chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Friday 10/10/2008: Patient was in good shape when I took him to MD - for a review of his blood test results.  He was advised to get a flu shot.  They were available in the lobby with a paper from the Dr.  He got the flu vaccines shot.  Saturday 10/11/2008: He sounds as if he has a hard time breathing. -7 P.M. - Saturday 10/11/2008: Patient goes to hospital via ambulance.  911.  Sunday 10/12/2008: Patient called me to advise me that he is in the hospital.  Monday 10/13/2008: I visit patient in hospital and he is non-responsive and barely alive.  Monday 10/13/2008: Patient died from pneumonia.  Prior to the flu vaccine he was in good health.  I believe the vaccine should not have been advised as it killed him. 10/28/08 Death certificate states COD as respiratory failure w/pneumonia & myelodysplasia as contributing causes.  10/28/08 Reviewed hospital medical records of 10/12-10/13/2008. FINAL DX: CHF; A-fib w/RVR; acute respiratory failure; acute exacerbation of COPD; acute exacerbation of chronic renal insufficiency & failure; malnutrition. Records reveal patient experienced SOB, bilateral leg edema, atrial fibrillation w/rapid ventricular response.  Cardioverted & admitted to ICU.  Developed acute respiratory failure, agitation, confusion worsened & placed on BiPAP.  Tx w/IV antibiotics.  Pt was DNR, no intubation.  11/25/08 Reviewed PCP medical records  Office record of 8/20/08 reveals pt disoriented s/p ER visit for visual disturbance, HA & temporal arteritis.  Had been started on steroids.  RTC 9/19/08 s/p ER visit after fall w/o sequelae.  RTC 9/29 w/fatigue.  RTC 10/10 stating felt better.  No record of flu shot, was given by unknown company in lobby of physician office building.
Sever pain injection site,nausea and vomiting, labored breathing, electic pain racing to all points on head and body, diareha,, continued maliase,  Symtoms have lasted at least 6 days.
30 minutes after vaccine I started getting a very dry mouth,  had a feeling of difficulty swallowing, felt like a lump in the throat, breathing required more respiratory effort the normal. I  placed a pulse ox on my finger, the heart rate was 120, but oxygen saturation was 99%.  I monitored the pulse ox which remained stable at 99%. The symptoms decreased after 2 hours. Followed by body ache, chills, headache , fatigue and soreness at injection site.  I was afraid to sleep by myself that night afraid my throat would close up so my mother watched me all night.
Chills; Body aches; Fever; Body is very sore; joints are sore; Headache is very strong; This is a spontaneous report from contactable consumer. A 73-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9262), via an unspecified route of administration on 03Feb2021 as single dose for covid-19 immunisation. Patients Medical history included High blood pressure. Patients concomitant medications were not reported. Historical vaccine included BNT162B2 (dose 1) as single dose for covid-19 immunisation. On 03Feb2021 within 10 hours of vaccination, patient got really chills, had body aches and fever all night, had Body sore and joints sore and strong headache. Patient reported she got her second vaccine yesterday (03Feb2021) morning and starting like around 11 last night, she started getting really chills and was having body aches and fever all night and my body is very sore, you know all my joints are sore and have like my headache is very strong. Patient was not received any treatment for the events hence patient wants to know if she could take acetaminophen for the events. Patient had not yet recovered from the events.  Follow-up attempts are completed. No further information is expected.
Gave a 16 year old male a COVID-19 injection; A spontaneous report was received from a pharmacist concerning a 16-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, gave a 16-year-old male a COVID-19 injection.   The patient's medical history was not provided.  No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, a nurse gave a 16-year-old patient a COVID-19 injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, gave a 16-year-old male a COVID-19 injection, was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
I woke on the 8th day after the shot with pain around the injection site, extra fatigue, and a migraine. These symptoms are currently ongoing
The patient experienced the following reaction(S) during the immediate   of observation:   0936- pt advised he was feeling dizzy and had a headache.  Pt was placed in wheelchair and taken to post-vac area.  Pt placed on floor in trendelenburg position with feet on wheelchair. 0941 BP: 151/108 P: 97 R:16 Sp02: 100% RA.  Pt still c/o headache with dizziness and diaphoresis.  VS continued to be monitored.  Pt states he is still dizzy while laying down.  Pt A&O x4. 0945 BP: 154/98 P: 91 R: 16 Sp02 95% RA.  Pt states at this time his headache has resolved, but continues to be dizzy.  0949- pt ambulated to wheelchair, pt states he continues to be dizzy and now has pressure between both shoulder blades. 0950: BP 180/110 P: 101 R: 18 Sp02 96% RA.  Pt attempted to contact a family member to drive him, unable to make contact.  Spoke with pt in length about concerns with blood pressure and pain between shoulder blades.  Pt stated he would like to go to the er for further evaluation.  1000: 911 was contacted.  Pt placed in hall for privacy.  1010: EMS on scene, pt care turned over to EMS. 1019- pt transported to ER via ems
Evening of vaccine had a headache. Next day severe body aches with fever much better after 24 hours.
Patient said he felt light headed after administration of shot.  He fainted and had a seizure that lasted around 10 seconds around 5 minutes after receiving vaccine
Moderna 3/24/21, 4/21/21, 12/7/21. Positive on 5/10/22
This spontaneous case, was initially received from other health professional on 05-Oct-2017, concerning a 3.5-year-old child patient. On 05-Oct-2017, the patient was administered with AFLURIA (dose: 0.5 ml, batch number: XT33908, expiry date: 30-Jun-2018, anatomical location: right deltoid, route of administration: intramuscular). The 3.5-year-old patient received AFLURIA TRIVALENT (not approved for use in children less than 5 years of age) (explicitly coded as Inappropriate age at vaccine administration). It was reported that, the patient was well and did not have any fever after the administration of the vaccine. The reporter assessed the event as non-serious. Follow up report received on 17-Oct-2017: The route of administration (intramuscular) of the vaccine was updated. It was reported that, the patient was well and did not have any fever after the administration of the vaccine. The narrative was amended accordingly. Non-significant case correction received 05-Oct-2017: Batch number (XT33908) was captured in the case form and narrative was amended accordingly.
rash; fever; pain in his arm; This is a spontaneous report received from a contactable consumer. A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date, 47 days ago at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. Historical vaccine included patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On an unspecified date, the patient experienced a rash, fever, and pain in his arm around the affected area. He specified the pain extended to his shoulder but is now localized at the affected area. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was only 11 at time of vaccination.  Consent form signed by mother, father entered DOB as 2008 when it is actually 2009.  Pharmacist verbally confirmed DOB with father at time of vaccination.  Online appointment also listed 2008.  When claim was billed to insurance, they gave DOB as 2009.  Pharmacist called mother and she confirmed DOB was 2009 and that they knew child was not yet eligible for vaccination per Pfizer EUA but they "did not think it would be a big deal."
Myalgia Fatigue Narrative:  missed work x 1 day following second dose
Site was sore after vaccination for 2 days. 6 days after vaccination on 18Jan, patient started experiencing urticaria, redness, and edema around localized injection site. 6.5x4.5cm. Patient states redness/swelling has not increased. Patient tried cocoa butter and lotion to prevent itching, both topicals were ineffective. Patient applied topicals around injection site, to avoid direct application to injection point.
coughing the day after first vaccine/Cough was dry; Coughed so much I lost my voice for 2 days; Cough was dry then became phlegmy - green phlegm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm, on 24Jul2021 at 11:00 hours, as dose 1 single (at the age of 67-years-old) for COVID-19 immunization. The patient medical history included Covid-19 (diagnosed prior to vaccination). Patient had no known allergies. Patient had no other vaccine in four weeks. Concomitant medications included fish oil, acetylsalicylic acid (low dose Aspir), calcium and Multivitamins. On 25Jul2021 at 09:00 hours (the day after first vaccine), patient started coughing, patient coughed so much that he lost his voice for 2 days. Patient stated that cough was dry then became phlegmy - green phlegm on Jul2021. Patient called the doctor to take COVID test and then patient tested on 01Aug2021 via nasal swab, but result was negative. Patient still had cough a week after 2nd covid vaccine. Patient had a doctor or other healthcare professional office/clinic visit for the events. Patient received no treatment for the events. The outcome of lost his voice was recovered on 27Jul2021 and not recovered for rest of the events.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Cold feet, chills, fever 101, body ache, joints pain, cramps in both feet, mild headache, shallow breathing and general weakness. These started around 9pm on date of vaccine 12/28/2018, and lasted most of the next day. Did not take any medication, but drunk a lot of water.
Pt vaccinated with Engerix-B developed gram negative sepsis suspected, low grade gever then 102 , pain in neck, pain in shoulder girdle, pain in upper thighs, sedimentation rate 138.
Patient called about 5-6 hours after vaccination stating he was not feeling well. He had fever, nausea and vomiting. Went to ER, but they measured his blood pressure and it was normal, they just sent him home. Followed-up with the patient the next morning, he stated his symptoms are much better now and are resolving.
Patient became anxious and shaking. Patient was monitored for 30 minutes and released. No medications were administered for treatment.
Brainfogged, he did not know where he was.; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Brainfogged, he did not know where he was.) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anticoagulant therapy since an unknown date. Concurrent medical conditions included Blood pressure inadequately controlled, Gout, Restless leg syndrome and Ulcer.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CONFUSIONAL STATE (Brainfogged, he did not know where he was.). At the time of the report, CONFUSIONAL STATE (Brainfogged, he did not know where he was.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       as per reporter patient uses concomitantly medications for Blood Pressure, anticoagulants, pain, gout, restless leg syndrome, ulcer and hypnotics. No treatment medications were reported.
pt may have allergic reaction to COVID injection, pt had second injection this past friday. rash to arms, swelling/tenderness to lt arm. pt on routine allergy medicine at home.
Leg pain; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), FATIGUE (Fatigue) and PAIN (Body aches) in a 91-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 Myasthenia gravis.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Leg pain), FATIGUE (Fatigue) and PAIN (Body aches). At the time of the report, PAIN IN EXTREMITY (Leg pain), FATIGUE (Fatigue) and PAIN (Body aches) outcome was unknown. Not Provided          No concomitant medication was provided.  No treatment details were provided.
Patient had diarrhea from date of immunizations until 11/27, when she vomited several times in one hour with bloody mucus until bile.  Patient had been able to eat a certain formula and 5 safe foods without difficulty before immunizations and after immunizations, is unable to tolerate any foods at this time (April 2017).  Patient had blotchy facial rash and some facial swelling with each formula feeding for several weeks after which have resolved.  Also, patient had been taking a few steps independently and had a couple of words at the time of immunizations.  After immunizations, patient only said one word until March 2017 and did not get back to taking a few steps independently or using 2-3 words until March 2017.  Patient also started sleeping about 20 hours per day through December and January.
Left thigh red, swollen and itchy site 5in x 4in no abscess, reaction began 24 hours prior to recheck in our office.
This is an initial report of an AE, received on 06Oct2015. A 39-year-old female received FLUBLOK intramuscular on 05Oct2015. On 05Oct2015, two hours after receiving FLUBLOK, the subject presented with a rash that was 8 mm x 4 mm, warm to the touch, raised with a bumpy appearance and itchy. It was also itchy at the injection site. She was given BENADRYL, orally and externally along with hydrocortisone cream. The next day the rash measured 9 mm x 4 mm and was sore, puffy and red. The nurse reported that it looked worse. At the time of the report, the event of rash had not resolved. The outcome for the itch at injection site was unknown. Medical/surgical history for the suspect included egg and latex allergies. Concomitant medications were not reported. The company's assessment of the causal relationship between rash and FLUBLOK is a possible relationship in light of the safety profile information that injection site reaction is an expected event, and between itchy at the injection site and FLUBLOK is also a possible relationship in light of the safety profile information that injection site reaction is an expected event. In summary, this case report does not change the known safety profile of FLUBLOK.
body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN and ROSUVASTATIN for an unknown indication.   On 20-Apr-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 20-Apr-2021, the patient experienced PAIN (body aches) and HEADACHE (Headache). At the time of the report, PAIN (body aches) and HEADACHE (Headache) outcome was unknown.            Treatment medications were not provided.  Action taken with the product mRNA-1273 is not applicable.
This is a spontaneous report received from a contactable pharmacist via a Pfizer sales representative. A female patient of unspecified age and ethnicity received PREVNAR 13 (Lot# N16560, Exp date 30Sep2017), via an unspecified route of administration in deltoid left, on an unspecified date at 9:30 AM, at 0.5 ml single, for immunisation. The patient was vaccinated at the pharmacy. The patient's medical history and concomitant medications were not reported. Days after vaccination the patient experienced infection, about two inches below the site of injection was red and swollen all on an unspecified date with outcome of unknown. The events were evaluated at doctor visit. Therapeutic measures were taken as a result if the events and included treatment with topical antibiotic Bactroban. The pharmacist believed that after Prevnar 13 was administered the patient experienced infection.
Grandma was undressing child last night & noticed redness, edema & skin hot to touch. Also noticed small red raised bumps under diaper band & on (R) leg. Temp at this visit 100.2.
Sick with both shots. But 2nd shot I got a big knot on my collar bone hurts bad,my head hurts really bad every since & behind my ears hurt when I wear my glasses  cant sleep comfortably arm hurts its been five days now,my first was just fatigue & common cold.I was told it normal just report it to you.
FluBlok given to 16 yo patient.  Vaccine intended for 18 and up only.
Presented to the ED with complaints generalized weakness prompting a call to EMS who found patient diaphoretic per report.  Patient endorses dry cough but denies any fevers, chills, chest pain, palpitations, lightheadedness or dizziness.  Upon arrival to the ED patient's initial vitals revealed hypoxia in the 80s and up to 90% on room air.  ABG revealed hypoxemia with PO2 70.6.  COVID-19 positive.  Patient was tachypneic max 22.  Mildly decreased sodium 134 and elevated serum creatinine 1.53 (baseline III to 1.5, patient with history CKD stage 3).  Decreased magnesium 1.5.   - Troponin elevated 117 with BNP 261.  EKG reveals sinus rhythm with no ST segment changes acutely. - Chest x-ra  Presented to the ED with complaints generalized weakness prompting a call to EMS who found patient diaphoretic per report.  Patient endorses dry cough but denies any fevers, chills, chest pain, palpitations, lightheadedness or dizziness.  Upon arrival to the ED patient's initial vitals revealed hypoxia in the 80s and up to 90% on room air.  ABG revealed hypoxemia with PO2 70.6.  COVID-19 positive.  Patient was tachypneic max 22.  Mildly decreased sodium 134 and elevated serum creatinine 1.53 (baseline III to 1.5, patient with history CKD stage 3).  Decreased magnesium 1.5.   - Troponin elevated 117 with BNP 261.  EKG reveals sinus rhythm with no ST segment changes acutely. - Chest x-ray pending at time of admission.   Patient is fully vaccinated against COVID-19 with Moderna x2.  Exposed to daughter who has COVID-19. Tested positive on 01/17/2022
Notice that my feet have been very cold. Describing as ?freezing? . Aching joints and knees
Information has been received from a licensced practical nurse concerning a 25 year old female with no medical history or allergies, who on 26 Jan 2007 was vaccinated a first dose of with Gardasil (yeast) (lot#653736/0014U). Concomitant therapy included hormonal contraceptives (unspecified). On 31 Jan 2007 (also reported as four to five days later), the patient developed hives. The patient went to her primary care physician for treatment of the hives. She was prescribed prednisone and Benadryl. Later that day, she went to the emergency room. On 01 Feb 2007 the patient told the nurse her hives were worse. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Employee had pain at time of injection and continued to have pain in left shoulder with worsening pain on 10/26/2020 and now decrease Range of motion of joint.  numbness and tingling in left 3,4,5 finger.
Severe blood pressure spike 220/134, pain in neck arm and chest, shortness of breath, pain in legs, swelling, cellulitis, inflammation in whole body
Discovered today at patients appointment that on 7/2/19 that LPN gave her a 3rd Menveo (only 2 doses in this series, not 3) instead of giving the MenB #1. No harm done to patient. MenB given at todays appointment.
Directly after injection, when pulling the shot out of the patients arm, the patient began to excessively bleed and a large hematoma started to appear.
Side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient wondering how long the side effects last after the vaccine. The reporter denied permission to follow up.
Injection site was erythematous.  On 11/11 worsened, became indurated.  On exam had an eryth patch 1.9 x 4.8 cm with slight induration.  Rx ibuprofen, Elacon.  No fever, no drainage.
Covid Arm.  Injection site is Red, fever, sore, swollen, itchy.  Started about 1 week 1 day after vaccination.
Rash in left arm 7days after receiving vaccine.   Rash started three inch then went to 4 inches diameter. felt hot, itchy and was slightly swollen.
Patient states she developed a rash on her body within 24 hours of receiving vaccine. 11/10/09 Medical records receoved for DOS 11/05/09. Office notes.  Rash all over trunk s/p vaccine. Benadryl w/good effect.
IMMEDIATELY AFTER RECEIVING VACCINE, PATIENT (WHO HAD ALLERGIC REACTION RASH AFTER 1ST DOSE) BEGAN FEELIN HOT, DIZZY, SOB, AND LIPS STARTED SWELLING. BROUGH TO OBS VIA W.C. AND PLACED IN TRENDELENBERG ON STRETCHER. DIZZINESS AND SOB RESOLVED, ICE PACK PLACED TO LIPS TO DECREASE SWELLING, DID START TO IMPROVE OVER PERIOD OF 15 MINS. VACCINATED ARM DID NOT HAVE RASH OR APPEAR TO HAVE REACTION, BUT DID HAVE UNCONTROLLABLE SHAKINESS UNTIL PATIENT REPEATEDLY MOVING ARM AROUND DID IT IMPROVE SUBSTANTIALLY. VSS THROUGHOUT EPISODE. SNCK AND WATER PROVIDED, STATED THIS HELPED HER FEEL BETTER AS WELL. ONCE S/S RESOLVED BESIDES MINIMAL SWELLING IN LIPS THAT REMAINED, PATIENT AND SPOUSE ESCORTED TO EXIT WITH NO ISSUES AT 1605, PATIENT TOOK OWN BENADRYL BEFORE LEAVING OBS AREA FOR ANY REMAINING REACTION ISSUES, AS SPOUSE WAS DRIVING. 1544 INITIAL BP 135/88 HR 78 RR 22 ATS 100% ON RA 1550 BP 112/76 HR 64 RR 20 SATS 100% ON RA 1600 BP 120/84 HR 71 RR 20 SATS 100% ON RA