chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative referring to a 12 year old male patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscular (lot number, expiration date, concentration, dose and frequency were not reported). Concomitant therapies included influenza virus vaccine and meningococcal vaccine. On an unknown date, the patient experienced hives, issues breathing/tremendous trouble breathing, his throat was swollen shut and facial swelling, additionally, it was reported that on an unknown date, the patient went to the emergency room and also he was hospitalized for several unspecified hours. Information regarding laboratories or studies were not reported. The reporter considered that dyspnoea and pharyngeal oedema were life threatening. At the time of the report, the outcome of urticaria, pharyngeal oedema, swelling face and dyspnoea was reported as recovered. The causality between GARDASIL 9 and the adverse events was not reported. Additional information has been requested.
Itching in the arm; Has a lump on the arm, Injection site is hard; injection site warmth; Injection site is hard; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in the arm), INDURATION (Has a lump on the arm, Injection site is hard), VACCINATION SITE WARMTH (injection site warmth), VACCINATION SITE INDURATION (Injection site is hard) and VACCINATION SITE ERYTHEMA (Injection site red) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack, Stent placement and Shoulder replacement. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), CARVEDILOL, CABERGOLINE and CALCIUM GLUCONATE, CALCIUM PHOSPHATE DIBASIC, ERGOCALCIFEROL, RIBOFLAVIN (VITAMINS, CALCIUM HYDROGEN PHOSPHATE AND CALCIUM GLUCONATE) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PRURITUS (Itching in the arm), INDURATION (Has a lump on the arm, Injection site is hard), VACCINATION SITE WARMTH (injection site warmth), VACCINATION SITE INDURATION (Injection site is hard) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, PRURITUS (Itching in the arm), INDURATION (Has a lump on the arm, Injection site is hard), VACCINATION SITE WARMTH (injection site warmth), VACCINATION SITE INDURATION (Injection site is hard) and VACCINATION SITE ERYTHEMA (Injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include applying ice on injection site.
I noticed 2 red patches on my right arm near the injection site on the day reported, that slowly grew to 3 red spots. They were tender and warm to the touch. The next morning they were at least 10 times bigger with huge red patches going down my arm from the injection site. They are not raised but they are still warm and sore to the touch. *My mother also had what is described as "covid arm" but occurred closer to her vaccination date, decided to report since we both got the same symptoms but mine was much later.
pain in lower right leg and knee / scan for blood clots / 14 days of Lovonox injections (2 per day)/ I see a hematologist on December 7
Pain in chest, abnormal breathing heartbeat, low /high blood pressure, fatigue, anxiety, nausea, and fever.
pt c/o sore arm few days p/vax which worsened w/redness, swelling & inc pain;saw MD 15NOV95; on 7DEC95 area has red papular healing rash; no swelling, some soreness;
2:33 Patient reports feeling lightheaded, drowsy, and headache. BP 160/98; HR 65; O2 99% on r/a. Vaccine site EMT in attendance. bilateral equal weak hand grasps, no drift noted. Oriented x 3. States she forgot to take her BP meds this morning. Patient refused ambulance per recommendation of EMT.  2:43 Patient states she feels fine and is ready to go home. BP 122/80; HR 64. Remains oriented to person, place, and time.. Client used a w/c to arrive and leave facility. Is accompanied with grandson.  Left with grandson.
36yo MD reported he was vaccinated w/1st dose of Recombinant in NOV89 & 2nd dose in JAN90; Subequently lab eval revealed SGOT 105, SGPT 245, Anti-HBs negative, Anti-HBc negative & HBsAG negative;
Immediately after immunizations, patient stated she was dizzy and light headed.  Had patient lay down and monitor vital signs - stable.  Observed in office for 15 minutes by LPN and physician.  Patient left office with no further complications.
Got the shot 2 months ago an now got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 04-Dec-2020.  This case involves a patient with unknown demographics who got the flu after flu shot (influneza), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient experienced the flu (influenza), two months following the administration of influenza vaccine.  laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information available on the batch number for this case.
30Jun97 recv 1 dose vax. 24Aug97 Pt administered tuberculin purified protein derivative and had 20mm induration. 26Aug97 lab eval indicated varicella antibody level of 0.71 (negative)
12/20/2022 tested positive on an at home COVID-19 test. No symptoms. Went to doctor. Doctor prescribed PAXLOVID and azithromycin. Had just a slight headache and a runny nose that day. 12/21 developed slight cough with body aches. 12/22 body aches, headache and runny nose stopped. Cough persists to time of reporting.
CHRONIC RESPIRATORY FAILURE 12/18/2022  &   1/31/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient reports that 2 hours after he received the Shingrix vaccination clinic he developed epigastric discomfort and felt dizzy as if he would faint. He then vomited and seemed to feel better. Because of the symptoms he presented to on Hospital emergency room and there was admitted for evaluation of syncope. Patient recalls that he underwent a CT scan of the brain which was okay, carotid duplex ultrasound studies which he reports was okay, was seen by Cardiologist and underwent a nuclear cardiac stress test which was abnormal. Under the direction of provider the patient was started on the above medications as indicated. He has been scheduled for a cardiac catheterization by provider for January 10, 2019 due to the abnormal findings on the nuclear cardiac stress test suspicious for angiographically significant coronary artery disease. Currently feels okay. Symptoms:  Dizziness, Headache & NauseaVomiting Treatment:  Metoprolol 12.5 mg BID ,Aspirin 81 mg every day ,Atorvastatin 20 mg every day
Breath holding episode, pt became pale and limp. 5 min post episode still pale and moaning in pain referred directly to ER.
Information has been received from a registered nurse concerning a 46 year old female patient who on 19-JUL-2010 was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (Lot number 666344/1657Y, expiring on 25-NOV-2011) SC, a 0.5 ml dose of ADACEL (Lot number C3382AA, expiring on 25-FEB-2010) IM at a separate injection site in the right arm, and a 0.5 ml dose of MMR II (HAS, Lot number 666248/1567Y, expiring on 06-NOV-2011) SC to her left arm. Concomitant medications included blood pressure medication (unspecified). On 20-JUL-2010 within 24 hours the patient reported developing a large, swollen, hot, pink to red area centered on the VARIVAX (Merck) injection site, that was growing in size. The nurse advised her to use cool compresses. On Friday, 23-JUL-2010 the patient reported a blisterlike rash on both of her legs, as well as fever and swollen lymph nodes in the right armpit. Nurse saw patient on Monday, 26-JUL-2010 and reported that the rash on the legs seemed to have cleared up to series of bright red dots, and that the fever had resolved, and that the swollen lymph node had returned to a normal size. Follow up information has been received from an other health professional indicated that the patient had never been seen at their clinic nor their hospital from what the health professional could tell. The health professional asked if we were sure it was one of their providers. Follow up information has been received from a physician reported that the patient was not their patient. Follow up information has been received from the registered nurse concerning the 46 year old female (also reported as 47 year old) patient who on 19-JUL-2010 was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (Lot number 666344/1657Y, expiring on 25-NOV-2011) subcutaneously in the right arm around noon, the sixth booster 0.5 ml dose of ADACEL (Lot number C3382AA, expiring on 25-FEB-2010) intramuscularly at a separate injection site in the right deltoid at noon, and the third 0.5 ml dose of MMR II (HAS, Lot number 666248/1567Y, expiring on 06-NOV-2011) subcutaneously to her left arm at noon. On 20-JUL-2010 the patient complained of pain and fever at VARIVAX (Merck) injection site (right arm) - large area red, hot and swollen. On 21-JUL-2010 redness increased in length 8 to 10 inches in length. On 23-JUL-2010 lump was noted in right armpit and was very tender. Patient still complained of low fever and blistered like rash at lower legs. The patient was recommended to have BENADRYL as directed and CALADRYL lotion to legs. If the symptoms were worse the patient was advised to consult with emergency room physician. There were no lab diagnostic tests performed. The patient recovered on 03-AUG-2010 after approximately 2 weeks. Additional information is not expected.
He was brought into the ER via EMS for altered mental status. He does have an underlying dementia but is normally able to hold a conversation and take care of himself. He was standing at kitchen sink staring off and drooling from his mouth. He was not able to answer questions, unable to find the words, and was weak. Admitted to hospital.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. In 2009 the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route, lot # not reported) and now in 15-MAY-2013, was at the pharmacy to receive the second dose in series of RECOMBIVAX HB. No adverse effect reported. Additional information has been requested.
nonspecific rash 1 day later; 17NOV92 unable to reach by phone & has not responded to letter;
Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Subsequently the patient experienced redness to the area, fever and other injection site reactions. The patient sought unknown medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
minor aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "minor aches". Additional information: This is the first of the two people in the family reported for minor aches after the Pfizer vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264597 Same reporter, drug and event; different patient.
diarrhoea; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhoea) and VACCINATION SITE PAIN (pain at injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIARRHOEA (diarrhoea) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, DIARRHOEA (diarrhoea) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD21-045219 (Patient Link).
Waited the 15 minutes plus after shot and stayed at the pharmacy.  Throat started getting scratchy on my drive home.  shoulder started to itch as well as my back a few hours after and a rash/ itchiness across both arms, back and face through the next day and a half.  used benadryl and ice packs to help with the itchiness. called my old rheumatologist and they said to contact the primary.  primary was OOO for another week so was not able to contact them. primary not helpful in many past appointments (including my drug allergies not being updated multiple times when having to review my chart) so have not tried to contact them again.
Rash covering my front and back torso, Left thigh, BUE. Also still have huge red area on left deltoid 3 weeks after my injection. I have tried Benadryl and Pepcid to see if it was a histamine reaction that I could stop. Also I now have a psoriatic arthritis flare and my plaque psoriasis is not being managed by topical treatments. The rash started at about day 5 and continues presently. The injection site was indurated and tender x 14 days.
Redness around injection site with welts/blisters, hot to touch with tenderness, headaches, cough, malaise, swelling around injection site.
Patient presented l with an acute respiratory distress with tachypnea, tachycardia and hypoxemia. Her chest x-ray showed bilateral infiltrates suggestive of COVID-19 pneumonia. She tested  her D-Dimer, ESR, fibrinogen levels were elevated as well. She was admitted to in respiratory isolation with all COVID precautions. When her vitals and oxygen saturation looks better at present. Pt stable and will be discharged home.
On 5/24 @ 8:30 pm swelling with knot; skin warm to touch. Next morning second knot appeared. "Looked like 2 mosquito bites" per mother.  Mom took patient to MD (on 5/26/11; MD stated "no infection.   Localized reaction". No treatment.  Also no redness noted.
developed a fever of up to 99F; sore throat; headache; diarrhea off and on for 2 days; chills; weakness; pains on the side of her neck; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 27Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization. On the second day (28Apr2021) the patient experienced a fever of up to 99 degrees Fahrenheit. She had chills and weakness. She had a sore throat with pains on the side of her neck, headache, and diarrhea off and on for 2 days. Today (03May2021) her headache was gone. Towards the latter part of the day her temperature goes up. The outcome of headache was recovered on 03May2021. The outcomes of fever, chills, weakness, sore throat, pains on the side of her neck, and diarrhea were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial report received on 03 December 2007 from a health care professional. An adult patient, with no concurrent illness, who was traveling on a cruise ship as an entertainer, had received a subcutaneous dose of YF VAX vaccine (lot number UF197AA) on 26 November 2007. The site of administration was not reported. At an unspecified amount of time later, the patient developed big red spots and burning at the injection site, along with sweating, fever, and nausea. The patient did not seek medical attention. Treatment received was not reported. At the time of this report, the adverse events were resolving. The reporter for this case is the same as for cases 2007-04169, 2007-04170, 2007-04171, 2007-04173.
blood sugars went up to 600 on the first night and has been in high 400's at night but sugars are fine during the day
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient received treatment with Paxlovid from 04Mar2023 to 09Mar2023. The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5], has been requested and will be submitted if and when received.
Pt experienced sycope immediately after injecting the HPV vaccine. The menactra was administered first. Patient lost conciousness for 10-15 seconds, eyes rolled back and her body experienced rigors. Patient was placed supine for recovery. Patient does not remember episode. MD immediatley brought to check on patient . Patient allowed to recover and was released without issue.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium
Well child exam for 12 month old male. Child was given IPV vaccine, dose #4. THis is too early; should not be given before fourth DOB.
Vertigo lasting more than 3+ hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 17:30 (Lot number: FF2587) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN taken for type 1 diabetes mellitus. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 07:00 AM), administration date: 16Feb2021, when the patient was 27 years old, for Covid-19 Immunisation, reaction(s): "Inappropriate schedule of product administration"; Bnt162b2 (Dose Number: 1, Location of injection: Arm Right, Vaccine Administration Time: 07:30 AM), administration date: 01Feb2021, when the patient was 27 years old, for Covid-19 Immunisation. The following information was reported: VERTIGO (non-serious) with onset 16Oct2021 09:00, outcome "not recovered", described as "Vertigo lasting more than 3+ hours". The event "vertigo lasting more than 3+ hours" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
The day following the vaccinations, patient began experiencing stomach pains, approximately 10-12 per day. Patient would cry and double over from the pain for approximately one to two minutes with each pain. She began eating and drinking very little. She was not experiencing fever or diarrhea. She was still having wet diapers and bowel movements. On the third day following immunizations, patient was taken to the doctor due to her lethargy, stomach pains and poor appetite. The doctor suspected a virus. She was taken back to the doctor on the seventh day following her immunizations, as she was showing no signs of improvement. The doctor ordered urinalysis, blood work, and an ultrasound. That same evening, patient's feet swelled and began bruising. She was unable to put weight on them because of the pain. We took her to the emergency room, where she was admitted. While in the hospital, patient had: IV fluids, antibiotics, x-rays of both feet, further blood work and urinalysis. Patient was admitted to the hospital, 12-11-2017 and was discharged 12-13-2017. The attending physician said that she was "70, 80, 90 percent certain" that patient had been suffering from Intussusception. No explanation was given for patient's swollen feet, or for the cause of the inflamed intestine.
UrticariaPruritus Narrative: 0933 PT STATES SHE FELT "ITCHY"/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. 0957 PT STATES NOW ITCHING TO PALATE; FEELS "SWOLLEN"; NO NOTED OBSTRUCTION TO AIRWAY NOTED; EMS CALLED; 1015 PT DECLINED TRANSPORT TO ER VIA EMS; REMAINS STABLE; SAT 98%; DENIES DIFFICULTY BREATHING. 1035- BENADRYL 25MG PO ONCE ORDERED BY DR, AND GIVEN BY RN. VSS; P-74; R-16; SAT-99%; BP-133/79; TEMP-98.6;PT ABULATED TO OFFICE; HUSBAND TO DRIVE PT HOME LATER TODAY.
RASH ON STOMACH; FATIGUE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug allergy.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, administered on 15-MAR-2021 14:45, in left arm, for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced rash on stomach. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on stomach, and fatigue. This report was non-serious.
Multiple swollen  and painful lymph nodes on right side (side of vaccine administration) in the areas of the armpit, below the clavicle, above the clavicle and on the neck at the clavicle. Pain and swelling will not abate.
Dose 1 given 3/2/2021 Lot # 025A021A  Patient was admitted with covid 19 to the hospital and discharged home
Reported 2 weeks of lower extremity pain, incidentally found on venous duplex to have bilateral arterial clots, vascular surgery consulted for management.