chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experiencing passing a ton of clots; I washed my face, it got extremely red; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) at the age of 20-year-old, via an unspecified route of administration, administered in the left arm on 19Jan2021 13:00 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included lupus and idiopathic thrombocytopenic purpura (ITP). Concomitant medications included mycophenolate mofetil (CELLCEPT), esomeprazole magnesium (NEXIUM), medroxyprogesterone acetate (DEPOPROVERA), and propranolol; all taken for an unspecified indication, start and stop date were not reported. The patient has known allergies to rituximab and amoxicillin. As a woman, the patient was having a lot of blood clots being passed. The patient doesn't get a period because of depo, but for some reason, she was experiencing passing a ton of clots on an unspecified date. Also, after the first dose, when she washed her face, it got extremely red on an unspecified date in 2021 (She did the same in the days before and that didn't happen). The patient underwent lab tests and procedures which included Covid test: negative on an unspecified date. The outcome of the events was unknown. No treatment was received for the events. The patient received the second dose of BNT162B2 on 11Feb2021 for COVID-19 immunisation administered at the left arm.  Information on the lot/batch number has been requested.
Redness, swelling, itching, heat at and around injection site.  Took diphenhydramine and swelling resolved somewhat as of 10/17/2013.
Headache, achy muscles and joints, like mild flu and fever 100.4 first night and next day low grade fever 99.2 and achy muscles and mild fatigue . By 8pm fatigue and mild headache and no fever.
severe joint pain; terrible headache; she was sick all night; This is a spontaneous report from a contactable consumer (patient's husband) via Medical Information Team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 (lot number and expiry date: unknown) dose 2, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Covid-19 immunisation. On 18Mar2021, the patient was sick all night and this morning (19Mar2021). On the same day (19Mar2021) the patient also experienced severe joint pain and terrible headache. The patient's husband wanted to know how long these side effects are supposed to last. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning "a couple of young ladies" (age unknown) who, on unspecified dates, were vaccinated with doses of GARDASIL vaccine (yeast). Subsequently, on unspecified dates, the patients experienced pelvic pain. At the time of this report, the patients' outcomes were unknown. No further information is available as the physician declined to be further involved in the reporting process.
fever; chills; fatigue; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A male patient of an unspecified age (reported as age: 65, unit: unknown) received BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had fever, chills and fatigue, on an unspecified date, the day after the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Headache, Malaise, Cough, Sore Throat, Chills, Diarrhea, Fever
I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.; I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) and IDIOPATHIC INTRACRANIAL HYPERTENSION (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) (seriousness criterion medically significant) and IDIOPATHIC INTRACRANIAL HYPERTENSION (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) and IDIOPATHIC INTRACRANIAL HYPERTENSION (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. Palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine. So, what are you going to do about it, diagnosis and documented. No treatment medication was provided by reporter.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) events of Arrhythmia (AESI) and Idiopathic intracranial hypertension, which occurred on an unknown date after mRNA-1273.222 vaccine, administered as a booster dose within COVID-19 vaccination schedule. Papilledema was also reported. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Was informed by local Medical Examiner that on 04/10/2021, 4 days after receiving second Covid-19 vaccine, that the pt slipped on a rug and hit her chin very hard and that she died. The family informed Medical Examiner that she was not feeling very well after receiving her vaccine and felt more fatigued than usual. Family raised concerned that the cause of her fall was due to vaccination. Medical Examiner ruled cause of death as a closed-head injury or cardiac arrhythmia, with significant other conditions at time of death being "mild symptoms following covid-19 vaccination"
the 1st one she had a little headache, the 2nd one it got worse, but the 3rd one was the worst (Lot#: EN6204).; all her joints have gotten swollen; doesn't have energy.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EN6204) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "1st one she had a little headache"; Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "the 1st one she had a little headache, the 2nd one it got worse".  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "the 1st one she had a little headache, the 2nd one it got worse, but the 3rd one was the worst (Lot#: EN6204)."; JOINT SWELLING (non-serious), outcome "unknown", described as "all her joints have gotten swollen"; ASTHENIA (non-serious), outcome "unknown", described as "doesn't have energy.".  Additional Information: Caller was told by her doctor to call us, and wanted to report that she got 3 Pfizer covid vaccines, the 1st one she had a little headache, the 2nd one it got worse, but the 3rd one was the worst (Lot#: EN6204). Caller says that all her joints have gotten swollen even though she doesn't have rheumatoid arhtritis and that she doesn't have energy.
pt recvd vax 15JUN95 & subsequently devel a generalized rash on 19JUN95;No further details were provided;
The Monocytes were slightly elevated at 13.2; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK-1931), via an unspecified route of administration in the left arm on 12Jan2021 10:30 at a single dose for COVID-19 immunization. There were no medical history. The patient have no known allergies to medications, food, or other products. Concomitant medication included omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient had a blood test on 14Jan2021 10:30 and the monocytes were slightly elevated at 13.2. The last blood test in Aug2020 showed the monocytes was 7. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. Outcome of the event was unknown.
Almost immediately had increased high level ringing in both ears. Has gotten worse in past three days. It is constant.
A report was received from a consumer on 06Jan04 concerning a 51 year old male vaccinee who experienced a severe headache approx 2 hours following vaccination, shortness of breath, heaviness in his chest and tightening of his throat approx 5 to 6 hours following administration of Fluvirin vaccine on an unspecified day in December 2003. On an unspecified day in Dec 2003 the vaccinee was administered Fluvirin and approx 2 hours later, the vaccinee experienced a severe headache and approx 5 to 6 hours later, the vaccinee experienced shortness of breath, heaviness in his chest and tightening of his throat. The vaccinee attended the ER and was treated with nitroglycerin and his pain subsequently resolved. The vaccinee stated that his BCG and blood tests were within normal limits. The attending physician did not provide a diagnosis for the vaccinees symptoms. The outcome was not reported. The vaccinee was also evaluated by his primary care physician who stated that she did not think the pt's symptoms were related to the vaccine. Follow up pending.
Fever up to 101.8F X 24-36 hours with inconsolable crying X 3 hours.
Pt complained of itching, erythema around injection area for 24 hours post 6th dose. No systemic symptoms.
My husband and took patient into her first month check-up on 4/30/18 and was going to get the second shot for Hepatitis B, the first dose was administered at the hospital at the time of her birth. During the appointment we discussed several different times that she was supposed to be getting the second shot in the series for Hepatitis B. When the nurse brought the shot in the room there was another nurse with her, whom she announced was being trained. After nurse gave her the shot we were told we could get her dressed and go. However, once we got ready to leave Dr. asked us to come back into the room where they told us that she was given Hepatitis A vaccine HAVRIX 720 ECU/0.5 mL. We are very concerned that this vaccine for Hep A was administered negligently and what possible harmful effects it may have on our daughter as it is recommended at 12 months but she was given it at one month. Upon apologizing for the error, we left feeling not very reassured that our daughter's safety was the main focus but rather the mistake was downplayed. It is impossible to find information on this scenario because it seems it has not occurred to anyone else. We called the CDC and the State Health Department and did not get satisfactory assurance that the critical error was safe. We are frustrated and would like to report this mistake as legal action may be taken if necessary. At this time, twelve hours later, there seem to be no adverse side effects but we are closely monitoring her. The frustration is that we did not agree to or give permission for the Hepatitis A vaccine nor were we asked if we wished to proceed with this nor were we given materials on the manufacturer who makes the vaccine.
patient lied about not receiving covid vaccine in January. They lied on the paper work and verbally. We gave them a 3rd covid vaccine because they lied about not receiving any. I only found out after running medicare
Patient passed out within minutes of receiving Pfizer Covid booster and flu immunization. Patient became nauseous and light headed and then started to shake. She quickly became unconscious and was lowered to the ground without incident. Patient regained consciousness within 30 seconds. Patient's feet were elevated and she remained in a lying position until nausea and lightheadedness subsided. Patient was offered lemonade once she sat up. She was monitored in the store for 45 minutes and fully recovered. Patient denied the need to call 911. Patient has a history of fainting and did so with her 1st COVID vaccine as well.
At 24 hours after injection, patient experienced red erythema to legs, hands and face.  pain around mouth.  fingertips became sensitive and red.  Self treated with oral Benadryl, one dose.   Patient was seen at local clinic and treated with Prednisone (10 day treatment).
coughing; Redness of the injection site; chills; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), VACCINATION SITE ERYTHEMA (Redness of the injection site), CHILLS (chills) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing), VACCINATION SITE ERYTHEMA (Redness of the injection site), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, COUGH (coughing), VACCINATION SITE ERYTHEMA (Redness of the injection site), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            No concomitant medication details were provided. No treatment information was mentioned.
onset of blood spotted stool on 8/4/99, mucous stool;no other sx;q
Dizziness; Felt miserable; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FEELING ABNORMAL (Felt miserable), PYREXIA (Fever) and CHILLS (Chills) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Dizziness), FEELING ABNORMAL (Felt miserable), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), FEELING ABNORMAL (Felt miserable), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.   Reporter did not allow further contact
Information has been received from a pharmacist concerning a 36 year old female employee at her hospital with allergic to penicillin, sulfa drugs, fluoroquinolone antibiotics and macrolide antibiotics who on 04-AUG-2009 was vaccinated with a dose of MMR II.  "About 3 days after receiving MMR II on approximately 07-AUG-2009, the patient developed fatigue, achiness and a fever with a temperature of less than 100 degrees F.. The employee was also "now" on 25-AUG-2009 experiencing nausea along with the fatigue and achiness.  On 20-AUG-2009 the employee experienced a fever with a temperature of 102.7 degrees F.  Complete blood count (CBC) was performed showing elevated white blood cells.  The employee sought medical attention by phone call.  At the time of report, the employee had not recovered.  Additional information has been requested.
Information has been received from a nurse practitioner concerning a 16 year old female with no pertinent medical history and no drug reactions or allergies, who on 11-OCT-2006 was vaccinated with the first dose of GARDASIL 0.5 mL IM. On 05-APR-2007, the patient was vaccinated with second dose of GARDASIL 0.5 mL IM. On 08-JUN-2007, the patient received the third dose of GARDASIL 0.5 mL IM. On 23-JUL-2008, the patient received a fourth dose of GARDASIL (lot # 658558/1061U) 0.5 mL IM. Concomitant therapy included DEPO-PROVERA on 23-JUL-2008. Two weeks ago (approximately 29-JUL-2008), the patient developed the following symptoms: fainting, dizziness, nausea and vomiting. The patient sought medical attention and was seen by the nurse practitioner. No labs diagnostics studies were performed. At time of reporting, the patient had not recovered. Additional information has been requested.
injection sites are pretty sore with good size lumps; injection sites are pretty sore, hot and red; injection sites are pretty sore; injection sites red; injection sites hot; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-hcp (Healthcare Professional) via Medical Information (Reference number- 00742744) and transmitted to Sanofi on 26-Aug-2021.  This case involves an 11 years old female patient who experienced "injection sites are pretty sore with good size lumps" (vaccination site mass) and "injection sites are pretty sore, hot and red" (vaccination site inflammation, vaccination site erythema, vaccination site pain and vaccination site warmth) after receiving vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 24-Aug-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6951AA and expiry date: 06-Jun-2022) via unknown route in the right deltoid for prophylactic vaccination.  On 24-Aug-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6964AA and expiry date: 19-Feb-2023) via unknown route in the left deltoid for prophylactic vaccination.  On 24-AUG-2021 the patient developed a non-serious events "injection sites are pretty sore with good size lumps" (vaccination site mass) and "injection sites are pretty sore, hot and red" (vaccination site inflammation, vaccination site pain, vaccination site erythema and vaccination site warmth), on same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "Caller states she has received allergy shots that were a lot worse but didn't mention any names."  Laboratory data was not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the reported events.
headache; sore arm at injection site; Generalized body aches/soreness; hot flashes; chills (but no fever); feeling tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 13:45 (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: Celiac (gluten allergy)" (unspecified if ongoing); "Known allergies: Celiac (gluten allergy)" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION. Vaccination history included: Bnt162b2 (Dose 1, Administration time=10:00 AM, Vaccine location= Right arm.), administration date: 11Feb2021, when the patient was 35 years old, for COVID-19 immunisation, reaction(s): "sore arm", "headache overnight". The following information was reported: HEADACHE (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "sore arm at injection site"; PAIN (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "Generalized body aches/soreness"; HOT FLUSH (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "hot flashes"; CHILLS (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "chills (but no fever)"; FATIGUE (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "feeling tired". Therapeutic measures were not taken as a result of headache, vaccination site pain, pain, hot flush, chills, fatigue. Additional information: The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt sat in waiting room area after vaccination. minute later, pt passed out in chair. did not fall. came to right away, but vision was still black/hazy for minutes to follow. became clammy and hot. reported heart racing and felt like throat was closing,but breathing remained normal. gave waterto pt, and ice pack. pt color and breathing became normal before EMS arrived on scene. pt went home with mom. Reported that she had not eaten anything prior
pt became pale, fainted & voided during this episode;tx w/ammonia inhalant & 02 via mask;referral to neuro;
Pt. developed local site reaction on right arm where injection was administered. Pt. received KEFLEX for reaction.
Initially just a sore arm, but a week after vaccination itching began at injection site with large oval reddish ring at injection site, lasting 48 hours so far and continuing. Mild discomfort and does not appear to be a dangerous reaction.
Fever (104), vomiting, swelling and redness around injection site.  She went to Emergency Dept during early AM hours, had ketonuria, treated with IV fluids, and prescribed clindamycin for possible cellulitis.  She continues with ongoing fevers until 6/17/12, with fluctuating redness/swelling of injection site - that was still gradually decreasing on 6/18/12 when I last saw her.  Ketonuria resolved on 6/14/12, blood glucose control acheived on 6/17/12.
Morning post vax, pt woke crying - bones, chest cavity, back hurt. No local rxn. Temp not checked.