chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 18Apr2021 at 11:00 as dose 1, single (Lot number: EW0164), in right arm and on 08May2021 at 11:00 as dose 2, single (Lot number: EW0176) at the age of 36 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2022 at 11:00 as dose 3 (booster), single (Lot number: 022J121A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Grave's disease" (unspecified if ongoing); "Allergic to morphine" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE, start date: 01Jan2017. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Jan2022 at 11:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 08Sep2023 to 13Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300307986 same patient, different drug/event;
3/26/2021 patient noticed large area of redness on right arm, grew to neck area over 24 hours; area of redness receded each day until 7 days after vaccination when symptoms resolved; injection site felt warm with knot, but not on arm or neck area where redness continued
Case number PHEH2013US024968, is an initial spontaneous report received from a physician on 25 NOV 2013 with the follow-up received on 07 JAN 2014. This report refers to a 56-year-old poly medicated female patient. Her medical history included dyslipidemia, arthritis, back pain, allergic rhinitis, insomnia, chronic obstructive pulmonary disease, hypothyroidism, hepatitis C, anxiety, hypertension, coronary artery disease, gastroesophageal reflux disease, gout, congestive heart failure, migraine headache, cardiac catheterization, hysterectomy, back surgery, alcohol use and tobacco use disorder. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309801, expiry date: MAY 2014) inadvertently one dose from opened and unopened MDV's that were stored below the recommended mentioned temperature, at dose of 0.5 ml intramuscularly into right deltoid on 21 NOV 2013 at 11:36. The reporter stated that, the vaccine was not frozen upon administration and was unsure if the vaccine had frozen during the temperature excursion. It was reported that, FLUVIRIN was opened and unopened MDV's reached 32 Fahrenheit (F) for 6  hours on 14  NOV 2013 and 16 NOV 2013. On 17 NOV 2013, it reached for 31 F for 6 hours. No more information was available.   Follow up received from physician on 07 JAN 2014: Updated patient demographics, medical history, concomitant medications and site and time of vaccine administration.
she started with swelling of lips; Since last 2 weeks, she started with soreness of body; complaining about shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Since last 2 weeks, she started with soreness of body), DYSPNOEA (complaining about shortness of breath) and LIP SWELLING (she started with swelling of lips) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included APIXABAN (ELIQUIS), DIGOXIN, ISOSORBIDE, LOSARTAN, MAGNESIUM OXIDE, METOPROLOL and SPIRONOLACTONE for an unknown indication.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN (Since last 2 weeks, she started with soreness of body) and DYSPNOEA (complaining about shortness of breath). On 19-Apr-2021, the patient experienced LIP SWELLING (she started with swelling of lips). At the time of the report, PAIN (Since last 2 weeks, she started with soreness of body), DYSPNOEA (complaining about shortness of breath) and LIP SWELLING (she started with swelling of lips) outcome was unknown.            Treatment for the event included Tramadol   This case was linked to US-MODERNATX, INC.-MOD-2021-080250 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080250:1st dose
Patient told us that his throat felt like tightening. Developed lactose intolerance. Urinated a lot. Back pain. Tiredness that lasted for weeks. Stool color changed. It felt like heat in the body for about a week. Felt weaker, without strength. When the vaccine was administered to him, he became dizzy and blurred vision.
Myalgia, Arthralgia, Fever,  swelling at injection site,chills,fatigue,lymph node under left armpit swollen. Told to see primary care physician if no  improvement Narrative:
This 37-year-reveived received his second dose of Covid-19 vaccine on June 11, 2021. On June 12, 2021 the patient complained of pain related to the Covid-19 vaccine, the patient was then treated with acetaminophen 650 mg which was effective in relieving his pain.   On June 17, 2021 I spoke with the patient health care provider who stated that the patient did not complain of pain related to the Covid-19 vaccine.
Developed a few spots, which became "pimple like" and itchy.  Diagnosed with chicken pox, approx. 32 pox to abdomen.
sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): RA4593476 .  A 57-year-old female patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57  for covid-19 immunization. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Fever" (ongoing); "Urinary tract infection" (ongoing). Concomitant medication(s) included: FLUOXETINE; OCREVUS; CALCIUM; VITAMIN D 2000; LIPITOR; EVISTA; MELATONIN; CRANBERRY; AMINOPYRIDINE; BACLOFEN. The following information was reported: ILLNESS (non-serious) with onset 02Dec2021, outcome "recovered", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day of vaccine (1-20-21)there was significant discomfort at the injection site, 1-325mg of acetaminophen taken prior to bed, resolved by next morning. Slept poorly that night(1-20-21) and woke up at 0630 on 1-21-21 with a headache and nausea. I took 2-325mg acetaminophen at ~0640, which helped with the headache, fully resolved by ~0900.  Nausea did result in 1 episode of vomiting at ~0705. Fatigue was present throughout the day 1-21-21. Woke up on 1-22-21 and all events were resolved.
CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This solicited report received from a health care professional concerned an adult of unspecified sex. The patient was enrolled in a non-company sponsored study. This report was also received from literature. The objective of the study was to do a retrospective, single-centre study, involving 254 patients vaccinated against COVID-19 infection, out of which five patients (4 women and one man) aged 31-62 years were described, who developed COVID-19 infection due to reduced humoral immunity to SARSCoV-2 following interaction between tozinameran, Ad26.COV2-S or elasomeran for immunisation against COVID-19 infection and ocrelizumab, rituximab or teriflunomide for multiple sclerosis. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis and started receiving disease modifying therapies (DMTs), including teriflunomide or ocrelizumab or rituximab. Out of five patients, one patient had received covid-19 vaccine ad26.cov2.s for immunisation against covid-19 infection. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, after 3 to 7 months post-immunisation, all patients (including the patient) experienced covid-19 infection (suspected covid-19 infection) with World Health Organization (WHO) covid severity of grade 1-4 due to reduced humoral immunity to SARSCoV-2. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test SARSCoV-2 spike antibody level in all patients was less than 20 µg/dL after immunization, with 4 out of 5 patients had spike level below the threshold of detection which led to confirmed immunological vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and confirmed immunological vaccination failure was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and confirmed immunological vaccination failure, and suspected covid-19 infection was not related. The author concluded that reduced humoral immunity to SARS-CoV-2 after vaccination in patients with multiple sclerosis (MS) on some disease modifying therapies (DMTs) are at increased risk of severe Coronavirus Disease 19 (COVID-19) and death. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230462641-confirmed immunological vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
PATIENT'S WIFE STATED THAT HE HAD SYMPTOMS SIMILAR TO COVID AND WAS ADMITTED INTO THE HOSPITAL.
Burning and radiating pain in my extremities. Most severely felt radiating from my butt and down through my legs and eventually into my toes and resulting in severe muscular weakness.  I started to feel it within 24 hours of the vaccine but it peaked at 48 hours. It?s better but not gone.
Approximately two days after receiving FLUZONE HD and PREVNAR 13 in the same arm the patient has throbbing, redness and pain. This occurred in the left arm. Slight itching.
inconsolable crying, fever, stopped talking & cooing for quite some time p/vax (approx 3wk);vomited in sleep;
Diarrhea; sick; had no energy; Feeling down; loss appetite; when he eats only eats very little; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207), via an unspecified route of administration in left arm on 14Apr2021 (at the age of 66 years old) as single for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (COPD) he was diagnosed several years ago; ongoing high blood pressure and he was diagnosed 10 years ago. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN69198), via an unspecified route of administration in left arm on 23Mar2021 (at the age of 66 years old) for covid-19 immunisation. Concomitant Medications included he takes breathing treatments. No further details provided. He stated that he had both shots in April. He had the first one the first week of April and one the last week of April. He further clarified that first shot 23Mar2021 and second shot 14Apr2021. He stated that since he got it he had no energy, sick, feeling down and out, loss of appetite, and when he eats that he eats very little on 26Apr2021. Wanted to know what was recommended. He stated that it feels like he has the stomach flu. He also experienced diarrhea on 12May2021. He clarified that it was for the Pfizer Covid shot. Wanted to if many people have called with side effects. Wanted to know if he should make an appointment with his doctor. The patient did not received treatment due to the events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a caller concerning a patient who on an unknown date was vaccinated with a dose of ZOSTAVAX (Merck). On an unspecified date the patient experienced shingles after receiving ZOSTAVAX (Merck). It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. No further information is available.
interrupted vaccine schedule/ the patient received her first 2 doses of GARDASIL quadrivalent on unspecified dates, 4 months apart, when she was 12 years of age; no adverse symptoms; This spontaneous report was received from a pharmacy intern and refers to a currently 23-year-old female patient. Her concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On an unknown dates (reported as when she was 12 years of age), the patient was vaccinated with two doses quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), injection (strength, route of administration, lot number and expiry date were not reported) for prophylaxis. This two doses of vaccine were administered 4 months apart. Currently, the patient would like to complete the vaccine series with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No adverse symptoms were reported.
Patient doesn't think vaccine was injected into muscle. Had a welt and some tissue sloughing that took about 3 weeks to resolve. Applied warm compresses to injection site.
Approximately 6 hours after receiving the vaccine, I got a fever and body aches. This lasted for approximately 24 hours. I am pregnant and my due date is 9/25/21.
Chest pain, shortness of breath, fatigue, moody, headache, dry mouth, no appetite, eyes bother me, and  tired all the time
Within 5 minutes, patient was sweating, flushed, and stated that he was about to faint. Patient fainted and was unable to respond to verbal or motor commands. Patient had rapid, shallow breathing. Patient's hands/arms were twitching very slightly. Patient was moved onto the floor and rolled onto his side after he started to gag like he would vomit. Once on the floor, patient regained consciousness within 1-2 minutes and was able to sit up after another 5 minutes. Paramedics arrived and examined him. He left under his own power.
Patient presented with swelling, redness, and difficult breathing starting the morning of 11 OCT 21. Patient was treated with pepcid and solumedrol administered intravenously.
Pt w/otitis media at time of immunization, vaccinated with DTP developed fever of 105, inflammation of joints & slept for 13 hrs - unable to rouse.
Soreness in arm at injection site.; This is a spontaneous report from a contactable consumer. A 19-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 28Mar2021 at 17:00 the patient experienced soreness in arm at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The clinical outcome of the event vaccination site pain was recovering at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient complained of leg pain and swellin on the 14th of April and was admitted to Hospital on the 16th of April due to pain increasing in severity and affecting ability to ambulate. She later spiked a temp of 100.9. Left forefoot erythematous and warm to touch with large bulla over fourth metatarsal extending to webspace between 4th and 5th toes. Patient is currently in ICU, Intubated and unresponsive.
Metallic taste in her mouth.  Violent shaking for 11.5 hours and pulled muscles in her stomach and back.  Injection site hot.  Fingers on that side were white  Dizziness.  H/A.  Vomiting
Pt came in on 11/3/09 for cough. Was found to be eligible for H1N1 nasal vaccine. Pt was given vaccine on 11/3/09. On 11/6/09 pt returned to office c/o numbness/tingling in teeth, feet and hands. Pt stated these where sx he experienced prior to getting the H1N1 vaccine but did not state he had them on the day of receiving the vaccine. Pt currently in Rehab Center.
Patient received Flublok and Shingrix vaccines on 11/16/2021. Patient was seeking the second dose of Shingrix and Flublok vaccine was also marked atop the vaccine form. Following the dose, it was discovered that the patient previously received the Flublok vaccine on 09/04/2021. Patient was alerted of the duplication.
Initial information received on 01-Mar-2019 regarding an unsolicited valid serious case received from a consumer. This case is linked to case 2019SA060500 (same reported, patient's brother). This case involves a 36 months old male patient who experienced autism, while he received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a serious autism (autism spectrum disorder) and  developmental regression unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant. (Other relevant tests included no lab data.) Final diagnosis was autism. It was not reported if the patient received a corrective treatment. The patient was not reported for developmental regression and for autism. According to reporter her children were normal and then started to regress. According to reporter adverse event is related to vaccine. List of documents held by sender- none.; Sender's Comments: This case concerns a child patient who presented with autism and developmental regression following vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer. The time to onset is unknown. Moreover, birth history, medical condition at the time of vaccination and lab tests ruling out alternate etiologies, particularly neurological, were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.
Rash, probably herpes zooster 2 days post Hep B. Questionalbe folluculitis.
got Covid after 4 Pfizer Covid vaccines; got Covid after 4 Pfizer Covid vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; ATORVASTATIN; EZETIMIBE taken for blood cholesterol abnormal; MONTELUKAST; MUCINEX; SYNTHROID; VITAMINS NOS. Patient also reported that she was taking another blood pressure medication but doesn't know name for it.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid after 4 Pfizer Covid vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: got Covid. It was further reported that in May, patient had her 2nd booster and 2 weeks later flew to (City name) and they (patient and her husband) both got Covid. Hers was a home test.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient received Fluzone HD. waited for wife in pharmacy and was feeling fine. However about 15 minutes after they left patient felt light headed and passed out. Patient is doing well and following up w/cardiologist.
non therapy-responder; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 57-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, less than a year after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine.  Additional information received were as follows: The age at vaccination was not reported. The healthcare professional reported that the patient received the 3 dose series of Hepatitis B vaccine this past year. The doctor said that the patient had no antibodies against Hepatitis B vaccine, which led the patient to be therapy non-responder. The reporter consented to follow up.      Lab Comments: Lab test done on an unknown date
Abdominal discomfort ( 4 hrs p/1st dose) & about 2 hrs p/each one; Has taken 3 doses already;
tingling in the hands; burning metallic taste in his mouth; burning metallic taste in his mouth; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 42-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   Concomitant products included ibuprofen (Motrin).   On 7th May 2021, the patient received the 1st dose of Engerix B adult (intramuscular). In May 2021, less than a week after receiving Engerix B adult, the patient experienced tingling of extremity, taste metallic and burning oral sensation. On an unknown date, the outcome of the tingling of extremity, taste metallic and burning oral sensation were not recovered/not resolved.   It was unknown if the reporter considered the tingling of extremity, taste metallic and burning oral sensation to be related to Engerix B adult.  Additional details were provided as follows: The patient received 1st dose of Engerix B vaccine and started feeling a burning metallic taste in his mouth and tingling in his hands. The reporter gave medical disclaimer and referred to healthcare professional. The reporter consented to follow up.