chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was supposed to get the 1/2 dose Moderna (50mcg/0.25ml) and it was documented on his immunization record that he received the 100mcg/0.5ml dose instead. We do not know if this was a documentation error, or if the patient was administered the incorrect dose.
Patient felt lightheaded immediately after receiving Japanese Encephalitis vaccine. This vaccine was the fifth and last vaccine given on 12/28/2022. Patient received vaccine at 4:07 PM and immediately felt lightheaded. Patient was seated on exam table and began to pitch his body forward. Patient was able to lay back on exam table with his feet up. Patient did not lose consciousness and continued to speak with this RN. Patient was provided with a cool compress for his forehead.  Patient remained supine for 10 minutes and then patient reported he felt better and was able to sit up and walk without experiencing any dizziness.
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt complained of feeling as if passing out and when approached, he wanted us to call 911 and layed on floor to prevent from getting worse. he claimed laying down made him feel better. Pt was responsive and was breathing normal however, was getting pale. Upon the arrival of Medics, pt was back to normal and all his vitals ( blood pressure, EKG, Oxygen level) were normal. Pt refused to go to the hospital and after waiting another 15 minutes he was picked up by his family member.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning an eight-year-old female. Neither the patient's past medical history nor concomitant medications were reported. On 10-Oct-2009, the patient received expired FLUMIST. The product expired on 24-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. There were no late occurring adverse events. Additional information was received on 28-Feb-2011 and incorporated into the narrative: no late occurring adverse events.
Patient presented to pharmacy with swollen  arm, redness and itching at injection site.  Reaction was becoming worse as time went on.
FEVER 103AXILLARY ONSET MIDNIGHT AFTER IMMUNIZATIONS ADMINISTERED AT 430PM
Fever 101F. Shingles noted on 2nd day. Took Enbrel injection on01/23/2021
2nd dose was out of the temperature requirements; asked her to come again for the dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (2nd dose was out of the temperature requirements) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (asked her to come again for the dose) 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 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (2nd dose was out of the temperature requirements) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (asked her to come again for the dose). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (2nd dose was out of the temperature requirements) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (asked her to come again for the dose) had resolved.            No concomitant drugs and treatment medications were reported.
Client developed fever 102F, increasing crying, "difficult to console".  Symptoms began five (5) hours after vaccinations.  Doctor noticed and instructed to give Tylenol.  Fever reduced to 99F after Tylenol.  Symptoms continued "off and on" x 36 hours.  Parent denies injection site soreness and/or redness.
Patient presented with a maculopapular rash that started on his chest 3 weeks ago and has spread to his abdomen, lower legs, and most recently his right forearm.  He has been treating with benadryl, over-the-counter hydrocortisone cream, and neosporin.  I started him on a  21 day prednisone taper dose pack
tingling and numbness bilateral feet and bilateral arms to fingers.  Fingers still affected 3 days later.  Muscle aches
Pt. seen in ER on 3/11/15 c/o pain to injection site left arm, left leg and headache. Had fever earlier and heart racing at home. Pulse 127 in ER, BP 131/86.
Client stood up to make 2nd dose appointment, she stated "Where am I? I feel funny." She was escorted to the observation area to lie down. Vitals stable. Clients friend arrive to observation area and informed us that client has history of seizures and takes daily Keppra. Clients friend stated" she becomes confused, stares off, and doesnt know where she is" Client is seeing a neurologist for seizures. Client was able to provide home, DOB, address, phone number, etc. Clients friend stated "I will drive her home" Vitals stable. Client was escorted out to car with friend at 10:45am
Patient stated within the last week, her injection site began to itch. Upon looking at the area, the point of injection was pink, and a circular area around the site was very slightly pink. The patient stated she felt her skin was slightly bumpy in that area. Could possibly be COVID arm.
experienced diarrhea; Vomiting; has not eaten anything but a couple of jelly sandwiches; He said his arm was a little sore; patient had arm soreness and he said his arm is just a little bit tender; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 16:30 (Lot number: FK5127) at the age of 6 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "severe seasonal allergies" (unspecified if ongoing), notes: patient does have pretty severe seasonal allergies.; "Cough" (unspecified if ongoing), notes: Patient had a cold probably 3 weeks ago and it lingered and he has a slight cough; "Cold" (unspecified if ongoing), notes: Patient had a cold probably 3 weeks ago and it lingered and he has a slight cough. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 16Nov2021 06:30, outcome "recovering", described as "experienced diarrhea"; VOMITING (non-serious) with onset 16Nov2021 06:30, outcome "recovering", described as "Vomiting"; DECREASED APPETITE (non-serious) with onset Nov2021, outcome "unknown", described as "has not eaten anything but a couple of jelly sandwiches"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "He said his arm was a little sore"; TENDERNESS (non-serious) with onset Nov2021, outcome "unknown", described as "patient had arm soreness and he said his arm is just a little bit tender". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.  Additional information: The patient underwent investigation assessment. He had no site reaction and did not require emergency room visit, was just in home care and did not go to physician office. The prior vaccinations (within 4 weeks) and family medical history were reported as none.
Developed temperature to 102 and blotchy rash, fever resolved.  AM developed severe pruritis, not responsive to antihistamine.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (strength, lot#, expiration date, dose and route were unknown). The temperature excursion for GARDASIL was supported with in-house stability data. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 9 year old white male with a sulfa allergy and no other medical history who on 29-OCT-2001 at around 10:00 am was vaccinated with SC in the right arm with a 0.5 mL first dose of Varivax (lot # 639684/0976L). There was no concomitant medication. On 23-JUL-2006 the patient developed varicella. Medical attention was sought. On 26-JUL-2006 the patient was diagnosed with a case of breakthrough varicella. He had multiple vesicles with some crusted over. No laboratory diagnostic tests were performed. He was treated and on 28-JUL-2006 the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Vaccinee (case #2) rec'd a 1st booster dose of Engerix-B (lt deltoid) on 20FEB90 p/testing showed failed to respond to a previous series of 3 "RECOMBIVAX" vax). Testing for titers on 12MAR90 & on 27MAR90 indicated did not seroconvert.
HYPOXIA 3/20/2023 ANEMIA DUE TO CKD
pain in the arm; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249 and expiry date: unknown), dose 1 via intramuscular, administered in Arm Right on 13Jan2021 as DOSE 1 (age at vaccination: 50-years-old), SINGLE for covid-19 immunisation. Her flu shot was in Oct2020. Medical history included , seasonal allergy. There were no concomitant medications. The patient experienced pain in the arm on 13Jan2021. Outcome of the event was recovered on an unknown date.  Follow-up attempts are completed. No further information is expected.
99.8 F fever, strong headaches, body aches within 24 hours after the vaccine was administered heavier-than-usual bleeding (with big lumps of blood 2-3 times a day) three days after the vaccine was administered, headaches continued through day three
Patient complained of Red, Swollen, Hard area 1 in away from injection site. Area was approx. 3in . in diameter. Reaction lasted 4 days.
Second dose was given on July 12th. The next day I was in the ER with chest pains and abdominal pain. Admitted to the hospital on the 14th. Had an endoscopy and an ultrasound done. Also had at CT scan with Contrast done. Diagnosed with Acute Pericarditis, esophagitis and duodenitis. These issues continue to persist. Have an upcoming appointment with a gastroenterologist. Still have flare ups of chest pain and terrible digestive issues.
Patient reported to pharmacy with welts on her arm and stated that she had pain and itching on the arm she had taken the shot.  I observed the welts and informed her to go to her doctor and advised her to take Ibuprofen for the pain and cortisone for the itching.  She has an appointment on the next day so she would see him then.
Pain during injection (more than I've had with any previous injection of any type); significant soreness and some pain, and intermittent burning sensation down arm, from shoulder, into the next day.
This was the patient's 2nd dose of Pfizer vaccine. Patient received their 1st dose of Pfizer 12+ vaccine on 12/12/21. On 1/11/22, the patient came to the pharmacy to receive their 2nd dose of Pfizer vaccine. At the time of the 2nd dose, the patient was 13 years old. Patient should have received the Pfizer 12+ vaccine, but received the Pfizer 5-11 year old vaccine. Attempted to reach the parent twice to inform of the vaccine error, but unable to make contact.
Chills; sore arm; fever/Fever; 101 temperature; body aches; fatigue; Headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as dose 1, single for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. After her first dose (on Thursday), the next day, on an unspecified date in Mar2021 (Friday ), patient experienced sore arm, fever (101 temperature), body aches, fatigue and a little bit of headache . On Sunday, the fever was gone. At the time of report, it was reported that, it's her 8th day and still experiencing severe fatigue and body aches. Also, on an unspecified date, patient had chills. Patient is reported to be so anxious about what's going on with her, where she need to talk to some one who could tell her whether she need to go hospital. The outcome of the event fever was recovered  on an unspecified date in Mar2021 and of fatigue and body aches was not recovered, and of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme Tiredness, Headache, Muscle pain everywhere, Cold and Hot Flashes, Fever, Nausea, pain on left arm, congestion, coughing up mucus, and coughing.
nose to run; Miserable; Initial information received on 03-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from the patient.  This case involves an unknown age and unknown gender patient who experienced nose to run and miserable while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, form, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious "nose to run (rhinorrhoea)" (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious "miserable (feeling abnormal)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "My last shot caused my nose to run for 3 months. That was 4 years ago this year. I was so miserable. Only time it didn't run was when I was asleep. I had to hold a Kleenex under my nose to drive. Since then. I have not had the flu or a runny nose. It stirred up a hystaming. I suffered. I'm sorry about that. But wasn't my fault."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (nose to run, Miserable).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event nose to run and was Recovered / Resolved on an unknown date for the event miserable.
This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.A male patient in his 30's received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 20Apr2021 (Lot number: ER8731) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: TINNITUS (non-serious), DIZZINESS (non-serious) all with onset 20Apr2021, outcome "unknown" and all described as "Ringing in the ears and dizziness a few minutes after the vaccine"; VOMITING (non-serious) with onset 20Apr2021, outcome "unknown", described as "vomited". Therapeutic measures were not taken as a result of tinnitus, dizziness, vomiting.Additional information: The patient did not have any medical treatment; they were just given some water.No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021457276 same reporter/drug/AE with different patient;US-PFIZER INC-2021457177 same reporter/drug/AE with different patient;US-PFIZER INC-2021438548 same reporter/drug/AE with different patient
pt recvd vax & exp n,v,d & poss sl fever occurred 2 days p/vax; sl-moderate sore arm @ inject site, denies redness;
Patient fainted 2 minutes after getting the vaccine. Recovered within  5 -10 minutes. 911 called, vitals checked, all normal.
Headache within hours, severe dry mouth. Took Tylenol and went to bed early. Upon waking, felt ok until getting up. Headache, dry mouth returned with just a walk to the bathroom. At 5pm, took temperature @ 99. By 7pm, rose to 100.
suspected pulmonary embolism; shock; cardiac arrest; This is a spontaneous report from a non-contactable consumer (patient's wife). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 04Mar2021 at 11:45 AM at a single dose for COVID-19 immunization.  Medical history reported as none.  The patient has no known allergies. The patient's concomitant medications were not reported.  The patient experienced a suspected pulmonary embolism on Monday 08Mar2021 at 11:30 AM. Embolism led to shock and cardiac arrest. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received unspecified treatment for the events. The patient died on 08Mar2021 at 11:30 AM.  It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: suspected pulmonary embolism; shock; cardiac arrest
Fever didn't start till around midnight, 10/6. 100.6 was highest point. Fever was gone by 10 AM, 10/7 but returned early afternoon. Stayed over 100 till after mid night and "slowly" broke till gone by 9AM, 10/8. Felt like I'd been run over by a bus the rest of the day and was some better Saturday. Back to normal routine yesterday.
Weight gain; COVID; COVID; nose (forget exactly what, but potentially congestion related); This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 25 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Weight gain" (unspecified if ongoing), notes: on medication earlier this year for several months (maybe around 6) causing weight gain, now off medication. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Aug2021, outcome "unknown" and all described as "COVID"; NASAL CONGESTION (non-serious) with onset Aug2021, outcome "not recovered", described as "nose (forget exactly what, but potentially congestion related)"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "Weight gain". Clinical course: The patient had Covid in Aug2021 and her nose (forget exactly what, but potentially congestion related) is still not all the way back to normal. She was on a medication for several months earlier this year (as reported, forgot exact number but potentially around 6 months) that was causing excessive weight gain. She is now off the medication but this could also have been during the vaccine window (either after vaccine receipt or during vaccine receipt). As of now, she has an extra 60 lbs to lose. Reporter is unsure about the dosage received, what vaccine was received, and when received.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Sender's Comments: Based on the available information a contributory role of BNT162B2 to the reported events COVID-19, Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
large rash that started out looking like hives, now growing larger over the course of the past few days. Rash showed up about 6 days after vaccination. Size is about 3"x6"
Patient almost fainted; reported feeling "heavy headed" and warm. Patien't skin was clammy to the touch. Pt was instructed to lie down. He was given cold water to drink and ice pack for his head. He was able to walk and leave the pharmacy after about 40 minutes.
1-WEEK AFTER RECEIVING THE VACCINE  I DEVELOPED SPOTS AND LIGHT FLASHES IN MY RIGHT EYE. I WENT TO THE HOSPITAL AND HAD A ULTRASOUND OF THE EYE TO CHECK FOR HEMORAGE BEHIND EYE. IT WAS CLEAR. FOLLOWED UP WITH EYE SPECIALIST THE NEXT DAY AND WAS DIAGNOISED WITH Posterior Vitreous Detachment. I HAVE NOW SEVERAL LARGE FLOATERS IN THE EYE.
Reaction occurred on upper arm on bicep, not at injection site. Redness, hard to the touch, warm to the touch, approx. 2 inch diameter.
We're having some side effects; Pounding migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (005570).  A male patient 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: ADVERSE EVENT (non-serious), outcome "unknown", described as "We're having some side effects"; MIGRAINE (non-serious), outcome "unknown", described as "Pounding migraine".  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Additional Information:  The patient taking the Pfizer-BioNTech COVID-19 Vaccine. she stated "I'm calling because we got the shot yesterday and we're having some side effects, my boyfriend is having a lot more. He has a pounding migraine.
Pt received vaccination in clinic around 14:30 at 22:00 pt's mother found him in crib with head shaking quickly from side to side. Seizure thought to be febrile seizure temp 101. pt given Acetaminophen. Pt tolerated QT 3/7/02 w/o problem.
Information has been received from a physician concerning a 61 year old female with psoriatic arthritis who on 10-JUL-2007 at 11:30 was vaccinated SC on the left with a first dose of ZOSTAVAX (lot # 657559/0462U). Concomitant therapy included ENBREL. On 11-JUL-2007 in the morning the patient experienced parathesias of the legs and arms and numbness or buzzing of the scalp. There was "-NVF", sensation was not ascending, loss of sensation in the right lower extremity and numbness. The sought unspecified medical attention in the emergency room and a doctor's visit. The patient was scheduled to see Neuro on 23-JUL-2007. Additional information has been requested.
Patient reported some redness next day followed by intense itching thru 10/12/2009.  Erythema 50 cent size and blotchy.
Soreness for 1-2 after injection. Splotchy rash at injection site on day 3. Itching, hives, rash, and hot to the touch at the injection site and tender lymph nodes in the underarm area 7 days later.