chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not feeling well / feeling like still under the weather / really feeling ill; tired; chills; feeling week nausea; severe stomach pain; dry hives; sweat; achy all over; ear ache; could not sleep; fever; no apatite; leg cramps; neck pain; sore throat; diarrhea; itchy face; This is a spontaneous report from a non-contactable consumer (patient). A female patient of 7-decade received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 as dose 2, single for COVID-19 immunization. The patient medical history include respiratory Infection in Oct2019. The patient concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient stated she received her second dose of the Pfizer covid vaccine on 05May2021 and she was still not feeling well, feeling like still under the weather, tired, chills, feeling week nausea, severe stomach pain, dry hives, sweat, chills, achy all over, really feeling ill, ear ache, could not sleep, fever, no appetite, did not feel well. She was not tested. Patient stated she also experienced leg cramps, neck pain, sore throat, diarrhea, Itchy face. She wanted to know about it and how long it takes to go away. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Right after I got the shot my head started feeling numb, and soon after I started breaking out in hives all over.  It has gotting a little better, and my head feels better but I still have the hives all over.
Six (6) days following vaccination at school, my son complained of stomach pain. 10 days post-vaccination he complained of scrotal/groin pain, pain in lower limbs, left hand and a raised palpable purpuric rashes were noticed on his lower limbs by me and the doctor at ER, where I took him that Friday evening. Diagnosis of Henoch-Schonlein purpura (HSP) was made at 2nd hospital, where he was transferred to. Case has progressed to HSP nephritis in the nephrotic range and was just placed on Immunosuppressor drugs- Prednisolone, Cyclosporine; Lisinopril, ZANTAC and Fish oil by a Nephrologist at 3rd hospital.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, 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), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.included anti-viral product Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the reported events  DRUG INEFFECTIVE and  COVID-19 cannot be excluded for the suspect drug BNT162b2.
mild pain at site of injection; intense headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (intense headache) and VACCINATION SITE PAIN (mild pain at site of injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced HEADACHE (intense headache). On 04-Apr-2021, the patient experienced VACCINATION SITE PAIN (mild pain at site of injection). At the time of the report, HEADACHE (intense headache) and VACCINATION SITE PAIN (mild pain at site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a nurse prescriber refers to a 75-year-old female patient. Patient's pertinent medical history/drug allergies, concurrent diseases and concomitant therapies were not reported. On an unknown date in February 2017 (also reported as 2 years ago), the patient was vaccinated with PNEUMOVAX 23 1 dosage form for prevention of pneumonia (prophylaxis). Other suspect therapies included antimicrobial (unspecified) for treatment of cellulitis-like rash. On an unknown date in February 2017 (onset date reported as 2 years ago) the patient experienced cellulitis like reaction in the unspecified arm the vaccine was administered, which was spread to the chest. Then the patient sought for medical attention by attending to emergency room at hospital. The patient received treatment for event of cellulitis like rash with an unspecified antibiotic and developed an unspecified reaction to the antibiotic (adverse drug reaction). No product quality issues involved in this case. The outcome of events cellulitis and adverse drug reaction was reported as recovered. The reporter considered adverse drug reaction to be not related to PNEUMOVAX 23. The causality assessment was not provided for cellulitis. Upon internal review, the event cellulitis was determined to be medically significant.
A report was received from a health professional on 17Oct02, concerning a 52 year old female vaccinee who experienced an injection site reaction, fever and itchiness which started after receiving Fluvirin on 14Oct02. On 14Oct02, the vaccinee received her yearly vaccination. Thirty minutes after the injection, the vaccinee noticed a small welt at the injection site that was itchy and that evening the welt had grown to the size of a baseball and was red, hard, and itchy. She was treated with diphenhydramine hydrochloride cream and capsules with some relief of the itching. She has not yet recovered. The reporter has assessed the relationship of the vaccine to the event as probable.
patient received 0.25ml instead of 0.5ml of Moderna Bivalent Booster Dose
This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (had reaction after second dose), CHILLS (Chills), PAIN (body aches), HEADACHE (very terrible headache.Very very bad headache) and BEDRIDDEN (2 days she was in bed) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026120A - 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Blood pressure med, LISINOPRIL, carvedilol                                                     Heart, ezetimibe                                                      Cholesterol, ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, RETINOL, TOCOPHEROL, VITAMIN B NOS (MULTIPLE VITAMINS) and ESZOPICLONE (8 HORAS) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (had reaction after second dose), CHILLS (Chills), PAIN (body aches), HEADACHE (very terrible headache.Very very bad headache), BEDRIDDEN (2 days she was in bed), TINNITUS (ringing earing and tinnitus.they never gone away, almost 2 month ago), INSOMNIA (preventing her from sleeping), DIZZINESS (Dizziness), BALANCE DISORDER (balance issue), NAUSEA (Nausea), MALAISE (Today is in bed again feeling is going to been sick again), MYALGIA (muscle pain) and VOMITING (Vomitting). At the time of the report, UNEVALUABLE EVENT (had reaction after second dose), CHILLS (Chills), PAIN (body aches), HEADACHE (very terrible headache.Very very bad headache), BEDRIDDEN (2 days she was in bed), TINNITUS (ringing earing and tinnitus.they never gone away, almost 2 month ago), INSOMNIA (preventing her from sleeping), DIZZINESS (Dizziness), BALANCE DISORDER (balance issue), NAUSEA (Nausea), MALAISE (Today is in bed again feeling is going to been sick again), MYALGIA (muscle pain) and VOMITING (Vomitting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon internal review on 04-Aug-2021, the age units corrected to years.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 1st March 2023, the patient received Havrix. On 1st March 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-Mar-2023 Reporter's Comments:  A medical assistant called in to report the administration of an expired Havrix dose to a 59 year-old female patient.  The reporter asked how to proceed with this patient. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received Havrix after expiration date, which led to expired vaccine used.
Nothing at injection site - however swelling of elbow and lower arm/hand of same arm that the shot was given in.  Significant pain and couldn't move arm.  Went to physician next morning, who gave cortisone shot and sent for check at local hospital to see if blood clot occurred.
On the 17th I suffered a severe migraine at 2:00 AM went down the hallway and threw up most of the day. My vision was off and it felt like the top of my head was about to explode. I went to the Walk-in clinic to get treatment.
Second herpes zoster Shingrix, administered on 2/12/2021 to a 61 year old male, associated with palpable (2.5cm), sensitive lymph node (the size of an olive) in the arm pit on same side as the injection (for comparison: the first Shingrix 8 weeks prior was administered on the other side of the body caused no palpable swollen lymph nodes).  Fever 2.9F above baseline 12 to 20 hours post 2nd injection, and the fever subsided after 36 hours (comparison: the first Shingrix fever was 1.7F above baseline 34 to 42 hours post injection). Noticed lymph node swelling 72 hours post 2nd injection.  Attributed the symptom to the vaccination. Self reporting via VAERS.
Approximately 20 minutes after receiving Janssen COVID19 vaccine patient was noted to complain of a headache and nausea. Also reported being able to taste the vaccination in her mouth. Patient was monitored for additional 15 minutes and began to complain of dizziness. Patient did not experience any respiratory distress.
Within hours increased temp 102.8 degrees - 103 degrees, chest tightness, pneumonia RT LL, aches entire body headache, malaise, headache.
Inappropriate route of vaccination; Iching of the injection spot and Redness about the size of a half dollar; Iching of the injection spot and Redness about the size of a half dollar/Redness after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), INJECTION SITE PRURITUS (Iching of the injection spot and Redness about the size of a half dollar) and INJECTION SITE ERYTHEMA (Iching of the injection spot and Redness about the size of a half dollar/Redness after vaccination) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 06-Aug-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), INJECTION SITE PRURITUS (Iching of the injection spot and Redness about the size of a half dollar) and INJECTION SITE ERYTHEMA (Iching of the injection spot and Redness about the size of a half dollar/Redness after vaccination). On 06-Aug-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, INJECTION SITE PRURITUS (Iching of the injection spot and Redness about the size of a half dollar) and INJECTION SITE ERYTHEMA (Iching of the injection spot and Redness about the size of a half dollar/Redness after vaccination) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Follow-up document received,  contains no new information.
The first time that I had this feaccion was after the influenza vaccine, one year after the H1N1 EPIDEMIC. In which I was diagnosed with RA. Now a few days after reciving this vaccine for COVID-19 my joints started to swell and became painfull, the swelling have been control with the increase of prednisone but there has been an increase of joints affected, in other words, my RA is now worse. We did a blood test to measure if I have created any antibodies and it came back None reactive (0). So I dicided not to continue with the vaccination.
My Grandson's daycare had an outbreak of COVID. He had it on 9/17/21 and I had symptoms on 9/19/21 but tested negative with the at home COVID test. On 9/22/21 I tested positive with COVID on the at home COVID test. I had cold symptoms including dry cough, a lot of fatigue, headache, significant sinus congestion, body aches, fever, chills, upper back pain, and lung discomfort. I continue to have some headaches, lung discomfort, some coughing, some sinus congestion, and significant fatigue. I am now using an Albuterol inhaler.
Syncopal episode in elevator after leaving our office. Seen for well child visit. Rec'd ADACEL & MENACTRA and hemoglobin test. Initial BP: 117/56 HR 55. Post episode: 102/69 HR 50.
100.5 fever Servere body aches Extreme neausea And throwing up  Headache
Pt recvd vax on 24JUN92 & the next day devel bilateral rash on forearm & around the inject site; rash remitted p/24 hrs; no further details were provided;
pt recvd vax; pt devel jaundice, nausea & abdominal discomfort; pt dx w/ "probable hepatitis";
Patient vaccinated x3 (Pfizer: 2/18/21, 3/11/21, 12/15/21)  Patient found to be COVID+ during hospitalization on 5/11/22
The patient called  the office 10/13/20 at 8:37am to report that she had hives and was concerned it was related to the flu vaccine she received 10/12/20. The patient stated the area around the injection site looked normal, there was only a small red spot where the injection was given. She did however have hives all over her body and reported they were very pruritic. The patient had been taking Benadryl since the symptoms began and felt the hives were improving.  The patient was advised to continue Benadryl every 4-6 hours and to call if she is not improving.
Passed away; Had seizures 2 days after receiving his first dose; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) and SEIZURE (Had seizures 2 days after receiving his first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Passed away) (seriousness criteria death and medically significant) and SEIZURE (Had seizures 2 days after receiving his first dose) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, SEIZURE (Had seizures 2 days after receiving his first dose) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided. Reporter stated she knows of someone and is not totally sure which vaccine was taken, but says Moderna. Action taken with respect to mRNA-1273 was not applicable.  This is a case of a sudden death of a Male patient who reportedly had seizures 2 days after receiving his vaccine. Reporter is unsure of vaccine that patient received and this can be a confounding factor. Very limited information has been provided regarding these events.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Sender's Comments: This is a case of a sudden death of a Male patient who reportedly had seizures 2 days after receiving his vaccine. Reporter is unsure of vaccine that patient received and this can be a confounding factor. Very limited information has been provided regarding these events.; Reported Cause(s) of Death: unknown cause of death
No reaction in the first 15 mins, then I continued on with my day. Came home, then probably the next day i started feeling flu-like symptoms. Uncomfortable, aches, pains, which is my normal reaction to vaccinations like that. That lasted a few days. Two weeks later i tested positive for Covid19 and ended up in the emergency room. They tested me, put me in a room for a few days. I asked them to take an xray of my chest because it was really hurting. I had a blood clot in my right lung, and water in my left lung. They had me on oxygen for a few days. They said had I not had my vaccinations I would probably have been dead. They discharged me because my oxygen levels weren't dangerous. I think they gave me some short term medications, maybe antibiotics, but i dont remember. They just said go home and stay there for a while. This was the second time i had contracted covid. My body has been beaten and battered over the last 12 months, and im still waiting to get back to 100%. I feel like at this point im maybe 75% capacity. I dont feel as good as i would like to feel. I got pneumonia this month (5/22)
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves male patient (age unknown) who received PENTACEL instead of vaccine QUADRACEL. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect PENTACEL lot C5444AB, expiry date 22-Nov-2019 via unknown route in unknown administration site instead of injection of suspect QUADRACEL lot number, expiry date not provided. It was an actual medication error due to wrong vaccine administered and wrong technique in product usage process. It was reported that a patient inadvertently received the Dtap/IPV portion of PENTACEL instead of the ordered QUADRACEL. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender- none.
REFROZEN AND THAWED VACCINE WAS ADMINISTERED; VACCINE WAS PLACED IN THE FREEZER, THEN THAWED OUT OVERNIGHT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-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 MAY-2021, the subject experienced refrozen and thawed vaccine was administered. On MAY-2021, the subject experienced vaccine was placed in the freezer, then thawed out overnight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the refrozen and thawed vaccine was administered and vaccine was placed in the freezer, then thawed out overnight was not reported. This report was non-serious.
stomach ache; soreness on injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), VACCINATION SITE PAIN (soreness on injection site) and FATIGUE (fatigue) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), VACCINATION SITE PAIN (soreness on injection site) and FATIGUE (fatigue). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), VACCINATION SITE PAIN (soreness on injection site) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a physician (also the father of the subject) and described the occurrence of encapsulation reaction in a 2-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline) as well as DTAP (unspecified manufacturer). Concurrent vaccination included IPV (manufacturer unspecified) given on 02 March 2009. There were no concurrent medications. On an unspecified date when the subject was 2 years old, he received 1st dose of DTAP. Approximately 2 to 3 days following administration of DTAP, the injection site was red, inflamed and encapsulated. The subject was taken to the emergency room and the encapsulation was filled with puss and had to be surgically removed. This required stitches and the subject developed a scar. The redness, inflammation and encapsulation were reportedly improved. The same thing happened to the subject following his 2nd dose of DTAP when he was 4 years old (dates not provided). Within 2 to 3 days of administration of the 2nd DTAP dose, the subject developed injection site redness, inflammation and encapsulation. These events were described as improved. On 02 March 2009 at 13:00 the subject at the age of 5 received 3rd dose of INFANRIX. The next day, on 03 March 2009, the subject developed a rash that at the time of reporting continued to worsen, spreading down the leg. It was reported that the subject was unable to bear weight on that leg. The rash was described as red, irritated and very painful. Additionally, he was running a fever which was treated with TYLENOL. The subject's pediatrician reported that the subject had cellulitis. He was started on antibiotics. The outcome of cellulitis, unable to bear weight on leg and fever were unknown at the time of reporting. The physician considered the events were probably related to vaccination with INFANRIX and DTAP.
swollen lymph nodes, pain from bicep down to wrist, entire arm swelling, left breast pain, red rash under left arm
Covid arm symptoms...... Itchy reddish rashes 9 inches long along my left arm.  Covid-arm started 9 days after vaccine jab, and still going on up to now from February 13- ongoing to February 20.
Pt received vaccine yesterday, last night started with hives, redness, swelling pain at site, c/o some feeling like she was going to pass out when she stands, not as of this AM.