chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID after 3 vaccine doses; Tested positive for COVID after 3 vaccine doses; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant) with onset 08Dec2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "Tested positive for COVID after 3 vaccine doses". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive; (30Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of not being able to swallow, shortness of breath, and feeling like throat was closing.  He became extremely pale and his lips turned blue.  He was given Epinephrine Injection .3 mg.  His symptoms improved.  He was able to walk and talk after injection and never lost consciousness.  He was transferred by ambulance to ER for further evaluation and monitoring. His twin brother suffered the same symptoms about 5 minutes later- as he had received the shot about 5 min after his brother.
Beginning around 4pm: fatigue, nausea, headache Nausea and headache resolved by 9:00am on 4/4/2021 Fatigue resolved by 9:00am 4/5/2021
Treatment of COVID-19 using paxlovid; Treatment of COVID-19 using paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 27 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: ER8735), in left arm, on 07May2021 as dose 2, single (Lot number: EW0168), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: EW0185), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST, start date: 05Aug2022; LEVOCETIRIZINE, start date: 25Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19 using paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative, notes: Had a positive test after 3 negative tests following treatment; (2022) Negative, notes: Had a positive test after 3 negative tests following treatment; (2022) Negative, notes: Had a positive test after 3 negative tests following treatment; (2022) Positive, notes: Had a positive test after 3 negative tests following treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
It started about 12 hours after the vaccine. I had all the classical symptoms of Hay fever but with fatigue. I had a mild dry cough, and headache. This lasted for about 36 hours and went away.
large rash all over her body; big, humongous, distinguished rash; achiness; fever; headache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (achiness), RASH (large rash all over her body), PYREXIA (fever), HEADACHE (headache) and INJECTION SITE RASH (big, humongous, distinguished rash) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN (achiness), PYREXIA (fever) and HEADACHE (headache). On 06-Jan-2021, the patient experienced RASH (large rash all over her body) and INJECTION SITE RASH (big, humongous, distinguished rash). On 30-Dec-2020, PYREXIA (fever) had resolved. At the time of the report, PAIN (achiness), RASH (large rash all over her body), HEADACHE (headache) and INJECTION SITE RASH (big, humongous, distinguished rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product history was not provided. Treatments for these events include Zyrtec and her migraine medication for the headaches.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
THE RESIDENT STARTED HAVING SYMPTOMS OF COVID 19 ON 2/3 (COUGH AND SHORTNESS OF BREATH). RAPID TEST WAS NEGATIVE, BUT PCR TEST WAS POSITIVE. SHE RECEIVED TREATMENT FOR COVID WITH IVERMECTIN, DEXAMETHASONE, ALBUTEROL MDI, MUCINEX, AND Z-PACK. SYMPTOMS PROGRESSED AND SHE PASSED AWAY ON 2/15/21.
Inappropriate Covid vaccine was inadvertantly administered.  Janssen Covid vaccine was administered, previous dose was was PFizer.  Supervisor was immediately notified and client's mother was notified . Incident report was completed.  Mother of client was contacted the following morning and she stated that he was doing fine.
A/Fib Heart Palpitations  Going to see a Cardiologist and was put on a Beta Blocker
Coughing, sneezing, watery eyes, felt difficulty with breathing, felt like throat swollen. Dr. re-evaluated pt. moving good air. Oxygen Sat 98% BENADRYL 25mg PO given.
Fatigue, muscle body aches, nasal congestion, headache, sore throat, fever
Initially swollen red arm and flu symptoms. Then episodes that resemble Parkinson's, tourettes and tardive dyskinesia formed. New diagnosis of tourette's syndrome was made.
No additional AE reported.; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a Medical Assistant referringand refers to a 13-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included cardiac murmur, cafe au lait spots, clubfoot, and congenital valgus foot deformity. She had no known allergies. Concomitant medications included measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (manufacturer unknown) and hepatitis a vaccine (+) inactivated (manufacturer unknown).   On 11-JUL-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis, lot #U025790, expiration date: 19-AUG-2023, administered subcutaneously in the right arm for prophylaxis (strength was not provided). The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in temperature of 6.4 degree Fahrenheit (F) for 1 hours 45 minutes. There was no previous temperature excursion reported.  It was reported that the patient came in for a recheck of her heart murmur and to catch up on the vaccines. Measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (manufacturer unknown), hepatitis a vaccine (+) inactivated (manufacturer unknown), varicella virus vaccine live (oka/merck) (VARIVAX) were ordered by the physician. The vaccines were drawn up and given to the patient. Later, when checking the data logger from the freezer, it was discovered that the vaccines had gone through the excursion. The manufacturer was called and it was determined that the vaccine (varicella virus vaccine live (oka/merck) (VARIVAX)) was still viable. The excursion was reported to the state system. The patient did not have an adverse reaction to the vaccine. The vaccine (varicella virus vaccine live (oka/merck) (VARIVAX)) that was kept in a freezer went under excursion because of a move to a new building. The excursion was minimal.
I was given a flu vaccine on the 11th at 4:30 pm and by the next morning my arm was very sore and  I was weak very sleepy, muscle ache, slight fever. Stayed in bed all day and was better by 8:00 pm on the 12th.
Moderna Covid-19 vaccine EUA  2/2/21 fatigue, headache, pain at site and nausea 2/3/21 body ache, heachache, nausea, fatigue 2/4/21 abdominal pain, body ache, fatigue, nausea, headache 2/5/21 heart rate up to 130, fatigue, nausea, body ache, abdominal pain
small raised bumps on chest & back consistent w/the chicken pox only 5-6 total lesions;
The patient experienced a bright red rash that extended from her upper left ear to the upper chest that has not reduced in size. This began about 30 minutes after receiving her vaccine. She described it as broken capillaries. She has no other symptoms at this time. She spoke with the manufacturer and they told her to see her primary care physician. However, she said she does not want to do this. She still has the rash currently.
major swelling of all cheeks and lips area; major swelling of all cheeks and lips area; This is a spontaneous report received from AbbVie from non contactable other Healthcare professional. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that the patient had received 3 ml of VOLITE in lips area, cheeks CK45. After 4 months on an unknown date, the patient had received COVID-19 2nd vaccination. After 2 days following vaccination on an unspecified date, the patient had complained of major swelling of all cheeks and lips area. Therapeutic measures were taken because of major swelling of all cheeks and lips area and included 40 mg prednisone for 5 days and fexofenadine for 7 days. The patient symptoms had improved and were ongoing. The outcome of all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt complained of systemic itching, especially on chest and abdomen. She also complained of lower rib area chest pains that were stabbing in nature and flu-like symptoms.
This report describes a 7 month old male who died after receiving Infanrix. Medical history, concurrent conditions, and concurrent medicaitons were not specified. On 02/01/2002, the vaccine received an injection of Infanrix. It was not known if he had received previous doses of Infanrix. On an unspecified date post-immunization, the vaccinee died. Per F/U 5/10/02; pt had increased labored respirations and fever of 102.7F. He also had nasal flaring, cough was tachypneic and had a weak cry. He was lethargic. Arrested in ER, medical staff unable to resuscitate. Microscopic report: evidence of viral tracheitis and laryngitis as well as bronchopneumonia. Also has mild lymphocytic epiglottitis. Adrenal gland with increased congestion.
12 Hours after administration Patient had very strong chills and fever and had to take ibuprofen Body aches especially local for 7 days site swelling 6 days slept the whole day (drowsy all day long) headaches on and off. These reactions were similar to those reported at first dose, but of a stronger intensity
patient with bilateral posterior knee pain, bilateral Achilles tendon pain, and left fourth toe pain. These were severe enough to cause inability to walk
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: Gh9694), in left 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's relevant medical history and concomitant medications were not reported. Past drug history included: Illsone antibiotics, reaction(s): "Known allergies: Illsone antibiotics", notes: Known allergies: Illsone antibiotics. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound symptoms- positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine COVID 19 Treatment, Paxlovid from 30Nov2022 to 04Dec2022. Known allergies: Illsone antibiotics.
I now have numbness in my fingertips. It is bad in 3 fingers. Still there after 2 days. 11/9/09 Vaccination record received and updated.
6JUL onset fever 102 & vomiting 4-5 hrs p/vax; also c/o dizziness; vomited x 3 during noc; tc to mom 7JUL Am-fever down, no more vomiting; tc form mom 4PM 7JUL fever 104.3, nausea; APAP given;
his arm is still hurting a lot; This case was reported by a consumer and described the occurrence of pain in arm in a 16-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, less than a week after receiving Meningococcal B vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's parent. The age at vaccination was not reported but could be 15 or 16 years.  The patient received Meningococcal B vaccine a week ago and experienced pain in arm which was still hurting a lot. The reporter asked was that normal and how could he/she help him. The follow-up would not possible as no contact details were available.
After first shot, felt like balance was completely off and head was dizzy (most noticeable when driving on highway). After 2nd shot, experienced numbness and burning pain in the nerve endings up and down my legs (especially the back of my legs), arms, and general weakness in limbs.
Blisters, papules on Left Arm, chest, back, and leg.  Began 4/3/03, progressing 4/6/03.  Rash generalized over entire body.  Seen in ER and no treatment given.
Right leg: red, swollen, 3x5cm.  Treatment: Benadryl, Tylenol, cool compress
Ith the first vaccination I had upset stomach and clamy forehead about an hour after vaccination. Then within a 3 week time period I kept getting sicker then, the day after my second dose (which caused me no reaction, which I thought was weird as everyone reported that one having more side effects) I had become so sick that I went to the ER and found I had diabetic ketoacidosis.  It runs in my family to have type 2 but later in life. What was also strange is that Inhad a physical not long before the vaccine through my PCP Dr. and my A1C labs came back elevated but within normal limits....
Patien developed rash approximately two inches in are on right deltoid one day after receiving the Anthrax immunization. Patient stated that are was warm and itchy. Pateient was prescribed benadryl, topical steriod cream and placed on nquarters for 24hrs.
Patient had a papular rash around MMR site and a faint red area of non-palpable erythema around the IPV site
Rash; Upper arm hardness; Upper arm swelling to elbow; Upper arm swelling to elbow; Arm warmth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Upper arm swelling to elbow), VACCINATION SITE WARMTH, RASH, VACCINATION SITE INDURATION (Upper arm hardness), and VACCINATION SITE SWELLING (Upper arm swelling to elbow) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic migraine since 1949, Drug allergy (Penciillin, Sulfa, erthymicin) and Pollen allergy. Concomitant products included BOTOX from 15-Jun-2020 to an unknown date for Chronic migraine, RIZATRIPTAN from 06-Jan-1995 to an unknown date for Migraine, VITAMIN D from 06-Jan-2017 to an unknown date and PROLIA from 06-Jan-2017 to an unknown date for Osteoporosis, LEVOTHYROXIN from 06-Mar-2000 to an unknown date for Thyroidectomy, VITAMIN B3, POTASSIUM, and CALCIUM for an unknown indication.    On 05-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PERIPHERAL SWELLING (Upper arm swelling to elbow), VACCINATION SITE WARMTH, VACCINATION SITE INDURATION (Upper arm hardness), and VACCINATION SITE SWELLING (Upper arm swelling to elbow). On 05-Feb-2021 at 5:00 PM, the patient experienced RASH. On 19-Feb-2021, PERIPHERAL SWELLING (Upper arm swelling to elbow), VACCINATION SITE WARMTH, RASH, VACCINATION SITE INDURATION (Upper arm hardness), and VACCINATION SITE SWELLING (Upper arm swelling to elbow) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Doctor told to take L-lysine and Claritin for second dose.   This case was linked to MOD-2021-096853, MOD-2021-096853.
Injection site is red and swollen. Approximately the size of a dime. Was the approximately the size of a quarter before. Also site of injection appears to be lower than the recommended site. Pt. is seeing physician today.
No additional adverse effects reported; Improperly stored dose of MMR II was administered to a patient; This spontaneous report was received from a consumer referring to a female patient of unknown age.   The patient's concurrent conditions, medical history or concomitant medications was not reported.   On 01-JUN-2020, dose of Measles, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) lot # S014430 and expiration date 09-MAY-2021 (dose, frequency and route of administration were not reported ) as prophylaxis, which was improperly stored (temperature unknown by reporter) in a timeframe of 20 hours was administered to the patient. The temperature was unspecified and it was mentioned that the vaccine did not experience temperature excursion or recorded by a data logger. It was reported that the call was not made due to data logger and no previous temperature excursion occurred.  No additional adverse effects reported by the patient.
Stomach ache and headache on 11/16/2021 and 11/17/2021
he got muffled hearing and hearing radio septum/decreased hearing in the right ear after the 1st dose; Pressure, decreased hearing and ringing in the right ear after the 1st dose; Pressure, decreased hearing and ringing in the right ear after the 1st dose; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP) for a Pfizer sponsored program.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Feb2021 16:00 (Lot number: EN6203) as dose 1 single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LORATADIN. The following information was reported: HYPOACUSIS (non-serious) with onset 02Mar2021 06:00, outcome "unknown", described as "he got muffled hearing and hearing radio septum/decreased hearing in the right ear after the 1st dose"; EAR DISCOMFORT (non-serious), TINNITUS (non-serious) all with onset 02Mar2021 06:00, outcome "not recovered" and all described as "Pressure, decreased hearing and ringing in the right ear after the 1st dose". The event "pressure, decreased hearing and ringing in the right ear after the 1st dose" was evaluated at the physician office visit. Additional information: Due to the adverse event the patient was enquiring that whether the patient should take second dose or not. Prior to the vaccination patient was not tested positive for covid. No follow-up attempts are possible. No further information is expected.
Freezer was out of range PROQUAD was administered when it was still out of range; No additional AE reported; This spontaneous report has been received from a medical assistant concerning a 4-year-old female patient. Her concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 22-AUG-2022, the patient was vaccinated an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) administered as prophylaxis on the left thigh, lot number W016358 with expiration date 16-NOV-2023 (dosage regimen and route of administration were not provided). The previously mentioned vaccine underwent a temperature excursion of 7.3 Fahrenheit (F) for 144 hours. According to the reporter the freezer was out of range and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was administered when it was out of range (Product storage error). The vaccine did not have previous temperature excursions. No additional adverse event was reported.  This was one of several cases received from the same reporter.
After nasal vaccine student felt head get heavy/felt tired; rest 10 minutes extra in observation, ate crackers and drank water. State she felt ok, then back to class. Father notified.
SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 was not reported, administered on 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 2021, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effects on 2021. This report was non-serious.
There has not been an adverse event.  The patient received the Pfizer Vaccine on 1/18/21 at an off site clinic,  we had our own clinic at our facility on 2/6 and the resident had a temperature and did not get the booster.  On 3/15/21 patient received the Moderna vaccine stating that they did not receive the vaccine at all.    There has been no adverse reaction, however the resident did receive one Pfizer vaccine in January and one Moderna vaccine in March and there are no studies out there stating if or what may occur if someone has two different brand of a vaccine.
Bruising that spread and didn?t heal, eventually went to doctor and was found to have ITP with a blood platelet count of 4