chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 30-MAY-2017, the patient was vaccinated with one single dose of PROQUAD injection, lot # M026879 with expiry date on 27-NOV-2017, subcutaneously for prophylaxis. Concomitant therapies included properly stored STERILE DILUENT used to reconstitute the dose of PROQUAD. Administered vaccine experienced a temperature excursion of 14 degrees Fahrenheit for 8 hours. There was also a previous temperature excursion reported, with 19 degrees Fahrenheit for 12 hours. Data logger was involved in recording the excursion. No adverse effects were reported. Additional information has been requested.
Around 430pm my right upper began to get red also my chest began to get red (blotches) I began to feel my heart  racing also slight tightening in my throat approximately a half hr later all symptoms went away.
First symptom 0115 8/31/2023 severe abdominal pain (pain level 6) that lasted 40 minutes then it subsided. Itching on arms and head started 0500 08/31/2023 and is still present. No rash present since vaccination. Abdominal pain returned 9/1/2023 1300 lasting 10 minutes (pain level 2). Nausea present at this time for the past 1 hour. No emesis. Headache began 1750 9/1/2023 with vision changes "flashing lights" left eye. Flashing lights no longer present were present about 30 minutes. Headache remains.
Diagnosed with covid; Diagnosed with covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).   A male patient in his 20's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with covid". The event did not Results in death, life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The patient has been diagnosed with covid. Individual told the reporter today (is nurse but is not involved/was not told in a professional setting). A male patient mid-late 20s (public figures - can find all info including birthdays online. withheld the reporter think is almost 30.). This is a recent event. Not sure what vaccines are provided in (withheld) but the patient is likely vaccinated. Saw this article yesterday, last updated 24Dec2021 (includes people telling him to get well soon).  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858742 same reporter/vaccine/event, different patient;US-PFIZER INC-202101872619 same reporter/vaccine/event, different patient
Pt felt hot and near syncopal episode. Pt said she gets like this with blood draws. Blood pressure 94/60,68,18, Crew took patient outside to sit and patient stated she felt better. Patient refused to go to hospital. Signed refusal form.
period immediately following vaccination had more blood clots, darker blood; period immediately following vaccination had more cramps; lymph node under her left armpit was inflamed.; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (period immediately following vaccination had more blood clots, darker blood), DYSMENORRHOEA (period immediately following vaccination had more cramps) and VACCINATION SITE LYMPHADENOPATHY (lymph node under her left armpit was inflamed.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (period immediately following vaccination had more blood clots, darker blood), DYSMENORRHOEA (period immediately following vaccination had more cramps) and VACCINATION SITE LYMPHADENOPATHY (lymph node under her left armpit was inflamed.). At the time of the report, MENSTRUAL DISORDER (period immediately following vaccination had more blood clots, darker blood), DYSMENORRHOEA (period immediately following vaccination had more cramps) and VACCINATION SITE LYMPHADENOPATHY (lymph node under her left armpit was inflamed.) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  The patient took Moderna Booster dose on 27Nov2021, batch number 014F21A, on Right Arm.   This case was linked to MOD-2021-405167, MOD-2021-405203 (Patient Link).
Pt. gasping for air, not moving air in lung fields, glassy eyes, stimulated pt and gave O2, pt able to take a deeper breath and then gasping again, lasting several minutes, pulse ox 77%, 911 called, continued 100 % O2 and stimulating baby to keep awake, baby would take bottle which helped regulate breathing while recieving blow by O2, pulse ox improved to 93%, breath sounds with crackles and wheezing which were not present during exam prior to vaccines, after coughing a few times (loose cough), Bs much improved as far as lung volume and no crackles and wheeze, pulse ox improved to 99%, taken to ER by ambulance, HR remained between 160 and 140 during episode, of note were some abnormal findings in musculature during exam and that mother stated she fed pt cereal once and had choking episode.
Pt had small red area appear day after vaccine. The next day most of his upper arm was red, slightly edematous, and warm to touch.
2/3/14 at 415 PM. Parent notified health dept by phone, describes symptoms - (R) side of daughters face red rash from top of (R) side of head to the (R) side of chin, eye was swollen closed and sclera was red. Parent took her to the ER and Dr did not order any tests, they observed her and sent her home as symptoms subsided. T 99.3.
After receiving my second dose I had severe body chills in the middle of the night between 1am - 3am.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 20Apr2021 at 09:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 31Mar2021 at 09:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation and experienced no adverse events. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 01:00, after receiving the second dose, the patient experienced severe body chills in the middle of the night between 01:00 - 03:00. The event 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 the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe body chills in the middle of the night between 01:00 -03:00 was resolved on 21Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient states after receiving the 3rd dose of Moderna 01/26/2022, started experiencing symptoms that evening of fever, nausea, abdomen pain, pain at the injection site, and muscle aches. Symptoms subsided after 3 days. No noted Primary visit/communications.
Pt called office reporting that 5 days after her injection, she had some joint pain, shoulder soreness and tenderness in her lymph nodes under her arm, which did improve and subside.
pt started having redness, skin rash all over her body, mild fever at the night after vaccination was done. Reports no breathing problems. pt came to consultation window at Wed 7/7/2021 at 7 pm with rash symptoms and temp 98.7 'F. Was advised to take diphenhydramine 25 mg and follow up with PCP. Patient states there is no PCP. Was advised to go to emergency in case of worsening symptoms despite OTC recommendation.
Pain and Burning/stinging sensation at the injection site; Swelling at the injection site; Rash at the injection site; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PAIN (Pain and Burning/stinging sensation at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain and Burning/stinging sensation at the injection site). In March 2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE RASH (Rash at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PAIN (Pain and Burning/stinging sensation at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE RASH (Rash at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information also included the Benadryl Cream
This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 03-JUN-2013 the patient was vaccinated with first dose of GARDASIL (Dose 0.5 milliliter (ml)), intramuscular. Concomitant medications were not reported. On 03-JUN-2014, the patient was vaccinated with second dose of GARDASIL. No adverse effects were reported. The outcome of the patient was vaccinated with first dose of GARDASIL on 03-JUN-2013 and second dose of GARDASIL on 03-JUN-2014 was unknown. Additional information has been requested.
12/10/08 at 4pm she had a seizure and quit breathing 911 was called-had high temp (104 degrees I think)- suspect febrile seizure; had been fine prior to this; however day care and parents noted she stopped talking after 12/1/08. 12/16/08 resumed babbling/talking.
Pt had HAVRIX and ZOSTAVAX vaccines on left arm. Stated that she could not lift the arm above her head 3 days after admin, was extremely painful. ZOSTAVAX on the back of the arm, HAVRIX on "side".
Janssen COVID-19 Vaccine EUA -Chills with rigors for approximately 2 hours -Fever intermittently for approximately 24 hours -Headache  for approximately 24 hours -Fatigue for approximately 48 hours
Fever up to 103, severe headache, Fever lasted 5 days, headache still persisting at 8 days, sores in mouth developed on 5/12.
Mild inflammation with erythema 8-10cm now spreading down upper arm from site of vaccination (gradual increase erythema spread over 2 days since vaccination) + warmth to site - increase drainage, no pt fever.
Symptoms started mild after 14 hours after administration: body aches, after 22 hrs. I started to feel nauseous at first then I had  chest pain, headache, chills, back pain, body aches (muscle pain) and dizziness
p/vax pt devel vesicle on chest progressed to rupture, resolve & recur over 3 1/2 wk;6 lesions p/next anthrax;
Joint pain and inflammation, fatigue, swelling, petchial rash on lower legs. No fevers. Plus headaches.
im getting chest pains by where my heart is as well as pains up and down my left arm where the shot was taken that started since i got the first dose.
Patient presented at clinic today with a diffuse red pin point rash on arms, trunk area, neck and stated genital area.  Denies itching.
I had shingle shots and later I got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of vaccination failure in a adult 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but selected as an adult as per the vaccine indication. The patient received Shingles shots and later got shingles. The reporter stated that, the vaccine was not preventable. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
A non-serious spontaneous report of "patients over 49 years of age received H1N1 LAIV" was received from a non healthcare professional concerning a 54-year-old female. No past medical history and concomitant medication was reported for this patient. On 23-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
ONE OF FOUR PTS DEVELPD FEVER, CHILLS AND ARTHRALGIAS AND PALPITATIONS WITHIN 24 HRS AFTER IMMUN. NO RESIDUAL EFFECTS NOTED WHEN SEEN BY PHYS 5-1-90.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose 4 (booster), single (Lot number: FL3209) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative on Ag test on day 5 post-dose; Negative, notes: I tested negative on Ag again on day 9 post-dose; Positive, notes: I tested positive by home Ag on day 11; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The had no known allergies. The patient was treated with Paxlovid from 23Jul2022 to 27Jul2022 for COVID-19. The patient completed his course of Paxlovid and tested negative on Ag test on day 5 post-dose, with complete resolution of symptoms. He tested negative on Ag again on day 9 post-dose. On day 10 post-dose he developed sneezing and nasal congestion. He tested positive by home Ag on day 11.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Patient received immunizations on 10/1/07 at approximately 3:00pm.  At that well child exam, patient was found to be a healthy 4 month old.  On 10/2/07 patient was taken to the ER because he was having difficulties breathing.  His oxygen level was in the low 70s.  A chest xray revealed that patient's lungs were "cloudy."  Patient was put on oxygen.  The hospital ran more tests to determine the cause of patient's lung condition.  After two days at Hospital, patient was transferred to another Hospital in another city to see a pulmonary specialist.  The specialist felt that patient had a viral infection that needed to "run it's course."  Patient had a total of 3 chest xrays and 1 CT scan.  They also did blood work, cystic fibrosis test, and RSV test.  All tests came back negative.  Patient spent 14 days in the hospital and was released on oxygen.  Patient is now at home on approximately 1/4-1/8 liters of oxygen.  Patient has no other symptoms and his chest sounds "clear."  We did not get any real answers or reasons while in the hospital.  Another appointment is scheduled for 10/26/07 with the pulmonary specialist.  They will also do another chest xray at that time.  11/14/2007 MR received for DOS 10/4-16/2007 with D/C DX:  Hypoxia.  Viral Pneumonia.  Respiratory distress.  Child presented to local hospital with tachypnea and decreased O2 sats.  Temp = 38.5'C.. Pt was admitted and did well except   for persistant hypoxemia but w/o distress.  Transfered to higher level of care for further mgmt and care.   Started on abx,albuterol nebs, Chest PT and supplemental O2. Pulmonary consult with assessment of bilateral alveolar pneumonitis. Pt was unable to fully wean from O2 so was d/c home on O2. F/U 10/26/07 with pt weaned from daytime O2, still requiring supp O2 at night. 1/12/2010 Patient continued to have respiratory issues until 2/08. He never had a "clear" chest x-ray.
4 month old patient accidentally received Kinrix; patient accidentally received Kinrix instead of Infanrix; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th June 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th June 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was practice manager.  The 4 month old patient accidentally received Kinrix instead of Infanrix which led to inappropriate age at vaccine administration and wrong vaccine administration. No symptoms were reported.  The reporter consented to follow up.
Injection site: itching and severe pain with contact and arm use; overall: severe malaise, severe headache, minor to moderate stomach pain, nausea, overall bad flu feeling. Folks need to be warned they may need support to manage children and take a day or 2 off for these symptoms. I am a single mom, nurse, and had not expected this severe of an immune response.
After getting flu shot last year and bamm, caught the flu; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient with unknown demography who experienced the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced the non-serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
redness on left arm started to fade away on 3/10/21 and continues to fade away at present time. No other signs and symptoms present.
At the injection site, my arm is continuously twitching. You can physically see it and I can feel it.
Reported tongue tingling and increased heart rate from low 90s to 130. No airway compromise resulted and tongue tingling resolved after 1 hour.
She got her vaccine, the day of the vaccine she had just a sore left arm.  On Monday 7/24/23 she had what she had was an eye infection.  Her eye swollen,  had video visit and she diagnosed an eye infection and a sinus infection and put her on antibiotics.  On Tuesday she started with nausea, vomiting and diarrhea.  On Friday she did not take it anymore, did not want another video visit and her husband took her to the ER.  There they officially diagnosed her with shingles.  She got an IV, antinausea medicine, they put her on an antiviral pill.  Her shingles was in her eyes, she saw an eye doctor on Friday afternoon, again on Monday and she sees him again tomorrow.  The eye doctor told her to continue the antiviral and put in artificial tears a few times a day and to stop the antibiotic the ER physician gave her.  She has lost 13# in one week.  She is also having headaches, which the ER told her was not unusual.  The thing that she never knew was that shingles is only one sided.   She is also taking Tylenol for the headaches.  She is improving with her symptoms, she is not having the nausea, vomiting or diarrhea and able to eat.  The spots are drying off and shrinking around her eye.  The ones in the eye itself are getting better as she is able to see better, but her eye is still swollen, but is hard to tell.  They are also looking for damage to the cornea and that is why she has to see them frequently.  She was told to see her PCP if her N/V/D did not stop to come back.
9:48 am Patient received TdaP (L) and then MENACTRA (R) and stated she felt dizzy and passed out on exam table. O2 stats and vital signs were taken and patient continued to rest on exam table with c/o feeling dizzy and sick to stomach. 10:15a 911 was called to transport patient to ER for c/o dizziness and nausea.
GOT INJECTION AT 11:40AM, DEVELOPED REDNESS AT THE INJECTION SITE BY 4PM, EVENTUALLY BECAME A HARD LUMP BY THAT EVENING, LUMP AND REDNESS INCREASING IN SIZE EVERY DAY, HOT TO THE TOUCH, PAINFUL TO TOUCH AND ALL THE TIME.