chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling in face around nose and cheek area.; Right leg under knee swollen; swollen lymph node on right side of face in front of ear with alight pain,; On Monday aftershot notice swollen lymph node onright side of face in front of ear; Tired; Felt woody 1 hour after shot.; Soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 14:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included paracetamol (TYLENOL EXTENDED RELIEF), glycyrrhiza glabra root (LICORICE ROOT), zingiber officinale root (GINGER) and althaea officinalis root (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took codeine (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 23Apr2021 at 15:00 the patient experienced, felt woozy 1 hour after shot, soreness in left arm. On 24Apr2021, the patient experienced tired second day through 4th day. On 26Apr2021, the patient experienced (on Monday) after shot noticed swollen lymph node on right side of face in front of ear with a light pain. On 27Apr2021, the patient experienced (on Tuesday) right leg under knee swollen, went to doctor Wednesday. On 29Apr2021, the patient experienced (Thursday) swelling in face around nose and cheek area. The events felt woozy 1 hour after shot, soreness in left arm, tired, swollen lymph node on right side of face in front of ear with a light pain, right leg under knee swollen resulted in doctor or other healthcare professional office/clinic visit. The event swelling in face around nose and cheek area did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of any of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt woozy 1 hour after shot, soreness in left arm, tired, swollen lymph node on right side of face in front of ear with a light pain, right leg under knee swollen, swelling in face around nose and cheek area was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache ( within 5 minutes) Tinnitus ( within 20 minutes) Tingling and numbness lips and tongue and ears( within  10 minutes lasted 3 hours) Pain (burning stabbing) in left shoulder, elbow, wrist, and thumb. ( within 10 minutes) Nauseous   ( within 15 minutes) Muscle pain to touch ( within the next 3 hours) Swollen lymph nodes in neck ( next day) Most lasted 7 full days except mouth, toy fur and ear numbness Left shoulder still painful Burning stabbing pain in every joint by day 2
Dizziness, nausea, blurry vision. 114/70, HR 60, 99%.  Exit time 1:25pm.
Unknown if related to third dose.  Developed hives after being exposed to known COVID positive individual. Exposure date 4/5/22, hives on 4/7/22.  COVID negative per 3 antigen tests, 1 molecular test and 1 PCR test.
This spontaneous report was received from a female registered nurse of unknown age referring to herself. Concurrent conditions included allergy to sulfonamides, BIAXIN and AVELOX (drug hypersensitivity). The patient's pertinent medical history was not reported. On approximately JULY 2003, the patient was vaccinated with a dose of PNEUMOVAX23 (lot #, dose, frequency and route of administration were unspecified. in the left arm.  On an unspecified date in JULY 2003, her left arm became "grapefruit" size swollen (peripheral swelling), ,red (erythema) and hot to touch (skin warm). It was stated that the patient did not die, that she was not  hospitalized and that the adverse events were not life threatening. No PQC was involved. At the time of the report, it was stated that the patient recovered from erythema, peripheral swelling and skin warm within one month, by AUGUST 2003. The relatedness of PNEUMOVAX23 with the adverse events was not reported. This is  one of several reports from the same source. Additional information has been requested.
Hives around eyes and mouth, neck, chest, per phone call from mother. Advised Benadryl 1/2 tsp q 6 hours. Complete recovery. No site reaction. Not seen; telephone contact only.
Pt developed severe migrane, sharp right upper quadrant abdomen pain, severe bloating, metal taste in mouth, fatigue, nausea. Pt self tx with decrease in food intake, increased clear fluids and tea. Pt is still experiencing upper right quadrant pain but decreased intensity. No constipation or diarrhea.
Fever, NauseaVomiting, a week post vaccine developd abd pain, nausea, fever/chills. Narrative:
Information has been received from a nurse practitioner concerning an 8 or 9 year old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 11/22/2005, the patient developed breakthrough with more than 50 lesions. Besides the external lesions she had lesions in her mouth and down her throat. Unspecified medical attention was sought. The patient's outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
DIAGNOSED BLOOD CLOT; This spontaneous report received from a patient via a company representative concerned a 51year old female. 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, Expiry: Unknown) dose not reported, 1 total administered, 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 (within 30 days of vaccination), the patient was diagnosed with blood clot and was hospitalized (date unspecified). Duration of hospitalization was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of diagnosed blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  20210832291-Covid-19 vaccine ad26.cov2.s-Diagnosed Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
First I started feeling very weak, then chills, then fever up to 103 F for 2 nights, swollen arm for 1 week.
pt exp chills & fever p/receiving 1st dose of Engerix-B;
Body is weak/ feeling weak in her body; dizziness/ keeps being dizzy; Left arm joint pain (injection arm).; Left jaw bone pain; Two fingers in right hand asleep; Feels like she has a cold, nose feels wet; Not walking fast, doesn't want to fall. State that this is weird because she feels like her body is weak.; Left arm joint pain (injection arm); This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0196, Expiration date: was not reported) via an unspecified route of administration (age at vaccination 62-year) in Right Arm on 20Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took septra and experienced drug hypersensitivity (Caller mentions she is allergic to Septra, like Bactrim). Patient previously received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0181, Expiration date: was not reported) via an unspecified route of administration (age at vaccination 62-year) in Left Arm on 29Jun2021 as dose 1, single for COVID-19 immunization and experienced her left-hand fingers went to sleep for about 7-8 hours. Prior Vaccinations (within 4 weeks) / list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as None. On 20Jul2021 the patient experienced dizziness/ keeps being dizzy; in Jul2021 the patient experienced left arm joint pain, body is weak/ feeling weak in her body, left jaw bone pain, two fingers in right hand asleep, feels like she has a cold, nose feels wet, Caller mentions that she is not walking fast, doesn't want to fall. state that this is weird because she feels like her body is weak, left arm joint pain. AE does not require to visit Emergency Room/Physician Office. Caller states that she has a question; Says that she had the vaccine on 20Jul2021 and keeps being dizzy, today she woke up and her body is weak, asks if this is normal after the vaccine, what she can do possibly about it. She states she is trying to call her primary care but is having difficulty getting through; States that her husband has called health insurance company for her also. Caller denies any medications, medical conditions, labs, testing or treatments relevant to report. The seriousness of the events was reported as non-serious. The clinical outcome of dizziness/ keeps being dizzy was recovering, while the outcome of all other events was unknown.   Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The patient did not have any adverse events post injection. It was reported that the storage condition at the time of the excursion was at refrigerator. Maximum temperature reached was 64-degree Fahrenheit, and excursion duration was approximately 7 hours. The vials were returned to the refrigerator. No changes in visual inspection. Pertinent details: At the time they were unpunctured. It was reported as Tran date as 23-Mar-2022 No treatment medication information was given.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow up received contains no new information. On 20-Apr-2022: Follow up received contains patient information and dose number.
This spontaneous report was received from a 62 year old female patient regarding herself. The patient's pertinent medical history included shingles twice, rheumatoid arthritis and breast cancer. The patient was allergic to morphine. On 14-OCT-2015, the patient was vaccinated with ZOSTAVAX (dose, frequency: 1 injection) in the right arm. Concomitant therapies included acyclovir and prednisone. On 16-OCT-2015, the patient experienced joint pain and on 18-OCT-2015, the patient had upper respiratory infection. The patient sought medical attention and cefdinir was given as treatment to the events. The outcome of joint pain and upper respiratory infection was reported as not recovered/not resolved. The relatedness of the events with ZOSTAVAX was not reported. Additional information has been requested.
Itching started on arms and then moved to back about 45 minutes after shot. Hives and itching spread to neck, shoulders and scalp.
Stiff arm, headache, fever, reaction at injection site(raised welts) tiredness, night sweats.
Information has been received from a registered nurse concerning her 14 year old niece with no pertinent medical history and no allergies or drug reactions, who on 29-MAY-2008 was vaccinated with the second dose of HPV 4L1 6 11 18 VLP vaccine (yeast). There was no concomitant medication. The nurse reported that in "mid June 2008", her niece experienced a generalized, "petechial-type rash". The above was diagnosed by a dermatologist as leukocytoclastic vasculitis. At the time of the report the patient had not recovered. Additional information has been requested. 11/5/08-records received-note of 9/23/08-Left leg superficial perivascular infiltrate of lymphocytes with erythrocyte extravasation consistent with progressive pigmentary purpura. No neutrophilic infiltrate or fibrinoid degeneration of vessels is identified to suggest a true vasculitis. Allergic contact dermatitis. 10/27/08-cancelled follow up appointment.
Muscle twitching, pain at injection site, itching (patient had both arms injected, left is causing more pain, both arms itching). Itching did not begin until 5 days later.
Local site reaction less than 10mm redness, sore and under arm soreness. 3rd day onset of hives. Benedryl given along with steroids.
Within a minute patient felt the vaccine enter her heart then she passed out while standing up. She did not have a measurable blood pressure or heartbeat. Did not wake up for over 3 minutes. Upon awakening, went in and out of consciousness and spasmed, eyes rolled back with each seizure. Continues to have spasms years later. One pupil is larger than the other due to brain damage.
The first 2 doses were no issues. 3 days after getting the booster, I developed some hives on my neck. Since then, I have had an internally itchy face, internally itchy forehead, internally itchy hands, cheekbones, tight lip, tight side lip, swollen lip sensation, swollen tongue sensation, itchy tongue sensation, full body flare ups, puffy eyes and post nasal drip for the last 3 months. Each symptom comes and goes as it pleases. We checked autoimmune diseases, and blood tested for different allergens and even had my sinuses checked. My symptoms dont all happen at once but atleast one or the other is constantly happening and it comes and goes as it pleases.  As a background, I am not allergic or have not been allergic to anything my whole life (I have been vegetarian all my life). No particular food allergies, no laundry detergent allergies, no environmental allergies. This started happening 3 days after I took the booster. I tried changing my diet and checking if its some food; changed locations in case its some environment and it has still not gone.
Seemingly extreme pain in arm, where functionally lifting arm becomes impaired at certain angles and directions.
Scattered erythematous macules, vesicles on the hands, foots. Clustered vesicles on the perineal areas, anus area, bilateral elbows, scatterred vesicles on the legs, around mouths.
Client waited 15 approximately 15 minutes after vaccination before she left. When she left, she had no signs of adverse reaction. Client states that at about 4:10 PM she developed a full body rash and itching. She also stated her lips were tingling but denied difficulty breathing. I instructed client to seek immediate medical attention. Client took Benadryl and went to her PCP. Her PCP prescribed a medication (not sure what medication). Today client states she feels better. States the rash is gone but she still has some itching.
Patient is a(an) 4 y.o. male who is here with parent, an additional history source. Patient had febrile seizure in May. It was associated with HFMD, had a fever and then had a seizure which was still happening when they got to the ED. He recovered.   2 nights ago he was playing video game and had a seizure that lasted 2 minutes and was generalized. He had 103 temp at the time.he got MMRV, DTaP-IPV and Pfizer COVID vaccine 8 hours prior to the seizure. After the seizure mom gave ibuprofen, he fell asleep for about 20 min, and awoke afebrile and was acting normal. He has been normal since.
He had the vaccine and on 02/15/2021 we went to the ER and admitted to hospital with pneumonia, he was in oxygen, antibiotics, and steroids.  After that he appeared to be getting better and then at a follow up x-ray the pneumonia still hadn't clear. He has been in oxygen every day since 02/15/2021. The antibiotics and steroids stopped for some period. In early May they did another chest x-ray and they said it was still not clear and they restarted the antibiotics and steroids again. By that time he had already had the 2nd vaccine. In May he had some scans for his cancer and blood work. He had some Keytruda infusions between the 1st and 2nd dose of the vaccine.
Severe fatigue, generalized  myalgia, weakness, sleep disturbance, mild shortness of breath  Onset of sx were ~10-12 hours after receiving shot, symptoms lasted ~24h. Did not seek any medical care. Took 2 doses of Tylenol 500mg about 8 hours apart, Tylenol provided some relief but still felt very poorly.
This case was reported by a pharmacist via call center representative and described the occurrence of sinus infection in a adult female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) and (batch number 2453L, expiry date 12th February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, several days after receiving SHINGRIX, the patient experienced sinus infection. The patient was treated with Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the sinus infection was unknown. It was unknown if the reporter considered the sinus infection to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The age at the vaccination was not reported. The healthcare professional reported that, the patient developed sinus infection a few days after receiving the SHINGRIX vaccine. The healthcare professional stated, the patient was being treated with antibiotics for sinus infection. The reported expiry date (12th February 2012) for SHINGRIX vaccine was incorrect and was updated to 12th February 2021, according to sales database.
Information has been received from a physician concerning a patient who "recently," in 2007, was vaccinated with a dose of Zostavax. On an unspecified date in 2007, the patient developed shingles. Unspecified medical attention was sought. a product quality complaint was not involved. Additional information was received from a nurse in the physician's office who reported that the patient's shingles did resolve. The patient's shingles were described as "kind of like sunburn" and the lesions were drying up. The patient was considered recovered. Follow up information received on 01-OCT-2007 from the consumer indicated that she wishes to be reimbursed for the cost of the vaccine as well as the cost of Valtrex and doctor visits. She noted that within 24 hours of receiving the vaccine, she developed a "sore" on her left arm. The next day she had "several sores" on her left arm. She developed 7 blisters on her left arm, and her skin was sensitive on her left arm and shoulder and the left side of her neck and face. She was experiencing "joint pain" on 10-FEB-2007. No further information is expected. Shingles was determined to be another important medical event by the physician.
Erythema, edema around injection site about 3cm raised ring. Diffuse edema, induration right upper arm, shoulder to elbow.
pt recvd vax SEP94 & 27SEP94 pt exp redness & swelling @ the inj site;rxn lasted approx 3 to 4 days;
woke up in the morning with a sweat; headache; neck hurt really really bad; woke up and froze; chills; sore arm; cough on and off; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (woke up in the morning with a sweat), HEADACHE (headache), NECK PAIN (neck hurt really really bad), FEELING COLD (woke up and froze) and CHILLS (chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included METOPROLOL, ROSUVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HYPERHIDROSIS (woke up in the morning with a sweat), HEADACHE (headache), NECK PAIN (neck hurt really really bad), FEELING COLD (woke up and froze), CHILLS (chills), PAIN IN EXTREMITY (sore arm) and COUGH (cough on and off). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (woke up in the morning with a sweat), HEADACHE (headache), NECK PAIN (neck hurt really really bad), FEELING COLD (woke up and froze), CHILLS (chills), PAIN IN EXTREMITY (sore arm) and COUGH (cough on and off) 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.   Reporter did not allow further contact
Unable to lift arm , Arm pain 6-7, extreme fatigue, headache, light body chills.
Initial information received on 21-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 37-year-old male patient, who was vaccinated with 0.5 ml first dose of DAPTACEL (batch number: C52068A) via intramuscular route instead of ADACEL (expiration date: 19-May-2019 and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
My son, 3 years old, had blood work done 2 weeks after getting his 1st dose of Pfizer vaccine.  His body was attacking his platelets (count at 45) and he previously had 0 health issues.  We have seen a Pediatric Hematologist who is almost certain that he now has ITP.