chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of nausea in a 19 year old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. Concurrent mediations included Valacyclovir hydrochloride (Valtrex) and Ibuprofen. The subjects medical history included high pitched crying following the administration of the MMR II virus vaccine, as an infant, the MMR series was discontinued. The subjects concurrent conditions were not reported. On an unspecified date in June 2005 the subject received 1st dose of Engerix B (lot number not provided). Approximately 2 hours after vaccination with Engerix B, the subject experienced nausea and a headache. The pharmacist stated the patient complained the headache was the worse headache that she had ever experienced. Approximately three days later, on an unspecified date in June 2005, the patient developed a rash on her chest, back, and arms, and muscle pain. The  headache and nausea resolved after three to four days, the rash resolved three weeks after onset, the resolution date of the muscle pain was an unknown date in July 2005. The pharmacist considered the events nausea, headache and rash to be possibly related to vaccination with Engerix B.
The day of the vaccination I became bed bound with an extreme fever where I could not move, the body pain was unbearable. This lasted two straight days. Within two weeks I began experiencing terrible pain like indigestion, heartburn, and left sided upper chest pain. This was also the onset of night sweats, not being able to sleep, not being able to stay asleep when sleeping. I went to Dr. who didn?t want to do much and didn?t want to attribute it to the vaccine. Finally I was prescribed Omeprazole  and had an EGD completed. The EGD did not show anything. I continue to take Ompepraxole and never had any problems like this. For the other symptoms I finally talked Dr. into letting me see a specialist as I felt my numbers for my hormones were far too high, when they should be scaling back for my age. My Estrogen has shot up excessively. This is known to cause cancer, so of course I was concerned. I saw Dr. who recommended I now take progesterone, as my estrogen is so high and progesterone is bottoming out. He also was unable to explain why.
Skin became itchy day after vaccination leading to itchy rash over body 2 days after vaccination. Patient advised to take Benadryl and contact PCP in regards to allergic reaction. No indication of trouble breathing or worsening rash at time of documentation.
it was an immune response; rashes all over his body but more specifically on his hands and feet that have continued up until today; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (it was an immune response) and RASH (rashes all over his body but more specifically on his hands and feet that have continued up until today) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced IMMUNISATION REACTION (it was an immune response) and RASH (rashes all over his body but more specifically on his hands and feet that have continued up until today). At the time of the report, IMMUNISATION REACTION (it was an immune response) and RASH (rashes all over his body but more specifically on his hands and feet that have continued up until today) had not resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that, 10 days after dose patient experienced rashes all over body but more specifically on his hands and feet that continued up until the day. Patient went to the emergency room and had spoken to an allergist regarding his symptoms. The allergist stated it was an immune response to something. Because of that, they believed it was the vaccine.  No concomitant medication was provided.  No treatment information was given.
I developed a severe skin cellulites (infection) at injection site with swelling, redness, heat.  I was required to seek medical attention and placed on Keflex for the reaction.
Cold sore started, lasted for a week, numbness to right side of face and scalp developed ten days later and is still ongoing. Hospitalized for 4 days, CT, MRI ruled out stroke. Transverse Myelitis has been diagnosed. Steroids are being taken.
Red itchy spot size of half a dollar/ Itchy; Red blotches all over arm and it is spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Red itchy spot size of half a dollar/ Itchy) and VACCINATION SITE ERYTHEMA (Red blotches all over arm and it is spreading) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Red itchy spot size of half a dollar/ Itchy) and VACCINATION SITE ERYTHEMA (Red blotches all over arm and it is spreading). At the time of the report, VACCINATION SITE PRURITUS (Red itchy spot size of half a dollar/ Itchy) and VACCINATION SITE ERYTHEMA (Red blotches all over arm and it is spreading) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Fever. Diarrhea. Heavy fatigue. Swollen arm. Red rash. Nausea. Sneezing. Wheezing. Heavy chest. Coughing. Phlegm.
At 8pm 3/11/21 I was very tired and cold. (different than chills from a fever). Did not feel feverish. At 4am 3/12/21 I woke up with severe muscular pain in my entire body and severe head pain. I took 2 Advil and went back to sleep. Woke up at 8:00am 3/12/21 with severe back ache and headache. Took 3 Advil and pain subsided over the next 3 hours. Did not have to redose Advil.
Patient called 11/21/21 stating that two day s after receiving her Pfizer booster she started developing a rash at the site of injection. It has gradually spread to her chest. Patient has a doctors appointment 11/22/21. Patient stated she had no other sign or symptoms. Advised to call emergency if difficulty breathing developed.
High fever, extreme body aches, extreme weakness, excessive thirst for next 24 hours extreme confusion and blurry vision for next 4 days. Extreme confusion to the point where I did not recall the names of my parents in the ~15 hours after the shot.  delayed menstrual cycle for next two months
At 3 months, noticed he could not lift head, could not grasp with his hands and he was very floppy baby. Diagnosed with microcephaly, seizure disorder, mental retardation and CP. follow up report received 10/29/02 "Mother report that her son is mentally retarded as a result of the vaccine". The annual follow up received on 9/3/03 states continues much the same. Profoundly mentally retarded.
Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-MAR-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU, lot # L044530 with an expiration date on 09-FEB-2017 (dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Around December 12, 2021 I started with a sore throat, for about 4 days. I had head cold symptoms, stuffy nose and headache on day 3 of onset of symptoms. On day 2 of symptom onset I received a rapid test and it was negative. By days 5 or 6, the symptoms were gone. I only saw a doctor for the rapid test and did not get prescribed or take any medications. On day 14 from symptom onset is when I had the pulmonary embolism. I had SOB. I waited to see my doctor and got on anticoagulation. I had not have any problems since then.
After 4/7 first dose, injected place itches swollen, around 4/14 there is a rash and itchy  on the arm not at the injection site but on the arm close to the injection place, until today 4/17 it still there but it light up a bit however when wake up feels a bit headache not sure whether it relates or just didn?t sleep well ...saw website has similar case, thought I should report as a vaccine receiver
Have not had a period since receiving the last shot; DOSE 1 on 12Jan2021 and DOSE 2 on 06Aug2021; This is a spontaneous report from a contactable nurse, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via intramuscular route of administration on 06Aug2021 at 14:30 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1284), via intramuscular route of administration on 12Jan2021 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. On 19Aug2021, the patient had not had a period since receiving the last shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent lab tests and procedures which included COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the event not had a period since receiving the last shot was not resolved at the time of this report.
Moderna vaccine given at 1156 DOB 03/01/1970 IM to R deltoid. Lot number 015M20A, exp 7/29/2021. Pt had allergies to shellfish and amoxicillin (stating hives and anaphylaxis).  Pt started itching at 1215 so sat by pt and monitored pt closely as she wasn?t sure if she was just being nervous. Pt was itching by her mouth under her mask and behind right ear. I couldn?t see anything that looked like rash or hives.  At 1218 I noticed her R ear was now swollen and red. Pt continued to c/o of itching and states it has now progressed to her feet. She called the ambulance while this nurse gave 0.5mg SQ epinephrine L upper arm. VS: BP 140/82, HR 101, RR 20, 99% RA. Pt breathing easy and regular with no issues with airway. Pt states itching much better and was gone from her feet within a few seconds of giving the epinephrine. Pt questioning if she really needs to go by ambulance. This nurse did encourage going by ambulance as if anything happened that patient went unconscious on the way to the hospital that the ambulance staff could keep her safe by giving her more medications.  1223: Assisted patient by w/c to cot to lie down as she was feeling shaky from epinephrine. This nurse staying with pt at all times while waiting for ambulance. Pt called husband and is talking to this nurse throughout this situation. Pt breathing easy and regular.  1230: Pt states itching better, and redness on R ear is getting better. Husband has arrived to be with pt and wait for ambulance. Pt states still itches but still gone from her feet. Redness on ear remains good. Pt talked with husband about concern of taking ambulance. This nurse did state she thought it was safest way for pt to be transported in case anything happened further on the way to the hospital but the patient does have the right to refuse the ambulance.  1240: Pt states itching feels like increasing some. States itching to her hair, face, and feeling like all itching all over again. This nurse gave 50mg Benadryl IM to RUQ buttock. Pt tolerated well. No bleeding to site after injection. Ambulance arrived right after injection given. Report was given to ambulance staff after they had time to assess patient. Pt and husband agreed for pt to leave with the ambulance.  Ambulance staff had pt walk to ambulance at 1245. Pt stable when leaving with ambulance staff.
Pt was admitted to hospital from the ED for cyclical vomiting on 4/3/21 after receiving the first dose of vaccine on 3/26/21. Per guidelines, Each hospitalization is to be reported.
LARGE LOCAL REACTION.  LASTED TEN DAYS. TREATED WITH ANALGESICS, TOPICAL ICE, BENADRYL AND TOPICAL OVER THE COUNTER CORTISONE CREAM.
Mild Body aches, joint aches, pain at injection site from arm up through left side of head, soreness through left side of body, fatigue. All symptoms were mild
Per the patient's note to us: "Since I was there, I asked for a flu shot, which I did receive. I woke up at 2:00 am on Tuesday morning with a horrible case of vertigo that lasted for 2 days, and now I have a bad cold. Some say vertigo can be caused by the shot, and others say that is not the case.  Either way, in my mind it has to be associated with the shot, because I was perfectly fine until I got the shot. I have had vertigo before, but it never lasted more that 12 hours. Prior to this flu shot, I never had any after effects from the shot. "
" 15mins after vaccine I felt dizzy with Pounding   head" VS monitored 150/99 HR 80 o2 sat 97% RR 15. Seen by Dr. EKG done repeat VS148/96 HR 83  O2 Sat 97%  RR18
Information has been received from a registered nurse concerning a 23 year old female with skin allergies and a rash to other medications in the past who on 05-FEB-2007 was vaccinated IM in the right deltoid with a third dose of Gardasil vaccine (yeast) (lot # 654702/0011U). There was no concomitant medication. The patient tolerated the vaccination well. 3 to 4 weeks post vaccination on 06-MAR-2007 the patient noticed a lump at the injection site deep in the muscle. The lump was a pea in size and was oblong in shape in the right deltoid approximately 1 cm, which was the injection site deep in the muscle. No redness, pain or fever noted. The patient took therapy with ADVIL as needed. The patient was seen last week, on approximately 13-MAR-2007, and the lump had gotten smaller from the last week. As of 20-MAR-2007 the patient had not fully recovered. The patient took therapy with ADVIL as needed. The patient was seen last week, on approximately 13-Mar-2007, and the lump had gotton smaller from the last week. As of 20-Mar-2007 the patient had not fully recovered.Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. The patient had no illness at the time of vaccination. Concomitant therapy included ZOLOFT and LOESTRIN. No additional information is expected.
Headache - severe; general malaise - not feeling well; itching and burning - red, angry rash started on left arm. And also over part of my chest. I called the doctor and the doctor (virtual appt and email) gave me stronger medication - Hydroxyzine HCL 25 mg - four times a day and the same cream as last time Triamcinolone Acetonide 0.025%.  They helped calm it a little bit. I had the headache two days. I was not able to work. I had the itching and burning symptoms for two weeks. I had another outbreak of herpes symptoms - I have used Valtrex for since 1998  - and that had been keeping the herpes symptoms away  - and now I am having herpes outbreaks again but not as severe as it has been those years back. I continue on the Valtrex.
pt recv vax over the subsequent 4 wk gradually devel some redness & tenderness @ inj site (persisted 2-3months) also devel severe arthralgias, & gen weakness & lethargy; tx w/Keflex for 14 days
Felt sharp pain upon vaccine receipt. For 3 wks. can only lift arm to 45 degrees. Ibup/heat recommended. Also to follow-up with provider if continues.
Adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient had an adverse event  No concomitant medication was reported  No treatment medication was reported
mild pain in left arm same day as injection; next day mild/moderate headache, fatigue, body/muscle aches, and pain in left arm
Janssen COVID-19 Vaccine EUA 24 hours of SEVERE pain in every muscle and especially neck, eyes, head, face, jaw. Also fever, nausea, vomiting, inability to sleep, intense tiredness. After 24 hours, all symptoms continued but were milder for 2 more days. Couldn't eat at all for 3-4 days.
Red worm-like rash radiating from injection site around back of arm and slightly underneath arm about 3-4 inches. Warm and slightly itchy.  Gradually disappeared but took about 10 days.
1:42 injection 1:58 reported tingly lip and feels funny, Benadryl 50mg given, no injection site reaction, lip and tongue unremarkable  POX 99, P 78, bp 128/66 2:05 feels "funny, " dropping papers, appears nervous 2:20 DNS reported improved tingle 2:30 Dr. evaluated cleared resident to go home before Benadryl kicks in, tired.   She stated "I feel fine"
Fever 105 w/seizure within 24 hrs. Seen in ER, given Tylenol and Motrin.
Admitted 11/22/2021 with breakthrough COVID infection, COVID positive test on 11/14, symptom onset 11/8
pt started feeling chest pains apprx ~1 wk after vaccination, EKG normal, echo shows mitral valve prolapse
Pt attended outreach clinic and received Moderna COVID-19 Vaccine dose #1 at age 16. Current EUA states Moderna vaccine is ineligible for pts < 18yo; pt was not an original participant on provided list. Pt left in stable condition and per CDC recs is ok to receive dose #2.
pt recv vax & w/in 12hr post vax exp nausea, fainting, stomach cramps, & fever;pt feels that the rxn was severe;sx resolved in 36hr;
During my first vaccine I experienced a bruise on my arm that lasted ~3 weeks. My arm swelled (including my fingers which looked like sausages) for a few hours that night.  I also felt like I experienced slight chest congestion for a week or two after. The second vaccine (lot number listed on this form) I have a bruise that in my opinion is worse than the one from the first shot.  The bruise is still present after 1 week. I also feel slight tenderness around the joint area. I have not heard of these symptoms being advertise Will this cause joint damage? Additionally form both vaccines I experienced fever, body aches and obviously a sore arm.
Patient received her second dose of Moderna COVID-19 vaccine on 1/28/21 at 11:39AM. Patient took cetirizine 30 mg the night prior to her dose and cetirizine 20 mg the morning before her dose. At 11:44 AM patient reported symptoms of pruritus, nausea, dry heaving, elevated respiratory rate and feeling hot. Patient was given pepcid, additional cetirizine 10 mg and zofran. She was brought to the ED, reported feeling sob, numbness and tingling in her bilateral hands and feet. No rash but itching. Given epinephrine IM and Solumedrol with good response. Discharged to home on prednisone, zyrtec, pepcid and epipen. At home she felt well the first night. Next night she woke up with fever 103.2F. Took Tylenol.  Temperature was 101F for next 2 days, controlled with Tylenol.  Also diarrhea x 2 days.
It started off with sore throat, burning eyes, diarrhea. I tested positive with COVID-19 on 02/22/2023. I had a telehealth with my provider on 02/22/2023 and prescribed PAXLOVID.
I work in health care and therefore was offered the vaccine.  After about 1hr my hands, feet and nose became very cold and my temp dropped to 94 degrees.  I felt very cold.  My blood pressure was 90/30.  This never happened to me before.  It took about two hours for my temp to go back to normal and for me to feel my normal self.   I had Covid 19 in August.
contracted COVID; contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Feb2021 (Lot number: EL3247) at the age of 43 years as dose 2, single and (Lot number: el3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "recovered" (2022) and all described as "contracted COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive; (14Jan2022) positive; (19Jan2022) negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: other vaccine in four weeks. Adverse event contracted COVID. no covid prior vaccination  Follow-up attempts are completed. No further information is expected.
Moderna COVID-19 Vaccine EUA. Experiencing tinnitus, ringing in the ears. Soreness in neck, but I think that's from playing with my girlfriend's young daughter.
Breakthrough case hospitalized with complications of COVID-19 including hypoxia, pleural effusions, and interstitial edema. First positive test on 5/10/21. Hospitalized on 5/18/21. Other symptoms include shortness of breath and cough.
Severe pain top of shoulder to hand.. head ache, fever,  Pain going up and down spine, nausea, leg pain. Arm weakness Took Tylenol  and called her Doctor who advised. Symptoms still there but coming and going
BP 130/82, AP 70, R 74. Within moments of vaccination, pt complained of hot pain in left arm radiating to fingers. Ice applied to site within minutes pain aleviated and was localized to muscle, deltoid, at vaccination site. Pt s/s resolved grasp, warm to touch, good capillary refill no further pain, c/o pt referred to Rrt for f/u of his reported Hx of diabetes. Pt returned later to advise he had gone to HC and has appt for March 2, 2010.