with flu; Very severe oral outbreak of Herpes Simplex; This case was reported by a physician via sales rep and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis and covid-19 vaccine for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on an unknown date).   In April 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of COVID-19 VACCINE. In January 2021, the patient started covid-19 vaccine at an unknown dose and frequency. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever, chills, induration, erythema, swelling arm, feels awful, influenza-like symptoms and herpes simplex. On an unknown date, the outcome of the fever, chills, induration, erythema, feels awful, influenza-like symptoms and herpes simplex were unknown and the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the fever, chills, induration, erythema, swelling arm, feels awful, influenza-like symptoms and herpes simplex to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had first dose og Shingrix without issue prior to receipt of COVID vaccines. As then had both doses of covid vaccines second dose in JAN 2021. The patient also received recived second dose of Shingrix in April and experiencing Fever , Chills , Massive induration and erythemia, arm  swelled up. and overall felt beaten down like flu for a few days ,severe oral outbreak of herpes simplex and required Valtrex for treatment for a week. No issue with Shingrix first dose prior to covid vaccines. Consented to follow up was unknown.
PFIZER VACCINE DILUENT - SODIUM CHLORIDE 0.9%  INJECTION - 0.3 ML WAS ACCIDENTLY GIVEN TO PATIENT, NO HARM WAS REPORTED
This report concerns a 2 month old male pt who on 9/4/01 was vaccinated with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Concomitant vaccination, the same day, included a 1st dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (INFANRIX), a dose of streptococcus pneumonia vaccine (PREVNAR) and a dose of poliovirus vaccine inactivated. On 9/5/01, the pt experienced a "probable, post vax, seizure" and was hospitalized overnight for observation. This was originally reported by an RN. Additional information has been requested. Follow-up info from the registered nurse reported that on 9/5/01 the pt had been napping and according to the pt's mother, he woke up with severe screaming and then arched his back and thrust head backwards. His eyes were open, turned red, his lips and tongue were blue and he was foaming/babbling at the mouth. He ahd a momentary blank stare. The event lasted 30 seconds, then suddenly stopped and then baby continued to sleep. There was no eye deviation and no arm or leg jerking was noted. He was afebrile and did not vomit. The pt's mother called the office 5 minutes later stating that the child was acting normal but sleepy. The baby was seen at the physician's office and was afebrile, sleeping, however awakened easily with his exam, appeared normal and was alert with a good suck. He was then admitted to the hospital for observation. EEG and labs. Upon admission to the hospital, the pt was assessed and he was febrile and his color was pink. His MEENT exam showed normocephaly, normotensive fontanelles and he had positive/positive red reflexes. His tympanic menbranes, nares and throat were clear. His neck was supple without masses or adenopathy. His chest was clear. His cardiovascular exam showed a regular rate and rhythm and normal S1, S2 without S3, S4 or murmur. His abdomen was soft without hepatosplenomegaly, masses or tenderness. His extremities were without deformity. His genitourinary exam reported that he was a normal male, circumcised with bilaterally descended testicles. His skin was without rashes and his tone was normal. The physician's assessment was a probable seizure, post vaccination. Possible breath holding spell. The plan ws to evaluate for any other seizure etiology and observe him for 24 hours with monitoring, EEG and labs. Upon admission, the physician reported that if his labs and EEG were all normal, the physician was "going to presume that this was a mild seizure, secondary to his DTP and would recommend no further pertussis." The pt's EEG, WBC, creatinine, urea, electrolytes and blood glucose level were all normal. The pt was discharged from the hospital on 9/6/01 and subsequently recovered. This was originally reported by a registered nurse. No further info is expected.
This spontaneous report was received from a registered nurse regarding an unspecified number of male patients of unknown age. The patients' pertinent medical history and concurrent conditions were not reported. In approximately July 2016 (reported as "after June 2016"), the patients were vaccinated with VARIVAX injection, subcutaneously, lot # L050956, expiration date:17-DEC-2017(strength, dose and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse events were reported and no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning an 18 year old female with a history of two past episodes of seizures (one occurred in 8th grade and another occurred when the patient had her ears pierced) who on 28-Dec-2006 was vaccinated with a first dose of HPV vaccine (yeast) (lot 654389/0961F). The nurse reported that after the dose was administered, the patient felt nausea and while she was lying down, she experienced a "20 second seizure". The patient received unspecified medical attention. The nurse stated that the series would not be completed. At the time of this report, the outcome was unknown. Upon internal review, the patient's seizure was considered an other important medical event. Additional information has been requested.
Pt exp hair loss following vax w/Hep B vax; No further details were provided;
Extreme Nosebleeds - applied blood clotting agents.  Following up with Otolaryngology and the Neurologist on 11/14/2022
It was after the booster, which I am not sure it was related for sure, but when I was filling a syringe dose for my spouse my eye would twitch and I lost my train of thought and it was odd but I never thought about it. Then about a week after the booster, I started to lose my balance a bit but it went away and nothing was out of the ordinary. I went to work and everything was normal. Then on the 4th of November I began walking funny, and I lost my balance and fell and began vomiting for 4 hours straight. I was taken to the hospital and I was kept there for 3 days. I still have a bit of balance issues and I could not drive a car for almost a whole month. The equilibrium of my ears are not balanced. Slowly they are getting better but they are not fully recovered still.
3 days p/vax pt exp the following sx chills, fever (not measured), diarrhea, h/a, myalgias, soreness @ the inject site; abdominal distress & fatigue;
Information has been received from a physician concerning a female who was vaccinated subcutaneously with 0.65 mL of zoster vaccine live (Oka/Merck) ("lot # 0829U"). On 21-OCT-2007, the patient developed vesicles. At the time of reporting the patient was recovering. Medical attention was sought, the patient was seen at the physician's office. There was no product quality complaint. Additional information has been requested.
om 5/8/21 at 9:00 PM, felt light headed, stepped outside for air, returned to closest chair, calling to significant other, I feel dizzy.  Sat in chair, staring blankly, not responding to calling, or physical touch. breathing shallow, facial and lip color pale, pasty white gray.  weak pulse. 911 called, and responded 8-9 minutes later. By the time they arrived, patient had aroused and  aware of his surroundings,. Although color was slow on returning to normal. EMS arrived, BP 120/80. Patient refused to go to ER . On 5/10/21 at 2:00am, patient woke up and had a nosebleed lasting 2 hours, pouring from nose. 911 called and transported to medical center for cauterization, nasal packing  and observation.  5/11/21 developed a reddened rash on right hand, lasted 5 days.  Nasal packing removed on 5/13/21. No further complaints at this time.
The patient accidentally received Pfizer as a second dose, but they had received Moderna as a first dose.  No adverse events reported by the patient during monitoring.
At 1456 Patient received 1st dose of Pfizer BioNTech (SARS-CoV-2) vaccination.  Within a couple minutes patient fell with +Headstrike & + LOC x 2 minutes approximately. Staff called a 911 ambulance.  Patient without any acute changes. Vital Signs WNL. Slight soreness with localized redness and edema on anterior skull. No visual or sensory changes. Patient able to move freely, all digits and extremities. Patient reported not eating anything of substance and being without any meaningful oral fluid intake today. Patient was kept still anticipating C-collar placement by EMS. EMS from 911 ambulance chose not to place patient in C-Spine precautions and sat patient up. Patient reported some slight dizziness. They place patient on stretcher as patient opted to bring patient to hospital.
Information has been received from a health professional concerning a 13 year old male who on 30-OCT-1999 was vaccinated with a dose of varicella virus vaccine live. On 06-FEB-2006 the patient developed chickenpox. It was noted that the patient's symptoms were similar to cold symptoms with weakness, followed by a rash. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
had both shots in 2019, had shingles this year/ Suspected vaccination failure; 2 episodes of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 17-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received both dose of Shingrix and this year patient had two episodes of shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding the laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
had a large local reaction, Upper leg swollen from the hip to the knee; dtap on 1/22/09 and 4/23/09; dtap on 1/22/09 and 4/23/09; This case was reported by a physician via sales rep and described the occurrence of swelling of legs in a 18-month-old patient who received DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTaP (received 1st dose on 22nd January 2009).   On 23rd April 2009, the patient received the 2nd dose of DTaP vaccine. On 23rd April 2009, unknown after receiving DTaP vaccine, the patient experienced drug dose administration interval too short and inappropriate age at vaccine administration. On an unknown date, the patient experienced swelling of legs. On an unknown date, the outcome of the swelling of legs, drug dose administration interval too short and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the swelling of legs to be related to DTaP vaccine.  Additional details were provided as follows:  The reporter stated that the patient received DTaP vaccine on 22nd Jan 2009 and 23rd April 2009, which led to drug dose administration interval too short and inappropriate age at vaccine administration. The patient reportedly had a large local reaction after the 2nd dose in the thigh, the patients upper leg was swollen from the hip to the knee. No additional information was available regarding product, patient, event, etc. The reporter consented to follow up.
Symptoms started morning of 11/29/22 and most are still  happening. Vaccine was taken 11/27/22. She is experiencing a very bad headache that won't go away unless sleeping, body aches & pain, sore throat, tiredness,  nausea, stomach pain, random stabbing pains in her chest.
It was coughing with flem. Similar to a light sinus infection. Flem was a yellow color. This only last a few days.
Approximately one week after receiving the first jab, I developed shingles.; This is a spontaneous report from a contactable Nurse (Patient). A 51-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, (Batch/Lot Number: EH9899), dose 1 intramuscular on 21Dec2020 (age at the time of vaccination was 51-year-old)) as dose 1, single for COVID-19 immunisation. The patient's medical history was none. The patient's concomitant medications were not reported. The patient experienced approximately one week after receiving the first jab, she developed shingles on 31Dec2020. Patient was diagnosed at the same hospital that she works at, and where she received the vaccine. It was reported that, event resulted in emergency room visit. Patient did not have pregnancy at time of vaccination. Patient had no Known allergies. The patient had not received any other vaccine within 4 weeks and any other medications within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination. Post vaccination, the patient underwent lab tests and procedures which included Covid test (Nasal Swab) was negative on an unspecified date. It was reported that patient took second dose of bnt162b2 (Lot number: EL 0142) via intramuscular route on 11Jan2021 for covid-19 immunisation. Treatment included Antiviral medication and topical lidocaine patches for the event. Outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
A fine red, non raised rash on abdomen and back. Does not itch. Had a fever with the rash.
Entire upper left arm edematous, red, warm and tender. Tx: acetaminophen or ibuprofen/ice pack.
missed work; Headache; Fatigue; Nausea; Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of missed work, Headache, Fatigue, Nausea, and Joint pain in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced headache, Fatigue, Nausea, Joint pain, and Muscle pain. On 05-Apr-2021, the patient experienced missed work. At the time of the report, missed work, Headache, Fatigue, Nausea, Joint pain, and Muscle pain outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant products usage were not reported by the reporter. Treatment details not included.
feeling dizzy and this symptom persists; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: EN6203; Expiration Date: Jun2021) via an unspecified route of administration, administered in left arm on 20Feb2021 09:00 (age at vaccination 63 years) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021, the patient experienced feeling dizzy and this symptom persists. They would like to know if that a normal side effect. The patient received unspecified medication to treat the event, but it was not helped. Outcome of the event was not recovered  No follow-up attempts are possible. No further information is expected.
was diagnosed as vision loss; The vaccine did not prevent shingles as intended; Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not reported) as recommended for routine adult health maintenance for prevention of shingles. However the vaccine did not prevent shingles as intended (vaccination failure and herpes zoster).   The patient was treated for an outbreak that was diagnosed as vision loss (blindness). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.   As further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering other damages.   The outcome of blindness, herpes zoster and vaccination failure was unknown. The reporter considered vaccination failure, blindness and herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, blindness was considered a medically significant event.  Additional information has been requested.  This is one of seven reports received by the same reporter.; Sender's Comments:  US-009507513-1911USA011066: US-009507513-1911USA011701: US-009507513-1911USA011702: US-009507513-1911USA011705: US-009507513-1911USA011706:
I started my menstrual cycle a few hours after injection.; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 15:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC) and bupropion hydrochloride (WELLBUTRIN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took etonogestrel (NEXPLANON) implant which prevents her from having a menstrual cycle. On 18Apr2021 at 22:00, a few hours after injection, the patient started menstrual cycle. She had a Nexplanon implant which prevented her  from having a menstrual cycle. This was her first menstrual cycle in a few years. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event a few hours after injection the patient started menstrual cycle was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. Between the dates 05-JUN-2015 and 27-JUL-2015, the patients were vaccinated with an unspecified doses of GARDASIL lot # K014891 with expiration date 10-MAY-2017 and lot# K011562 with expiration date 08-APR-2017 (dose, strength, route of administration and expiration date were not reported) which were improperly stored. No information on patients concomitant medication was provided. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
I developed a sore left nipple in Nov 2021. I contacted my PCP and arranged to visit her about this. She referred me for a mammogram at the main hospital on Nov 16 2021.  The mammogram result was gynecoastia.