chrisvoncsefalvay/vaers-outcomes huggingface dataset:
~NEW PATIENT COMPLAINT: diarrhea-- ~ONSET OF SYMPTOMS: approx 7 weeks ~QUALITY SYMPTOMS: Pure water, No blood, normal 3-5x/day, yesterday q30-45 min, none today yet ~MODIFYING FACTORS: No relief with immodium,  took atropine pills -left over from ER visit 1 yr ago-some slowing ~TRIGGERS :  ? anthrax shot ~SEVERITY: ? improved today ~ASSOC SX: Nausea yesterday-now resolved,  Vomited once yesterday also,  No abd pain, no fever,  no wgt loss,  no night sweat. ~MISC HPI:   PCS next Tuesday, Got Smallpox, thyphoid , anthrax--7 week ago--developed diarrhea- for 2 week then resolved for few days prior to second anthrax on 8/14- then diarhea x 2 weeks then resolved, then got 3rd anthrax shot on 9/17 and developed diarrhea next day.    No recent travel,  No sick contacts,  No recent abx.
Onset of chickenpox rash 8 days after immunization. No complications noted, and no treatment required.
Patient came complaining of soreness and swelling of her left side of her body (arm, side, and leg). When examining her arm, the location of the immunization was swollen and very warm. Patient's arm was also red from the area of the immunization given towards her arm. Referred patient to go to hospital or PCP to get it checked.
a rash is noted left anterior thigh: 6-7cm by 4 cm;  the color is mainly red;  it is best characterized as moderate swelling;
Patient had pain, swelling and redness at the injection site that lasted 10 days.  He actually reported that on 8/16 (10 days after receiving the vaccines) his pain was radiating from the injection site to his shoulder and all the way to below the elbow. I recommended  that patient see his doctor. I informed him that these side effectts are be expected for 24 to 48 hours after the injection. Having the pain 10 days later is not usual.
Started having pain at the injection site without any redness. The pain has continued to where my whole body aches, very tired and have a temperature of 100.3 degrees
Got shingles twice I did, no third shot allowed\ Suspected vaccination failure; Get shingles twice I did; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine and got the shingles twice, third shot not allowed. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Within 48 hours of receiving vaccine developed low grade fever 100. Cold like symptoms runny, stuffy nose. 72 hrs began dry cough.
This spontaneous report was received from a back office lead and refers to a 24 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly, into left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
HIGH FEVER; EXTREME HEADACHE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced high fever, and extreme headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, and extreme headache. This report was non-serious.
103 fever at 1:00am 07/08/15 could not bare weight on legs or walk on night of 7/7/15 after receiving vaccines. Did not start bearing weight until 07/09/15.
chills, h/a, inc BP, inc pulse, back pain all sx lasting 5hr;
pt had a positive COVID test on 8/23/22; 8/29/22 pt brought to ED via EMS with increased confusion and dry cough; positive test for COVID; CXR showed COVID pneumonia; given empirical IV ABX, steroids, vitamin D, Remdesivir, O2 supplementation, Albuterol, mucolytics; pt's condition declined; terminal; comfort measures; pt passed away in the hospital
no adverse event; 2 Separate, Improperly Stored GARDASIL 9 Doses were administered to 2 Separate Patients on 02/10/2023. Improperly Stored / Administered Vaccine; This spontaneous report has been received from a consumer, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 10-FEB-2023, the patient was vaccinated with an improperly storage dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis (lot number: U029033, which was determined to be valid, with an expiration date on 13-MAR-2024) (product storage error) (strength, dose, scheme, route and anatomical location of administration were not reported). The administered dose underwent a temperature excursion of 30.9 degrees Fahrenheit (F) for 4 hours and 30 minutes. No previous temperature excursion occurred, and no additional adverse event was reported.  This is one of several reports received from the same reporter.   ; Sender's Comments:  US-009507513-2302USA005112: US-009507513-2302USA007648: US-009507513-2302USA005112:
Pt got flu shot at pharmacy on 10/29/16 developed swelling and redness to injection site next day. Seen in our office 10/31/16 swelling/redness measured 4 x 10 cm.
Have extreme inflammation under left armit armpit, left chest and the whole area is super tender, sore and painful. Also had severe chills, fever and splitting headache day after the shot
fear of death; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 2, single (Lot number: EN6202) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "I have had a serious accident" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN9581), administration date: 05Feb2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "Fear of death". The following information was reported: FEAR OF DEATH (non-serious) with onset 2021, outcome "unknown".  Additional Information: It was reported that the patient was vegan and practiced yoga for 50 plus year doing fine even though she had a serious accident. She overcame all of that and reported that 3 shots took all of that away. She reported that it was never listed that the  underline diseases or effects of covid shots caused her fear of death and job loss and reported that she accepted the poison.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146105 Same patient, different dose/event;US-PFIZER INC-PV202300123302 same reporter/patient/product, different dose/event;
No additional AE reported; a dose of M-M-R II and VARIVAX were both administered to the patient intramuscularly; Information was received from pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-AUG-2022, a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant Human albumin)(M-M-R II) (0.5 ml, lot # U028162, expiration date 09-SEP-2023) and varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml, lot # T032322, expiration date 22-SEP-2022) were both administered to the patient intramuscularly for prophylaxis (incorrect route of product administration). No additional adverse event reported.
unspecified number of patients were administered improperly stored PROQUAD and VARlVAX; No additional adverse events were reported; This non-valid spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. No information regarding the patients' concurrent conditions, medical history or concomitant medications was provided.  On unknown dates, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) (exact doses, frequency, route of administration were not reported) lot # S003447 with expiration date: 04-FEB-2021. The above vaccines were stored in temperatures from 6 degrees Fahrenheit (F) to 14 F for 40 minutes. There were previous temperature excursions: in between 6 F to 14 F for 3 hours and 30 minutes, in between 15 F to 46 F for 4 hours and in between 15 F to 46 F for 2 hours and 30 minutes. The Digital Data Logger was not involved in recording the inappropriate storage.  On unknown dates, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) (exact doses, frequency, route of administration were not reported) lot # S021322 with expiration date: 09-JUL-2021 and lot # S022757 with expiration date: 22-JUL-2021. On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact doses, frequency, route of administration were not reported) lot # S022916 with expiration date: 19-JAN-2021; lot # S030208 with expiration date: 25-MAR-2021 and lot # S012532 with expiration date: 20-OCT-2020. The above vaccines were stored in temperatures from 6 F to 14 F for 40 minutes. There were previous temperature excursions in between 15 F to 46 F for 4 hours and in between 15 F to 46 F for 2 hours and 30 minutes. The Digital Data Logger was not involved in recording the inappropriate storage.  All the vaccines were reconstituted with sterile diluent (manufacturer unknown) that was properly stored. No additional adverse events were reported.   Lot # S003447 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 04-FEB-2021 was confirmed. Lot # S021322 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 09-JUL-2021 was confirmed. Lot # S022757 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 22-JUL-2021 was confirmed. Lot # S022916 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported as 19-JAN-2021 was confirmed. Lot # S030208 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported as 25-MAR-2021 was confirmed. Lot # S012532 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported as 20-OCT-2020 was confirmed.
It started with the first one with extreme hot flashes and they didn't stop. They seemed to stop and they flared up again. I started to have little bits of issues that didn't feel normal. My scalp broke out, which happened also years ago. It brought to the surface things that have been under control. Like psoriatic arthritis about 20 years ago and I haven't had anything until after the shot. Then I had splotches of things. Just a lot more body aches and pains that I didn't have. I always have pain but these were different pains. They ran an ANA test to see if I had developed any autoimmune issue. It did come up as I did have autoimmune issue. They ran a couple tests to see what they were, and they didn't come up with anything specific. They looked through the common ones and nothing came up, just generalized autoimmune. She tried to treat me with Plaquenil but I had an allergic reaction with it and had a rash on my chest. So last week she started me on methotrexate. So my doctor is still trying to figure out how to treat it. Still considered a generalized thing right now.
Client received their vaccine in the vaccination room. Client ambulated independently to the observation room.  Observation staff approached client and greeted them. Observation staff seated client and instructed them to notify staff if they are experiencing any symptoms.  Client began to feel faint and lost consciousness before they could alert staff. Client fell forward resulting in a contusion and abrasion on their forehead and nose.  EMS and Safety officer notified via radio.  EMS arrived to the scene and placed client in supine position.  Client regained consciousness. EMS began assessment.  Vitals taken 1st BP: 98/45 Safety officer arrived to the scene.  Client transferred to wheelchair and taken to EMS area. Vitals taken 2nd BP: 103/56 Client refused to be transferred to hospital. Client completed observation time in EMS area.  Client able to ambulate independently to exit. Client transported home by friend.  Time course, approximately 1 hour from start to finish.
25MAR mom called clinic to report pt hospitalized; 20MAR body rash, t104; 23MAR pt taken to MD given ATB mom also sick; 24MAR to ER also devel vomiting & diarrhea; adm to hosp; 29MAR d/c to home;
cvxThis spontaneous report has been received from a physician referring to a currently 70 year old non-pregnant female patient. The patient's medical history and concurrent conditions were not reported. The patient had not any drug reactions or allergies. Concomitant therapies included CRESTOR, NEXIUM, CLARITIN-D, TANZEUM, TRADJENTA, Z-PAK, ONGLYZA, metformin and glyburide (+) metformin hydrochloride. On an unknown date, the patient was vaccinated with an unspecified rubella vaccine (manufacturer unknown) (strength, dose, route, lot #, expiration date or anatomical location were not reported) for prophylaxis.  She received an unspecified number of doses. On an unknown date, the patient visited the physician's office and a blood work was performed, then, it showed a low rubella titer. There was no further information or details provided. The outcome of the low rubella titers was unknown. The causal relationship between the low rubella titers and the rubella vaccine (manufacturer unknown) was not provided. Additional information has been requested.
Chest pain; Breathing difficulty; Part of my body is like burning now; side of my body, my back is burning; This is a spontaneous report from a contactable consumer. A 18-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 24May2021 (Batch/Lot Number: EW0183) as DOSE:1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date patient experienced chest pain , breathing difficulty, part of my body is like burning now; side of my body, my back is burning. Consumer stated, I am having some side effects from my vaccine, chest pain and difficulty breathing and then a part of my body is like burning now. Do you know if it's an allergy? I don't know what it is? Consumer stated, Yeah, really bad chest pain like the first day I took it which goes away but today I am experiencing the back of my body really some it should I don't know, something wrong in my body. Consumer stated, the breathing that has gotten better but reactions today, side of my body, my back is burning. Consumer stated, I have just received the first shot. The date that was I believe that was 24MAY at, I believe that 2:05. Expiration Date of first dose of COVID Vaccine: Consumer stated, No, I don't see it expiration date, I only see the date I took the Vaccine. Consumer stated, I would say the first day I experience like chest pain and little difficulty to breathe and then that went away. That was the first day yes and the second day no symptoms and then the third day I have been just happen initially today just like the back of my body is like burning. Consumer stated, I believe on the right side, I got the shot on my right arm I believe. Consumer stated, all medical condition I have just allergies that is it. (Further not clarified. Hence, not captured in tab). Consumer stated, I have not taken any treatment. Consumer was informed about the for the concern and was provided with the number as ## and requested to dial the option 3 and informed about timings as 8AM to 8PM Monday to Friday and 9AM to 3PM Saturday and Sunday as per time. The outcome for the events was unknown.  Follow-up attempts completed. No further information expected.
Patient received GARDASIL and MENVEO Tdap 7-27-15. One week later started bruising easily. I saw her 9-1-15. Platelets were 16. They are stable.
very itchy at injection site; a rash at injection site 1.5 inch; (deep pink) redness; slightly light headed; black and blue at the injection site; numbness at the injection site; light pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (slightly light headed), VACCINATION SITE DISCOLOURATION (black and blue at the injection site), INJECTION SITE HYPOAESTHESIA (numbness at the injection site), INJECTION SITE PAIN (light pain at injection site) and INJECTION SITE RASH (a rash at injection site 1.5 inch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN (ADVIL 12 HOUR) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (slightly light headed), VACCINATION SITE DISCOLOURATION (black and blue at the injection site), INJECTION SITE HYPOAESTHESIA (numbness at the injection site) and INJECTION SITE PAIN (light pain at injection site). On 08-Mar-2021, the patient experienced INJECTION SITE RASH (a rash at injection site 1.5 inch) and INJECTION SITE ERYTHEMA ((deep pink) redness). On an unknown date, the patient experienced INJECTION SITE PRURITUS (very itchy at injection site). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) (topical) for Adverse event, at a dose of UNK dosage form. At the time of the report, DIZZINESS (slightly light headed), INJECTION SITE HYPOAESTHESIA (numbness at the injection site), INJECTION SITE PAIN (light pain at injection site) and INJECTION SITE PRURITUS (very itchy at injection site) outcome was unknown, VACCINATION SITE DISCOLOURATION (black and blue at the injection site) had resolved and INJECTION SITE RASH (a rash at injection site 1.5 inch) and INJECTION SITE ERYTHEMA ((deep pink) redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included Centrum. Treatment details also included cold compresses.
Received 2 mth vaccines. Fever that night started with redness of labia the next day. Spread to entire diaper area and above diaper line by 48 hrs later. No redness at injection site.
PT INITIALLY NOTICED LUMP IN AREA WHERE VACCINATED, AREA BEGAN SWELLING THROUGHOUT MORNING - AREA AFFECTED IS FROM LEFT SHOULDER TO LEFT ELBOW. OVERNIGHT, AREA BECAME VERY ITCHY AND UNCOMFORTABLE. SHE STATES AREA THIS MORNING IS VERY RED, HOT TO TOUCH, LOOKS LIKE A VERY LARGE HIVE. SHE CALLED THE PHARMACY TODAY 10/12/15 AT 1030AM TO ASK IF SHE COULD TAKE TYLENOL. UPON DISCUSSING SYMPTOMS, I TOLD HER SHE NEEDS TO CONTACT DOCTOR TODAY FOR EVALUATION AND ASKED HER TO CALL US BACK WHEN SHE GETS MORE INFORMATION.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 at 14:30 as dose 1, single (Lot number: EN6021), in left arm, on 10Mar2021 at 15:45 as dose 2, single (Lot number: EN6199), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: 320308D), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid (Lot number 6F7861) from 24Feb2023 to 28Feb2023.
Fever 105 7 days following MMR given SQ; had febrile seizure (2nd one, 1st 2 wk prior);
Child had tunnel vision and vision was black, no LOC, could hear mom talking, room temp 72 degrees F. Pt given water and chocolate in office.
pt fainted after vaccine while in waiting area, no further issues, she was fine within a few minutes
Approximately 20-25 minutes after receiving Moderna Booster (6 months after 2nd dose of regular Moderna vaccine), I developed minor swelling on my bottom lip and tingling/pain inside my mouth. This felt similar to allergic reactions I?ve had to food; I experience ?oral allergy syndrome? (as diagnosed by my long-time allergist) to various fruits and vegetables associated with specific types of pollen. The symptoms associated with the event peaked approximately 40 minutes after the administration of the vaccine, and then started to decrease spontaneously approximately 1 hour after vaccine administration. There is still some lingering numbness and tingling on my tongue and lower lip 5 hours after vaccine administration, but the severity continues to diminish progressively over time without medical intervention.
This spontaneous report was received from a registered nurse concerning an unknown number patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with PEDVAXHIB injection, lot number M007762, expiration date 07-DEC-2018 (dose, route and anatomical location of administration were not reported), which were improperly stored at 60 F for 1 hour and 30 minutes. There was no previous temperature excursion. Digital data logger and product quality complaint were not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.