chrisvoncsefalvay/vaers-outcomes huggingface dataset:
t105-106 R 5 day post vax; vomiting for 3 dyas & diarrhea for 7 days; red spots on face; pale to grey color to skin; parents took pt to clinic;
Patient recieved HPV vaccine. Patient did not eat before and did not get much sleep the night before. After a minute patient stated he did not feel well and started to faint. Patient also had seizure activity. I immediately put patient on exam table and he immediately recovered BP 94/51. Patient laid for 5 minutes and felt better. Sat patient up and gave water BP 93/60. Stood patient up and felt dizzy again. Laid patient down for a few minutes and sat patient up again. Gave patient a sucker to suck on. Stood patient up and felt dizzy again. Laid patient back down for 5 minutes. Sat patient up and gave orange juice. Stood patient up and he felt dizzy again. Laid patient down for 5 minutes BP 90/42. Sat patient up and gave patient crackers BP 100/66. Patient stated he felt alot better now. Stood patient up and he stated he felt good enough to walk BP 86/58. Walked patient to car. Informed patient to eat more and get more sleep. Also to go home and rest for a while. Also informed patient if he gets worse to go to ER or call 911.
Pt came to ER c/o abdominal pain, nausea, and vomiting x 4 days.
After the 1st shot, I had 2.5 weeks of severe fatigue, my femurs deeply ached, and crushing headache. after the 2nd shot, I had fatigue but on 1/30/2021 I was woken up by hives. I took Benadryl and they went away. On 1/31/2021 I was woken up by hives again and 4 hours later, my throat began to close up and my stomach was crampy. I went to the ER and rec'd epi, Decadron, & Pepcid to great relief. However 2/1/2021 my throat began to close up again and I went back to the ER and they just gave me Decadron. I now have to see an allergist and take Xyzal 20 mg/day, Pepcid 80 mg/day, and Singulair 10 mg/HS to keep the hives and throat closing from coming back.
Within 20 minutes of receiving vaccine, noted increasing pain in left shoulder, which radiated to left scapula and back of neck. Within one week of vaccine, noted numbness in left hand and lower arm, as well as pain in shoulder area. Two weeks later, noted numbness in left side of face and throat, as well as some left leg numbness and tingling.  Consults made to Physical Therapy, Pain service and Neurology.
The current adverse even is prolonged pain deep within the injection site, as well as shoulder pain and fatigue in left arm. The pain has persisted for almost a month, and has not subsided. I also experienced a swollen lymphnode under left arm, which lasted about two weeks after the 2nd injection.
12/23 - FLU LIKE SYMPTOMS (TEMP OF 99.7, CHILLS, BODY ACHES AND SWEATING) WHICH BEGAN AND LASTED APPROX 24-40 HRS AFTER BEING VACCINATED.
After second dose: I was fine for the first day. I got it at 10 am and then around 7pm started feeling chills and started to feel sick. A few hours later I got a fever and then got very sore. The next day around 5 pm I got a horrible pain in my upper back and stretched to my chest. It was unbearable. It did not hurt to breathe but it hurt to sit. It hurt in increments. I do not think it was muscular as it didn?t hurt when I moved or stretched. This lasted into the night. Next day, today, all is well. Just sore arm.
The most serious event was a fever of about 99.5 degrees 12 hours or so after having received the shot. This fever persisted through the night/early morning, relented the next day, then returned the following night. It was also accompanied by moderately severe chills and body aches--enough to be shivering slightly and to make me use a personal heater the second night despite it being summer--and in my personal experience, were more severe than I would normally expect from a fever of only 99.5 degrees. While the fever and chills went away for good after the second night, the body aches persisted through the third day, although they were much milder by that point. Also, curiously, for the first three or four days or so after the shot, my nose felt as if I were recovering from a cold (yet I haven't had a cold in over a year). Specifically, it was like my nasal mucous wasn't thin enough for me to have a runny nose, yet wasn't of normal thickness either. Accordingly, I had very mild nasal congestion upon laying down, and for the few days, did not produce hardly any dried nasal mucous. Finally, as would be expected, I had mild pain in my arm where the shot was administered. This pain was again mild and only when I moved my arm in certain directions, and it subsided after three or four days or so as well.
Irritated throat; Coughing; Voice was a little gravely; clearing her throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Irritated throat), COUGH (Coughing), DYSPHONIA (Voice was a little gravely) and THROAT CLEARING (clearing her throat) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Bee sting.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced THROAT IRRITATION (Irritated throat), COUGH (Coughing), DYSPHONIA (Voice was a little gravely) and THROAT CLEARING (clearing her throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in January 2021 for Adverse event, at an unspecified dose and frequency. In January 2021, THROAT IRRITATION (Irritated throat), COUGH (Coughing), DYSPHONIA (Voice was a little gravely) and THROAT CLEARING (clearing her throat) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: No new event information received. Information provided included address, email address, and correct spelling of last name.
Information has been received from a physician concerning a 10-year-old male student with an allergy and no known drug allergies who on 28-AUG-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. Concomitant therapy included Sudafed. The physician reported that on the evening of 28-AUG-2007, the patient developed pruritus around the legs, a red macular area over the right ankle as well as papules and a vesicle. The physician also reported that, at the time of the follow up appointment, the patient also had papules on the back and shoulder which were itchy, but non were scabbed. A dermatologist examined the patient and indicated that it was probably a varicella-like rash. The patient had no fever with this reaction. No laboratory/diagnostic tests were performed. The patient subsequently recovered. Additional information is not expected.
10 min after 2nd dose of anthrax, had dizziness, throat tightness, chest pain that worsened over the next 20-40 min.  Pt was brought to the ER and given IV Solumedrol, Benadryl, Zantac with complete resolution of symptoms within 15 min of onset of IV.
3 weeks after injection, I started experiencing acute ovarian pain, heavy menses, lots of blood clots, and the length of my periods increased from a normal 5 days to 10-15 days.  The ovarian pain was constant (not just during ovulation or period) and at times debilitating.  My OBGYN ran blood tests and a pelvic ultrasound was performed on December 6, 2021, revealing growth on my ovaries and uterus.  I had surgery on March 16, 2022 to remove the right ovary, drain the cyst on the left ovary, and remove polyps in my uterus.  It is too early to tell whether the surgery resolved bleeding and pain issues.
ARM DID NOT HURT AS BAD AS EVERYONE MAKES IT OUT TO BE ONLY WITH A LOT OF PRESSURE; FEVER OF 100.3 IT SLOWLY WENT DOWN THROUGHOUT THE DAY THO PATIENT STILL FEEL A BIT HOT 2 DAYS LATER; VERY LIGHT HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced arm did not hurt as bad as everyone makes it out to be only with a lot of pressure, fever of 100.3 it slowly went down throughout the day tho subject still feel a bit hot 2 days later, and very light headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.3 F. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever of 100.3 it slowly went down throughout the day tho patient still feel a bit hot 2 days later, and the outcome of very light headache and arm did not hurt as bad as everyone makes it out to be only with a lot of pressure was not reported. This report was non-serious.
Beginning with my second menstrual cycle after the shot (2nd of series); I experienced extremely heavy bleeding with intense cramps and burning accompanied by fatigue. This continued with all of my following cycles every 22 days, lasting 4-5 days. I would utilize an entire box of super absorbant tampons (18 ct.) every two (2) days. Approximately November 2021 I went to my family doctor due to this continued sequence of events impeding my life. She referred me to the Physician listed above, who performed an ablation of the uterus. Since the procedure I had spotty or sparse menstrual cycles for approximately three (3) months; with no further menstrual cycles to date. Fatigue continues to date.
palmer and plantar psoriasis; psoriasis/palm of hand and bottom of feet getting progressively worse; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis/palm of hand and bottom of feet getting progressively worse) and PSORIASIS (palmer and plantar psoriasis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No medical history was reported.  Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   In July 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PSORIASIS (psoriasis/palm of hand and bottom of feet getting progressively worse). On an unknown date, the patient experienced PSORIASIS (palmer and plantar psoriasis). The patient was treated with APREMILAST (OTEZLA) at an unspecified dose and frequency. At the time of the report, PSORIASIS (psoriasis/palm of hand and bottom of feet getting progressively worse) and PSORIASIS (palmer and plantar psoriasis) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Action taken of co-suspect was reported as drug discontinued with respect to all the events.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of breakthrough psoriasis/palm of hand and bottom of feet getting progressively worse and palmer and plantar psoriasis with HUMIRA(ADALIMUMAB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Live follow-up received additional event palmer and plantar psoriasis were added with all the relevant information, Action taken of both suspect vaccine and co-suspect was updated, Concomitant vaccine was added.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 23-NOV-2011, the patient's healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, the patient was treated by healthcare providers at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
4cm area of erythema and warmth around site of DTaP injection left deltoid.
1-31-2020 5 P 48 hours after receiving shingles (Rt) right cheek felt "newd" sore. (rt eye area (Rt) cheek swellon, "mild"numbness cheek to chin area, warm tender. Went to local urgent care Tx: Decadron 10 mg IM Rx: Medrol dose pack 4 mg tappery dose. Pt states reported to pharmacy thought they reported.
Initial and follow-up information has been received from a 64 year old retired pharmacist with penicillin and sulfonamide allergies who on 01-APR-2008 was vaccinated at 10:30 am in the upper left arm with zoster vaccine live (Oka/Merck). Concomitant therapy included LIPITOR, losartan potassium (MSD), NORVASC, hydrochlorothiazide, "tucor," atenolol, vitamin D and CENTRUM SILVER. Subsequently, on 02-APR-2008 the patient developed redness and swelling at the injection site for a period of 5 days. The patient also developed a blister type rash on her upper right facial cheek. The outbreaks were linear across her cheek and under her eye. The outbreaks persisted for 12 days. The patient also reported she had slight transient pain in that area. Medical attention was not sought and there were no lab studies performed. The report the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information is not expected. This is one of several reports from the same source.
Was in for a Pneumococcal Vaccine that Dr ordered and was to be given. MA inadvertently gave her 0.5cc of Prevnar in right arm, notified dept of health and spoke to representative, she let us know there would be no adverse reaction and only would need the Pneumococcal at age 65 yr.
Still have a big lump at the injection site, still a little red and a little warm to touch
Started to feel her throat, lips and eyes swelling.  No breathing problems.  Went to ER at 7:58 PM and got subcut epinephrine, 125 mg IV solumedrol, and 25 mg IV Benadryl.
fever to 100.5, c/o of chest discomfort, abd pain, dec appetite, h/a, knee pain;
Redness and swelling to right thigh after she got 2 months vaccines, per vaccine records, received HIB and PCV13 in this location, denies spreading rash, difficulty breathing, cough, or vomiting, fever 101F, applied cold compress with some improvement Mom states was "4 quarters (coins) width, given Tylenol, mom also noticed small reaction at injection site on left thigh in the AM on 2/14/17, eating and drinking well.
redness and inflammation about size of silver dollar, white round nickel size spot in the middle of redness, hot to touch and sore
on December 20th in the evening i got a fever of 99.8.  When inwoke up the next morning I had a few dozen itchy blisters on my abdomen and back. I checked with my primary care physicisn who confirmed it was not the expected reaction to the vaccine and it sounded like I had contracted chicken pox from the vaccine. By Wednesday 12/22 i had hundreds of itchy blisters covering my whole body.
Patient presented 15 minutes after second Moderna vaccine administration with report of blurry vision. She also endorsed URI symptoms (with sick children at home with similar symptoms) x1 day. We checked a rapid covid/flu which was negative.  Likely other viral URI.  Her visual acuity testing was R 20/30, L 20/30, B 20/70. She states that the blurriness actually went away by time of discharge, however I will refer her to optometry for a full vision exam.
lump appeared saturday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 10:30 (Lot number: Unknown) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MASS (non-serious) with onset 25Sep2021, outcome "unknown", described as "lump appeared saturday". Therapeutic measures were not taken as a result of mass.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Patient received other medications within 2 weeks of vaccination. Patient was not diagnosed with covid-19 prior to vaccination. Patient has not been tested for covid-19 since the vaccination. The patient had no known allergies. The vaccine was administered in a pharmacy. The event occurred on 25Sep2021 (reported as Saturday). Device date reported was 27Sep2021.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Initial report received from a healthcare professional on 23 SEPTEMBER 2013. A female patient, whose age, medical history and concomitant medication were not reported and has had flu vaccine in the past, had received a FLUZONE (batch number, dose, site of administration were not reported) intramuscularly on 19 JANUARY 2012.  On unspecified date, the patient complaint that hands and feet were swollen for 3 days with itchy skin. The patient received ZYRTEC as corrective treatments and laboratory investigations were not reported. At the time of this report, the event was resolved.  Documents held by sender: None.  Additional information received  from the nurse on 13 NOVEMBER 2013. Outcome of the event changed from unknown to resolved.
Patient received two doses of Fluzone HD in one season, No AE; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient who was vaccinated with two doses of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] in one season (lot number: UJ308AA and expiration date: 30-Jun-2020) first dose on October and on 16-Dec-2019.  Medical history and concomitant medication was not reported.  This was an actual medication error case due to extra dose administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
States low-grade fever, fatigue, ?, blurred vision. Has not felt well last few weeks, extreme fatigue 3/14/03. Called in sick 3/17/03, today acute onset of high BP 170/113, diaphoresis, decreased vision, dizzy, headache, Saw MD with felt it was and vaccine reaction. Orders two more drys (four total) off work.
Patient states she became short of breath and wheezy within a half hour of having the injection on Friday. She became weak and had to have assistance getting into the house. She sat to rest briefly, then got up to go to the bathroom and noticed her legs, feet, and hands had swollen, felt as though something was squeezing/pinching her wrists. She also had redness, swelling, and irritation at the injection site. Over the weekend, her daughter encouraged her to seek medical attention, so patient called a provider office. She declined further evaluation and states her symptoms are improving, and she feels much better today.
This case was reported by a physician (also the father of the subject) and described the occurrence of vaccine underdose in a 31-year-old pregnant female subject who was vaccinated with HAVRIX (GlaxoSmithKline).  There were no concurrent medications.  On 5 March 2009 the subject received 1st dose of HAVRIX at 1.0 ml (1440 elisa units) in the left arm.  During vaccine administration, the needle was not secured on the prefilled syringe and some of the dose leaked out onto the subject's arm.  The physician was not sure how much of the dose the subject received.  This was considered to be a vaccine underdose and a case of vaccine exposure during pregnancy.  No adverse events were reported.  It was noted that the subject was due in 8 months from the time of reporting.  Follow-up information was received from the reporting physician on 30 March 2009.  It was reported that the vaccine spilled out before the total injection could be made.  Last menstrual period was unknown.  On an unspecified date, the subject had a miscarriage.  This case was assessed as medically serious by GSK.
08/30/2006 in the evening began running fevers and had a few episodes of vomiting.  She has had a Tmax of 103.  Her appetite has been decreased.  She has not had diarrhea or urinary problems.  Mom has not noted any cold symptoms.  She has not had a rash.  She has continued to have fevers this morning- it was 102.1 rectally in clinic this morning.
Pt developed symptoms 15 minutes after 1st dose of Moderna. Tiching, tongue tingling (denies swelling, troubles breathing or swallowing)  Pt was brought back to treatment area, 1325 given diphenhydramine 50mg  for itching, vitals taken- BP elevated (171/89, 175/88, 179/82).  Tongue tingling improved (not resolved) with diphenhydramine, itching worsened, diaphoretic. Emergency response called 1340. BP Checked 180/102. Pt transported to ER via Emergency Response Team
Narrative:  Injection site pain, swelling, and redness; nausea; fatigue; itching. Symptoms most prominent on Day 2 then improved with each day.
This spontaneous report was received from a physician assistant via field representative referring to a 67 year old female patient. The patient's medical history or concurrent condition were not reported. On 31-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (1 single shot, strength, formulation, lot#, exact dose, route were unspecified). On an unknown date in October 2015, "last week", the patient developed shingles. The patient had sought unspecified medical attention. The outcome of the event was unknown. Additional information has been requested.