chrisvoncsefalvay/vaers-outcomes huggingface dataset:
So about four days after my vaccine, I had an increase of migraines headache. They have been getting worse since taking the vaccines. I had migraines before the vaccine, maybe one a month and now I had about 20 or more a month. My doctor has been trying a lot of different preventive meds and nothing seems to help. It changed my periods, it has increase them a lot. I bleed heavier and stay on more days. Extreme fatigue, nausea and in general I don't feel the same since taking any of the vaccines. I have a lot swelling and information throughout my body. The doctors still don't know why. That are still running test on me.
rec'd Tdap 4/26/19    reported 5/2/19 that increased pain, bruising and spasm left arm,  was seen in the ED and place off work one day and light duty 2 - 3 days
Exactly 12 hours after injection, sever body aches, chills, sleeplessness
Patient reported a fever of 103 F, and she also reported a welt the size of 8 inches round.  She was advised to take tylenol or ibuprofen for the fever, to ice the arm, and to take some benadryl.
Information has been received from a physician concerning a 12 month old male patient with no pertinent medical history and no drug reactions or allergies who on 21-FEB-2011, was vaccinated SQ with 0.5 ml dose of MMR II (lot# 666250/1070Z). There was no concomitant medication. It was reported that on 26-FEB-2011, the patient developed a rash on his hands and feet. The patient was examined in the office on 01-MAR-2011 and was found to have a diffuse maculo-papular rash. There were no lab diagnostics studies performed. At the time of the report, the patient had not recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 666250/1070Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a 4 year old male who was vaccinated with a dose of varicella virus vaccine live (date not reported). The reporter stated the patient has experienced 2 break through case of chicken pox. It was noted the cases were considered mild. It was noted that there were no details provided on the cases. Unspecified medical attention was sought. Additional information has been requested.
tested positive for Covid; This is a spontaneous report from a sponsored program. A contactable nurse reported that a patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The nurse reported, the patient had first vaccine a week and a half ago and then they tested positive for Covid. Now, took another test and are now negative for Covid, but are also without antibodies. The outcome of event was resolved.  Information on the Batch/Lot number has been requested.
Swollen right upper lip, left arm elbow down to finger tips. right index finger and  palm of hand.
light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=ELC142) via intramuscular on 13Jan2021 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. Medical history included allergies: Reactive airway to chemicals/perfumes/smoke. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), calcium, fish oil, echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (lot number=EJ1685) via intramuscular on 23Dec2020 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. No other vaccine in four weeks.  On 13Jan2021, the patient had a headache in the evening and took Ibuprofen before bed. She woke up about 3:30 AM 14Jan2021 to use the bathroom and had vertigo. She carefully maneuvered to the bathroom and back to the bedroom, drank some Powerade and sat on the bed for a bit before she slowly laid back down. She did feel flushed while experiencing the vertigo. She was able to get back to sleep for a few more hours. When she got up about 7:15 am she felt light headed but did not have any more vertigo. Treatment for event headache included Ibuprofen, no treatment received for other events. Patient did not have COVID prior vaccination, did not test COVID post vaccination, patient was not pregnant. The outcome of events was recovered.
Patient with 2 doses of COVID vaccine, last dose 03/21/21 who admitted through ED for chest/back pain. Not hypoxic during her stay, has pancreatic cancer with metastasis. Discharged from hospital with hospice due to cancer progression and died on 12/19/2021. Provider discharge note (from hospital) below: "Reason for Admission: Patient came in the the emergency department by EMS stating she has unbearable back and chest pain for "a couple weeks". Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)- These were her acute medical issue addressed this hospitalization: Chest pain--probably from COVID pneumonia. EKG looked OK. Pneumonia due to COVID-19 virus, mild disease, diagnosed 12/3. NOT hypoxic. Pancreatic tumor with METS to Liver, SMA, spleen, this is significant, and likely the cause of her symptoms. CA 19-9 was WNL. Very poor performance status at this time. Oncology seen on 12/13. Dr. recommends a Hospice approach only at this time. Her daughters have agreed to a Hospice care approach as recommended. Papers signed with Hospice 12/13/21. Type 2 diabetes mellitus, without long-term current use of insulin. A1c was 6.5, Acute low back pain--resolved, Leukocytosis-- No clinical infection apparent. May be from malignancy. Severe protein-calorie malnutrition (*)- encourage PO. Chronic bilateral low back pain with left-sided sciatica. Anxiety, Gout, Chronic kidney disease (CKD), stage III (moderate), Nausea vomiting and diarrhea - resolved. Elevated troponin, Normocytic anemia, 5 mm nodule apical right upper lobe. Remained very weak and debilitated. Very high risk for DVT given COVID and likely Pancreatic CA. DC today with "Hospice Care".
Moderna vaccine was administered - reported by patient  I95.89 CHRONIC HYPOTENSION 8/16/2021 HYDROPNEUMOTHORAX J96.00 ACUTE RESPIRATORY FAILURE 8/18/2021 HYDROPNEUMOTHORAX I95.89 CHRONIC HYPOTENSION 8/16/2021 ATRIAL FLUTTER, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 8/18/2021 ATRIAL FLUTTER, UNSPECIFIED I95.89 CHRONIC HYPOTENSION 8/16/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION J96.00 ACUTE RESPIRATORY FAILURE 8/18/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION
sore red enlarging round raided spot on my arm; sore red enlarging round raided spot on my arm; sore red enlarging round raided spot on my arm; horrid fatigue; I napped and napped again and turned in at 6 pm and slept until 6 am; felt flushed off and on; This non-serious case was reported by a consumer and described the occurrence of localized erythema in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Shingles vaccine (only vaccine patient have ever had a reaction to were the shingles where it was a horrid arm experience).   On 20-OCT-2023, the patient received Arexvy. In OCT-2023, 24 hrs after receiving Arexvy, the patient experienced fatigue (Verbatim: horrid fatigue), sleep excessive (Verbatim: I napped and napped again and turned in at 6 pm and slept until 6 am) and feeling abnormal (Verbatim: felt flushed off and on). On 21-OCT-2023, the patient experienced localized erythema (Verbatim: sore red enlarging round raided spot on my arm), pain localized (Verbatim: sore red enlarging round raided spot on my arm) and local swelling (Verbatim: sore red enlarging round raided spot on my arm). In OCT-2023, the outcome of the fatigue, sleep excessive and feeling abnormal were resolved (duration 48 hrs). The outcome of the localized erythema, pain localized and local swelling were resolved (duration 48 hrs).   It was unknown if the reporter considered the localized erythema, pain localized, local swelling, fatigue, sleep excessive and feeling abnormal to be related to Arexvy.     It was unknown if the company considered the localized erythema, pain localized, local swelling, fatigue, sleep excessive and feeling abnormal to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2023 The patient self-reported this case. The patient wanted to report that the day after he/she had the RSV (Arexvy vaccine) he/she developed a huge sore red enlarging round raided spot on his/her arm. Also, about 24 hours after patient had such horrid fatigue and he/she napped and napped again and turned in at 6 pm and slept until 6 am. The patient felt flushed off and on. Less than a week after receiving Arexvy, the patient experienced feeling abnormal. About 48 hours after the vaccine patient felt more back to normal in Oct-2023. The follow-up could not be possible as no contact details were available.
5 hrs post vax thumb & middle finger became swollen lt hand, Seen in ER, Dr in hosp indicated the nerve was probably injured therefore swelling occurred
11JUN91 fever 104-102 x 2 days; fever 101 lasted 5-6 more days p/rash appeared 3 wks on entire body; seen by MD tx APAP;
DEATH; This spontaneous report received from a parent concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, after receiving the vaccine the patient died from an unknown cause of death and it was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0.20220326240-covid-19 vaccine ad26.cov2.s -Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient came into clinic 1.5 weeks later with a painful rash on arm. Has severe pain in R arm two days prior to 12/4/20 visit. Upon evaluation by Dr. it was diagnosed as Shingles. A 7 day course of Valacyclovir was prescribed to treat.
Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tingling in r hand, dizziness and chills throughout the day  They would come and go.  Late afternoon, Biceps went into spasms all fingers aching.  After nap at 06:00 woke up and all symptoms gone.  On 01/10/2021, woke up with tingling and burning from bilateral knees to toes.  Lasted 2 hours and then gone.  In afternoon 1 episode of dizziness and hot flashes followed by chills.  01/11/2021  Slight headaches. No bodyaches or other symptoms.
14 year old female patient accompanied by her mother. Patient reports swelling on injections site arm. At the moment of evaluating patient she appears calm, breathing without difficulty. No observation or palpable edema on extremities, no redness. Reports mild discomfort when touching injection site. Cold compresses intermittently placed. She is kept in observation for 30 minutes. Vital signs BP 140/90 P 107 R18 Sat 98%.
LEFT ARM SWELLING AND TIGHTNESS, RED RASH ON INNER ARM LEFT ARM (VAC ADMINISTRATION ARM).
IgA Nephropathy; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (IgA Nephropathy) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IGA NEPHROPATHY (IgA Nephropathy) (seriousness criterion medically significant). At the time of the report, IGA NEPHROPATHY (IgA Nephropathy) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: proven glomerular disease Proven glomerular disease in patients recently vaccinated against SARS-CoV-2..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IGA NEPHROPATHY (IgA Nephropathy) to be related.    No concomitant medication reported. No treatment medication reported. 28 patients were reported of de novo GN within native kidney biopsies and one disease flare in an allograft.  Company comment This literature-non-study case concerns a 57-year-old male patient with no medical history reported, who experienced the serious, due to medically significant, unexpected event of IgA Nephropathy, which occurred on an unknown date after the 2nd dose of mRNA-1273 vaccine. Biopsy: proven glomerular disease in patients recently vaccinated against SARS-CoV-2. No further information regarding the clinical course and treatment of the events were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-539890, MOD-2022-539891, MOD-2022-539892, MOD-2022-539893, MOD-2022-539894, MOD-2022-539895, MOD-2022-539885, MOD-2022-539897, MOD-2022-539898, MOD-2022-539899, MOD-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539903 (Patient Link).; Sender's Comments: This literature-non-study case concerns a 57-year-old male patient with no medical history reported, who experienced the serious, due to medically significant, unexpected event of IgA Nephropathy, which occurred on an unknown date after the 2nd dose of mRNA-1273 vaccine. Biopsy: proven glomerular disease in patients recently vaccinated against SARS-CoV-2. No further information regarding the clinical course and treatment of the events were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Left leg on the thigh there are pinpoint blue/red rash all over. It?s localized to mainly the thigh but there is some spots below the knee.
This case was reported by a pharmacist and described the occurrence of influenza in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In 2013, "over the last 30 days," the subjects received a dose of FLUARIX (unknown details). In 2013, "over the last 30 days," less than one month after vaccination with FLUARIX, the subjects experienced influenza. The pharmacist reported that "several" subjects "who were vaccinated with FLUARIX over the last 30 days (different days) came down with flu." At the time of reporting the outcome of the event was unspecified.
I received a regular flu shot in my left arm on Monday at 4 pm on Tuesday at 2pm I felt extremely dizzy and saw white lights feeling like I was going to faint. Took my blood pressure it was extremely low lol 97/63, this feeling lasted about 45 minutes. After 45 minutes I felt better and my B/P returned to normal. This has never happened to me before after taking a flu shot.
Patient stated that after receiving the PREVNAR 13 vaccination the next day her arm swelled up, she developed a rash within a week and the area turned blue, started healing and then her skin started peeling and her skin around the area was very dry and continued to peel.
Myalgia, Fever, Soreness in right arm; Pain in right axilla Narrative:
pt states about a week after 1st covid vax she would feel a tweaking pain underneath the right breast.  This happened a couple of times a week.  She then took her 2nd covid vax on 7/26/21 LOT # 078C21A.  After that she developed a mass on the bottom of the right breast like a bloody boil.  It burst and bled.   She went to a Midwife for this and was prescribed antibiotics and referred to Dr.  She had a mammogram and US in October 21, 2021.  She was told to come back for a FU check up another mammogram.  She went for a covid booster shot on 1/27/2022 LOT# 0165212A.  A few days after this she developed another mass on the bottom of her right breast.  It burst and bled like the first mass. She saw Dr. in Feb 2022 and was prescribed more antibiotics.  These two spots began morphing into two little lumps.  It turned into a raging infection.  She went back to Dr. in Sept 22.  She let him know she thought it was related to the vaccine since this started the week after 1st vaccine.  She was issued more antibiotics and will FU w/ him on 10/13/22.  She still has lumps and they are bloody w/ puss at this time. The only time she ever bled from her breast was one week after 1st Covid vax.  She feels like it is a permanent reoccurring problem for her.
Nausea, fever, chills, sore arm, headache. There was some swelling in my throat about an hour after the shot but that did go away.
130PM 19NOV93 felt warm, fussy, t101; t105 @ 8PM sz @ 630PM lasting 20 mins eyes rolled back, jerking of head;
p/vax rt deltoid arm had red area w/a little puffiness surrounding it;did not require MD office visit;
Patient complained of dizziness and said she was going to pass out. Observation nurse called site clinical lead over, at that time the patient was  responding to verbal cues. Mask was taken down and she was guided to  take slow deep breaths, continued to report feeling as though she was going to pass out. Site clinical lead then noted patient with fixed gaze to the size, clenching hands and rigid posture. Observation nurse called for EMS assistance. Patient breathing slowed, mouth open, eyes remain fixed to the size with rigid posture for 5-10 seconds. Patient did not respond to any verbal cues. Site clinical lead and observation nurse  lowered patient to the floor, at which point patient became responsive. Responded correctly to reason for visit to site, location and how she was feeling. Denied history of seizures or stroke. Reported feeling anxious and needing to use the bathroom. Did not appear to lose bowel control at any point.  Patient was very diaphoretic and pale, but alert overall. Cold compresses applied to forehead and back of neck while patient remained supine. EMS arrived and had patient sit up, at which point she again became very pale and reported feeling as through she was going to pass out. EMS transported to hospital for further evaluation.
Based on telephone conversation with child's mother: Swelling and redness at site of injection. 28 hr after injection 09/23/2002.
COVID vaccine breakthrough event. Patient was vaccinated Moderna on 1/4/21  026L20A, 2/1/21 029L20A, and boosted on 11/12/21 033F (this is the incomplete lot number that the database shows.)
small mark from the needle; small mark from the needle and after 3 days it increased in size to smaller than a dime, was very itchy, and was beet red; small mark from the needle and after 3 days it increased in size to smaller than a dime, was very itchy, and was beet red; she still has hyperpigmentation from it; This is a spontaneous report from a contactable nurse (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number was not reported), via an unspecified route of administration in Feb2021 as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported that she had a small mark from the needle and after three days it increased in size to smaller than a dime, was very itchy, and was beet red. She took Benadryl and applied hydrocortisone cream on it and the symptoms resolved later that day. She mentioned that she still had hyperpigmentation from it. Outcome of the event hyperpigmentation was not recovered, while the remaining events recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number could not be requested. No further information is expected.
generalized itching; feeling of tightness of throat; shortness of breath; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (generalized itching), THROAT TIGHTNESS (feeling of tightness of throat) and DYSPNOEA (shortness of breath) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FEXOFENADINE, ALPRAZOLAM, CARVEDILOL, VITAMIN B12 (CYANOCOBALAMIN AND ANALOGUES), Esterase, THIOPHENE and USTELL for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PRURITUS (generalized itching), THROAT TIGHTNESS (feeling of tightness of throat) and DYSPNOEA (shortness of breath). On 15-Feb-2021, THROAT TIGHTNESS (feeling of tightness of throat) and DYSPNOEA (shortness of breath) had resolved. At the time of the report, PRURITUS (generalized itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous report as received from a registered nurse refers to an approximately 21 year old female patient. The patients concomitant medications were none. The patient had no pertinent medical history or drug reactions or allergies. On an unknown date in 2011, the patient was vaccinated with a second dose of VARIVAX (Merck) (lot number, expiry date, and route was not reported). On an unknown date in 2011, the patient developed a varicella like syndrome with rash. She stated that it was like chicken pox. She stated it may have been reported at that time. The outcome of varicella like syndrome with rash is recovered. The patient sought medical attention. Additional information has been requested.
This a 28 year old male who developed bloody diarrhea three (3) to seven (7) days after receipt of multiple vaccinations. He received Yellow Fever vaccine on 10/16/2002 and Hepatitis A and IPV on 10/21/2002. He denies any prior history of hemochezia, chronic diarrhea or other gastrointestinal symptoms. He subsequently underwent colonoscopy which revealed multiple colonic perforations in the left colon and splenic flexure. He underwent a subtotal colectomy with ileostomy on 12/19/2002. The pathology results are listed in the diagnostic test section of this summary. He progressed well over the course of the following 18-months. He had a Ileoanal J-pouch procedure with loop ileostomy, 07/06/2004 and subsequent Proctectomy and Ileoanal J-Pouch procedure. He has been cleared to return to full duty without restriction. However, he is concerned about receiving and future immunizations. He feels that the colitis was a result of him receiving multiple vaccinations in a short time period. The HC was consulted to investigate his concerns.
pt recv vax 6JAN98 & c/o itching on both arms;fine prickly red rash noted over both arms;no rash noted anywhere else on body;BP 150/100, P100;no c/o diff breathing;rash beginning to clear on both arms;
First dose of Moderna COVID-19 EUA.  about 3 days after first dose developed mild nausea, weakness, fatigue/mental fog, mild dizziness/feeling lightheaded, dry throat and mildly sore throat and ear (nasopharyngeal) Still feeling this way on day 4 (that is today the day I am reporting)