chrisvoncsefalvay/vaers-outcomes huggingface dataset:
yesterday at midnight, he threw up; This is a spontaneous report received from a contactable male consumer (patient) to a Pfizer sponsored program.   A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: UNKNOWN Expiration date: UNKNOWN), via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of Mar2021, the patient experienced vomiting. The caller said that he and his wife received the 1st dose yesterday (24Mar2021) at noon, but yesterday at midnight, he threw up. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Feeling ill; Dizzy; nauseous; fatigued; Taste and smell off; Taste and smell off; Feel loopy and drugged; Feel loopy and drugged; This is a spontaneous report received from a contactable consumer (patient) reported herself. A 38-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration at left arm on 07Apr2021 12:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. Patient relevant medical history None. Patient do not have any allergic to medications, food or other products. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination,patient was the patient diagnosed with COVID-19. It was none patient received any other medications the patient received within 2 weeks of vaccination. Patient did not diagnose with COVID-19 prior to vaccination and since the vaccination the patient has not been tested for COVID-19. The patient experienced feeling ill, dizzy, nauseous, fatigued, taste and smell off, feel loopy and drugged on 07Apr2021 12:30. Patient did not receive any treatment for the events. Since the vaccination, patient has the patient been tested for COVID-19Outcome of events was not resolved.   No follow-up attempts are needed. No further information is expected.
Information has been received from a health professional concerning a white female who on 27-AUG-1997 was vaccinated with a dose of Varivax (Lot # 623130/0568E). Subsequently, the patient developed a generalized rash of 50-200 lesions. It was unknown if a fever or cough were present. The patient was not hospitalized. This was MD documented/evaluated. Vaccine failure was noted. Follow-up information indicated that no further information was available. No additional information is expected.
Large red spots w/white centers over entire body approx one hour p/immun given; Taken to ER & was dx as allergic rxn & given DPH IM & rx of DPH PO;
the patient was administered an improperly stored dose of ROTATEQ on 5/22/2020; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 22-MAY-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660704, expiration date 20-MAR-2021 (exact dose, dose number, dose site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes on an unknown date. There was no previous temperature excursion. Digital Data Logger was involved.
ABDOMINAL PAIN; HEADACHE; FEVER; CHILLS; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 115 pounds, and height was 64 inches. The patient's concurrent conditions included non-smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. 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 12-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 chills. On APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and fever on APR-2021, and had not recovered from abdominal pain. This report was non-serious.
Severe Insomnia- it has been 4 sleepless nights at the time of reporting.
Swelling and itching of both ears, macular papular rash on face, hands, arms, chest.
"Chest area felt tight", stomach upset, slight nausea, felt hot but did not check temp, no vomiting, no diarrhea. Had bowel movement (does not normally have one at night). Had gone out to dinner that night, "probably ate too much" and had 2 glasses of wine. No SOB, symptoms lasted until 4:30 AM. Feeling better (called 10/11/2018). Advised calling MD to report symptoms and advised calling 911 in future for chest tightness.
Arm (upper) was red and warm. It looked like a reaction. Painful (rt) arm.
he had a bad accident; he had a bad injury; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program COVAX US Support. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 23Mar2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was trying to reschedule his second COVID-19 Vaccine dose that was due on 13Apr2021 because he was in a bad accident and still in the hospital. He can't take the second dose today because he had a bad injury, he wants to know how to reschedule his second dose. The patient reported he had his first COVID-19 Vaccine shot 3 weeks ago, and he was supposed to get his second COVID-19 Vaccine shot today. The patient was hospitalized for he had a bad accident (accident) from an unknown date to 13Apr2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
0845 received injection  0900 started to have palpitations and feeling of ?jittery? BP 132/88, HR 98, RR 14 0912 states feeling better. BP 126/82, HR 88, RR 12 0915 palpitations resolves, states feeling ?normal?. Patient left clinic. Instructed S/S to report or seek medical attention.
Pt w/tenderness & swelling 10 days p/inject @ site of inject;
UNABLE TO WALK/COULDN'T WALK/CAN'T MOVE TOES OR LEGS; FELL DOWN; INFECTION; This spontaneous report received from a patient concerned a 64 year old male of an unspecified race and ethnic origin. The patient's weight was 310 pounds and height was 73 inches. The patient's concurrent conditions were diabetic, hypertension, depression, and painful right knee. He was regularly taking pain medications and anti-hypertensive medications. He had emergency visit for painful right knee. He stated that he was in need of knee replacement. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1803018, expiry: unknown) dose was not reported, with frequency 1 total administered in left arm on 25-MAR-2021 for prophylactic vaccination when he visited emergency room for painful right knee. No concomitant medications were reported.  On 26-MAR-2021 (in morning), the patient was unable to walk. He tried to get out of bed and fell down. He called the ambulance and they took him to hospital emergency room (ER). He was admitted to the hospital. Initially, the doctors thought his spine was the issue and discussed spinal surgery with him. However, when the tests were done found that spine was okay. Later, his bloodwork was performed results were not reported. They did some additional tests and discovered an infection. He also, scratched his back and doctors thought the scratch maybe caused the infection, but they did not know. He received anti-biotics for 16 weeks but it did not worked. At the time of this report, he was still can't move his toes or his legs and cannot walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to walk/couldn't walk/can't move toes or legs, and the outcome of fell down and infection was not reported. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage).; Sender's Comments: V0: 20210829039 - Covid-19 vaccine ad26.cov2.s- unable to walk/couldn't walk/can't move toes or legs and fell down. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-FEB-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-JUN-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed FAMVIR for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Swelling in my right thigh just above the knee; This is a spontaneous report from a contactable consumer, the patient. This case is for vaccine first dose. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration on 02Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced swelling in right thigh just above the knee on an unspecified date in Mar2021. Patient stated, "I was treated for swelling in my right thigh just above the knee on 16Mar2021. I have been advised by medical personnel to notify your company and provide the information stated above". The patient was hospitalized for swelling in right thigh just above the knee from 16Mar2021 to an unknown date. Therapeutic measures were taken as a result of swelling in my right thigh just above the knee. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Approximately 4hrs after injection experienced pain and itching at injection site and left arm from elbow to shoulder. Continued for 5 days and resolved. Took benadryl at night every night.  Itching again at 2wks post injection for 4 days.  Again took benadryl at night for 4 days.
This spontaneous report was received from a pharmacy technician, refers to multiple unspecified patients of unknown ages and genders. Concurrent condition and medical history were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored of PNEUMOVAX 23 lot # L010598, expiration date 06-AUG-2016 (strength, dose #, dose, route of administration, anatomical location were not reported). There was not a product quality complaint involved. No adverse effect were reported. This is one of several reported from the same source. Additional information has been requested.
This spontaneous report as received from a physician refers to unspecified number of unknown age. Current conditions and medical history was not reported. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX injection (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, (Oka/merck) VARIVAX was improperly stored for an unspecified amount of time and administered to an unspecified number of patients. No adverse effects reported. The outcome was unknown. product quality complaint was not reported. No further information provided. This is on of several reports received from the same reporter. Additional information has been requested.
Temperature around 100 Dry heaves, headache Weakness Could not control urine Covid arm for two weeks
High pitch buzzing in ears and head going on for two plus months. Diagnosis is Tinnitus after a thorough exam at the ENT doctor. I was told there is no treatment for this condition.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 59-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment details were provided.  The reporter stated that because their facility has not been able to download the digital data logger, they have been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the State was made.  There had been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.  Reporter stated that no adverse reactions were reported by any patients.
8OCT92 recvd 1 dose of Engerix-B & 10OCT92 pt's mom called reporting MD to report found pt in crib dead approx 830-930AM (sudden infant death synd?); pt taken to medical examiner, autopsy report pending;
After receiving the vaccine and sitting, the patient fainted for a brief moment. After waking, he said that he's fainted before when he gets cuts.  He drank some water and sat for another half an hour and we measured his blood pressure twice. First it was 90/70. He sat for a while longer and we measured it again at 108/73 and he said he was feeling better.
Heart palpitation; she felt flushed in the face and neck and couldn't sit for 15 minutes; she felt kind of weird; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101448746 (Pfizer).  A 64-year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Lot number: EN6204, Expiration Date: Jun2021) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1 single, Lot number: EN6203, expiry: Jun2021), administration date: 03Mar2021, when the patient was 64 years old, for COVID-19 Immunization.   The following information was reported: PALPITATIONS (non-serious) with onset Jun2021, outcome "recovering", described as "Heart palpitation"; FLUSHING (non-serious) with onset 24Mar2021, outcome "unknown", described as "she felt flushed in the face and neck and couldn't sit for 15 minutes"; FEELING ABNORMAL (non-serious) with onset 24Mar2021, outcome "recovered" (2021), described as "she felt kind of weird". The event "heart palpitation" was evaluated at the physician office visit.  Additional Information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller was calling on behalf of her sister who had the two doses of the Pfizer covid vaccine. The caller knows the third booster dose is coming up and the patient is refusing to get it because she can't see anything in the research about heart palpitations. The patient had heart palpitations and so on and is wondering if there is any research on this? This happened after the second dose. The patient had the vaccine in May and the summer was terrible, she has had heart monitors and that kind of thing. This information is third hand from the patient to the caller.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101295794 same reporter/product/event, different patient
Patient experienced an approximately 2 inch oval raised itchy erythematous area at injection site lasting approximately 5 days.  She also had a fever of 101.3 orally on 7/2/11 in the evening.  Patient also complained of headache and nasal congestion days following vaccination.
This spontaneous report was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored oral, ROTATEQ (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regards to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient(s) who may have experienced the symptom. She stated that they "always" received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reprots received from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a infant unk patient who received ENGERIX B pediatric. On an unknown date, the patient received ENGERIX B pediatric at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information provided: An about 12 week-old infant was vaccinated with ENGERIX B in hospital at birth. The ENGERIX-B vaccine was stored at too cold of a temperature.
Patient with syncope episode after receiving HPV and MENACTRA vaccines. Laceration to scalp and concussion due to fall. EMS transported patient to ED where patient was admitted overnight.
Hospital Course:  Patient with significant past medical history of diabetes 83 spastic paraplegia neuropathy hypertension CAD presented to Hospital with severe worsening pain of the right foot. Patient apparently 3 weeks back due to her neuropathy and spastic paraplegia tripped and fell.  She normally uses a walker which got caught in a rug and she fell down.  She had some difficulty getting up but otherwise did not feel bad for a few days about a week back she started having some pain in the right foot then she noticed some coldness and discoloration of the right foot last 2 days she has been having unbearable pain in the right foot.  She presented to the ER where CT angiogram of the abdomen showed  1. Occlusion of the right external iliac artery just distal to the inferior hypogastric origin with reconstitution at the level of the knee. There is distal occlusion of the right posterior tibial artery as well.   2.  High-grade atherosclerotic stenosis of the proximal left femoral artery with segmental distal femoral artery occlusion associated with reconstitution of the distal popliteal artery above-the-knee. There is also diminished three-vessel runoff  involving primarily posterior tibial artery.   3. 4.5 cm region of consolidation at the left lung base, potentially pneumonia, rounded atelectasis or a peripheral mass, not fully imaged. When clinically feasible a standard CT scan of the chest would be of benefit. Patient is now admitted to the hospital for further treatment with IV heparin and vascular surgery has already evaluated patient and plans for surgery today.  We will start patient on IV Rocephin for possible pneumonia.  Patient was started on IV heparin.  2D echo was done which showed left ventricular hypertrophy dilated right ventricle ejection fraction 34%.  On 10/12/2021 she underwent right iliofemoral endarterectomy right profunda femoral endarterectomy and patch angioplasty right lower extremity angiogram with runoff right femoral renal to below-knee popliteal arterial bypass with graft.  Patient was treated with IV Rocephin and Zithromax for possible pneumonia.  Patient had urinary retention and bump in the creatinine nephrology for the patient and a Foley catheter was placed she received bolus of normal saline and renal ultrasound was done.  Patient's condition got worse.  Patient coded and was transferred over to ICU on 10/14/2021.  Patient was made DNR.  Patient had multiple codes and expired around 16 00.
Developed shingles. I have no autoimmune issues, I'm not stressed, I'm only 45 and very healthy. The vaccine seems to be the only unusual event and a possible trigger for the shingles I developed.