chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Couple of days after first Vaccine my left leg just above my ankle on underneath the skin it felt like the blood getting very hot and feverish for a few minutes then go away for awhile then do it again and happening constantly.  Then  in my 3rd week it jumped to middle of leg and then up to lower knee (all left leg), then go back down to ankle.   It just feels like hot blood under the skin.   I then called my primary doctor and they had me do in as I was concerned it could be a blood clot, but he checked and assured me it wasn't.  Dr. said they have been seeing patients with same issue I am having, having the Pfizer shots but those people have in both legs or both arms and  he really couldn't give me a answer but to report to CDC.   He said to proceed with second shot which I did and still having same issue.   I called my primary doctor back again this week as this continues with "Hot Spots" and I was experiencing numbness in two small toes on left leg and next 2 toes tingling and concerned for these  "Hot Spots" (no rashes).   He is now setting me up  for a sonogram to reassure me it isn't a blood clot.      I was never sick with the shot, just minor soreness in arm for following day and tired on first round.  Called me a prescription in for Gabapentin 300mg.
CHILLS; LOW-GRADE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chills, and low-grade fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low-grade fever, and chills. This report was non-serious.
Warm, raised, red rash approx. 10cm below injection site. Injection site is unremarkable. No pain no itch. 5cm in diameter not round.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. information regarding relevant medical history and concurrent condition were not reported. On 28-JUN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L031272, expiration date 19-NOV-2016, dosage and route not specified). No adverse effect reported. Additional information has been requested.
EXTREMELY SORE, not able to lift the arm upwards or sideways, extremely painful and sensitive, the injection site turned "HOT" after 24 hours or so. Patient extremely uncomfortable for over 4 to 5 days. Patient took Ibuprofen 600 mg a few times in a day starting 1/10/19, after consultations with the pharmacist and a follow up call was made each day to see if the condition was not getting deteriorated. Her condition started improving after the start of OTC, Ibuprofen doses. By 12th she was feeling a little better and by 13th she was much better.
Usual symptoms about 12 hours later:  achy, very tired, terrible headache, and chills.  Arm sore and somewhat red.  Symptom I thought may be an allergic reaction occurred 48 hours later with a red rash on stomach and then rash traveled to my back the next day.  Rash slightly itchy, but not bad.  Rash gradually faded within 3 days after injection.  If this is an allergic reaction, my concern is that it may intensify if booster is needed.
Administered past expiration date. Vial moved from freezer to fridge on 10/7/21 with 30 day expiration of 11/6/21.
Inflammation (particularly after 2nd dose); Inflammation (particularly after 2nd dose) which exacerbated pre existing conditions.; This is a spontaneous report from a contactable consumer or other non hcp.   A 43-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 30Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation  .  Medical history included autonomic nervous system imbalance from an unknown date and unknown if ongoing , ehlers-danlos syndrome from an unknown date and unknown if ongoing. Concomitant medication(s) included hydroxyzine (HYDROXYZINE) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported; thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported; clonazepam (KLONOPIN) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; turmeric [curcuma longa rhizome] (TURMERIC) taken for an unspecified indication, start and stop date were not reported; ginger [zingiber officinale rhizome] (GINGER) taken for an unspecified indication, start and stop date were not reported.  The patient experienced inflammation (particularly after 2nd dose) (inflammation) (non-serious) on 2021 with outcome of recovered , inflammation (particularly after 2nd dose) which exacerbated pre existing conditions. (condition aggravated) (non-serious) on 2021 with outcome of recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of inflammation (particularly after 2nd dose) (inflammation), inflammation (particularly after 2nd dose) which exacerbated pre existing conditions. (condition aggravated).
Follow-up info received from the pt's physician provided the following: concomitant vaccine; illnesses at time of vaccination; relevant diagnostic tests/ lab data; and medical history. A health care professional reported that a 42 year old female pt received a dose of Flumist on 10/27/03 and experienced a drug interaction and menstrual spotting. The pt experienced a drug interaction and menstrual spotting. On 10/29/03, the pt indicated she "started menstrual spotting and got her period on 11/3/03." This event occurred one week early. The pt stated that she is currently continuing the Nordette-21 and should not have her period. She indicated that this has never happened before. No additional info was available at the time of this report.
Shot given and she felt warm right away. Then throat became tight, became pale and then face ansd neck became numb.
This spontaneous report was received from a registered nurse, referring to a 6 month old patient of unknown gander. The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not reported. On an unknown date, the patient received a dose of ROTATEQ orally (lot # and expiration date were not reported) for prophylaxis. Afterwards, from 45 minutes to 1 hour after receiving the vaccine, the patient vomited. By the time of the report, the outcome of the event was unknown. The reporter's causality assessment between vomiting and ROTATEQ was not provided.
Systemic: Chills, Systemic: Joint Pain, Systemic: Other- Pain and numbness on the left jaw/face-Severe.
Severe reaction; A spontaneous report was received from a Consumer concerning a unknown age and gender of patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced severe reaction.  Treatment details included unknown  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of severe reaction was not reported.
Pain, redness, induration at injection site; onset within 24 hours of injection, treated with antibiotic by another physician.  Feverishness.
pt received vaccine on 2/3.  early on 2/4 developed chest pain, dyspnea, and was seen in ED and diagnosed with acute exacerbation of CHF and NSTEMI type 2, and anemia.  on 2/5 transfusion was started and pt developed worsening dyspnea and then PEA arrest.  Pt achieved ROSC and was transferred to the cardiac intensive care unit where he required vasopressor support.  he subsequently declined and died on 2/7
This spontaneous case reported by a nurse, describes the occurrence of accidental overdose (received 0.5mL Moderna instead of 0.25mL booster dose) and pain in extremity (pain in arm) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 012H21B) for COVID-19  immunization. No medical history reported. On Nov 19, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. In November 2021, patient experienced pain in extremity (pain in arm). On Nov 19, 2021, patient experienced an accidental overdose (received 0.5mL Moderna instead of 0.25mL booster dose). In November 2021, pain in extremity (pain in arm) resolved. On Nov 19, 2021, accidental overdose (received 0.5mL Moderna instead of 0.25mL booster dose) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Low grade fever - Tuesday to Saturday Extreme headache: Tuesday Body aches, cold sweat, and minor headache: Tuesday - Saturday  Blood Clot found in my leg behind my knee Saturday (today). Symptoms of pain and swelling started Tuesday. Reached high pain point Thursday and it didn't get better so I was recommended to go to the emergency room.
Headache; This is a spontaneous report from a contactable consumer (Reporter's Grandson). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) for COVID-19 immunization.The patient experienced headache on an unspecified date after the last vaccination (might be after third day of vaccination). The outcome of event was unknown.  Information on the lot/batch number has been requested.
Pain, swelling, hardness and red lesion at injection site. Also very itchy. Symptoms of "COVID Arm."
Within 30 minutes hot flushed feeling in face, tightness and chest and throat, dizziness. Same symptoms as allergic reactions to other known allergens
Patient states that the site of her flu shot given on 11/14/17 became "feverish, red and very sore" beginning on Sunday after church on 11/19/2017. According to pharmacist, patient reported to pharmacy on 11/22/2017 with "a circle of feverish redness approximately 3 inches in diameter" on left arm at site of flu shot injection. Upon my first consultation with patient regarding the adverse event today, she stated that pharmacist instructed her to place an ice pack on the area of warm redness. Patient states that the redness and warmth completely cleared up 3 days later on 11/25/2017.
Throwing up multiple times-had never done this before. Extremely lethargic, pale and quite unresponsive. Checked out at ER, but was fine.
received an ACT-HIB vaccine on 14Mar2023 that expired on 05Mar2023 with no reported adverse event; Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 1-year-old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] on 14-Mar-2023 that expired on 05-Mar-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant: PCV 13.   On 14-Mar-2023, the patient received suspect HIB (PRP/T) VACCINE powder and solvent for solution for injection at an unknown dose (lot UJ649AAA, expiry date: 05-Mar-2023) via intramuscular route in the thigh nos for immunisation.  On 14-Mar-2023 the patient received an act-hib vaccine that expired on 05-Mar-2023 with no reported adverse event (expired product administered, same day latency). The caller asks if the dose is valid, if he should be revaccinated, and if so, when.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
p/vax felt soreness going down from buttock t knee & up to back;sore on site of anthrax #5;
pain at injection site left arm; pain from hip to back of ankles left side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site left arm) and ARTHRALGIA (pain from hip to back of ankles left side) in a male patient of an unknown age 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.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site left arm) and ARTHRALGIA (pain from hip to back of ankles left side). At the time of the report, VACCINATION SITE PAIN (pain at injection site left arm) and ARTHRALGIA (pain from hip to back of ankles left side) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood pressure measurement: (High) High blood pressure 152/92.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site left arm), BLOOD PRESSURE INCREASED (high blood pressure 152/92) and ARTHRALGIA (pain from hip to back of ankles left side) in a male patient of an unknown age 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.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site left arm), BLOOD PRESSURE INCREASED (high blood pressure 152/92) and ARTHRALGIA (pain from hip to back of ankles left side). At the time of the report, VACCINATION SITE PAIN (pain at injection site left arm), BLOOD PRESSURE INCREASED (high blood pressure 152/92) and ARTHRALGIA (pain from hip to back of ankles left side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Employee developed large whelp at injection site, approx. 50mm in circumference. Whelped area was reddened and warm to touch. Employee states area was extremely itchy.
COVID arm.  Injection site soreness, swelling, rash and itching. Rash continued to get bigger over the week.
Pt complained of soreness in left arm with pain at injection site radiating to clavical and scapular areas. Pt saw nurse at Occupational Health Center at Brigham  Women's and was told it was due to the flu shot and it should subside in 2 days or so.  Pt fully recovered.
Swelling of dermal filler in jowl area which started the day after I had the vaccine. These dermal fillers were placed roughly 8 months ago.  (I also had the usual side effects of chills/shaking/fever that started 8 hrs after the vaccine).
Headache, fatigue, nausea on 04/22/2021. A red itchy rash broke out on 04/23/2021 on right arm near injection site, and on neck and upper torso.
Body aches/body aches after 2nd dose; Bone-aches grade 1, in a scale from 1 to 10, not very intense/Bone-aches after 2nd dose; Patient feels terrible/Patient feels scared/Patient felt terrible after 2nd dose; Headache/Headache after 2nd dose; Fever/Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches/body aches after 2nd dose), BONE PAIN (Bone-aches grade 1, in a scale from 1 to 10, not very intense/Bone-aches after 2nd dose), FEELING ABNORMAL (Patient feels terrible/Patient feels scared/Patient felt terrible after 2nd dose), HEADACHE (Headache/Headache after 2nd dose) and PYREXIA (Fever/Fever after 2nd dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches/body aches after 2nd dose), BONE PAIN (Bone-aches grade 1, in a scale from 1 to 10, not very intense/Bone-aches after 2nd dose), FEELING ABNORMAL (Patient feels terrible/Patient feels scared/Patient felt terrible after 2nd dose), HEADACHE (Headache/Headache after 2nd dose) and PYREXIA (Fever/Fever after 2nd dose). At the time of the report, PAIN (Body aches/body aches after 2nd dose), BONE PAIN (Bone-aches grade 1, in a scale from 1 to 10, not very intense/Bone-aches after 2nd dose), FEELING ABNORMAL (Patient feels terrible/Patient feels scared/Patient felt terrible after 2nd dose), HEADACHE (Headache/Headache after 2nd dose) and PYREXIA (Fever/Fever after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication reported No treatment medication reported It was reported that patient had concern about spread her illness to her son.
sores in mouth; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (sores in mouth) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CLOPIDOGREL, ESOMEPRAZOLE and ROSUVASTATIN for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced STOMATITIS (sores in mouth). At the time of the report, STOMATITIS (sores in mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events,  included nystatin, clotrimazole and gabapentin
December 2021 - started getting sporadic headaches, every once in a while, (this was not typical for me at all, I have no history of this). January/February 2022 - headaches started to become more frequent, i.e., every 4-7 days March 2022 - headaches started coming on every day, and if I cannot get them under control they turn into migraines. April 2, 2022 - Suddenly, I heard a very loud ringing in my right ear (tinnitus) followed by a severe headache and earache in my right ear, the tinnitus has not stopped ever since. I can hear my heartbeat within my head when the tinnitus is at its worse. It is now May 2022 and I still have the tinnitus. April 3, 2022 - Went to urgent care for headache, tinnitus in right ear, and earache in right ear; was told I had no ear infection; was told to take ibuprofen for pain, use cold compress for headache, take Flonase in the event it had anything to do with sinuses/allergies, and eat sour candy in the event it was a salivary gland issue. I was told to see a specialist if symptoms did not get better. April 8, 2022 - (worsening symptoms) Saw an ENT/specialist, was told my salivary gland was swollen, did not find an ear infection, could not explain tinnitus and was sent to imaging for a CT scan (was told to continue taking ibuprofen for pain).   Results of CT scan done on 4/22/22 prompted a referral to on call Primary Care Physician.  On call PCP has sent in a referral for an MRI of my pituitary gland and another MRI of my brain.  Referral to Neurology has been made, appointment scheduled for 5/24/22.  [MRI of pituitary gland done on 5/3/22, MRI of brain done on 5/5/22]. Note: Since March, I have had difficulty concentrating at work due to the headaches/migraines causing me to get behind (which has never been the case in my nearly 30 years as a professional), the tinnitus has been relentless and makes it difficult to sleep at night, tinnitus gets louder and softer with no rhyme or reason.  My quality of life has not been the same since December 2021. I've had quite a bit of bloodwork done over the past several weeks (last few weeks of April/beginning of May 2022).
Pt has a quarter-sized welt. Pink, upraised. Cool to touch. Advised ice and BENADRYL and monitoring. Asked to verify allergies equals none. Asked if had flu vaccines in past equals yes.
PATIENT EXPERIENCED REDNESS AROUND THE SITE OF INJECTION AND MODERATE PAIN AT THE INJECTION SITE.
I contracted COVID-19 on 01/23/2022 with symptoms of severe fatigue, headache, weird taste sensation, shallow cough, body aches, abdominal pain, difficulty swallowing, swollen tonsils, constipation, diarrhea, loss of appetite, hallucinations, ear drums are bulging, difficulty waking up or concentrating, brain fog, shortness of breath, chest tightness, not being able to complete normal activities, chills, and felt feverish. I only had to use my inhaler 3 times throughout the illness. My symptoms did not improve until after 04/18/2022, and I am still experiencing lingering symptoms of brain fog, fatigue, difficulty swallowing/digesting, swollen tonsils, ear drums are bulging, chest tightness, shortness of breath, swelling in my lower extremities, and put on weight. I was diagnosed with Long Term COVID-19 and I am waiting to have an echocardiogram.
Patient presented to clinic with parents for 1 dose of Pfizer's covid-19 vaccine. Parents stated on paperwork that  patient eligible for Covid-19 vaccination. Patient received a dose of Pfizer's over 12 covid-19 vaccine on 8/1/2021. 21 days later patient received a second dose of Pfizer's covid-19 vaccine on 8/22/2021. Upon filing an insurance claim it was discovered that patient's date of birth is unspecified date making him ineligible for Covid vaccination at the time.
30JAN98 pt presented to clinic stating rt arm was hurting & red;RN examined rt arm-found 2inch in diameter red spot on deltoid, arm was hot to touch & pt stated arm hurt from deltoid down to fingers-referred pt to MD;
2wk p/vax devel small papular rash;lesions began to grow;28AUg98 presenting w/papular, rash on legs, abd;
Patient experienced burning sensation immediately and has progressively lost up to 80% of function/strength in right arm over 5 months.
Severe headache over left-side of head and behind left eye since Thursday evening upon waking up.