chrisvoncsefalvay/vaers-outcomes huggingface dataset:
With the first dose  I felt sick for 1 day. I called out.  The morning after receiving the 2nd dose I had severe fatigue, joint pain, my wrist and my armpit was budging, I noticed swelling my clavicle on my left side, chills, and dizzy. I had to miss work for 2 days. I had to lay bed in for 2 days. By 3rd it was much improved but I still feel weak. About 4 days after receiving the vaccine I was back to feeling my self.  On 2/14-15/2021, my face was itching, I scratched it, and there is a small abrasion. My face started to swell, around 2AM this morning I had to go to the ER because my eyes were getting small, the swelling was getting worse. I also had bumps that looked like hives on my face,  there was some fluid coming out of my face. I went to  early this morning,     The ER doctor said she thinks it is not infected she thinks it is inflamed. I did not mention that I had recently received the COVID  vaccine and did not realize that it may be linked to the vaccine until later in the day. She prescribed Hydrocortisone 0.5 % cream  and Mupirocin 2% cream.   Since I have been home the ER the swelling has worsened. My face is painful, it feels like an orange peel when you touch.
This case was reported by a nurse and described the occurrence of allergic reaction in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number TA422, expiry date 30th June 2019) for prophylaxis. Previously administered products included Influenza shot (received every year for the past 14 years). On 5th October 2018, the patient received FLULAVAL QUADRIVALENT  2018-2019 season. On 5th October 2018, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced allergic reaction and urticaria. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction and urticaria were unknown. It was unknown if the reporter considered the allergic reaction and urticaria to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by a nurse for herself. The age at vaccination was not reported. The patient experienced allergic reaction, described as welts with severe itching on thoracic area, trapezoid and popliteal area. The patient had taken Benadryl 50 mg on 5th October 2018 and another Benadryl 25 mg on 6th October 2018. The nurse tried to figure out if there was a molecular component that was different from the previous shots she had received compared to this year so she could avoid further allergic reactions in the future. The nurse wondered if there were a few people this year, who have had an allergic reaction to this year's vaccine.
T105, pale blue color, breathing difficulties, rash, consistent crying for over 24hr;
SINUS CONGESTION, WEAKNESS, AND RASH ON FACE AND RIGHT ARM.
Patient with severe dizziness and intractable nausea/vomiting. Upon admission to the ED last night his platelet count was 9. He has a subconjunctival hemorrhage OS and frank hematuria, besides the epistaxis. Pinpoint erythematous lesions noted on his forearms. No other bleeding noted.  ADAMTS13 level confirms TTP .  Patient now on day 4 of PLEX treatment.
Syncope: Source of Information: Patient and Available medical record. History of Present Illness:  Patient is a 86 y.o. male with the past medical history of advanced dementia who presented from group home facility for complaints of syncopal episode. On examination patient is alert not in distress however not answering any questions which appears to be his baseline he does have advanced dementia obeying few commands. Per EMS sheet patient was found sitting on barstool per group home staff, patient appeared to be passed out approximately for 2-3 minutes. Limited history available secondary to patient's status. ED course 158/98, heart rate 103, respiration 18, SPO2 96% on room air, ammonia level-28, TSH-1.19, ETOH-none 10, troponin-I is 0.01, sodium-142, potassium-4.2, GFR-57, BUN/creatinine 20/1.30, lipase-192, Covid-19 positive, AST-74, AST-39, no leukocytosis, CT brain without any acute process.
This spontaneous report as received from a physician refers to a 68 year old female patient. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) and experienced allergy to vaccine. There was no concomitant medication provided. The outcome of allergy to vaccine was unknown at the time of the report. The reporter considered allergy to vaccine to be related to PNEUMOVAX 23. Additional information has been requested.
My shoulder became sore and stiff, than spread across the back of my neck and down my left arm. After that my joints started to ache. Than I got the chills with no fever. Extreme fatigue. Occured for 24hrs. Side effects started to ease up after that. Lots of rest.
I started to feel symptoms on the morning of Wednesday, September 1, 2021. My partner started to feel sick a few days before me. On August 31, I took a COVID test and it was negative. When I felt sick on Wednesday, my partner was sick as well and he tested positive COVID. I took another COVID test on Thursday, September 2nd and it was positive. My symptoms got worse over 3 or 4 days with a fever from 99 to 101, extreme exhaustion, fatigue, and fogginess. After a few days I started to feel better. The fever went away but I lost my sense of smell and taste. My fever was going away, but my neurological symptoms felt like they were getting worse. The fever and exhaustion had got better since being quarantined. It has been about a month, but I have still experienced a little bit of exhaustion, fogginess, and not feeling like doing as much as I used to. About a few ago I started to smell and taste again. I feel like I am about 95% better now. I couldn't work for two weeks because of the exhaustion I had and feeling like all I wanted to do was sleep.
Fever, chills, painful and swelling like a golf ball but redness bigger than a baseball.
no additional adverse events; an adult patient was administered a pediatric dose of RECOMBIVAX HB; This spontaneous report was received from a medical assistant referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 27-MAY-2020, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # R001530 wit an expiration date on 07-NOV-2020, for prophylaxis. No additional adverse events were reported. . combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R001530; expirationdate: 07-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Expired 2nd Dose Given of the Series; Initial Report Received on 26-Sep-2023  A retail pharmacist reported that a 69-year-old female patient (race and ethnicity unknown) was given an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and it was the 2nd dose of the series.  Medical history and allergies at the time of vaccination were not reported. Medications at the time of vaccination were not reported.  On 21-Aug-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot # 937228, expiration date 30-Aug-2023, NDC # 43528-003-05) intramuscularly in the right arm.  On 26-Sep-2023, the patient received an expired second dose of HEPLISAV-B vaccine (Lot # 937228, expiration date 30-Aug-2023, NDC # 43528-003-05) intramuscularly in the right arm. No adverse reactions were experienced by the patient to the reporter's knowledge.    No further information was provided.  Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
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 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 1:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (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 70.97.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 08 AM, 09 AM temperature was 32, 32 total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 PM: 43, 1PM: 44, 2 PM: 46, 3 PM: 46, 4 PM: 44 and 5 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 Fisher brand 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.
No additional AE/PQCs reported; Administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent concurrent conditions, medical history and drug reactions or allergies, if any, were not provided.   The medical assistant reported that, on 16-SEP-2020, the patients was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHA (dose number, route, dose, and anatomical location of administration was not provided; witch lot number T015598 has been verified to be a valid lot number, expiration date reported and validated as 02-NOV-2021) for prophylaxis.   The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was exposed to a temperature excursion of 20.5 degrees Fahrenheit for a time frame of 1 hour 54 minutes, which was detected by the Digital Data Logger. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (12.3 degrees Fahrenheit) for 23 minutes. No adverse effects or product quality complaints were reported.
Pneumococcal conjugate on 26-JAN-2007, 06-NOV-2006, 08-AUG-2006 and 15-FEB-2006; Pneumococcal conjugate on 26-JAN-2007, 06-NOV-2006, 08-AUG-2006 and 15-FEB-2006; This spontaneous report was received via Pfizer from a consumer regarding herself a female patient of unknown age. No information was provided regarding the patient's medical history or concurrent conditions. The patient was allergic to amoxicillin, penicillin, sulfamethoxazole-trimethoprim, azithromycin and cefdinir. The patient's historical vaccine included: Hepatitis B Vaccine (Recombinant) (manufacturer unknown).  On 15-FEB-2006, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported) and haemophilus influenzae type b (Hib).  On 22-MAR-2006, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown), Diphtheria (+) Tetanus (+) Pertussis (DTaP), inactivated poliovirus vaccine (IPV).  On 24-MAY-2006, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown), Diphtheria (+) Tetanus (+) Pertussis (DTaP), haemophilus influenzae type b (Hib).  On 08-AUG-2006, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), Diphtheria (+) Tetanus (+) Pertussis (DTaP), haemophilus influenzae type b (Hib), inactivated poliovirus vaccine (IPV).  On 06-NOV-2006, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), influenza vaccine.  On 26-JAN-2007, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (manufacturer unknown) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported) and with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).  The patient subsequently experienced allergy to vaccine, redness, soreness and swelling at the vaccination site, nausea, dizziness, headache, drug hypersensitivity and lactose intolerance on vaccination with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine  (GARDASIL), Hepatitis A Vaccine, Inactivated (manufacturer unknown), Hepatitis B Vaccine (Recombinant) (manufacturer unknown), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (case # 2107USA008849) and overdose on vaccination with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (case # 2108USA000378) and extra dose administered.; Sender's Comments:  US-PFIZER INC-2021644192: US-009507513-2107USA008849: US-009507513-2108USA000378:
This spontaneous report as received from a pharmacist refers to a unspecified number of patients of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L048848 with expiration date on 09-AUG-2018, (route and anatomical location were not provided). The time frame was reported as 10 hours with a temperature between 0 degrees C and 1 degree C. A first excursion of 14 degrees C had occurred previously which lasted 2 hours on an unspecified date. The pharmacist reported no adverse effects. There was a data logger issue involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was 5 years old but administered the 6 month-4 year Pfizer dose
had a rash underneath his injection site; experienced strong muscle aches mid-chest up, arms, back, hands, & jaw two nights in a row; This is a spontaneous report from a contactable consumer (the patient) .    A 75-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 13:00 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation  .  Medical history included hypertension  (Takes high blood pressure medicine).   In the past the patient received an unknown vaccine against hay fever and experienced rash. On 23Feb2021 the patient received the first dose of BNT162B2 vaccine.    The patient experienced experienced strong muscle aches mid-chest up, arms, back, hands, & jaw two nights in a row  on 18Mar2021 01:30 with outcome of not recovered , had a rash underneath his injection site  on an unspecified date with outcome of unknown.   Course of the event: After 2nd shot, the patient experienced strong muscle aches mid-chest up, arms, back, hands and jaw two nights in a row. Took Tylenol. Since then, once almost every day, usually weight training or fast walking, the patient  experienced the same ache, maybe not as severe as the first two nights but it sure does get his attention. The patient been checked out at the ER to insure it's not a heart issue per  primary care physician. The emergency room doctor told the patient his EKG was fine and his bloodwork didn't show anything.   No follow-up attempts are needed; No further information is expected.
pt. recd. 3rd dose of hepatitis b vac. & experienced a sore arm which persisted for 3 days.
Patient thought they received Moderna previously, documented that on pre-vaccine checklist, and scheduled today for second dose Moderna, Denied having vaccine card, received Moderna vaccine, then returned with vaccine card after visit, nurse noted patient previously received Pfizer not Moderna.  Nursing administrator notified, NA notified clinical director for guidance. Although, mixed-series doses is not considered approved per the EUA and the CDC has specific guidance for exceptional circumstances to interchange them, it is still an error; however, per the CDC "Do not repeat dose". Patient notified of error, encouraged to report any unexpected side effects / adverse effects ASAP to clinic and follow up with provider if needed, if emergent sx arise notify 911/EMS. Patient verbalized understanding and agreement. No s/sx adverse effects noted thus far.
After vaccination that day, patient was too tired to get out of bed to do his evening walking exercises. On 6/10/2021 3:00 am, patient unable to support himself on the commode and was put back to bed. Next couple of days patient was too weak to get out of bed. 6/14/21 1:00 am, patient became very congested and unable to remove fluid in his lungs, wife called medics and patient was admitted to hospital for 2 days with pneumonia. 6/16/21 7:00 pm, patient discharged from hospital. That night, patient became very congested despite continuous suctioning through the mouth, patient experienced respiratory distress and lungs congested with fluids, 2:30 am medics was called and paramedic performed invasive deep suctioning of lungs via his nose on way to the hospital, upon arrival at hospital they performed another deep suctioning of lungs before sending patient to the ICU. 6/21/21 4:00 pm, patient discharged from hospital in stable condition, doing physical therapy and occupational therapy at home.
Arm is little sore; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiration date: was not reported), via an unspecified route of administration on 09Feb2021 as DOSE NUMBER, UNKNOWN SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Feb2021 the patient experienced arm is little sore. Outcome of event was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187758 Same reporter/product, different patient/events
Low grade temp (100 deg f) beginning about 3 hours after receiving shot.  Became very tired and loss of appetite followed by diarrhea about 8 hours after shot followed by mild headache through the next 24 hours.  I am reporting this mainly because my reaction was unexpected and happened on the first dose.  I have not yet received my second dose.
Information has been received from a registered nurse referring to multiple patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M018810, expiration date: 28-MAY-2018; dose and route unknown) for prophylaxis. From 14-OCT-2016 to 06-DEC-2016, the GARDASIL 9 was stored under temperature between 32 Fahrenheit and 36 Fahrenheit for totally 135.5 hours. The GARDASIL 9 was stored under temperature between 46 Fahrenheit and 77 Fahrenheit for totally 40.5 hours. Data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA012145: US-009507513-1703USA005337:
THIS PATIENT REPORTED TODAY THAT THE FLU VACCINE HE RECEIEVED 12/4/06 PRODUCED SWOLLEN NODULES AT BOTH NIPPLES, 2 DAYS POST VACCINATION. PATIENT SEEN BY HIS OWN PHYSICIAN AND TOLD THIS WAS MOST LIKELY AN IMMUNE RESPONSE TO THE VACCINE. HIS PHYSICIAN WILL FOLLOW-UP IN ONE MONTH.
Vaccine administered intramuscularly to right deltoid. Patient became diaphoretic, ashen, and had  episode of syncope within 1 minute of injection. Patient placed in modified Trendelenburg position.  Continued to have bradycardia, hypotension, diaphoresis over the next 30 minutes. 3 mins following episode: HR 48, BP 100/58. 10 minutes following incident and in sitting position, BP drops to 80/48, HR 43. Returned to Trendelenburg position. Placed on 1 L oxygen via nasal cannula. EMS called 30 minutes after incident patient remains diaphoretic HR 58, BP 113/71. EMS transports to Medical Center for observation and IV fluids.
This spontaneous report as received from a nurse. She states that doses of ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included live, oral ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II and live, oral ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details when she is able to retrieve the information. SR # provided. It is not know at this time if there have been any adverse effects. Rotavirus vaccine date given 10/31/2012, Medical record # 147602, Lot # 0210AE. Additional information has been requested.
Two days post vax, the pt developed diarrhea with cramps and abdominal pain which lasted one day. The pt was being treated with amoxicillin for otitis media at the time of immunization. The amoxicillin was discontinued due to diarrhea and resumed four days post vax.
I started to have a scratchy throat. The next morning I had a severe headache. On the 4th day I developed a low grade fever, fatigue, cough and nasal congestion. About 4 days later I went in to see the doctor, and they did a COVID-19 test that came back positive. I got medication to help with my cough, and steroids. I was unable to keep taking the steroids because my throat started to close up. So I just took Nyquil day and night time. I still have fatigue, and congestion in my throat, and head.