chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had the Vx and still got the Shingles/Suspected vaccination failure; Still got the Shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Feb-2023 Report's comment: The case was received from the patient via interactive digital media. The patient had the shingles vaccine and still got the shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient developed hives, swelling & redness at injection site, fatigue, body aches, and chills. Hives, swelling and redness are all still present 1/30/23.
Pt reports she had psoriasis flareup all over her body about 2 days after receiving the second dose of COVID vaccine, she did not report which manufacturer she received.
swelling, raised, red where she got the shot; swelling, raised, red where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling, raised, red where she got the shot) and VACCINATION SITE ERYTHEMA (swelling, raised, red where she got the shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling, raised, red where she got the shot) and VACCINATION SITE ERYTHEMA (swelling, raised, red where she got the shot). At the time of the report, VACCINATION SITE SWELLING (swelling, raised, red where she got the shot) and VACCINATION SITE ERYTHEMA (swelling, raised, red where she got the shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Extreme shaking from feeling cold. Put on sweat pants and extra blankets and took acetaminophen Lasted half an hour. Soreness of arm and general sense of malaise. Began last night and lasting into this morning.
Symptoms began with itching sensation in the scalp and neck, exploded into full body hives (urticaria) forming blisters. Treatment on February 24 included injection of epinephrine and oral antihistamines and steroids. The cycle of Prednisone, Famotidine, and cetirizine has conclude (lasted a total of 14 days), but hives have not completely subsided and still persist, appearing on the arms, lower abdomen, between legs and glutes, and scalp. Topical treatment with hydrocortisone cream helps with the itching sensation and will cause the location to revert to normal over a few hours.
same day, soreness in arm, dizziness and brain fog, headache.  Headache continued for one week.  After 7 days, injection site started itching, day 8 had a blistering rash and hard, swollen area about 2" in diameter.  Felt feverish beginning on 6th day.  Still have rash that is swollen and warm to the touch at day 9.
This case meets criteria for vaccine breakthrough review. SxS include a few days PTA of weakness, hypoxia, cough, congestion, severe headache, body aches, SOB, decreased appetite.
My father called me from his car in the parking lot saying that he needed help, he wasn't feeling well and he could not move his legs. He was in a minor car accident right before he arrived in the parking lot coming from pharmacy to try to pick up his medication, but he could not gain control of the car because he said he could not feel his legs. I proceeding to the car and he wanted to get up. He got out of the car and leaned on it for support. Then his legs gave out and he fainted. I was able to catch him and laid him on the ground to break his fall. I proceeded to call 911. he was hospitalized from 10/24 to 10/30, on 10/30 he fell in his bathroom as a result of leg weakness again and fractured his hip. He had to get a partial left hip replacement, he is still currently in the hospital.
Within 30 minutes I complained of feeling out of it. Zoning out and hallucinating. A few hours later I was driving  and had difficulty swallowing and breathing. 911 was called and I went to an unspecified hospital for anaphylactic reaction. I have never had anaphylactic reaction prior to this vaccine.
administered the second dose earlier than 28 days; mental disorientation; dizziness; itching at injection site; headaches; muscle pain; fatigue; chills; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose earlier than 28 days), HEADACHE (headaches), MYALGIA (muscle pain), FATIGUE (fatigue) and CHILLS (chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HEADACHE (headaches), MYALGIA (muscle pain), FATIGUE (fatigue), CHILLS (chills), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (swelling at injection site), DIZZINESS (dizziness) and MENTAL DISORDER (mental disorientation). On 27-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose earlier than 28 days). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Adverse reaction, at a dose of 1 dosage form. On 27-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose earlier than 28 days) had resolved. At the time of the report, HEADACHE (headaches), MYALGIA (muscle pain), FATIGUE (fatigue), CHILLS (chills), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (swelling at injection site), DIZZINESS (dizziness) and MENTAL DISORDER (mental disorientation) had not resolved.            Patient's concomitant medications included unspecified medicines for asthma and allergies.  Patient experienced these symptoms following both the vaccination doses. Patient took Acetaminophen as treatment as reported that it had helped. Patient also reported that a lot the adverse events she experienced would come and go, and the patient was not fully recovered from it.   This case was linked to MOD-2021-037556 (Patient Link).
Nausea, vomiting, chills, headache, stomach pain. BPs 149/85 (pulse 64), 115/69 (pulse 69).
PASSED OUT; ERRATIC BODILY MOVEMENT FOR THREE SECONDS; CONFUSED; SLOUCHED OVER IN CHAIR LIKE HE PASSED OUT; STARTLED; PALE; DID NOT KNOW NAME; FELT TIRED; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported that on 07-APR-2021, the patient while sitting in the observation area slouched over in chair like he had passed out. On 07-APR-2021, he began to have erratic bodily movement for three seconds. He lowered to the floor. He opened his eyes and was very startled and confused. He did not know name. He was evaluated by emergency medical services (EMS), and all the tests were normal. He refused transfer to the hospital. On 07-APR-2021, he complaint of feeling tired, and was pale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the erratic bodily movement for three seconds, confused, felt tired, slouched over in chair like he passed out, startled, pale, passed out and did not know name was not reported.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210417256, 20210417209, 20210417456 and 20210417122.; Sender's Comments: V0-20210417550- Covid-19 vaccine ad26.cov2.s-Passed out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Pt post receiving first Moderna Covid-19 Vaccine was in hallway, standing in line to schedule second Covid 19 Vaccine, per patient "became light headed, had tunnel vision".   Pt noted to start leaning toward wall by RNs at schedule table, bumped right shoulder on wall.  RN steadied patient,  RN2 came to assist - held patients head as lowered to floor.  Patient was alert and oriented to person, place and time once on the floor.  Pt "stated she usually passes out with lab draws".  Pt rested on floor, then moved to a seated position and offered juice which she accepted and drank one carton.  Pt was moved to a chair next to RN and observed for 30 minutes.  Pt told nurse who had administered the vaccine that she had just worked out prior to coming to her appointment.   Patient was told to go to the ER to be examined.  Patient refused, stating "I am good, this has happened before and I am comfortable driving home and do not want to go to the ER."   RN 2 offered to call a family member or friend and patient refused the need to call anyone.
Headache. Nausea. Chills. Sneezing. Mucus. Ears ringing. Fatigue/ ADVIL BENADRYL Lots of sleep 10 days. Airborne.
SWEATING; CHILLS; WEAKNESS; HEADACHE; SORENESS LEFT ARM; This spontaneous report received from a parent concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included occasional migraine headaches, and other pre-existing medical conditions included the patient has no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination, on left arm. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced soreness left arm. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced weakness. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021 19:00, treatment medications included: paracetamol. On 17-MAR-2021, the subject experienced sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness left arm, chills, weakness, headache and sweating was not reported. This report was non-serious.
Patients husband called to state that he believes the patienthad a reaction to the vaccines that she receivedyesterday on 04/04/2019. Husband stated that the wife complained of pain at the injection site where the vaccine was administered. He also stated felt "weak" and almost passed out on 04/05/2019. Reffered husband to take wife to the emergency room.
This spontaneous report as received from a nurse refers to a 11-week-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 07-DEC-2016, the patient was vaccinated with an expired dose of ROTATEQ, orally (lot# L008054, expiration date: 30-NOV-2016; dose was not provided). No adverse effects were reported. Additional information has been requested.
ARM TENDERNESS AND PAIN; REDNESS IN ARM; SWELLING OF INJECTION SITE; STING AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced sting at injection site. On 09-APR-2021, the subject experienced redness in arm. On 09-APR-2021, the subject experienced swelling of injection site. On an unspecified date, the subject experienced arm tenderness and pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm tenderness and pain, and redness in arm, and the outcome of sting at injection site and swelling of injection site was not reported. This report was non-serious.
Large, 2 inch diameter (approximately equal to 2 x 2) bruising with red line (approximately equal to 1 1/2 cm) extending 3 inches down arm. No soreness reported / no pain or discomfort.
Body pain; Body is on fire; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Body pain) and FEELING HOT (Body is on fire) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body pain) and FEELING HOT (Body is on fire). At the time of the report, MYALGIA (Body pain) and FEELING HOT (Body is on fire) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided. No treatment information provided.
Started with arm pain after 3 hours which got worse than last shot which was only arm pain. Then few hours later bad body aches felt like bad pain in my bones all over and chills couldn't get warm I noy slept 1 hour even after the Tylenol because hurt so bad all night, didn't take temp hurt to move. All day Friday feverish ranging from 99-102. I normally run cold took temp Thursday morning 96.7.  Saturday fever down to 97.5 but felt woozy, tired, weak all day felt hungry again.  Sunday today woke up at 5am metallic taste in mouth temp 96.2 and felt a bit chilled.  Also last two nights tickling cough but that could be allergies again
Arm pain/numbness at site of injection then down arm to hand/fingers. Arm pain has subsided but still having difficulty with left index finger pain. Could not work for 3-4 days due to arm pain.
The following day after being vaccinated, my lymph nodes swelled causing radiated pain in my arm, shoulder, shoulder blade, upper breast, ribs and shooting pain up and down my are for almost a month.
Patient complained of tenderness, lump, and mild rash at the injection. No shortness of breath or difficulty breathing.
Nauseous; legs became very achy; Chills; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiry Date: unknown), via an unspecified route of administration on 12Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. On 12Jul2021, the patient experienced Chills, Nauseous, legs became very achy. It was reported that "I took the first shot yesterday and at about midnight last night my legs became very achy and I have chills but no fever and now today I felt a little bit nauseous so I was just wondering I thought that all was supposed to happen on the second shot not on the first shot." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Tiredness, headache, shivering (lasted 3 hours, beginning at midnight and subsiding around 3am 11/17/20), nausea.  Tiredness, feeling cold,  and sore arm pain lasted into next day.
Within a day of receiving the vaccine, she had a hard and reddened area at site of injection. This resolved in a few days. When she woke up 8 days after the vaccine, the injection site was again hard, itchy, erythematous and warm to the touch. Feels over the course of the day this is worsening.
w/in less than hr of vax pt devel extensive urticaria on body, face & extremities & red, swollen ears, eyelids & lower lip;also hive over the spot where recv DTAP;tx epi, corticosteroids & antihistamine;
throwing up, diarrhea, constipated, weight loss, hair loss, belle palsy, high blood pressure
10/17/21 SEEN IN THE ER AFTER FALLING AT HOME. REPORTED FEVER, HEMATURIA, DIZZINESS. COMPLAINS OF LEFT FLANK PAIN WITH CHILLS.  DISCHARGE 10/21/21 TO health care FACILITY. WITH DIAGNOSIS OF ESBL ECOLI INFECTION UTI/BACTEREMIA.
Systemic: swelling/knot on wrist of injection arm and ankle of right side-Mild
Extreme flu like symptoms lasting 2 weeks. Woke up arms bent at elbow for awhile I has no control to use my arms, walking pushing grocery cart on sidewalk my legs involuntary began to run had no control sidewalk had ice I fell only way I stopped sprained left arm went to hospital 2 days later my arm got worse I had a NP look at me told her about the vaccine she had no interest. Called pharmacy was told all people react to vacines differently, Almost on a mid afternoon basis I get extremely tired lay down sleep for around 2 hours wake up feeling sick body aches headache joint pain.
9-30-11 Mom noticed blood in stool. Occult blood in stool positive times 2.
After 3rd injection (HPV-9), child became pale and stated he felt dizzy. Child fainted and regained consciousness after approx. 20-30 seconds. Child was sitting. He did not fall. He did not hit head.  EMS was called to evaluate child. It was determined that he was stable and could go home. Mother advised to watch child and to call EMS or to take child to the ER if any issues or concerns. Child alert and oriented and denied complaints, upon leaving Clinic.
Child is 12 years old.  Pfizer dose 5-11 given  no adverse reactions noted
New onset Severe colitis and severe malaise requiring IV fluids. Symptoms are still occurring and  diagnostic tests still being performed.
patient was given an extra dose of the vaccination, he is not having any adverse side effects at this time
COMPLAINED OF FEELING DIZZY POST VACCINATION.  SHOT:  1133, COMPLAINT MADE:  1145.  MONITORED-  VS :  02 SAT:  85% R.A., P:  85, R:  20;  BP;  138/76. LEFT WITHOUT COMPLAINTS AFTER MONITORED TIME.
Headaches, nausea, dizziness. Treatment was rest and otc pain medication (Ibuprofen). Symptoms we mostly abated by Sunday 4/4 and were not present morning of Monday 4/5. Dizziness returned Monday 10:30 and Nausea 13:30
nausea; fever; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: NAUSEA (medically significant), outcome "unknown"; PYREXIA (medically significant), outcome "unknown", described as "fever"; HYPERTENSION (medically significant), outcome "unknown", described as "high blood pressure". The events "nausea", "fever" and "high blood pressure" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; Body temperature: Fever. Therapeutic measures were taken as a result of hypertension. The patient's doctor was having difficulty in controlling her blood pressure. The patient had been in the emergency room five times in the last two years. She is afraid to take the 2nd booster. She felt she won't make it through another vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
low level headache - persistent stiff neck muscle weakness in legs general feeling of lassitude  the time course is one week since vaccination
Within 5-6 hours I experienced severe widespread joint paint, a temperature of 102 degree, and extreme fatigue.  I had a seizure that lasted approximately 1-2 minutes.
Tested positive for COVID 19 with fever, general malaise, and congestion; Tested positive for COVID 19 with fever, general malaise, and congestion; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 was not reported. Concomitant medication(s) included: CITALOPRAM; PANTOPRAZOLE; PREMPRO; CELECOXIB. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Feb2023, outcome "recovered" (11Feb2023) and all described as "Tested positive for COVID 19 with fever, general malaise, and congestion". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Feb2023) Positive; (11Feb2023) Negative; (16Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: 60 year old female with no underlying health conditions or risk factors for severe COVID-19 was fully vaccinated with primary series of Pfizer COVID-19 vaccine plus original booster plus new Bivalent booster in Oct2022. tested positive for COVID 19 with fever, general malaise, and congestion on 03Feb2023. Paxlovid was prescribed and taken on 03Feb. Course was completed on 08Feb Symptoms resolved quickly and fever resolved by 08Feb also. COVID test was negative on 11Feb. On 16Feb, runny nose and slight cough returned. COVID test was positive. No fever.   The lot number for the vaccine [BNT162B2, BNT162B2 OMI BA.4-5; BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events Drug Ineffective and COVID-19 and the suspect drug cannot be completely excluded.
PT WAS GIVEN INJECTIONS ON 4-6-11 AT ABOUT 2:40 PM. WAS DX W/ ALLERGIC RHINITIS. MOM STATED ABOUT 6 PM HE STARTED TO RUN HIGH FEVER AND VOMITING. WOULD NOT KEEP ANYTHING DOWN. MOM STATES STILL NOT KEEPING ANYTHING DOWN,  HAS APPT TODAY [4/7/11] AT 9:00 AM - POSS. REACTION TO MMR
Fever L arm pain, nasal congestion/runny, chills, burning in chest, fatigue
Patient had bruising and the injection site. States no pain. Disappeared after 2 days.