chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed swelling, redness to injection site with extension of erythema approximately 24 hours after Pneumovax given. Pt had no reaction to flu vaccine given in other arm.
BEEN SICK AFTER RECEIVING FLUMIST; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided).    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) 0.2 ml, via unspecified route, on 19-DEC-2015.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On 19-DEC-2015, the patient experienced been sick after receiving flumist (preferred term: Sick relative).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Product Role: Suspect
Patient left after 15 minute wait time after receiving second COVID-19 vaccine. Patient then returned at 0632 to vaccine clinic stating that she was having numbness and tingling to jaw and lips and left ear. Vitals were obtained: 115/73, HR, 74, O2 Sat: 97% on RA. Patient denies any SOB of difficulty breathing. Patient has no noted welts or redness noted.    0635: Patient was given 25 mg of Benadryl, PO and patient is drinking her coffee.    0640: patient sitting up in chair, patient denies any tingling and or numbness to jaw, lips, and left ear. Patient states " I can not believe I am feeling so much better.  I have no numbness at all."    0702: patient feeling much better, and denies  any SOB, edema, numbness and or tingling. Patient vitals: B/P: 113/58, HR: 76, O2 Stat: 97% on RA. Patient did ambulate out of clinic with out issues. Advised patient on signs and symptoms to look out for and when to seek medical attention. Patient verbalized understanding.
This spontaneous report as received from a medical assistant refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On an unspecified date between mid-June and 14-SEP-2017, the patient was vaccinated with improperly stored dose of ROTATEQ, orally (dose number, exact dose were not reported; lot # M018958 with the expiration date of 03-MAR-2018), for prophylaxis. No adverse effects were reported. The dose of ROTATEQ underwent a temperature excursion of 34.57 degrees Fahrenheit for the time frame of 17 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA007917.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX lot # M005971, expiry date 02-FEB-2018 for prophylaxis. No adverse event was reported. The vaccines were stored at a temperature of 12 C for 63 hours, and in the range of -14 degrees C to -10 degrees C for 487.5 hours. Digital data logger was not involved. There was no previous temperature excursion. No product quality complaint was involved. No additional information was available. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010627.
ARM SORENESS; FEVER; TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced fever, tiredness, and arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, tiredness and arm soreness was not reported. This report was non-serious.
Pt vaccinated with MMR developed temp 104.8 & fine rash,lt otitis media
Pt. received Tdap. Outside of age prescribed. Last DTaP given 8/25/05.
had the Covid arm for about 24 hrs. It was a red square patch on my left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (had the Covid arm for about 24 hrs. It was a red square patch on my left arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (had the Covid arm for about 24 hrs. It was a red square patch on my left arm). On 20-Mar-2021, VACCINATION SITE ERYTHEMA (had the Covid arm for about 24 hrs. It was a red square patch on my left arm) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.  Patient DOB was reported as ??-???-1976.   This case was linked to MOD-2021-409598 (Patient Link).
Information has been received from an 83 year old female registered nurse, concerning herself. Early in 2000, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not reported) (Lot # and expiration date were not reported). In the summer of 2010, the patient broke out with a moderately-severe case of shingles, which lasted 9 months (in approximately 2010). The patient sought unspecified medical attention. Unspecified medication was given for the event as she did not recall what they gave her. At the time of the report, the patient's outcome of broke out with a moderately severe case of shingles was recovered. The relatedness for broke out with a moderately severe case of shingles was unknown for ZOSTAVAX. Additional information has been requested.
"pt recv vax 16AUG96 & 19AUG96 pt devel mastitis which resolved by 20AUG96;med prescribed but pt did not take it;27AUG96 pt devel inc diffuse redness @ site of inj, red maculopapular, pruritic skin rash on face, trunk, thigh & arms;"
This spontaneous report was received from a magazine article referring to a 97 years old female patient whose squamous cell carcinoma was thought to be untreatable, lesions had developed over much of her right leg, in such numbers and size that chemotherapy and surgery were ruled out as treatments. Approximately in July 2016 (reported as "two years ago from 13-JUL-2018"), on a hunch, her doctor tried an unorthodox approach she injected each tumor with GARDASIL. The result: All the tumors completely and rapidly disappeared. The patient's son stated that the outcome was more than what he had even hoped for, it was like the tumors were going through a dying phase, one by one. And he hoped that this treatment could be further tested and used in clinical trials, as the benefit was just too practical to be ignored. The doctor first administered two vaccine doses in the patient's arm. Several weeks later (in 2016), additional injections were administered directly into some of the patient's tumors. The treatment was applied a total of four times, spread out over an 11-month period. Less than a year following the initial direct-to-tumor vaccine injection, all of the treated tumors disappeared. What's more, over the two year post-treatment period, there has been no skin cancer recurrence. The doctor was surprised that all of the patient's tumors regressed, even those that were not directly injected with GARDASIL. The deputy chief medical officer said "the concept of injecting a vaccine or an infectious agent into a cancer tumor is not in and of itself new. What's new is the use of the HPV vaccine. And what likely has happened here is that by injecting it into the tumor cells the vaccine helped the patient's own defense mechanism respond in such a way as to attack the cancer in that location." The doctor's own research, involving two prior patients (captured in US-009507513-1707USA006525 and US-009507513-1707USA005911), had suggested the vaccine might curb skin cancer growth.; Sender's Comments: US-009507513-1707USA005911: US-009507513-1707USA006525:
Sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the friend's son got sick from Shingrix vaccine. This case has been linked to US2019180830, reported by the same reporter.
Pt began adverse reaction the same night as vaccination. Pt experienced flu like symptoms for 6 weeks post vaccination followed by neuropathy in feet, hands, right side of body, including throat. Pt was hospitalized 9 times in the last 1.5 years and experienced stroke, heart catheterizations, percutaneous coronary intervention, sepsis. Pt experiences twitching,  electrolyte imbalances, kidney failure, dehydration, neuropathy, chest pain, closing of right side of throat (inability to eat at times with rapid weight loss). Pt was a full time dentist and forced to retire as a result of vaccination injury. Pt now takes multiple new medications and experiences side effects from those such as Plavix 75mg PO daily, Eliquis 5mg PO BID, Lasix 20mg PO daily, oxycodone-aceta 10-325mg PO as needed q 4 hours, Xanax 0.5 mh PO as needed, metoprolol 50 mg PO daily.  Pt diagnosed with CIN or "critical illness neuropathy" as a result of vaccination. Pt also had to do PT for 5 months total as a result of many hospitalizations post vaccination injury. Pt still experiences numbness throughout body and chronic pain and anxiety none of which he had prior to vaccination.
Headache, chills, memory loss, dizziness, nausea, rash on chest and shins, itchy skin, leaky breasts.
I got the first dose of the Moderna COVID-19 vaccine on Monday, January 4. I had a mildly sore arm for the first couple of days following the vaccine, but that was about it for side effects. I noticed my face was a little flushed when I was driving home afterward, but I chalked it up to being excited and nervous and wearing a face mask.  Seven days later, it started to feel itchy around my vaccination site (upper left arm). There has been some mild swelling around the site, in addition to being itchy. The area is also warmer than the rest of my arm or body. For one night, it was uncomfortable sleeping on my left side.  Starting on the 8th day after the vaccine, there is a small amount of redness just above the vaccine site, about an inch and a half wide, a little larger than a quarter.  Here are my doctor's notes, who I saw on January 12: Patient is a 40 y.o. female who presents for evaluation of rash/ possible injection reaction  involving the left upper arm. Rash started yesterday.. she noted slight swelling, warmth, and itching with pink erythema in a spot just above the area of her arm where she had her COVID injection 1 week ago. She received the Moderna vaccine.   Associated symptoms: no associated symptoms. Patient denies: fever, headache, arthralgia, abdominal pain, nausea, myalgia, decrease in energy level. She did not have significant pain at the time of the injection, and had a mild sore arm the following few days but no other symptoms after the shot. The warmth and swelling began just yesterday, almost a week later. She has reported this to the VARS website. She is employed by public health and is going to work at a covid vaccination site tonight, checking in people who are getting vaccines.  She has a h/o sensitive skin, but no h/o hives or urticaria, no previous injection reactions. She get racing heart from epinephrine but no other known allergies.  She denies dizziness, dyspnea, SOB, cough, or sensation of swelling in throat.  She has been using ibuprofen, cold compresses for sxs with some relief.  Assessment:  Probable injection site reaction, delayed reaction No strong evidence of cellulitis but we discussed signs and symptoms to be watchful for such as increased swelling and redness or tenderness of the overlying skin, fevers, chills, body aches.  Plan:  Medications: Benadryl 25 mg administered in clinic and discussed use of antihistamines to reduce injection site reaction. She can continue use of ibuprofen and cool compresses as well. Avoid over cooling of skin as this may also cause local reaction.  If pain, redness, or other sxs of concern progress she should follow up.  Verbal patient instruction given. Follow up: as needed.   If no further increase in sxs she should be able to receive her second vaccine but would premedicate with Benadryl to prevent local reaction again.
On 12/11/17, start having chills, body aches, and stiffness that night after flu vaccine. These symptoms has persists to the present. On 12/15/17 started having diarrhea, nausea, vomiting and aches. Went to Urgent Care for treatment today. - 12/18/17.
Expose for tree hours to someone with covid19; Haven't taking the second dose yet; Experience a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Expose for tree hours to someone with covid19), PRODUCT DOSE OMISSION ISSUE (Haven't taking the second dose yet) and MYALGIA (Experience a sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced MYALGIA (Experience a sore arm). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Expose for tree hours to someone with covid19) and PRODUCT DOSE OMISSION ISSUE (Haven't taking the second dose yet). At the time of the report, EXPOSURE TO SARS-COV-2 (Expose for tree hours to someone with covid19), PRODUCT DOSE OMISSION ISSUE (Haven't taking the second dose yet) and MYALGIA (Experience a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported by the reporter. Treatment details was not reported by the reporter. Patient that she had been expose for three hours to someone with covid19, and she wanted to know if she should take the vaccine know.
5:20 pm shot, 6:30 pm Aching, tenderness, 9:30pm stiffness, severe aches and pains, pain to my neck- applied ice and took acetaminophen. 7:30 am tenderness, pain,  applied ice 9:30 am chills aches, nausea (flu-like) other joints aches (knee, wrist).
Very sore arm of shot; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via unspecified route of administration in the left arm on 15Mar2021 at 03:00 (at the age of 67-years-old) as a single dose for Covid-19 immunisation. The patient's medical history and Concomitant medication were not reported. Allergies to medications, food, or other products was reported as None. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The Patient had not tested positive for COVID-19 since having the vaccine. The patient received the most recent dose of COVID-19 vaccine in a Public Health Clinic/Administration facility. On 15Mar2021, the patient experienced pain in arm. The patient did not receive treatment for the reported event. The event pain in arm was recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
April 8 and 9: sore arm April 10: headache   April 11: headache and fatigue April 12: headache, fatigue, chills, sore neck and 100.4 fever
Head felt so sick; fatigue/exhausted; dizzy; chilly; cold; achy; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), PAIN (achy), HEAD DISCOMFORT (Head felt so sick), DIZZINESS (dizzy) and CHILLS (chilly) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), PAIN (achy), DIZZINESS (dizzy) and CHILLS (chilly). On 18-Mar-2021, the patient experienced FATIGUE (fatigue/exhausted). On an unknown date, the patient experienced HEAD DISCOMFORT (Head felt so sick). At the time of the report, NASOPHARYNGITIS (cold), PAIN (achy), HEAD DISCOMFORT (Head felt so sick), DIZZINESS (dizzy), CHILLS (chilly) and FATIGUE (fatigue/exhausted) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications was included.  No treatment medications were reported.   This case was linked to MOD21-057846, MOD21-030427, MOD21-043912 (Patient Link).
Red swollen area running between the 2 injection sites on (L) thigh - appeared 7 days after vaccination. Treated with cool compresses. Did not feel deep - likely no muscular involvement.
Developed a somewhat mild case of tinnitus within a month of second covid vaccine, thought it would go away but it just got worse which led me to go see an ENT. The ENT verified I had hearing loss which he said is one of the causes of tinnitus and there is no "magic pill" that he could give me to make it go away. I did tell him I didn't have the 24/7 tinnitus prior to the vaccine. Here I am a year after my second vaccine and the tinnitus is worse and has not stopped since it first started some 11 months ago. Constant ringing in the ears.
After 9 days out, developed an itchy, 2 inch red lesion at injection site.
Mother took child to ER d/t swelling right deltoid area, MD wrote right deltoid region warm to touch, erythematous, mildly indurated, no streaking, Dc'd with instructions to apply ice, hydrocortisone cream 2X 5 qd and may give Benadryl orally.
I was diagnosed with severe ulcerative colitis about two months after my second vaccine. I started having symptoms about 1 month post vaccination. I ultimately was hospitalized for ten days with severe bleeding from ulcers in my colon. I am now on Remicade for my ulcerative colitis. I believe the COVID-19 vaccine revved up my immune system such that it attacked my own body. I was genetically predisposed to autoimmune disorders, but had not had any diagnosis or symptoms prior to the COVID-19 vaccine.
Chest pain, difficult breathing, severe headache. Treated with Benadryl and Toradol.
Lost eye function - can barely open eye. Eye can still focus, but takes a few seconds. Eyelid stays closed by itself, patient needs to physically lift eyelid with finder to open and focus eye.
UTI; Weakness; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI), ASTHENIA (Weakness), CHILLS (Chills) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI), ASTHENIA (Weakness), CHILLS (Chills) and PYREXIA (Fever). On 06-Mar-2021, ASTHENIA (Weakness), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Flu, nausea, chills, headache, fatigue, muscle pain. Arm injection site was very swollen, had pain, and was very red.
Information has been received from a consumer concerning her daughter who in May or June 2007, was vaccinated with the first 0.5 ml dose of GARDASIL vaccine (yeast) and on 04-AUG-2008 was vaccinated with the second 0.5 ml dose of GARDASIL vaccine (yeast). The patient delayed the shot because of contacting mononucleosis from her classmate. The patient had had no ill effects from the delay. No product quality complaint was involved. No further information is available.
Pt had focal seizures on left lower extremity then on left upper extremity getting to be generalized which lasted for about one hour. He was given Ativan and Dilantin. He continued to have brief eye deviation both downward gaze and nystagmus, about 5 seconds for a few hours. He has not had any seizures after that.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 21-Jan-2021, EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.            Concomitant medication was not reported. Treatment medication was not reported. The patient had the first dose of the Moderna vaccine on 21-Jan-2021 with no adverse side effects and will be getting their second dose on 18-Feb-2021.
Narrative: Patient report neck pain, tingling on tip of tongue and lip lasting 30 seconds. Symptoms resolved and vitals were stable. No visible swelling noted per nurses assessment.
Approx 2 minutes p/vax pt fainted & landed on nurse's arms; pt was placed flat on the floor & legs were elevated; regained consciousness in 6 to 7 seconds; VS P50, Resp 14, BP 90/70;
Sinus tachycardia with frequent premature ventricular complexes in a pattern of bigeminy, biatrial enlargement, nonspecific ST abnormality, abnormal ECG Symptoms include shortness of breath, feeling of burning in chest, feeling of pounding and irregular heartbeat (skipping beats), fatigue No treatments recommended Frequency of symptoms was greatest between 12/10/2021 and 12/26/2021, symptoms have continued since then but less frequently  Note: This occurred after the booster dose of Covid-19 Vaccine, which was by Phizer/BioNTech, the first two doses were by Moderna
Moderna COVID-19 Vaccine EUA  Rash on arm size of my fist, plus open sore at injection site.  Started fading after 2 days