chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Almost passed out; Vomiting; Heat on side of head; A spontaneous report was received from a consumer concerning a 80-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced almost passed out/loss of consciousness, heat in head/feeling hot and vomiting.  The patient's medical history was not provided. Concomitant medications included inhaler and statin.  On 22 Feb 2021, approximately three hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 031L20A) for prophylaxis of COVID-19 infection.  On 22 Feb 2021, three hours later, the patient experienced heat on side of head and almost passed out a medically significant event. On 26 Feb 2021, the patient had heat in head again and did pass out and vomited. The patient was hospitalized when passed out and did tests and everything was ok. Treatment details included anti-nausea medication.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events almost passed out, heat in head and vomiting was resolved on 27 Feb 2021.; Reporter's Comments: This case concerns an 80-year-old female who had a serious unexpected event of loss of consciousness along with NS events of unexpected feeling hot and expected vomiting.  Event onset the same day as the first dose of mRNA-1273. Treatment with anti-nausea medication. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt.recvd. vax 20FEB91 & developed a red spot on pallet.20FEB91 exp. symptoms of URI & fever subsequently developed rash on cheek & otitis media.25FEB91 symptoms worsened & rash became generalized.
Localized swelling/redness (L) deltoid area. No fever. Monitor clinically, TYLENOL.
Felt flushed, at one point felt faint, anxious, heart racing. BP 134/90 HR 80 @ 1125. Reported chest tightness and anxious a few minutes later. BP 150/108 HR 80 @ 1141. Assisted to Emergency Department across the street.
Patient passed out while sitting in chair, rolled to floor and immediately regained consciousness. No injuries noted. Monitored for 30 minutes with vital signs after episode. History of "passing out" during blood draw.
Information has been received from a health professional concerning her 12 month old son, with no medical history and no allergies, who on 3/15/2005 was vaccinated with a dose of varicella virus vaccine live (lot 647536/0825P). Concomitant vaccine administered on the same day included a dose of measles mumps rubella vaccine (lot 648606/0558P). The next day, on 3/16/2005 the patient experienced a fever. One week later, on approximately 3/22/2005, the patient developed diarrhea, his speech decreased, he became sensitive to foods, did not respond to people, and began banging his head and arching his back. The patient had been treated by a nutritionist and many other medical specialists (unspecified). He had been treated with pancreatic enzymes, bacteria for his gut, and holistic vitamins. Diagnostic studies were performed (no results provided). An endoscopy and colonoscopy were planned. It was reported that the patient had been to the emergency room several times. At the time of the report the patient had not recovered. No product quality complaint was involved. The patients reaction was considered to be immediately life threatening, disabling, and an other important medical event by the reporter (OMIC). Additional information has been requested. A lot check has been requested. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released.
Patient came into store on 11/24/12 and complained of rash and pain. Rash is about 3-4 inches above injection site. I told patient to check with physician. Also noticed rash around elbow area but not around injection site.
Patient stated she experienced paleness for 2 weeks,  was extremely lethargic, a period of time she felt as though she were paralyzed for 1 hour when she could not move her arms and legs, and her legs felt extremely weighted throughout the 2 week period after receiving the vaccine.
On Wednesday, March 17, 2021 client received her first dose of Pfizer COVID vaccine (LOT # ER2613, EXP 7/2021) at approximately 2:55pm.  Client waited in Observation Area and was observed by EMT to have blotchiness in both hands 15 minutes later. Client also stated to EMT her "throat  feels tight and dry." EMT alerted Lead RN  while EMT took vitals at 3:25pm. Vitals: BP: 110/80, HR: 125 bpm, O2 sat: 96%. Upon assessment of client, Lead RN authorized EMT to administer 50mg of Diphenhydramine HCL oral solution per protocol with a water bottle at 3:36pm. Another set of vitals were taken following administration of Diphenhydramine HCL oral solution. Vitals at 3:38pm: HR: 78 bpm, O2 sat: 97%. Final set of vitals were taken at 3:46pm: BP: 118/86, HR: 71 bpm, O2 sat: 96%. Client stated the initial throat tightness with dry throat and mouth subsided after administration of Diphenhydramine HCL oral solution. At 3:50pm client was educated by Lead RN & EMTs on s/sx of adverse reaction and when to go to the ED/call MD. Client left vaccine site with a steady gait at approximately 3:52pm.
Severe fatigue, temperature spikes to 102 degrees, severe muscle, joint pain, headache, brain fog
Swelling of the right deltoid area.  Bright red and painful x 3 days.
Patient received 3rd dose of COVID-19 vaccine (Pfizer. Lot #051B22A) on 08/03/2022. COVID-19 + on 11/29/2022, deceased 12/09/2022.
Immediately after the injection, I experienced an irregular small light red patch at the injection site about 3 inches by 2 inches.  I had pain and mild itching at the injection  site for two days and then the pain and itching stopped and the red patch faded.  Seven days later, in the evening of February 9th,  the red patch returned  and it was darker and became larger - round, about 3 inches across.  It was slightly swollen and warm to the touch.  It was accompanied by intense itching, but no pain.  This skin reaction has been lasting for two days now.  My doctor, by phone, recommended Benadryl but I don't have that in the house and we're having a snow storm and I can't go out to get it.  I took Extra Strength Tylenol before bed last night and it relieved the itching.
two days after the vaccinations were given, pt developed seizures, fever, HA and CSF pleocystosis. Mom initially noticed he was not responding to her calling him when he was outside, she walked up to him and he was focused on a fence post not moving to the call of his name. He has a "blank stare".  He was transported via EMS to ER where he was admitted for 9 days to pediatric ICU with seizures and apneic events. Upon discharge, his presumed diagnosis is viral meningitis.
buzzing sensation in his ears within 2 days; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (buzzing sensation in his ears within 2 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 21-Jan-2021, the patient experienced TINNITUS (buzzing sensation in his ears within 2 days). At the time of the report, TINNITUS (buzzing sensation in his ears within 2 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.    This case was linked to US-MODERNATX, INC.-MOD-2021-091903 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091903:Second dose case
Genera side effects:  fatigue, headache, muscle pain, joint pain, chills, nausea & vomiting, ? fever.        Plus:  Dizziness & weakness, tinnitus. 4"x5" hard, hot, swelling at site of injection. These effects were noted the same on first injection but not nearly as extreme.  After 4 days feeling better but dizziness & tinnitus remains along with arm tenderness.
progressive lower extremity weakness starting less than 24 hrs after shot, unable to walk unassisted in 48hrs  to unable to left legs onto hospital bed on admission 9/28 morning. Admitted for MRI Thoracic and spinal tap then 5 days of daily IgG infusion. I noticed no further progression of weakness and slight improvement. During next two weeks at home developed DVT in right leg, very little to no improvement until about 3 weeks after discharge then a very gradual improvement and with regular PT improved to walk without walker after 6 weeks.
The second day I became very tired and started out with a discomfort in by upper back, between my shoulder blades.  Later in the day I started feeling pressure, like someone was pushing on my back.  By evening, the pressure in by back was worse and felt winded.  It felt as if someone was squeezing me somewhat.  Breathing in made the pressure between by shoulder blades worse.    Due to having the prior lung surgery/condition I contributed it to that.  I did not contact my physician but decided if not better within a day I would.  The third evening the pressure seemed to be releasing and went away.
Difficulty breathing that lasted for a week; Dizziness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing that lasted for a week), DIZZINESS (Dizziness) and RASH (Rash) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing that lasted for a week), DIZZINESS (Dizziness) and RASH (Rash). At the time of the report, DYSPNOEA (Difficulty breathing that lasted for a week), DIZZINESS (Dizziness) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Patient tested positive for COVID-19 on 8/28/2021 and was admitted to the hospital on 8/30/2021.
The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 28-JUL-2016, the patient was treated by a physician for vesicular outbreaks, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term 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, and pain and suffering, and other damages. Additional information has been requested.
Patient Passed Away at Hospital after being admitted for one day. He went to the hospital complaining of lack of appetite and weakness.
asthma attack; having problems breathing; substantial pain around injection site.; fever; allergic reaction; This is a spontaneous report received from a contactable consumer or other non hcp. A 20-years-old female patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 01Mar2021 15:45 as Dose 1,single for covid-19 immunization.Medical history included food allergy and milk allergy from an unknown date and unknown if ongoing. Concomitant medications included bupropion,sertraline, drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for an unspecified indication, start and stop date were not reported.The patient experienced asthma attack, having problems breathing, substantial pain around injection site,fever and allergic reaction on 01Mar2021 21:00.The patient had not received any other vaccine within 4 weeks.The patient was not pregnant.The patient was not diagnosed with covid prior vaccination and not tested for covid post vaccination.The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2013US025072 is an initial spontaneous report from a medical assistant received on 26 NOV 2013. This report refers to a 12-years-old male patient. His medical history and concomitant medications were not reported. It was reported that he received only Men CYW-135 liquid conjugate of MENVEO (batch number: X13016) intramuscularly on 21 OCT 2013 and did not receive Men A lyophilized conjugate. No adverse events  were reported following the maladministration.
Immediately after flu shot began feeling tingling to neck and mouth, then feeling of tightness to neck and mouth.  Stated felt "weird".
Patient reported her arm was sorer than usual after vaccination and it started a couple days after shot. Also, the area of injection became itchy the next day and has persisted until now 10/14/19.
Relentless vomitting over a 7 hour period, stomach pain, headache lasting two days, extreme fatigue - bedridden for about 32 hours other than to get up and vomit.
This spontaneous report as received from a registered nurse refers to a 17 months old male patient. The mother of the patient reported to the nurse that the patient began wheezing on 29-JUL-2013. On 30-JUL-2013 the aptient was vaccinated with a doe of MMR II, subcutaneous injection (dose, site of administration were not reported) (lot # reported as H017433; exp. date unspecified). Other suspect therapies included a dose of VARIVAX (Merck) (indication, strength, dose, subcutaneously and site of administration were not reported) (lot # reported as J001181, exp date unspecified) administered on 30-JUL-2013. On 31-JUL-2013 the patient came back to the office and was diagnosed with a croup. The patient was prescribed oral steroid ORAPRED as a treatment. The outcome of croup was reported as not recovered. The relatedness between therapy with MMR II and VARIVAX (Merck) and croup was not reported. Additional information has been requested.
Reporting on behalf of facility. Aggregate Report per COVID-19 Vaccine Information Brief dated 9/9/2022. Monovalent COVID vaccine administered as booster after FDA authorization. Ten patients were given Moderna monovalent COVID vaccine after FDA authorization of bivalent booster. Dates 9/2/2022 - 9/7/2022. Delay and confusion regarding vaccine information brief. Since that time, bivalent boosters received and provider/staff education provided. Please let me know if you have any additional questions. Thank you.
This spontaneous report was received from a Nurse practitioner referring to a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. On 06-MAR-2015, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, anatomical location, lot number and expiration date were not provided). On 06-MAR-2015, the patient "fainted shortly" after receiving the dose of GARDASIL 9. The patient did not die, no laboratory tests or diagnostic procedures were performed and no treatment was given. The outcome of syncope was unknown. No product quality complaint was involved. Additional information has been requested.
PAIN, SWELLING, EGG-SHAPED HARD KNOT AT LEFT DELTOID INJECTION SITE WITH WHITE CENTER; FEVER OF 101 TO 103 FOR 24 HOURS.
Patient had 3 doses of Pfizer COVID vaccine on 10/11/21, 3/26/21, and 2/26/21.  Patient is hospitalized now (admitted 3/15/22) with COVID
Patient started feeling tingling, numbness in left arm, shoulder, left side of eye, a little bit of blurred vision. He waited around about 40 minutes and it did not go away.  Advised patient to have someone take him to the ER to be check on. No driving himself.
I had a new health condition of cardiac arrest on 02/18/2022 and taken to the Hospital. No pre-existing condition and admitted 02/18/2022 - 03/02/2022.
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female patient who on 30-Sep-2010 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot# Unknown) (lot#666121/0597Z) (Exp date 19-Aug-2010), IM. The patient also received on the same date a dose of VARIVAX (Lot # 666694/1710Y) (Exp date 04-Dec-2011). Physician stated that the patient had received GARDASIL (Lot# Unknown) and was pregnant. It was reported that another physician in the practice had given GARDASIL to this patient. The patient at that time had denied pregnancy and did not know her last menstrual period because it was irregular. On 26-OCT-2010, the patient had come into the physician's office complaining of pain in the rib. The physician wanted to do an x-ray so prior to doing the x-ray and did a urine pregnancy test for the patient which had been found to be positive for pregnancy. The patient was currently complaining of being tired. Laboratory diagnostics studies revealed "HCG levels 104630. On 27-Oct-2010 did CBC that was normal, lipid panel was normal, urine test for chlamydia still pending and syphilis test still pending". At the time of the report the patient had 8 weeks of gestation (LMP approximately on 02-SEP-2010; EDD on 09-JUN-2011). The outcome for pain in the rib and tiredness was unknown. Additional information has been requested.
Received shot at 7:15 in the evening on March 8th. When I woke up March 9th I had a basic headache.  Starting at around 1:30 on that headache worsened to debilitating, migraine like. I couldn?t get out of bad, I felt nauseated on and off. I couldn?t look at electronics and had a little bit of light sensitivity.  I slept as much as I could. The headache lasted all evening. When I woke up today, March 10th, the headache was almost gone and no nausea.
patient stated they started to feel light headed after vaccine was given then "blacked out" according to their memory. Patient's dad placed patient on the floor and rolled her onto her side. 911 was called and patient was coherent when EMS arrived. Patient and dad opted to go with EMS to get checked out at the hospital.
Injection site itching, intense enough that I had to itch with palm of hand. About 5 mins later a raised ring appeared at injection site with two pimple like bumps. I rubbed the site with rubbing alcohol. Went to bed, itching subsided and raised bump went down
On day 7 post injection- developed redness, swelling, itching and hard lump.   On day 9 symptoms increased and size of redness spread to 3 inches in diameter.
Pt got Engerix-B in 1 arm then Havrix in other arm.Right after the Havrix,pt reported feeling lightheaded.I had her put her head on the table for a few minutes.Approximately 3-5 minutes later,I found her in a seizurelike state & administered the epipen.She recovered within a few seconds after the epipen,though still clammy & the EMT came about 5 minutes later.
Severe Fatigue.  Then on 4/12/2021 developed Bells Palsy
No adverse effects were reported; Was administered a dose of imporperly stored vaccines; This spontaneous report was received from a Certified Medical Assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 09-JUL-2019, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # S005724 expiration date on 10-JUL-2020 and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast ) (GARDASIL 9) lot # R032766 expiration date on 31-AUG-2021 (route of vaccination, strength and dose number were not provided) for prophylaxis.  It was stated that, the Hepatitis A Vaccine, Inactivated(VAQTA) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast ) (GARDASIL 9), were exposed to a temperature excursion of above 47°F (92.3°F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. The vaccines were not involved in any previous temperature excursion, and report was made due to a data logger. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA012632: US-009507513-1907USA012634: US-009507513-1907USA012635: US-009507513-1907USA005377:
pt had redness at the site of injection about the size of a quarter the morning following the injection. She called in the morning and was advised to ice the site and mark the perimeter so she would know if it was getting better or worse. She was also instructed to take an over the counter pain reliever if needed but she cannot do do intolerance. Pt called sunday am and the reaction was no better or worse so she was instructed to go to an urgent care or her md to have it checked.
Fainting and self- urination. Symptoms Resolved at home and did not seek medical treatment