chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 13-SEP-2019, the patients were inadvertently administered improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R026541 with expiration date 11-JUL-2020 and lot # R029814 with expiration date 05-JUN-2020 (exact dose, injection site and route of administration were not reported) both for prophylaxis. Administered doses of vaccine experienced the temperature excursion of 51.62 degrees Fahrenheit for 10 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  The case is non-valid due to lack of patients' identifiers.  Upon receipt of follow-up information from medical assistant on 24-MAR-2020, the case now becomes valid as distinct patient identifiers were provided.   This case is regarding a 5-month-old female patient. On an unknown date in June 2019, the patient was vaccinated with a first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route, anatomical location, lot/batch # and expiry date were not reported). The patient's second dose was scheduled in August 2019 but the patient was vaccinated late with second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route, anatomical location were not reported) (lot # R026541 with expiry date: 11-JUL-2020) on 13-SEP-2019. On 17-OCT-2019, the patient was vaccinated with another dose (captured as third dose) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541).  This is one of the several reports received from the same reporter.
pt is immunocompromised and requested 4th dose (booster) of moderna vaccine. pt was given 0.5ml instead of 0.25 ml. we were not aware of correct dosage prior to vaccination despite researching. dose seemed appropriate.
Case number PHEH2012US023573 is an initial spontaneous report received from a consumer on 28 Nov 2012: This report refers to multiple patients whose identifiers were not reported. These patients were vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly at a dose of 0.5 ml on unknown dates. After vaccination these patients experienced pain in the limb which limited the limb movement. The outcome of the event was not reported. No further information was provided.
Minor reaction. Redness, rash and soreness occurred at injection site. This was for the DTaP vaccine but I do not know the brand. Area is still irritated today but slightly better.
I started having several symptoms of COVID-19.  I had fever (went up to 102.8), chills, high pulse, diarrhea and cramping,  and slight headache for about 3 or 4 days.  Then, I was having sharp, severe shooting pains in my ring finger and elbow.  I talked to my primary care doctor's office 3 times.  I went to the emergency room on Thursday, March 18th.  The hosptial did a CT scan of my chest and abdominal area, a urine test, some blood work, etc.  I also had a COVID-19 test on both March 18th and March 21st.  They were both negative.
Bruise /red mark on left arm (in front of injection site) developed 1 day after injection.  On 1/15 (7days after injection), itchy, swollen rash appeared in same location.  Resolved with hydrocortisone ointment.  On 1/16/21 (8 days post injection), red, non-itchy, non-painful rash appeared in same location.  Not warm to touch.  Rash remains as of 11:10pm.
The pt experienced a temp of 104 lasting 3 days, fatigue, disorientation, reddened eye. Treated with tobrimyacin.
A nurse reported that a 73 year old female received an injection of Pnu-Imune 23 on 10/16/00 and subsequently developed an injection site reaction characterized by redness and soreness. On 10/17/00, the swelling, redness and pain was more severe, extending from slightly above the injection site down to her wrist and involving the hand. She was seen by the physician and treated with hydroxyzine and applications of cold compresses. Additional information received on 1/5/01, indicated that the pt recovered.
pfizer monovalent covid vaccine given as bivlaent booster in error.  Patient notified, recommended bivlaent booster in >= 2 months after erroneous injection
pain and swelling right clavicular area and right side of neck Narrative:  Employee stated she developed pain and swelling in the right clavicular area on 1/10/21 and used warm compresses but noticed swelling and pain in the right side of neck on 1/11/21. no sob, no fever
A medical assistant reported that a 36 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Ultrafined (Wyeth) on 04/18/00. On 04/23/00, the patient developed a large hive which was described as red, sore, and itchy.
3 days after vaccinations congested, fussy 7 days after vaccinations very fussy,congested and febrile 10 days after vaccinations very fussy, very congested, febrile and lethargic 10 1/2 days after vaccinations all of above symptoms plus un-responsive and no muscle tone- later that evening paralysis from neck down Per annual report-daughter can not walk.  Has lower limb weakness.  Legs have not developed normally-trunk & diaphragm weakness, pulmonary problems.  See attached.  Her life has been drastically altered-see attached medical report.
patient received Menactra vaccine instead of indicated meningococcal B vaccines, no adverse event; Initial information was received on 15-May-2020 regarding an unsolicited valid non-serious case from the nurse.  This case is linked to case 2020SA129700(same reporter).  This case involves an 18 year old male patient who  was vaccinated with the 0.5 ml third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6455CA and expiration date was not reported) via an intramuscular route in the right deltoid for prophylactic vaccination on 15-May-2020 instead of MENINGOCOCCAL VACCINE B.  The patient had received the two doses of Menactra in past. The patient did not receive any concomitant vaccine.  This was an actual medication error case due to wrong vaccine administered.  At the time of reporting, adverse event was not 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.
Case previously recorded as MA2009-4320. Initial case report received from a health case professional via agency, on 11 NOV 2009. A male patient was vaccinated with 0.5 mL once of S-OIV FLUVIRIN (batch no. 102125P1) i.m. on 11 NOV 2009. No adverse events were reported. Agency reference no.: NA09-007978.
I was feeling fatigued, had a sore throat, it made it's way up into my sinus cavities, I had a fever of 101F, I lost my taste for five days, On March 1, 2023, I choose to test with a home COVID-19 test it came back positive. I called my PCP who prescribed PAXLOVID, I started taking it immediately. It took me eight days to get over the worst of it. I tried going back to work but I could not make it through the day. My blood pressure would drop, I would need to sit and rest. That lasted another eight. I still have a bit of a cough left; my energy is returning.
Child developed diffusely spread mildly puriutic papular rash over entire body.
Nausea; chills, fever, malaise, painful site with redness & swelling.
? 1155 Pfizer covid 19 vaccine administered.   ? 1210 Patient complained of bump, left deltoid.  Ice pack applied to left arm. ? 1235 Nurse reiterated common side effects with vaccine, patient verbalized understanding and advised to contact pcp and/or urgent care if worsens. Left with no other complaints.
Resident was not having any complaints after injection, Vitals were being monitored Q-shift for 72 hours and up to the time of incident vitals were stable, Administrator received phone call approximately 120am stating resident was complaining of SOB and Chest pain, RN supervisor came to assess resident and determined that she needed to be sent out. EMS was called and in route and resident was having conversation with night shift staff member and suddenly ceased talking and had passed away. Resident was a DNR at the time of incident.
There was no  adverse reactions- he was given the Bivalent booster instead of the second primary dose of Pfzier.
Woke up with hives Sunday 9/14/08, covering most of body. immunized 9/8/08
She had abnormal Pap smear with subsequent positive HPV testing recently despite being fully immunized.
Abdominal aortic stenosis. Vascular Surgery consulted and performed open femoral artery exposure bilaterally; endovascular aortic stent graft Gore Excluder device placement to the infrarenal aorta; left renal artery balloon expandable covered stenting on 10/26/21. ASA was started post-op but plavix initiation delayed until after kyphoplasty. She should continue plavix for 6 months and low doses ASA lifelong. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Difficulty breathing, wheezing, paleness, weakness, dizziness, fainted, slurred speech, nose bleed and fever.
I was talking to the patient about giving the COVID vaccine and asked him if he wanted to watch or look away. Patient reports he wanted to look away during the administration of vaccine. Patient reports he would like the vaccine in the left arm. The moment the needle when in to the left deltoid the patient pulled away, and I was unable to administer the vaccine injection at that time. Discussed with father if he wanted to try again on the right arm and father with patient agreed to try again. Needle was switched out and syringe was re-primed. Went to administer the covid vaccine in the right deltoid, as I was administering the vaccine the patient pulled away for the second time, some of the vaccine was squirting out of the syringe as patient pulled away. Patient may have gotten roughly 0.1 ml of the COVID vaccine. Patient and father did not want to try for a third attempt today. Will follow up with pfizer to see if he needs an additional dose. Bandages applied to both needle site injections. Patient well but tearful as father reports that he usually doesn't a really good job with vaccines and is unsure as to why he pulled away today.
Disorientation; Extreme fatigue; runny nose; shoulder pain; This is a spontaneous report from a contactable Other HCP. This 52-year-old (at the time of vaccination) female Other HCP (patient) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6200) via an unspecified route of administration on 21Feb2021 at 01:00 pm at single dose on left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Vaccine was administered at hospital facility. Medical history included anxiety (dates unspecified), known allergies; no. Concomitant medications included citalopram 100 mg one time a day. Other vaccine was not administered in four weeks. Patient experienced extreme fatigue, disorientation, runny nose, shoulder pain on 21Feb2021 at 1:30 pm. Treatment for adverse events was not given. Patient did not have covid prior vaccination and covid was not tested post vaccination. The outcome of events was not recovered.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a bad experience after vaccination. The patient was unable to get out of bed for 2 days each time. Felt like the flu or something. The patient said that if she knew it would be that bad she would have been better off getting shingles. The patient's physician was charging  her a lot of money, The patient wanted to know was there any reimbursement or he would be going public about this.
Mother called the local Health Department on 7/1/21 to report that her son received the 1st dose of the Pfizer vaccine (Lot# ER8735) on 5/24/21 and the 2nd dose of Pfizer on 6/4/21 (Lot# ER8735) which is less than the recommended 21 day interval.  She reported her son had no adverse effects and feels "fine."
60 mm top to bottom. 90 mm left to right. Discomfort, redness, hard, and warm to touch.  Referred to Provider evaluation and develop continue plan of care.
embolic stroke, embolic left renal infarction, non ST elevation myocardial infarction
Patient woke up on 7/5/2021 with a swollen left hand (same arm as injection).  She stated it is red and hot to the touch.  She is also feeling a throbbing pain.  Pharmacist advised her to take some ibuprofen and put ice on the hand to see if it resolved the problem.  Pharmacist advised her to seek medication treatment if medication and ice did not help.  Patient was also notified to let primary care physician know the next business day of reaction.
redness area 1.5-2 inches at the injection; Injection site hot to the touch; Itching at the injection site; Pain at the injection site; Redness at the injection site; Chills; Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness area 1.5-2 inches at the injection), VACCINATION SITE WARMTH (Injection site hot to the touch), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis. Concomitant products included VITAMIN D NOS for Osteoarthritis.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), CHILLS (Chills) and MYALGIA (Muscle pain). On 24-Jan-2021, the patient experienced ERYTHEMA (redness area 1.5-2 inches at the injection), VACCINATION SITE WARMTH (Injection site hot to the touch) and VACCINATION SITE PRURITUS (Itching at the injection site). On 14-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and MYALGIA (Muscle pain) had resolved, CHILLS (Chills) had not resolved. At the time of the report, ERYTHEMA (redness area 1.5-2 inches at the injection), VACCINATION SITE WARMTH (Injection site hot to the touch) and VACCINATION SITE PRURITUS (Itching at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient treated with cool pads in the injection site.
Beginning in the late afternoon, I started feeling moderate chills. Beginning in the mid to late evening, the chills got noticeably worse. Probably around 2 or 3 in the morning, they got to the point where I was visibly shivering. When I woke up this morning, I had recovered from the chills.  For most of today, I haven't had much of an appetite, have felt sluggish, and have had minor body aches.  On my first and second doses of the vaccine (4/14 & 5/5), I had VERY minor chills. On both occasions, they were so minor that I didn't realize I was having side effects until they had passed.
One COVID vaccine causes heart problems; Hives; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (One COVID vaccine causes heart problems) and URTICARIA (Hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CARDIAC DISORDER (One COVID vaccine causes heart problems) and URTICARIA (Hives). At the time of the report, CARDIAC DISORDER (One COVID vaccine causes heart problems) and URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient reported getting hives and heart problems with Moderna COVID vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Information has been received from a health care professional concerning a female consumer who in April, May and October 1991 was vaccinated with Hep B vaccines. On 6/15/92 blood work revealed a negative hep b antibody. In April, June, and November 1963, the pt was again vaccinated with the Hep B vaccine. On 11/16/99 the pt experienced a needle stick at work and was immediately titered which showed nothing. It was noted that during the first series the pt experienced a severe asthma attack requiring treatment with prednisone and that this was thought to interfere with her immune response to the first series. Upon medical review, the pt's asthma attack was considered an "other medical event." Additional information has been requested.
Hot at injection site; itchy at injection site; Redness at injection site; A spontaneous report was received from a Consumer concerning a 89-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itchy at injection site, redness at injection site, hot at injection site.  The patient's medical history was not provided. Concomitant medications reported were xanax for drug use for unknown indication.  On 6 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the events itchy at injection site. redness at injection site, hot at injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  On an unknown date the outcome of events, itchy at injection site,redness at injection site, hot at injection site were not reported.  Based on comment Injection site Pain, Injection site erythema and Pruritus coded (Vaccination site warmth, Vaccination site erythema and Vaccination site Pruritus)
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/7/2023 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD)
March 30, Weakness, light headed , no energy, upset stomach. March 31 slept 24 hours could not wake up, April 1, weak, could not sit up, wanted food, too weak to eat. My brother , retired fire caption medic, called 911 to ha e my father transported to ER
NO SYMPTOMS.  KINRIX (DTAP/IPV) VACCINE GIVEN TO A CHILD LESS THAN 4 YEARS OF AGE. NO ADVERSE EFFECT.
My brother delayed his second dose of Shingrix for 19.5 months after the first dose, due to the pandemic.; This case was reported by a consumer via interactive digital media (Shingrix GSK Chatbot) and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 19.5 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient was the reporter's brother. The age at vaccination was not applicable for this report. The patient delayed his 2nd dose of Shingrix for 19.5 months after the first dose, due to the pandemic. The reporter asked if the patient needs additional dose. No further information was reported. The follow up was not possible as no contact details were provided.
Pfizer 12/21/20, 1/11/21, 10/22/21. Positive on 7/13/22
subacute thyroiditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2021 at 16:00 as dose 2, single (Lot number: EW0168) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: ER8729; Location of injection: right arm; Vaccine Administration Time: 04:00 PM), administration date: 06Apr2021, when the patient was 29-year-old, for COVID-19 immunisation. The following information was reported: THYROIDITIS SUBACUTE (non-serious) with onset 22Nov2021, outcome "recovered", described as "subacute thyroiditis". The event "subacute thyroiditis" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of thyroiditis subacute.   Additional information: The patient did not receive other vaccine within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient took thyroid medication as treatment for subacute thyroiditis. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient was tested for COVID post vaccination. Dose 1 vaccination date was also reported as 06Apr2022 and dose 2 vaccination date was also reported as 04May2022.  Follow-up attempts are completed. No further information is expected.
Pregnant - 13 weeks and 6 days- due date is October 1, 2021. Around 6 pm the night of my shot on April 1 I started with a headache, that progressed into a migraine, chills, fever. Tylenol was not helping. The next morning I called my doctor because the tylenol was not helping and they prescribed fioricet to bring my fever down and take the migraine away. Migraine went away later that night April 2, 2021 but felt weak that night into the next day.