chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested COVID positive; tested COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004281.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 12Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Nov2022, outcome "unknown" and all described as "tested COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2022) Positive, notes: It was reported that the patient tested, COVID positive on the morning of 18Nov2022.  Clinical course: On 18Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 vaccine dose 1, dose 2, and was administered dose 3 on 12Feb2022 for COVID-19 immunisation. It was reported that the patient tested COVID positive on the morning of 18Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. Improperly stored doses of GARDASIL 9 (dose and route were unknown; lot number was M009378 with expiration date 23-APR-2013), had been administered to unspecified patients on unspecified dates since 17-AUG-2016. The temperature and time frame of the vaccine storage was 34.2 F for 104 hours and 49.0 F for 39 hours. There was no previous temperature excursion. Data logger issue was involved. No adverse experience had been reported. Additional information has been requested.
Dizziness, numbness hands & feet (feeling cold) for 2 hours, extreme thirst, chills for 6 hours, injection site pain 2 days
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot# K026385 exp: 15-DEC-2016, Lot: K011800 exp: 21-AUG-2016, Lot: reported as K018961 exp: 15-OCT-2016 respectively; strength, dosage and route unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not want to be contacted.
Patient received flu vaccine on 10/21/02. Starting itching on 10/22/02. Still itching 10/23/02 and a knot appeared at injection site. Told patient to take Benadryl. Call back if blood pressure changes, nausea, or rash.
her heart rate dropped to 40-45 beats per minute.; This is a spontaneous report from a contactable female consumer or other non hcp from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported) via an unspecified route of administration on an unspecified date as Dose 2, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported) via an unspecified route of administration on an unspecified date as Dose 1, Single for COVID-19 immunization. The patient experienced her heart rate dropped to 40-45 beats per minute on an unspecified date. Patient had a weird side effect after the Covid vaccine with dose 2. The patient underwent lab tests and procedures which included heart rate: 40-45 on an unspecified date dropped to 40-45 beats per minute. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
administered an expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date 10th October 2021) for prophylaxis.   On 19th November 2021, the patient received Shingrix. On 19th November 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received expired dose of Shingrix on the day of reporting, which led to expired vaccine used. No other symptoms noted by patient. The reporter consented to follow up.
Pt received 1st Covid Shot Saturday 10:30am.  Felt some abdominal cramping that evening, and when she woke up on Sunday, had abdominal pain, nausea, vomiting, and a small amount of diarrhea.  She continued to vomit all day, and became weak/dizzy.  Went to ER, where she was found to have Diverticulitis and Dehydration.  She was given IV fluids and anti-nausea medicine and hasn't had any further vomiting over Sunday Night.  Patient will continue oral antibiotic treatment for Diverticulitis at home.
Initial solicited report received during market research on 05 October 2015 from a consumer in the study. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subejct had burn for couple of days. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported.  List of documents held by sender: none.
pt recv vax; c/o fussiness; approx 12 hr of inconsolable crying; fever 101 noted;
Right arm-painful and swollen at site became itchy white and hard.  Later that evening pain and swelling spread to shoulder and beneath arm-as swelling progressed arm became redder and redder and more painful.  Till she came into clinic.  Lymph nodes swollen.  Received antibiotic Keflex, Medrol on 11/10/2003.  Client doing well.
Other-zoster related conditions; Shingles; Information has been received from a lawyer, regarding a case in litigation, concerning a patient (pt) of unknown age and gender. There was no information provided regarding the pt's concurrent conditions, medical history or concomitant medications. In or around 2012, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location, and route of administration were not reported) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date, reported as subsequent to the zoster vaccine live (ZOSTAVAX) inoculation the pt was treated by physician for shingles and other zoster-related conditions. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX), the pt has and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Hives for 2 weeks that have not gone away. They started a week after the booster shot of Moderna. I have even using antihistamine OTC and cortisone cream as well as anti itch cream, also was using a Medrol pack but it seems to create more issue, only did 3 days of it. Stopped last night the Medrol pack but continue with the Benadryl and cortisone creams.
Almost passed out; Pounding heart; extreme soreness; Weakness; Nauseous; Aches/pain; Chills; Severe headache; A spontaneous report was received from a consumer concerning a 66-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced the events  almost passed out, aches/ pain, extreme soreness, pounding heart, weakness, chills, severe headache and nausea.  The patient's medical history was not provided. Concomitant medications reported were levothyroxine, fish oil and multivitamins.  On 11-Feb-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11-Feb-2021, the patient experienced chills, severe headache, aches, pain, and took ibuprofen. Those side effects went away. On 12-Feb-2021 she experienced extreme soreness, pounding heart, weakness, nauseous, and almost passed out.  She called the paramedic to evaluate her symptoms.  No further details were provided.  Treatment for the events included ibuprofen.  Action taken with mRNA-1273 in response to the events was unknown.   The outcomes of the events, chills, severe headache, aches/pain, extreme soreness, pounding heart, weakness, nausea and almost passed out, were considered unknown.  The reporter assessed the events almost passed out, aches/ pain, extreme soreness, pouring heart, weakness, chills, severe headache, nauseous as possibly related to study drug; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
11/4/08 School nurse & family called with complaints of red, swollen right arm in area where chickenpox vaccine given.  Site was red, raised & 8 cm in diameter per school nurse.  Family states child had fever the evening of 11/13/08 but no pain at site.  Child's fever resolved the next day.  11/18/08 Site was resolving-pink and 1/2 the size per school nurse.
I thought I was going to pass out; rapid heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 72 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Jan2022 10:30 (Lot number: FK9729) at the age of 72 years as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: IgG deficiency; "rheumatoid arthritis" (ongoing), notes: take methotrexate for rheumatoid arthritis; "IgG deficiency" (unspecified if ongoing); "Asthma/COPD" (ongoing); "osteoporosis" (ongoing); "Nerve pain" (ongoing); "Pain/inflammation" (ongoing); "Pain/inflammation" (ongoing); "Weakened immune system" (unspecified if ongoing); "Asthma/COPD" (ongoing). Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis (ongoing); GABAPENTIN taken for neuralgia (ongoing); CELEBREX taken for pain, inflammation (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 7:30 AM, Anatomical site of injection: Upper left arm, Route of administration: Intramuscular, Batch/Lot Number: EN6201), administration date: 10Mar2021, for Covid-19 Immunization, reaction(s): "No adverse event"; Bnt162b2 (Dose: 2, Time: 7:30 AM, Anatomical site of injection: Upper left arm, Route of administration: Intramuscular, Batch/Lot Number: DBP6955), administration date: 31Mar2021, for Covid-19 Immunization, reaction(s): "No adverse event"; Bnt162b2 (Dose: 3, Time: 11:00 AM, Anatomical site of injection: Upper left arm, Route of administration: Intramuscular, Batch/Lot Number: FC3187), administration date: 20Aug2021, for Covid-19 Immunization, reaction(s): "No adverse event". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 26Jan2022, outcome "recovered" (27Jan2022), described as "I thought I was going to pass out"; HEART RATE INCREASED (non-serious) with onset 26Jan2022, outcome "recovered" (27Jan2022), described as "rapid heartbeat". The patient underwent the following laboratory tests and procedures: heart rate: (26Jan2022) increased, notes: Rapid heartbeat.  Clinical course: It was reported that the patient had no real issues with the first three doses. The patient had a rapid heart beat with the fourth dose. Patient had were a rapid heartbeat that started about 5 hours after the shot. It intensified a couple hours later. That started within a few hours of the injection. It continued for several hours becoming very rapid to the point that the patient thought that he/she was going to pass out. That lasted about half an hour then back to just a fast beat but tolerable. By the next day it was normal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Specific relevant test for thromboembolic events with thrombocytopenia was reported as None . No follow-up attempts are possible. No further information is expected.
Right after injection: felt warm, but no pain, swelling; very minor itching on scalp, other arm and back.  Day 1-6 after injection: no adverse events, very minor soreness at injection site but no redness or any other sign of inflammation Day 7 after injection (almost exactly 1 week to the hour): felt a minor pain, soreness and itching. After touching and short scratching immediate swelling, redness, raised bump (about the size of 2 quarters) and heat. Minor itching all over the body. Slowly calmed down but still raised skin (almost like an insect sting) and warm to touch. No fever or any other side symptoms.
pt recvd vax; became "manic" as described by mom; was hyperactive, but not "unhappy"; never became rigid but there was some arching of back;
slept 12 hours; tired; Temperature has been bouncing around/not gone higher than 106; really bad cold; reaction; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (really bad cold), IMMUNISATION REACTION (reaction), SOMNOLENCE (slept 12 hours), FATIGUE (tired) and PYREXIA (Temperature has been bouncing around/not gone higher than 106) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced NASOPHARYNGITIS (really bad cold), IMMUNISATION REACTION (reaction) and PYREXIA (Temperature has been bouncing around/not gone higher than 106). On 20-Nov-2022, the patient experienced SOMNOLENCE (slept 12 hours) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (really bad cold) had not resolved and IMMUNISATION REACTION (reaction), SOMNOLENCE (slept 12 hours), FATIGUE (tired) and PYREXIA (Temperature has been bouncing around/not gone higher than 106) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, Body temperature: the value had not gone higher than 106.         No concomitant medication was reported. The patient had no problem with any of the shots so far-the first two doses and two boosters.  The temperature had been bouncing around and had not gone higher than 106.
This 78 year old female presented to the ER complaining of pain and redness to her right cheek for the past 2 days. She was apparently stung by a bee and this is how the redness started. It has grown since that time. She has some pain and swelling. She was started on Keflex for cellulitis to the right cheek secondary to a bee sting.  I appreciate your asking me to examine your pt who suffered from severe left arm pain which began following a tetanus injection in the left deltoid area after she was stung by a bee in her face on 8/5/01. The pain was initially localized but gradually spread to the hand, particularly the 1st and 2nd digits. The pain was unrelenting and prevented the pt from using her arm. In particular, she could not place her arm behind her back or raise it above 90 degrees horizontal. The pain began to subside after 1 month to 6 weeks. The pt underwent physical therapy X 5 and had an orthopedic evaluation. The neurological exam was unremarkable with preservation of strength and reflexes as well as sensation. Cervical spine movements were intact as well. Cranial nerves were intact. The most important finding was one of focal pain over the anterior edge over the deltoid toward its insertion on the humerus. This area was very tender and reproduced the pt's pain. There was a minimal ache over the posterior shoulder area, perhaps in the supraspinatus tendon. There was very slight tenderness at times with range of motion of the shoulder, which cannot explain the pt's primary complaint and may simply relate to the MRI findings. Discussion: The history made me suspicious that the pt might have suffered a post vaccination brachial plexitis, but based on my exam, this appears to be unlikely. The pain lasted much too long and unless the syndrome has fully recovered, there are no residual findings. I rather believe that the injection took place in the tendinous part of the deltoid. I felt that a local infiltration might be of benefit, which was performed with Xylocaine 2 percent and abolished the localized pain. The pt should apply heat for the next several days and engage in range of motion exercises to eliminate any contributing factor from the shoulder. This procedure may need to be repeated, perhaps with local steroids. I anticipate that it can further improve, although such entity can sometimes linger for quite some time.
Developed stools with bloody mucus, foul odor 5 days after ROTATEQ given - ? anal fissure (not clearly seen). No elevated stool frequency irritability or other signs of illness.
Pt called 3/6/08 in morning wanting to know information on flu shot she was given. She said that ever since receiving vaccine she has had chronic pain in her arm. Her doctor said she had an inflammatory disease and patient wanted to know if was brought on by flu vaccine.
no adverse event.  my clinical coordinator instructed me to fill this out.  abrysvo was reconstituted with fluzone hd and injected.
Received Second Dose of HEPLISAV-B 23 Days Later; Initial Report Received on 08-Oct-2020  A workplace supervisor reported that a 23-year-old female employee (race and ethnicity not provided) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 23 days after the first dose.  No medical history was reported.   No concomitant medications were reported.  On 08-Sep-2020, the patient received the first dose of HEPLISAV-B (Lot # 933621, expiration date 26-Jul-2021 and NDC # not reported) at an unspecified facility.  23 days later, on 02-Oct-2020, the patient received the second dose of HEPLISAV-B (Lot # 933621, expiration date 26-Jul-2021 and NDC # not reported) at an unspecified facility.  At the time of report, the patient had not reported any reactions to the vaccination.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
pt recvd vax & devel what was dx as cellulitis characterized by redness & swelling in the arm of inject; pt was treated w/ATB & react resolved; reporter states MD revised dx to local erythematous react-pt did not have cellulitis
became lightheaded feel a little off, dizziness, jaw starting to lock and hurt, started dry heaving, feeling of anxiety, has no taste
The pt experienced a 3x3 cm red, warm, and indurated area to the left leg. A nurse reported that a 12 month old male received Prevnar, Varivax, and haemophilus B conjugate vaccines on 10/4/00. On 10/13/00, the infant developed an injection site reaction characterized by redness, warmth, tenderness, swelling and blisters at the site of Prevnar administration. He was treated with Keflex and hot soaks. The infant recovered.
No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from other health care professional referring to a 4-year-old male patient. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 13-JAN-23, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number W008711 has been verified to be a valid lot number, expiration date: 14-MAR-2024) (dose, route of administration, vaccination scheme frequency, and anatomical location were not reported) for prophylaxis, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported), and with diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (dose, route of administration, vaccination scheme frequency, anatomical location, indication, lot number, and expiration date were not reported). The administered doses of the vaccines experienced a temperature excursion at -10.5 degrees Celsius for 1 hour and 34 minutes. It was not mentioned if there was a data logger implied. There was no previous temperature excursion. No additional adverse event (AE) was reported.  This is one of several reports received from the same reporter.
Diarrhea 48 hours and going; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Feb2021 at 10:00(at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included penicillin allergy. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications within two weeks. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. On 27Feb2021 the patient experienced diarrhea 48 hours and on going. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was not recovered 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.