chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother elected to have child receive 4 vaccinations. 2 given in each arm. Two nurses injected the vaccines simultaneously. After the 2nd injection given - child immediately noted to have eyes roll back in head and slump in chair.  Child regained conciousness after approx 10 seconds. Reported a headache. Child given water and fruit snacks. Said she was feeling better. HR 76, O2 98%. Child assisted back to lobby where family was. Child appeared pale, reported feeling dizzy and blurred vision. BP 80s/40s. Assisted to laying position on ground. Given more water. Cool packs place on forehead, wrists, and stomach. Encouraged to drink more water. Remained concious. BP rechecked after 10 minutes: 94/61 laying. HR 62. O2 96%. Face pink. Child reports feeling better. Approx 30 min after syncopal episode, assisted back to sitting. Recheck BP 101/64. Child able to ambulate without symptoms.  Child left the office with mother.
PATIENT REPORTS A  TEMP OF >104, CHILLS, AND  BODY ACHES,  ALSO REPORTS FEELING LIKE HIS JOINTS WERE ON FIRE, IE RIBS, AND JOINTS. PATIENT DID REPORT A SIMILIAR REACTION TO HIS SECOND SHOT.  THERE MAY HAVE BEEN EXPOSURE TO COVID, PT IS WAITING TO BE TESTED.
Patient experienced flu-like symptoms 26 hours post second dose of pfizer covid vaccine.  She missed work for one day and was instructed to take over the counter tylenol to help resolve her symptoms.
Information has been received from a physician via Poison and Drug Center (PDC) referring to a baby patient of unknown age and gender. The patient's medical history and concurrent condition were unknown. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, lot# and route unknown) and a dose of VARIVAX (Merck) (dose, lot # and route unknown). The physician reported that the vaccines were administered using potentially tainted diluent, which was extra diluent in the physician's office (lot #LO28090 with expiration date of 26-MAR-2018), but was not provided with the vaccines. At the time of reporting, it was unknown if the patient continued to receive M-M-R II and VARIVAX (Merck). Additional information been requested.
Following the vaccine the next day she had the normal discomfort, tiredness and the arm was sore for about a week.  Then on 2/11/21 she had an ocular migraine, and as that ended she was hit with an intense pain in her head that she had never experienced before.  It lasted for hours, for the rest of the day.  She took Ibuprofen which did not do anything.  She looked up online and the  clinic had a report on what to do for the migraines, and she took Ibuprofen and strong coffee.  She does that and was able to ward it off and stop it some.  Then it continued to happen during the day and the pain is so intense.  The day before yesterday, 3/9/21 the regimen of coffee and ibuprofen did not improve.  It goes from the top of her head, down to her neck and sore to touch behind her ears.  It is now a dull headache around her whole upper skull.  She lives alone and her children do not live anywhere close to her.  She is also having horrendous fatigue and is not able to get much done such as shopping, also shortness of breath and pounding heart beat generally is very active and some days she is not able to get dressed due to the symptoms.   She went to UC and she had them do a COVID test, which was negative and sent to the ER at and her BP was 191/75, and was told to FU with her neurologist and internist and had no answers for her headaches.
PATIENT VISION BECAME BLURY, AND PATIENT EXPERIENCED COLD/HOT FLASHES
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/02/21,pfizer,Lot#EL0142. 2nd dose: 01/23/21,Pfizer,Lot# EL9262. Diagnosed covid positive:07/09/21. Exposure:community. Symptoms:Sore throat.
irregular vaginal bleeding/ period should not start for another two weeks, the period started within 36 hours after the vaccination; Dose 1 (31Mar2021)/Dose 2 (09Aug2021); This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 09Aug2021 18:00 (at the age of 33-years-old) as dose 2, single for covid-19 immunization in a Pharmacy or Drug Store.  Patient had no relevant medical history or known allergies.  The patient is not pregnant at the time of vaccination. Concomitant medication included regular birth control pills (unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 31Mar2021 10:00 at a dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19. On 11Aug2021 12 am, the patient experienced irregular vaginal bleeding described as the period should not start for another two weeks however the period started within 36 hours after (as reported) the vaccination. Treatment was not taken for the event. The outcome of the event was reported as recovering at the time of the report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates from November 2015 to 25-FEB-2016, the patients were vaccinated with an unspecified number of doses of VAQTA lot # L014068, expiration date: 02-NOV-2017 and lot# L018499, expiration date: 25-FEB-2017 (dose and route of administration were not reported). Administered doses of VAQTA underwent temperature excursions at 46.72 Fahrenheit degrees, for 23 hours 49 minutes (0ver 3 month frame). There were no adverse effects reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Intussusception. Required partial colectomy.  2/24/09-records received for DOS 1/8-1/13/09-DC DX: Intussusception. Presented with 2 day history of lethargy and vomiting, increased fussiness increased reflux. Attempted pneumatic reduction of intussusception unsuccessful. Partial reduction by laparoscopy and partial colectomy with removal of terminal ileum and ileocolostomy. Intussusception irreducile and resection of terminal ileum and right colon.
Tender to touch; Redness and Swelling of left arm 24 hours after vaccination; Swelling 5.5 in long and 3 inch wide/swelling of arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender to touch), VACCINATION SITE ERYTHEMA (Redness and Swelling of left arm 24 hours after vaccination) and VACCINATION SITE SWELLING (Swelling 5.5 in long and 3 inch wide/swelling of arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-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 TENDERNESS (Tender to touch), VACCINATION SITE ERYTHEMA (Redness and Swelling of left arm 24 hours after vaccination) and VACCINATION SITE SWELLING (Swelling 5.5 in long and 3 inch wide/swelling of arm). At the time of the report, TENDERNESS (Tender to touch), VACCINATION SITE ERYTHEMA (Redness and Swelling of left arm 24 hours after vaccination) and VACCINATION SITE SWELLING (Swelling 5.5 in long and 3 inch wide/swelling of arm) outcome was unknown.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
has muscle soreness at the injection site; left very fatigued / feels tired; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th April 2021 12:00, the patient received the 1st dose of Shingrix (intramuscular). On 20th April 2021, 5 hrs after receiving Shingrix, the patient experienced injection site muscle pain and fatigue. On an unknown date, the outcome of the injection site muscle pain and fatigue were not recovered/not resolved.   The reporter considered the injection site muscle pain and fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The patient received 1st dose of Shingrix in the left arm and 5 to 6 hours later he left very fatigued and had muscle soreness at the injection site. The patient stated that the night before reporting, he slept like a baby, which was not normal for him. The reporter did not consent to follow up and did not give permission to contact healthcare professional.
12/22/04 Patient called to say her left upper arm is still sore where she received HIB vaccination on 12/15/04 (ordered by MD in preparation for pending splenectomy). Arm pain increased with movement, wakes her up at night. Has notified MD.  This nurse recommended using warm/cold packs and taking Tylenol or Advil. Still sore for 7 days.
For the second dose i had the same symptoms nausea, tiredness and could not sleep at night. My doctor told me to take some medication for the second dose that helped.
Pt received first GARDASIL injection 4/10/09. On 4/12/09, noted 1cm round tender axillary node.
1. Bruising at injection site 5/7/2013. 2. Swelling of left arm 5/7/2013. 3. Low grade temp- states noticed 5/12/2013. 4. Limited range of motion- physical therapy initiated.
Injection site swelling, hive at the injection site, left upper arm swelling, increase temperature at the site of vaccination, headaches
pt recv vax 12SEP96 & 16SEP96 pt was adm to ICU w/a low platelet count;CT scan revealed abnormalities;pt began bleeding from mouth, 18SEP96 & brain dead;cause of death was cerebral hemorrhage;MD unsure if events r/t vax;
Shortness of breath and chest tightness starting the day after the second dose of the vaccine. This was also present after the first dose of the vaccine, but much milder. I also experienced, chills, headache, and body aches. I took Tylenol for these symptoms and took 2 zyrtec for the shortness of breath. All symptoms lasted only about 24 hours. They seem much better on 2 days after the vaccine.
I produced so much mucus through the night I woke up as it was coming out of my nose and mouth. It then progressed to headaches, fever, body aches, I used a home COVID 19 test that came back positive. I called my physician to let them know I had tested positive for COVID 19 and requested the PAXLOVID. They agreed that I should be taking it and called it in to my pharmacy. I started taking it immediately I started feeling better within two days, remained in quarantine the whole five days. I used TYLENOL to help with the headache and body aches.
began itching breakout w/red splotches all over body,  erythematous macules to arm legs, trunk, abd, no drainage, periorbital edema;pupils equal, ear, nose, throat, heart & lung ok;
After second dose I woke up with a severe reaction. I could not move my arm and could not get dressed. This had happened 20 years earlier when I was first diagnosed with RA. I took Ibupropen and went to my family doctor the next day. He gave me predizone and it worked. After that I started having RA pain everyday and had to start taking my meds again. I also have been to the dentist a couple of times with gum pain that started at the same time. The dentist can not find anything wrong with my teeth or gums but the pain started at the same time as the RA flares.
Hurt in arms and legs muscles and had lumps come and go in arms and legs. Sugar test was twice as high as before shots. I'm a Diabetic. Shots were given on 8/1/01, 8/4/01, 8/8/01, 8/15/01 and 8/29/01.
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient reported previous history of fainting at the sight of needles, administered vaccine, patient responded well, stated "that was all", then sat for his 15 minute wait, fainted and hit his head, small cut above his left eye, EMS called, alert and responded
Caused Migraine headache to come back; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Caused Migraine headache to come back) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MIGRAINE (Caused Migraine headache to come back). On 26-Feb-2021, MIGRAINE (Caused Migraine headache to come back) had resolved.
Patient received 2nd dose of COVID vaccine on 1/20/21.  Patient became symptomatic on 4/5/21 with runny nose and headache. Patient then reported loss of taste and smell on 4/9/21.  Patient received a monthly scheduled PCR COVID test for work on 4/9/21 and received a COVID positive test result on 4/10/21
Unqualified employee per  eligibility criteria.  The nurse in the vaccine clinic was auditing employee vaccines and found that an employee 44 years old had received the 2nd booster for covid-19. The information was found in the employees intraportal file. The employee came for their booster. I registered the employee, and followed the protocol of screening questions and checking the vaccine card before the employee received the injection. employee agreed that they were here for the 1st booster and they needed to be vaccinated per policy. the employee did not have their complete vaccine card. After contacting the employee they stated they had more than one vaccine card, and was aware that they had received a 2nd booster but was unware that the 2nd booster does not apply to them. The employee stated that they are well and have not experienced any adverse reaction or injury.
My under lip started to swell and my chest became slightly tight before I left the grocery store. Symptoms remained mild but my chest was still slightly tight several hours later.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 11:00 as dose 4 (booster), single (Lot number: gh9703), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INSULIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Investigational results for Lot # GH9703: Batch and lot tested and found within specification was checked. Product Description (CR): COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot-# (CR): GH9703. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9703. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (Name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning an approx 4 yr old female who on 23Aug04 was vaccinated SC with a dose of varicella virus vaccine live (lot 647092/0885N). Within 2 weeks of the vaccination, the pt experienced redness, swelling, tenderness and warmth at the injection site. On 04Sep04 the pt was examined by the physician and the physician found 6 varicella lesions on her face, neck, scalp and right forearm. On 07Sep04 the pt was seen again and a blackening scar was observed at the injection site. It was reported that it looked to be developing cellulitis. The pt was treated with (Duricep) and will be seen for follow up on 17Sep04. It was reported that the pt was recovering. Additional information has been requested.
Had tetanus shot 9/11/08 1430. On 9/12/08 at about 1200 donor started to have nausea (mild). Donor did not treat the nausea. Nausea was intermittent for 3 days and cont to be mild. On 9/15/08 nausea was completely gone and did not return. No vomiting reported. Denies other symptoms.
Pt felt "fainty" 2 days after vaccine. Went to ER - had blood tests and EKG per pt. Discharged after several hours and instructed to follow up with MD. MD prescribed "med to thin blood" once daily. Pt then showed me referral for TEE/Cardiogram for Atrial Fib.
first dose in January 2020 / 2nd dose had not yet been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Chills/shivering; Feeling hot; Low grade fever; Sweating; Joint & muscle aches & pains; Joint & muscle aches & pains; Headache; Indigestion; Reflux; Insomnia; Fatigue; Joint & muscle aches & pains; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 36-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 12Apr2021 11:00 (at the age of 36-year-old) at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient was not allergies to medications, food, or other products. The patient did not receive 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 has not been tested for COVID-19. Patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 22Mar2021 14:45 (at the age of 36-year-old) at dose 1, single for covid-19 immunisation and experienced sore arm. On 12Apr2021 22:00 the patient experienced Chills, shivering, feeling hot, low grade fever, sweating, joint and muscle aches and pains, headache, indigestion, reflux, insomnia, fatigue. Patient did not received treatment for the adverse events. Outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
swelling underneath the left arm/hard lump; not able to rise left arm; tenderness at injection site; muscle underneath left arm hurts; fatigue; tiredness; little itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little itching), SWELLING (swelling underneath the left arm/hard lump), PAIN IN EXTREMITY (not able to rise left arm), VACCINATION SITE PAIN (tenderness at injection site) and MYALGIA (muscle underneath left arm hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ?40233A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PRURITUS (little itching). On 19-Mar-2021, the patient experienced SWELLING (swelling underneath the left arm/hard lump), PAIN IN EXTREMITY (not able to rise left arm), VACCINATION SITE PAIN (tenderness at injection site), MYALGIA (muscle underneath left arm hurts), FATIGUE (fatigue) and FATIGUE (tiredness). At the time of the report, PRURITUS (little itching), SWELLING (swelling underneath the left arm/hard lump), PAIN IN EXTREMITY (not able to rise left arm), VACCINATION SITE PAIN (tenderness at injection site), MYALGIA (muscle underneath left arm hurts), FATIGUE (fatigue) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient takes high blood pressure medication.  Patient was treated with Tylenol every 4 hours.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot number M034187 with expiration date of 17-MAY-2019 for prophylaxis (dose, route of administration and anatomical location were not reported) and Merck sterile diluent for prophylaxis (lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion 47.3 degrees F for 50 minutes and 34.9 degrees F for 1 hour. There was previous temperature excursion reported as 47.5F 48 minutes and 35.4F for 30 minutes. A "data logger" was involved. This is one of several cases received from  the same reporter. Sender's Comments: US-009507513-1810USA002882; US-009507513-1810USA003390.
Mother called stating that child developed hives/welts over legs, buttock, arms, 2 areas on back and one on face the evening (6 pm) after receiving PENTACEL and PROQUAD at 1015 am. Went to ER for treatment. Clear next day 1/22/14. Had hives again after nap 1/22/14. Not as bad. 4 on legs and on arm.