chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had 2nd vaccine shot on 3/11, body aches and fever on 3/12, woke on 3/13 with excessive uterine bleeding, bleeding slowed in the afternoon, returned during the night into morning of 3/14, went to er. Received labwork and vaginal ultrasound, discharged and told to follow up with gynecologist. Contacted gynecologist on the evening of 3/15-Dr called in prescription for progesterin Took progesterin and bleeding continued. Saw Dr in office on 3/16-had 6+ hours of uncontrolled bleeding (using 5 super plus tampons and pads per hour. Dr prescribed Tranxemic acid-took until the afternoon of 3/18 when I contacted his office asking if the bleeding should have stopped. I was told to go the ER. I continued to bleed uncontrollably. I was admitted to Hospital - received 2 blood transfusions,  heart monitoring- on 3/19/21 I had emergency surgery for a cervical polyp. D&C /Polypectomy due to uncontrolled bleeding. Both surgeons   state there is no explanation and I could have died. I still have low hemoglobin and am going to receive iron infusions.   I am happy to supply lab work & results . This was an occurrence w/ no real explanation. It was very scary.
I woke up feeling achy , cold and a headache. I felt that way the entire next day (Thursday) with 102.5 fever. On Friday, I still had just over a 100 degree temp. I continued to have a mild headache for about a week afterwards. On Saturday, I got a fever blister on my nose/inside my nose.  This lasted a week and I get this a couple of times a year when my body is stressed. I think the vaccine caused this. This took about a week and a half to recover from but then I had burning sinuses. Could be allergies but I don't ever get this like this. I feel like the booster shot was stressful on my system due to my RA. I'm concerned about if I have to get the booster next year again since each time I've gotten the vaccine, I've had a stronger reaction.
A nurse reported the occurrence of a 50 year old female who did not respond to a series of hepatitis B recombinant (Engerix-B) for prophylaxis.  The subject had no relevant medical history or concurrent medications specified.  The subject had a current unspecified condition, which required dialysis.  On an unspecified date, the subject completed a four injection series of hepatitis B vaccine recombinant (Engerix-B).  On 01/09/03, an unspecified titer was drawn which resulted in a negative result.  Comment: This report has been linked to report A0392068A due to the same reporter.
received Moderna vaccines on 3/25/21, 4/29/21 tested positive for COVID-19 by PCR on 6/14/21, asyptomatic-was tested due to upcoming procedures at our facility
Bleeding from the side of his foot close to the ankle bone; Dose received: 3; Dose received: 3; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 301358A), via an unspecified route of administration, administered in left arm on 30Sep2021 10:30 (at 75 years old) as dose 3 (booster), single for COVID-19 immunization. Medical history included possible Penicillin allergy from an unknown date. The patient had no history of COVID prior to vaccination. The patient has not been Covid tested post vaccination. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (lot number EW6199), on 05Mar2021, on left arm; then second dose of BNT162B2 (lot number ER8733), on 26Mar2021, on left arm, both for COVID-19 immunization. On 30Sep2021 16:30, the patient began bleeding from the side of his foot close to the ankle bone. It continued for 15 minutes and stopped while applying direct pressure. Estimated blood loss onto floor and into rags: one-half cup measure. The outcome of the event "bleeding from the side of his foot close to the ankle bone" was recovered on 30Sep2021 16:45.   Follow-up attempts are completed. No further information is expected.
Second covid booster shot (unsure of manufacturer) given in left arm. Localized redness, swelling, pain and itchiness.
17 hours after administration I had chills, heavy sweating, body aches, diarrhea, and a rash developed over a lot of my body.
Rash appeared 24 hrs post injection. Lasted approx 24 hours then resolved w/o complications.
This spontaneous report as received from a physician refers to a 26 year old female patient with seasonal allergies. On 10-APR-2013 the patient was vaccinated with GARDASIL lot # 0420AE, dose #3 (route and dose not specified). On 11-APR-2013, the patient experienced dizziness, rash all over the body and headaches. About two weeks later, on approximately 25-APR-2013, the patient experienced additional symptoms which included: joint pain, fever and chills. The reporter noted that on approximately 25-APR-2013, the patient was beginning to feel depressed and discouraged by the continuing symptoms. On an unspecified date, a CAT Scan, Spinal Tap, Ultrasound and unspecified bloodwork lab diagnostic tests were performed (results not provided). The patient sought medical attention by a follow up visit with the Doctor. The outcome of the events was reported as not recovered/not resolved. The causal relationship was not provided. Additional information has been requested.
Swollen Lympnodes left arm; aches; chills; fatigue; bruising soreness swollen at injection site; bruising soreness swollen at injection site; bruising soreness swollen at injection site; fever; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 07:45 (at the age of 53 year) as dose 2, single for COVID-19 immunisation at Workplace clinic. Medical history included High Blood Pressure, Hypothyroidism and High Cholesterol. Patient had no known allergies. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Concomitant medication(s) included amlodipine besilate (NORVASC); simvastatine (SIMVASTATINE); levothyroxine sodium (SYNTHROID); furosemide (FUROSEMIDE). The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), dose 1 via an unspecified route of administration in Left arm on 19Jan2021 at 08:00 AM for COVID-19 immunisation. On 10Feb2021 at 12:00 PM, patient experienced swollen lympnodes left arm, aches, chills, fatigue, bruising soreness swollen at injection site, fever all of the above lasted for 3 days, patient swollen lympnodes under left arm have just started to go down on Tuesday and patient have started being able to use my arm more with each day. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovered on an unknown date in Feb2021.  Follow-up attempts are completed. No further information is expected.
she also experienced numbness in her hands and fingers and body after the first initial vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (she also experienced numbness in her hands and fingers and body after the first initial vaccination.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-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 HYPOAESTHESIA (she also experienced numbness in her hands and fingers and body after the first initial vaccination.). At the time of the report, HYPOAESTHESIA (she also experienced numbness in her hands and fingers and body after the first initial vaccination.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-396582 (Patient Link).
felt achy all over; 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 PAIN (felt achy all over) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Past medical history not provided).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (felt achy all over). At the time of the report, PAIN (felt achy all over) outcome was unknown. Not Provided          Concomitant medications taken by the patient were not provided. Treatment information was not provided.
This spontaneous report as received from a female patient of unknown age refers to herself. The patient's pertinent medical history and drug reactions or allergies were not provided. On an approximately 24-SEP-2014 (reported as "about 1 week ago"), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). It was unspecified if the patient took any concomitant medications. The patient stated that, on an unspecified date in approximately 2014, she experienced swelling around the ZOSTAVAX injection site. The outcome of swelling around the injection site was unknown. The relatedness between the event and the ZOSTAVAX was unknown. Additional information is not expected because the reporter did not provide any contact details and no follow up is available.
Burning pain in chest one day after receiving flu vaccine; located in substernal area; belching.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was stored in freezer, one to two vials were taken out and placed in the fridge each day as needed. No concomitant medications were provided by the reporter. No treatment was given.
A nurse prospectively reported that a 24 year old female patient received a dose of hepatitis A inactivated and hepatitis B recombinant vaccine during the second trimester of pregnancy. On 2/23/01 and 3/29/04, the patient received the first two doses of Twinrix. On an unspecified date in May 2004, the patient became pregnant. On 9/7/04, during the second trimester of pregnancy, the patient received the third dose of Twinrix. This case was reported by a nurse and described the occurrence of growth under the lip in a female newborn infant. The mother of the subject received the third dose of hepatitis A inactivated and hepatitis B recombinant vaccine on 9/7/04, during the second trimester of pregnancy. Case A0528858B refers to the infant. Please see case A0528858A for details of the mother of the infant. The subject was born. At the time of birth, the subject had a red, raised growth on the under the lip. As of 5/19/05, the nurse reported that, "the area has gotten smaller since birth." Comment: Growth on lip was assessed as medically serious (OMIC).
The evening following immunization in R/arm, it became very painful & throbbing. In pm, unable to move arm & not feeling well. Today, arm is red & very swollen. Advised to see MD & keep elevated w/ice. Tx'd w/Cephalexin.
The product was refrigerated on 29-OCT-2021 beyond expiration date 13-OCT-2021; HCP said that 606 doses were given after expiration date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date.) and PRODUCT STORAGE ERROR (The product was refrigerated on 29-OCT-2021 beyond expiration date 13-OCT-2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 29-OCT-2021 beyond expiration date 13-OCT-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date.) and PRODUCT STORAGE ERROR (The product was refrigerated on 29-OCT-2021 beyond expiration date 13-OCT-2021) outcome was unknown. Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No adverse events were reported. No temperature excursion was reported. The vial was initially placed in the refrigerator on 29-Oct-2021. Treatment information was not provided.
WITHIN 24 HOURS OF IMMUNIZATION, SHARP PAIN AND TENDERNESS DEVELOPED IN RIGHT SHOULDER ABOVE WHERE IMMUNIZATION WAS PLACED; NO FEVERS, FEELS WELL OTHERWISE, NO SHORTNESS OF BREATH. AREA 20X20CM TENDER TO PALPATION AROUND RIGHT SHOULDER.
got first dose of Shingrix 9/11/2020 and has not gotten the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of 0.5 ml received in an unknown arm by intramuscular route on 11th September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by patient. Age at vaccination was not applicable for this report. The patient had not gotten the 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Patient only received the suspension, of the Shringrix vaccine the full dose was not given.  Patient was contacted and notified of the error. Instructed to return in 4 weeks for the full dose.  The patient denied any complications at the time of notification.
Patient developed TINU about 1.5 months after receiving second Pfizer COVID vaccine dose.
has them now, got the shot/suspected vaccination failure; has them now; he is miserable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 85-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient experienced 2 times shingles before vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure and feeling miserable were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient got the Shingles shot after the reporter had shingles. The patient had shingles now and this was his 3rd time and he was miserable. The reporter stated that it differently was not a fun thing to have and she would not want her worst enemy to had them. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown. The follow up would not possible as contact information was not available.
Ongoing dizziness, headache, visual and auditory sensitivity with facial numbness with scalp sensitivity and headache.
Fever (to 100.5), headache, cough, myalgia, dizziness.
slight paralyzing in the arm; weakness in the arm; 1st vaccine was painful/ pain in my R arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old patient received BNT162b2 (BNT162B2), on 05Jun2021 as dose 1, single (Lot number: EW0217) at the age of 60 years intramuscular, in left arm 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) with onset 05Jun2021 at 10:00, outcome "recovering", described as "1st vaccine was painful/ pain in my R arm"; MONOPLEGIA (medically significant) with onset 05Jun2021 at 10:00, outcome "recovering", described as "slight paralyzing in the arm"; MUSCULAR WEAKNESS (medically significant) with onset 05Jun2021 at 10:00, outcome "recovering", described as "weakness in the arm". Therapeutic measures were not taken as a result of monoplegia, muscular weakness, pain in extremity.  Clinical course: it was reported that patient was not administered with booster dose. 1st vaccine was painful for 3 months. I am trained in medical therapeutics as well. I have Experienced pain in my R arm for other a year, I have weakness in the arm to do normal takes like walking my pet, carrying item and rotation mobility. Upon awakening from sleep, I have slight paralysis in the arm having to pick it up with my L arm until I get up. Abductor/abduction is my about 12 inch from my side to left R arm. My rotation is about 80 percent now, seems to be improving some.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202200089160 Same patient/vaccine, different vaccine dose;US-PFIZER INC-202201359617 Same patient/vaccine, different vaccine dose;
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had back pain, chills and pain/body aches, with outcome of unknown. Therapeutic measures were taken as a result of back pain, chills and pain. Additional information: The patient stated Tylenol was not helping. He would like to take Ibuprofen and inquired if it allowed to take Ibuprofen because Tylenol does not do anything for his pain. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
PT WAS SEATED IN CHAIR WAITING FOR 15 MINS AFTER THE VACCINE AND HER MOM CAME TO GET ME JUST A FEW MINS AFTER SHE SAT DOWN AND SAID SHE PASSED OUT FOR A FEW SECONDS AND WOKE BACK UP. I PUT HER BACK IN THE IMZ ROOM, ASSESED HER AND ASKED FOR 911. SHE STATED SHE WAS FEELING BETTER AND DIDNT WANT 911 CALLED. I GAVE HER SOME WATER AND A COLD RAG AND FAN AND CALLED MANAGEMENT. SHE SAT IN THE ROOM FOR AN ADDITIONAL 30 MINS AND SAID SHE FELT FINE BEFORE SHE LEFT. I WILL FOLLOW UP WITH PT TOMORROW TO MAKE SURE SHE IS STILL DOING WELL.
Patient started having reaction to vaccine two days after delivery. Rash swelling and itching at injection sight. They thought patient was possibly getting infection so he was given rocephin IM observed and sent home with instructions to F/U the next day.
pt presented to ED with increasing SOB over past week; O2 sats 70% on 2 L via NC; c/o cough, fever, aches; positive for COVID; CXR showed multifocal pneumonia; required emergent intubation; became hypotensive; treated with vasopressors, antibiotics, decadron, remdesivir, baricitinib; condition worsened; cardiac arrest with respiratory failure due to COVID
This spontaneous report as received from a medical assistant refers to a 66 year old female patient. On 01-OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX23 lot # J006921, expiry date 09-AUG-2014. On an unknown date in 2013, the patient experienced injection site reaction that she described as soreness in her arm and warm to touch and soreness in her arm and warm to touch. No treatment was rendered for the events. The outcome of the events were reported as recovering. The patient was scheduled for a follow up appointment. This is one of the 3 reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a health care worker refers to a 17 year old female patient. The patient was allergic to amoxicillin. The patient had no other pertinent medical history. On 01-APR-2013, the patient was vaccinated with GARDASIL dose 1 (Lot # H020002). On 17-JUL-2013, the patient was vaccinated with GARDASIL dose 2 (Lot # H017698). No adverse events were reported with dose 1 and 2. On 21-NOV-2013 the patient was vaccinated with GARDASIL dose 3 (Lot # J009788). The patient was not on any concomitant medications. On 21-NOV-2013, the patient felt dizzy about 5 minutes following the vaccination and the patient was kept at the office for duration of 15 minutes. The patient reproted that on 21-NOV-2013, she developed headache on the left side and neck pain on the left side (same side as GARDASIL vaccination) after the patient left the office. On 22-NOV-2013 when the patient woke up, she experienced numbness of lower lip and teeth pain (teeth hurt). The patient sought medical attention. No treatment was rendered for the event. No lab tests were performed. The outcome of neck pain on the left side (same side as GARDASIL vaccination), teeth pain and numbness of lower lip was reproted as not resolved. The outcome of headache was unknown. The outcome of patient felt dizzy was reported as resolved on 21-NOV-2013. Additional information has been requested.
admitted to hospital that evening with acute intracerebral hemorrhage felt to be from a cerebral venous thrombosis with dense left hemiplegia.  one week later, developed bilateral upper extremity cephalic vein thrombosis that the following week, 4/21/21, continued to propagate
NONE Stated DTAP (Infanrix) was administered, vaccine expiration date 10/10/05. the MA told me when she filled up vaccine adm. record. I called the manufacturer and subsequently referred to CDC for guidelines. To repeat the DTAP, administer new 10/27/05.
tingling of mouth and tongue with feeling of some tongue swelling, but no wheezing or shortness of breath. slight itching in general. lasted til next day without need of epi pen