chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after receiving the influenza vaccine pt c/o feeling nauseous and "seeing black and blue".  Within 2 mins pt lost consciousness after her eyes rolled back and after becoming pale and diaphoretic.  911 called.  Pt regained consciousness before EMS arrived. 10 mins after EMS arrived pt lost consciousness again, recovered in 1 min.  Pt taken to ER.  Pt recovered before being taken to the ER.
I would say it was on the Wednesday where I noticed I wasn't feeling well and had a headache and I went into air conditioner air and I was noticing that I need to increase the temp due to feeling cold and was feeling achy and went to bed early.  I got up the next morning and I work at a school and got my test PCR done there and there had been positive employees the previous week and I decided to test and was positive.  My symptoms have stayed mainly at headache and not feeling like doing much at all today is better and I am able to do more around the house but not up to a hike or anything as long as I don't push myself too hard.  I did have somewhat of a scratchy throat yesterday and drank hot tea with lemon and honey and that helped a lot.
Body aches & pains, starting about 12  hours after booster shot.   This seemed like a normal reaction. 23 hours after... was exhausted & experiencing a bit of brain fog (left my lunch bag & purse in my classroom, decided I didn't need either since I had my keys & was too tired to walk down the steps to get them). Day 3: taught in the morning, slept all afternoon.   Skin was very sensitive to touch/movement, still had body aches.  Day 4:  still off a bit- took another nap.    Went for a mile walk & was sweating.  Sweat all night like I had a fever (I did not). Day 5:  Feeling normal, just a little tired.
Fever to 100.4 on day 1 after vaccine, to 101.9 on day 3 after vaccine. Acute kidney injury (creatinine rose from 1.73 to 2.43) requiring hospitalization.
He started wheezing and having stuffy nose with a mild cough and kept on the entire week.  On Sunday he had a fever all day long and got up to 103.7 and was not coming down and constantly coughing and wheezing bad.  We called the on call Pediatric doctor and they suggested we go to the ER and his temperature there was 104.3.  They gave him a chest X-ray and COVID-19 test and both were negative.  They said he had a ear infection and offered antibiotics but we declined them.  He tested positive for Rhino Virus, and Human Paraovirus. They advised to administer Ibuprofen since my wife refused the antibiotics.    He has a appointment today with his regular pediatrician for follow up.
Patient had seizure-like episodes several hours after receiving her vaccines. EMS was called, transported the patient to the EC where she underwent in infectious evaluation, was started on antibiotics, underwent evaluation with a CT head which was normal and was admitted to the acute care floor. She remained on antibiotics for 48 hours while undergoing rule out of a serious bacterial infection. Urine, blood and CSF cultures were all obtained and were negative. MRI head was normal. Neurology was consulted who started the patient on Keppra. No further seizure episodes were noted following admission. Of note, mom has a diagnosis of epilepsy as well. She is being followed by Neurology.
Second dose give on 14th day; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose give on 14th day) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901 and 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose give on 14th day). On 01-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose give on 14th day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was reported.
This spontaneous report as received from a a medical assistant refers to a 5 year old patient of an unknown gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. On 27-APR-2017, the patient was vaccinated with an expired dose of M-M-R II, recombinant human albumin (rHA), lot# M001200, expiration date: 28-AUG-2016 subcutaneusly. The sterile diluent used for reconstitution was not expired. The patient experienced no adverse reactions. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA000210:
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 68 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 14-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 14-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
This is the second time I have had severe tinnitus after a Pfizer Covid-19 shot. It was bad after the second shot and much worse - often debilitating - after the third shot. It makes me dizzy and nauseous and is unrelenting. I experienced severe headaches after the first shot which lasted about 5 weeks, until i ended up taking aspirin,w hich seemed to help. No tinnitus to speak of then. But the second two shots have left me with progressively worse tinnitus. This is not something I've ever had in my life before, and it is destroying my quality of life!! I am not on any other medications, and I do not have any other health conditions. I am healthy, not overweight, exercise well. But the ringing in my ears will not go away or subside and I don't know what to do!! Please help! It very clearly started right after the vaccine, and I resent articles saying there is no proof of this being caused by the vaccine. it is very clearly caused by the vaccine!
Lips itchy; throat hoarse by 12/15 face and lips swollen with rows of blisters on each lip; mouth extremely tender and sore; blisters on face and below nose; doctor took picture.  Consider this reaction in conjunction with Patient's daily dose of 15 mg. of prednisone.
Started with hives on 12/11/2018 9pm, next morning, continued with hives, difficulty breathing and cough on 12/12/2018 sent to emergency department on 12/12/2018 at 10:00.
Gave Preservative-Free Fluzone to child younger than 6 months of age thinking the patient had to be 6 weeks to receive the flu vaccine. Observed child about 45 minutes following the shot and no allergice reaction had occurred. Called mom the following day (today) and mom has not noticed any abnormalities in her daughter such as difficulty breathing or redness/swelling at the injection site.
Pt. reports immediately feeling tingling in both hands and some dizziness with mild nausea. Pt. denies ever having similar reaction to vaccines or blood draws. He reported he does have an allergy to "streptomycin mixed with penicillin". Pt's BP initially elevated in treatment room. EKG ordered and reviewed by physician. As time passed pt. reports symptoms "dissipating". Pt. evaluated for 30 minutes and sent home with ER precautions given.
This spontaneous report was received from a physician and refers to a 12 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-MAY-2017, the patient was vaccinated with first dose of GARDASIL 9 injection intramuscular for prevention of Human Papillomavirus (HPV) (anatomical location, lot number and expiration date were not reported). On an unknown date, the patient developed a lump the size of a quarter at the injection site (vaccination site mass), that lasted a little over a month. It was reported that the patient sought medical attention, however, no treatment was provided for the event and the patient had not received any additional doses of GARDASIL 9 due to this reaction but might complete the series at a later time. Additionally, it was reported that there might had been something wrong with the medical assistant's injection technique because there had been multiple other unspecified patients who had also developed a "lump" at the injection site after receiving unspecified injections administered by the same medical assistant. The reporter did not provided the causality assessment between the event vaccination site mass and therapy with GARDASIL 9.
Welts on her hands ( resembling mosquito bites)/Hives in the groin; dry and chapped hands; places with missing skin in her hands; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts on her hands ( resembling mosquito bites)/Hives in the groin), DRY SKIN (dry and chapped hands) and SKIN DISORDER (places with missing skin in her hands) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N), LIDOCAINE, METFORMIN and SIMVASTATIN for an unknown indication, ENALAPRIL.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced URTICARIA (Welts on her hands ( resembling mosquito bites)/Hives in the groin), DRY SKIN (dry and chapped hands) and SKIN DISORDER (places with missing skin in her hands). At the time of the report, URTICARIA (Welts on her hands ( resembling mosquito bites)/Hives in the groin), DRY SKIN (dry and chapped hands) and SKIN DISORDER (places with missing skin in her hands) outcome was unknown.
tested positive between doses 1 and 2 of the vaccine; tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported same events for six patients. This is 1st of Six reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist was giving Covid vaccinations in a nursing home. It was reported that the patient was tested positive between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home. Those patients were tested every day. The pharmacist started administering the second doses. One patient was administered the second dose and then somebody said, "Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, we're under the impression you wait 90 days if they've been given antibodies after that to give the second dose. One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest who were hospitalized did not receive their second injection. Caller asked, "What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and drug ineffective due to temporal relationship.  This case will be reassessed once additional information is available.,Linked Report(s) : US-PFIZER INC-2021222954 same drug/reporter/event, different patient;US-PFIZER INC-2021222956 same drug/reporter/event, different patient;US-PFIZER INC-2021222957 same drug/reporter/event, different patient;US-PFIZER INC-2021222953 same drug/reporter/event, different patient;US-PFIZER INC-2021222955 same drug/reporter/event, different patient
Narrative: Patient with Breakthrough covid infection 2 doses of moderna vaccine previously received. Treated with monoclonal antibody.
COVID; COVID; Moderna  Dose Number: 2 / Pfizer / BioNTech Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2 NOS), on 09Sep2022 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "unknown", described as "Moderna Dose Number: 2 / Pfizer / BioNTech Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; negative, notes: About 7 days after first negative covid test, cold like symptoms returned. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received COVID 19 Treatment with Paxlovid, Treatment start date was 25Jan2023, Treatment stop date was 29Jan2023, Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On Saturday morning which was day 2 after the shot, woke up with a swollen lymph node under my arm on the injection site side; Dose received: 3; Injection site pain; Headache; Nausea; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 09Dec2021 at 14:15 (Lot number: FJ1620) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: ER8735, Anatomical location: Left arm, Administration time: 15:30), administration date: 27Apr2021, when the patient was 44 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0151, Anatomical location: Left arm, Administration time: 12:00), administration date: 06Apr2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 at 14:15, outcome "unknown", described as "Dose received: 3"; VACCINATION SITE PAIN (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Injection site pain"; HEADACHE (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Nausea"; LYMPHADENOPATHY (non-serious) with onset 11Dec2021 at 09:00, outcome "not recovered", described as "On Saturday morning which was day 2 after the shot, woke up with a swollen lymph node under my arm on the injection site side". Therapeutic measures were not taken as a result of vaccination site pain, headache, nausea and lymphadenopathy.  Additional Information: The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
The manufacturer of the Vaccine is Pfizer (the field to document the manufacturer does not allow Pfizer to be entered, for this reason I am documenting it here). 1- From the first day she developed cellulitis on her left arm, in the area where the vaccine was administered, 2- After three days she began to feel palpitations (eg, like a tachycardia). 3- Five days after the first Pfizer vaccine, my breast and right lung hurt. Which did not allow me to breathe normally. Due to severe and intolerable pain.
Provider wrote down the vaccine for the MA to give. The provider wrote the wrong shot to be given.
In May, I felt some kind of numbness and tightness in the nose, around the eyes, in the frontal sinuses. Oppressive sensations and some kind of pressure around the nose, eyes, in the frontal sinuses, mild headaches; tightness in the bridge of the nose, especially radiating to the head when bending over; radiating pain to the eyes, forehead;  There was no runny nose, no cough, no fever, no discharge. My first visit was to a therapist in May. She gave me a referral to BMRI. When the answer was received, there was sinusitis. She prescribed Azithromycin-250mg antibiotic for me. and advised to contact the earworm. 1. In May, I visited an earworm. He confirmed the diagnosis and gave me another antibiotic Amoxicilyn / Clavulanat for 10 days. I drank the antibiotic, but everything was the same. 2. I went to another earworm and he referred me to another lab at BMRI. The diagnosis was confirmed. The doctor prescribed me a procedure to widen the canal. There was no pus or other discharge. The state of health has remained the same. Then he sent me to Nose and Brain. The result was the same. He gave me one more drink with the antibiotic Amoxicilyn / Clavulanat, but I didn't drink it because I have diabetes and kidney problems. Today my condition has not been deceived
Redness of upper arm where injection was given, warm to touch, slight swelling. All per mother during phone conversation.
Extreme fatigue, lethargy, body aches and chills began in August 2021.  Bloodwork on 9/3 indicated low free T4.  Developed extreme carpal tunnel in right arm and shooting pain through shoulder.  Seen by primary doctor on 9/30, repeated bloodwork and treated for hypothyroidism.  Put on Synthroid medication daily.    Brain fog and fatigue continued, in addition to development of migraines and occasional nausea.  Follow up bloodwork indicated a decrease in blood count across the board (Red Blood Cell Count, White Blood Cell Count, Hemoglobin, etc.) led to need for Colonoscopy and Endoscopy for diagnosis (performed on 12/10/21).  Treated for SIBO with Xifaxan antibiotics and Gastritis with Omeprazole.  Notably, the batch number for my first Pfizer vaccination is the 2nd highest in adverse events reported, my second dose the 38th highest, so my continued fatigue, chills and hypothyroidism - none of which I had experienced prior to vaccination - are a result of the vaccine itself.
This case was reported by an other health professional via sales rep and described the occurrence of injection site swelling in an adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included Down's syndrome. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, influenza-like symptoms and skin discoloration. On an unknown date, the outcome of the injection site swelling, influenza-like symptoms and skin discoloration were unknown. It was unknown if the reporter considered the injection site swelling, influenza-like symptoms and skin discoloration to be related to SHINGRIX. Additional details were provided as follows: The reporter was a phlebotomist. The age at vaccination was not reported. The sales representative stated that during in-service with reporter's practice, the reporter mentioned that her aunt had severe swelling at the injection site, large round spot on her upper arm, and also had flu like symptoms. The reporter did not agree to follow up.
Received Flumist H1N1 at school clinic. Began vomiting @ 4:30p- Continued until 10:30p.
nausea & abdo discomfort; receiving vax because of exposure to cat that was hit by car; the cat was mangled & destroyed w/o exam; 19OCT93 completer sereis & cont to have mild abdo discomfort & mild nausea; recovery status not given;
BAD RINGING IN THE EARS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced bad ringing in the ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad ringing in the ears was not reported. This report was non-serious. This case, from the same reporter is linked to 20220714792 and 20220715147.
The day after the second dose of the Pfizer vaccine, my father started to experience lethargy, headaches, nausea and vomiting. These are all advertised as common symptoms of the second dose so he did not seek medical treatment until 5/11/21, five days after. He went to the emergency room, his systolic blood pressure was over 200. A CT scan showed bleeding going from his basal ganglia to the right ventricle of his brain. His blood pressure had gotten so high that he had a hemorrhagic stroke. He has since been in the ICU. He had to undergo a ventriculostomy, was put onto a ventilator, and has now had a tracheostomy.  He still has not regained full motor function and will have a long road to recovery after the stroke.