chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tiredness; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of fatigue (tiredness) and injection site pain (soreness at the injection site) in an 87-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 (no historical condition reported.). concomitant products included blood thinners, hydrochlorothiazide and atorvastatin calcium (atorvastatin an), blood thinner and acelol.   on 13-feb-2021, the patient received dose of mrna-1273 (Moderna covid-19 vaccine) of (batch no. 031l20a) by (unknown route) at an unspecified dose for prophylaxis of COVID-19 infection.  The action taken with mrna-1273 (Moderna covid-19 vaccine) (unknown) was unknown. No treatment medication was reported.  on 13-feb-2021, the patient experienced fatigue (tiredness) and injection site pain (soreness at the injection site). on 13-feb-2021, injection site pain (soreness at the injection site) had resolved. at the time of the report, fatigue (tiredness) outcome was unknown.
SEVERE REACTION TO PFIZER COVID VACCINE WITH ORAL MUCOSA AND GUM BLEEDING, HEMATOMA FORMATION IN THIGHS, SEVERE BONE PAIN, DIARRHEA STARTING 3 HOURS AFTER FIRST DOSE, NEEDS TO BE REPORTED TO CDC AND FDA.   She is here today because of a recent experience with her COVID vaccination. As stated 3 hours after the vaccine, the patient spontaneously developed significant bleeding in her oral mucosa all over the place and it is impacting to see the photographs that she has related to this. Subsequently she developed a large hematoma in the left thigh. The symptoms slowly subsided. She had diarrhea, fever and pain in her lower extremities. The diarrhea still persists until today. She has 1 large loose bowel movement a day with no passage of blood in the stool. No abdominal pain to speak of. It raises the question if the vaccine that was Pfizer vaccine, triggered an autoimmune condition or some other activation of coagulation that triggered the significant abnormal bleeding that she developed at that time. We know that patients with thrombocytosis can clot or can bleed and I think in this occasion she bled. She never has had an episode of thrombosis as far as we have recorded. Therefore, I think we need to check on all these issues including coagulation and she will require an analysis of PT, PTT, fibrinogen as well as platelet function studies.   copied from  dictation
Information has been received from a physician concerning a 14 month old female patient with cardiac disorder who on 07-APR-2009 was vaccinated with a first dose of ROTATEQ (Lot # not reported) 2ml, orally.  On 14-APR-2009 the patient experienced rotavirus.  The patient sought unspecified medical attention.  Test for Rotavirus was performed.  Additional information has been requested.
This case was received from a consumer on 22 May 2007. A consumer reported that "her friend's child died from a DPT shot". No additional information was provided.
This spontaneous report was received from a medical assistant and refers to a 4 month old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On 09-OCT-2018, the patient received inadvertently a dose of VARIVAX 0.5 ml once, intramuscular, lot # R007695, expiration date 14-MAR-2020, for prophylaxis. The reporter stated that the patient received this dose of VARIVAX several months earlier than indication of 12 months (drug administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent lot # N030721, expiration date 20-JUL-2020. No adverse effects were reported.
Sore left upper arm at injection site, pain when I lifted my arm above shoulder height-rubbed gently, took acetaminophen  twice. Symptoms greatly reduced 48 hours later. Headache, lower back pain, fatigue and fever.  The pain reliever helped with these symptoms. I also drank herbal tea with honey and rested or napped during the day.  I used a heating pad on my lower back to relieve the pain.  Other than a bit of a headache the next morning (11/8/2021) the symptoms were gone.  As of 4:20 pm 11/08/2021, I only have a bit of soreness in my left arm.
Vertigo & nausea/vomiting the first night after the shot, followed by 2 full days of frequent dizzy spells and muscle twinges/pain up and down right side of body (injection side). This is in addition to fever, chills, severe headache, light and sound sensitivity, injection site pain, and fatigue. We expected the fever/chills/nausea/fatigue but not the spinning vertigo and very frequent (hourly)  ongoing dizzy spells, which are much more concerning.
fever; sore arm in the location of the injection.; hoarse throat & raspyvoice; aches all over my body.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and suspected COVID-19 on 22Dec2020. The patient was non-allergic to medication, food or other products. Concomitant medications included Flovent diskus of 250 microgram (mcg) and albuterol (MANUFACTURER UNKNOWN) both for an unknown indication from an unknown date. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 20Mar2021 at 19:00, the patient experienced sore arm in the location of the injection, very sore/aches all over body and fever/aches had lasted approximately up to 36 hours. The patient experienced hoarse throat raspy voice, which patient had assumed due to it. The patient had not received any treatment for the events. On an 22Dec2020, the patient had tested for COVID-19 which resulted in positive and on 21Mar2021, the patient had tested for body temperature which resulted in 100.3-degree Fahrenheit. The 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 events. The clinical outcome of the events fever and general body pain were resolved with sequelae on 23Mar2021 at 07:00 whereas that of the events sore arm in the location of the injection, hoarse throat & raspy were resolved with sequelae on an unknown date.   No follow-up attempts are possible; No further information is expected.
Around 10 minutes after receiving vaccine, pt. c/o feeling flushed, hot and light headed.  Pt. assessed by staff.   BP: 100/68, HR: 68, RR: 16, O2 sats: 97%.  No other symptoms noted.  Pt. declines to go to emergency room.  Will follow up with PCP if needed.
BLOOD VESSEL IN THE RETINA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination.The batch number was not reported and has been requested.No concomitant medications were reported. On an unspecified date, the subject experienced blood vessel in the retina. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from blood vessel in the retina. This report was non-serious. This case, from the same reporter is linked to.
hearing loss (high frequencies)    tinnitus benign paroxysmal positional vertigo (BPPV)
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Insomnia, Injection site swelling and redness, Narrative: Received 1st dose 12/31/20 and within hours had quarter-sized raised, red itchy area at site of injection- which lasted 72 hours. Received 2nd dose 1/29/21 and within hours developed red, raised, itchy area at the injection site, but this time size of a baseball. At 2:00 am on 1/30/21 developed fever (up to 100.7), arthralgias, myalgias, nausea, headache, insomnia. Reports significant symptoms x 48 hours, with nausea, fatigue and headache persisting to 72 hours. No known prior COVID infection
I took a nap in the afternoon and woke up with a sore throat. I was out of town so I drove back. The sore throat worsened and I had a headache. I also had a runny nose so Friday morning I completed an at home COVID-19 Test and it  was positive. I called my doctors office. I took ibuprofen and antihistamine. I was prescribed Paxlovid. I started the first dose on Friday night. I have continued taking the medication and I have improved. I did have to stop taking 2 of my normal medications while taking the Paxlovid.
Adverse Event - Patient has a history of passing out, asthma and Anxiety. After she got vaccinated, patient was dizzy, so vaccination nurse lay the patient down on the floor. Patient was alert, oriented times 3.  Vital signs initiated at 2:40pm- BP 130/90, HR 105,  R 18, O2 sat 87%). Vital Signs were normal ) . vital signs normal at 2:55pm at with BP 130/80, HR 89, R 20, 02 sat 99 %.  Client vomited , was anxious and was not getting better. Client complained of chest pain. Nurse initiated to call 911
pt recv vax & lt leg turned red from the knee down to foot;no resp distress was noted;pt referred to ER for eval;
Lot of people who took 2nd shot have been sick for 3 and 4 days; 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 VACCINATION COMPLICATION (Lot of people who took 2nd shot have been sick for 3 and 4 days) in a  patient of an unknown age and gender 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 VACCINATION COMPLICATION (Lot of people who took 2nd shot have been sick for 3 and 4 days). At the time of the report, VACCINATION COMPLICATION (Lot of people who took 2nd shot have been sick for 3 and 4 days) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-348466 (Patient Link).
SHOT WAS GIVEN 2 DAYS AFTER THE BEYOND USE DATE. THE DEYOND USE DATE W 11/22/2022. WE HAVE CONTACTED PFIZER.
10 min after I received vaccine I got very nauseated, faint, etc. Came home and went right to bed with chills and became very tired. Next night got very bad pain in my chest for 4 hrs and have felt not great since.
VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; No adverse event; VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and PRODUCT TEMPERATURE EXCURSION ISSUE (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE).    Concomitant medication was not reported. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
This spontaneous report has been received from a Registered Nurse referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 03-AUG-2015, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # K010535, expiration date: 27-AUG-2016, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source. (MARRS number 1508USA003819, 1508USA005117, 1508USA005118, 1508USA005119, 1508USA005120, 1508USA005121, 1508USA005122, 1508USA005124, 1508USA005125). Additional information has been requested.
Initial report received from a non-health care professional on 25-Nov-2013. A male patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number, route, and site of vaccination were not reported), on an unspecified time. On an unspecified date, after receiving vaccine the patient experienced a real area at injection site that has been getting larger, more red, swollen and has a hard knot under the skin which is about the width of a half dollar coins. Corrective treatment was not reported. At the time of this report the outcome of adverse event was unknown. Documents held by sender: none.
Temp of 101.5F & screaming episode lasting 6 hrs; Also stopped breathing & turned gray;
Hives, Skin turned red, and face turned red in warm, over span of 1 hour from vaccination time. Starting to have Shortness of breath and chest felt tight prior to being transported to Emergency room.
Repetition of the second dose; second dose administered was not stored at a proper temperature; 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 PRODUCT STORAGE ERROR (second Dose administered is not stored at a proper temperature) and EXTRA DOSE ADMINISTERED (Repetition of the second dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ALLOPURINOL for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (second Dose administered is not stored at a proper temperature). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Repetition of the second dose). At the time of the report, PRODUCT STORAGE ERROR (second Dose administered is not stored at a proper temperature) and EXTRA DOSE ADMINISTERED (Repetition of the second dose) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient received dose #1 of Pfizer vaccine on 12/18/20 and dose #2 on 1/8/21. Lot #EH9899 for both. Patent reports that she received rituximab for RA about 1 week before testing positive for COVID-19 at testing site. Patient quarantined for 10 days; near end of that period, presented to outside hospital due to SOB. Patient was hospitalized for 5 days from 3/19-3/24/21. Discharged on dexamethasone and home oxygen.
Around 1:00 am on the 2/3/21 I got a fever and was shivering.   When I got up I was very weak and tired.   I started with a headache in the evening of 2/2/21
I was not feeling well my Thorat was killing me, my head was fuzzy, and I just felt sick. I took a COVID-19 Home Test the next day and it was positive. I called my health care provider, and they did get me on the antiviral. I did have diarrhea and I was just exhausted but the worst thing was my throat was hurting so badly.
minor pain at injection site for 48 hours following injection 12 hours following injection had minor pain in shoulders headache and general malaise 15 hours following injection approximately 20 hours following injection major body aches & chills & head ache, woke up with a fever of 102 F 24 hours following injection and fever subsided by 29 hours following injection Mild headache continued until 31 hours following injection and symptoms were gone by 36 hours following injection
Shingles; Neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient experienced neuropathy and shingles.  As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. In addition, the patient sustained severe and permanent personal injuries. The outcome of the events of neuropathy and shingles was considered as not recovered. The reporter considered the events to be related to zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the event of neuropathy was determined to be medically significant. The events of neuropathy and shingles were considered to be disabling.
dizziness; fever; horrible fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (dizziness), PYREXIA (fever) and FATIGUE (horrible fatigue) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059721A) for COVID-19 vaccination. No Medical History information was reported.  On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced DIZZINESS (dizziness), PYREXIA (fever) and FATIGUE (horrible fatigue). In August 2021, DIZZINESS (dizziness), PYREXIA (fever) and FATIGUE (horrible fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant treatment was reported. No treatment medications was reported   This case was linked to MOD-2021-324103
Reaction noted 2 days after 2nd Moderna vaccine, continuous Oxygen has been ordered ( patient has been seen several times for Sx: COPD exacerbation Fatigue Myalgia Hypoxia
My son has developed a lump under his collar bone that is causing pain. It is sensitive to touch.
Headache Pain/Discomfort and itching at injection site, fatigue, swollen glands, sore throat with mucus Narrative:
Rash all over body with itching same day, three doses of Benadryl given by mother.
feet developed burning and tingling; feet developed burning and tingling; two days after the shot I developed severe back pain sciatica; two days after the shot I developed severe back pain sciatica; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 13Jan2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown), administration date: Dec2021, for Covid-19 immunization, reaction(s): "did not have a reaction to the first one that patient was aware of in Dec2021 ". The following information was reported: BACK PAIN (non-serious), SCIATICA (non-serious) all with onset 15Jan2022, outcome "not recovered" and all described as "two days after the shot I developed severe back pain sciatica"; BURNING FEET SYNDROME (non-serious), PARAESTHESIA (non-serious), outcome "unknown" and all described as "feet developed burning and tingling". The events "two days after the shot i developed severe back pain sciatica" and "feet developed burning and tingling" required physician office visit. Additional information: Two days after the shot, patient developed severe back pain sciatica since that time patient have had seen his primary care a chiropractor orthopedic podiatrist as his feet developed burning and tingling. His back is not getting better and was feeling like no one cares, no one was helping. Patient thought that this needs to be investigated and needed help.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200554784 same product/events, different patient
Raising Heart for 24 hours after first shot of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Raising Heart for 24 hours after first shot of Moderna vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Raising Heart for 24 hours after first shot of Moderna vaccine). At the time of the report, TACHYCARDIA (Raising Heart for 24 hours after first shot of Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.
pt recv vax 23JUL96 & 3MAR98 pt devel full blown, breakthrough varicella w/more than 60 disseminated lesions;pt was febrile;