chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms; swollen lymph nodes in her neck; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and LYMPHADENOPATHY (swollen lymph nodes in her neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0114214) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.   On 24-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and LYMPHADENOPATHY (swollen lymph nodes in her neck). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown and LYMPHADENOPATHY (swollen lymph nodes in her neck) had not resolved.            no treatment drugs were reported no concomitants were reported   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow-up information received on 13 Aug 2021 contains no new information.
1/31/2023 Presents via EMS for evaluation of altered mental status. Family reports she has become increasingly more somnolent over the past several weeks. Nursing staff at LTC facility tried to wake her from a nap this afternoon and she was not waking. Staff reported patient being "clammy." EMS was summoned as patient is a full code. EMS arrived and patient was acutely alert and responsive. Patient indicates that she did not respond to the nursing staff while they were trying to awaken her because they were "just talking stupid." Patient offers no complaints  Plan ? Admit patient to ICU, close hemodynamic monitoring, IV fluid resuscitation, broad-spectrum IV antibiotic coverage ceftriaxone plus azithromycin to cover superimposed bacterial pneumonia, complicated UTI ?Treat COVID-19 pneumonia with IV remdesivir and Decadron ? Treat influenza B pneumonia with Tamiflu given acute onset of symptoms ? Oxygen therapy via facemask, wean as needed On admission to ICU, patient desaturated to 85% on room air and was placed on oxygen by facemask improving to 96%.  ASSESSMENT/PLAN Active Problems: Complicated UTI (urinary tract infection); COVID-19 virus infection; Influenza B; Encephalopathy; Severe sepsis; Acute metabolic encephalopathy  Death report indicates client died Immediate Cause: Covid-19 pneumonia; Other Significant Conditions Contributing: Influenza B, Interstitial Lung Disease. She died at Hospice.   Reporter does not have access to further medical records. If additional information is needed, please contact the admitting hospital and place of death:
Covid monitoring documentation. PT admitted 11/23/21 documented to have positive covid. PT received Pfizer 8/19/21 Lot FC3182 for dose 1. Dose 2 was Pfizer given on 9/10/21 Lot 30135BA.
This spontaneous report has been received from a pharmacist (also reported as a nurse) referring to unspecified patients of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. O n 30-DEC-2016, the patients were vaccinated with an improperly stored (RECOMBIVAX HB, with lot # M032649, expiration date 11-NOV-2018 and lot# M034894, expiration date 11-NOV-2018, (route of administration, dose and frequency were not provided) for prophylaxis. The reporter stated that the temperature range  of the vaccine  was 1.4 Celsius (C) and the time frame was 46 minutes, also she stated that the previous temperature excursion was 9.4 Celsius (C) during 1 hour and 35 minutes, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA000848: US-009507513-1701USA007904: US-009507513-1701USA007902:
COVID-19 breakthrough case. patient presents to ED with complaints of cough and SOB.  She also has fatigue and generalized weakness.  She received the Johnson&Johnson COVID-19 vaccine on 3/12/21.   Admitted 8/21/21.  tested positive for covid at outside clinic on 8/21/21. Diagnosed and treated for covid-19 related acute hypoxic respiratory failure. Improved and was discharged on 8/26/21.
Guillain-Barre-like syndrome with progressive weakness/multiple falls for 3 weeks. Recent vaccine history shows that pt received their influenza and tetanus together. Suspicion that it might be one or both vaccines causing the reaction. Pt also stated that she is a recovering alcoholic and has PMH significant for childhood Hodgkin lymphoma.
TRUMENBA was given as an alternative to MENVEO or MENACTRA. No adverse reaction reported to this facility.
Started with immediate facial flushing, progressed to light-headed, headache, severe fatigue. Following day had brain fog, dizziness, nausea, slight blurred vision, headache, severe fatigue, body aches. Symptoms mostly resolved after 48 hours post vaccine.
No additional adverse effect; a patient received improperly stored PROQUAD; This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-AUG-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S027466, expiration date 02-MAR-2021 (dose and route of administration were not reported) for prophylaxis. The administered vaccines experienced temperature excursion of 47 degrees Fahrenheit (F) to 77 F (66 F) for 3 days. There was no adverse event reported. There was no previous temperature excursion. The digital data logger was involved.
11/15/14 at 1130 Patient visited the facility to receive an influenza injection. Five minutes after the injection the patient complained of sweating, nausea, and a fast heart beat. The patient was seated with her head back and her feet elevated. Patient was alert, OX3, able to move all extremities. Skin warm and clammy, Resp even and unlabored. No wheezing noted, no rash noted on the body. Patient denied chest pain, SOB, Headache at this time. An icepack was applied to the back of her neck and offered sips of Gatorade and continued to monitor. Patient denied not eating today and yesterday. She verbalized just wanting to stay in the house all the time after losing her job. Patient denied homicidal/suicidal thoughts or depression. Patient say she just don't have a appetite. Encouraged patient to eat small frequent meals even if she is not feeling hungry. Patient denies a medical history of heart problems, HTN, diabetes or psychiatric problems at this time. Vitals at 1135 BP 91/55, HR 101, Resp 24, Temp 98.2 orally Fifteen minutes after interventions, patient denied Headache, SOB, chestpain, nausea, pain level was 0. Vitals 107/62 HR 60 Resp 16 Temp 98.2. Skin warm and dry, color pink, no rashes noted, no wheezing noted. Patient was dismissed home in stable condition ambulating without assistance. ER precautions given, go to the ER or call 911 with SOB, chest pain, call PCP with new symptoms.
sore arm; fatigue; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus (Start Date: 10 years ago Recent change in status such as improvement or worsening: about the same).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-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 PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2022-571116, MOD-2022-571130, MOD-2022-571131 (Patient Link).
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 04-DEC-2015 the patient was vaccinated with improperly stored doses of MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient was given child vaccine instead of bivalent booster.  Patient has been notified and will come into the pharmacy to receive full dose of Pfizer bivalent vaccine.
on 6/5/19 around 5 pm I started feeling sick to my stomach, extremely tired, headache and shivering. The site of the injection is red, has a hard lump and is hot to the touch
Started by week feeling. Throat felt as if closing, coughing trying to catch breath. Lips felt tingling and numb (this would come and go).
The patient has had abnormal papanicolau; has tested positive for HPV; This spontaneous report has been received from a physician via a company representative referring to a 51 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis.         On an unknown date, the patient had abnormal papanicolau test (smear cervix abnormal) and tested positive for human papilloma virus (HPV) (human papilloma virus test positive). At the reporting time. The outcome of smear cervix abnormal and human papilloma virus test positive was unknown. The causality assessment was not provided.
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 14Aug2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on an unknown date inJul2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 14Aug2021, the patient experienced sore arm. The event did not result in a visit to the doctors or other healthcare 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 sore arm was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. no treatment taken
Patient was seen in ED on 5-15-2019 for a rash and swelling , Patient was given steroid inject and benadryl .
swollen eyes blocking some vision; swollen nose and cheeks; swollen nose and cheeks; swollen eyes; This is a spontaneous report from a contactable consumer or other non hcp.   A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported),  via an unspecified route of administration, administered in Left arm on 03Mar2021 11:30 (at the age of 48-years-old) as dose 1, single for covid-19 immunization  .  Medical history included allergy to bees. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks and no other medications within 2 weeks. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced getting swollen eyes 2 days after vaccination, by 3rd day she had  swollen eyes blocking some vision, swollen nose and cheeks . The adverse event resulted in physician office visit. Treatment was taken for the events with steroid. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
This medically confirmed spontaneous report (initial receipt: 16-Oct-2012) concerns a 31-year-old female patient, who had no pertinent medical history or drug allergies. She was not taking any concomitant medication. On 16-Oct-2012 the patient received AFLURIA (batch number: P59908) injection at a dose of 0.5 mL intramuscularly. On 16-Oct-2012 the patient experienced dysgeusia immediately after administration of AFLURIA. No lab diagnostic study was performed. The patient sought medical attention in the pharmacy. No treatment was given to treat the event. The event outcome was not recovered.
Headache, Arthralgia, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, LOCAL LYMPHNODE TENDERNESS/SWELLING/RIGHT SIDE  Narrative:  Other Relevant History:
The patient experienced excessive crying; This spontaneous report was received from a physician concerning a 15-year-old female patient. Information regarding the patient's pertinent medical history, concomitant medications or previous drug reactions/allergies was unknown by reporter.  On an unknown date in January 2020 reported as, (last week), the patient was vaccinated with her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dosage schedule, anatomical location, route of administration, lot number and expiration date were unknown by reporter), unspecified flu vaccine as vaccination (dosage schedule, anatomical location, route of administration, lot number and expiration date were not reported) and meningococcal ACYW conj vaccine (CRM197) (MENVEO) as vaccination (dosage schedule, anatomical location, route of administration, lot number and expiration date were not reported). Subsequently, the patient experienced excessive crying. In addition, the patient did not sought medical attention and it was unknown by reporter if any laboratory diagnostics or studies were performed.  The outcome of crying and the causal relationship between the event and all the aforementioned suspect therapies were not reported.
No adverse event; Patient received the vaccine from an expired lot; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from an expired lot) and NO ADVERSE EVENT (No adverse event) in a 20-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from an expired lot). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from an expired lot) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from an expired lot).    Age of the patient was reported as 20 year 4 months.  Concomitant medication of the patient was not reported.  The patients in the facility received the Moderna vaccine between 08-Apr-2022 and 15-Dec-2022. ID was reported as 80777027399.  No treatment information was provided by the reporter.
I developed a hive/rash below and above my waist line on my stomach area.  I also felt bloated in my lower stomach.  I noticed it when I was undressing for bed. It was a mild reaction that came and went quickly once I laid down to go to sleep.  Some belching relieved the bloating in my stomach.
16-month-old female given covid-19 pfizer vaccine for ages 5-11 years of age 0.3ml not diluted.  No reaction or adverse event has occurred from this incorrect dose. No changes to health as reported by parent at time of event and follow up call today 11/15/23 parent reports no concerns.
Patient fully vaccinated (Moderna) but not boosted, admitted to the hospital with COVID-19 and associated hypoxia
No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. The patients age was reported as 60 Year 5 Month. Treatment information was not provided. NDC ID: 80777027398.
Information has been received from a RN concerning a pt who was vaccinated in 1999. Subsequently, unspecified medical attention was sought  and it was found that the pt had not seroconverted.
had broken out in hives from "head to toe"; This spontaneous report was received from a the patient's mother, and refers to a 3 year old male patient. The patient concurrent condition included drug hypersensitivity to cefinir (OMNICEF) . The patient's medical history included eczema.     On an unknown date, in approximately 2009, when the patient had 3 years; he was vaccinated with an unspecified measles vaccine (dose, route of administration, manufacturer, lot number and expiration date were not reported) and then, on an unknown date, the patient broke out in hives from head to toe. No treatment was given but however unspecified blood work was performed with unspecified results and the patient saw a physician  On an unknown date, the patient recovered from the hives. The causal relationship between the unspecified measles vaccine and the event was not reported.
Patient (date of birth: 01/27/1974) received the 1st COVID vaccine (PFIZER, Lot #: EW0179, and expiration date: 08/2021) at 11:48AM. EMT made contact with the patient in the observation area around 1225. The patient complained of "right ear redness and swelling" and stated it was a "sign" to her of an impending allergic reaction. EMT visually assessed the patient's ear and saw no swelling, only light redness. Patient was advised to sit in the zero gravity chair for further evaluation. At 1227, baseline vital signs were taken, while patient was sitting: blood pressure: 114/68, heart rate: 77, respiratory rate: 12. Skin was cool, dry, and normal for ethnicity. Nurse then responded to EMT with patient. EMT asked the patient if she was taking any medications. She stated that she is taking WELLBUTRIN and has allergies to gluten and latex. At 1233, a second set of vitals were taken: blood pressure: 118/78, heart rate: 84, respiratory rate: 12. Skin was cool, dry, and normal for ethnicity. Patient was negative for orthostatic pressures. EMT advised the patient to continue to sit in the zero gravity chair for an additional 30 minutes, to observe for additional signs and symptoms. Patient was educated by EMT regarding the signs and symptoms to look out for and when the patient should contact her primary care provider. The patient was also given the information to sign up for V- safe as well as educated regarding the importance of doing so. After the observation time was completed, around 1: 00PM, the patient walked out of the site unassisted and with a steady gait.
Woke up in the middle of the night with severe body aches, head ache, fever, chills, fainted for 30 seconds.
1) rigors without fever; 2) severe HA. These both lasted approximately 6 hours.
Pt broke out in rash/hives that lasted 5 days. Pt took BENADRYL. Unrelieved by CLARITIN.
Fever of 99 by afternoon and 100 by evening, finally ending the following day PM; fatigue for 4 days; stomach ache for entire day and next.
One week later my arm started to itch. It swelled up with a ball shape that was red and warm at the injection site.  A few days later the ball shape melted flat but looked like a big ringworm.  It didn?t hurt, and stopped itching.
Patient vomited twice on 10/14/04 at 3am and 5am starting 9 hrs after receiving the Flumist vaccine. Patient had no previous symptoms and no one in family did. Patient on 10/29/04 tested positive for strep throat.
This spontaneous report as received from a registered nurse refers to a 2 years old patient with no pertinent medical history and drug reactions or allergies. The patient was vaccinated with dose 1 of MMR II (Lot # 0134AE expiration date 10-OCT-2014) on 10-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on 10-JUL-2012, the patient had an injection site reaction described as a large white area (seemed to be fluid filled) formed immediately after the vaccination was given and then became a 2 by 2 inch area of redness, 1 day after onset of therapy. The injection site reaction was resolved within 30 minutes of vaccination. The patient was treated with arnica gel and ibuprofen. There were no Lab diagnosis or studies performed. This is one of several reports received from the same source. Additional information has been requested.