chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days after receiving the first dose patient developed a lump on his arm that he received the shot in around the deltoid area. The lump is still there today, 8/7/21 when he came in for his second dose.
Information has been received from a physician concerning a female (age unknown) who was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient's experienced eyes swelled shut and a rash on her arm and body after receiving her first dose of Zostavax (Oka/Merck). Unspecified medical attention was sought. Outcome of the patient was unknown. No product quality complaint. Additional information has been requested.
I immediately felt a lot of pain, experienced extreme light headed ness, ringing in ears, had to remove my mask as I felt I beaded more air. I became so dizzy, lightheaded that 2 people had to hold me up and escorted me (as I slouched) to a tented cot in the area. I felt I drifted back and forth into a black out state for about 20 minutes.
Fever within 16 hours of vaccine lasting for 48 hours,  general muscle aches lasting under 48 hours, fatigue, non-productive cough persisting more than 3 days
I feel nauseous today; Itchy; Warm to touch; The bump is about 4 inches long and 3 inches wide; Red Raised area at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (The bump is about 4 inches long and 3 inches wide), VACCINATION SITE ERYTHEMA (Red Raised area at the injection site) and NAUSEA (I feel nauseous today) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (The bump is about 4 inches long and 3 inches wide) and VACCINATION SITE ERYTHEMA (Red Raised area at the injection site). On 25-Jan-2021, the patient experienced NAUSEA (I feel nauseous today). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (The bump is about 4 inches long and 3 inches wide), VACCINATION SITE ERYTHEMA (Red Raised area at the injection site) and NAUSEA (I feel nauseous today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
uncontrolled itching all over, followed by histamine reaction/ hives..  continuous since 2/16.... colleague with same exact symptoms, received 1 day apart from one another, from same facility,   this was our booster shot, received 2 moderna vaccinations prior, asymptomatic for both.
935AM pt presented to ER c/o diff breathing, tingling around lips, skin warm & dry;bilat wheezing on expirations;coughing forcefully;10AM breathing better lungs CTA all fiedls;1030AM breathing clearly still;tx w/02, epi, Nebulizer;
Woke out of sleep 1am with very painful arm 6/10. Diarrhea the next day, very tired, not hungry. Mild mental confusion. Light fever 100.00
Vaccine breakthrough, symptomatic.   Inpatient admit 8/23-9/5.   Expired.
The next day of vaccination, patient arm started to swell around her elbow. It is warm to the touch and red. Patient reported this to the RPH and was advised to see her doctor should her symptoms not subside.
Heaviness in left arm after receiving the shot, with tingling in my left pinky finger and general numbness in the other fingers on my left hand. Was given a 50mg shot of benadryl in my right arm which helped alleviate the heavy feeling but the tingling in my pinky continues to come and go.
2 days, post vax, there was a hard, reddened area 2 3/4" X 3". Temperature spiked to 102.3F, 37 hours, post vax.
numb hand 24 hours after injection; arm pain; shoulder and neck pain; fever 101degrees
after both doses got shingles\ suspected vaccination failure; Shingles; Rash on right side of stomach front to back and is currently spreading down leg,; Burning rash; Itching rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax and COVID-19 VACCINE (received both vaccines approximately 6 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 7th September 2021, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, generalized rash, burning sensation and itchy rash. The patient was treated with valaciclovir (Valacyclovir) and FLUCONAZOLE (FLUCONAZOLE CREAM). On 15th September 2021, the outcome of the shingles, generalized rash, burning sensation and itchy rash were recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the vaccination failure, shingles, generalized rash, burning sensation and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The reporter states that previously has shingles as a child and received Zostavax vaccine as well. The reporter states received both COVID vaccines approximately 6 months ago. The patient received both doses of Shingrix and now has shingles. The reporter states shingles started with rash on right side of stomach front to back and was currently spreading down leg, complaints of itching and burning with rash. The medical care sought and valacyclovir and fluconazole cream prescribed, and rash was fading away. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Patient was administered the dose of 0.5ml rather than 0.25ml of the vaccine. This was discovered after he had left the clinic site. Before leaving, he had been monitored for the standard 15 minutes post vaccinnation without any signs of adverse reaction. Moderna was called. Instructed to file. Mom was called and notified of the incident. Instructed to monitor for signs of adverse reaction. Follow up with PCP if necessary. Followed up with Mom the day after incident as well, no adverse reactions reported.
Initial report received from  healthcare professional on 10 OCT 2014. A male patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number, dose, dose  number, route and site of vaccination not reported on 10 OCT 2014. It was reported that, after unspecified time after vaccination, the patient did not feel well, could not focus, was flushed, dizzy and light headed. The patient had no hives. The patient was moved to the emergency room. Lab investigation details and corrective treatment were not reported. The outcome of the event was reported as unknown.  Documents held by sender: none. Follow-up information received from a health care professional on 26 FEBRUARY 2015. On 10 OCTOBER 2014, same day after vaccination the patient did not feel well, could not focus, was flushed, dizzy and light headed. On 10 OCTOBER 2014, the patient was completely recovered from the events.  Documents held by sender: none.
Moderna vial with BUD 2/12/22 was given to Covid Vaccine Clinic on morning of 2/14/22. Booster 4th dose for immunocompromised individuals was administered to patient at 0859 this AM. Error was discovered at 0915 when doing daily routine vaccine inventory. Expired vials quarantined. Moderna contacted and awaiting further guidance. Reporting via VAERS.
11/26/21 presents to EC ED for "fever, SOB, cough". PMHx of "psoriatic arthritis on immunosuppressant therapy, HTN"
Day after I became very cold(which I never am) my fingers were turning very white , my face and fingers were swelling as well. the n on the third day after dose I got light headed felt like I was going to pass out. My blood pressure was 90/ 60( low for me) then I started to get these burning surges across my chest down my left arm and up into my left jaw.  This lasted about 3 hours.
Started showing signs of fever in the morning. Was sitting on the couch (3:30 PM) when he slumped over. After 15-30 seconds, we turned him over. He was blue and not breathing. Began administering CPR for about 1 min, when decided to take him to the ER. His color returned on the ride to the ER. Total of 4 mins between event and admission to ER.
Approximately 9 hours following administration of the vaccine (about 4:50 am), the patient reports that a few minutes after getting out of bed to use the restroom, she experienced a sudden wave of nausea, ringing in her ears, head feeling like it was under water and vision blacked out. She reports that she felt she would pass out so she laid down where after a few minutes, her vision, hearing and orientation returned. By 11:30 the next morning, her resting heart rate read 91 bpm and continued to fluctuate between 90 to 103 until 4:15 where her heart rate remained between 107 to 114 bpm for about an hour before going back down to the 90s. The patient also reports that during the afternoon, she experienced labored breathing and upwards of 30 breaths per minute at one point. Her breathing resolved to between 13-17 breaths per minute by the 4:15 pm. Blood pressure was somewhat elevated from her normal to 128 over 65. By the next morning, her heart rate returned to 68 to 73 bpm which is her baseline heart rate. Doctors over the phone advised that these reactions were outside expected reactions and should seek medical attention from her primary care to evaluate if there is an underlying issue r/t the symptoms. Otherwise, the patient reports rest and hydration were the primary treatment.
I had a sore throat and pain in my ear. I was tested for COVID-19 and Strep and tested negative for both. I contacted my doctor and was prescribed Amoxicillin.  I am feeling much better now.
Ear pain, scratchy throat, headache, muscle pain, fatigue, fever, severe chills. Listed in order of occurrence following vaccination.  Only treatment was Tylenol, hydration and sleep.
fever, chills, aches, nausea and vomiting. Fever, chills, and aches had presented in previous doses, but the intense nausea and vomiting were unique to this dose and intense.
1/7/04 10:00 A.M.--Child crying inconsolably and nothing will calm him.Advised to call physician 10:30 A.M.--Still crying, and will not eat well.Has appt. to see Dr at 3. 1:00 P.M.--Baby sleeping lightly after Mom turned on vaccuum, still not wanting to eat.  Mom has given Tylenol 4:30 P.M.--Has seen Dr.Temp was 98.1. Mom was instructed to begin alternating ibuprofen with the Tylenol, and told to return if temp goes up, child begins crying inconsolably again or if he will not eat at all.  Baby has taken "about an ounce" of formula. 1-8-04 9:00 A.M.--Child began crying again during the night and had Temp over 100 which did not come down with ibuprofen, so Mom took him to E.R. where they gave him a Tylenol suppository.Fever is still up but he has been sleeping.Baby is to see Dr.again at 2:40 p.m. 1:00 P.M.--Not crying at this time.Taking formula better. 1-9-04 4:00 P.M.--No further crying and is eating better.Was able to go to Daycare today.Mom reports that at appt. last evening, Dr. found bilat. ear infection which was missed in E.R. and started child on antibiotics.
16JUL96 @ brother's house pt woke up 645AM & told brother not feeling well, getting drink;brother heard pt fall-went to kitchen & pt lying on floor jerking around;911 called;
Area around injection site is raised, red warm to the touch, painful, and larger than a half dollar. Advised Tylenol and cold compress. F/U with us with any changes or concerns less than 1% reporting from injection.
Headache; injection site pain.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8728) via an unspecified route of administration in the right arm on 22Mar2021 at 10:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included unspecified cholesterol medicine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 22Mar2021 at 13:00 (three hours after injection), the patient experienced injection site pain. It was reported that, the pain was uncomfortable but was not limiting use. The patient was able to sleep on the site at night. On 22Mar2021 at 20:15 (10 Hours after the injection), the patient had mild headache. Headache and arm pain were ameliorated by ibuprofen one dose before sleeping and another dose five hours later in the middle of the night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events injection site pain and headache were resolved on unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient given GARDASIL vaccine about 4:00 PM.  At about 4:10 PM patient states throat swelling, unable to breath, nausea.  Patient out in supine position for about 15 minutes with frequent checks.  Felt much better - release to parent.
Leg red; Swollen foot; This case was reported by a consumer and described the occurrence of redness of legs in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced redness of legs and swelling of feet. On an unknown date, the outcome of the redness of legs and swelling of feet were unknown.   It was unknown if the reporter considered the redness of legs and swelling of feet to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. It was reported that the patient experienced reaction to second shot leg red swollen foot.
On 09/26/2021 I have shortness of breath, fatigue and muscle soreness and it still continues. The doctor originally thought it might be a blood clot, but that was ruled out.
Patient presented to our facility due to progressive swelling of his LLE. Patient is an avid cyclist and reports he began training again for the spring season approx. 1 mo ago.  He had L calf tightness present for a few weeks as well as slightly painful knees which he attributed to his age and mild deconditioning over the winter.  He traveled with infrequent stops on 4/2/2021 to visit family.  He continued to have discomfort and increasing ankle pain, thus presented to ER.  LE ultrasound venous dopplers performed showing extensive DVT: L femoral, popliteal, posterior tibial and peroneal veins.  CT also demonstrated acute PE w/in distal R and L main pulm artery and w/in bilateral segmental and subsegmental pulm arteries involving all the lobes.  Patient had remote history of LE DVT in 2017 after  mild bumping of leg and placed on Xarelto for 6 mo. Had genetic testing completed at that time which was negative. He has had no clotting issues since. ( Received Moderna COVID-19 vaccines on 2/3/21 and 3/3/21. Reports brain fog and fatigue approx. 20 hours after vaccination followed by the above.) Patient discharged on rivaroxaban.
pt recvd vax; exp extreme fatigue 1 wk p/ each dose of vax;resolved;
Extreme arm pain, from shoulder to elbow.  Couldn?t move arm.  Pain was so bad at times, it brought me to tears.  Became nauseous with pain.  Lasted for approximately 24 hours.
(L) deltoid region red - warm and tender - Mother took to ER for evaluation. Put on antibiotics.
8APR97 5PM pt devel fever 102, whining, appetite dec;became lethargic 9APR97;taking fluids well;instructed to call pt MD for eval;devel sl bumpy rash on forehead, chest & back;called MD & reported fever 9APR;irritable
On dose 1, I had a strong allergic reaction at injection site - hot, super swollen (like circumference of a softball) and very hard with lots of pain. The hardness felt like scar tissue and lasted for nearly 2 weeks even after swelling went down.  2nd shot - also had swelling and pain at injection site.   However, then in early June inexperienced an extreme systematic allergic reaction to something unknown (no new foods or medicines or detergents/soaps had been used), which caused a rash to spread across my entire body. Welts, swelling and extreme itching and discomfort.
fever; chills; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain). At the time of the report, PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Swelling, redness at injection site, pain & swelling around injection site causing arm pain & numbness/tingling. Itching at injection site and itchy eyes.
Exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Exposure via breast milk) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 013L20A) , while the mother received the product for COVID-19 vaccination.     Concomitant product exposures included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 05-Dec-2020 to an unknown date for Pregnancy.   On 23-Dec-2020, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The mother's last menstrual period was on 15-May-2021 and the estimated date of delivery was 25-Feb-2021. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Exposure via breast milk). The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The vaginal delivery occurred on 24-Feb-2021, which was reported as Full-term. For neonate 1, the birth weight was 3560 grams (7lbs 14oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. At the time of the report, EXPOSURE VIA BREAST MILK (Exposure via breast milk) had resolved.            No concomitant medications provided. No treatment details were reported.   This case was linked to MOD-2021-010811, MOD-2021-010811 (Parent-Child Link).   See case MOD-2021-010811,MOD-2021-010811 for details regarding the Parent case.  Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant Follow up Appended - LMP & EDD updated
Information has been received from a nurse, concerning her daughter who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot # not reported). Ten minutes later, the patient experienced dizziness. When the patient stood up, she fell over and had a bruise on her eye. On an unknown date, the patient recovered. The patient sought medical attention with the nurse. There was no product quality complaint. Additional information is expected.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ?  9/25/2021 Is this your first or second dose- 3rd Booster Date of symptom onset - ? 9/26/2021 Symptoms - ? Headache, body aches, chills fever (101.0, and 100.6) Last day of work and shift - ? NA Home remedies- Employee stated she took Tylenol for the fever Any improvement- The Tylenol seemed to be helping the fever Recommendation- Advised employee to continue taking Tylenol as needed for fever per pack instructions.  Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
The injection site and approx 2 inches around the injection site started swelling, turning pink, firm and warm to the touch and also had a very prominent border at 10am. By 1pm the size of the swelling was much larger and it became a lot more firm, red, and very hot to the touch. He was starting to pull and scratch at the area and became fussy during diaper changes. I administered TYLENOL suspension (6.5mL) by mouth and also BENADRYL (2.5mL) by mouth. I also applied a cold compress to the site for approx 10-15mins. By 7pm the redness spread and covered a large portion of the front of his thigh. The following morning at 6:30am his leg was the same so I took him to emergency room. They performed a sonogram of the area and diagnosed him with cellulitis and prescribed clindamycin 15mg/mL. I was unable to fill his prescription at the time so he never took it. This morning (the next day) the swelling and redness has subsided. It is still slightly warm to the touch and a hard knot at the injection site remained.
Tested positive for COVID-19; Tested positive for COVID-19; Dose 3 (booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Dec2021 (Lot number: FF8839) at the age of 47 years as dose 3, single, intramuscular, administered in arm left, administration date 03Mar2021 (Lot number: EN6203) as dose 1, single and intramuscular, administered in arm left, administration date 24Mar2021 (Lot number: EL3248) as dose 2, single for covid-19 immunisation. Relevant medical history included Hypothyroidism (unspecified if ongoing). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has no known allergies. Concomitant medication(s) included SYNTHROID. The following information was reported VACCINATION FAILURE (medically significant) with onset 30Dec2021, outcome unknown, COVID-19 (medically significant) with onset 30Dec2021, outcome recovering; IMMUNISATION (non-serious) with onset 07Dec2021, outcome unknown. The event tested positive for covid-19 and tested positive for covid-19 was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures sars-cov-2 test (30Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.