chrisvoncsefalvay/vaers-outcomes huggingface dataset:
July 17 2021  I woke up with severe body aches Base headache  Could not breath well wheezing Fever max : 101.4 Threw up 1 time empty stomach  This went on till Sunday July 18th Barely slept  July 18th went to the COVID-19 drive thru testing site, was worried I had breakthrough Covid-19  Tested rapid and lab- both negative  Then saw doctor Thursday later that week, got another rapid test- it was negative.  Doc said I had some sort of bronchitis virus or attack
Seven hours after receiving my second dose, I developed flu-like symptoms--fever of 100-101 degrees, full body aches, fatigue, and chills, in addition to a sore left arm. These symptoms continued for 18 hours. It was difficult to sleep.  I had the flu three years ago but this felt more severe. Symptoms were treated first with 200mg ibuprofen with no response and then with Tylenol, which improved symptoms.  I stayed in bed for most of those 18 hours to rest. Two days after receiving my second dose, I had a headache for the whole day.  The headache then became a migraine. Both treated with aspirin. Three days after the second dose, I felt fatigued, weak, and still had a headache. To my understanding, the first two days of ailment reflect my body's immune response and the final two are typical of my body's stress response. However, I have not experienced either in response to a vaccine.   I should also mention my first menstrual cycle after receiving the first dose of the vaccine was shorter than usual. My periods are not always regular so it may be a coincidence, not causation.
MOM STATES ONCE PT ARRIVED HOME, SHE NOTICED A RED/SPLOTCHY/ITCHY RASH AROUND INJECTION SITE OF LEFT THIGH- THIS PROGRESSED UP HIS BELLY FOR THE NEXT FEW DAYS WITH INCREASED FUSSINESS.
started to feel achy in the evening on 6NOV; devel a sore arm w/swelling & redness on 7NOV; also devel diarrhea on 7NOV; GI sx progress to vomiting 9NOV; resolved; arm remains sore to touch; no hardness;
CLIENT VACCINE CARD INDICATED 2 PREVIOUS DOSES AND ELIGIBLE FOR BOOSTER. BOOSTER ADMINISTERED. DATA ENTRY OF BOOSTER REVEALED 3 PREVIOUS DOSES. THEREFORE THE DOSE ADMINISTERED IS THE 4TH DOSE.
Patient reports pain in arm around site of injection, inability to raise arm due to discomfort. Onset of symptoms approximately 10-8-15. Progressive worsening of symptoms. Patient tried heating pad at home with no relief. No other symptoms reported.
NOTHING AS A RESULT OF SHOT.  I WAS ADVISED BY FACILITY TO REPORT TESTING POSITIVE FOR COVID ON 9-15-22.
Patient is deceased.  Hospitalized (11.17.21);  COVID-19 positive (11.17.21);  Fully vaccinated PLUS booster. Admission Date: 11/17/2021 Date of Death: 11/23/21 Time of Death:  2:13 AM Preliminary Cause of Death: COVID-19 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Lactic acidosis  Encephalopathy acute  Non-traumatic rhabdomyolysis  AMS (altered mental status)  COVID-19  HOSPITAL COURSE: Patient is a 64 year old male with past medical history significant for alcohol abuse, cirrhosis, prior hepatitis C infection, diabetes, left BKA. He presented to the ER 11/17 after being found unresponsive at home (reportedly found by program after several uncollected meals left on doorstep). CT head with possible subdural hygroma. CT spine without acute abnormality. CT t/a/p with possible contusion to left upper arm and left anterior chest wall, liver cirrhosis with portal hypertension. He was incidentally found to be COVID positive but was admitted on room air. Patient was orientated x0 but was protecting airway and was admitted to hospitalist service. Overnight, patient became more obtunded and was transferred to ICU 11/18am and emergently intubated. Blood cultures from admission 2:2 positive for staph aureus. Neurology and infectious disease consulted. CT thoracic and lumbar imaging without evidence of abscess (currently unable to obtain MRI due to inability to complete questionnaire).  Pt was breath stacking, therefore changed into PSV mode.  During turns, pt suddenly desatted requiring full vent support and 100% FIO2.  Stat CXR was done and NEG for pneumothorax.  CTA chest was ordered and demonstrated pneumotosis of colon, portal venous system and gastric.  LP + for Xanthochromia.  Family was updated and decided not to pursue ongoing aggressive care.  He was pronounced at 02:13 on 11/23/2021. Brother was called and updated.
Red, raised and very hot at site of shot for three days and very cranky, followed by abdominal pains, then fever and felt sick to her stomach on the 4th day after.  Had urine tested, throat culture and a series of blood taken and received IV fluids in hospital.  Everything came back negative.
After arriving home developed fever (did not check), sweating, triggering vertigo (which patient takes medication for, however, has not had an episode in a long time), left arm burning and warm to the touch at the injection site. Slept the next couple of days. arm felt alittle better, however, had a large (10cm) area of redness and some bruising at the injection site. Over general malaise continued for 4 days.
pt. came back to the observation after ten mins.  pt stated that she was having a raising heart, anxiety, after due to feeling shaky and very nervous.   Pt. PMH is anemia.  denies history of allergic and anaphylatic reaction.  V/S BP 111/84, P 102, R 20, O2Sat 98%.   Pt. monitored for additional 30 mins.  She was not shaky anymore.  Denies going to ER for check up, but promised to follow up with her PCP when she gets home.
Severe Shingles type skin rash on groin and buttocks x 7+ days.
did not have any adverse effects; she got some of the ROTATEQ on her hands; 2 of the ROTATEQ tubes from a pack of 25 were leaking and the spikes were broken off; she got some of the ROTATEQ on her hands; she got some of the ROTATEQ on her hands; This spontaneous report was received from a 30-year-old female medical assistant, who refers to herself. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 06-APR-2020, after opening the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1660970, expiration date 17-JAN-2021) foil pouch, the medical assistant got some of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) on her hands. She stated that 2 of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) tubes (lot # 1660970, expiration date 17-JAN-2021) from a pack of 25 were leaking and the spikes were broken off. It was also reported that 5 doses of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) from the same pack of 25, were administered on multiple unspecified dates prior to finding the 2 broken tubes, there were no issues with those 5 tubes. She did not seek medical attention, as the event occurred at the office and the physician was notified immediately. No adverse effects were reported. Lab diagnostic studies were not performed.  This is one of several reports received from the same reporter.
10/15/07 following flu vaccine pt felt flushed, warm had some flushing on chest and neck 10/16/07 States she still feels some flushing-this is not noticeable. Has 4cm localized warm, mildly erythemic area at injection site.
Rash on both forearms, under the skin, very itchy, with red bumps.  Pain in both legs, upper thighs next to pelvis, knee pain, pain getting worse, high anxiety.
Patient experienced sneezing, chills, and throat swelling beginning three and one half hours after vaccination. She took oral diphenhydramine and then injected an epi-pen.  After one and one half additional hours she experienced severe abdominal cramping and injected diphenhydramine.  She did not go to the hospital.  She does not have a primary care physician.
Patient was given DTaP and Kinrix  instead of DTaP and HIB.  Parent notified via provider, no adverse reaction.
soreness to her left arm.; feeling itchiness around the injection site; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 (Batch/Lot number: unknown) at the age of 64 years 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness to her left arm."; VACCINATION SITE PRURITUS (non-serious), outcome "recovered", described as "feeling itchiness around the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PAIN IN WHOLE BODY; NERVE PAIN IN JOINTS; COULD NOT GET OUT OF BED; CHRONIC, SEVERE JOINT PAIN(SHOULDERS, HIPS, AND KNEES); This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. The patient had received 3 rounds of steroids. On 01-SEP-2021, patient tested negative for rheumatoid arthritis, lyme disease, and west nile. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced pain in whole body. On MAR-2021, the patient experienced nerve pain in joints. On MAR-2021, the patient experienced could not get out of bed. On MAR-2021, the patient experienced chronic, severe joint pain (shoulders, hips, and knees). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from chronic, severe joint pain(shoulders, hips, and knees), pain in whole body, nerve pain in joints, and could not get out of bed. This report was non-serious.
Lymphadenopathy. Painful and swollen lymph nodes in armpit, arm, above collar bone, neck and ear.  Began with just armpit and the next day all the rest were painful and swollen. Ibuprofen, after 24 hours they dont feel as painful.
lost the sense of smell of specific scents; missing the ability to properly detect the volatile sulfur scents; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 16:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 08:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 17Apr2021, after about two weeks after the last injection, the patient lost the sense of smell of specific scents. The patient was missing the ability to properly detect the volatile sulfur scents. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lost the sense of smell of specific scents and missing the ability to properly detect the volatile sulfur scents was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Misadministration of hepatitis B vaccine child received two doses on same day. No symptoms reported.
Checking on patient after vaccine administered.  Patient was lethargic & described head hurting.  Patient has diabetes.  Became diaphoretic shortly thereafter with a BP of 180/110, HR 115 and RR 26.  LOC's decreased.  Chest rubs began.  Patient given Coke, but unable to drink effectively.  2 packs of granular sugar put under tongue.  Patient began to slur words, skin clammy.  Epi-pen administered in right arm and patient was moved out of car to the ground.  Patient began to shiver and slurring words.  We began to warm patient.  EMS arrived and took over.  Patient transported to Hospital.
less appetite; unable to walk; incohernet speech; COVID; injection site pain; little dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (little dizzy), GAIT INABILITY (unable to walk), INCOHERENT (incohernet speech), COVID-19 (COVID) and DECREASED APPETITE (less appetite) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced DIZZINESS (little dizzy) and VACCINATION SITE PAIN (injection site pain). On 23-Jan-2021, the patient experienced GAIT INABILITY (unable to walk), INCOHERENT (incohernet speech) and COVID-19 (COVID). On 26-Jan-2021, the patient experienced DECREASED APPETITE (less appetite). On 23-Jan-2021, GAIT INABILITY (unable to walk) and INCOHERENT (incohernet speech) had resolved. On 26-Jan-2021, DIZZINESS (little dizzy) and VACCINATION SITE PAIN (injection site pain) had resolved. At the time of the report, COVID-19 (COVID) and DECREASED APPETITE (less appetite) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, COVID-19: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator Patient Take intravenous fluids as a Treatment medication
Patients left side of tongue swelled, no difficulty breathing , starting at 11:30 am on 5/20 and ending at 7pm on 5/20
Pt. received vaccines on 10/20/04. Reported back to the office on 10/21/04 in the afternoon that the injection area was very red and swollen at which time an appointment was made for 8:30 AM. He was given Rocephin at the visit and given Bactrim for 10 days. Dx was allergic reaction vs cellulitis.
Fully anticoagulated pt on Eliquis 5 po bid with 100% medication compliance admitted on 4/20/21 with left arm pain. U/s demonstrated left brachial vein acute thrombus. U/s read by radiology from still frames only. I reviewed the u/s with the radiologist and it strongly suggests presence of left brachial vein thrombus. Pt offered endovascular treatment and taken to the cath lab on 4/21/21 in pm. U/s in the cath lab in my presence demonstrated no evidence of thrombus. NO symptoms of PE. Pt discharged home the same evening on eliquis 10 bid for 2 weeks. NO previous hematology evaluation to my knowledge despite h/o recurrent DVT/PE ~ 5 years ago.
Swelling (mild to moderate), redness, and itching to both hands -- nausea onset about 30 minutes after vaccine administration, but resolved after a short period of time; instructed patient to take 50mg (2 OTC tablets) of Benadryl and I will check back with her in 45-60 minutes, she also will mark where redness extends on her arm and we will compare in 45-60 minutes; a visit to urgent care may be needed if benadryl does not control/limit extension of reaction.
quite a bit of bleeding after the second dose; if the dose was lost in the bleeding or if the dose was given incorrectly; pain in the arm; tired; This is a spontaneous report from a contactable consumer (daughter). A 67-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot: not reported) dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a lot of blood compared to the first time, pain in the arm, tired on an unspecified date. Reporter stated that her father takes blood thinners and experienced quite a bit of bleeding after the second dose. She says he thinks the dose might have leaked out with the blood. She thinks he should have gotten the same amount as her mom. They both had antibody tests completed and her mother had a good antibody result, but her father did not. Reporter asked, Does that have to do with the bleeding afterward. Was the dose not properly stored. She thinks it has to do with the way the dose was administered. Does he need to get a third dose of the vaccine. In case the second dose was given improperly is it safe to get a third dose. Was the dose not properly stored. What would it take for him to get a third dose. Response was "that I don't know if the dose was lost in the bleeding or if the dose was given incorrectly. I could not say if the dose was properly stored or not and referred caller to the vaccination provider to discuss". She stated her father had the following side effects: pain in the arm, tired after the first dose no. No side effects after the second dose other than the bleeding. Outcome of the events was unknown.  Information about batch/Lot number has been requested.
Headache & Myalgia Narrative:  Moderate to severe arm soreness, muscle aches and headache lasted about 36 hours.
Fatigue, started 3 hours after shot Nausea, started 5 hours after shot Muscle stiffness, started 7 hours after shot Headache, started 7 hours after shot
Pt received Pfizer on 2/10/21 and was scheduled today to receive 2nd dose. Pt received from the adminstering nurse a dose of moderna. Writer is not the administer nurse.  Pt is aware and no side effects occurred.
Coughing; seasonal allergies; she had injection site pain; Rash; she experience a burning; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (she experience a burning), PRURITUS (Itchy), COUGH (Coughing), SEASONAL ALLERGY (seasonal allergies) and VACCINATION SITE PAIN (she had injection site pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced BURNING SENSATION (she experience a burning), PRURITUS (Itchy) and RASH (Rash). On an unknown date, the patient experienced COUGH (Coughing), SEASONAL ALLERGY (seasonal allergies) and VACCINATION SITE PAIN (she had injection site pain). On 07-Mar-2021, BURNING SENSATION (she experience a burning), PRURITUS (Itchy) and RASH (Rash) had resolved. At the time of the report, COUGH (Coughing), SEASONAL ALLERGY (seasonal allergies) and VACCINATION SITE PAIN (she had injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
ADMINISTED JANSSEN COVID-19 VACCINE AS SECOND DOSE  AFTER PFIZER COVID-19 VACCINE; This spontaneous report received from a pharmacist concerned a 47 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced administed janssen covid-19 vaccine as second dose after pfizer covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administed janssen covid-19 vaccine as second dose after pfizer covid-19 vaccine was not reported. This report was non-serious.
On  08/30/2021 Patient came with her mother and father to get get the covid-19 vaccine. after talking to them I gave them forms to fill out and told her she will be getting the Pfizer vaccine. She then said all of them will get Pfizer vaccine. I went and got their Pfizer vaccines ready. I check their cards  and dates of birth to make sure. right as I was about to take their vaccines to the room to give them, patient came rushing to let me know that she don't want the pfizer vaccine and that they prefer the Moderna vaccine and they are sorry to have made me prepare the Pfizer vaccine. I said ok , I have other people waiting but l get their vaccines changed from Pfizer to Moderna. I then discarded the Pfizer vaccines i had prepared for them and got moderna vaccines ready. Because of the rush and confussion I totally forgot that patient is 15 years old and cannot take Moderna vaccine untill she's 16years old.  After I gave them their Moderna vaccines, they thanked me. on 10/07/2021 she came back for the second does. We couldn't give her the Moderna vaccine again because she is under age. She will get it only when she's 16 years of age.
patient was administered a dose of improperly stored Varivax; This spontaneous report was received from a registered nurse and refers to a 8 year old male patient. The patient's medical history and concurrent conditions were not provided.  The reporter stated that on 25-NOV-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (product storage error )lot # S021926, expiration date on 15-JUL-2021, for prophylaxis (strength, dosage, frequency and route were not provided), the sterile diluent used for reconstitute the vaccine was properly stored. It was stated that varicella virus vaccine live (oka/merck)(VARIVAX) was under 15 °F, to 46 °F (35.7 F) for 4 hours 40 minutes, 6°F to 14°F (10F) for 45 minutes and 15 °F to 46 °F(44.7 F) for 8 hours. There were not previous temperature excursion, digital data logger was positive.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a patient who may vaccinated with a dose of FLUZONE (Batch number: UJ005AF, expiration date: 30-Jun-2019, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was a actual medication error due to incorrect product storage (FLUZONE QUAD excursion stored at 49.5 F for 2 hours and 20 minutes). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.