chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Throat felt as though it was closing up, face swollen, hard to breath, heaviness in chest, chest red with hives, feverish, and lightheaded.
Gastroparesis; Colitis collagenous; Worsening of diabetes; Blood sugar abnormal; Nausea aggravated; Vomiting; Diarrhea aggravated; This is a spontaneous report from a non contactable consumer reported for self. This 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via Intramuscular on Mar2021 as 2nd dose, single for COVID-19 immunisation and ongoing pancreatin (CREON) from 04May2021 orally at 1 or 2 capsules with meals depending on the volume,1 capsule per snack for exocrine pancreatic insufficiency. Medical history included no tobacco use, no alcohol use, NSAIDS allergy, codeine allergy manifestated by nausea, vomiting, omeprazole allergy manifestated by full body rash, penicillin allergy manifestated by rash. Past medications include penicillin, codeine and omeprazole. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on Feb2021 at age of 70-year-old for COVID-19 immunisation. blood sugar level was labile, worsened diabetes, worsened nausea and vomiting with creon (pancrea-tin). In May2021, the patient experienced Gastroparesis/ gastroparesis worsened, worsened diarrhea, Colitis collagenous, blood sugar level was labile, worsened diabetes and worsened nausea. On 10Jun2021, the patient experienced vomiting. Once patient was on Creon her husband noticed Gastroparesis worsened. Her diarrhea became worse. Prior to 10Jun2021, she was never vomited for at least a year. Physician wanted to switch Zofran to emend to manage severity of her nausea but it was not implemented yet due to financial reasons. Her husband did not have the time to provide the concomitant medications during the call. She had a shot of CoVid-19 vaccine before at least one symptom happened therefore CoVid-19 vaccine was considered as co-suspect product. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. The patient was treated with ZOFRAN. Spontaneous report from a consumer of with events of non-serious gastroparesis worsened, worsened diarrhea, collagenous colitis. Action taken with pancreatin was dose not changed. Outcome of the events was not recovered. The reporter's causality for the events of gastroparesis worsened, worsened diarrhea, collagenous colitis onset in May 2021, blood sugar level was labile, worsened diabetes, worsened nausea, vomiting and worsened diarrhea, collagenous colitis onset in May2021 was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A non-serious spontaneous report of "we inadvertently administered H1N1 LAIV to a person over 49" was received from a pharmacist concerning a 56-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 08-Feb-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
lt arm became reddened & edematous;sx started about 2hr p/vax w/itching;by evening slight redness noted;26JAN99 sx were worse;
Patient reports nausea and dizziness following vaccinations. Patient states she was feeling anxious . Took patient vitals to find them stable. Patient states her symptoms had recovered and refused transport to ED.
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from Physician Assistant. This case is linked to cases 2018SA269762, 2018SA274507, 2018SA274519, 2018SA274521, 2018SA274523, 2018SA274524, 2018SA274525 and 2018SA274522 (same reporter). This case involves a 67 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI993AB, expiry date: 18-MAR-2019 via unknown route (site of administration not reported) on 13-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that doses were viable at that time and temp indicator in shipping container did not show a change in temperature. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
an expired dose of ACTHIB was inadvertently administered with no AE; Initial information was received on 19-Jul-2021 regarding an unsolicited valid non-serious case from nurse and physician via call center via Global Medical Information (Reference number- 00687962).  This case involves a three-month-old female patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), IODINATED GLYCEROL (IPOL [IODINATED GLYCEROL]), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination.  On 19-Jul-2021, the patient received a 0.5 mL of Second dose of suspect HIB (PRP/T) VACCINE (lot number: UJ359AAA and expiry date: 11-Jul-2021) via an intramuscular route in right leg for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported that, "nurse reporting an expired dose of ACTHIB was inadvertently administered. Caller with question on whether dose needs repeating."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt developed scattered papular, red rash on trunk; no pruritus and afebrile. First appeared PM of 7/26/01. Active child. Currently still has rash.
No additional AE; patient received GARDASIL 9 instead of Quadracel; This spontaneous report was received from a health care professional concerning a 5-year-old female patient. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On 23-JUN-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot #1780878, expiration date 02-DEC-2023, for prophylaxis (dose, route of administration, and injection anatomical location was not provided), instead of diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL); it was stated that the wrong vaccine was administered (Wrong product administered). No additional adverse event was reported (No adverse event).
Pt. received vaccine 12 hours past expiration. No adverse event. MD contacted pt. pt. declines revaccination.
This case was reported by a nurse via sales rep and described the occurrence of fainting in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, immediately after receiving BEXSERO, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown. It was unknown if the reporter considered the fainting to be related to BEXSERO. Additional details were received as follows: The age at vaccination was not reported. The patient fainted shortly after vaccination with BEXSERO. The reporter did not agree to follow up from GlaxoSmithKline.
Problems swallowing, throat tightness. Dry foods and also meats getting stuck, and even just simple swallowing throughout days. 5 days so far, has not subsided yet. No pain, just dry throat and discomfort. Btw, my manager had same series of vaccine, also Pfizer, he got his booster 4 weeks ago, same issues with throat closing up. His symptoms lasted few weeks. This repeat pattern is why I self-report. not sure if this could get more serious for other patients.
I saw a large red welt around injection site; woke up with the injection site itching; following day I had injection site pain for about 14 hours; A spontaneous report (United States) was received from a Consumer concerning a  73 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced following events injection site pain, injection site pruritis, injection site reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 09-01-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 10-01-2021, The patient experienced injection site pain for about 14 hours.  On 16-01-2021, patient woke up with injection site itching. On 17-01-2021, Patient saw a large red welt Patient took Benadryl and put cold compress on it throughout the day.  Action taken with mRNA-1273 in response to the events was not reported.   On 10-01-2021, injection site pain for about 14 hours resolved.  On 16-01-2021, patient woke up with injection site itching event outcome unknown.  On 17-01-2021, Patient saw a large red welt. Next day it was still there but a lighter red color, event recovering/ resolving.
On 3/12/03, mom unable to awaken child, unresponsive and his eyes were rolled back in his head this AM. Pt transported to hospital by ambulance and admitted to PICU. Dx'd with epileptic seizures. Rx'd Phenobarbital 2 tsp po at bedtime. Hospital discharge summary states fever.
As a citizen I took the Moderna vaccine on 15 APR 20201. Four days after taking the vaccine I developed a blood clot in my heart.  On the morning of 19 APR 2021 at 0730 I began having chest pain, I thought I had pulled a muscle while exercising the night before. Throughout the morning the pain in my chest got worse until  I called  emergency services. The EMTs told me I had a blood clot in my heart and rushed me to the hospital. Once at the hospital I  had an angioplasty . No stint was inserted.   After the surgery the doctors told me I had very large veins and a strong heart after the clot was removed  flow returned and no stint was needed.   The doctors also told me that they could not rule out the COVID vaccine as the cause of my blood clot as the rest of me heart looked good with no visible plaques or build up.   Official Diagnosis Anterior STEMI- POBA ot LAD Integrillin infusion Fit and Well Moderna vaccine 1 week ago  Diagnostic Findings -Left Main Stem - Normal LMS Left Anterior Descending- LAD 100 % stenosis restored flow   Conclusion -Aspirin 75 mg od for life - prasugrel 10mg of for 1 year - ECHo Sec prevention, Integrillin infusion 24 hrs - Card rehab  I work out every day- prior to the blood clot  Blood clot left in heart chamber- taking blood thinners to dissolve.
headache; aches; Flu like aches; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, general body pain and influenza-like symptoms. On an unknown date, the outcome of the headache, general body pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the headache, general body pain and influenza-like symptoms to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. after vaccination, the patient experienced headache, general body pain and influenza-like symptoms. The patient asked how long these symptoms would last.
Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: 635342) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EM9809), on 19Mar2021 as dose 2, single (Lot number: EP6955), on 05Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 21Mar2022 as dose 4 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Dec2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Dec2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  RITONAVIR (PAXLOVID) from 29Dec2022 to 03Jan2023.
BODY PAIN; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry date: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported. On 10-JUN-2021, the subject experienced body pain. On 10-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and body pain was not reported. This report was non-serious.
Patient stopped breathing after PCV13 injection given. Pt unresponsive for 2 min. Pt was stimulated and began to cry, pt was still lethargic. Vitals taken and pt monitored for 1/2 hrs.
Patient came into the pharmacy 2 weeks after vaccination, and reports having pain on her left arm and having difficulties lifting the arm to a certain height which wasn't a problem she had before, she was counseled to try topical anesthetics, oral ibuprofen and apply topical ice but none of that has improved her pain. She went to her doctor and he performed x-rays with a referral for an orthopedic doctor for her left shoulder.
patient recived a dose of pneumovax23 that was expired; patient had developed redness and swelling at injection site; patient had developed redness and swelling at injection site; This spontaneous report was received from a medical assistant refers to a 9-year-old female patient. The patient had a history of vaccination with a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (lot number and expiration date unknown by the reporter) on an unknown date. The patient was found to have low titres for pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) when tested on an unknown date. No concomitant medication was reported.  On 01-MAY-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and frequency unknown) lot # N030111, expiry: 21-APR-2019 (expired product administered), intramuscular for prophylaxis.  On an unknown date after the vaccination in May 2019, the patient experienced redness (injection site erythema) and swelling at the injection site (vaccination site swelling). The outcome of injection site erythema and vaccination site swelling was reported as not recovered. Causality assessment was not reported.
Confirmed Breakthrough Case   COVID-19 (Moderna) 1  02/03/2021 Moderna 038K20A   COVID-19 (Moderna) 2  03/05/2021 Moderna 030A21A   COVID-19 (Moderna) 3  04/23/2021 Moderna  Unknown LOT # COVID-19 (Moderna) 4  11/10/2021 Moderna Unknown LOT#
Info has been received from a medical assistant concerning a 53 year old female who on 10/28/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641532/1353L). On approx 10/28/2002 the pt developed arm swelling, soreness, and flu-like symptoms such as nausea, vomiting and lethargy. The pt had received a dose of pneumococcal vaccine 23 polyvalent in the past. The medical assistant also provided info regarding another pt (WAES #0211USA00180). The pt sought unspecified medical attention. Additional info has been requested.
Patient is still experiencing severe arm pain several weeks after her injection.  (Husband got one day prior also having pain) different day, different immunizer - She has tried tylenol, ice pack, lidocaine patch and still experiencing this pain.
"myalgias chills since yesterday  moderna shot # 2 2 d ago no f no rash redness no sob no wheezing no swelling lips throat tongue  no weakness or fatigue"
Pt with recent varicella exposure, who was vaccinated with first and second doses of varicella virus vaccine live failed to seroconvert. Although the pt failed to seroconvert there was no evidence of a rash.
I received the vaccine in Feb. and March of 2021. That summer, I climbed a flight of stairs and noticed my heart was pounding and I was out of breath. After this continued, I asked doctors about it and I was dismissed. Within several more months I started twitching involuntarily. Even my eye balls would twitch in their sockets. I could visually see my muscles having spasms throughout my body. My skin would raise up and down. My feet and hands began to fall asleep on their own accord. I would get zaps in my face and feet so painful I would yell out in pain. I lost vision and have lived with a significant reduction in my vision. The overall impact on my body took away my ability to work out like I used to. Just the other day I gasped for air and almost threw up after just a short workout trying to push it like I used to. My life got taken away from me. I "all of a sudden" tested positive for herpes two. EVEN THOUGH I was negative (I have the test) when I got the vaccine and I had NO new partners. The stupid thing triggered my T cells to malfunction.
right arm was sore; This case was reported by a consumer and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After the 1st dose of Shingrix injection the patient experienced right arm was sore for a couple of days.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR219429:2nd dose US-GLAXOSMITHKLINE-US2020AMR222149:1st dose
101 degree fever, cold chills, body aches, severe headache, body sweats, very tired. I drank a lot of water, slept, and took Advil every 4 hours to try to manage my fever.
Within 5 minutes of injection,, Red rash strip down middle of face from forehead to chin, Face Flushing, Face itching. Within 1 hour of injection,, Sore joints.  Treated with OTC benadryl and Ibuprophen Symptoms Resolved in 2 hours
NAUSEA THE SAME DAY AND DAY AFTER THE INJECTION. A WEEK LATER, I AM EXPERIENCE  SWOLLEN, HOT, RED AND ITCHY AT THE INJECTION SITE.
female patient received the first dose on 08May2021 and second dose on 08May2021 for covid-19 immunisation; fatigue; hard time of breathing; This is a spontaneous report from contactable consumer. A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0176) via an unspecified route of administration, administered in Arm Left on 08May2021 at 13:00 and second dose via an unspecified route of administration, administered in Arm Left on 08May2021 (Batch/Lot Number: EW0185) as single dose for covid-19 immunisation. The patient's relevant medical history included drug hypersensitivity from penicillin. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Jun2021 at 12:30 PM, patient experienced fatigue and had a momentary hard time of breathing. Patient ended up laying down for about 15 minutes and was able to continue the day. AE resulted in congenital anomaly or birth defect. Patient did not received any treatment. The outcome of the events fatigue and hard time of breathing was recovered on 22Jun2021 and another event was unknown.   Information on Lot/Batch number was available. Additional information has been requested
The pt developed a skin rash on 11/29/01. She was seen in my office with typical skin rash of varicella on face (cheeks and chin), neck, upper chest wall, arms, abdomen, etc.
The day after the vaccination ( Monday, 2/14) I was lethargic  when I got up in the morning and by mid afternoon I had a fever of 100 degrees (orally).  I took 2 extra strength tylenol around 4 pm and 2 more when I went to sleep around 10:30 pm. I felt much better when I woke up on Sunday(no lethargy, didn?t feel feverish) but around 2 pm I noticed a red, blotches rash all around my neck, and my upper torso. There?s was also a rash on  the right side of my upper back. I called my PCP but the office was closed for President?s Day. I didn?t feel that the symptoms warranted going to the ER, but I took 2 25mg tabs of Benadryl at 3 pm. It is now 7 pm and the rash on my neck and upper torso looks unchanged but, I also noticed it had spread to the crook of both elbows Otherwise, still feel fine. Body temperature is 98.9 orally, which is slightly higher than my normal temperature, which tends to be around 98 degrees. I  had a similar, but, much more severe reaction to Ibuprofen about 10 years ago, though it started out in similar fashion and got progressively worse over 3 - 4 days. I had to go on a regimen of Prednisone for 2 weeks to bring it under control