chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VARIVAX was administered to a patient prior to discovering the temperature excursion/improperly stored VARIVAX administered to a patient/temperature excursion involving their VARIVAX vaccines; This spontaneous report as received from a nurse practitioner refers to a 13-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-MAr-2021, the varicella virus vaccine live (oka/merck) (VARIVAX) experienced temperature excursion of 31.8 degrees Fahrenheit for 5 hours and 30 minutes. On 16-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, subcutaneously, frequency reported as "x1", lot # T022314, expiration date 30-JUN-2022 (anatomical location was not reported) for prophylaxis. During the temperature evaluation it was reported that the varicella virus vaccine live (oka/merck) (VARIVAX) was administered to a patient prior to discovering the temperature excursion. There was no previous temperature excursion reported. The digital data logger was involved.
Became lightheaded within 30 minutes.  Developed stomach cramps and diarrhea  and chills through the night.  The next day had a headache  and muscle aches in her legs.  Vaccination site was also very sore, feverish and had a small lump .  Symptoms were much better within 2 days.
Full body rash started Friday 1/21/22 which was itchy and in patches from head to toe. It comes goes and moves locations. Went to the doctor starting Monday 1/24/22. I was informed that this rash is the same as that seen in patients 2 weeks post booster repeatedly. With this rash came a ringing in my left ear. By Wednesday 1/26/22 I am deaf. in my left ear from tinnitus caused by the COVID moderna booster.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter stated that on unspecified dates ranging from 15-JUN-2015 through 18-JUN-2015, the patients received doses that were improperly stored of VARIVAX (strength, lot number, expiration date, dose # and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
experienced pain around left collarbone area, pain comes and goes; pain has spread to left shoulder and left upper arm; pain has spread to left shoulder and left upper arm; dose number: 3; experienced red painful bump over injection site; experienced red painful bump over injection site; experienced red painful bump over injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 10:00 (Lot number: EJ8757) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sulfa drug allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Left), administration date: 04May2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left), administration date: 13Apr2021, when the patient was 29 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 10:00, outcome "unknown", described as "dose number: 3"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 15Dec2021, outcome "recovered" (Dec2021) and all described as "experienced red painful bump over injection site"; BONE PAIN (non-serious) with onset 25Dec2021, outcome "not recovered", described as "experienced pain around left collarbone area, pain comes and goes"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 25Dec2021, outcome "not recovered" and all described as "pain has spread to left shoulder and left upper arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site mass, vaccination site pain, vaccination site erythema, bone pain, arthralgia, pain in extremity.  Additional information: The patient didn't received any other vaccines within 4 weeks prior to the COVID. The patient not received any other medications within two weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Vaccinated on 15Dec2021 - experienced red painful bump over injection site for 1 week.  On 25Dec2021 - experienced pain around left collarbone area, pain comes and goes, pain has spread to left shoulder and left upper arm.  No follow-up attempts were possible. No further information was expected.
This case was reported by a healthcare professional and described the occurrence of vomiting in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included PEDIARIX; GlaxoSmithKline given on 20 July 2009; HIB (non-gsk); Sanofi Pasteur MSD given on 20 July 2009, PREVNAR; Wyeth Labs given on 20 July 2009. There were no concurrent medications. On 20 July at 11:45 the subject received 2nd dose of ROTARIX (1 ml, oral). On 20 July 2009, 10 to 15 minutes after vaccination with ROTARIX, the subject experienced vomiting. At the time of reporting the outcome of the event was unspecified. Follow-up information recieved on 11 august 2009 indicated that the event of vomiting resolved. It was also reported that the subject had recived a first dose of ROTARIX on 20 May 2009 and experienced vomiting. Concurrent vaccines given were injected intramuscularly at 0.5ml dose each on 20 July 2009. For details involving the second dose of ROTARIX and vomiting refer to case AO79928BB.
severe headache within 24 hours (resolved within 1 day), rash between breasts and onto upper abdomen - applying prescription ointment, remains ongoing
Pneumonia booster, arm swelled up, hot, could hardly move it.  In am the arm was even more swelled up and hot despite cold packs. Pain not quite as much but swelling moved into elbow and  arm looked red.
This spontaneous report as received from a pharmacist refers to a male child (currently 37 years old). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, as a child, the patient was vaccinated with one dose of MMR II (dose, route of administration, lot # and expiration date were not reported). On an unknown date, as a child, the patient experienced chickenpox. It was unspecified if the patient developed a chickenpox before or after receiving MMR II. It was also provided that on unknown dates, the patient was vaccinated with the doses of PROQUAD (dose, route of administration, lot # and expiration date were not reported) and VARIVAX (dose, route of administration, lot # and expiration date were not reported), but no adverse effects were reported for either product. The outcome of chickenpox was unknown. The relatedness between chickenpox and MMR II was not reported. Additional information has been requested.
The patient felt lightheaded and nausea and had trouble catching breath.  The patient was observed for 15 minutes and released on own accord after symptoms resolved.
5 minutes after vaccines patient became dizzy, complained of headache, and vomited 1 time.  Hypotensive, observed in clinic for 2 hours.
Seen today for swelling & Redness L.T. - Kinrix 10mmx85mm - itchy R.T. Proquad 35mmx30mm initially hot and hard day after vaccine given 6/10/22 - seen today 6/13/22
Swelling, heat and pain in right arm increasing from 11-7-17 in afternoon to 11-10-2017 afternoon. Notified provider. Started on doxycycline and CIPRO on 11-10 after texting a picture of her swollen arm to her provider (patient was in out of town and could not get to the clinic until later that evening.) Dr ordered a sonogram to check for a clot, which was done and it was negative for clot. Then antibiotics were started. Swelling & pain decreased and were mostly gone on 11-13-17. No problems now.
Problems with both eyes since about a month after the first vaccine (Moderna) in March 2021, for over two years now. Burning, itching, red, leaking tears, dropping lower eyelids, puffy inflamed upper lids. So bad that it effects my work, my pleasure time, reading, and driving.
The patient was extremely nervous to the point of shaking before the IMZ. Patient felt a hot rush go over her immediately after administering her vaccine. She felt faint and nauseated. I laid the patient on the floor with legs up and placed a cool towel over her neck area. She stated she was not sure about taking the covid vaccine and she felt it would cause her to have a heart attack because she had read about it. I gave the patient cold water to drink. Her HR was 103. We talked and tried to calm her some then retook her HR  after 10 minutes. It had decreased to  84. After 20 minutes the patient decided she wanted to stand. We went from the floor to the chair then eventually on her feet. I feel the patient was so nervous she put herself into a panic attack. She repeatedly asked if I have had any patients die from the vaccine, how many people we have had get blood clots and heart attacks after having the vaccine. After 30 minutes the patient decided she felt well enough to go home.
prolonged sz activity w/bilat cerebral infarctions-resp arrest & cerebral edema w/in 24hr of vax;death w/in 36hr of vax;tx w/med;mechanical ventilation;
Dizziness, UrticariaPruritus, HYPERtension, Syncope, flushing Narrative:  flushing/dizziness during clinic session (pt is a chiropractor) with patient, vs checked--bp 200s/130s (normotensive at baseline), red face/chest, itching, weaknes; syncope (fell to floor, only remembered waking up on the ground); rec'd benedryl 50mg IV from EMS, then transported to local ER, observation and improved to baseline.
body aches; flu-like symptoms; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included RIVAROXABAN (XARELTO), METOPROLOL, AMIODARONE HYDROCHLORIDE (AMIDARONE), HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN AND HYDROCHLOROTHIAZIDE) and LEVOTHYROXINE for an unknown indication.    On 27-Feb-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (body aches), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills). At the time of the report, PAIN (body aches), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that he didn't take any treatment for his symptoms as he was on so many other medications
This is a spontaneous report from a contactable female consumer (patient). A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date, patient had a dental procedure after receiving her 1st dose of vaccine. She was supposed to take steroid but now she wanted to know when she can take the steroid after she gets her 2nd dose. The outcome of the event: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Erythema, warmth 20 cm x 20 cm. Swelling of (L) arm extending past elbow.
On 10/31/13 noted (R) eye not closing completely and (R) side of mouth asymmetry. Referred to physician for evaluation of possible Bell's palsy, MD prescribed VALTREX and Prednisone.
No initial reaction. Five hours post-vaccination, arm pain, sudden headache over right ear and extreme bloating (stomach appears to be that of a nine month pregnant woman). Took Tylenol 500mg for pain and tumeric 1000mg and budesonide 3mg to relieve some bloating pressure. Was up with a pain level of 10 and nausea and vomiting at midnight. When having a flare, she typically would have a slow build over days, having increasing levels of bloat and pain and swollen feeling eyes. Following the vaccine she went from 0 pain to a constant 10. Her cpr was measured 4/3/21 to be  0.9 the day after the vaccine following budesonide 9,mg it was 6.3
Patient is a 91 y.o. Caucasian male with past medical history of acne rosacea, cerebral atrophy (noted on CT scan 2016), CKD stage 3, OSA (uses CPAP), CAD, cervical spine degenerative disc disease, depression, diabletes mellitus type 2, diabetic neuropathy, dyslipidemia, hypertension, GERD,  hypogonadism, lumbar spinal stenosis, obesity, osteoporosis and past alcohol and tobacco abuse (both in remission) who was brought by ambulance to the ED for evaluation of vomiting x 3 days. Patient report diarrheal symptoms on Monday (7 days ago). Thursday evening patient reports he had trouble going to the restroom-constipation which is not new for him. Patient states he started vomiting shortly there after and developed pain.  Reports pain in his side is similar as the pain he was experiencing in May 2021 when he was in IPR and diagnosed with an ileus/gastroenteritis. He has been at home the last 2 days with continued nausea and vomiting with vague diffuse pain but elected to call 911 today because the pain and vomiting hasn't improved. He has tried to sip on liquids to keep hydrated
headache; This is a spontaneous report from Support. A contactable consumer reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced severe headache on 12Feb2021 and wanted to know if he can take Tylenol. The outcome of the event was unknown.  Information of Lot/ Batch number have been requested.
Sudden lip swelling and dropping. Did a tele health visit with a doctor, he recommended that I go see  a doctor in person. Went to an Urgent care and was prescribed prednisone
This spontaneous report as received from registered nurse (who worked in a health clinic) refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II (dosing details and lot number unknown). On an unknown date, a routine titer testing was done and an unspecified number of patients had negative titers for MMR. The patients came back to receive a booster dose of M-M-R II. The outcome of the negative MMR titers was unknown. No product quality complaint was involved. Causality assessment was not provided. This is one of the two reports from the same reporter. Additional information has been requested.
Per FDA proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and local authority instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes.
Rapid heart rate, frequent stools, wt loss (7lbs), chest heaviness, throat pain, neck tenderness, loss of appetite, lasting 4-6 wks. all symptoms with the exception of rapid heart rate and chest heaviness reslved. hospitalized 10/10-11/14. Dx idiopathic cardiomyopathy. THe medicao records received on on 2/11/04 state tachycardia and idiopathic cardiomyoopathy were confirmed andd premature beats.
Injection given IM L deltoid, bruising, weakness, headache, nausea, (weakness was generalized). increase in B/P. Physician advised pt not to take another vaccine. Increased BP meds to help lower B/P.
2 hrs following this second set of immunizations, child developed generalized rash and vomiting following feeding, again.
I received the J&J shot after work on Friday around 5:30 p.m.. Around 3 a.m. Saturday morning, I woke up with a fever and chills. My head was hot. My body was cold. I had a pretty severe headache as well.  My body ached all over. Muscle and joint pain. I took Tylenol, but it didn't seem to do much. I spent all day Saturday in bed or on the couch. I ran a fever of 100.9 to 101.6 all day Saturday. My body ached making it hard to go up or down stairs. I was weak feeling and I was exhausted just going to refrigerator to get juice or water. Not much of an appetite all day. Also, arm was sore and bruised at the shot location. That was the least of my issues. Today is Sunday and I am feeling better now. I feel like the worst is absolutely behind me, but I felt so terrible yesterday, I thought I should report my issues.
Gave wrong vaccine. Gave Prevnar 13 when HIB should have been given.
Pt reported dizziness and sleepiness lasting a few seconds. Vitals assessed. BP 140/80 mmHg, HR 90 bpm, and SpO2 99%. Patient reported not sleeping well and history of anxiety. Patient given water. Patient reported that was around his normal blood pressure. Patient also reported not remembering if he took his blood pressure medication this morning. Patient refused reassessment vitals and  transportation. Pt left facility with steady gait and unlabored respirations.
PATIENT WAS TESTED ON 8/11/21 AND TESTED POSITIVE TO COVID
Patient was behind on vaccines. The day of 2021-02-15 we tried to catch him up with dtap, IVP,PCV13, HAV. MMR & varicella unfortunately patient was given double varicella by opting MMRV & varicella individually. He ended up getting double varicella and vaccine.
hx of psoriatic arthritis & had sx of arthralgia of hands following the  1st dose of vax;
Patient after the vaccination during the waiting period started having vision changes, dizziness, shortness of breath, itching, paleness, sweating, throat a little tight. 911 was called, and patient monitored very close with Epipen out and ready to use if needed. 911 team arrived to store patient had some water and was starting to feel better. Patient ended up feeling fine and it was thought after all tests to be an anxiety attack. No medication was given. Patient did not go to ER.
Minor patient,  with known history of severe anxiety that causes nausea and vomiting as well as migraines. Mother reported child was extremely anxious prior to vaccination. Pfizer Peds Vaccination administered at 1619 on 12/13, At 1630 patient vomited and c/o HA with no additional symptoms indicating  s/s  anaphylaxis. RN provided emesis bag, and water and RN assisted patient to cot to lay down. Patient reported improvement in symptoms after rest and water.
No adverse effects reported; one dose of an improperly stored vaccine was administered to one patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided. On 02-MAY-2019, the patient was vaccinated with one dose of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, subcutaneously, lot # R017799 with expiration date on 19-DEC-2019 (frequency was not reported) for prophylaxis. Concomitant therapies included sterile diluent (Merck Sharp & Dohme). The vaccine underwent temperature excursion of 12.7 degrees Fahrenheit for 50 minutes. There was previous temperature excursion of 6.8 degrees Fahrenheit for 20 minutes on 01-MAY-2019. The digital data logger was involved in recording excursion details. Sterile diluent was stored in the correct temperature storage range. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA007760: US-009507513-1905USA010266:
Patient reported numbness, tingling of left arm on 8-5. Stated could not use left hand, could not grip. Follow-up call patient stated hand had drawn up into a fist and was difficult to open.
Moderna 4/28/21 Lot# 016C21A;  Moderna 5/26/21 Lot# Lot# 048B21A
No additional adverse events reported; improperly stored Proquad was administered to a patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 29-SEP-2021, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot# T027115, expiration date: 07-FEB-2022, albumin status has been verified as recombinant human albumin (rHA), 0.5 (units not provided) (route of administration and anatomical location were not provided) for prophylaxis.   Administered dose of vaccine experienced the temperature excursions between 6 and 14 degrees Fahrenheit (F): (8.5 F) for 18 minutes, and 11.9 F for 1 hour. There were no previous excursions reported. No adverse events were reported.
Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; This spontaneous report was received from an adult female patient, concerning to herself via medical record from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 1902USA002572). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.     On 09-MAR-2017, the patient was vaccinated with pneumococcal polysaccharide PPV23 (manufacturer unknown) (dose, route of administration, anatomical site, vaccination scheme, lot number, and expiration date were not provided). It was reported that other doses of pneumonia (manufacturer unknown) (dose, route of administration, anatomical site, vaccination scheme, lot number, and expiration date were not provided) were administered on approximately 2019 and 2020, she did no recall that exact date (inappropriate schedule of product administration).  This is one of two reports received from the same patient. ; Sender's Comments:  US-009507513-1902USA002572:
Initial information received on 02 October 2007 from another manufacturer, report number WAES0708USA05829. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a registered nurse concerning six patients who were vaccinated with Varivax (Oka/Merck). Subsequently, the patients experienced breakthrough chickenpox. A product quality complaint was not involved." "Follow-up received 20-SEP-2007: Follow-up information has been received from a registered nurse concerning a 21-month-old female with no pertinent medical history or allergies who on 20-JAN-2007 was vaccinated in her left thigh with her first dose of ProQuad (Oka/Merck upgrade process) (lot # 656165/1387F). It was unknown if there were any illnesses at the time of vaccination. On 20-JAN-2007 concomitant vaccines included fourth dose of Trihibit (Sanofi Pasteur) (Lot # V1465AA & VE959AA), a fourth dose of (Prevnar) (Wyeth) (Lot # B08684A), and first 0.25 mg dose of influenza virus vaccine (unspecified) (Sanofi Pasteur) (Lot # UT2176JA). On 18-AUG-2007 the patient developed numerous lesions on her face. The patient was prescribed with acyclovir (ZOVIRAX) 200mg-5 mL three times a day for 5 days. The patient recovered from the adverse event at an unspecified date. The event was considered to be an other important medical event by the reporter. It was noted that the patient's sibling (WAES # 0709USA03345) experienced an adverse event. This is one of several reports from the same source. Additional information has been requested." Tripedia lot numbers reported as V1465AA and VE959AA are not valid sanofi pasteur lot numbers.