chrisvoncsefalvay/vaers-outcomes huggingface dataset:
01/07/2022:   Event occurred after 1 dose of Janssen  vaccine.  74-year-old male who presents with abdominal pain.  Patient was brought in by EMS for 2 days of abdominal pain.  Patient states that the pain is left-sided.  He states he is also experiencing some nausea but has had no vomiting. No respiratory distress.  Remains in hospital.  plan for discharge today -Jan 11/2022.
Severe cramping followed by Vomiting and Diarrhea over about 5 hours, then very tired for the remainder of the day.  No appetite until almost midnight of the day of the event, 23 hours from the beginning of the symptoms.
I am reporting my COVID 19 symptoms. I tested positive on 01/19/2022. I started with a cough, fever for 4 days, body aches and no appetite. I didn't lose my smell. I was very tried and fatigued. This was my second time getting COVID and it was less severe than before. I had it the first time in 01/2020. I had a virtual visit and was prescribed some meds, steroids and cough medicine for the 2nd time. I am still having bronchitis symptoms.
Headache about a week, but decreasing during that week, tiredness for about 3-4 days, soreness at injection site about 1-2 days,  general itchiness most prominent between 2 - 5 days after, still there but I think that is due to the fact that I scratched it when it was most prominent.
Patient stated, headache, muscle stiffness, nausea, accompanied by an unbearable migraine occurred approx. 24 hours post vaccination. Pt took Tyelenol which relieved the muscle pain, rehydrated self to minimize symptoms fr. migraine.
developed Bell's palsy; This is a spontaneous report from a non-contactable consumer via a sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, for Covid-19 immunisation. The patient medical history and concomitant medications were not reported.  It was reported that "I wasn't sure if this was reportable or not because wasn't sure if this was identifiable patient. Reporter told me he had heard of a teenage patient that was related to someone he knew who developed Bell's palsy after receiving vaccine. If I receive any more information will keep you posted. He did not officially say it was Pfizer vaccine they received, but am reporting just in case as I am not aware of other Covid vaccines being given to teenagers." Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This study case was received from the investigator in a trial on 12 March 2013. A 45-year-old male subject, who had a past medical history of palpitations, pounding heart without exercise, and an abnormal electrocardiogram (ECG) on 23 April 2011 (also reported as past medical history, abnormal ECG reported as no), developed non-specific myocarditis on same day after receiving a injection of ACAM2000 (SP Biologics Co., (lot number, site and side not reported) on 12 December 2011. On 12 December 2011, the same day, the subject was diagnosed with non-specific myocarditis. An ECG was reported as abnormal on 23 April 2011 (reported as diagnostic testing, noted in past medical history as prior to vaccine administration). Troponin I result, MRI of brain, MRI of spinal cord, MRI of heart, and lumbar puncture were reported as not performed. Echocardiogram results on unspecified date were reported as not available. Concomitant medications, treatments and hospitalization were not reported. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
pt recv vax around 1PM; when home took nap;woke up about 230AM neck red blotchy rash;
No additional adverse events reported; administered after improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 18-OCT-2021, the patient was vaccinated with improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) lot # U002534, expiration date 24-JUL-2022, dose of 0.5 milliliter (formulation, strength, anatomical location and route of administration were not reported) for prophylaxis. The temperature excursion was reported as 8.5 degrees Fahrenheit (F) for 18 minutes and 11.9 degrees F for 1 hour (cumulative timeframe of 1 hour and 18 minutes). It was not reported if a digital data logger was used to capture the temperatures. There was no previous temperature excursion. No further information given. No additional adverse events reported.
This spontaneous report has been received from a nurse, concerning to a multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were provided. On an unknown date, the reporter stated that multiple unspecified patients were vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. that was reconstituted with a properly stored sterile diluent. No adverse event was reported. The vaccine was stored at a temperature of 47° Fahrenheit to 77° Fahrenheit, time frame of 5 to 15 minutes, no previous temperature excursion was reported. The call was placed because of a Digital Data logger report. Product quality control was no involved. Additional information has been requested.
headache; every bone in her body hurt; painful GI cramping; freezing to death; her joints hurt; This case was reported by a consumer via call center representative and described the occurrence of headache in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 26th January 2021, less than a day after receiving Shingrix, the patient experienced headache, bone pain, gastrointestinal cramps, feeling cold and joint pain. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the bone pain, gastrointestinal cramps, feeling cold and joint pain were recovered/resolved.   It was unknown if the reporter considered the headache, bone pain, gastrointestinal cramps, feeling cold and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient reported that she received shingrix dose and had headache, was freezing to death, her joints and every bone in her body started to hurt on the evening of vaccination day. The patient reported laying on her couch for 3 days. The reporter reported painful GI cramping, which started on the evening of the same day. The reporter reported that the freezing, joint/bone pain, and gastrointestinal cramping resolved after 2 to 3 days. The reporter reported that about having no temperature or flu after taking the vaccine. The patient was unable to provide the email/fax number of her physician, her own fax number, as well as the dose, lot number or expiration date of the second shingrix dose.  The patient declined to provide her address and phone number. The reporter consented to follow up.
This spontaneous report as received from a License Practical Nurse (LPN) refers to an 18 year old patient. On 13-MAR-2014 the patient was vaccinated with an expired dose of VARIVAX (lot # H006536, exp date 09-MAR-2014) 0.5 ml dose, subcutaneous route. Concomitant therapy was not reported. No adverse events reported. Additional information has been requested.
got diagnosed with have covid on 15Apr2022; got diagnosed with have covid on 15Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 21May2021 at 19:00 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Apr2021 at 18:00 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes/ type 1 diabetic" (unspecified if ongoing), notes: Diabetes/ type 1 diabetic for 36 years; "eosiniphilesophagitas" (unspecified if ongoing), notes: eosiniphilesophagitas; "1st dose: Moderna/ 2nd dose: BNT162B2" (unspecified if ongoing), notes: 1st dose: Moderna/ 2nd dose: BNT162B2. Concomitant medication(s) included: HUMALOG; OMEPRAZOLE, start date: 10Dec2021. The following information was reported: COVID-19 (medically significant) with onset 15Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "got diagnosed with have covid on 15Apr2022". Therapeutic measures were taken as a result of covid-19.  Clinical Course: She was type 1 diabetic. She was currently using a insulin pump to adjust her blood sugar. Just got diagnosed with have covid on 15Apr2022. purchased PAXLOVID ON 16Apr2022. She took one dose, Reaction/event in terminology (LLT): She was a type 1 diabetic for 36 years. She took one dose at night and right after she took it her blood sugar started skyrocketing. She ended up taking 20 units in shot form and it dropped down to 300. She took Paxlovid at 5:00 pm it was 10:00 pm she had dosed a total of 50 units of insulin, and it has barely dropped. Is this a normal effect of Paxlovid if you have diabetes. She know some drugs like Prednisone skyrockets sugar levels and no matter how much insulin you take it will not lower because of the drug, does Paxlovid have the same effect, since she had taken this, and she had an awful taste in her mouth. Was wondering if that also was caused by Paxlovid. Treatment received for the adverse event was took large dose of insulin through syringe.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
down; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-healthcare via inbound (reference number-00481707) and transmitted to Sanofi on 18-Feb-2021.  This case involves a female patient (age unspecified) who was down (depressed mood), while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was down (depressed mood) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, for 14 weeks.  The reporter wanted to know the ingredients of the 2016 formulation of FLUZONE HD (high dose)  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  On an unknown date, the event recovered.  There will be no information available on the batch number for this case.
Patient received flu & pneumo vaccine on 10-30-07. Came to office on 10-31-07 with generalized pain whole body and fatigue which started 10-30-07 in the afternoon after getting flu/pneumo. Slight headache. Started in arms, now whole body. Positive rib pain with movement. No fever or nausea. Has had flu shot previously with no problems.
Approximately 3 days after second shot I noticed  small various sizes of circular lesions on the right hand -approximately 6 later the lesions began to increase in size and started to cause panful itching and sever skin hardening- I attempted various OTC lotions and ointments to alleviate my pain and itching to no avail - now panic and depression started and I immediately sought professional medical attention both phycological and physical attention - the condition has worsened and spread to entire body from head to toe - and as of today I am still seeking and resolution to my chronic condition- I am under the care of a dermatologist who has given me multiple diagnoses such :  Psoriasis, Eczema , contact Dermatitis and neurological  dermatitis amount
Heart Palpitations - Friday afternoon 5/21/21 about 72 hours after vaccination. Patient complained of heart palpitations after school Friday. he said he felt them after PE class. He also experienced them on Saturday, 5/22 about 96 hours post-vaccination. I didn't make the connection to his vaccine dose until his mom sent me a news report about it on 5/23.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, 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), 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 included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PROCARDIA [NIFEDIPINE]; LEXAPRO; METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HOT FLASHES; EXTREME ARM PAIN; MINOR CHILLS; FATIGUE; RAN A TEMPERATURE OF 99.8; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced hot flashes. On APR-2021, the subject experienced extreme arm pain. On APR-2021, the subject experienced minor chills. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced ran a temperature of 99.8. Laboratory data included: Body temperature (NR: not provided) 99.8 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ran a temperature of 99.8 on APR-2021, and the outcome of extreme arm pain, minor chills, hot flashes and fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210458832.
No adverse effects reported; the patient was inadvertently administered a dose of MMRII intramuscularly rather than subcutaneously; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 30-NOV-2020, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, vaccination scheme, anatomical site of injection were not reported; lot number and expiration date were unknown by the reporter) as prophylaxis, intramuscularly rather than subcutaneously (incorrect route of product administration). No adverse effects reported.
pt recv vax&was found unresponsive next am;to hosp where pt pronounced dead;
This spontaneous report was received from a nurse via a company representative, referring to an approximately 20 year-old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 08-AUG-2009, the patient was vaccinated with the first dose of GARDASIL injection (strength, dose, route, lot # and expiration date were not provided) for prevention of human papilloma virus (HPV). Subsequently, she received the the second and third doses of GARDASIL injection on 30-OCT-2009 and 20-APR-2010 (strength, dose, route, lot # and expiration date were not provided), also for prevention of HPV. On 29-NOV-2016 (also reported as "recently"), the patient tested positive for HPV. At the time of the report, the outcome of the event was not recovered. No action was applied with GARDASIL (also reported as therapy was continued; conflicting information). The causal relationship between GARDASIL and the event was, was unknown. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: R8733), in left arm, on 20Apr2021 as dose 2, single (Lot number: EU0170), in left arm and on 22Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Pre-Diabetes" (unspecified if ongoing). Concomitant medication(s) included: Levothyroxine; Liothyronine; Labetalol; Hydrochlorothiazide; Tramadol; Diclofenac; Gabapentin; Acetaminophen; Vitamin D [Colecalciferol]; Zinc. Past drug history included: Lovenox, reaction(s): "Known allergies: Lovenox". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 include COVID 19 Treatment from 22Aug2022 to 26Aug2022. Clinical information: Patient took other medication in 2 weeks. On 3rd day of treatment, symptoms markedly improved. Only symptom at end of treatment was fatigue. Remained in isolation for full 10days. 7 days post treatment felt congested. 8 days post treatment had congestion, myalgias, fatigue, loss of appetite, dry cough and headache No fever, though taking Tylenol for arthritis pain. Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
This case was reported in a literature article and described the occurrence of uveitis in a 52-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On an unspecified date the subject received 1st dose of Hepatitis B vaccine (unknown). One day after vaccination with Hepatitis B vaccine, the subject experienced uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurred because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Patient was given a Pfizer Covid Vaccine that was expired on 2/4/22.
This initial spontaneous case, was received from a pharmacist on 12-Oct-2017, concerning a male, adult patient of unspecified age. It was reported that FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine, approved for use in persons 65 years of age and older and not approved for use in adults 18-64 years of age. On 11-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, batch number, expiry date: not reported, anatomical location: deltoid). As the patient was below 65 years, considered as inappropriate age at vaccination. The patient did not experience any adverse event after administration of vaccine. The outcome of the events was not reported. The pharmacist considered the case as non-serious.
Information has been received from a registered nurse referring to a 14 year old male patient. No relevant medical history or concurrent conditions were reported. On 29-OCT-2015, at the age of 13, the patient was vaccinated with his first dose of GARDASIL (dose, route, lot# and expiration date were not reported). On 17-NOV-2016, at the age of 14, the patient was vaccinated with a dose of GARDASIL 9 (dose, route, lot# and expiration date were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt had previously received the smallpox vaccine x30 years ago in her left arm. Pt reports she is now having swelling, redness and warmth at the smallpox vaccination site and NOT the shingles vaccine injection site.
Pain from Shingrix; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had pain.
Woke up in the middle of the night with chills. Feeling feverish but no fever present. Muscle and joint pain along with severe headache and fatigue.
On 12/26/2022 I was very exhausted and weak, everything hurt. I couldn't make my bed. I had chills and wanted to sleep. I felt so weak. I took a shower and went to bed. My hair hurt, I couldn't touch my hair and my eyes were so itchy. I took a COVID-19 test and it was positive. I called my doctor immediately and she prescribed PAXLOVID after a consultation. I have been taking it now with no side effects except for the bitter taste in my mouth. My symptoms now just feel like a have a cold. I feel tired, just to make soup and a sandwich for lunch made me feel extremely tired.