chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case report was received from a nurse on 25-Jun-2018. The report describes a 21-year-old adult male consumer who suspected blood in stool following the intake of VAXCHORA (lot number: 7000009 and expiry date: 28-Feb-2019) for cholera prevention. The consumer took VAXCHORA on 25-Jun-2018. Subsequently, on the same day, he suspected blood in his stool. The nurse reported that the consumer had a formed stool, and the water (in the toilet) was pink-tinged. The nurse stated that the consumer confirmed that had never happened before. The consumer did not have any medical conditions (specifically no history of GI conditions), chronic medications, vitamins, or supplements. The consumer did not report any history of constipation, straining, or fissures. Also, the consumer denied drinking any red beverage, such as GATORADE. He also denied eating anything that was red. The consumer was a vegetarian. The nurse stated that she had spoken with the consumer, and he was feeling fine. The event got resolved on the same day and did not happen again. Blood was found only once in the stool. The consumer neither received any treatment nor had any laboratory tests or blood work done regarding this event as it had resolved. The action taken with VAXCHORA with respect to the event suspected blood in stool was not applicable. The clinical outcome of the event suspected blood in stool was resolved. Sender's Comments: Company comment: In this case, a 21-years-old male consumer had taken VAXCHORA in the morning and on the same day he reported that there was blood in his stool. He said that he had formed stool and the water (in the toilet) was tinged pink. The patient denied having any medical conditions, specifically no history of any GI conditions. He was not taking any chronic medications, vitamins or any supplements. The event occurred only once and resolved on its own without the patient receiving any treatment for the same. Moreover, there was no laboratory tests done to conclude that it was blood in stool. The common etiologies of blood in stool are conditions like constipation, anal fissure, hemorrhoids, colonic polyp, etc. and any GI condition was ruled out in this case. Also, the colour was noticed as tinged pink which is not in line with the usual colour of blood in stool. Based on the available information, it could not be confirmed if the patient actually experienced blood in stool or it was just an incidental finding. Also, in view of the fact that this was a single isolated episode which resolved without any treatment, the causal association of the event with VAXCHORA is assessed as unlikely related.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a female neonate whose 27 year old mother was vaccinated with the first and the second dose of GARDASIL, 0.5ml, IM., (lot number not reported) on 29-SEP-2012 and 13-JAN-2012, respectively. It was reported that on an unknown date, the patient was diagnosed with bilateral preauricular sinus (congenital anomaly). At the time of the report, the patient's outcome was unknown. On an unspecified date, during pregnancy, the patient's mother experienced pregnancy induced hypertension. (MARRS# 1202USA01011). Additional information has been requested.
Nausea; Headache; Fever; Felt sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (received 1st dose on an unknown date and felt sick (nausea/headache/fever)refer case US2022AMR013100).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, nausea, headache and fever. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the nausea, headache and fever were unknown.   It was unknown if the reporter considered the sickness, nausea, headache and fever to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR013100  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient had received a dose of Shingles vaccine and felt sick for a week, nausea/headache/fever. But the patient guessed it's better than getting shingles. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR013100:1st dose
Mom reported that Thursday early evening, noted left arm began swelling, firm, very red color. Area marked per mom was 65mmx70mm; applied cold pack. Brought for check up on 4/4/03. Area looks better; a very faint pink color still little firm. Observe and call PRN.
Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL.  The patient's relevant medical history, concomitant medication, and past drug history were unknown.  On unknown date, after being administered GARDASIL, the patient complained of getting "sick" more often.  It was unknown if there was any laboratory data.  As of 09-FEB-2009, it was unknown if she continued to receive GARDASIL and it was unknown if she continued to get "sick" more often.  This is one of several reports received from the same source.  Additional information has been requested.
Client call and complained of nausea and vomiting x 7, after ingesting 3rd dose of Typhoid vaccine that started 5/9/16. On 5/10/16 client had a fever and headache. Nurse advised client to stop vaccine and start taking flds. and food in small amounts.
2" ROUND CIRCLE AROUND VACCINE AREA. IT IS HARD AND WARM TO THE TOUCH, ITCHING AND SWOLLEN RAISED ABOUT 1/2 INCH.
A non-serious spontaneous report of nurse administering FLUMIST to students experienced adverse events, breathing difficulty, chest discomfort, dizziness, sore throat and headache has been received from a health professional concerning two adult female nurses, subsequent to administering FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient did not receive FLUMIST. The reporter indicated that two registered nurses who worked in an area remote to the facility, called and reported that on specific days that these nurses were involved in adminstering FLUMIST to 30 or more students at school vaccination clinics, these same RN's experienced sore throat, dizziness, headache and chest discomfort that resulted in breathing difficulty. They both indicated that these events resolved about an hour after they left the school. The reporter also indicated that these schools have been flooded in the past. The reporter considered the possibility that these events may be a result of exposure to mold that may have developed in these schools. The outcome of all the events was resolved.
SUMMARY OF PATIENT PROGRESS:   STATUS: Progressing as expected towards goals - continuing present plan   Primary Problem: Acute respiratory failure COVID 19   Key findings related to primary problem: Pt is awake and pretty much nonverbal. Not in any pain or distress. Pt was desating to 84% on room air this morning. Pt back on 2L oxygen and sating 93-97%. Pt is discharging later this afternoon once the oxygen gets delivered. Pt's father will take the patient home in car. Treated per MAR. POC reviewed with patient.   Other key findings: Fall precaution maintained.         Note Details  Author (R.N.) File Time 9/9/2023  2:52 PM Author Type REGISTERED NURSE Status Signed Last Editor  (R.N.) Specialty GENERAL, OTHER Hospital Acct # Admit Date 8/28/2023  ED to Hosp-Admission (Discharged) on 8/28/2023  ED to Hosp-Admission (Discharged) on 8/28/2023   Detailed Report  Note shared with patient Care Timeline  08/28   Admitted from ED 1916 09/09   Discharged 2024
began 2JUN92 hives on lt arm, below deltoid on inner/outer aspect to elbow; itchy x 3 days;
COLD SYMPTOMS; FLU LIKE SYMPTOMS; ACHE; SWEATS; 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: 1805018 expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. On 16-MAR-2021, the subject experienced ache. On 16-MAR-2021, the subject experienced sweats. On 16-MAR-2021, the subject experienced flu like symptoms. On 22-MAR-2021, the subject experienced cold symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and sweats on 21-MAR-2021, and was recovering from flu like symptoms, and cold symptoms. This report was non-serious.
VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA; ACUTE LIMB ISCHEMIA; VACCINE-ASSOCIATED ARTERIAL OCCLUSIONS; This spontaneous report was received from literature. This report concerned a patient of an unspecified age, sex, race and ethnicity. The objective of this study was to describe acute limb ischemia secondary to vaccine-induced thrombotic thrombocytopenia. 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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine-induced thrombotic thrombocytopenia, and acute limb ischemia with vaccine-associated arterial occlusions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine-induced thrombotic thrombocytopenia, acute limb ischemia and vaccine-associated arterial occlusions was not reported. The authors emphasized on acute limb ischemia secondary to vaccine-induced thrombotic thrombocytopenia. Vaccine-associated thrombosis had previously been described in patients presenting with cerebral sinus thrombosis, deep venous thrombosis/ pulmonary embolism, or mesenteric venous thrombosis. Only recently had arterial thrombosis gained attention. A new entity known as vaccine-induced thrombotic thrombocytopenia (VITT) had been associated with the coronavirus disease of 2019 (COVID-19) vaccines produced by AstraZeneca and Johnson and Johnson.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230247328.; Sender's Comments: V0: 20230255013 -vaccine-induced thrombotic thrombocytopenia. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
CP with elevated troponin >37,000  being admitted to cardiology team at  a local HCF troponin 37,315
Swelling around eyes (severe)-approx. 2 days. Swelling tongue and throat-approx. 2 hrs. Increased heart beat-approx. 2 hrs. Approx. 3 hrs after vaccine given. Treated with antihistamine.
(L) arm red/swollen/indurated mild "itchiness" per pt mild pain no fever blisters - superficial - where band aids were applied (? latex allergy) went to ER last pm (3/29/11). Got KEFLEX & BENADRYL.
Information has been received from a physician via company representative referring to a 12 year old female patient. On unspecified dates, the patients was vaccinated with GARDASIL 9 (dose 1 and 2 timely, lot number and route not provided). The patient did not experienced adverse reactions with the first two doses. In January 2016 ("sometime last week"), the patient was vaccinated with the third dose of GARDASIL 9 (lot number and route not provided). The patient fainted after administration of GARDASIL 9. The patient was not injured and "kept down" as well as monitored for an unspecified amount of time by the physician. The patient recovered not long after being monitored. There was no product quality issue (PQC) involved. Additional information is not expected as we could not contact the physician.
PATIENT STATED THAT HE THINKS THAT HE HAD A COUPLE OF SEIZURES.  FELT BAD FOR SEVERAL DAYS.
Mother called to report her daughter had woken up at 4:00 AM with severe itching/hives at injection site on right arm and cont' down arm to fingers.  No temp, no severe swelling.
Pt vaccinated with DTP given at 9:45AM pt sleepy, drooley temp 100 at 11:45AM irritable when awake, Pt seen at 1PM.
RIGHT ARM WAS SWOLLEN AND RED TO WRIST FOR 5 DAYS. FIRST DAY AFTER HAD FEVER OF 102.5 DEGREES WHICH CONTINUED FOR 5 DAYS (HELD DOWN WITH TYLENOL). DIFFICULTY SLEEPING DUE TO DISCOMFORT IN ARM.
Problems with autoimmune psoriasis (Psoriasis); This spontaneous case was reported by a patient family member or friend and describes the occurrence of PSORIASIS (Problems with autoimmune psoriasis (Psoriasis)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Problems with autoimmune psoriasis (Psoriasis)). At the time of the report, PSORIASIS (Problems with autoimmune psoriasis (Psoriasis)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
itchy when they appear; Rash; little red spots; his symptoms are worsening; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration in left arm on 10Feb2021 at 11:00 (at the age of 78-years) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. The patient did not experience any event prior vaccination. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EK4174), via an unspecified route of administration in left arm on 20Jan2021 (at the age of 78-years) as dose 1, single for covid-19 immunization. The patient had no additional vaccines administered on same date of the Pfizer suspect. Following second dose of vaccination, on 10Feb2021 the patient had rash; little red spots, itchy when they appear, all over body and worse on arms. The patient stated that his symptoms had worsened from 10Feb2021, spots were not that noticeable, but they looked like mosquito bites. They were mostly on his arms and looked almost like they were under the skin. Other locations on his body, like his shoulders, they looked like they were on top of the skin. Patient also stated that the bumps are not raised, just a red blotch on his skin which were maybe 1/16th of an inch or less in size. This resulted in physician office visit and the patient was advised to put lotion and hydrocortisone cream on it by this doctor. The patient underwent lab tests and procedures in between the first and second dose on an unspecified date in 2021 at his 6-month check-up and included blood test resulted normal. The outcome of the events was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Injection site itches; Has a bruise at the injection site; Injection site burns; Very painful; Redness spreading, getting larger/Injection site is red; Arm swelling is hard; Arm swelled up, getting bigger going around arm/Swollen beyond inj site; This case was reported by a consumer and described the occurrence of injection site itching in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE QUAD) for prophylaxis.   Previously administered products included COVID-19 VACCINE with an associated reaction of injection site inflammation (on an unknown date received vaccine).   On 28th November 2022, the patient received the 1st dose of Shingrix (intramuscular) and FLUZONE QUAD (intramuscular). On 29th November 2022, 1 days after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the patient experienced injection site itching, injection site bruising, injection site burning, pain, erythema of extremities and induration. The patient was treated with lidocain and calamine. On an unknown date, the outcome of the injection site itching, injection site bruising, injection site burning, pain, swelling arm, erythema of extremities and induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site bruising, injection site burning, pain, swelling arm, erythema of extremities and induration to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's Comment: The reporter reported that the patient received Shingrix and Fluzone quad 2022-2023 in the same arm on the same day. Both vaccines were administered intramuscularly in right arm deltoid in same pharmacy. The reporter did not have lot number. On Tuesday patients arm began to swell up. It keeps getting bigger and it was hard. It was going around her arm. The redness was getting larger and spreading out more. It was not in one concentrated area. It was going underneath the armpit and down to her elbow under her arm. The injection site was red, swollen, hard, burns and itches. The patient also had a bruise at the injection site. The patient was treated lidocaine topical cream, calamine lotion and has iced the area for an hour. These events had not resolved, and they did not seem to be letting up and seems to be getting worse. Today it was swelled up, bigger and hard. It was unknown if the reporter considered the injection site itching, injection site bruising, injection site burning, pain, swelling arm, erythema of extremities and induration to be related to Fluzone quad 2022-2023 vaccine
Pt has a past medical history significant for dementia, breast CA, and tobacco abuse. The pt has symptoms of diarrhea, nausea, poor PO intake, and increasing confusion which has been going on for several days. Pt has had subjective fevers and chills at home. Pt was found to be COVID-19 positive.
Local reaction = 4 x 5 cm erythematous induration on left upper arm.
severe abdominal pain/abdominal cramping; Lack of appetite and slept; Lack of appetite and slept; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 22Sep2021 17:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization at the age of 56 years old in the Pharmacy or Drug Store. Medical history included migraine headaches and sulpha allergy from an unknown date. The patient was not pregnant at time of vaccination. Concomitant medications included estradiol, zonisamide, sumatriptan, calcium and vitamins. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Sep2021 at 1:00 AM, 8 hrs after injection , the patient experienced severe abdominal pain, the intense pain did not subside for minimum of 8 hrs. Had on/off abdominal cramping for 48 hours after receiving the Pfizer COVID shot. The patient stated, "Lack of appetite and slept when I was not awakened by the intense pain." No treatment was given for the events. The outcome of the events was recovered on unspecified date.  The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Patient administered second dose with a 21 day interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered second dose with a 21 day interval) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered second dose with a 21 day interval). On 05-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered second dose with a 21 day interval) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or treatment details reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: NNI; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 (lot# 030A21A) with no associated adverse events.
Minor outbreak of Herpes Type 1 (cold sore above lip) Treating with Valtrex at time of second dose of vaccine. Valtrex prescribed by primary care doctor?s covering physician
Fever w/lump on back of neck; on 5APr & 6APR lump is discrete, small & sl painful; Improving on 9APR91;
could not sleep (toss and turn all night); Headache; Flu like symptoms; Chills; This is a spontaneous report received from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: lot number: EL3247) via an unspecified route of administration in the left arm on 23Feb2021 at 11:15 (at the age of 50-year-old) and her second dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: EL3247,) via an unspecified route of administration in the left arm on 16Mar2021 at 10:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 10:30 PM, the patient could not sleep (toss and turn all night), experienced headache, flu like symptoms and chills. The patient did not receive any treatment for the events. The clinical outcome of the events could not sleep, headache, flu like symptoms and chills were recovering.   No follow-up attempts are needed. No further information is expected.
Fever of 102 and extreme leg pain. Pain was severe enough family came to clinic for evaluation. No redness or swelling. Symptoms appeared 12 hrs after vaccination. Treatment is ibuprofen.
Initial was hot, red and very sore.  Four days later it is still red and hot and extremely itchy.  I have tried Benadryl and a cortisone cream without any success.  It actually appears to be getting worse.  I will actually be calling my doctor tomorrow to see if I can get some prednisone to calm down the itching. After vaccines, I tend to get an inflamed  arm with redness, soreness and hot to the touch.  This is the first time I have experienced severe itching at the site.  I had nothing with the first injection of Moderna.
Patient should have received 0.5mL but received 0.25mL instead.  He has not had any adverse reaction