chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive after receiving the first dose; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events in two patients. This is the first of two reports.  A patient of unspecified age and gender received their first dose of  BNT162B2 (lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The reporter queried on after low long will the antibodies be present after receiving first dose and would it show up in antibody testing. Further reported they have 1-2 patients who tested positive after receiving the first dose. The reporter also queried any recommendations on vaccinating them for the 2nd dose if they test positive in between the two doses and that they have one vial left over from last week, today at noon the 5days will expire. If they dilute it now at 10am do they have to use it by noon or add 6hours from the time of dilution. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unspecified date. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516039 same drug and event in a different patient
ARMS HURT SO MUCH THAT JUST A SLIGHT MOVEMENT SENDS SEARING PAIN UP IN ARMS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) 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 arms hurt so much that just a slight movement sends searing pain up in arms, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea and arms hurt so much that just a slight movement sends searing pain up in arms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210413906.
Pt reports that the day after receiving Hep-B in LD, she started having fever, tremors in extremities and loss of ability to extend/adduct her left arm. She still had feeling in arm but was not able to move it without manually moving it with her other hand. She reported that she had spasms in her neck muscles prior to vaccinations.
My body has broke out from head to toe, when it first started breaking out/It  start first as a rash, it's all over my entire body; itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), administration date: 2021, for COVID-19 Immunization; Covid-19 vaccine (Primary immunization completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: RASH (medically significant), outcome "not recovered", described as "My body has broke out from head to toe, when it first started breaking out/It  start first as a rash, it's all over my entire body"; PRURITUS (non-serious), outcome "not recovered", described as "itching". Therapeutic measures were taken as a result of rash, pruritus.  Clinical information: Patient stated "My body has broke out from head to toe, when it first started breaking out, I started itching but you couldn't see anything but in about 3, 4, 5 weeks later, It start first as a rash, it's all over my entire body. I tried Prednisone, Steroids, I've got kind of cream that you could possibly imagine and nothing, absolutely nothing." Patient was asked if he has consulted a health care provider and he responded, "I have been to two dermatologist, doctor and I was going to another medical doctor on Wednesday, but I was telling you I was in a bad shape." Caller added "The doctors for whatever reason, I didn't know whatever reason, but the doctor should have reported this to CDC." Patient stated, "I would say if I had the shot in Feb2021 and this Mar2023, would say this rash would went away." Caller additionally asked if there was a way to reverse the effect he was currently experiencing. Caller confirmed that he received the Pfizer BioNTech covid-19 bivalent vaccine for ages 12 and older and he mentioned that he was 71. Already took Prednisone, steroids, and applied cream but absolutely nothing helped caller. Transfer agent thinks caller mentioned caller received the 1st shot in 2021 but transfer agent was not able to get additional information. Caller mentioned something about Mar2023, transfer agent thinks that was when caller started experiencing the rash, but transfer agent was not sure. Is there a product complaint to report? Yes. Description of Product Complaint: PC was not on suspect product. Body has broken out from head to toe and started itching, already took Prednisone, steroids, and applied cream but absolutely nothing helped. No additional information provided due to caller disconnecting prior to completion of transfer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mom stated p/shots pt became fussy, cried for 4hr, when formula taken diarrhea as soon as drank;sl fever (temp not taken);to pvt MD 24JAN97 130PM; throat looked sore;no meds x/Ibuprofen;legs sore to move-sore to touch, raised area
States next am woke up with "pins and needle" sensation in both legs waist down . bottom of feet no sensation. walking deliberately , slowly and stiff. Monday 4/12- slight improvement remained stiff, slight improvement with numbness. 4/15- states 80 % improvement with ability to ambulate , decreased sensation now focused in the hip and groin area. Tylenol and Ibuprofen taken 1 day post vaccination.
REPORTS REDNESS, SWELLING AT SITE, WITH HARDENED AREA MEASURING ABOUT 3 INCHES. CHILD TAKEN TO ER ON 03/28/2017 AT 2000.  ER DOCTOR ADVISED TO USE IBUPROPHEN AND APPLY HYDROCORTISONE TO AREA.
10:45 am after receiving vaccine was sitting in room on chair while twin brother got his shots. She fell off chair to her left and appeared to faint. Never completely lost consciousness but appeared confused. Had client lay out flat on floor with legs up - ammonia whiff under nose. Recovered quickly so that could spread to nurse. 10:50 am BP 120/40 pulse 80. No complaints from client. No swelling noted on head or face. Denies pain. 10:55 am BP 100/60 Awake and speaking with nurses. Gave Apple Juice. 11:00 am BP 104/50. Pulse 88. Spoke with Dr., in the building. He recommends once the client stabilized release to mom. Tell mom to report to child's PMD or pediatrician any changes in behavior, swelling on head, that may develop. Nurse conveyed this information to client's mom. Gave Graham crackers and peanut butter. 11:05 am BP 100/48, pulse 80. No complaints. No swelling on head felt. Awake and speaking appropriately to nurse. 11:10 Awake and playing with IPOD. 11:15 am BP 108/50, pulse 88. No lumps felt on head. Denies complaints. 11:30 am nurse walked client to mom's car out nearest exit.
suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer via interactive digital media 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) 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.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was one of the 16 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088496:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088502:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088503:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088507:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088505:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088497:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088499:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088476:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088506:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088495:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088494:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088504:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088476: US-GLAXOSMITHKLINE-US2021AMR088499: US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476
Within 5 minutes of receiving vaccine, patient was hot and covered in a full body sweat, seeing spots, kept losing consciousness, nauseous. I couldn't get a reading on the BP monitor at that time as it was too low to read and she couldn't move her limbs. While waiting  for EMS she could breathe fine, I could feel a faint pulse, but I had to keep taping her leg and talking to her to keep her awake. She was able to tell us her name and how many fingers I was holding up. I kept trying to get her to squeeze my hand, but I could only feel the tips of her fingers twitching and the whole time she was unable to move her feet/toes. I was able to look at her HR on her watch right before EMS arrived and it was at 62 and by that time her body temp seemed to be back to normal as her Mom said she felt cool and clammy. The BP reading by EMS was 100/60 and they tried to get her to stand but she couldn't and she still kept wanting to roll her head back and sleep.
- 3/8/21 Had Johnson and Johnson covid-19 vaccination (lot 1802068). - 3/16/21 MRI abd/pelvis showed that mass was likely a large bowel lipoma.  MRI also incidentally showed a thrombosis of the middle hepatic vein.  Mild hepatic steatosis was also noted.  Incidental pancreatic cystic lesion at 0.5 cm was noted. - Referred to vascular.
Patient hasn't received 2nd dose yet; 5 days after receiving 1st dose, she contracted with covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (5 days after receiving 1st dose, she contracted with covid) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced COVID-19 (5 days after receiving 1st dose, she contracted with covid). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet). At the time of the report, COVID-19 (5 days after receiving 1st dose, she contracted with covid) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include blood pressure. No treatment medication was reported.
Headache, muscle aches, joint aches, chills/shivering, fever.  I took acetaminophen at midnight, woke up an hour or so later and the chills/shivering were gone but the rest of it stayed for 24hrs.  After that it was mostly soreness at the injection site and some muscle/joint discomfort.  The headache was gone thankfully as was the chills/fever.  The pharmacist fully prepared me for the possibility of the side effects so I was prepared.
I have a huge hard ball around the area where it was vaccinated. It is red around the area. itching is happening as well.
Approximately 1 month after second vaccine dose, symptoms of Behcet's Disease exacerbated. Patient had oral aphthous ulcers every other month previously and did not need medication at that time. After vaccination, patient started to experience multiple monthly exacerbations of ulcers that made it difficult to eat/talk. Genital ulcers presented soon after. Multiple ulcers worsened over the following months, requiring the patient to be placed on daily medication to mediate these symptoms.
MODERNA + PREVNAR 20 WERE ADMINISTERED TO THE INCORRECT PATIENT. NO ADVERSE SIDE EFFECTS UPON IMMEDIATE INJECTION. PATIENT + DR AWARE. PT STAYED FOR ADDITIONAL OBSERVATION. PT LEFT AMBULATORY OUT OF OFFICE. Addendum by MD, on June 30, 2023 12:26:13 EDT (Verified) She was supposed to receive TDaP. I discussed the mix up with pt using the video interpreter service. Apologies extended  I advised pt that although the vaccines given were in error as she is about to start immunosuppressive therapy with Otezla a second bivalent covid booster is in line with current CDC recommendations as it relates to persons with a compromised Immune system  I advised pt that because she mentioned having diarrhea and a fever for several days with the initial bivalent booster and seemed resistant to receiving covid shots going forward I did not press the issue. Pt also informed that all of her previous covid were Pfizer brand however mixing and matching btwn Pfizer and Moderna brands approved by FDA.  We also discussed that she received a second Prevnar20, the initial vaccine was given 6mths prior.  Pt advised that she is unlikely to develop any adverse effects related to vaccines given other than similar symptoms developed following previously administered bivalent booster.  Pt was allowed to ask questions, she stated she was ok and requested that her covid card be updated.  I  informed pt to wait 2wks before starting the Otezla to ensure her body mounts a good immune response to vaccines given.  Pt agreeable.  Pt will f/u with me in 3wks but , If she any concerns/ ?'s develop In the meantime she is  to call the office.  Clinical supervisor Informed of Incident SRS filed. SARS-CoV-2 (COVID-19) mRNA BNT-162b2 vac 01/21/2022 SARS-CoV-2 (COVID-19) mRNA BNT-162b2 vac 04/27/2021 SARS-CoV-2 (COVID-19) mRNA BNT-162b2 vac 04/06/2021
My blood pressure reading is over 200; My blood pressure was stable and controlled and suddenly after taking the booster, my systolic started going up and up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year and 4-month-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, LOT# EP7534), administration date: 18Mar2021, when the patient was 62-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2, Lot: EP7533), administration date: 08Apr2021, when the patient was 62-year-old, for Covid-19 Immunization. The following information was reported: HYPERTENSION (medically significant) with onset 2021, outcome "not recovered", described as "My blood pressure reading is over 200; My blood pressure was stable and controlled and suddenly after taking the booster, my systolic started going up and up". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) over 200; (01Apr2022) 208 over 118; lab test: (unspecified date) Unknown result. Therapeutic measures were taken as a result of hypertension. Consumer stated that he got the booster (clarified as COVID-19 booster vaccine) in Octo of last year. He had very high Blood Pressure, 200, he never used to have that. He wanted to know why after he had the booster blood pressure reading is over 200." Consumer stated that his blood pressure was stable and controlled and suddenly after taking the booster, his systolic started going up and up. He had two procedures, a foot operation and a dental implant surgery cancelled because his blood pressure is too high, over 200. He stated that he need to know all side effects from the booster. He never had blood pressure this high. Consumer stated, "he just wanted to know what side effects and how many other people have high systolic readings like him." He is on more medications than ever before in his life and he is on Clonidine, Imdur, several other Edarbi, and on lot of potent high blood pressure pills because of this." Consumer stated, "It is persisting without the medication regularly my systolic, like today 208 over 118, reflects with my medication."  No follow-up attempts are possible. No further information is expected.
Injection site pain.  Worsening since date of vaccine.   4 days after injection and arm is still very tender to touch.  Site of injection is firm compared to left arm.      Site is not infected or red.  Just very tender.   Husband had vaccine at the same time and  did not experience this.  Also experienced headache, aches and feeling tired for 24 hours post injection.    Headaches persists
Approximately 45 mins after receiving vaccine I felt like I was going to pass out. Laid down at home, heart racing. BP was 178/100 and HR 120 in supine. Drank juice on way to ED; Approximately 45 mins after receiving vaccine I felt like I was going to pass out. Laid down at home, heart racing. BP was 178/100 and HR 120 in supine. Drank juice on way to ED; Approximately 45 mins after receiving vaccine I felt like I was going to pass out. Laid down at home, heart racing. BP was 178/100 and HR 120 in supine. Drank juice on way to ED; This is spontaneous report from a contactable healthcare professional (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284), intramuscular at the right arm on 29Dec2020 07:15 at a single dose for COVID-19 immunization. Medical history included depression. No known allergies. The patient is not pregnant. No COVID prior vaccination. Facility type (vaccine) was hospital. No other vaccine in four weeks. Concomitant medications (in two weeks) bupropion hydrochloride (WELLBUTRIN XL), vitamin B complex, bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), ergocalciferol (VIT D), zinc and L-lysine. On, 29Dec2020 at 08:00, approximately 45 minutes after receiving vaccine she felt like she was going to pass out. Laid down at home, heart racing. BP was 178/100 and HR 120 in supine. The patient drank juice on way to emergency department and started feeling better about 1 hour later. The events resulted in emergency room/department or urgent care. No treatment for the events. The events were assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on unspecified date.
14:30 pt had a vasovagal symptom, pt reported dizzy as soon as he sits on the observation area. Pt reported it happened when he had blood draws, usually feels cold sweats and light headed. 14:31  lay down pt elevated legs vitals 132/70 62 97% room air. 14:33 had pt sit vitals 134/72 70 97% water sips given, pt recovered completely, ER precaution given. Pt acknowledged understanding. Observed for another 15 minutes. 14:50 Pt left after being observed for 15 minutes.
Had been vaccinated with Pfizer. x2 doses in the past.. developed cough and loss of smell then loss of tstae
Information has been received from a physician concerning a patient who was schedule to receive ZOSTAVAX (Merck) was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). There was no product confusion involved. The patient had not experienced any known symptoms. Follow up information was received from a registered nurse. It was reported the 67 year old patient was inadvertently vaccinated with VARIVAX (Merck) (lot # 661980/1145X, exp.: 12-AUG-2010) due to human error. The reporter explained that their medical center policy no longer permitted the office to order ZOSTAVAX (Merck) (MSD). The office could only administer ZOSTAVAX  (Merck) (MSD) if a patient purchased the vaccine from his/her pharmacy. The nurse who administered the VARIVAX (Merck) thought that the office still ordered and stocked ZOSTAVAX (Merck) (MSD) and did not pay attention. The reporter stated that there was no problem with the label that led to the product confusion. The reporter indicated that the physician confirmed that the patient did not have any adverse experiences. Additional information has been requested.
SEVERE SWELLING & RASH ON THE ARM THAT MOVED DOWN TO THE ELBOW, THE BACK OF THE ELBOW IS STILL SWOLLEN & HAVING RED RASH 2 MONTHS AFTER THE SHOT.
Incomplete vaccination schedule since march/No second dose since march; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Incomplete vaccination schedule since march/No second dose since march) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 PRODUCT DOSE OMISSION ISSUE (Incomplete vaccination schedule since march/No second dose since march). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Incomplete vaccination schedule since march/No second dose since march) had resolved.            Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.   Reporter did not allow further contact
Cough started 2/21/01. Vomiting phlegm the weekend before 3/3/01 and 3/04/01 crying with no tears. She was eating and had no fever. Stool very runny. Saw doctor on 3/1/01. She lost 5 oz from 2/13/01 to 3/01/01. Doctor found nothing wrong. Autopsy states cause of death as sudden infant death syndrome.
I was tired from a trip out of town. By Friday the 8th of March, I knew I was ill. I came down with a significant chest congestion, coughing and fatigue. We tested negative for COVID-19. I was told it was a virus possible Bronchial Infection. I was given a prescription for Doxycycline. I sure they did not know much beyond that what was going on. It been a week and a half ago. I still have a residual cough. This is the first time I?ve been sick in many years.
Patient stated he experienced muscle aches and  extreme fatigue the day after receiving the vaccination, but was feeling better after a couple days.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/20/2022 LACTIC ACIDOSIS, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/20/2022 ATHEROSCLEROSIS OF AORTA