chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 17 November 2010 from an investigator participating in a trial. A 5-year-old male subject (initials not collected), who had received a 0.25 mL injection of flu vaccine (trade name, manufacturer name, and lot number not reported) in 2005 with no problems, experienced accentuated injection-site reaction 17:16 hours after receiving a first intramuscular left deltoid injection of either, INFLUENZA VIRUS VACC QUAD A & B, or INFLUENZA VIRUS VACC NO PRESERV. TRIVAL A&B SV-U ALT-B, or FLUZONE No Preservative 2010-2011 on 11 November 2010. The lot number of the administered product was not reported. The subject's left arm from the elbow to the shoulder had severe swelling (that stopped on 16 November 2010), redness, hardness and was hot to touch the morning following vaccination. The subject was seen in the emergency room and diagnosed with allergic reaction to vaccine. Corrective treatment included BENADRYL prn, and KEFLEX for 10 days. The subject has not recovered. According to the investigator the event was related to the study vaccine, but not to the trial procedures. The investigator considered the event to be an "Other: important medical event" specified as: severe injection site swelling, redness, hardness and hot to the touch and the subject was seen at the emergency room and diagnosed with allergic reaction and treated with BENADRYL and cefalexin. The serious adverse event lead to the subject's termination from the clinical trial. Documents held by sender: None. Medical assessment: Transient severe local injection site reactions are expected after administration of different formulations of FLUZONE vaccine. The Investigator has not provided a final diagnosis, injection site reaction versus allergic reaction. Treatment with steroid was not required implying it was not a severe reaction. Also antibiotics were prescribed for treatments of the event, indicating some infectious process was suspected. It is not known if any diagnostics were performed to confirm or support the tentative diagnosis. Though a possible relation with vaccination is possible, more information will be requested to fully assess the case/make a causality assessment.
Pt feeling dizzy & faint post vaccination (BP 101/64; HR 88; RR 16).  Assisted to observation.  VS stable (BP 103/65; HR 88; RR 15). No respiratory distress. Resting in bed quietly w/parents at bedside.  Assessed at bedside by NP. Pt states she is ok & wants to go home. No discomfort & discharged pt home in stable condition.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE GENERALIZED CONVULSIVE EPILEPSY
Booster shot was administered 27 December 2021. Developed shortness of breath and increased heart rate starting about 15 February 2022. Hospitalized on 6 March 2022 and diagnosed with unprovoked multiple pulmonary embolisms without DVT . Was treated with heparin and with a thrombectomy to remove embolisms from lungs. Received oxygen therapy while in hospital and while recovering at home. Continuing to recover and taking Eliquis regularly.
Seasonal flu shot, was not told type.  Okay for a few hours, then got very nauseous.  Light-headed.  Fatigue.  Chills.  Two sessions of throwing up/heaving, plus a few instances of watery diarrhea.   Minor headache  overnight and following morning.  Nausea and fatigue still evident, but less so.  Keeping down water and ginger ale and bread.
after right above my clavicle on my right side was swollen and tender to touch. It took until day 8 or 9 to still be swollen and palpable but not tender.; about 9 hours after right above my clavicle on my right side was swollen and tender to touch. It took until day 8 or 9 to still be swollen and palpable but not tender.; This is a spontaneous report from a contactable Nurse reported for herself. A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Pfizer) second dose at right arm intramuscularly on 09Jan2021 07:30 AM at single dose for covid-19 immunisation. The historical vaccine include bnt162b2 on 19Dec2020 07:45 AM first dose at right arm intramuscularly at single dose for covid-19 immunisation in hospital. Medical history included ongoing covid-19. Prior to vaccination was the patient diagnosed with COVID-19. There was no allergies to medications, food, or other products. Concomitant medication within 2 weeks of vaccination included paracetamol (TYLENOL), ibuprofen, omeprazole (PRILOSEC) and gummy hair skin and nails vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second shot on 09Jan2021 about 9 hours (05:00 PM) after right above her clavicle on her right side was swollen and tender to touch. It took until day 8 or 9 to still be swollen and palpable but not tender. As of 30Jan2021, it's been 3 weeks and still there just as big but not tender. There was no seriousness criteria for the events results in death, life threatening, Disabling/Incapacitating and congenital anomaly/birth defect. Since the vaccination, has the patient not been tested for COVID-19. There was no events treatment for the events. The outcome of the events were not recovered.  Information on the lot/batch number has been requested.
pt has mental health disability, pt came in April for Janssen vaccine and returned in May for another dose, pt states she recalled receiving a vaccine but did not recall what was it for, she states the home she is staying at was requesting she have the covid vaccine so that is the reason she came in in may, I asked pt if she had her Janssen vaccine card and she responded " I think so", I asked pt how she was feeling she responded fine, I informed pt I would schedule an appointments with provider, pt declined she said she was ok, per Dr.  gave pt ER precautions, pt agreed. Followed up with pt 4 days later, pt stated she was fine, and she asked if she needed to return for her second vaccine, I informed pt there was no need to.
I feel like death. I feel like I have covid and the flu and there using me for a battleground
New onset A-Fib within 2 days of receiving his smallpox vaccine (SPV).  On 3/26/08, pt received his 1st SPV in his left arm (more than 3, but less than 15 jabs).  He reports normal vaccine site progression with a "take".  On 3/28/08, before lunch while laying down, pt noted sudden onset "racing, strong heart beat".  When he stood up, he felt weak.  He felt lightheaded with position changes and felt like he was out of breath and felt like he was "panting like after running".  Initially, he talked to a corpsman who thought this was probably related to electrolytes and instructed pt to increase fluid intake and "take it easy".  On the a.m. of 3/30/08, pt continued to experience palpitations, lightheadedness, dyspnea and weakness.  He sought medical evaluation and was hospitalized through 3 April.  There, he was placed on atenolol and ASA.  His heart rate slowed, but he still felt lightheaded, tired easily and was dyspneic.  With any activity he was aware of a significant increase in his heart rate and noted his heart pounding in his chest.  He denies any type of chest pain.  He noted generalized body aches and fatigue between post-SPV day 3 and 10.  He was transferred on 4/6/08 where his evaluation and treatment continued.  Around 10 April, all his symptoms had essentially resolved.  On 4/12/08, pt was transferred to NMCSD for additional evaluation.  He is currently in Medical Hold.  He is asymptomatic on atenolol.  Pt received his 2nd anthrax vaccine in his right arms on 3/21/08 (documented) and also typhoid IM vaccine on 3/7/08.  He did not experience unusual or prolonged local or systemic symptoms over the next week.  He denies any personal history of palpitations, HTN, valvular disease, angina, thrombus, TIAs, vascular disease or pulmonary disease.  His CVD RFs are all negative.  He has family hx of A-Fib on his mother's side (GF, GM and uncle), but no family history of CAD, drownings, MVAs, seizures or sudden death.  Prior to deployment, pt was running about 3 times per week.  Symptoms: Palpitations, Dyspnea (shortness of breath), Dizziness Weakness. 6/18/08-records received-3/29/08-C/O palpitations and racing strong heart beat, weakness, lightheadedness and dyspnea. 3/30/08-symptoms continued which showed A-fib. Admitted to hospital from 3/30-4/3/08- symptoms resolved.
Information has been received from a nurse practitioner concerning a female who was vaccinated with Pneumovax 23. Concomitant therapy included an allergy shot in the same arm. The patient was seen in the office. Additional information has been requested.
Severe and debilitating fatigue, body aches, headache, soreness at injection site. Symptoms laste 3 days
Syncope which began early in the month of September and continues.  Associated with a constant feeling of lightheadedness and mild nausea.  Has seen Cardiology with no reason for this to happen.  Waiting on holter monitor reports.  No lab abnormalities including electrolytes and cardiac markers including troponin and EKG.
Swollen lymph gland at left underarm. Pain in underarm. Swelling persisting 48 hours later.
Blister under her bottom lip; Blister on her tongue; Fever; Chills; Stayed in bed all day; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Stayed in bed all day), LIP BLISTER (Blister under her bottom lip), BLISTER (Blister on her tongue), FATIGUE (Feeling very tired) and PYREXIA (Fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (Feeling very tired). On 27-Feb-2021, the patient experienced BEDRIDDEN (Stayed in bed all day), PYREXIA (Fever) and CHILLS (Chills). On 28-Feb-2021, the patient experienced LIP BLISTER (Blister under her bottom lip) and BLISTER (Blister on her tongue). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (Stayed in bed all day), LIP BLISTER (Blister under her bottom lip), BLISTER (Blister on her tongue), FATIGUE (Feeling very tired), PYREXIA (Fever) and CHILLS (Chills) 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 relevant concomitant medications were reported.
DAY 1- two hours after vaccine my right arm and right leg felt restricted, numb and had some tingling in my hand, dull headche, muscle pain and dizziness. Day 2-  mild pain at injection sight, muscle pain and general tirednes, dull headache,dizzy,  right arm& left arm felt restricted and numbness in right pointer finger.  Right leg felt restricted and pain behind the knee. Day 3- dizzy, dull headache, faint, high blood pressure, right arm & leg and left arm felt restricted and numbness/tingling in right hand. Pain behind right knee persisted.  Went to ER Sunday early afternoon. Diagnosis is a cerebral venous thrombosis in sinus cavity.   Still experiencing general weakness/tired, dizzy/unbalanced.
Breakthrough case admission after three vaccines Pfizer 3/4/21 Lot# EN6202;  Pfizer 3/25/21 Lot# EN6207;  Pfizer 12/9/21 Lot# FG3527
pt recvd vax & devel inconsolable screaming for 3 & 1/2 hrs; tx w/ APAP;
It started with that Saturday when I was at the gym and had shortness of breath. I went to the doctor and they thought it was a virus. By Tuesday, I could not breathe. We called 911 and I went to the hospital. They did a CAT scan and noted I had 20+ blood clots, but two of them were large and pushing on my heart causing heart failure. I was transferred to another hospital and when I was stable enough they did a thrombectomy. A week later I was discharged and I was better, but not 100%. I was put on blood thinner and will be on them for lifetime.
patient received Engerix-B expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 33-year-old female patient who received HBV (Engerix B) (batch number 239TF, expiry date 4th June 2022) for prophylaxis.   On 5th July 2022, the patient received Engerix B. On 5th July 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comment: Nurse reports that an MA gave a patient an expired dose of Engerix-B. The vaccine administration facility was the same as primary reporter. The reporter did not ask about follow up as health care professional wanted to remain anonymous. The reporter did not consent to follow up. Additional supportive information: The patient received Engerix B, which was already expired in 4th June 2022, which led to expired vaccine used.
Tingling and numbness in bilateral legs the day of the vaccine while driving noticeable numbness and tingling while driving 3 days after receiving the vaccine today is the 3rd day
Pt IS COMPLAINING OF RIGHT SHOULDER PAIN SINCE VACCINATION - JUST NOTIFIED ON 8.6.18.
Last menstrual cycle March 20. Typically 30 day cycles never longer. First dose of covid vaccine was April 2. Was 8 days late for April period. Started on April 26 and was due April 19. Haven?t ever been late more than 1-2 days since onset of periods (23 years ago).    About 24-36 hours post 2nd dose  I keep getting short 15/20 second headache almost brain freeze on either side of temple. Only happens handful of times 2 days post injection so far.
hives; with itching; inflamed; This is a spontaneous report from a contactable consumer (Patient reported for herself). A female patient (age: 52, unit not reported) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on 10Mar2021 03:00 as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. On unspecified date of Mar2021 the patient experienced hives with itching about eight hours after receiving vaccine. The patient stated that she had itching all night and has raised bumps. Patient queried if she could take benadryl for the itching. Patient had hives and was inflamed. The outcome of the reported events was unknown.  No follow-up attempts were possible, information about lot/batch number could not been obtained.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 29-Apr-2021 at 11:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 11:52 AM, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.93.  Concomitant products were not provided.  On 29-Apr-2021, Excursion time was 10 AM, temperature was 33, total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 AM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45 and 4 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
69 patients received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 patients received expired vaccine) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 patients received expired vaccine). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 patients received expired vaccine) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. It was reported that the original was kept -15 to -25 and then shipped and kept refrigerate. This lot was shipped 06-Dec-2021 and the new expiration date should have been 05-Jan-2022 due to the refrigeration of the vaccine.
Received DTaP, IPV, HIB, MMR on 9/13/02. On 9/16/02 seen by PCP, right foot, knees are swollen and painful.
Narrative:  COVID infection following COVID vaccine series 02/11, Moderna, dose #1 03/11, Moderna , dose #2 08/13 pt cc: fatigue, rhinorrhea, sore throat, exposure: unknown 08/14 COVID swab, result: detected
This initial spontaneous case, was received from a pharmacist on 20-Oct-2017, concerns a 19-year-old, adult, female patient. This was fourth out of 04 reports. On 10-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 195216 and expiry date: Apr-2018). On 10-Oct-2017, the patient was administered with influenza vaccine that reached 72F for up to 90 hours and had no adverse effects. It was reported that, the FLUCELVAX was left out of the refrigerator for a couple of days. The reporter assessed the case as non-serious. Follow-up received up on 26-Oct-2017: It was reported that, the patient had no adverse effect after the vaccination. Narrative amended accordingly.
101.9 Fever (Apr 7 evening to Apr 8 evening) Severe Headache (Apr 7 afternoon to Apr 8 evening) Muscle pain especially lower extremities (Apr 7 afternoon to Apr 8 evening)
This spontaneous report was received from a healthcare professional referring to a 15 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 26-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Patient passed out about 3 minutes after Moderna Covid19 vaccine EUA administration and came to really quickly and decided to move to a chair.  No difficulty breathy per paramedics but when they arrived she passed out a second time and paramedics opted to take patient to hospital for observation.
improperly stored vaccine was administered; This spontaneous report was received from a pharmacist, concerning a 14-years-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and drug allergies were not reported.   On 04-SEP-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as 05-JAN-2022, that was improperly stored (product storage error) as prophylaxis (dose #, anatomical location and route of administration were not reported). There was no product quality complain involved.  It was unknown if there was previous temperature excursion. Temperature was reported as "stated in the refrigerator". A data logger was not used.  "Lot number [T00341] is an invalid lot number for [varicella virus vaccine live (Oka/Merck)]."