chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M007764, expiration date 30-JAN-2018 (dose, anatomical location and route of administration were not specified). No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
just kind of having blackout; Severe fatigue/fatigue; Severe myalgia; Some congestion; Severe headache; Haziness; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. In Dec2020, the patient experienced just kind of having blackout, severe fatigue, severe myalgia, some congestion, severe headache and haziness. On day six, symptoms improved and suddenly he/she was having symptoms again, severe myalgia, some congestion severe headaches and fatigue. The outcome of the events was unknown.  The information about batch/lot number has been requested.; Sender's Comments: This report fails to include the basic information that is required for an independent medical evaluation. Assessment is postponed after receipt of a more complete case report. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Night of vaccine patients' states mild shaking, not associated with a fever.. Approx 30minutes after taking advil shaking ceased. Shaking also occurred with second vaccine as well
I administered an initial dose of the Pfizer vaccine to patient , 15yo who presented with his father and his brother, , on 8/28/21 @ 12:05 p.m.  Pt stood behind his father while his father was watching me about to vaccinate his brother.  There was a noise and another patient waiting around yelled, "He fainted!"  Pt's father turned around and pt had fallen from a standing position and hit his head on the floor.  I called out to Syed to call a "code white" overhead. We placed cotton balls from a shelf underneath his head, gave him an ice pack and talked to him.  He was talking and asking what happened, knew his name, where he was.  We were able to move patient to a chair with his father and a manager both standing next to him.  I gave him another ice pack and a bottle of cold water in case he was thirsty.  The patient took a sip then his head fell forward and the water fell out of his mouth.  Patient was being held by his father and a manager, he did not fall out of the chair. I called out to to call 911.  The patient was unconscious for less than a minute, very pale and not very responsive, but the decision was made to hold on to him and leave him in the chair rather than try to move him to the floor.  When the paramedics arrived, they evaluated him, and after a conversation with  and his father,  did not end up leaving with them.   asked for another bottle of water.  He continued to sit down, regained some of his color back, and after about 45 minutes, , his father and brother said they were leaving and would continue to monitor him.  We used 2 ice packs and 2 bottles of water responding to this AE.  -DRB 8/28/21  I called  parents later 8/28/21 @ 6:50 p.m.,  mother answered.  Mother said he was fine, he ate a big lunch and is playing video games.  She denies any complaints of any headache or memory loss, they think  just stood up too fast. Confirmed 2nd appointment, mother said he would return and receive the 2nd dose as scheduled.  -DRB 8/28/21 @ 6:50 p.m.
Patient complained to wife of not feeling well in evening after the vaccination and expired at home during the night.
pt in ER w/t105; seen in ER day a/w/fever & sz; felt that was febrile seizure; mom states pt had runny nose & cold type sx; PE included t104.4 & pulse 172, lymphadenopathy; neutropenia, viral synd, lymphocytosis, atypical lymphocyte;
Erythema, urticaria, along posterior aspect of rigth arm from elbow to site of innoculation.  No induration, ulceration, or other break in the skin. Treated with Keflex 250mg PO QID x 10 days
pt recvd vax & exp jerky movements then stops & resumes 15-20 mins later; exp twitching & c/o stiffness @ time; c/o pain rt shoulder;
Information has been received from a pharmacist refers to an approximately 75 years old female patient with none medical history, drug reactions or allergies. In 2009, the patient was vaccinated with first dose, 0.5 ml PNEUMOVAX23 (lot number not provided) intramuscularly, right upper arm. On 01-DEC-2012, the patient was vaccinated with 0.5 ml PNEUMOVAX23 intramuscularly, right upper arm (lot number H013394; exp: 05-MAR-2014). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed pain and a red, itchy rash at the injection site that lasted for 4 days. No treatment information was reported. The patient seeks medical attention, she called the pharmacy. Laboratory test diagnostic were not performed. The outcome of pain and a red, itchy rash at the injection site was reported as recovered. The relatedness for pain and a red, itchy rash at the injection site was unknown for PNEUMOVAX23. Additional information has been requested.
Pt felt nauseated, went extremely pale, got dizzy/lightheaded. Pt had not eaten anything the morning prior to her immunizations.
This spontaneous report was received from a physician referring to 19-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 07-JUN-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA012768:
Slurred speech; His lips were cracked; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (Slurred speech) and CHAPPED LIPS (His lips were cracked) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSARTHRIA (Slurred speech) and CHAPPED LIPS (His lips were cracked). At the time of the report, DYSARTHRIA (Slurred speech) had not resolved and CHAPPED LIPS (His lips were cracked) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) CAT scan was clear.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Two days after the 1st dose, he started having slurred speech. Initially they thought his lips were cracked due to the professional mask he wears at work but as time went on, it became noticeable.  Lab data -  The patient had 62 tests  and all came back normal  and  scheduled for a MRI.  No Concomitant were provided. No treatment Medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Updated lab data. On 10-Sep-2021: Follow up received on 13Sep2021 includes no new information On 10-Sep-2021: Follow up received on 13Sep2021 includes no new information. On 11-Sep-2021: Follow up information was received include no new information. On 16-Sep-2021: Includes no new information.
Developed sores (Ulcer) in both nostrils, mouth and lip exactly 1 week after receiving first shot.
Patient had headache, muscle aches, rash, fast heart rate, difficulty breathing (relieved with rescue inhaler), fever. Occurred several hours after vaccine administration. No reaction to previous flu vaccines.
Narrative: COVID infection following COVID vaccine series 02/11, Moderna , dose #1 03/11, Moderna , dose #2 09/29 pt cc: cough, diarrhea, fatigue, myalgias, rhinorrhea, exposure; unknown 10/01 SARS-COV-2 Variant Sequencing result: pending 10/01 COVID swab, result: detected 10/9 clinically resolved
Arm is sore; Her eye is watering; Eyelid is sowllen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore), LACRIMATION INCREASED (Her eye is watering) and SWELLING OF EYELID (Eyelid is sowllen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore), LACRIMATION INCREASED (Her eye is watering) and SWELLING OF EYELID (Eyelid is sowllen). At the time of the report, PAIN IN EXTREMITY (Arm is sore), LACRIMATION INCREASED (Her eye is watering) and SWELLING OF EYELID (Eyelid is sowllen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rash on arms both; popular and small vesicular rash; popular and small vesicular rash; This is a spontaneous report from a contactable physician. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Mar2021(at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products.  The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on 09Mar2021 (at the age of 47-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, the patient underwent PCR (nasal swab) and the result was Negative. On 04Apr2021 four days after the second vaccination, the patient experienced rash on both arms, popular and small vesicular rash. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with triamcinolone. The clinical outcome of the events rash on arms both, papular and small vesicular rash were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
begin to itch like crazy; lump on injection site; red lump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (begin to itch like crazy), INJECTION SITE MASS (lump on injection site) and INJECTION SITE ERYTHEMA (red lump at injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (oesophageal), Anxiety, Thyroid disorder and Hypertension.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (begin to itch like crazy), INJECTION SITE MASS (lump on injection site) and INJECTION SITE ERYTHEMA (red lump at injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (begin to itch like crazy), INJECTION SITE MASS (lump on injection site) and INJECTION SITE ERYTHEMA (red lump at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes blood pressure meds, thyroid med, anxiety med, acid reflux med. Treatment medication include allergy pills.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.  Injection site itching, injection site erythema and injection site mass are consistent with the product safety profile.
Information has been received from a registered nurse concerning a male in his 60's who on 04-AUG-2010 was vaccinated with the first dose of VARIVAX (Merck) (Lot # 665423/1295Y) (route no reported). The nurse reported that about 2 weeks after his first vaccination on approximately 18-AUG-2010, the patient developed a rash. The rash was described as mild and "bubbled" on his arm and leg. The nurse stated that the patient had done a yard before he developed the rash. On an unspecified date, the patient had recovered. The patient did not seek medical attention. Additional information has been requested.
Patient admitted for labor and delivery on 7/20/21, is asymptomatic for COVID-19 SxS but admission test resulted positive.  Delivered baby 7/20/2021; birth weight of newborn 3.62 kg (7 lb 15.7 oz).  >14 days post vaccination  completion.
Swollen and red area in my child's left thigh after 12 hours of injection, 3rd series - same brand. Area swollen bigger than 2 inch which has covered at least 60% of her thigh. 3rd day after injection area has worsen and tendered, contacted pediatricians and answered questions asked.  4th day swelling decreased and 5th day massive bruise occurred. It looked painful however child didn't seem to avoid using the leg and no fever noticed.
Headache, Myalgia, Arthralgia, Fever, Rash, Injection site pain, injection site swelling, Chills Narrative:
Arm swollen and warm to touch; Fever 102. Two episodes of emesis. Recommend apply cold pack to area, Tylenol as directed by manufacturer.
Patient brought this complain (to the administering pharmacist/pharmacy) for the first time today 9/25/18 at 3.05 pm stating her left arm started hurting 3 days after the vaccine was administered (8/7/18). Patient specified that her left arm has been feeling heavy, sore and inflamed thus causing her to have limited mobility (in forward and backward movements). Patient confirmed she has not seen a physician yet for this issue but has tried taking Meloxicam but stopped due to side effects.
Rash, Fever - Information has been received a registered nurse from concerning a 15 month old female patient who on 6 Jul 2000 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #633095/0254K).  On 14 Jul 2000 the patient experienced a generalized rash and a fever of 39.8 celsius.  unspecified medical attention was sought.  On 16 Jul 2000 the patient recovered.  Addition information has been requested.
Admission Date: 7/17/2022 Discharge Date: Jul 22, 2022  PRESENTING PROBLEM: Elevated troponin [R77.8] COVID-19 [U07.1] Takotsubo cardiomyopathy [I51.81]   HOSPITAL COURSE: Patient is a 78 y.o. male with past medical history significant for hypertension, hyperlipidemia, type 2 diabetes mellitus, GERD who is admitted for COVID 19, elevated troponins, fluid overload. General medicine is consulted for acute hypoxia, concern for CAP. At 2030 7/18 pt was noted to be tachypneic with RR 36 and required increased O2 needs, satting 90% on 4L. Patient was given IV Lasix 40mg to treat flash pulmonary edema. Patient has a new wet-sounding cough. Had fever of 37.8 yesterday evening that resolved with acetaminophen. New focal consolidation appreciated on CXR. WBC 11.6 -> 9.5 -> 14.5. He has also noted to have worsening mental status throughout admission, at times requiring prn haldol.    Initially the patient was admitted under Cardiology and had 2 elevated troponin patient was taken for left heart catheterization cardiomyopathy that was nonobstructive.  Patient was started on ceftriaxone and doxycycline for treatment of community-acquired pneumonia.  In addition he was receiving Lasix.  Patient respiratory status improved and he was off of oxygen.   The patient had delirium psych was consulted for medication adjustments and patient has slept well, the next day the patient was awake alert oriented and felt much better.   Cardiology was knee imaging patient's medications for the cardiomyopathy.  He was initially started on Eliquis for the paroxysmal atrial fibrillation and he will follow-up within at least 3 weeks.  The patient was discharged on beta blockers, losartan, Lasix, and he will be started on spironolactone and SGLT2 outpatient.   During his stay the patient was found to be hypernatremic that improved after diuretics.  Patient hydrochlorothiazide was discontinued given that it could cause hyponatremia.   PT/OT did evaluate the patient and initially had recommended subacute rehab however the patient was adamant about going home therefore he was sent home with a walker and advised a 24 hours supervision by his spouse and/daughter.  Additionally home health care is being scheduled for him.  The patient was instructed to follow up with primary care doctor within few days and to follow up with Cardiology within 3 weeks.  The patient was discharged home in a stable condition.
Arthritic attacks in both hands, wrists,right elbow and left shoulder; gout; This is a spontaneous report from a contactable consumer. This 62-year-old male consumer (patient) reported for himself. A 62-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 13Apr2021 at 13:00 (at the age of 62-year-old) as a single dose for covid-19 immunisation. Medical history included coronary stents (2010) and gout flares (none in the past five years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks of vaccination (unspecified medications). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had no known allergies. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 23Mar2021 at 12:30 (at the age of 62-year-old) as a single dose for covid-19 immunisation. On 15Apr2021, patient experienced Arthritic attacks in both hands, wrists, right elbow and left shoulder and gout on an unspecified date in 2021. The attacks would migrate from place to place. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of arthritis and gout included treatment with steroids. At the time of this report, the outcome of event arthritis was recovering, and gout was unknown.  No follow-up attempts are needed. No further information is expected.
4DEC92 mom came to clinic; mom had taken pt to hosp ER 3DEC92 because of reaction to vax; large bump around area of inject; 9DEC92 area sl red;
This spontaneous report was received from a register nurse referring to an unspecified number of patients of unknown age and gender, whom concurrent condition and medical history were not provided. On an unknown dates in 2015, reported as since 02-NOV-2015, an unspecified number of patients were vaccinated with GARDASIL lot # K010215, expiration date 05-MAY-2017, oral (Dose, concentration and dose number were not provided) exposed to temperatures outside of the recommended range, concomitant therapies were reported. No adverse experience was reported. This is one of two reports received from the same source. Additional information has been requested.
48 hours after getting the booster, my heart rate has been fluctuating as low as 46 and as high as 130. For the most part it?s been between 50-105.
migraine; throwing up in the middle of the night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "migraine"; VOMITING (non-serious), outcome "unknown", described as "throwing up in the middle of the night".  Additional information: Patient want to check if she needs to quarantine herself after the 2nd dose. She got the 1st dose last 10Apr2021 and 2nd dose was on 06May2021. She experienced Migraine and headache in between doses and throwing up in the middle of the night that's why she wasn't able to go to the 2nd dose scheduled for 01May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 46 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin, amoxicillin. Concomitant medication(s) included: LISINOPRIL; LEXAPRO; PANTOPRAZOL [PANTOPRAZOLE]; METOPROLOL; LORAZEPAM. Past drug history included: Known allergies: amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: known allergies: Penicillin, amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: patient had known allergies of Penicillin, amoxicillin.
redness & 2-2 1/2 cm raised area just below site (redness surrounding) of MMR; no other sx devel; p/1 hr area had completely faded; 27SEp93 contacted mom-no further problem;