chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 3-year-old female who on 19-AUG-2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 27-AUG-2005the patient developed less that 50 lesions and on 28-AUG-2005 the patient developed a fever. Unspecified medical attention was sought. No further information was available at the time of the report. No product quality complaint was involved. Additional information has been requested.
My vision was blurred all day the day I received the vaccine. I started noticing my bladder felt really full and I didn't feel like I could void. This lasted all day then the next day. It was odd. I felt bad too.I can't really attribute this to anything but the flu shot, but I am not certain what caused it.
Swelling and inching a large bump at site of injection 6 days after I had the vaccine.
Received vaccine on 7/28/21; on approx. 8/6/21 started symptoms of slight numbness in left arm and left side of face.  The symptoms progressively got worse for the next week and Pt called the pharmacy today 8/12/21 to report the adverse reaction.  He stated it was bearable at this time. Instructed him to contact his primary care provider and if symptoms got worse to go to Urgent Care. Pt lifts weights daily and he was advised to discontinue until symptoms subsided.
Redness, swelling, hot to touch 10 x 7 cm red induration.
Immunes given on 12-4-09. She developed fever, had seizures, transferred to hospital.
Systemic: Lymph Node Swelling-Severe, Additional Details: After administration of the first vaccine, the patient reported to their doctors office with severe lymphedema of the left arm. The patient was vaccinated in their right arm.
Within aprox. 2 minutes of receiving second dose I couldn't breathe but it passed within less than one minute. I wasn't experiencing anxiety about the shot, I was calm when it happened and sat down but it went away. I waited the duration of time as requested without further incident so I did not report it to the nurse sitting in the room.  After I thought more about it as it was definately a little "freaky", I thought I probably should have. I am assuming it was just my body acknowledging/recognizing the vaccine.
The patient told us that she had gotten her first dose as a Moderna at a different facility, so we gave her the second dose of the Moderna today. Per  the patient had received Pfizer as her first dose of the vaccine. The patient had no adverse reaction to either vaccine.
Had moderna vaccine on Jan 12th arm became red and very swollen as well as headache and fatigue .  My arm felt better by Jan 15 .  unfortunaletly I started having dis comfort in my arm and was very shocked to see it swollen red and itchy on Jan 20th which prompted me to seek care from my personal physician Dr.
Pneumonia; Disease progression; They found a 9cm mass on her liver.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist and Other Health Professional reported that an 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) at the age of 83-year-old, at single dose for covid-19 immunisation; palbociclib (IBRANCE, Film-coated tablet, strength 100 mg), via an unspecified route of administration from 24Jul2020 (Batch/Lot number was not reported) to 30May2021, at 100 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. It was reported patient stopped the palbociclib a few days ago. It was notified on 25Jun2021 Friday. Patient was home hospice now. She had pneumonia after her COVID vaccine a month ago and then when she went on for her scans they found a 9cm mass on her liver. So the doctor decided to stop palbociclib as a sign of disease progression and she was declared home hospice. There was no hospitalization. The patient underwent lab tests and procedures which included scan: found a 9cm mass on her liver in 2021. The action taken in response to the events for palbociclib was permanently withdrawn. The outcome of events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association and the limited information available, the causal association between the event pneumonia and the suspect products palbociclib and BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Chronic headache, dizziness ,head   pressure, jaw pain and ear ringing Failed: topomax, steroids, botox shots physical therapy, gabapenpin, medical cannabis
really bad pain on the arm of the injection for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really bad pain on the arm of the injection for a couple of days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (really bad pain on the arm of the injection for a couple of days). At the time of the report, PAIN IN EXTREMITY (really bad pain on the arm of the injection for a couple of days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications were provided
Pt reports difficulty swallowing, numbness to lips and mouth area, sensation of eye swelling.  Pt appears anxious.  Medics on site for evaluation; VSS.  Pt left AMA.
Myalgia, NauseaVomiting, Fatigue, right arm soreness Narrative: 1/6 received the vaccine. developed some fatigue later that day. 1/7 12 hours later woke up with body aches all over, nausea, and right arm soreness. later in the morning developed a headache. Denies vomiting or other symptoms. She called in sick for work on 1/7. 1/8 employee reports she's returned to work today and symptoms have resolved.
Nov 20- Started as a few small bumps but on his torso, back and neck. Nov 24-  The size of the bumps are small but has spread all over his body including inside his ears. They itch and get red and inflamed if the shower is too warm. Nov 30 - The bumpy rash is transitioning into brown spots. My sons torso, back and neck are spotted while the remainder of his body still has bumps. Dec 1- Now his entire body is marked with brown spots and small bumps.  Dec 8 - We see where the rash has changed from bumps to  mixed brown spots and is now starting to look dry scaly. Dec 15- Most of the rash is gone but he is still very scaly Dec 25- Brown spots of the rash are reappearing.
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# M005732, expiration date 19-OCT-2017) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 9 and 25 degrees Celsius (also reported as "10.2 C") for 2 hours; and a previous temperature excursion between 9 and 25 degrees Celsius (also reported as "10.4 C") for 1 hour and 50 minutes in two different time frames. Moreover, it was reported that a digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested
Reporting a vaccine administration error.  Patient was given a dose of Moderna vaccine that was expired at the time of administration.  Vial that dose was drawn from was moved from freezer to fridge on 8/30/2021 at 8:45pm, starting a 30 day expiration per manufacturer.   Error was discovered on 10/5/2021 after a subsequent vial from the same box was identified as being expired.  Manufacturer was contacted on 10/6/2021  for guidance.  Manufacturer indicated on 10/6/2021 that they will "conduct an analysis to determine if the vaccine administered past 30 days provided the necessary protection against a COVID-19 infection".  Patient was contacted and informed of the vaccine administration error.  Patient reported mild AE's consistent with common Covid-19 vaccine AE's (arm pain, low grade fever) that have resolved.  Patient is awaiting follow up guidance from manufacturer.
According to patient, within 12 hours of vaccine adminstration, she began feeling some pain on/around injection site.  Patient examined site and found blistering type of lesion.  Patient presneted back to me 2 days after vaccination was given.  Approx. 10mm blister type lesion noticed lateral to site of injection (approx 25-30cm away from injection site)  Patient states pain was not that bad any more ( 2 days later )  No other signs or sx present.  NKA/NKDA.  No tx given.  Do not know if lesion has resolved yet.
Itching at injection site: treated with Benadryl 50mg with resolution of symptoms.
Narrative:  Patient received covid 19 vaccine(J&J) 4/10/2021 about 3 weeks later experienced loss of balance/weakness/memory changes/possible stroke
Muscle Aches (mild to moderate).  Joint pain (mild to moderate)  Insomnia (mild to moderate)
Mild Tinnitus several hours after vaccination.  Tinnitus still present after 2 weeks
09/09/21 @ 900AM-patient received Pfizer vaccine 0.3 ml (Lot FC3183) -> Error due to patient received Moderna (Lot 088D21A) on 08/13/21
Pain and itching; She didn't get out of bed, slept all day; Rash; Pink circular blotches on her face, body, and arms; Pain and itching; doctor told her she is allergic to the COVID shot; She was sick for seven days; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, expiry date not reported) via an unspecified route of administration, on an unspecified date at dose 1, single for covid-19 immunization. Medical history included high blood pressure and high cholesterol. The patient had pneumonia, Flu vaccination on an unspecific date and not been allergic to penicillin. The patient's took unspecified concomitant medications. The next day after the vaccination, the patient experienced rash and it progressed, pink circular blotches on her face; a lot of it was on her body and arms, front and back of her body and doctor told her she is allergic to the covid shot, pain and itching, she didn't get out of bed, slept all day and was sick for seven days. It was also reported that something in the serum of the COVID shot caused her to have such a reaction. The outcome of the events was recovered on an unspecified date in 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hot, red, painful , itchy, swelling about the size of a softball at the injection site area.
Patient was given Hepatitis A 12/5/14. She develop pimple like rash at the injection site. The pimples or blisters have popped and scabbed over. Tx with hydrocortisone not helpful. Mom claimed the area is getting larger.
I couldn't eat.; fever; Chills; Headaches; so bad that it was hard to put my head on the pillow. The headaches were the most; Patient wanted us to know that it was the severity of the headache that bothered me.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (I couldn't eat.), PYREXIA (fever), CHILLS (Chills), HEADACHE (Headaches; so bad that it was hard to put my head on the pillow. The headaches were the most) and HEADACHE (Patient wanted us to know that it was the severity of the headache that bothered me.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (I couldn't eat.), PYREXIA (fever), CHILLS (Chills), HEADACHE (Headaches; so bad that it was hard to put my head on the pillow. The headaches were the most) and HEADACHE (Patient wanted us to know that it was the severity of the headache that bothered me.). At the time of the report, DECREASED APPETITE (I couldn't eat.), CHILLS (Chills), HEADACHE (Headaches; so bad that it was hard to put my head on the pillow. The headaches were the most) and HEADACHE (Patient wanted us to know that it was the severity of the headache that bothered me.) outcome was unknown.
PATIENT HAD BIG RED ROUND MARK ON HER LEFT THIGH, WAS A BIT SWOLLEN AND SHE WAS HAVING TROUBLE WALKING BECAUSE IT WAS PAINFUL. TREATMENT WAS MOTRIN AND HEAT PATCH.
pt recvd DTP/OPV/HIBTITER 21DEC92 in the evening; in AM of 22DEC92 pt broke out in a rash (generalized) w/runny nose x 1 day; r/o viral exanthem-r/o reaction to vax;
5/19 Rehab admi, 78yo male with multiple medical problems including HLD. HTN, GERD, RA on prednisone, DM with neuropathy, CAD, CKD admitted on 5/5  for right foot infection.
Woke up about 12 hours later, teeth chattering, dizziness, nausea, arm extremely sore, chills and feeling really cold and couldn't get warm. She had diarrhea, lightheadedness, couldn't keep anything down. She tried drinking ginger ale.  Lasted for about 20 hours. She started feeling better afterwards. Later she had no taste for food which lasted about 2 weeks. After 5 weeks, she has no taste for wine.
On the 8th day after the initial injection, there was a sudden onset of pain, swelling, redness, and itching at the injection site. There was pain and swelling at the injection site on the 2nd and 3rd day after the injection, but no noted symptoms day 4 - 7.
hot rash at the injection site; itchiness; rash at the injection site; pain/discomfort and redness at the injection site; redness at the injection site/red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PAIN (pain/discomfort at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site/red at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain/discomfort at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site/red at the injection site). On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PRURITUS (injection site itchiness) and VACCINATION SITE RASH (rash at the injection site). On 22-Jan-2021, VACCINATION SITE PAIN (pain/discomfort at the injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site/red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment included Advil.
dose number=3; Tested positive for Covid on at home test; Tested positive for Covid on at home test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "Tested positive for Covid on at home test". The event "tested positive for covid on at home test" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Other. Therapeutic measures were taken as a result of covid-19.  Additional information: The patient had not received any other vaccine within 4 weeks and medications within 2 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested positive since the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Initial misuse report received from health care professional on 16 Oct 2013.  A 0.25 ml dose of FLUZONE was administered to 2 week old patient on an unspecified date. No adverse event was reported. List of documents held by sender: none
Noticed swelling of thigh at injection site. Larger than 3" diameter. Hot to touch. Taken to hospital.
On 8/16 mother called and said daughter's right leg was swollen the size of a softball, warm and had red streaks. Mom had given warm baths, 2 today and Tylenol. Bled after 2nd bath, told to call Dr due to size of reaction and red streaks. Pt saw Dr regarding reaction. He did not feel it was cellulitis, but a significant reaction to the immunization. By 8/21 the reaction had gone down some, but still had a hard lump. Told client that tetanus can cause a lump that may last for days or weeks, but will gradually absorb. Recommended she talk with Dr prior to school shots.
Days 1-4 of vaccine, high fever (up to 102), body aches, chills, fatigue and need for many hours of sleep.  Day 4 - 14 physical symptoms turned into emotional/psychological symptoms.  Thought patterns scrambled. Paranoia. Depression. Terror.  Obsessive paranoid thoughts.   At two points, I contemplated having my daughter take me in for psychological evaluation. These symptoms eventually subsided into brain fog, confusion, etc. The psycho-emotional symptoms eventually resolved themselves.  I felt like myself after 14 days.
This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies or concomitant therapies were not reported. On an unspecified date in 2017 (reported as: "2 years ago"), the patient was vaccinated with the first VAQTA (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis and on 27-MAR-2019, the patient was vaccinate with a second dose of VAQTA (lot # R022983 and expiration date: 09-AUG-2019) (dose, frequency, route of administration were not reported) for prophylaxis.
This spontaneous report was received on 19-JAN-2017 via a company representative from a physician assistant regarding an 11 month old male infant. The physician assistant told the field representative that an 11 month old male patient was seen in her office on 19-JAN-2017 with presentation of a rash. The patient's parents told the physician assistant that the patient "was administered varicella VARIVAX, "M-M-R", and PEDVAX HIB about 1 week ago." (The site of vaccinations, the doses of vaccinations, the Lot numbers and expiration dates of vaccinations were not reported.) The physician assistant visually inspected the rash and determined it was shingles. The physician assistant has a photo of the rash which is "significant." The rash is "Dermatomal, not vesicular, and appears over his right flank over his buttocks, around his abdomen, and his back. The rash clusters around his waist." The physician assistant said "the VZV kit is not an option." Because the patient is new to the office, there is no paperwork currently available to verify exactly which vaccines were given. The office plans to reach out to the parents for more information to confirm exactly which vaccines were given, where they were given and when. AE filed for miscellaneous product since the specific product that may have caused the rash can not be identified at this time. (All three vaccines were entered as suspect therapy. Further clarification is expected.) It was unknown if any lab diagnostic studies were performed or not. Treatment of event was not further specified.   The patient's present status was reported as not recovered. No additional information was available. On 01-FEB-2017, the field representative called back with additional information. The reporter stated the child was actually 12 months of age prior to receiving the vaccines. His birthdate was provided and added to the database. The patient received the vaccines at the state department of health. The patient saw the physician on 19-JAN-2017 and has yet to do a follow-up. No additional information to report. Additional information has been requested.
at 09:21 AM patient started to feel dry mouth and dizziness. patient denied any other symptoms... vital signs checked and patient was stable, heart rhythm via auscultation was stable , lung sounds assessed via auscultation and stable. monitoring time extended to another 15 minutes which in total 30 minutes. patient stated that he did not eat or drink anything today. patient given a cup of water. patient frequently assessed during the extended 15 minute waiting period and symptoms did not progress. at the thirty minute assessment , patient denied all symptoms . second set of vitals taken and were stable. patient  advised to go home and ER precautions given.  1set of vitals BP 132/83 HR 99, O2 96%, RR 20... 2nd set of vitals BP 131/83, HR 80, O2 97% RR 22
pt recvd vax; 12 hrs following 3rd dose pt exp nausea; pt exp also severe headache that lasted for 48 hrs;
Student was administered above mentioned immunizations at 9:30 am on 1/25/2023, became flushed and Syncopal after receiving Immunizations. Student denies respiratory distress or throat swelling. Endorsed facial flushing, rash on chest, and syncopal sensation after receiving immunizations. B/P during event was 110/80, 80 P, 12 Resp.  Student also states she did not eat breakfast and had not had water that morning.  Student was given juice, water, and a granola bar after the event, states she felt better, then became syncopal again. This occured three times, then  was called for continued syncope. Student was evaluated, states she felt better, and declined to be seen in ED. Student was observed in Clinic for 45 minutes after left. Went home with mom and instructions of when to be seen in ED for certain Sx. Student and mom verbalized understanding and agreed.