chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a hot red swelling at first the size of my cupped palm at vac. site- spread down my arm by 10:00 that night to elbow with the border going straight across my forearm an inch above the fold- very swollen and tight like a lobsters big claw-hurt alot and had very little mobility- by today (2 days later) swelling subsiding some-still red and swollen but can move again
About 4 days post vaccinations small streak about 1" on (L) thigh - this area darkened & enlarged. Seen while traveling for what was diagnosed as cellulitis & 7 day course of antibiotics was ordered on 3/21/11. Site is improving today. Child is not otherwise ill.
Swellness of lymph nodes in armpit, tightness in chest, pain in left leg, left shoulder, left side of neck
hive reaction, no fever, no SOB;tx w/DPH & resolving;onset rash 2hr p/vax;
Have Rheumatoid arthritis,  and has been under control, but 3 days after vaccine,  right wrist became swollen and very painful.  Day 4 right wrist was causing excruciating pain and could not be use without major pain. Rheumatologists prescribed prednisone.
Received oral vaccine for Rotavirus only that day. Had a full physical checkup that morning at doctor for 5 month well check. Everything was perfect, he was acting completely normal. Two hours after vaccine was administered our child started showing symptoms. Crying and excessive fussiness but more markedly was starting to appear very lethargic. No eye contact at all for almost 12 hours. Eyes rolling in back of head, not able to focus on our voice or face. Groaning in and out of sleep over and over. Like this for hours. Looked severely ill. Had to end up taking him to the ER bc we believed his life was in danger.
bruise to her back; rash on back of neck/rash all over her body; redness; swollen area back of neck/ swollen area to her back; a lot itchier; This is a spontaneous report from a contactable Nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via intramuscular on left deltoid on 21Jan2021 at 14:00 at single dose to prevent Covid 19. The relevant medical history included obese from an unspecified date. Concomitant medications were reported as none. The patient experienced rash on back of neck/rash all over her body on 26Jan2021 at 19:30, swollen area back of neck/ swollen area to her back on 26Jan2021 at 10:00, redness on 26Jan2021 at 19:30, bruise to her back on 27Jan2021 at 10:00, a lot itchier in Jan2021. The nurse stated that she wanted to report that she had the Pfizer vaccine last Thursday. Stated that two days prior to the report that a rash started on the back of her neck and stated yesterday it was a lot itchier (as reported). Stated that she got undressed to put her PJs on and noticed that she had a fine raised rash everywhere and it was swollen. Stated that she went through her house to see if there was anything that could have caused it. Stated that she went to that doctor at the time of the report and was started on Prednisone taper. Stated that the doctor was concerned about the Prednisone reducing her ability to prevent antibodies. Stated that the doctor stated that he was unsure if she should get the second dose. Caller wanted to ask questions about these things. Had not started the Prednisone yet. Stated that there was redness to the back of her neck and back. Stated that the swelling was to the back of her neck and back. The events did not require a visit to Emergency Room but required a visit to Physician Office. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The event bruise to her back was reported as non-serious, while the events rash on back of neck/rash all over her body, swollen area back of neck/ swollen area to her back and redness were reported as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "rash on back of neck/rash all over her body", "swollen area back of neck/ swollen area to her back and redness" and the administration of the COVID-19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Developed motion sickness, with nausea, and vomiting, after first vaccine; Developed motion sickness, with nausea, and vomiting, after first vaccine; Developed motion sickness, with nausea, and vomiting, after first vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 8 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: FTHRSASK5127, Expiration Date: 10Jan2022) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MOTION SICKNESS (non-serious), VOMITING (non-serious), NAUSEA (non-serious) all with onset 14Nov2021, outcome "not recovered" and all described as "Developed motion sickness, with nausea, and vomiting, after first vaccine". The event "developed motion sickness, with nausea, and vomiting, after first vaccine", "developed motion sickness, with nausea, and vomiting, after first vaccine" and "developed motion sickness, with nausea, and vomiting, after first vaccine" was evaluated at the physician office visit.  Additional information: Children go on one long car ride a week and it happened on 14Nov2021, 21Nov2021, and 28Nov2021. No additional vaccines were administered on same date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks), patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).  The reporter considered "developed motion sickness, with nausea, and vomiting, after first vaccine" not related to bnt162b2.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events motion sickness,  nausea,  vomiting and the administration of the vaccine cannot be excluded.
Fever, leg weakness, leg bruising and some of the veins got hard. Leg weakness. Still have some bruises and sometimes my legs feel weak. Fever was temporary.
Migraine; Abdominal discomfort; aversion; nasal congestion; pain; parosmia; photopsia; arthralgia; pyrexia; This case was received via VAERS (Reference number: 1093397) on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Migraine), ABDOMINAL DISCOMFORT (Abdominal discomfort), AVERSION (aversion), NASAL CONGESTION (nasal congestion) and PAIN (pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included UTI (UTI 4 days before.). Concomitant products included CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MIGRAINE (Migraine), ABDOMINAL DISCOMFORT (Abdominal discomfort), AVERSION (aversion), NASAL CONGESTION (nasal congestion), PAIN (pain), PAROSMIA (parosmia), PHOTOPSIA (photopsia), ARTHRALGIA (arthralgia) and PYREXIA (pyrexia). At the time of the report, MIGRAINE (Migraine), ABDOMINAL DISCOMFORT (Abdominal discomfort), AVERSION (aversion), NASAL CONGESTION (nasal congestion), PAIN (pain), PAROSMIA (parosmia), PHOTOPSIA (photopsia), ARTHRALGIA (arthralgia) and PYREXIA (pyrexia) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-155904 (Patient Link).
Information has been received from a registered nurse concerning a female infant who was vaccinated with Rotateq. Subsequently five days after vaccination, the patient experienced ten to twelve episodes of diarrhea in a day. Subsequently, the patient recovered. The same this happened after the second dose. The patient sought unspecified medical attention. Additional information has been requested.
Most of the toes have developed the "COVID toes"/chilblains reaction within a week of receiving the vaccine.; Reddened areas on toes that are very sore and sensitive to any pressure.; There are reddened areas on toes that are very sore and sensitive to any pressure.; Most of the toes have developed the "COVID toes"/chilblains reaction within a week of receiving the vaccine.; Sensitive to any pressure; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 13:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included chilblains. The patient did not have any allergies to medications, food or other products. 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 included multivitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 17Apr2021, the patient experienced most of the toes had developed the "COVID toes"/chilblains reaction within a week of receiving the vaccine. It was reported that patient had a chronic chilblains-like condition (no diagnosis was done, not sure what type of doctor to consult to figure it out, just based on symptoms) that had not flared for over a year, so the patient thought there was a connection. The reaction in the toes was the exact same as what would happen when her "regular chilblains" flared up. There were reddened areas on toes that were very sore and sensitive to any pressure. No itching. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events most of the toes had developed the "COVID toes"/chilblains reaction within a week of receiving the vaccine, reddened areas on toes that were very sore and sensitive to any pressure were not resolved at the time of this report.    No follow-up attempts are needed; information about lot number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) negative, notes: after testing negative one day after completion; (19Jul2022) positive, notes: positive antigen test 6 days after completion of the course of antivirals. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication details: other medication in 2weeks product Birth control, Other medication in 2weeks marlissa, other medication in 2weeks, start date 01Jun2022, other medication in 2weeks stop date 20Jul2022. Recurrence of original symptoms and positive antigen test 6 days after completion of the course of antivirals after testing negative one day after completion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortness of breath; Tightness in chest; Soreness in arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Sep-2021 and was forwarded to Moderna on 05-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tightness in chest) and MYALGIA (Soreness in arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 031A21A and 939902) for COVID-19 vaccination.     Concomitant products included FINASTERIDE, ALFUZOSIN and ALLOPURINOL for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tightness in chest) and MYALGIA (Soreness in arm). At the time of the report, DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tightness in chest) and MYALGIA (Soreness in arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED -----------------------------------------------------------------------------------------------------------------------------  CARDIOGENIC SHOCK 11/18/2021 AORTIC VALVE STENOSIS  CARDIOGENIC SHOCK 11/18/2021 ATRIAL FIBRILLATION, PERSISTENT  CARDIOGENIC SHOCK 11/18/2021 HX OF MITRAL VALVE REPLACEMENT    SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC  CARDIOGENIC SHOCK 11/18/2021 PRESENCE OF CARDIAC PACEMAKER  CARDIOGENIC SHOCK 11/18/2021 AORTIC VALVE STENOSIS  CARDIOGENIC SHOCK 11/18/2021 AORTIC VALVE STENOSIS  CARDIOGENIC SHOCK 11/18/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  CARDIOGENIC SHOCK 11/18/2021 SYSTOLIC HEART FAILURE, UNSPECIFIED ACUITY  CARDIOGENIC SHOCK 11/18/2021 ATRIAL FIBRILLATION, PERSISTENT  CARDIOGENIC SHOCK 11/18/2021 CARDIOGENIC SHOCK
Patient has had severe shoulder pain since the injection occured (almost a week ago). Patient is having trouble moving arm and is having a lot of pain. Was seen by a provider at clinic and is receiving medications (prednisone taper, tylenol #3, augmentin)  to help with pain and inflammation.
Fatigue; arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration on 06Apr2021 (at the age of 22-year-old), as dose number unknown, single for COVID-19 immunisation. Medical history included asthma started on an unknown date. The patient didn't have any known allergies. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) and budesonide; formoterol fumarate (SYMBICORT) both for an unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient experienced fatigue and arm soreness. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event fatigue and arm soreness was recovering.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amendment of narrative data as "known_allergies: No" provided and Final sentence was updated.
bruises in arm of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruises in arm of vaccination) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruises in arm of vaccination). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CONTUSION (bruises in arm of vaccination) 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.   No concomitant medication details was reported.
Frequent diarrhea for 4 days; emesis twice; fever up to 103.5 for four days; crankiness with poor appetite; rash on leg and cheeks.
On 12/14/99, the pt developed chickenpox. It was reported that as of 12/14/99 there were approximately 5 lesions. The pt also had a fever of 100.4. There were seven vesicular lesions on the pt's chest, one on the left thigh, and two on the abdominal area.
The vaccine vial was in the refrigerator for more than the 10 week period.  No adverse reactions reported.
(L) arm with edema & redness; warmth at site of immunizations given 04/30/12. (Area app. 4 x 3 cm). Pt. also c/o H.A.'s. TX = monitor s/s & any increase in size; call if worsens. (Seen in office 05/01/12 for s/s).
Patient received both pneumonia and flu shot. She fainted at stores. Vital signs stable. Patient also said pain at injection site that tingle down back. Patient admitted to not eating much that day and had previous problems with hypoglycemia.  Follow up on 10/18/04 states: "Problem at Pneumovax site."
Seen 5/17/01 - c/o temp 103, (teething) drooling, no vomiting good activity - sick 4 nights prior, seen 5/13. Motrin - stops temp then return when went off. PE: was ?, (B) jaw tender
Patient cam to office to have 2nd dose of pfizer Monovalent covid vaccine for 5-11 yr. Patient was administered covid bivalent  for 5-11 yrs.
PATIENT GOT DIZZY AND FELL THE NIGHT FOLLOWING THE VACCINATION AT ABOUT 11PM. SHE WAS UNABLE TO GET UP,  THE NEXT DAY (SUNDAY) EMERGENCY WAS CALLED AT 4PM, AND SHE WAS TAKEN TO THE HOSPITAL WHERE SHE STAYED FOR 2 DAYS, AND WENT TO A REHABILITATION FACILITY AFTERWARDS FOR SEVERAL MORE DAYS
Intense vomiting the following morning beginning at 9 am for approximately 2 hours. Similar to food poisoning, but all breakfast food eaten was well with sell by date, plus had eaten them during the week before. After this, minor sore throat and sniffles for 2 more days.
Around 12 hrs after my vaccine, I got chills, muscle pain, a couple muscle spasms. The morning after, exhaustion & headaches.
patient received vaccine at 1:55 pm, at 2pm husband informed us she was having a reaction, the pharmacist and myself when outside to evaluate the patient, after noticing the patient was having trouble breathing feeling tightness and itchiness in the throat, tongue was swelling and was having palpitations so I administered the epi pen on the right thigh. By 2:05 patient was fully able to breath and started feeling better.
Within 15 minutes the right side of my face became itchy.  My tongue also felt a weird sensation.  By 12:30 am that night my chest became itchy and I had red bumps on my chest, then around 2 pm the next day my stomach began to get itchy and red with a red bump.
Patient also received a 2nd dose of Jynneos on 9/7/22. Symptoms of Monkeypox started on 11/8 and he was tested on 11/10 with a result of +Monkeypox.
heat coming off of the area the vaccine was administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat coming off of the area the vaccine was administered) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (heat coming off of the area the vaccine was administered). At the time of the report, VACCINATION SITE WARMTH (heat coming off of the area the vaccine was administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Within several hours after receiving injection, patient began feeling disoriented, confused and experiencing diarrhea.  Patient does not recall the events - was told so by her husband.  Resolved on it own.
2nd shot- severe headache, fever, body aches, right arm pain and swelling.   Back ache around shoulders and neck. Lasted 2 days so far.
This spontaneous report has been received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # reported as M344370, expiration date 13-FEB-2019; doses, routes of administration, and frequencies were not reported) for prophylaxis. The vaccines were exposed to a temperature excursion range from 47°F to 77°F for a total time frame of 30 minutes. There were no previous temperature excursion or data logger involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008587: US-009507513-1704USA009553:
We were both sick the whole winter.; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, 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 Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:  This case reported by patient herself (wife). The age at vaccination was not reported. The patient received flu shot and experienced sick (whole winter). This case had been linked to the case US2020AMR202143 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202143:Same reporter