chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 15SEP17 at about 0930, Typhoid and Japanese Encephalitis vaccines administered intramuscularly into left arm. Within 15 minutes face became flush, increased body temperature, runny nose, feeling of pressure within head, and visible full body inflammation/puffiness. Around 1430 developed a fever and sweats which broke about 1500. Developed a fever and sweats again around 1700 which broke approximately 1755. On 16SEP17 developed increased flue like symptoms with bad headache, full body muscle soreness, acute pain across brow and eye sockets, foggy headed, poor concentration. 17SEP17 Woke up at 0654 to severe myalgia, severe muscle stiffness/cramping/spasm throughout entire body. Radiating pain stemming from base of skull, running length of spine and radiating outwards along major nerves along ribcage. Debilitating migraine in scalp, forehead, orbital sockets and pain in the eyes. Neck pain and soreness/stiffness prevented ability to touch chin to chest. Noticeable delayed cognitive function. Delayed speech, tripping over tongue when speaking, slurred words. Decreased vision in both depth perception and clarity. Extreme pressure behind eyes, forehead, and temples. Runny nose, acute pain and pressure behind nasal cavity. 1350-1830 remained in fetal position on floor due to muscle cramping and inability to complete tasks due to severe pain and inability to focus long enough to complete tasks. During that time contacted nurse hotline, instructed to take ibuprofen, drink water and go to the emergency room immediately if unable to stay awake, loss of consciousness or seizures. 1830 symptoms decreased enough to go about the rest of the day and complete tasks but with great difficulty. 4hrs after contacting nurse hotline, hotline nurse called back to check in and advised seeing primary care doctor the following day. 18SEP17 ran normal run route that is routinely run and found it to be severely difficult and taxing. Suffered severe light-headedness, blurred vision, chest pains, difficulty breathing, and vision pinholed almost losing consciousness when reaching the top of a hill on the run. Run was abnormally difficult beyond the norm. Approximately one week later conducted an intense, 35 minute, routine sprint workout and felt ?normal? until the end of the workout. Had heart pains, irregular heartbeat, and despite maximum exertion heart beat was weak in nature. Continue to experience irregular headaches, impaired vision, poor concentration/memory, when falling asleep see blinding, painfull, bright flashes of light, and consistent lethargy and poor sleep patterns.
Mild headache similar to fever that lasted a couple of days on and off. I felt a little warmer than usual but not enough to even bother taking my temperature. I may get a headache once or twice a year.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 24-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 296 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
ER Triage Note   a 33 year old MALE presents to Emergency   Department on 01/10/22 15:29.       Tetanus status: Last Tdap: Mar 28, 2013      LMP:  NA - male    Chief Complaint: Visit CC: Left arm pain/ CP/ tachy/ hypoxia. Patient is a 33 year old MALE who is being admitted to the Hospital. This patient meets inpatient  level of care because  covid positive, hypoxia, cardiomyopathy .  Expected duration of stay is at least 2 midnights to receive treatment  as outlined in the assessment and plan. I anticipate the patient to be  discharged to Home.  Patient is being discharged from HOSPITAL Family  Care Unit today JAN 14, 2022.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with IBUPROFEN (MOTRIN IB) at a dose of UNK, qd. On 04-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved.            Relevant concomitant product usage were not reported by the reporter   This case was linked to MOD-2021-022506 (Patient Link).
rash consistent w/erythema multiforme which occurred 12 days post vax;
When he urinated there was pure red; The second vaccination was two weeks later; This is a spontaneous report from a contactable consumer (Patient). This consumer is reported that:  A 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date (at the age of 81 years old) as dose 2, single for covid-19 immunisation. Medical history included Crohns colitis diagnosed around 20 years ago, or 25 years ago when he quit smoking, brittle diabetic type 1 and lung neoplasm malignant from Jul2018 to an unknown date lung cancer, non small cell. Concomitant medications included insulin glargine (LANTUS) taken for diabetes mellitus inadequate control, insulin aspart (NOVOLOG) and mesalamine. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration, administered in left arm on 20Mar2021 as dose 1, single for covid-19 and experienced when he urinated there was pure red. On an unspecified date, the patient experienced when he urinated there was pure red two weeks after the second vaccination. Caller adds it is pure, it looked like pure blood. It was not light red, it was dark red. It was about the same color when he cut his hand the last time. Caller turned around and had an MRI the other day and they said his urinary tract is normal, they found nothing. He does not understand that at all. He does not know if it has anything to do with the Pfizer stuff or not. He searched and cannot find anything. Caller is going to have to go in and have the doctor go in his bladder with a scope which he is not happy about. He hopes that the doctor finds nothing but then if he finds nothing what does that mean. He was went to the physician office. He does not like the emergency room so he did not go. He did not want to go to the emergency room because Covid is going around. It has been over a month since the second shot and there is no more redness. The patient underwent lab tests and procedures which included computerised tomogram: normal and magnetic resonance imaging: normal on an unspecified date. The outcome of the event he urinated there was pure red was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
difficulty moving the shoulder; This non-serious case was reported by a physician via sales rep and described the occurrence of mobility decreased in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (intramuscular). On an unknown date, an unknown time after receiving Arexvy, the patient experienced mobility decreased (Verbatim: difficulty moving the shoulder). The outcome of the mobility decreased was resolved (duration 8 weeks).   It was unknown if the reporter considered the mobility decreased to be related to Arexvy.     It was unknown if the company considered the mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-OCT-2023 A GSK MSL Field Representative reported that a physician stated in his office that patient (no distinguishing factors provided), received the Arexvy vaccine, and had difficulty moving the shoulder the vaccine was administered in for 6 to 8 weeks after administration. The GSK MSL Field Representative did not have any further information about this event, nor any information about lot/expiry or date of administration. The reporter consented to follow up. This case is linked with US2023AMR152006 and US2023147931, by same reporter.; Sender's Comments:  US-GSK-US2023147931:1st female patient US-GSK-US2023AMR152006:2nd female patient
Allergy, with red dots around the hole body; Swelling of the arm where the injection was given; Experience fever; Hives; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PAIN IN EXTREMITY (Pain in the arm), HYPERSENSITIVITY (Allergy, with red dots around the hole body), VACCINATION SITE SWELLING (Swelling of the arm where the injection was given) and PYREXIA (Experience fever) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced URTICARIA (Hives), PAIN IN EXTREMITY (Pain in the arm) and PYREXIA (Experience fever). On 23-May-2021, the patient experienced HYPERSENSITIVITY (Allergy, with red dots around the hole body) and VACCINATION SITE SWELLING (Swelling of the arm where the injection was given). On 23-May-2021, URTICARIA (Hives), PAIN IN EXTREMITY (Pain in the arm) and PYREXIA (Experience fever) had resolved. At the time of the report, HYPERSENSITIVITY (Allergy, with red dots around the hole body) and VACCINATION SITE SWELLING (Swelling of the arm where the injection was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment was reported.
Within the first two hours soreness and headaches. The rest of the afternoon extreme  headaches, nausea, body aches. By 8:30pm beyond cold shivers and sweating buckets of sweat/ overheating yet was cold. 2am vomiting, 5am sore throat and still sweating and shivering with hives and head aches. Lasted all of Friday and Saturday. Saturday night just headaches, sore throat, hives, and intense sweating. Sunday morning body aches, head aches, and still lose of appetite. This experience is the worst thing I?ve ever encountered. The head aches were undesirable.
Patient was given Moderna Bivalent Pink cap as first dose. Patient will be revaccinated.; No known symptoms; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID. The original narrative from the sender is the following:  "Patient was given Moderna Bivalent Pink cap, as first dose. No known symptoms. Patient will be revaccinated. Primary case provider called and advised parents of the incident".  The causal relationship between Vaxelis and the events "Patient was given Moderna Bivalent Pink cap as first dose. Patient will be revaccinated" and "No known symptoms" was assessed as not applicable due to the nature of these reported events.  Of note, these events do not concern Vaxelis, but rather COVID19 vaccination. Vaxelis should have been considered as a concomitant. However, the case was databased to mirror what was reported in VAERS.  No further information is expected. is not working, added State under vaccine facility information and Reporter State.
Vision changes, chronic Migraines, difficulty with balance and ambulation,chest pain, Degenerative Disc Disease, seizure like activity, dizziness, bladder Incontinence, increased issues with IBS
Dizziness, late menstruation cycle (have never missed a period before, very regular)
Patient fully vaccinated with Pfizer on 2/12/21, 3/5/21, and boosted on 9/24/21. Originally diagnosed with COVID as an outpatient in November 2021. Treated with monoclonal antibody infusion. Presented to facility on  12/27/21 and admitted. After discharge, she was readmitted on 1/7 to other facility for 24 hours. Presented back to facility on 1/24 with significant respiratory distress, admitted and discharged on 2/1/22. Since discharge on 2/1/22, patient continued to have shortness of breath on 2-3L of oxygen. Re-admitted to facility on 2/8/22.
After the vaccination I had the typical chills, fatigue, and body aches . I felt like I had the flu. They were moderate and lasted a few days. I was still able to work though. I felt chills and body aches intermittently after that.  I took my Stelara shot after that 3/15/2021 and it felt exactly like when I had the COVID vaccine. I had some side effects from Stelara prior to the vaccine but nothing like the chills and body aches. And they were severe this time. Shaking chills to the point I had to stay in bed, painful goosebumps, diarrhea after eating. I'm wearing long sleeve hoodies in 90-110+ degree weather right now. My doctor ended up switching to Tremfya thinking it was the Stelara and it still happened. Just like after I received my COVID vaccine. I spoke with my pain specialist about this and she reported that several other patient had reported similar side effects post COVID vaccine. There is no way for me to know if this is from the vaccine or not. However, I have never felt this sick before  and its not resolving. It will come and go and intensity will change, but it never resolves. Intermittently I have my fingers and toes turn purple and it is painful and they also itch since right after the vaccine. Not like an allergic reaction though . My doctor has mentioned that I may have Raynaud's disease.
6:30 PM - itchy right eye - Benadryl was administered 7:15 PM  - nose bleedson nostril where the vaccine was sprayed
24h post injection pt had a nodule distal to the injection site (rt injection arm) it was larger than a quarter, warm to touch and painful, pt stated that it started as some bruising the evening of the injecton and that formed the following day. i discussed with the pt and aske if they had a temp, pt denied. I told the pt to follow-up with primary care dr. recommended, pt said they will
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) three days after vaccination reporting rash and pruritis on the leg and palpiatations starting two days after vaccination. Vital signs within normal ranges. Prescribed diphenhydramine and recommended home managment. Discahrged stable.
Client c/o vomiting 2 days after shot. On 11-15-01, symptoms resolved. Client felt vomiting was not associated with vaccine.
MOUTH ITCHY IMMEDIATLY AFTER THE VACCINE, ALSO WAS A LITTLE DIZZY. WENT AWAY WITH BENADRYL 30 MIN LATER, HOWEVER AT AROUND 1000 I STARTED COUGHING AND COULD NOT STOP. BECAME DIAPHORETIC. USED MY OWN EPI PEN AND THEN WAS TRANSPORTED TO ER AND MONITORED FOR ADDITIONAL 3 HOURS.
Shingles/suspected vaccination failure; SHINGLES; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's comment: This case was reported by a consumer via  interactive digital media. The reporter's husband and reporter had the shots and reporter's husband still got the shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
3 inch by 2 inch red raised itchy rash to injection site, last 2 days and improved.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 49 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: Jan2019; BUPROPION, start date: Jan2014. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Negative, notes: My symptoms started on 20Jul2022, although I tested negative (home test) that day; (20Jul2022) Positive, notes: My symptoms started on 20Jul2022, although I tested negative (home test) that day and positive (strong red line) the following day; (27Jul2022) Positive, notes: On the 27th I tested positive (faint line) with a home test; (28Jul2022) Negative, notes: On the 28th I tested negative with a home test; (31Jul2022) Positive, notes: On the morning of the 31st I definitely felt worse and tested strongly positive on a home test; (28Jul2022) Positive, notes: On the 28th I tested negative with a home test but also tested positive with a lab PCR test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course includes, adverse event: Patient's symptoms started on 20Jul2022, although patient tested negative (home test) that day and positive (strong red line) the following day; started a 5 day course of Paxlovid that Evening. Patient's symptoms had mostly subsided before the end of treatment (last dose was the morning of 26Jul). On the 27th I tested positive (faint line) with a home test; on 28th I tested negative with a home test but also tested positive with a lab PCR test. On the 30th patient was concerned symptoms were returning, on the morning of the 31st patient felt worsened and tested strongly positive on a home test. The illness has been milder than the initial illness to date.  No follow-up attempts are possible. No further information is expected.
body aches; shivers; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), CHILLS (shivers) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced PAIN (body aches), CHILLS (shivers) and PYREXIA (fever). At the time of the report, PAIN (body aches), CHILLS (shivers) and PYREXIA (fever) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient's other vaccination details included two doses of Jansen, in which First Primary Janssen dose was taken on 17-Mar-2021 and 2nd Primary Janssen dose was taken on   28-Oct-2021. Other Moderna covid-19 vaccination details were as follows: patient received third dose of as first Monovalent Booster dose on 17-Jun-2022 with batch number 058A22A, fourth dose as Bivalent Booster dose on 16-Oct-2022, fifth dose as Bivalent Booster on 27-May-2023. Patient's husband received Spikevax vaccination at the same time.  Patient's arm was reported as fine. Patient had satisfaction with Moderna vaccination in the past.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742491 (E2B Linked Report). This case was linked to MOD-2023-742557, MOD-2023-742579 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742491:Husband's master Case
Soft ball sized bump at injection site; Injection site soreness; Injection site warm and red; Injection site warm and red; sneezing; Itchy and sore throat; Itchy and sore throat; Sinus issues; Arm soreness in joints on right side; nausea; mild headache; A spontaneous report (United States) was received from a consumer concerning a 67-years- female patient, received Moderna's COVID-19 vaccine (mRNA-1273 and experienced a soft ball size bump/ injection site irritation, injection site that is sore, red and warm, sneezing, itchy and sore throat, sinus issues, arm was sore in joints on the right side/ myalgia, nausea, mild headaches.   The patient's medical history included the patient has  had sickle cell traits since 17 years of age. No relevant concomitant medication were reported  On 11 feb 2021, the patient received their first planned dose of mRNA-1273 (Lot number: 024M20A) intramuscularly in right upper arm  for prophylaxis of COVID-19 infection.   On 11 feb 2021,prior to receiving  mRNA-1273  the patient experienced a soft ball size bump/ injection site irritation, injection site that is sore, red and warm, sneezing, itchy and sore throat, sinus issues, arm was sore in joints on the right side/ myalgia, nausea, mild headaches.the patient felt like she's coming down with a cold.The patient did not receive any treatment  Action taken with mRNA-1273 in response to the event was unknown    Outcome of the events,a soft ball size bump/ injection site irritation, injection site that is sore, red and warm, sneezing, itchy and sore throat, sinus issues, arm was sore in joints on the right side/ myalgia, nausea, mild headaches were unknown.
Swollen erythemic, warm cellulitis L leg secondary to Tripedia. Gave Benadryl, course of antibiotics.