chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Horrendous reaction; Left arm injection site tingling; Felt tired; Back pain; Ran a fever; Congested; Left arm injection site still feels hot to touch; had vomiting; lingering shortness of breath; A spontaneous report was received from a consumer 71-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced horrendous reaction, left arm injection site tingling, felt tired, back pain, ran a fever, vomiting, congested, left arm injection site still feels hot to touch and lingering shortness of breath.  The patient's medical history included Covid-19 approximately two weeks prior to receiving the injection.  Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 23-Dec-2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient reported that she had a horrendous reaction after receiving the Moderna vaccine (mRNA-1273) on 23-Dec-2020.  She stated that on that day, her left arm tingled and she felt tired.  During the night, she stated that she had back pain, ran a fever, vomited and was congested.  The patient said that although she experienced these symptoms for 3 days, she did notice some improvement over the course of the 3 days.  As of 28-Dec-2020, she reported that her left shoulder, the injection site, still felt hot to the touch and that she still had some lingering shortness of breath.    Treatment information was not provided.  Action taken with mRNA-1273 in response to the events, horrendous reaction, left arm injection site tingling, felt tired, back pain, ran a fever, vomiting, congested, left arm injection site still feels hot to touch and lingering shortness of breath, was not provided.  The outcome of the events, horrendous reaction, left arm injection site tingling, felt tired, back pain, ran a fever, vomiting, congested was reported as recovering and for left arm injection site still feels hot to touch and lingering shortness of breath was reported as not recovered.; Reporter's Comments: This case concerns a 71-year-old female patient with medical history of recent COVID-19, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious listed events of fatigue, fever, and vomiting, and the non-serious unlisted events of horrendous reaction, left arm injection site tingling, back pain, nasal congestion, injection site warmth, and lingering shortness of breath.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date these unknown number of patients were vaccinated with PNEUMOVAX23 (lot#, dose, route not reported) that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Labored breathing; chest pains; fast heart rate; This is a spontaneous report from a contactable consumer reported for himself. A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 13May2021 11:30 AM as unknown, single (at age of 15-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Medical history included choanal atresia, tonsils and adenoids removed, ear tags. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were none. On 04Jun2021 09:00, the patient experienced labored breathing, chest pains, fast heart rate. The adverse events resulted in emergency room/department or urgent care, hospitalization for 2 days. The adverse events received treatment included Aspirin, Ibuprofen. The patient underwent lab tests and procedures which included Nasal Swab: negative on 05Jun2021. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Fifteen minutes after the 2nd Moderna injection, she felt short of breath as she was leaving the facility.   She drove home.  Her symptoms worsened a couple of days later, she notified her physician who saw her in his office.  She was tested for covid, which was negative, and  prescribed an inhaler and an antibiotic.  The inhaler "did not help at all".  She took 1 dose of the antibiotic, and vomited.  She did not take the antibiotic after that.  She continued to have worsening shortness of breath and went to the ER 2 days later.  She received a breathing treatment, blood labs, chest xray,  She was discharged home.  A few days later she returned to Dr office and was sent for a CT scan that day.   The report showed left axillary swollen nodes .   She received a script for Clindamycin for congested sinuses, which she is still taking.
October 3, 2022, I tested positive for COVID-19 on a at home. I had a cough, slight fever, fatigue, slight sore throat. I called my doctor the same day and he prescribe me Paxlovid. I have to take the Paxlovid for 5 days straight. I started taking it on October 4, 2022.
Smell smoke periodically since the second dose.  A strong smell of smoke that last for 15 seconds or so.  The day after it happened a couple of dozen times.  A month later it's only 1-3 times a day.
PT recd 3 doses of Engerix-B (1cc/IM lt del) on 16AUG90, 17SEP90, & 5MAR91; HBsAB tests were neg on 20JUN91; recd 4th dose on 25JUN91;
Swelling and pain with warmth to touch, to right deltoid region. Subjective fever per mom. Patient referred to ER for treatment. Tylenol and movement of arm advised at time of vaccination.
This spontaneous report was received from a advanced practice registered nurse, via medical assistant, referring 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 reported. On 29-JUN-2018, the patient was vaccinated with ROTATEQ one dose, orally (strength, dose number, lot # and expiration date were not reported) for prophylaxis. On 24-AUG-2018, the patient was vaccinated with expired and improperly stored dose of ROTATEQ one dose, orally, lot # M035828 and expiration date 28-MAY-2018 (strength and dose number were not reported) for prophylaxis. Administered doses of vaccine were exposed to the temperature excursion prior to expiration (temperature excursion and duration were not reported). It was unknown by reporter if data logger was involved and if there was previous temperature excursions. There was no adverse effects reported.
Administered 2nd booster to patient under age 50 (43yrs).  No resulting adverse event known.
The patient requested the third dose of Pfizer. Pfizer was processed, but 0.25ml Moderna was administered.
massive headache, 11 hours post vaccination at midnight.  Extreme arm pain, throbbing, burning, joints felt swollen, extreme abdominal pain (like someone wrenching my intestines and organs), aching neck, body pains and felt like I was freezing btwn midnight and 3 am.  Had lay still in a fetal position for it to calm down at 3am.
Vaccine was pulled from freezer 06/23/23 and was stored in the refrigerator since; no adverse event; Expired vaccine was administered.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered.), PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 06/23/23 and was stored in the refrigerator since) and NO ADVERSE EVENT (no adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Aug-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 06/23/23 and was stored in the refrigerator since) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered.), PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 06/23/23 and was stored in the refrigerator since) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered.) and PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 06/23/23 and was stored in the refrigerator since).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
FLUMIST given approximately 900am on 11/1/10. Came to Health Room twice complaining of pain at (L) side of head & forehead.
Patient requesting a vaccine adverse reaction report following receipt of 6/28/2017 PPSV23 vaccine to her left arm. She advised it was recommended by her HCP due to her diabetes. She stated 24 hours after receipt of the vaccine the site was red, some swelling and sore to touch/move arm around. Over the next few days, she noted 2 other red spots further down her arm directly under the vaccine site. She sent a picture for review. She denied it itching, no trauma and not ointments/lotions or change in detergents/soaps/et al. She advised the reaction resolved on it's own in 4 days. She has had no further reoccurance. No site reaction with concurrent right arm Tdap vaccination.  Symptoms: RASH & OTH NONSPEC.
Patient reports that she developed left arm localized swelling, redness, and soreness within 1 hour of the shot. On Monday 01/114/2018 at approximately 6 AM patient began having diarrhea, headache, fever, body aches, and a hard time eating. Patient saw NP from Dr. and was seen on Wednesday 01/16/2019.
RASH TO RIGHT THIGH WITH PAPULES, REDNESS AND HEMATOMA.
This subject is a 73 year old female who was admitted to the hospital due to increased dyspnea, cough and sputum on 8/7/03 while enrolled in the RSV 11 study with RSV vaccine. The subject received RSV vaccine or placebo and Influenza vaccine on 10/16/02. The subject developed lung cancer 6 months post immunization (diagnosed in April 2003) and presented with increased dyspnea, cough and sputum 295 days post immunization and was admitted to the hospital 295 days later on 8/7/03. Subject died in hospital 6 days later on 8/13/03. The event was reported by the investigator as not related to the study product. A follow up report received 8/26/2003 adds: This subject is a 73 year old female who was admitted to the hospital due to increased dyspnea, cough and sputum on 08/07/2003 while enrolled in the RSV 11 study with RSV Vaccine. The pt received RSV Vaccine or Placebo and Influenza vaccine on 10/16/2002.  The subject developed lung cancer 6 months post immunization (diagnosed in April 2003) and presented with increased dyspnea, cough and sputum 295 days post immunization and was admitted to the hospital 295 days later on 08/07/2003. Pt died in hospital 6 days later on 08/13/2003.  The event was reported by the Investigator as not related to the study product. Medical Records received on 8/26/2003 states pallor and unresponsive.
Other than brusing and a sore muscle, on 01/05/2021 at 3AM, I noticed my stomach felt bloated after drinking soda. It got worse through out the day. At 5:30PM, I took medicine for gas.  By 6:30PM, the pain was worse so I went to UC and after a check up, I was sent to the ED for a CT scan and they found an inflamed appendix. I had surgery to have it removed. After surgery, I developed asthmatic pneumonia which led to a 7 day hospitalization.
2.5 hours after receiving 2nd vaccine I developed left lower facial numbness. And additional 30-45 minutes after that I began having throat swelling/tightness and chest tightness. I went to the ER and was found to have and elevated heart rate and blood pressure. I had taken Benadryl prior to going to the ER and was given IV prednisone and Pepcid there. After a 2 hour observation my symptoms had subsided and I was released. The next morning I began having chest tightness again. My PCP called in a script for prednisone and advised me to also take Benadryl and Motrin as needed.  I am still have intermittent facial/neck numbness, anterior and posterior neck pain; as well as intermittent headaches and axillary pain.
got over 65 high dose .he is only 61 but had no adverse effects. will talk to oncologist next visit
Pt said that there was a red mark or line on his arm going around his arm below the deltoid muscle. He said the line was about 1.5 inches by 1/2 inch in size. It was red & itchy and sensitive to the touch. This first started several days after the shot was given and stayed for 2 days.
Feeling of skipped heart, lightheadedness.  Went to ED and diagnosed with symptomatic PAC's and high blood pressure.  Holter and Echo were ordered.  PAC's now resolved, but blood pressure remains elevated.  Changed Nifedipine to amlodipine 10mg.  Still working on normalizing blood pressure with new combinations of medications
PATIENT REPORTED FEELING INCREASE LEVELS OF ANXIETY, WHICH SHE IS ATTRIBUTING TO THE ADMINISTRATION OF THE VACCINE.
vaccines that were administered to patients after excursion occurred; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 12-AUG-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T002846, expiration date reported and validated as 23-JAN-2022) for prophylaxis, that experienced a temperature excursion (product storage error). Digital Data logger was involved. The administered dose of the vaccine experienced a temperature and time frame of -10.2 degrees Celsius for 1 hour and 53 minutes. No previous temperature excursion was reported.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA014803:AE Case # 01697212 US-009507513-2009USA000113: US-009507513-2008USA014888: US-009507513-2008USA014697:
CURRENTLY SUFFERING WITH COVID; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced currently suffering with covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of currently suffering with covid was not reported. This report was non-serious.
Swelling encompassing the entire right deltoid, redness, warm to touch,firmness and tenderness...these symptoms started approx. 5 hrs after injection.
8/3/18 Patient received 2 vaccines in the office. Mom called 1/2 hr. later noted pt. had some abnormal movements of left side of his face for about a minute and slurred speech 10-15 mins. She mentioned that he had similar episodes a year ago; concerned if this episode was vaccine reaction. Returned to clinic acting normal, responding. Addendum: 08/04/2018 01:54 AM Mom called on phone about 1/2 hr. later that they noted pt. had some abnormal movements of left side of his face and had slurred speech for about 10-15 min. She mentioned that he had similar episode a year ago, concerned if this episode was a vaccine reaction, by the time she called pt. was acting normal self, seemed to have some droop of left side of mouth, did not have any other abnormal body movements. Patient was quite upset, agitated and crying with vaccine administration. Asked mom to RTC for evaluation. On return mom reported that a year ago he had a similar episode, was taken to ER and was admitted to the hospital, he had full workup for seizure and was told as possible febrile seizure and was later had F/U with pedi. neurologist, was advised watchful monitoring. On evaluation when pt. returned to clinic today, about an hour later he was acting his normal self, active, responding and interacting very well. Speech was normal, eye exam normal, with EOMI, PERLA, face symmetrical, normal neuro exam. Discussed in detail with mom about the etiology of the episode - possible focal seizure, cause of it could be from agitation and crying, but not adverse reaction to vaccine as child is clinically well at this time reassured mom, advised watchful monitoring and advised on seizure precautions, F/U with neurologist ASAP. Mom expressed understanding and agrees with the plan, she felt very assured after the exam and advice. 08/04/2018 01:56 AM, Assessment: possible seizure. 08/04/2018 02:25 AM, abnormal movement of left side of face lasted for about 1 min per mom, report.
Pain in arm immediately and has continued in her shoulder, her hand curled up and she couldn't straighten fingers for 20 minutes after 2 weeks, but that has resolved now, she thought she was having a stroke, now only experiencing pain at the injection site area
vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 021F21A) for COVID-19 prophylaxis. No Medical History information was reported. On 30-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported.  All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date and no additional information provided. Date Stored in Standard Freezer for the lot 021F21A was 2 degrees F high, -1 degrees F low on 30-Nov-2021.  No treatment medication was reported. This case contains information for the 22nd of 45 adults described by the reporter.
About 2 hours after my second dose I became very ill. It started with me becoming extremely cold. I slept in my snow suit the first 3 nights. I woke up the next morning with the most awful body aches. I started having zinging pains in my joints with my lower extremities joints much more intense. My head pain was a 10 and my neck was very stiff. My spine hurt. I was sneezing had two days with a low grade fever. Now my temp has been running low. I had chest pressure that made me feel winded. my glands under my jaw are still swollen and at night I get white ulcers in the back of my throat. Still fatigue. Starting my second course of steroids. They helped but was off one day and was sick again that evening. Vomiting, diarrhea.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Aug2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 65 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Benadryl, reaction(s): "Known allergies: Benadryl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID-19 Treatment included Paxlovid from 07Sep2023 to 11Sep2023. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
4 hrs p/vax pt exp an asthma attack, relieved by use of inhaler; also devel very red, swollen, purulent eyes, which continue to be red & swollen 18 hrs later;
Patient presented to the ED and was subsequently hospitalized for acute renal failure, subhepatic abscess, MSSA bacteremia within 6 weeks of receiving covid vaccination.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 91 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 19-APR-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
TIA/mini stroke; This is a spontaneous report from non-contactable consumer via Pfizer Sales Representative. A 5-decade-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included insulin dependent diabetic in mid 40s. The patient's concomitant medications were not reported.  The patient experienced TIA (transient ischaemic attack) /mini stroke on same day he received COVID vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
temp elevations persisting 4-6 days post vax; daytime t99, noc t102-103-tx w/APAP; 27JUL94 persisting > 7 days; t elevation persisted 4-5 days pt irritable;