chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/16/2021 around 5:30pm I noticed pain in my right armpit. but it's increasing in intensity as time progresses.  Like a constant pain in my armpit; It was initially just odd and  uncomfortable; I assume it's lymph nodes, and it's not an emergency situation, but I wanted you to know for your records. (If swollen lymph nodes do not fall under the category of "adverse event," I apologize form is understanding.); This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the right arm on 15Apr2021 at 10:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included herpetic viruses all currently dormant (Epstein Barr Virus; Herpes Simplex I and II), osteoarthritis and food allergy that caused anaphylaxis but is unknown what it was. The patient did received medication(unspecified) within two weeks of vaccination (the patient reported that the space was too small to answer fully for other medications).The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) via an unspecified route of administration on 24Mar2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient also took promethazine (PHENERGAN), levofloxacin (LEVAQUIN) previously and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 17:30, the patient experienced pain in right armpit. It was initially odd and uncomfortable, but it increased in intensity as time progressed, like a constant pain in the armpit. The patient assumed that it was lymph nodes and it was not an emergency situation, but the patient wanted us to know for the records. (The patient also felt that, if swollen lymph nodes does not fall under the category of "adverse event," she apologized for the misunderstanding). No therapeutic measures were taken as a result of the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events pain in right armpit, odd and uncomfortable feeling and swollen lymph nodes was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
1 of 5 patients who exp an inject site react w/in 24 hrs p/vax; react was the size of a quarter, hard, raised & warm to touch; afebrile; no tx initiated;
patient has not received her second dose past 42 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has not received her second dose past 42 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has not received her second dose past 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has not received her second dose past 42 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Right arm sore and can''t lift her arm up, after booster.; has been having arm soreness in the site of injection or left arm until today; Her left arm feels okay now and is a bit swollen.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101482847 (Pfizer).  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 05Oct2021 (Batch/Lot number: unknown) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Right arm sore and can''t lift her arm up, after booster."; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "has been having arm soreness in the site of injection or left arm until today"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Her left arm feels okay now and is a bit swollen.". Therapeutic measures were taken as a result of pain in extremity. Additional information: Patient had the first two vaccines with no problems. Patient taken Tylenol for treatment which makes her sleepy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical On 27-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
Had a menstrual cycle in 12/2020 prior to first vaccination and did not have another one till 4/2021
Lymphadenopathy; mild fatigue; Myalgia; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), intramuscular in the left arm on 12Jan2021 at 16:30 as a single dose to prevent COVID. The patient's concomitant medications were not reported and it was reported that she had no relevant medical history. The patient previously received the first dose of BNT162B2 on 22Dec2020 at 14:00. The patient did not receive any other vaccine/s on the same date as BNT162B2, did not have prior vaccination within four weeks of receiving BNT162B2, and did not experience any adverse event following prior vaccinations. The patient experienced mild fatigue and myalgia on 13Jan2021, and lymphadenopathy on 14Jan2021. Seriousness for the events was reported as serious (medically significant). The patient received her second dose of the Pfizer Covid Vaccine on 12Jan2021 at 16:30. She experienced mild fatigue and myalgia after 24 hours which has improved. She clarified that the mild fatigue and myalgia resolved by this morning. She felt lymphadenopathy in her lower neck and supraclavicular area. Stated it was almost fullness she can feel, there was no redness and it was not tender. She was hoping this was related to the vaccine that she got in her left upper arm. She went to the CDC and Pfizer website and saw that lymphadenopathy was mentioned but it was a small percentage. The patient declined any treatment. The events did not require a visit to the Emergency Room of Physician's office. Outcome of the events fatigue and myalgia was recovered on 15Jan2021, while for the event lymphadenopathy  was not recovered. The reporter's causality assessment between the events and BNT162B2 for the events fatigue and myalgia was related, while for the event lymphadenopathy was unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events fatigue, myalgia and lymphadenopathy are possibly related to suspect BNT162B2 administration. 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.
No adverse event; Pedvaxhib administered after temperature excursion; This spontaneous has been received from a medical assistant, concerning a 10-months old male patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 16-DEC-2022, the patient was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular Injection, intramuscularly on the left thigh (lot number W006596 has been verified to be valid; expiration date reported and established as 11-OCT-2024) (strength and dose were not provided). The administered dose of the vaccine was stored at a temperature of 47.9 degrees Fahrenheit (F), during a time frame of 47 minutes, as recorded by a digital data logger. There was not a previous temperature excursion reported. There was no adverse effect reported.
After 2 hrs Pt has stomach cramps, later asthma sx increased, had a few palputation.  Took IBUPROFEN.  In evening had fever + chills.  Next day (10/22) feels better.
Tingling of left arm where shot was given, closing of eyes (possible fainting); Tingling of left arm where shot was given, closing of eyes (possible fainting); This is a spontaneous report from a contactable nurse via Pfizer sales representative.   A 17-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA) on an unspecified date at single doses for immunisation . The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced tingling of left arm where shot was given and closing of eyes (possible fainting); patient stayed for a few minutes and left without further complications. Events were reported as non serious. Final outcome of the events was reported as unknown.Information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a contributory role of TRUMENBA towards the occurrence of events tingling of left arm where shot was given and closing of eyes (possible fainting) cannot be fully excluded.
resident passed away in his sleep; Patient recieved dose 5 booster; Patient recieved dose 5 booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cerebrovascular accident" (unspecified if ongoing), notes: History of MI (Myocardial infarction), Dementia, COPD, Penicillins; "Myocardial infarction" (unspecified if ongoing), notes: History of MI (Myocardial infarction), Dementia, COPD, Penicillins; "Dementia" (unspecified if ongoing), notes: History of MI (Myocardial infarction), Dementia, COPD, Penicillins; "Chronic obstructive pulmonary disease" (unspecified if ongoing), notes: History of MI (Myocardial infarction), Dementia, COPD, Penicillins; "History/Allergies: Penicillins" (unspecified if ongoing), notes: History of MI (Myocardial infarction), Dementia, COPD, Penicillins. Concomitant medication(s) included: REMERON; MEMANTINE; PLAVIX; CARVEDILOL; ACETYLSALICYLIC ACID; TRAZODONE. Vaccination history included: Covid-19 vaccine (Dose Number: 01, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 02, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 03, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 04, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (death, medically significant), OFF LABEL USE (death, medically significant) all with onset 08Sep2022, outcome "fatal" and all described as "Patient received dose 5 booster"; DEATH (death, medically significant) with onset 10Sep2022, outcome "fatal", described as "resident passed away in his sleep". The patient date of death was 10Sep2022. The reported cause of death was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: resident passed away in his sleep
TC from pt 9/4/12 to report she has had pain in (L) deltoid since 6/27/12. Denies having any redness, swelling, hematoma or any marks on arm after injection. Has not sought medical care. Pt referred to urgent care ctr for assessment by MD, Pt seen 9/5/12 at urgent care.
Fever up to 100.6, muscle soreness, aches, back pain, exhaustion, winded, soreness. The symptoms extended throughout the following day and dissipated by 9p that day.
Patient was stable going into vaccination and had been for approximately 5 months. Within 12 hours of vaccination, he was showing signs of extreme mania, and within 24 hours, he was psychotic.   Psychosis lasted approximately 3  days and was treated with anti-psychotics. Residual effects (confusion, short term memory loss) remain.
Vaccinated 16 year old patient with Pfizer booster shot, but booster is not yet approved for patients under 18 years of age. Patient did not show any initial adverse effects from booster shot (was monitored for 15 minutes  post-vaccination).
Covid-19 positive test; Covid-19 positive test; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccination included BNT162b2 given on unspecified date as dose 1, single for COVID-19 immunisation. The patient experienced COVID-19 positive test on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
expired vaccine was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number D24J7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 7-JUN-2022 Reporter's Comment: The reporter stated that the expired Kinrix vaccine was administered by error to a patient. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Kinrix vaccine which was already expired, which led to expired vaccine used.
The first shot I was tired and I felt like I was in a fishbowl.; The first shot I was tired and I felt like I was in a fishbowl.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Feb2022 (Lot number: Fj6369) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gerd" (unspecified if ongoing); "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "The first shot I was tired and I felt like I was in a fishbowl.".  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination and since the vaccination the patient did not tested for Covid-19.  No follow-up attempts are possible. No further information is expected.
pt reports area is warm to touch, slightly swollen over the phone. pt also reported diarrhea, vomiting, lightheaded, dizziness. Pt advised to go to UC
Severe vomiting, Diarrhea, nausea, injection site pain, lower back pain, dry mouth  Vomiting stopped after 24 hours. Nausea continued for 4 days. General malaise for a week.
The shot had me sick in bed; This case was reported by a consumer via  interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine and sick in bed for a week. The patient stated that she/he sure hope it did its job. The follow up would not be possible as no contact details were available.
Patient presented to the emergency department due to sepsis, positive for COVID-19 on 01/25/2022 and progressed to acute hypoxic respiratory failure requiring mechanical ventilation which is likely multifactorial, this is considered a breakthrough case
Severe fatigue, stiffness in neck, shoulders, knees and thighs, brain fog, blurred vision, jaw pain  First started on May 9th, got worse on May 23 rd, continued on into June, went to see Dr. at Hospital on June 3rd, after looking at blood tests and brain MRI results, he diagnosed it as  PMR (Polymyalgia Rheumatica) on June 3rd, prescribed Prednisone. I started taking 10mg prednisone from June 5, Got some relief, but not 100%, started taking 20mg prednisone from June 17 to July 1st. Since July 1st, alternating 20mg and 15mg. The symptoms have still not gone away completely. I still feel the fatigue and some stiffness with any small activity.
Patient experienced absence seizure which lasted a maximum of 40 seconds of unconsciousness, no shaking, eyerolling or abnormal jerking movements. 15 Minutes after episode, Patient appeared sluggish with decreased activity. Afterwards she returned to her normal behavior.
rash all over body with itching, fatigue, headache, myalgia, nausea
Dizziness, light headedness, nausea began about 2 min after vaccine administration and patient recovered about 1 hr. 15 min later. Client laid down - elevated feet.
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 48 year old male pt who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 5/23/00, 7/22/00, and 12/22/00 "according to the client." This represents a schedule of 0, 2 and 7 months rather than the recommended schedule of 0, 1 and 12 months. On 9/3/03, the pt's attorney alleged that the pt "suffered right arm pain, left shoulder pain, and right and left upper arms myalgias. The onset of his symptoms is not clear at this time." Upon follow-up received 1/12/04, the pt's attorney alleged that the pt 'received vaccinations in May 1999." The attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "fever, chills, joint pain, arthralgias, flu-like symptoms, fatigue, tingling in hands and feet." Additionally, the pt was alleged to have developed "complications of diabetes and neutropenia." The attorney further alleged that the pt suffered pain that was described as "debilitating at times" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of an infectious disease specialist and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
pt recv vax 1NOV96 & pt devel vomiting & diarrhea w/o fever 48hr p/inj;pharmacist related there were other pt that exp vomit & diarrhea who did not recv vax;this is one of 25 cases reported;
Minimal erythema around site. Neck/trunk multiple erythematous blanchable lesions scattered.
Pt given Pneumonia vaccine 8/11/04. Pt returned to clinic 8/13/04 with arm swollen left from elbow through shoulder and left upper chest. Patient received MDP and Zyrtec.
Cough, myalgias, shortness of breath, chest pain, fatigue, tremors, paresthesias
Five minutes after receiving her 1st COVID vaccine, patient began complaining about  itchiness and swelling of her tongue, along with chest tightness and shortness of breath. Patient also begin feeling lightheaded.  Patient was assessed and was found to  be breathing, but her pulse was weak and thready.  A blood pressure cuff was applied to patient right arm, but the monitor was unable to generate a specific blood pressure number. Patient was administered 0.3 mg of epinephrine intramuscularly in her right thigh. She was also given 10 ml (25 mg) of diphenhydramine.  Patient was moved from the sitting to the supine position.  Patient's subjective dyspnea improved, and her airway remained intact, with no cyanosis noted. Patient was able to talk normally after a few minutes. Her pulse improved and was strong (+2) about 5 minutes after the epinephrine injection.  911 was called and paramedics arrived about 5 minutes later. Patient was taken away by the paramedics to the hospital, stable and in good condition.