chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case received, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 59-year-old, adult male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patent was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252227 and expiry date: 31-May-2019] which underwent temperature excursion. The patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. This case (201805341) was cross-linked to the source case: 201805327 reported by the same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (59-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Fever 104 degrees, pallor, perioral cyanosis & trembling.  Emesis x1.  Rapid onset within 24 H of vaccinations.  Transported to local ED where septic W/U was negative.  No other signs/symptoms of disease.  Fully recovered within 48 H.
Brother died; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 36-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced brother died. During the phone call received, the reporter stated, "I want to thank you for your vaccine, it was most likely that, that got my 99-year-old aunt, she would've died in her sleep anyway at 104. No cane, no walker. Full head of hair.  Something slipped up the heart now. You're the responsibility party. This man from the (inaudible) brother died. He was 36 years old, I don't know if that was yours." The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Brother died
Approximately 2 weeks post vax the pt developed approximately 24 skin lesions on the stomach, back and torso. They were described as appearing like chickenpox. Pt also experienced mild diarrhea, fatigue, an injection site lump, and injection site itching. Pt developed injection site redness and induration. The rash was described as red, elevated, singular bumps without vesicles. The duration was approximately 5 days.
This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The nurse reported that on an unknown date, the unspecified patients was vaccinated with an improperly stored dose of VARIVAX (lot # L024252, expiration date 30-JUN-2017) (dose, route and frequency unknown) for prophylaxis. No adverse effects were reported. No further information provided.   Temperature: 14.5 F Time frame: 48 minutes No previous temperature excursions. Call was due to a data logger: Yes Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On or about 15-JAN-2017, the patient received ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided) for its intended purpose: the prevention of shingles. As a direct result of the ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. Patient did not have a shingles outbreak until 07-JUN-2017. As a direct result of ZOSTAVAX, patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, patient sustained severe and permanent personal injuries. He suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of the events was not recovered/not resolved.  Causality assessment was related. Shingles outbreak was considered to be disabling.
Pt recvd 3rd dose of Hep B vax on 22JAN92; pt exp pain @ the site of inject; pain persisted for a few seconds; no further details were provided;
Patient has 3" by 6" purple area of left side of upper mid back that had started the day after receiving the vaccine on 2/8/19 and still continuing on 5/16/19. She says it fluctuates to achy to irritated to painful.
Patient later complained that he felt pain soreness and numbness to muscle after receiving the injection. Patient did not report any discomfort to vaccinator immediately after receiving vaccine. Patient was observed for 15 minutes without adverse effect.
Fatigue 3 hours later, migraine for two days, nausea for 3 days, sore arm for three days
Red rash on scalp; Scalp is itching; Scalp hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on scalp), PRURITUS (Scalp is itching) and FEELING HOT (Scalp hot to the touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on scalp), PRURITUS (Scalp is itching) and FEELING HOT (Scalp hot to the touch). At the time of the report, RASH ERYTHEMATOUS (Red rash on scalp), PRURITUS (Scalp is itching) and FEELING HOT (Scalp hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Severe headache; one week later on 12/28 suffered a ruptured aneurism. Currently in stage 5 coma.
tunnel vision; little woosy; This is a spontaneous report from a contactable consumer reporting for himself.  A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982) in left arm on 19Jan2021 08:30 at single dose for COVID-19 immunization. Medical history included shellfish allergy, asthma and high cholesterol; all from an unknown date and unknown if ongoing. Concomitant medication included simvastatin. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced events as stated, "like I was seeing tunnel vision and a little woosy" on 19Jan2021 13:00. No treatment was given to the patient for the events. The outcome of  the events was recovered on unspecified date. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and were not a congenital anomaly/birth defect.
pt developed T of 103 (R) to 330pm 28Feb91, to ER later in evening /w T of 105.7-pt admit to hosp mom states T "went up & down" X 3 days-no other sx, 3rd day T broke & child developed rash. Pt D/C @ this time. FMD-feels not vax related
Father of pt reports that pt's nose starting running (sinus drainage) one day later than redness at site. Today, 10 days after, pt has 2" pink circle with splotchy rash at injection site. Reports itching.
This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a female patient who received SHINGRIX for prophylaxis. On 1st January 2019, the patient received SHINGRIX. On 2nd January 2019, 1 days after receiving SHINGRIX, the patient experienced stomach pain and injection site tenderness. On an unknown date, the outcome of the stomach pain and injection site tenderness were not recovered/not resolved. It was unknown if the reporter considered the stomach pain and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: This case was reported via click to chat. The age at vaccination was not reported. The patient experienced stomachache and tender injection site. The patient asked, how long the events would typically last. The patient denied permission to contact their MD.
Face started swelling ,her whole face swelled up; Excruciating headache; Lymph nodes in her neck were swollen, could not turn her neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Face started swelling ,her whole face swelled up), HEADACHE (Excruciating headache) and LYMPHADENOPATHY (Lymph nodes in her neck were swollen, could not turn her neck) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included SECUKINUMAB (COSENTYX) for Rheumatoid arthritis, DULOXETINE HYDROCHLORIDE (CYMBALTA), PIROXICAM (PAXIL [PIROXICAM]), HYDROXYCHLOROQUINE, BUSPIRONE, AMLODIPINE, LEFLUNOMIDE, GABAPENTIN, HYDROCODONE, CALCIUM, VITAMIN D NOS and CURCUMA LONGA RHIZOME, PIPER NIGRUM FRUIT (TURMERIC +) for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced HEADACHE (Excruciating headache) (seriousness criterion hospitalization) and LYMPHADENOPATHY (Lymph nodes in her neck were swollen, could not turn her neck) (seriousness criterion hospitalization). On 30-May-2021, the patient experienced SWELLING FACE (Face started swelling ,her whole face swelled up) (seriousness criterion hospitalization). The patient was hospitalized on 03-Jun-2021 due to HEADACHE, LYMPHADENOPATHY and SWELLING FACE. The patient was treated with PREDNISONE ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, SWELLING FACE (Face started swelling ,her whole face swelled up), HEADACHE (Excruciating headache) and LYMPHADENOPATHY (Lymph nodes in her neck were swollen, could not turn her neck) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's treatment medication information also included  were antibiotics.  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.; 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.
Information has been received from a physician concerning an 11 year old Hispanic  female who on 01/09/00 was vaccinated with a 3rd dose of Hepatitis B vaccine recombinant. It was noted that at the time of vaccination, the patient had a sore throat and a cough and was diagnosed with an upper respiratory infection. On 01/11/00, the patient experienced right arm swelling, redness and a "hard to the touch" area about 30 mm in size. The patient was seen by a physician, no treatment was rendered. On 01/12/00 the patient recovered.
Hot, red, left leg swollen 19cm x 15cm area. Patient had fever as well noted next day after shot to left lower leg; Treated with cephalexin for cellulitis
Patient called pharmacy on 09/18/2020 to speak to pharmacist about lingering muscle pain, difficulty lifting left arm all the way up, as when putting on a shirt and was concerned that it is lasting this long (over 2 weeks) with no improvement Patien went to primary care md, took pain relievers with minimal relief.
I received my shot on Friday Jan. 22,2021. Other than a sore arm no other symptoms until Monday morning at 10:30 when suddenly I had a very sore throat. As time passed it got worse and I had trouble swallowing and speaking but not breathing. I work for a dentist and he looked at my throat and my uvula and soft palate were very swollen and red. He referred me to my primary physician who saw me late that afternoon.  I had no other symptoms except pressure in my ears. My doctor gave me a steroid injection and put me on prednisone for 5 days and amoxicillin 500mg, 1 gram twice a day. About 3 hours later the swelling had gone down enough for me to eat some and talk better. By the next day things were much better. I really don?t know if this was a reaction to the vaccine or not but many people have told me to report it. My doctor wasn?t sure if it was that or a bacterial infection. He treated me for both to get the swelling down.
Patient asked for pneumovax 23. Pharmacist gave it to her. The following day it came to our attention that the patient has already received this same vaccine on 08/18/2020 at our pharmacy (administered by a different pharmacist). NO ADVERSE EVENTS were reported by patient. This form is being filled out only for documentation purposes, that duplicate vaccine was given to this patient. Patient's doctor was notified. Patient knows as well. Incident report was filed.
Information has been received from a nurse practitioner concerning a 14 year old female who was vaccinated with the first dose of RECOMBIVAX HB and experienced hives. The patient received the vaccine at another facility. It was reported that the patient recovered from hives on an unknown date. Unspecified medical attention was sought. No product quality complaint involved. Additional information is not expected.
My front left tooth and two bottom teeth have been demineralizing and you can see through them now.; I have bone pain in my pelvic bone.; This is a spontaneous report received from contactable consumer (pharmacist reported for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0180; Expiration Date: Aug2021), via an unspecified route of administration on 22Jun2021 at 12:00 (at the age of 41-year-old), as dose 1, single; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EY0584, Expiration Date: Oct2021), via an unspecified route of administration on 14Jul2021 at 12:00, (at the age of 41-year-old), as dose 2, single in left arm for COVID-19 immunization at Pharmacy/drug store. The patient's medical history included multiple sclerosis, and ulcerative colitis. Concomitant medications included natalizumab (TYSABRI) taken for multiple sclerosis, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to Covid19 vaccine. The pharmacist reported that she had an adverse drug reaction, that has been occurring since her first COVID vaccine and she got her second COVID vaccine on 14Jul2021 and it was more pounced since that point of time. On an unspecified date, the patient's front left tooth and two bottom teeth had been demineralized and could see through them now and had bone pain in her pelvic bone. The events were persistent. It was progressively getting worst. Patient had appointment with her doctor and took blood test. Patient tried her pain medication that she had for Ulcerative colitis and had Tylenol. The patient bought toothpaste and mouth wash that contain high concentration of fluoride. The patient underwent lab tests and procedures which included blood test: unknown, on an unspecified date. The clinical outcome of the events was unknown.
tested positive for COVID.; tested positive for COVID.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Nov2022, outcome "unknown" and all described as "tested positive for COVID.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2022) Negative; (09Nov2022) Positive.  Clinical course: The patient had the Comirnaty bivalent booster vaccine on 06Sep2022. This was his fifth total vaccine (3rd booster). All vaccines were Pfizer. Last night on 08Nov2022 he developed cough, headache, low grade fever and chills. He tested negative on rapid antigen test last night, and on repeated testing this morning (09Nov2022) he tested positive for COVID. He is following up with his primary care physician. This is being reported as a breakthrough COVID infection 2 months s/p the Comirnaty bivalent booster vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Congestive Heart Failure Fluid builup in lungs Enlarged Heart Palpitations in beating of Heart
After 15 min waiting period, patient was walking to his car when he started with tingling to bilateral feet and hand. VS 152/100 P 61 R 16. Lungs clear, temp 97.8, 99% pulse ox. No dizziness, no flushing. At 15 minutes, slightly clammy to touch on upper extremities. Patient reports feeling well and tingling subsiding (none in L foot; only very slightly in bilateral hands, r foot). By 1140, back to baseline. Escorted to car in good condition.
I got the vaccine 12/21/2000.  I had some initial hardness at the site.  By the next day the harness was gone and I developed a bruise.  I never had any other side effects. On Wednesday 12/30/20 I noticed right under my bruise from the vaccine it became red, slightly itch, and hard.
On 4/5/2021, patient inadvertently received a 1st dose of Moderna at 17 years old. Error was discovered when patient presented for his 2nd dose of Moderna on 5/3/2021. Patient reports that he had no problems with the 1st dose Moderna and desires to receive his 2nd dose Moderna today. He turns 18 y/o in 17 more days (May 20th). Interim CDC guidance for COVID Vaccine states that if age 16 to 17 years old and Moderna was inadvertently administered as the first dose that the provider may administer Moderna vaccine as the second dose (as off-label use, because Moderna vaccine is not authorized in this age group. Medical order received to administer the 2nd dose Moderna, and the vaccine was administered.
SEVERE ITP PLATELET TRANSFUSION, IVIG X 2, PULSE DEX X4 DAY RITUXIMAB, PREDNISONE, PROMACTA SPLENECTOMY 3/8/21
Very Sleepy for two weeks; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Very Sleepy for two weeks), CHILLS (Chills) and PYREXIA (Fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-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 SOMNOLENCE (Very Sleepy for two weeks), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, SOMNOLENCE (Very Sleepy for two weeks), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) ,the reporter did not provide any causality assessments.   This case was linked to MOD-2021-231535 (Patient Link).
Monday 4/5 Pruritis  over face and torso and arms. Tues 4/6 at 5:00pm--Obvious development of Mild vesicular rash on cheeks, forehead, neck and 1-2 vesicles scattered on torso and thighs, behind knees and forearms.. Headache and fatigue, mild stomachache and diarrhea.  Warm shower with hypoallergenic soap (on suspicion of hay fever or poison ivy rash, though no poison ivy was seen in the area where he was playing in our yard). Cool air dried and applied topical Caladryl before bed (8pm).  Wednesday 4/7  - Worsening pruritus and rash. No fever, active and happy affect. Encouraged not to scratch to spread. Another warm shower. Refused caladryl after shower. By 6pm, most vesicles have burst and pruritus largely stopped.  Thurs 4/8 Rash spreading in 1-2 vesicles in other locations. Facial rash abating, drying. Called PCP and he recommended keeping pt. out of school until the rash dried, since rash can occur up to 1 month after vaccination.  Fri 4/9 Facial rash abating, drying. Called Health Dept to notify, left a message about the event.
Pfizer vaccine was diluted with Normal Saline Bacteriostatic 0.9%, which is not recommended. Pfizer and CDC contacted. CDC recommended repeating dose where improper dilution occurred. No sighs or symptoms reported by patient. Pt has since received their repeat 1st dose.
Patient received Pfizer BioNTech on 12-23-20 & 1-13-21. She woke upon 1-21-21 with Left side Bell's palsy, She did go to the ER and report attached. She also reported a tennis ball size swollen lymph node in R underarm (armpit) on 1-14-21 for a day or two. very tender to touch.
pt was crying constantly for 48 hrs p/1st immun; pt also had a high fever which was not documented w/a thermometer;
Left arm pain immediately, pain down arm for first 24 hours. After first 24 hours pain limited to elbow to shoulder area of left arm. Limited range of motion, painful to sleep on left side. Recommended for client to have evaluation by personal physician.