chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; A spontaneous report was received from a physician assistant on 19MAY2023 regarding a 22-year-old male patient who had "hives" (PT: Urticaria) following the administration of Vivotif (Typhoid vaccine live oral Ty21A; lot number: unknown) as an immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On 10MAY2023, the patient received the third dose of Vivotif following which he experienced hives. Reportedly, the patient was advised to see immediate medical help, and not to administer the fourth dose of Vivotif.  The outcome of the reported event was unknown, at the time of this report.  The action taken with Vivotif with respect to the reported event was withdrawn.  No additional information was reported.  Company comment: A consumer took Vivotif for immunisation and developed hives (urticaria). Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of urticaria is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: A consumer took Vivotif for immunisation and developed hives (urticaria). Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of urticaria is assessed as possible. The case is considered non serious as per medical assessment.
She had not eaten but 15 minutes after injection, she felt as if her blood sugar dropping. She purchased a candy bar and ate it on the way. Her husband was driving. She does not remember trip. She was still feeling bad and they got a shake, she was not able to chew. They went straight home and checked blood sugar which was 62. This was approximately 1 hour after she ate candy bar. She started to feel better after another hour and ate a hamburger. She proceeded to sleep a lot the rest of the day. She stated she has never had a low blood sugar episode that severe before.
Information was received from a lawyer regarding a case in litigation. A female patient, age unspecified, was inoculated with ZOSTAVAX on 22-SEP-2011 at a pharmacy as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain condition of herpes zoster also known as shingles. On or about 14-MAY-2016 the patient was treated at a medical center for a blistering vesicular outbreak which was then diagnosed as herpes zoster, shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Ringing in ears noticed approximately 6-7 hours after injection, intensity increased for approximately 18 hours then plateaued, and has remained at this plateaued level to the present with minor changes above and below this level. I had not been exposed to any loud, sudden, or unusual noises at any time for many days prior to injection.
Patient receiving his J&J vaccination and the vaccine leaked out, so when the needle was inserted into the Patient arm there was no vaccine to push. Technician stated she was 100% sure there was no fluid that was pushed into the PT arm.
Shot admin 8/18/15. Patient returned 8/22/15 w/swollen painful arm and shoulder. Doctor presented prednisone.
chest pains; can't get out of bed.; body aches; no energy; Fever; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Aug2021 18:00 (Batch/Lot number: unknown) at the age of 28 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "chest pains"; BEDRIDDEN (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "can't get out of bed."; PAIN (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "body aches"; ASTHENIA (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "no energy"; PYREXIA (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "headache". The events "chest pains", "can't get out of bed.", "body aches", "no energy", "fever" and "headache" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of chest pain, bedridden, pain, asthenia, pyrexia, headache.  Additional information: The patient did not have covid prior vaccination. The patient did not get covid tested post vaccination. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I feel that I am extremely on edge, and that my heart is working harder than normal. I have a history of high blood pressure in my family, and have also been diagnosed, but had been keeping it in check. But I can always feel when it isn?t right. First felt really anxious and was having heart palpitations. I?ve had mild chest pressure the whole time, but no shortness of breath. Zapped of all energy and slower cognitive processing. Took Losatran and baby aspirin the morning of (5/22/2021). Treated at urgent care and provided provided three chewable baby aspirin and amLODIPime.
Started with a headache approx 16 hours after injection. Felt fatigued so went to bed and slept for a little bit. Woke up to eat around 6pm on 1/13/21 and started to get chills and not feeling well along with the headache and fatigue so decided to lie back down. Woke up 1:30am on 1/14/2021 soaked in sweat and nauseous still having all the other symptoms. Took oral temp and was 101.4 shortly after vomited and started having some body aches and went back to bed. Woke back up 5am on 1/14/2021 fever had broke, still had headache, fatigue, and some chills and went to work, took imitrex to help with headache. 1/15/2021 woke up at 4:30am with slight headache feeling much better and by 1/16/21 most symptoms have subsided or gotten extremely better.
Dose of 0.3ml mistakenly administered.  Should have been 0.2ml.
pt exp an inject site react (swelling, redness, pain, hot to touch) w/in 24 hrs p/vax 30NOV; swelling was blistered & extended to underarm; 2DEC MD visit-swollen glands underarm; rx'd w/Augmentin; 3DEC swelling extended to elbow;
A FEW MINUTES AFTER RECEIVING VACCINE, PT STATED THEY FELT LIGHTHEADED AND FAST HEART RATE. GAVE PT WATER AND CHECKED HER BLOOD PRESSURE - BP WAS 227/138 WITH PULSE OF 123. 10 MINUTES LATER BP WAS STILL ABOVE 200 WITH NO PREVIOUS HX OF HYPERTENSION. TOLD PATIENT I COULD CALL AN AMBULANCE OR PTS DAUGHTER NEEDED TO TAKE HER TO THE HOSPITAL. PT WENT TO NEAREST HOSPITAL AND WAS RELEASED AFTER BLODD PRESSURE WAS UNDER CONTROL
Vaccine given 1/15/10, headache and encephalitis symptoms developed 1 wk later, hospitalized 2/5/10 for encephalitis.
inadvertently expired dose was administered; a vial that was punctured and left at room temperature for 5 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently expired dose was administered) and PRODUCT STORAGE ERROR (a vial that was punctured and left at room temperature for 5 days) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 048A21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022 at 5:15 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 01-Feb-2022 at 5:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently expired dose was administered) and PRODUCT STORAGE ERROR (a vial that was punctured and left at room temperature for 5 days). On 01-Feb-2022 at 5:15 PM, EXPIRED PRODUCT ADMINISTERED (inadvertently expired dose was administered) and PRODUCT STORAGE ERROR (a vial that was punctured and left at room temperature for 5 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient had no acute illness at the time of vaccination and up to one month before.  The vial was initially stored in the refrigerator at 27-Jan-2022. It was reported that, a vial was punctured on 27-Jan-2022 at 08:30 AM and left at room temperature for 5 days and was used in a vaccination on 01-Feb-2022 at 17:15. The vial did not undergo any temperature excursions. The vaccine was administered in deltoid muscle (unspecified). The patient did not experience any adverse event.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2022: Follow up information included patient's race, suspect vaccine dose information and narrative updated.
VACCINE GIVEN IN THE MORNING, MILD BODY ACHES STARTED WITHIN A FEW HOURS, AT THE 12 HOUR MARK SHIVERS BEGAN (NO FEVER) TEETH CHATTERING, FREEZING. THAT LASTED ABOUT AN HOUR. NEXT DAY INJECTION SITE WAS SOFTBALL SIZED AND VERY RED, HARD AND WARM THAT LASTED 3-4 DAYS (LESSENING EACH DAY, BUT SORE AND BOTHERSOME). BODY ACHES CONTINUED DAY AFTER VACCINE AND AT ABOUT 5-6PM DAY AFTER VACCINE, PT HAD LOW GRADE FEVER (99-101 DEGREES) LASTING ABOUT AN HOUR. HEADACHE OCCURED OVER THIS TIME PERIOD TOO. COVID19 IS GOING AROUND OUR AREA, PT GOT TESTED FOR IT AND WAS NEGATIVE. TWO DAYS AFTER VACCINE GIVEN, PT WAS BACK TO NORMAL (ONLY THING THAT LASTED FOR 3-4 DAYS WAS INJECTIONS SITE REACTION).
On the next day there was extreme swelling & redness plus pain in the entire upper left arm. Severe fatigue. Lost of appetite. Fever & chills. Lasting 5 days
When ever I happen to lay down some what fast I get really dizzy, also has happened when I have moved my head fast as well, I have never had this problem before.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181 10121) via an unspecified route of administration in the left arm on 03Sep2021 at 09:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Concomitant medication received within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Sep2021, whenever the patient happened to lay down some what fast, she got really dizzy. This also happened when she had moved her head fast as well and has never had this problem before. It was unknown whether therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event whenever happen to lay down some what fast get really dizzy, also had happened when had moved head fast as well, has never had this problem before was not resolved at the time of this report.
Patient verbalized that she has been SOB since her last COVID vaccine and was unable to lift left arm up to normal height and still has left arm pain. Patient verbalized that this has all been since her 2nd COVID 19 Vaccine. She received her 2nd Moderna COVID 19 vaccine on 05/10/2021.  According  to the VIS system it was a Pharmacy Store per VIS
He had a rash all over his upper body and face that did spread to his lip, started 08-15-2006, no fever.  Acts normal
The day after the second dose of the vaccine I had flu symptoms with body aches and chills.  I had severe nausea and vomiting that night and I could not keep my blood pressure medicine down. After a couple of hours I went to the ER they ran tests and gave me Zofran. The medication helped relieve the symptoms and I was discharged. I was fine the next day but I was very tired.
Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.; No adverse event; Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.).    No concomitant product use was reported.  Reporter stated that between 24-May-2022 and 03-Oct-2022 several patients received monovalent and bivalent moderna Covid-19 vaccine that had undergone several temperature excursions.  No other adverse events were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-673878, US-MODERNATX, INC.-MOD-2022-673836, US-MODERNATX, INC.-MOD-2022-673869, US-MODERNATX, INC.-MOD-2022-673181 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673878:same reporter US-MODERNATX, INC.-MOD-2022-673836:same reporter US-MODERNATX, INC.-MOD-2022-673869:same reporter US-MODERNATX, INC.-MOD-2022-673181:same reporter
Severe headache, vomiting, body aches with chills all began the evening of June 15th - the day of the vaccine. At home rest, Tylenol
Between 8:30-9:00 PM, patient started complaining that the site the vaccination was itching.  It looked red and slightly swollen around the injection at bedtime. The next morning patient complained that it was itchy again.  When I looked at it, the red swollen area was much larger-about the size of my palm, hot, and hard.  I called the nurse line at our pediatrician's office.  They said it is normal for the MMR/Varicella vaccine to itch, to ice it and give her Tylenol. The following day it did not look any better, so we scheduled an appointment for July 27th. We saw another doctor in the practice who said the swelling/redness was celluitis caused by external bacterial infection.  She prescribed Cephalexin for the infection. After completing the entire round of prescribed anti-biotics, the redness/swelling appears to be gone.  Patient has not complained of it bothering her since taking the anti-biotics.
Developed upper back pain which radiated bilaterally to the chest and abdomen from the level of the nipples to the lower abdomen. This was accompanied by a burning feeling and skin hypersensitivity. It radiated anteriorly to about the nipple level. Did not involve the sternal area.
Evening of 8/31/2018: Pt experienced pain at injection site and fever of 101 F. Over the weekend (9/1/2018-9/2/2018), pt continued to experience fever and chills. Pt took Tylenol for symptoms. As of 9/5/2018, upper arm area surrounding injection site is red, warm, tender, and inflamed.
Pt exp swollen glands, face, neck; hives initially then a fine rash over entire body, fever 101.5, vomiting, abdo cramps, red lips, swollen fingers; MD prescribed meds; pt was unable to take due to nausea, vomiting, cramps;
received vaccine 10:22am,  At 10:35am PSt voiced complaints of being faint and nausea, no report of dizziness, HA, or stomach pain.  Husband observant, came inside.  Attendee's skin pale/diaphoretic/clammy.  Attendee's respirations were not tachypneic or dyspneic, but were calm. Attendee assisted to the cot to lie down, legs elevated, cold pack.  10:50 Sitting up, VSS felt confident of ambulation, warm and dry sky, report of this same occurance with other lab draws or vaccinations.
No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 15-month-old female patient. The patient's illness at vaccination and pre-existing allergies, birth defects and medical conditions were reported as none. The birth weight was 7 lbs and 11.8 oz. The patient had one sister and one brother. Concomitant therapies included sterile diluent (manufacturer unknown) and HIB vaccine conj (tet tox) (HIBERIX).  On 31-MAY-2022, the patient was vaccinated with the second dose of temperature excursion varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U029496, expiration date: 21-SEP-2023) 0.5 ml subcutaneously at left thigh for prophylaxis (product storage error) at a private doctor's office. No adverse event was reported (no adverse event). The vaccine was purchased with public funds. The vaccine was used according to the instruction leaflet. The vaccine was in freezer and available for return/evaluation.  The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007524: US-009507513-2206USA007508: US-009507513-2206USA007509: US-009507513-2206USA007510: US-009507513-2206USA007511: US-009507513-2206USA007512: US-009507513-2206USA007513:
Initial report received from literature on 2 December 2014. This case is linked to case 2014SA169198 (same literature, same reporter, mother case). Before the development of a vaccine in 1937, Yellow Fever was one of the most feared and lethal diseases in human history. The live, attenuated Yellow Fever vaccine provides lifelong immunity and is safe for those with a developed immune system. Breastfeeding mothers, however, should not receive the vaccine as it may cause Yellow Fever in infants. Six cases of Yellow Fever transmitted via breastfeeding have been reported. These cases occurred when Yellow Fever vaccine was administered to breastfeeding mothers with infants from 10 to 15 days old. Serum and cerebrospinal fluid were positive for the Yellow Fever virus, and nucleotide sequences confirmed identical viral profiles between vaccine and cases. Such cases suggest acute central nervous system infection with Yellow Fever through breastfeeding. Further research is needed to evaluate more fully the risk of vertical transmission of such viruses via this route. Although vertical transmission of Dengue Fever and West Nile has been documented previously, little information exists regarding transmission of Yellow Fever via breast milk. A 6 patients (10 to 15 days old), whose medical history and concomitant medications were not reported, had received a dose of Yellow Fever Vaccine (batch number, route and anatomical site of administration were not reported) of unknown manufacturer via breastfeeding on an unspecified date. It was reported that, yellow fever was transmitted via breastfeeding. Serum and cerebrospinal fluid were positive for the Yellow Fever virus, and nucleotide sequences confirmed identical viral profiles between vaccine and cases. The patient's corrective treatment was not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
has not received their second dose in the series; This spontaneous report was received from a pharmacist and refers to a 41 years old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 08-JUL-2020, the patient was the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. But the patient had not received the second dose in the series (inappropriate schedule of vaccine administered).
This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 04-MAY-2016, the patient was vaccinated with an improperly stored ZOSTAVAX, lot # 1033311, 01-DEC-2016. No adverse effects were reported. Temperature of 30 Fahrenheit, 6 hours. There was no previous temperature excursion. Additional information has been requested.
left side lymph node swelling x3 days, began on 1/3/21, also has fatigue, has been afebrile, no other issues  Narrative:  Has not required medical attention yet. Today now feels there may be some ear pressure. Advised to f/u with PCP if ear begins to bother her more and update Occ. Health. No known exposures to anyone who has tested positive for COVID-19 infection.
Vaccine was diluted w smaller than recommended volume of diluent resulting in a more concentrated dose administered.
Severe dizziness and vertigo. But still not resolved fully. Worse on second day.  On going headache
Intial chlls, headache, severe muscle aches. Worsening headache and abdomenal pains over the next several days. Persistent chills, low grade fever abdomenal pain.
C/O chest tingling, "room getting dark", feels like passing out.  Felt dizzy.  BP 120/80, SO2 97%. HR 80
2-3 inch erythematous, swollen/raised rash at injection site.  Skin warm in affected area. 2 day after eruption slightly larger and pruritic