chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Night of injection, bad headache and visual symptoms. About 10 days later tinnitus left ear, unrelenting and ultimately marked decrease hearing left ear. Initial hearing was normal. End result is tinnitus and deafness left ear
PATIENT PRESENTED FOR VACCINE AND RECEIVED MODERNA VACCINE FOR 2ND DOSE BEFORE DISCLOSING 1ST DOSE WAS PFIZER. PATIENT 17 YEARS 6 MONTHS OLD. PARENT DID CONSENT FOR VACCINE ADMINISTRATION.
cardiac arrhythmias, including SVT and ectopic beats; cardiac arrhythmias, including SVT and ectopic beats; cardiac arrhythmias, including SVT and ectopic beats; This is a spontaneous report from a contactable Physician (patient). A 66-year-old female BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown) via unspecified route of administration, administered in left arm deltoid, on 18Jan2021 (Age at vaccination: 66) as DOSE 2, SINGLE for Covid-19 immunization. Patient took first dose of vaccine (lot number: unknown, expiry date: unknown), via unspecified route of administration, on 26Dec2020 (at the age of 66-years-old) as Dose 1, single for Covid-19 immunization. NDC number of Covid-19 Vaccine: Unknown. Patient medical history and concomitant medications were not reported. On 17Feb2021 after second vaccination, patient developed cardiac arrhythmias, including SVT and ectopic beats. He was otherwise healthy and was just calling to report that with the recent cardiac report. His question was if they had information or were aware of any long term cardiac events. The patient underwent lab test which included Holter Monitor test on 17Feb2021, results of which showed it was cardiac arrhythmia. Treatment regimen was not given as a result of the adverse events. The outcome of events was recovered on an unspecified date. ; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious event Cardiac arrhythmia cannot be totally excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from a healthcare worker refers to a 16 year old patient of unknown gender. The patient medical history and current conditions were not provided. On 22-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K023432 expiration date 18-JUN-2016. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
high fever of over 104.6, h/a, rash, sore throat, arm sore; back of neck hurt & lost of appetite;
Pt received DTP and OPV and experienced high pitched unusual cry, shaking episode - possible seizure.
Day of vaccination:  Pain/soreness at injection site and nearby arm muscles.  Took acetaminophen day of vaccination, which helped, and soreness has lessened over time, but still lingers. Morning after vaccination:  Muscle aches, chills, feverish.  Took acetaminophen every 6 hours and it helped somewhat, particularly in the morning, but was less effective as the day went on. Next day:  felt mostly better from feverish symptoms.  Pain/tenderness in arm has continued but lessened over time.
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death 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 unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information:  The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter; Reported Cause(s) of Death: Unknown cause of death
pt recv vax 12APR96 & 2JAN97 two spots were noticed on back of pt neck which were treated w/Bactroban;6JAN98 to MD office again w/worsening of the rash which was described as reddened w/scabs;6JAN97 lab eval was negative for Tzanck smear
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 28th December 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced a sore arm the day of vaccination. It has gotten better and now the pain was level 1 on the scale of 1 to 10 with 10 being the most painful. Reporter consented to follow up. This case has been linked with US2020000946, reported by same reporter.
11/13/15 itchy eyes, hands, back, face swelled, SOB. 11/16/15 taking BENADRYL - in PM, CLARITIN - in AM hydrocortisone cream.
Patient had Janssen COVID vaccine on 3/10/22, and was admitted to the hospital with acute resp failure on 1/25/22, and remains hospitalized at this time
Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient was having anxiety to receiving shot after injection. Store manager called 911. No signs or symptoms or anaphylaxis. Vitals all normal paramedics cleared her to leave without further medical attention.
Patient had severe headache for 24 hours, sleepless night, fever (99 degrees F.) and chills (24 hours after injection), and sore arm (both topically and under the arm pit). Headache, fever and chills were gone in 48 hours. Soreness in arm persisted 3 days.
Chills; Fever; Body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021. Concomitant products included LOSARTAN for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Chills, Myalgia and Fever, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Since receiving the vaccine, patient has had long lasting pain in her arm and has difficulty lifting her arm.
Pain & edema to left upper ext. (applied cool compresses to area. Headache. Was prescribed Prednisone at Urgent Care.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZIA) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided          Concomitant product use was not provided  by the reporter.  Treatment information was not provided.
Child received FLUMIST 10:00 a.m. Began running a fever of 103 that evening, and for the next four days, with nasal discharge, aches, no appetite.
Suspected vaccination failure; chronic break outs. About every 2 months I break out; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient got shingles at 59 years old for the first time).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: chronic break outs. About every 2 months I break out). The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2023 The patient self-reported this case. This case was reported by a patient via interactive digital media. The patient received Shingrix vaccine at 60 and now patient had chronic break outs, about every 2 months it break out. The patient took a viral antibiotic that kept on hand for it. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
I tested positive for COVID-19 on 3/23/2020, I was tested every two months and still had antibodies in my blood .  Last blood test 1/4/2021 tested positive for antibodies. Dose received 12:00pm 1/6, I was asymptotic until 9:00am 1/7 I started with muscle aches and felt chills and flushed.  Fever presented around 11:00am 100.8.  Went to bed at 1:30pm woke up at 6:00am next morning feeling 100% no fever.  On 1/9 at 10:00am presented its diarrhea for about an hour.  Then I was totally fine.  I will complete my second dose 2/3 and will continue to monitor my status.
Patient claims on evening of 02/13/2022, her injection site became very tender, warm and red.  She eventually experienced all-over body aches.  She took acetaminophen 500mg alternating with ibuprofen 400mg every 6-8 hours for pain. Overnight starting 02/15-02/16/22, pt claims she was awoken by the injection site becoming very itchy.  As of 2/16/2022, she claims body aches have resolved and tenderness of upper left arm has abated but is not entirely gone. As of 02/17/2022 she claims her arm is still itchy. Pharmacist advised she take diphenhydramine and contact her primary care provider.
This spontaneous report as received from the patient's mother refers to her 2 months old male child. Pertinent medical history was unknown. No allergies were reported. On an unknown date July 2014 the patient was vaccinated with ROTATEQ (2 ml, oral). Concomitant medications included other unspecified vaccines. On an unknown date in July 2014 the patient experienced diarrhea and mucous in the stools. The reporter states that she is a breastfeeding mother and she did not know whether the patient was developing some sort of sensitivity. On an unknown date in September 2014, the patient was vaccinated with another dose of ROTATEQ and also other unspecified vaccines. On an unknown date in September 2014 the patient again experienced diarrhea. The reporter said that mucous in stools was still present and did not resolved since July 2014. The reporter states that she did call her son's physician (details unspecified) and was told to monitor him and make sure her son got lot of fluids. No treatment was given for the events. No diagnostics studies were performed. The outcome of the events was reported as recovered/resolved. The reporter considered mucous in the stools to be related to ROTATEQ. The reporter considered diarrhea to be related to ROTATEQ. The causal relationship between some sort of sensitivity and ROTATEQ was unknown. Additional information is not expected as the reporter is not willing to be contacted.
Case number PHEH2011US01314 is an initial spontaneous report received from a consumer on 09 Aug 2011. This report refers to an 11 years old female patient. She was vaccinated with MENVEO (batch number: unknown) intramuscularly on 08 Aug 2011. On the same day she was also vaccinated with DTaP in the same arm. After vaccination a bump developed at the injection site for both the vaccines. The bump at the MENVEO injection site was half inch in diameter and was painful. It was hurting all night and she could barely sleep last night. The reaction was still persisting.
On day of vaccine, nausea started in 15 minutes after injection. Vomiting started half an hour after injection and continued for 3 hours.   9 days post injection, intense pain and hard lump at Injection site. Lasted for 2 days.  13 days post injection, large welt appeared at injection site. Sought medical attention at this point.
injection site pain; nausea; diarrhea; feeling unwell; This is a spontaneous report from a non-contactable other healthcare professional, the patient.  A 20-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3247, via an unspecified route of administration on 19Jan2021 at 12:30 (at the age of 20 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 20Jan2021 at 08:00AM, the patient experienced injection site pain, nausea, diarrhea, feeling unwell. The patient did not receive treatment for the events. The clinical outcome of injection site pain, nausea, diarrhea, feeling unwell was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
black eye; This spontaneous case was reported by a physician and describes the occurrence of EYE CONTUSION (black eye) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diarrhea, Sores mouth, Bruise, Cold sore mouth and Black eye. Concurrent medical conditions included Appetite decreased NOS and Weight loss. Concomitant products included ACYCLOVIR [ACICLOVIR] for Cold sore mouth, RUXOLITINIB PHOSPHATE (JAKAFI) for Polycythemia vera and Myelofibrosis, LISINOPRIL, CELECOXIB (CELEXA [CELECOXIB]), ROSUVASTATIN, LORAZEPAM, ACETYLSALICYLIC ACID (ASPIRIN LOW), VITAMIN D3, FOLIC ACID, VITAMIN B COMPLEX, PARACETAMOL (TYLENOL EXTRA-STRENGTH), PROBIOTICS NOS and LOVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced EYE CONTUSION (black eye). At the time of the report, EYE CONTUSION (black eye) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood test: numbers dropped quite a bit. In March 2021, Neutrophil count: dropped. In March 2021, Platelet count: come up a little bit. On an unknown date, Full blood count: blood counts were okay. On an unknown date, Weight: gained 3.2 pounds and increased from 123 pounds to 130 pounds.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 24-Sep-2019, the patient RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) dosage was changed to 5 milligram twice a day. On an unknown date, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram twice a day. On an unknown date, RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) dosage was changed to 5 milligram twice a day and RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) dosage was changed to 5 milligram twice a day. On 15-Mar-2021, the patient experienced EYE CONTUSION (black eye).    This case was linked to US-MODERNATX, INC.-MOD-2021-093449 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-093449:1st dose
Feels burning sensation in legs towards knees; Feel like all energy is being pulled out of me; Rash on top of feet; Exhaustion; aching all over Started on my legs; Felt lethargic; Can't even walk; Can't use arms or hands; Calves and veins hurt in back of legs; Felt very lightheaded, felt very dizzy; Shortness of breath after any exertion, lose breath if I am standing to long; Swelling in her hands; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Felt lethargic), GAIT DISTURBANCE (Can't even walk), LIMB DISCOMFORT (Can't use arms or hands), PAIN IN EXTREMITY (Calves and veins hurt in back of legs) and DIZZINESS (Felt very lightheaded, felt very dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Felt lethargic), GAIT DISTURBANCE (Can't even walk), LIMB DISCOMFORT (Can't use arms or hands), PAIN IN EXTREMITY (Calves and veins hurt in back of legs), DIZZINESS (Felt very lightheaded, felt very dizzy), DYSPNOEA (Shortness of breath after any exertion, lose breath if I am standing to long), PERIPHERAL SWELLING (Swelling in her hands), BURNING SENSATION (Feels burning sensation in legs towards knees), ASTHENIA (Feel like all energy is being pulled out of me), RASH (Rash on top of feet), FATIGUE (Exhaustion) and MYALGIA (aching all over Started on my legs). At the time of the report, LETHARGY (Felt lethargic), GAIT DISTURBANCE (Can't even walk), LIMB DISCOMFORT (Can't use arms or hands), PAIN IN EXTREMITY (Calves and veins hurt in back of legs), DIZZINESS (Felt very lightheaded, felt very dizzy), DYSPNOEA (Shortness of breath after any exertion, lose breath if I am standing to long), PERIPHERAL SWELLING (Swelling in her hands), BURNING SENSATION (Feels burning sensation in legs towards knees), ASTHENIA (Feel like all energy is being pulled out of me), RASH (Rash on top of feet), FATIGUE (Exhaustion) and MYALGIA (aching all over Started on my legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant product were reported  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received. New events were added (Fatigue, Myalgia, Asthenia).
Per Emergency Report and after speaking to patient the left arm became swollen, red and hot and her eyelids began to swell in the evening mentioned  about 7 hours after the injection. Patient stated also feeling nauseated and lightheaded for several hours. Patient received IV Benadry and Solu Medrol and was in the ED for approximately 2.5 hours under observation.  She was then released and has been taking Benadryl by mouth three times per day. On this day patient says her arm is quite a bit better but still having some eyelid swelling though improved.
Began noting a breast lump 9/2021  Biopsied ER/PR + HER 2- breast cancer MRI 3/17/2022 with hepatic mets multiple small pulmonary mets also noted. Liver biopsy 4/1/22 consistent with metastatic breast cancer. Noted to be pregnant when she went for port-a-cath. Choose to terminate pregnancy 3/31/22 to allow for complete chemo. ACT 4/5/22-7/23/22 . PET noted resolved axillary nodules and pulmonary nodules, Liver mets responding but still with activity. Sarted Lupron and anastrozole 8/10/22, Kisqoli addes 8/23/22.   I am not saying  MRNA vaccines caused this but I have seen way more and way younger breast cancer in this remote population in than in a  very long career. We have had 18 new cancers since the vaccines only 1  was unvaccinated.  This is the youngest ever.
Low blood pressure; blurry vision; fatigue; numbness of the right arm and right leg; nausea; This is a spontaneous report received from contactable reporter (Nurse) from a sales representative.  A 17-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 18Jul2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation; meningococcal vaccine a/c/y/w conj (CRM197) (MENVEO), on 18Jul2022 as dose 2, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: use Synthroid daily; "allergic to Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Menveo (dose 1, single), for Immunisation. The following information was reported: HYPOTENSION (non-serious), outcome "unknown", described as "Low blood pressure"; VISION BLURRED (non-serious), outcome "unknown", described as "blurry vision"; FATIGUE (non-serious), outcome "unknown"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness of the right arm and right leg"; NAUSEA (non-serious), outcome "unknown".   Additional information: Second dose of Menveo was administered on 18Jul2022, in the right arm and Trumenba was administered on the left arm, on the same day.  Follow-up attempts are completed. No further information is expected.
Patient states she started having pain 8/29/15 ice was applied due to being swollen, and also got a blister 8/29/15.
Patient received shot and went to the bathroom. When returning from the bathroom he felt dizzy and fainted while walking back from the bathroom.
Narrative:  Per reporter note "reports he does not take any immunizations due to h/o Guillain Barre' Syndrome 25 years ago."