chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling and tenderness in right armpit.  Tdap and MCV4 given in right deltoid.
Injection Site Pain, Tiredness, Chills, Fever, Nausea, Swollen Lymph Nodes (back of head), Arm Pain, Feeling Unwell, Lightheadedness
proctitis, hemorrhagic;resolved only p/Cipro; proctofoam was tried first w/only partial relief;hemorrhagic proctitis reoccurred about 3-5 days p/finishing cipro;
From initial information received on 10/29/04 from a physician regarding an adverse event occurring in the USA, it was reported that a female patient (age not provided) received MENOMUNE A/C/Y/W-135, lot number UB482AB, administered SC on 10/28/04. The same day, the patient complained of bilateral upper and lower extremity paralysis and was unable to speak. The patient recovered from these events. From additional information received on 11/01/04 from a telephone contact with the reporting physician, it was reported that the physician spoke with the patient on 10/29/04. After receiving the MENOMUNE A/C/Y/W-135, the patient went home and took a nap. As per the patient, when she awoke later that evening she was unable to speak and had difficulty moving. She went to the emergency room, but her symptoms resolved by the time she was seen by an emergency room physician. The patient did not receive any treatment. The reporter was unwilling to release any medical history, date of birth, or any additional information for the patient. (OMIC)  Follow up on 11/12/04 states: "From additional information received on 11/03/04 from a physician, the 18 year old pt was vaccinated with MENOMUNE A/C/Y/W-135 on 10/28/04 at 13:00. Approximately four hours later, at 17:00, the pt experienced transient paralysis of the limbs, eye lids and mouth. The pt was seen in the ER, observed and released. Reportedly, the pt recovered from these events."
Patient received Adult Pfizer diluted with 1.3ml of diluent instead of 1.8ml.
chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 013M20A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose). At the time of the report, CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose) had resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. It was reported that patient had chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose.   This case was linked to MOD-2022-656706 (Patient Link).
This spontaneous report was received from a medical assistant regarding a male patient of unknown age. The patient was vaccinated intramuscularly with dose 1, 0.5 ml GARDASIL (lot # 6730629AE, expiry: 16-DEC-2014) on 27-SEP-2012. No concomitant medications were reported. The patient had received the second dose of 0.5 ml GARDASIL (lot # not provided) intramuscularly on 28-NOV-2012 and third dose on 27-DEC-2012. No adverse experiences reported with any doses of GARDASIL. Additional information has been requested.
Approximately 2-3 minutes after injection patient stated, "I don't feel right." Throat then became "itchy and scratchy" Patient was given water to drink and waited in exam room. Patient was given Benadryl 25 mg IM @ 1202 and Kenalog 40 mg IM @ 1159 by nurse
2pm, very tired.  4pm, sick in stomach, dizzy and very weak.  The rest of that night and the next day just sick all over feeling, like flu but know you cant get flu from the flu vaccine.  No fever, in fact low temp.  Felt very hot at times though.  This is the third time in 8 years this has happened to me after the flu shot. Eight years ago same symptoms as above but also green mucus coming out of eyes.  Did go to ER that time.  They said it had nothing to do with the vaccine.  Was perfectly fine all three times before the flu vaccine.
Pt received above immunizations. Waited in waiting room and at 10 after injections began to complain of chest pain & pressure. VS taken EKG done pt transferred to hospital. Pt cleared at hospital and sent home. No further issues. Pt very nervous about receiving immus.
Engerix-B was given to 325 city employees & 6 months p/last dose 50 employees were tested & 18 tested sero neg;
TROUBLE BREATHING, PALPATATIONS, VOMITING, NAUSEA, CHILLS, FEVER, FATIGUE,  TWITCHING ON  INJECTED ARM, SWELLING IN ARM
Black nasal discharge; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 09:00 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; TOPIRAMATE; PAROXETINE; VITAMIN D [VITAMIN D NOS]; XANAX. The following information was reported: NASAL DISCHARGE DISCOLOURATION (non-serious) with onset 07Mar2021 18:30, outcome "not recovered", described as "Black nasal discharge". Therapeutic measures were not taken as a result of nasal discharge discolouration.  Additional information: The patient has no allergies to medications, food, or other products. Additional concomitant medication included multivitamin. The most recent COVID-19 vaccine was administered in the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose on 15Mar2021 at 09:45 AM in the left arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
From initial information received on 4/5/04 from a health professional regarding an adverse event occurring in the USA, it was reported that a 26 year old female patient received her third dose of IMOVAX RABIES vaccine, lot number W1419, administered IM in the left deltoid at 3:00 PM on 4/2/04. Four hours later, the patient felt pain and heaviness in her left arm, felt a lump over tricep, experienced swelling of the arm and swelling of fingers in left hand. Patient also experienced swelling of the lymph glands in her left axilla. Tylenol was taken as needed for treatment. The patient's recovery status is currently unknown. Follow up phone call to reporter on 4/21/04 to learn indication for vaccine series which was prophylactic since she is veterinary technician. Also, this patient has recovered and continued with the vaccine series without any reaction reported. From additional information received on 5/3/04 from a health care professional, the patient received his first dose of IMOVAX RABIES, lot number W1419, administered IM in the left  deltoid on 3/12/04 and his second dose of IMOVAX RABIES, lot number W1419, administered IM in the left deltoid on 3/19/004. The patient did not have any illnesses at the time of vaccination. No additional information is expected, therefore this case is considered closed.
Tested positive for COVID last Wednesday 11/24.  Patient admitted as inpatient on 12/4 due to worsening Covid-19 symptoms.  Extensive covid pneumonia.  Patient has known history of primary progressive multiple sclerosis and is on ocrelizumab
21YO MALE WITH HX OF FEAR OF NEEDLES AND VASOVAGAL RXN AFTER NEEDLES P/W LIGHTHEADNESS, DIAPHORESIS, AND BLURRY VISION IMMEDIATELY AFTER COVID INJECTION.  NO ACTUAL SYNCOPE.  DENIES CP/SOB, HA.  RXN IN PAST USUALLY OCCURS AFTER NOT EATING.  PT DID NOT EAT ALL DAY.  PT WAS LAID ON THE GROUND AND HAD IMMEDIATE IMPROVEMENTS.  PT WAS TAKEN TO OBS AREA AND GIVEN FOOD AND DRINKS WITH MORE IMPROVEMENTS. PE: HEART - RRR. LUNGS CTA NO WHEEZING 2:24 HR 79 RESP 16 103/70 SATS 100 2:37 HR 72 RESP 16  123/80  SATS 100 2:50  HR 90  RESP 17  119/86  SATS 99 2:58  HR 98 RESP 16 116/80 SATS 98  PT SIGNIFICANTLY IMPROVED.  ABLE TO WALK ON HIS OWN TO THE CAR.  PTS BROTHER IS THE DRIVER. PT RELEASED TO HOME.
pt recvd vax & 4 hrs p/vax exp chills, h/a, sore arm, weakness, sweating, mild SOB & palpitations; pt indicated walked 4 plus miles p/inject; pt treated sx w/anacin 1/2 tablet/day;
Sore arm after each dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm after each dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Cancer and RA.    On 25-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after each dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after each dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.   This case was linked to MOD-2021-350729, MOD-2021-350755 (Patient Link).
Information has been received from a medical assistant concerning her 16 year old daughter who on 11-FEB-2008 was vaccinated the third dose of with GARDASIL. During the last week of February 2009, the patient experienced anal bleeding and approximately 3 lesions around the anus. She was treated by a physician assistant in the office. The lesions were at that time "burned off". One week later the bleeding returned and the daughter had more than 30 lesions around her anus. Follow-up information was received from the physician's assistant concerning the 16 year old female patient with no known allergies and no illness at time of vaccination who on 04-APR-2007 was vaccinated IM with the first dose of GARDASIL (lot #: 655503/0012U) into the left thigh, on 21-AUG-2007 was vaccinated IM with the second dose (lot #: 658556/1060U) into the right thigh and on 12-FEB-2008 was vaccinated IM with the third dose (lot #: 657736/0389U) into the right thigh. In approximately January 2009, the patient developed multiple warts on rectum. On 05-MAR-2009, rectum biopsy was performed. The tissue of genital wart (rectum) was tested. It was reported the specimen consisted of a single tan, irregularly shaped tissue fragment measuring 0.3x0.3x0.2 cm. The surface was regular. The margin was inked black. The physician's diagnose by the rectum biopsy was condyloma. There was viral cytopathic effect characteristic of HPV infection. No high-grade dysplasia was seen. The patient was treated with podophyllin and "hyphinkater". Multiple warts on rectum/condyloma and characteristic of HPV infection were considered to be other important medical events. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 at 13:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 01Jan2021, stop date: 10Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: previous no symptoms and negative test; (Sep2022) Positive; (20Sep2022) Positive, notes: 20Sep with retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
2 BIG BRUISES IN LEFT LEG; This spontaneous report received from a patient concerned a 32 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816077, and expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced 2 big bruises in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 2 big bruises in left leg. This report was non-serious.
Patient got a third dose of 0.50 mL instead of a booster dose of 0.25 mL; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (Patient got a third dose of 0.50 mL instead of a booster dose of 0.25 mL) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In August 2021, the patient experienced ACCIDENTAL OVERDOSE (Patient got a third dose of 0.50 mL instead of a booster dose of 0.25 mL). In August 2021, ACCIDENTAL OVERDOSE (Patient got a third dose of 0.50 mL instead of a booster dose of 0.25 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.   Reporter did not allow further contact
Pt has returned to pharmacy with complaint: pain to left arm injection site. Pain radiates up over left sholder and up left side of neck, as well as down left arm to elbow. Site is red and inflamed to a 2.5 inch diameter. Pt complains of fever.
Symptoms: (05/01/21) Woke up with sore throat. Shortly developed stabbing chest pain that got progressively worse.  Treatment: (05/01/21) taken to ED, was given morphine for pain. EKG showed STEMI. Troponin levels were in the 20s . Was also given 325mg of Aspirin. Troponin levels finally decreased to ~6 on day three (05/03/21).  He was discharged that same afternoon on 5/3.
Pt recvd 1st Engerix-B vax 25JUL91 & 2 days later pt exp pain in elbow & wrists; 2 wks later exp aching in long bone of wrists, knees, kunckles; has problem handling objects; ER visit required; eye swell; poss thimersol rxn;
Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 20-FEB-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Patient was given an extra dose of MMR which is not needed because patient has completed a series of MMR. It was overlooked because the MMR was broken down separate column rather than in combo set.
Patient woke up in the morning with red bumps/rings on face, back, belly, bilateral arms, bilateral legs and patient has a chick pox on his buttocks.
Vaccine administered in office. That evening, developed redness, swelling, and tenderness at injection site. Blistery rash developed shortly afterwards. Taken to ED on 08/14/2016. Prescribed antibiotics for cellulitis. Follow-up in office on 08/15/2016. Appeared to have a bullous impetigo.
10days p/vax pt became sick. dx w/extremely bad case of measles, w/fever, rash, irritability, minor respiratory sx, & 1-2 slightly soggy-type stool, teal color. also kept bumping head against the wall.
Reddened arms and legs. Small dots around month, rash back of neck, coughing, more lethargic than usual.
I had the vaccination on March 2, 2021.  I had a sore arm the next day and it went away.  I was doing okay.  The night of the 9th my arm hurt a bit but did not think much of it.  On Wednesday I noticed a rash.  It got worse within the hour.   Today it burns and feels hot to the touch.  I visited the doctor this morning.  They gave me a prescription for an antibiotic because it showed signs of  cellulitis.
Numbness of left side of the face and tingling sensation from time to time (various times during the day).
This spontaneous report as received from a 74 year old female consumer reporting on herself. No drug reactions/allergies were reported. On 14-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On 25-MAR-2013, the patient was placed on therapy with DULERA (dose not reported) inhales, twice a day for pulmonary arterial hypertension. Concomitant therapy names were not reported. On 25-MAR-2013, the patient got hives on scalp and around the edge of her face when she started using DULERA. Action taken with DULERA was unknown. The outcome of hives on her scalp and around the edge of her face was unknown. Additional information is not expected.
It started with a weird sensation in my toes then up my back.  An oversensitivity.    Now I have back pain and weakness between my shoulder blades, neck stiffness, a deep uncomfortable feeling in my upper back that comes and goes.  I  have trouble sleeping.  The whole affair makes me depressed.  I cannot seem to fix myself.
sleep a lot; Blister; This is a spontaneous Other company report from a contactable physician (patient). A 91-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EL12184 and expiration date was not reported), via intramuscular on 02Mar2021 as dose number unknown, single for covid-19 immunization (at the age of 91-years-old ), hydrocodone bitartrate, paracetamol (VICODIN), via oral route from an unspecified date (Lot number was not reported) and ongoing, at 325 mg, 2x/day for an unspecified indication. Medical history included psychotic disorder. Concomitant medications included atorvastatin calcium (10 mg, 1x/day ), solifenacin (10 mg, 1x/day), colecalciferol (1 tablet twice a week), docusate sodium (3 in 1 week) taken for diarrhoea. On 04Mar2021 the patient experienced blister on left knee after sitting in the sun. On an unspecified date patient experienced sleep a lot. Relevant tests were none. The patient was recovered from blister in March2021 and outcome of sleep a lot was unknown.  The reporter's causality for the event of makes sleep a lot and Blisters on. Left knee after sitting in the sun was provided.  No follow-up information needed. Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
It was reported in a published article, title as stated above, that a 12 month old female was vaccinated with a first dose of Varivax vaccine. Suspect vaccination at the same time included a third dose of Pneumovax 23 vaccine (manufacturer unknown). The previously healthy girl presented with an 18-day history of increasing irritability, somnolence, and fever that began shortly after receiving the two vaccinations. Her past medical history included no previous vaccine reactions, surgeries, hospitalizations, or serious illnesses. A physical exam revealed a temperature of 97.8 degrees Fahrenheit, pulse 154, respiration 26, and blood pressure 126/59. She was a pale but playful girl with clear rhinorrhea, normal tympanic membranes, clear lungs, 2/6 lungs, 2/6 systolic ejection murmur, no organomegaly, and no edema. Laboratory tests revealed WBC 10.3, HGB 5.8, retics 4.3 corrected, Tbili 1.5, normal transaminases, direct Coombs' 3+ with warm autoantibodies present. The patient was admitted to the hospital and treated with IV steroids, IVIG, and one transfusion. Eleven days later she was discharged with a HGB of 9.7. Serology three months later revealed adequate IgG antibodies to varicella and a negative direct Coombs' test. She was tapered off steroids over four months, and there have been no relapses of hemolytic anemia in over three years despite subsequent vaccines.  No further information is available. A copy of the published article is attached as further documentation of the patient's experience.
1005 Hives Bilateral lower legs 1010 Gave Benadryl (12.5 mg 15ml)-1 ml PO 1040 All symptoms gone. No Hives. No difficulty breathing, no rash. Babe sleeping in mom's arms in no distress. Released to parent. Injection site with redness or edema.
feels weird; feelings of anxiousness; blood pressure it's a little high 143/92; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2021SA410476.  A 26 year-old male patient received bnt162b2 (BNT162B2), administration date 23Nov2021 (Batch/Lot number: unknown) as dose number known, single for covid-19 immunisation; dupilumab (DUPILUMAB), administration date 03Dec2021 (Batch/Lot number: unknown) as 300 mg. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feels weird"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "feelings of anxiousness"; BLOOD PRESSURE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "blood pressure it's a little high 143/92". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for dupilumab was unknown.  Additional information: As per the reporter on 03Nov2021 the patient developed a non-serious event feels weird (feeling abnormal), feeling of anxiousness (anxiety), blood pressure and it was a little high 143/92 (blood pressure increased). Action taken with Dupilumab (Dupixent) and Tozinameran (Pfizer BioNTech Covid-19 vaccine) was unknown for all events (feels weird, feelings of anxiousness, blood pressure and it's a little high 143/92). It was not reported if the patient received a corrective treatment for the events (feels weird, feelings of anxiousness, blood pressure and it's a little high 143/92).  The lot number for bnt162b2 was not provided and will be requested during follow up.