chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After about 15 minutes from when I administered the Janssen IMZ the patient raised her hand. She told me she was feeling faint. I told her to lie down on the floor and put her legs up on the chair. I got 4 wet towels and put one on her neck, two wrists, and forehead. I told her to just rest on the floor. I checked on her about every 5-10 minutes. After about 15 minutes she said she was feeling better. I told her not to stand up right away. She sat on the floor for awhile and eventually sat in the chair. She told me she was having someone pick her up at the store. Pt stated she was feeling better. She eventually left. I tried to phone the patient later to ask how she was doing but could only leave a message.
Post vax, the pt developed a fever of 101 with chills, positive erythema, indurated firm, hot to touch at injection site. Seen by physician and dx with cellulitis. Treated with Augmentin.
Patient obtained 2nd dose at 4/30/21. Recalls he went to store after leaving the clinic. Had itching on arm that was vaccinated. Then he developed rash on lower legs, neck, and back. Rash is slightly itching.
Left arm redness, tender to touch on 2/3/21 then increased area of redness on 2/4/2021 when pt eval via telehealth. Observed overnight w/ coolpacks & Benadryl. Next decreased symptoms 2/5/2021 zero pain & near resolved.
On February 2nd she woke up with a fever of 102F took some Tylenol around 3pm that evening. Around 4 o clock the next morning she woke up itching and with a fever, an hour later she had hives everywhere on her body. She said tried Benadryl and Tylenol nothing worked. On February 4th doctor prescribed Prodi zone and it did not help. On the February 5th went to the ER they hooked her up to the iv, gave her oxygen kept her there for 3 hours and sent her home with the prednisone pack and EpiPen because of her breathing and she felt a lot better.
little soreness for day or two; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little soreness for day or two) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, LEVOCETIRIZINE and SIMVASTATIN for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (little soreness for day or two). At the time of the report, PAIN (little soreness for day or two) outcome was unknown. Not Provided          No treatment information was provided.    This case was linked to MOD-2021-103056 (Patient Link).
A report has been received from a Health Professional concerning a patient born on 07-Sep-2012, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 07-Jan-2014. The reporter stated FLUMIST given by mistake to 18 month old (Preferred Term: Drug administered to patient of inappropriate age). The outcome of the event of FLUMIST given by mistake to 18 month old is unknown. The report was considered to be non-serious.
Flu Clinic took place at the company building on Tuesday and Thursday. Patient had gotten vaccine on Tuesday, but came back to location of clinic on Thursday saying she had a reaction to the shot and had missed work the day before. Patients arm was slightly bruised and swollen at and around the injection site. Patient was also complaining of headache and lethargy, but said there were no rashes or other swelling that had occurred. Said she had not gotten the shot in about 10+ years before yesterday. She said the pain and headache was reduced with ibuprofen/TYLENOL, but didn't know if she had a fever. She missed work the day after the shot but had shown up on the next day.
few itching spots; a rash all over her body; Diarrhea; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 07Dec2021 (Batch/Lot number: unknown) as dose 3 (booster) , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTERER: UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2; MANUFACTERER: UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021, outcome "unknown", described as "booster"; PRURITUS (non-serious) with onset 08Dec2021, outcome "not recovered", described as "few itching spots"; RASH (non-serious) with onset 07Dec2021, outcome "recovering", described as "a rash all over her body"; DIARRHOEA (non-serious) with onset 07Dec2021, outcome "unknown", described as "Diarrhea". Additional information: The caller was a consumer, she got the Pfizer covid 19 booster shot yesterday morning and by night she developed a rash all over her body and diarrhea. This morning the rash was almost gone, just few itching spots. Was that normal or should be worried about. Follow-up attempts completed. No further information is expected.
This case was reported by a physician and described an 87 year old male pt who received Engerix-B and subsequently tested positive for hepatitis B surface antigen. On 1/7/04, prior to immunization with Engerix-B, the pt tested negative for hepatitis B surface antibody. On 8/23/04, the pt received the 1st dose of Engerix-B (lot AHBVA077AB). Approximately 4 days later, on 8/27/04, the pt tested positive for hepatitis B surface antigen. The physician considered the event to be related to vaccination with Engerix-B.
erythema rash; This case was reported by a physician via sales rep and described the occurrence of red rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received Shingrix. In January 2020, 3 weeks after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient seen by doctor on 31st January 2020.
Patient developed approx 10 hives larger than a quarter on his legs. Itchy, hot, no other symptoms. Zyrtec, hydrocortisone cream topically and patient was using  ice packs
that evening HA, myalgia, arthralgia, cough, stuffiness, sore throat, loss of taste on sun
2 surgeries, Chemo, Radiation. Extensive 2 5 day (in hospital) Chemo stays and Stem cell transplant. Prior 2 oral polio 06/05/97 (lot # 0756D) and 8/7/97 (lot # 444062). Died 9/19/2003. 1/5/98: Office visit - sick. 4/9/98: Office visit - leg patches between knee and ankle. 8/14/01: Preschool physical 40.5 lbs, temp 100.6, BP 76/51, tired; Hemoglobin 9.2. Within week, sick. Dropped to 36lbs. by 9/4/01. Weight increased to 38lbs. Ear cut not healing. 10/02: Extensive blood work taken in preparation for stem cell transplant revealed 3 antibodies (Varicella, CMV, and Herpes Simplex). No further information received from medical record rec'd 06/13/2005. Hospital medical records received which revealed patient had dx of Stage IV Wilm's tumor w/+ pulmonary nodules & liver mets & had relapses.
Soreness/tightness in arm, difficulty lifting arm, limited range of motion, and tingling sensation in middle and ring finger in affected arm.
The second dose after day 36th; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (The second dose after day 36th) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension, VITAMINS NOS (MVI [VITAMINS NOS]) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 27-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (The second dose after day 36th). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (The second dose after day 36th) outcome was unknown. Not Provided          The time between the 1st dose and 2nd dose is 79 days.  Other Concomitant Medication provided Centrum Silver 1 tablet daily (Supplements).  The action taken with the drug was Not applicable.  No treatment  was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-092201 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092201:spouse case
Post 15 minute monitoring, parent/ dad noticed (2)small raised bumps under left eye; no additional wheals/ welts assessed or identified at this time. No itchiness reported. Denies any additional complaints at this time. Parent instructed to f/up as needed if any additional symptoms are noted.
Client was vaccinated at 8:47 am w/Janssen vaccine and at 0901, while in the recovery area, c/o increased nausea, having dry heaves, stated had a small emesis in her face mask.  vitals stable, c/o "it feels like I have been punched in the gut."  Continued w/nauseated feeling and urge to vomit for additional few minutes, 0910 stated, "I am feeling much better, it seems to be passing now", no further urge to vomit, remained in recovery area for additional 15 minutes, d/c to self care at 0925, stable w/no further c/o any kind.
6/14- Fever, chills nausea, large lump on arm, fatigue 6/15- fever, chills, nausea getting worse, lump on arm getting bigger and redder,  fatigue 6/16- nausea still getting worse, lump on arm still big and red, almost like a tennis ball size lump, fatigue
Breakthrough case admission after 4 vaccines  Pfizer 2/16/21 Lot# EN6200;  Pfizer 3/9/21 Lot# EN6207;  Pfizer 11/20/21 Lot# 320308D;  Pfizer 5/27/22 Lot# FM7553
Patient reported on 12/17/20 that she has been experiencing itching at vaccination site since her injection on 10/19/20. The area is red and sometimes develops hives/rash when it itches.
Cough periodic , cough hard hard to stop, having to eat soft food other food seems to hurt throat. Throat is very raw...( from the cough I'm sure) today I'm weak and have diarrhea...
A red rash developed on my arm where the shot was given.  I first noticed the rash on the 8th day after the first shot of the vaccine. The rash was  about 2.5" wide by 5" long.  My arm was swelling at the site of the rash, which felt very firm to the touch. It was  very itchy for 3 days. The symptoms gradually disappeared over about 7-8 days from the first day that the rash appeared.
Headache the afternoon of vaccine. Later that evening developed severe body aches and pain. 9pm severe chills and shaking that lasted on and off for 6 hours. Severe flu like symptoms the following two days. Tiredness persisted for a total of 5 days.
Patient presented to the ED and was subsequently hospitalized for atrial fibrillation with rapid ventricular response, severe sepsis secondary to UTI within 6 weeks of receiving covid vaccination.
Patient vaccinated on 4/3/2021 with first dose of Pfizer vaccine. Two weeks following his first dose, patient reports visible bright red blood in stool, which lasted for 3 days. His stool then turned black for the following 4 days. In total, symptoms lasted 7 days and resolved by 4/24/2021.
received the Covid 19 vaccine/then tested positive for the virus/symptomatic; received the Covid 19 vaccine/then tested positive for the virus/symptomatic; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at a single dose as Covid 19 vaccine. Medical history and concomitant medications were not reported. It was reported that the patient received the Covid 19 vaccine on 17Dec2020 and then tested positive for the virus on an unspecified date. She was scheduled to have the second vaccine on 07Jan2021, but she was not able to go to work because she's still symptomatic. She would like to know if there's an extension to the 21 days since she has the virus now. The outcome of the events was unknown.  Information about Lot/Batch number is requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
No Adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No Adverse event) in a 9-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 23-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    On 04-Apr-2023, the patient received first dose of monovalent vaccine (Batch/Lot number: AS1903B and Dose/volume: 25 micrograms).  Concomitant product use was not provided by the reporter.  The route of administration of suspect Moderna monovalent was reported as Mono and bivalent was reported as BI.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Less than 5 mins after Varivax given, pt developed erythema at and above injection site. Per drs order gave pt dose of oral benedryl.
6 hours from vaccine === Mild injection arm pain  12 hours == Severe injection arm pain (can?t raise beyond chest level) Chills  16 hours == High heart rate (160 bpm)  18 hours == 103 fever Severe headache Unable to sleep Exhaustion  ** Took 1000 mg of Tylenol at 21 hours  24 hours == Heart rate is now only slightly elevated (120 bpm).   ** Took 1000 mg of Tylenol at 25 hours  30 hours == Vomiting (x2) Heart rate is now normal  48 hours == Joint pain (shoulders and neck) Nausea subsides Temperature drops below 100 Headache is now mild  72 hours == Back to normal
Lg, tender, erythematous area of approx 8x 11 cm with  area of induration 6 x 7 cm, around site of Menactra vaccine. Tender area of eryth. and induration 3 x 6 cm of TDaP vaccine. Both vacc. given 3 days ago. Given Zyrtec 10 mg qd
Patient presented to the ED on 3/15/2021 with acute chest pain. Patient presented to the ED on 4/9/2021 for NSTEMI and was subsequently hospitalized. These visits were within 6 weeks of receiving COVID vaccination.
Vaccine Tuesday PM, woke up around 1am Wednesday morning with intense body aches and was not able to get comfortable. Hot and Cold flashes. Spot where vaccine administered was severely tender. Fell back asleep and woke up almost normal. Thursday morning woke up and had the feeling as if I had gotten water up my nose swimming and the feeling it gives you in the back of your throat. Headache. Friday - same feeling but worse headache, also little bit of runny/stuffy nose. Saturday - runny/stuffy nose. Headache. Congested. Sunday(today) - Same thing.
Vomited up My DiNNeR After Feeling Nauseous Befor eATIiNg. 2 Hours LATeR, Developed severe TeeTH Chattering, CHills AND SeveRe BoDy AcHes - Lasted THROUGHOUT THe NigHT. Some limited NAUSeA & ACHeS THe NeXT AM
Patient awoke with large knot approx. size of lemon, redness, warm, sore that itches.
Received flu vaccine injection 9/25/17. Contracted influenza virus 12/10/17 - confirmed at urgent care clinic by swab sample. Severely ill with fever greater than 102 degrees, severe cough, chills, x 5 days. Ineffective vaccine.
Approximately 10 minutes after being vaccinated, he began to feel unwell, was in a cold sweat, felt like vomiting, and passed out.
angioedema, began in my hands, feet and was mostly red/swelling in palm and arches   started the night before dose 2  within a week it was occurring in my face and then started to get a few hives as well up and down my arms met with Dr. who diagnosed me with either acute or chronic idiopathic Urticaria and angioedema - then later after it hit 6 weeks of symptoms it became chronic.  she said it will go away within 4 years. I do not think she feels it is related to the vaccine because it  did not occur immediately.  She has been working with me on symptom treatment with various antihistamines and other Rx and OTC to help manage it and improve quality of life. Currently take 20mg of Zyrtec and Pepcid each, am and pm, recently added Montekulast in pm which has finally made the hives stop breaking through on a daily basis, for now. I did get a cold over memorial day weekend and my face swelled up horribly along my lower lips and into my cheek as my body responded to fight it. She said that flare ups with viral infections or trauma to the skin can cause that with this condition. Had to change my nightly zyrtec to Hydroxyzine for two weeks to get back to normal. My concern is that the known condition might NOT be the case if it is related to the vaccine  which we are still not sure we know much about.  Also the fact that I have an auto immune disease could further complicate things
Severe swelling, redness and pain at injection site. Difficulty moving arm from severe pain. Seen ER - elevated WBC, CT nl. Saw hand/shoulder ortho - vaccine reaction diagnosis.
Employee received vaccine around 10 AM. Did not notice anything wrong until following AM when looked at upper arm red 4 inches below injection site and warm. No swelling. Observed area next 4 days and each day reaction decreased until normal on Friday 11/02/2001.
significant injection site pain; temperature 100 degrees rash on face. It resolved spontaneously over time.
on the 28th noticed a sudden red area size of a 50 cent piece, itches. at the site of the injection
Rt arm red and tender to touch.  warm to touch.  moves arm. swollen deltoid area.  5/30/03 phone call to mothershe stated child seen by a doctor on 5/29/03.  Dx'd with local reaction tX cold compresses and prn and cortaid ointment.  5/30/03 mother stated site looks better
Day after shot - Chills, Fever 100, Dizzy, Light headness 2 days treated with Tylenol once tylenol wore off symptoms would come back took tylenol for 24 hours every 6 hours.   Swollen arm at injection sight, area welted and itched. Took benydryl  for symptom - 4 days for arm swelling and itching to subside.
Syncope; 911 called; patient woke up promptly, was pale, but responsive
He had a cough, runny nose, fever of 103, red, sore throat, lack of appetite, and more tired than usual. We contacted his doctor, and he was prescribed cefdinir. He is still dealing with these symptoms at this time. His appetite is a bit better, but he still has a fever, and his cough is a little bit worse. He tested negative for COVID-19 and Flu.
Fever 101 for one day, headache/body aches/joint pain for 3 days, fatigue for 4 days
PT CAME TO HEALTH DEPT ON 5/18/2006 WITH DECREASED APPETITE, MACULAR FACIAL RASH, AND LETHARGY.  PT'S RAPID STREP TEST WAS NEGATIVE.  THE PATIENT WAS REFERRED TO DOCTOR BY FNP.  THE PATIENT WAS SEEN BY DR THE SAME DAY.
Post vax, the student nurse reported that on approximately 12/15/2000 the patient came to the office and there was a "golf ball size pink patch with a lump" at the injection site. The lump does not itch or hurt. Unspecified medical attention was sought. Additional information has been requested.
Patient not seen in office.  History obtained via phone from father of patient and patient herself.  Very early on 4/19/2021, 8hrs after receiving her 2nd Pfizer COVID-19 vaccination, patient began developing nausea, chills, sweating, fever and malaise.  Highest fever was 102.3', with symptoms treated with Advil 600mg.  Had x1 episode of vomiting that day, none since. The next day 4/20, patient woke up with new-onset lip swelling, progressing to periorbital swelling and swelling of her facial cheeks & rash.  She then began having a cough with some throat tightness with some mild discomfort with breathing in her throat, but no chest tightness or wheezing.  Tongue not swollen per patient.  Benadryl 25mg PO given multiple times and patient used her Albuterol MDI a few times as well, which helped.  She continued to have fevers to 101' throughout the day, treated with Advil again.  At night, patient then developed semi-itchy red "hives" on her legs. Per patient, she didn't feel she needed to go to ER for her symptoms or throat tightness/breathing issue.  She was still drinking & urinating well  and had been consuming light solids foods. The same day 4/20 in the afternoon, patient was prescribed over the phone Prednisone 60mg PO x1 which she first took after 5pm, with tapering dose over the next 4 days, in addition to increasing Benadryl to 50mg PO and starting Qvar 80 MDI BID, while using Albuterol prn. Via phone call to father this morning 4/21, patient reportedly slept well last night and woke up this morning with significantly less symptoms.  No longer having throat tightness/breathing issues, with much less periorbital/facial swelling.  Still fatigued but no longer having fevers, either.