chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Notes  12/18/2020            Subjective No chief complaint on file.   Patient is a 25 y.o. female who had no chief complaint listed for this encounter.       History of Present Illness   Patient is at the Covid vaccination clinic  Received her vaccination and approx 5 min following administration notified staff that she was feeling a little lightheaded Was also c/o feeling hot at time Patient admits that she did not have breakfast this AM and has not had anything to drink Denies throat discomfort or tingling No shortness of breath or headaches Patient brought to the bay for evaluation       History Review / Additional history   Review of Systems   Patient's medications, allergies, past medical, surgical, social and family histories were reviewed and updated as appropriate.    Objective   Blood pressure 126/74, pulse 88, SpO2 98 %, not currently breastfeeding. Physical Exam HENT:     Head: Normocephalic.  Cardiovascular:     Rate and Rhythm: Normal rate.  Pulmonary:     Effort: Pulmonary effort is normal.  Musculoskeletal: Normal range of motion.  Skin:    Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     Mental Status: She is alert.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.           Assessment / Plan   VSS on arrival to evaluation bay Following laying down for 10 min, drinking water, and eating a granola bar patient reports feeling much better.  Sat at the bedside for an additional 5 min with no recurrence of symptoms.  Repeat VSS Instructions given to go to the ED if worsening symptoms, lightheaded, throat swelling or shortness of breath. Encouraged to eat and drink prior to next immunization.
Systemic rash itchy / burning started on L arm and spread to torso and all other limbs over 1 week
Patient DNR/DNI on admission; on HFNC on admission quickly transitioned to continuous BiPap; developed bradycardia w/ asystole given multiple doses of atropine; unable to sustain heart rate
Right thigh with large circumferential erythema, edema.  Nurse follow up on 09/08/04 states: "Allergic reaction vs. Cellulitis."
Third day symptoms after first shot, extreme muscle pain , upper leg ,knee, foot, and groin!  Pain level aroun 7 for two weeks ,on and off ,nights mostly.  Pressure excellent the pain. Tylenol, Tramadole , no help. Dr visit on the 23 th , question of taking the second shoot.
Patient reported today 10/21/20 to get a copy of her vaccine record for work and reported that she was had muscle soreness at time of her shot. She said her immunizer had told her the needle did have to go all the way into the muscle and wanted to share that she experienced discomfort after her vaccine. I did tell her that the 1inch needle was used and I did have to insert it to administer the vaccine. I asked her if the injection site is okay, and she said she experienced some swelling but that had gone down. I asked if she could lift her arms above her head, and she demonstrated that she could. She did state after her shot it was painful for her to put on her shirts and lift her arms a certain way. She says she only experiences discomfort when she lifts her arms at a certain angle now. She says she is better and  no need to report, but I (the immunizer) told her I would regardless.
45 minutes of screaming uncontrollably the evening of the injection. Doctor suspects Prevnar vaccine.
Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (non-pregnant at the time of the vaccination) received first dose of bnt162b2 (BNT162B2; Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 09Mar2021 18:30 (at the age of 43-years) as single dose for COVID-19 immunisation. The patient was vaccinated at a public health clinic/veterans administration facility. Medical history included mitral valve prolapse (MVP) and multiple sclerosis. Concomitant medications included ibuprofen; metoprolol; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and celecoxib (CELEXA). There were no other vaccines in four weeks. The patient had previously known allergies to cefprozil (CEFZIL). The patient experienced soreness at injection site on 09Mar2021 21:00 with outcome of recovering.  No follow-up attempts are possible. No further information is expected.
Patient developed severe headache with phonophobia starting 6/7/21 two days following vaccine dose. On 6/17 she had word-finding difficulty and right-sided facial numbness which resolved spontaneously after 20 minutes.  Not on birth control, no h/o clots, no nuchal rigidity.
Painful, itchy rash at vaccination site 1 week after vaccine. Just started today so I will try Benadryl and Advil.
Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong; Circumstance or information capable of leading to medication error; The patients have not reported any adverse reactions; This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions). At the time of the report, TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (The patients have not reported any adverse reactions) to be not related. No further causality assessments were provided for TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    This case was patient number 2 out of 16 patients.  No concomitant medication information provided.  They administered Bivalent boosters from Bivalent Lot numbers of 061F22A and AS7170B. They wrote AS7170B on all 26 patient's vaccination cards.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696236.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696236:master case
Case number PHEH2014US007332 is an initial spontaneous report received from a health care professional on 11 Apr 2014. This case refers to a female patient of an unknown age. She was vaccinated with MENVEO (batch number: M12100) which had been stored below the recommended temperature at 1.9 degrees Celsius for two hours on an unknown date. She was recalled for revaccination. No adverse event was reported following this administration error.
This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022.  Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly ?invalid? dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic and this child has been offered an additional dose.
Tachycardia, fatigue, redness, pain, and swelling of injection site. Days later patient experienced hives around the injection site, as well as around her forehead/hairline. Tachycardia lasted several days.
This spontaneous report as received from a physician via field representative refers to a 16 year old male patient. On 04-FEB-2014 the patient was vaccinated with a first dose of GARDASIL (lot #, expiration date and dose was not reported). Other suspect therapies included Hepatitis A vaccine (manufacturer unknown) (lot #, expiration date and dose was not reported) administered on the same day, 04-FEB-2014. Concomitant therapies included MENACTRA received also on 04-FEB-2014. The physician also reported that the patient had not eaten that day. On 04-FEB-2014 the patient experienced a syncope event and passed out. It was stated that patient went to the Emergency Room. The outcome of all adverse events was reported as "client was fine". The relatedness between all the events and suspected therapies was not reported. Upon internal review reported term "passed out" was considered as a medically significant event. Additional information has been requested.
tachycardia that began within twelve hours and woke her up from sleep at around 30 hours post vaccination
Pt presented with urticarial rash and itching centered primary around site of injection and spreading outward from there. Administered BENADRYL and observed until 1 hour had passed after time of vaccine - urticaria & itching were better.
This is a spontaneous report from a contactable reporter (contactable consumer or other non HCP, Manager and immunization coordinator for the department of health) who reported for 4 patients via a sales representative. This is 2nd of the 4th report. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration on an unspecified date. The patient experienced body chills on an unspecified date with outcome of unknown.
Information has been received from a physician and a school nurse concerning a 11 year old male who on 06-JUL-1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  It was also noted that the child was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 07-APR-1995 and 16-JUL-1999. A school nurse reported to the physician that between 24-MAR-2005 and 09MAY-2005, the child developed a "more severe case" of chickenpox, noted to be breakthrough with 50 to 250 lesions. Unspecified medical attention was sought. The outcome was recovered. A product quality complaint was not involved. No additional information is expected.
expired dose administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  The date of refrigeration of the vial was 07-May-2021.   This case was linked to MOD-2021-363734 (Patient Link).
SHOT ADMINISTERED 6/30/03 - IT BURNED IMMEDIATELY, SINCE THEN, BEGINNING APPROXIMATELY A WEEK LATER, I BEGAN HAVING CONSTANT PAIN IN MY LEFT SHOULDER, THE JOINT AREA IN PARTICULAR. THE AREA HAS BEEN HOT TO THE TOUCH AND ICHES STILL. I HAVE HAD MUSCULAR ACHES THAT FEEL LIKE BRUISING. I HAVE AVOIDED USING MY ARM AS MUCH AS. AT NIGHT I MUST PUT PILLOWS UNDER MY ARM IN ORDER TO GET COMFORTABLE ENOUGH TO SLEEP.
I received my 3rd dose of Pfizer on 11/04/2021. My adverse event started on 02/2022 in the morning around 8:00AM lasted all day for 2 weeks. I had cold symptoms. I had stuffy nose and slight cough. I woke up with blood on my pillow. My ears were bleeding and I couldn't hear. I went to an urgent care where they diagnosed me as having ear infection and they prescribed me with antibiotics. They advised me to follow up with my regular doctor. I went to my primary doctor  told her the issue I had. She then prescribed me 2nd dose of the antibiotics for 16 days. After taking the 2nd dose my hearing was back to 50%. Once my ears were back to normal and I was able to hear everything. As a result of getting a cold I am now experiencing ringing in my ears. It's been about 1 year.
contracted Covid after the first dose of the Pfizer BioNTech Covid-19 vaccine; contracted Covid after the first dose of the Pfizer BioNTech Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 9 year-old female patient received bnt162b2 (BNT162B2), administration date 24Nov2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "contracted Covid after the first dose of the Pfizer BioNTech Covid-19 vaccine".  Additional information: Caller called on behalf of her 9-year-old daughter who got her 1st dose of the Pfizer BioNTech Covid-19 vaccine shot on 24Nov2021 but we then contracted Covid 3 weeks after and were symptomatic through the end of December. Her daughter had not gotten her 2nd dose. She would like to know how to move forward with her vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
As of Monday at 9:12am - large red area measuring roughly 4 inches by four inches, with a hard center of about 2 inches by 2.5 inches in size. Patient says the area seems to have gone down since Saturday evening when she first noticed the reaction around 4 pm. Saturday evening she had headache and chills that woke her from her sleep.
Pt received a bivalent 6mo-4y dose instead of the recommended monovalent for dose number 2 in the series.
Woke up fatigued the next day with a headache and soreness extending to the left side of my chest and back. My head feels like it's stuffed with cotton and it takes a second to process what people are saying to me.
Three hours after Hep A vaccine noticed hives on legs and foot, next morning, hives on hands and arms. Also tongue swelling and lips numb, some dizziness. Went to ER at university hospital at 8:45pm, received epinephrine and steroids.
Reported Labored breathing and slight throat swelling and itchy hives 5 minutes after injection. She was still able to walk and talk at the time. Pre-medicated  50mg Benadryl one hour before injection. Advised per ER to not give EPI shot and have patient come in to ER to be seen, she was taken to the hospital by ambulance. She was administered another dose of Benadryl and 2 EpiPen Shots. She was kept overnight for observation at Medical Center. She needed 1M Benadryl after her 1st dose and had throat swelling, felt dizzy and shaky legs after 1st dose. Per advisement of her Dr. we gave 2nd Dose, her Doctor new possibility of reaction but wanted patient to have due to respiratory illnesses, felt that the benefit outweighed the risk since she could potentially get COVID-19 and have worse issues. Patient was aware of risk of anaphylaxis/allergic reaction.
Red and warm area on left arm size of lemon that formed at the bicep level.  Noticed this occurence on 2/14/21 .  In a few days a minor rash developed as well,  with this red area.  As of 2/19/21, the area became itchy.  I applied cortizone 10 to help relieve the itch, but it has not had any effect  --  actually seems to be more irritated ?
Left arm became red, a little swollen & hot to touch within 24 hours after vaccine. At 36 hours patient was red from shoulder to below elbow. Patient was seen in the office put on Benadryl every 6 hours and Keflex for cellulitis.
I did get the shot but I got shingles anyway/ Suspected vaccination failure; I did get the shot but I got shingles anyway. I also had them in my eye.; I did get the shot but I got shingles anyway; Very, very painful; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient got the shot but got shingles anyway. Also had shingles in eye and were very painful. It took more than 2 months before the pain subsided.  The patient advised anyone to get the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Case number PHEH2014US008956 is an  initial spontaneous report from the healthcare professional (medical assistant) received on 01 May 2014. This report refers to a 11-year-old female patient. She was vaccinated with MENVEO (batch number: A12092) intramuscularly on 30 Apr 2014. On the same date, 15 minutes after vaccination she experienced red blotches on her arm and the area was hot and hard to touch. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Next day, no fever but cough started and had sore throat. Throat constriction and white foam started to come up and continues to today. Not as much foam now but continues. There is no blood or discoloration in sputum. No associated aches and pain but extremely uncomfortable. Drinking lots of fluid. Nothing at site of vaccination. Has not called pharmacy. Has never received pneumonia vaccine before.
Patient complained of metallic taste in mouth and tingling in top lip immediately after the vaccine. Resolved after 5 minutes.
Sx of dizziness and vomiting. Treatment includes IV fluid resuscitation, labs, cardiac monitoring.
About 5 minutes after the vaccination was given, the patient developed welts 2 inches above injection site. Benadryl was given right away.
Information has been received from an administrator referring to an adult female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 23-JAN-2018, the patient was vaccinated with 2 properly stored, expired, pediatric doses of VAQTA (0.5 ml, lot# M036459, expiration date of 18-JAN-2018, frequency and strength were unknown) intramuscularly in left deltoid for prophylaxis. No adverse effects reported. No product complaints involved.
The injection site itself became red and a bit swollen as expected but has faded; however, an itchy rash -- not a dotty shingles-type rash, but a swath of pink, grew on my right bicep. I initially had a little irritation from bandage tape I was using to cover the injection site with a sterile pad because my shirt kept irritating the site. The irritation from the bandage is normal for me. But this grew a lot in the days afterward and became big, which is not normal. I have never had bandage irritation that got this bad. Not sure if skin is extra-sensitive because of the shingles vaccine injection. Controlling with Benadryl and ibuprofen.
three weeks after my shot, i started to have ringing in my ears, my dr.told me its tinnitus.  on 12/20/21 i received the PFE booster, the ringing in my ears is now more severe.
This spontaneous report as received from a Vaccine for Children (VFC) coordinator refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M045206, expiration date 27-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 to 25 degrees Celsius for 36 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact. Sender's Comments: US-009507513-1704USA000476.
Diarrhea as well as swelling, itching and bruising at the injection site.