chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme irritability; Anger; Mood swings; Can't sit still; This is a spontaneous report received from a contactable consumer, the patient. A 44-years old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the right arm on 27Mar2021 at 16:00 (at the age of 44-years) as a single dose for COVID-19 immunisation. The medical history of the patient included bipolar disorder and fibromyalgia. The concomitant medications of the patient included lamotrigine (LAMICTAL XR), topiramate (TOPAMAX), ziprasidone hydrochloride (GEODON), benztropine (COGENTIN) and aripiprazole (ABILIFY) from unknown date and for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, the patient experienced that her bipolar medicines were not working. She had no episodes for 9 years. On 28Mar2021, the patient experienced the events extreme irritability, patient was not able to sit still, anger and mood swings. The adverse event did not resulted in a doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received any treatment for the adverse events. The clinical outcome of the events extreme irritability, not able to sit still, anger and mood swings were unknown.  No follow-up attempts are needed. No further information is expected.
No adverse events we were instructed to report to VAERS because vaccine was given to a pt under 18 yrs old
pt recv vax; devel T 101-102 fever,a maculopapular rash over trunk, irritability & mild erythema of the pharynx;
she said that she received on 29Sep and she tested positive today for covid; she said that she received on 29Sep and she tested positive today for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 33-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, 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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Nov2023, outcome "unknown" and all described as "she said that she received on 29Sep and she tested positive today for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Nov2023) Positive. The patient reported that it was not eve common because it had not been 2 months since she had the booster. it was disappointing to test positive after receiving booster and she had concerned about getting covid again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diarrhea  about 6hrs after injection chills fever body aches and dull headache continued for about another  24 hrs
pt recvd vax; 1pm started screaming until 4:30; called clinic; to MD; given meds; exp diarrhea; some swelling & redness on leg; MD felt pt had rxn to pertussis;
Patient in observation and complains of experiencing difficulty swallowing.  Redness to the face, and swelling of the lips noted. Patient also complained of feeling flushed  and having a rapid heartbeat. Patient AOx3 and GCS of 15. PMS present in all extremities. Lungs clear bilaterally. No hives present.  No injuries. Airway clear and patent. Some redness around the cheeks noted.   Vital  signs BP-122/8-, HR-108, RR-17, SpO2-99% on room air. Benadryl 50 mg given orally  at 10:22. Patient monitored.  Patient verbalizes feeling better. Redness in the face  decreases and lip swelling decreases.  Fire Department arrived on scene. Patient refused transport. Patient educated and  instructed to call 911 if symptoms persist or worsen. Patient released with a  driver at 1043.
This spontaneous report as received from a physician refers to a 54 year old female patient. In March 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, route not reported). In November 2012 the patient developed a case of shingles, it was a mild case that was not painful and manifested as "two spots right on her bra strap, on her ribs." The patient sought medical attention. She received VALTREX as treatment and had fully recovered. This is one of the two cases from the same source. Additional information is not expected.
I tested positive for COVID-19 on December 27. I had light symptoms of running nose. I got a prescription for Paxlovid December 29th, 2022. It was a 5 day course which I finished on January 2. I tested negative on January 4 & 5. I than tested positive again on the 6th of January & was positive for the next 5 days.
Pt c/o lightheadedness after vaccination.  Vital signs: BP 122/85, HR 92,  RR 20, 98%O2Sate.  Skin warm and dry.  Pt given oral fluids and snacks.  Encouraged patient to increase fluids and eat food.  Only had a granola bar for breakfast.  Patient dischargehome wiht parents.
Headache starting within 24 hours of vaccine, daily headaches since then, does improve with Ibuprofen but relief is temporary. No prior history of headache disorder
This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This was reported previously to manufacturer. The age at the vaccination was not reported. The pharmacist reported to field representative the day before reporting that the patient relative of his recently received the SHINGRIX vaccine and developed flu-like symptoms that lasted for 2 to 3 days.  It was unknown what number in the series it was or the exact date of the adverse event. No Product Quality Complaint (PQC) was filed.
Pt reported dizziness, tightness in chest and mild difficulty breathing about 2 minutes after receiving shot.  No other signs of allergic reaction upon examination.  Laid patient down and checked blood pressure which was normal (127/85). Patient stated that he still felt the same after several minutes of observation and felt little to no improvement.  Because he stated that he felt some tightness in his chest he was given 50 mg of diphenhydramine orally and EMS was called.  Patient stated that he began to feel better after the diphenhydramine.  EMS arrived and took vitals, patient refused going to hospital and left the pharmacy.
04/09/2022 A few days after my vaccination I started to cough and the doctor diagnosed it as rhinorrhea, no shortness of breath but a lot of coughing that was not under control. The Doctor prescribed benzonatate for symptoms, and they have not really gone away. Symptoms are still continuing as they were with minimal tapering of symptoms.
Pain and numbness in hands starting on the left side and spreading to both feet, eventually reaching elbows and knees. Pain was initially mild but grew worse until weeks after giving birth. Difficulty driving, typing, preparing food, dressing etc... Cortico steroid injection and x rays of hands to test for carpal tunnel syndrome. Surgery was recommended for a nerve release, and performed on right hand. Surgery did not improve condition, and doctor suggested everything would improve after giving birth. After giving birth there was no improvement. Doctor was reminded that pain was in both hands and feet. EMG was then conducted results were normal. Referred to neurologist. In office neurological testing. Small Fiber Neuropathy suspected. Skin punch biopsy to be scheduled.   Symptoms began improving mid January, but still troubling. *Had been participating in smartphone based tool, and was told to call to provide more information, but lost track of information.  Patient's first pregnancy, est delivery date 11/3/21, Baby born by c-section 7 lb 9 oz.
Following the first shot I had typical flu-like symptoms - fever, aches in joints and muscles, headache and brain fog. The second shot had the same symptoms as the first but after about 22 hours I apparently had some type of anaphylactic reaction - I remember going to the bathroom - but I woke up on the floor by the bed, and could not think how to get back in bed.  My wife called 2 neighbors who helped me up.  It was difficult to form complete sentences.  I was transported by ambulance to ER.  The ER ran a battery of blood tests, CT scan and chest x-ray. The ER doctors and oncologists concluded that I must have had a delayed reaction to the vaccine. Today, April 28, things are back to normal.
pt recv vax late AM 19JUL95 & on 20JUL05 530AM upon opening eyes toward window the trees & sky swirled so badly; felt sick to stomach; closed eyes immed; repeated this a few mins till got out of bed to go to bathroom sl diarrhea & vomiting;
A physician reported that a 20 month old female received an injection of Prevnar on 10/6/00. That evening, the child developed a fever of 102F, coughing and was lethargic. On 10/14/00, she was dx'd with bronchitis. The reporter stated that the bronchitis "turned into pneumonia". She was treated with Zithromax, albuterol nebulizer and Ryna (pseudoephedrine/chlorpheniramine). The child recovered.
Pt reported rapid heartbeat, was achy, fever, swollen, red hot to the touch at injection site, very sore and achy.
This spontaneous report was received from the nurse regarding a 2 year old patient of unknown gender. Information on patient's pertinent medical conditions, concomitant medication and drug reactions or allergies was not reported. On 27-AUG-2018, the patient was vaccinated with GARDASIL 9 (dosing details were not reported) lot # N035955, expiry date: 09-OCT-2020 for prophylaxis instead of PEDVAXHIB. No adverse effect reported. No product quality complaint involved.
Severe acute pancreatitis with multiple organ failure due to severe inflammatory response.  Spent 192 days (7 months) in the hospital fighting for my life.  I was intubated on a respirator several times, had kidney failure due to the inflammation, required dialysis, developed fluid abscesses, pleural effusions, was in a  drug-induced coma for 11 days, had respiratory failure on 9/27/21. I survived but not without lifelong effects now. Doctors said based on what I went through I am lucky to be alive.
pt recv vax 1JUN98 & devel redness @ inj site;over the period of the next day inj site was reddened tot he size of a faquetball & pt had fever of  99.1;pt evaluated in MD office 4JUN98;
Shortly after I received the shot, I had minor soreness in the spot of the injection. This was the only symptom for about 12 hours. At the twelve hour mark, about, I almost immediately started shivering uncontrollably. I was very cold ad sweating. I wasnt able to think clearly. My wife said I had a fever. Also, I had a headache. This occurred for about 6 hours. I was still cold and sweating, with a headache, for about another 4 hours, but it wasn't as extreme. I was still unable to think well. I had a desire to drink gatorade, not water, at this time. This was unusual. I drank about 2L of gatorade. I began to not feel cold, and only had a minor fever. Not sure how correlated these are. Over the next 10hrs or so, I slowly improved and was able to carryon daily activities.
Major Fatigue & flu-like symptoms since 4 days following injection; Major Fatigue & flu-like symptoms since 4 days following injection; This is a spontaneous report from a contactable consumer.    A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:45 (at the age of 76-year-old) as single dose for covid-19 immunisation.  Medical history included fatigue from an unknown date and unknown if ongoing. There were no concomitant medications.    The patient experienced major fatigue and flu-like symptoms on 23Feb2021 with outcome of not recovered.    No follow-up attempts are possible; information about lot/batch number cannot been obtained
Child had completed KBH and received in right thigh and PEDIARIX in left thigh. Child was in supine position with mother holding arms and staff holding legs. Child held his breath during injections and face turned red during injections. He started breathing afterward but did not cry vigorously, just let out of soft cry, whimpered and took his pacifier. Within a minute or two, he fell asleep. After discharge instructions mother commented that baby never slept this soundly before. Also mentioned he had a dose of TYLENOL prior to coming into office. Child was pale pulse 115-138, O2 sat 96-100%, resp 38-50/min per dynamap. VS remained steady. Pupils were constricted, no EOM and extremities limp. No response to tactile stimuli. Child was awakened with vigorous stimulation. Crying and suck reflex intact, PERL, EOM intact, equal body movements, VS stable. Episode lasted approximately 15 minutes. Child monitored approx 30 minutes and sent home with mother. Mother was called approx 2 hrs later and child was less interactive but fine otherwise. Mother called clinic next am to report child had emesis X2 during night and behavior was normal that am.
Patient began having severe arm pain the night of the immunization. Patient then began having trouble with lifting her arm and then had no range of motion in her arm the following days. The patient went to see an orthopedic Dr on 10/9 and then her primary physician on 10/10. Patient has been prescribed physical therapy for 2 weeks and then will have a follow up after that.
Weak, Vomiting, Pale, Diaphoretic, Greenish Yellow lips ( from emesis)
No adverse event; Patient was administered expired GARDASIL 9 on 07/12/2022; This spontaneous report was received from a nurse referring to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 12-JUL-2022, the patient was vaccinated with expired vaccine of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #1637648, expiration date: 19-JUN-2022) for prophylaxis (dose, strength, anatomical location and route of administration were not provided) (expired product administered). There was no temperature excursion reported for affected product as confirmed by reporter at current call time. No adverse event was reported (no adverse event).
I had symptoms of tickle in the throat very slight cough and very slight headache on January 31, 2022. On February 2, I felt much worse so I took an at-home test and it had a very faint line. We were taking a trip so I wanted to confirm so I went Urgent Care on February 2, 2022. They told me if I got worse and due to my asthma I could do Monoclonal Antibody infusion. At the beginning I didn't see the reason for it since I was vaccinated and boosted but by the following Saturday the 5th I was still feeling really sick and they told me that you have to be within the first portion of Covid or you can't get it anymore. I went on the website to see if I could qualify on Saturday and they had something that day so I scheduled for that day around 02/05/2022 at Noon. It was really easy and it went well and I did feel a little bit better within 24hrs but I continued to have symptoms so I called my doctor office on February 10th and talked to his nurse who said she was seeing some improvement with people who had lingering symptoms by prescribing a Zpack. I was prescribed zpack the 10th and I finished on the 14th by the 15th I was better. However, since I have had Covid, I have a small blister on the inside of lower lip. Sometimes it does get filled with fluid and get larger and it is not painful. It has not gone away since. I have not seen my PCP.
Swollen eyes, dark circles under eyes, burning sensation. Symptoms better but not completely healed.
Dose given in right arm syringe leaked and vaccine ran down arm. Repeated dose in other arm.
Initial unsolicited report received from a nurse on 29 July 2015. A 12-year-old male patient, whose pre-existing physician diagnosed allergies, birth defects, medical conditions included asthma and illness at the time of vaccination was reported as none and concomitant medication were not reported, had received an intramuscular dose of MENACTRA (batch number U5058AA) in left deltoid and also received an intramuscular dose of BOOSTRIX (batch number 5SR2L, manufacturer GSK) in left deltoid on 28 July 2015. On 29 July 2015, one day after vaccination the patient experienced fever of 100, then later at 2 PM the patient experienced fever of 102 along with leg pain and upset stomach. The patient required ER visit following the events. The patient was given TYLENOL as corrective treatment. Laboratory investigations was not reported. At the time of reporting final outcome of the event was not reported. List of documents held by sender: none. Follow up information received from nurse on 24 August 2015. It was reported that the patient was vaccinated at private physician office/hospital. The event outcome was recovered on an unspecified time.
The patient was given his 2nd dose at 22 days after 1st dose.  Discussed with individual when discovered at time of injection.  Explained to him that the second dose was given 2 days too early.  Encouraged he call our reporting line should he have any adverse affects.
Rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's Comments: The case was reported by patient via interactive digital media. The patient got rash after Shingles shot. Additional Supportive Information: Follow up would not possible as no contact details were available.
11/9/2021 pt had a positive COVID test; lives in SNF; pt on comfort measures; pt passed away in the SNF
Visible swelling of right arm over deltoid and extensor, aspect of triceps area with hyperpyrexia (up to 102) Full ROM but tender to touch. SX resolved in about 36 hours with full recovery.  MR received for an ER admit for c/o fever (102.7F), pain and swelling of the right upper arm at the pnemococcal vax. site.  PE: WNL except decribing a well-defined, erythematous, warm area of swelling on the RUE. Admitted for IV antibiotics. Final DX: Cellulitis, right arm.
pt recv vax 14OCT96 & 15OCT96 pt devel erythema & redness @ inj site;
I got chills on and off through the day starting at noon. At 10 pm in a matter of a second I went from wide awake to barely able to keep my eyes open and feeling like I got hit by a truck. I felt like I could not get in enough air when breathing. I would breath in and I felt like my lungs would feel the way you feel when you stretch the day or 2 after working out super intensely
Fatigue; Chills; Headache; Dizziness; Nausea; Heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache), DIZZINESS (Dizziness) and NAUSEA (Nausea) in a  patient of an unknown age and gender 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 was provided by reporter.  No concomitant medication reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache), DIZZINESS (Dizziness), NAUSEA (Nausea) and HEART RATE INCREASED (Heart rate increased). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache), DIZZINESS (Dizziness), NAUSEA (Nausea) and HEART RATE INCREASED (Heart rate increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 163 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. Treatment details were not reported.
12hrs p/vax devel SOB w/wheezing, fever 102.9 w/dysphagia, sore throat, neck pain, myalgias, syncope episode
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 1, single (Lot number: FK5127) and on 29Jan2022 as dose 2, single (Lot number: FL8094) at the age of 6 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: MIRALAX, Little Remedies Gas Relief. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Prior to vaccination (dose3), the patient was diagnosed with COVID-19".
Starting Saturday the 9th started to feel a pulsing sensation all through her body, on Sunday right arm close to her wrist could feel a strong palpitation this happened twice,  3 times since vaccination once three hours ago her jaw moved  on its own.   Reached out to pharmacy who referred her to VAERS, and did try to her doctor office today but they were closed and she did not want to leave a message.
patient died; tested post mortem blood samples and found fragments of foreign DNA in her spleen and these were positive for human papilloma virus; This spontaneous report has been received from a physician as a social media post referring to a female patient of unknown age.Information on patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with third dose Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, anatomical location, route, lot# and expiry date was not reported) for prophylaxis. On an unknown date, the patient died in her sleep six months after her third Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection due to unknown reason. On an unknown date, the autopsy (reported as post-martem blood test) was performed which showed fragments of foreign deoxyribose nucleic acid (DNA) in patient's blood and spleen and those samples were positive for human papilloma virus (HPV) (Human papilloma virus test positive). Physician also reported that it was not the result of natural HPV infection, most likely the DNA was bound to aluminum, which was also found in the patient. The physician further mentioned that HPV gene was foreign DNA and its detection six months after the injection was not normal. The physician also tested five samples of the vaccine sent from somewhere else and found HPV vaccine in each. Causality assessment between the events and the suspect therapy was unknown.; Reported Cause(s) of Death: unknown cause of death.