chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 at 09:45 as dose 1, single (Lot number: EK9231), in left arm, on 03Feb2021 at 13:15 as dose 2, single (Lot number: EL9264), in left arm and on 08Oct2021 at 09:00 as dose 3 (booster), single (Lot number: FE3592) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroditis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "known allergies: lots of foods sensitivities/intolerance" (unspecified if ongoing), notes: known allergies: lots of foods sensitivities/intolerances-gluten, corn, dairy, etc.; "sensitivities/intolerances-gluten" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: diary" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 11Apr2009. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: COVID setback- return of (very mild) symptoms and a positive test result. Intermittent sore throat from a scratch to sandblasted, thick post-nasal drip with mucous expectoration, occasional sneeze (allergies?), some rhinitis.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
The next day, I had a seizers that lasted for about 10 minutes. I do have a history of seizers. It was control for 10 years. I went to my neurologist. They did blood work to check my medicine levels and I also have an EEG schedule.
1hr p/shot pt started screaming, eyes won't focus, wouldn't eat for 10hrs;called MD advised more APAP
Large bruise or blood accumulation under skin on left lower thigh, 4 inches by 3 inches appeared about 3-4 hours after injection along with reddening of right ear. No other explanation of bruise/blood accumulation under skin that's still there 2 days later, not worsening, but still looks the same. Off and on chills and fatigue about 6 hours after vaccination continuing to the present.
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2009 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a health center pharmacy. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 11-NOV-2014 the patient was treated at urgent care for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 22-APR-2013 the patient sought additional (conflicting info) treatment at urgent care for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Patient's Left arm started hurting and was red beginning the next day 04202020 after the Shingrix shot was administered.The arm started itching the next day 04212020.The arm has continued to itch and has remained red.The patient will take a Benadryl to hopefully help with the itching and swelling.The patient will call her Doctor to tell her what has happened.I told the patient I will call her on Sunday to see how she is doing.I will follow up with her.Patient has reported no signs of fever but has a off and on headache which she believes is due to her sinuses.
Information has been received from a health professional concerning an adult female with an allergy to neosporin who on 03-APR-2006 (also reported as 04-APR-2006) was vaccinated with a dose of Varivax. On 17-APR-2006 the patient developed a bump at the injection site that was 3cmx3cm. By 20-APR-2006 the bump was 7cmx5cm. The bump was hot to the touch. The patient was treated with cold packs and Advil. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Fever 2-3 days ago. Broke out in red, spotted rash yesterday. Itches. Came to doctor's office today and Dx Varicella.
Significant blood in stool began within 3-4 days following Covid vaccination.  Continued for 4 months. After first 4 months, blood continues to occur by in 50% of stools.
flu-like symptoms; chills; arm started swelling up; real red; very sore; had a lot of itch; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (arm started swelling up), VACCINATION SITE ERYTHEMA (real red), VACCINATION SITE PAIN (very sore), VACCINATION SITE PRURITUS (had a lot of itch) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included CETIRIZINE for Allergy, LISINOPRIL, ROSUVASTATIN CALCIUM (CRESTOR) and POTASSIUM for an unknown indication.   On 18-Jan-2021, the patient received first 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) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm started swelling up), VACCINATION SITE ERYTHEMA (real red), VACCINATION SITE PAIN (very sore) and VACCINATION SITE PRURITUS (had a lot of itch). On 26-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 325 milligram. At the time of the report, VACCINATION SITE SWELLING (arm started swelling up), VACCINATION SITE ERYTHEMA (real red), VACCINATION SITE PAIN (very sore), VACCINATION SITE PRURITUS (had a lot of itch), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills) outcome was unknown. Not Provided      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.   Reporter did not allow further contact
Systemic: Fever-Severe, Additional Details: Husband called while driving home to report his wife called and said she is having a high fever of 105-106 degrees F. Asked if taken any acetaminophen or any other fever reducer. Reports she has taken ibuprofen and fever hasn't been coming down. Advised to take her to urgent care or emergency room. Advised could call Urgent Care to talk to nurse triage so they can let him know where it is best for her to be seen for the fever. Advised on giving acetaminophen if possible now.
Moderna 3/12/21, 4/9/21, 1/31/22. Positive on 7/28/22
This spontaneous report was received from a medical assistant and refers to an 18-month-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-MAR-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L014429 and expiration date 15-MAR-2018 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2014US017653 is an initial spontaneous report received from a pharmacist on 29 August 2014. This report refers to a 63 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145223) intramuscularly on 25 Aug 2014. On the same day after vaccination, he experienced hives. The outcome was unknown. Seriousness and causality were not reported.
Initial report received from a health care professional on 12 November 2010. A 15-year-old female patient, with a history of a "cold" with upper respiratory symptoms at the time of vaccination, received the first dose of MENACTRA on 04 June 2010 and then again on 29 October 2010 an injection (route and site not provided) of MENACTRA, lot numbers not reported. On an unknown date in October 2010 and after the second MENACTRA, the patient developed a stiff neck, severe headache and a fever of 102.6. No further information was provided. The outcome was not reported. Documents held by sender: None.
Minimal pain innodes under right arm; Pain in neck.; Very painful, swollen lymph nodes under the left arm.; Pain in left.; Pain in shoulder.; headache; fever; body aches; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 11:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroiditis. Concomitant medications included T3 and T4 thyro meds (medicines). The patient had known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021 at 21:00, the patient experienced very painful, swollen lymph nodes under the left arm. There was minimal pain in the nodes under the right arm. The patient also had pain in the left arm, neck and shoulder. Then the patient experienced headache, fever and body aches for two days following injection. It was reported that lymph nodes under the left arm were still swollen. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included the treatment with ibuprofen. The clinical outcome of headache, fever and body aches was recovered on 28Mar2021; while the outcome for painful swollen lymph nodes under the left arm, painful nodes under right arm, pain in left arm, neck, and shoulder were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received vaccines per protocol. Youth was accompanied without incident to waiting room, reseated and instructed to wait per vaccination protocol. He then stated he was having trouble seeing, and became visibly pale. He was supported by two healthcare personnel and complied with instruction to lie on exam table.  Alert and oriented to person, place and time. Upon questioning, he stated that he had "a bowl of ramen" around noon and appeared flushed. Patient was given a snack size bag of candy and consumed this in sitting position. He stated he felt better and was helped to his feet and ambulated without assistance in the care of his father.
My eyes became very dry, irritated. It almost appears that I am developing a sty. My vision in my right eye is blurred and all of this happened 2 days after my 4th dose of Moderna. I am seeing my ophthalmologist.
Approximately 4 hours after receiving the flu shot she started projectile vomiting for about 4 times, it lasted a total of 30 minutes and then stopped.
Tingling of the Lips; dizziness; Pain in Sinuses; Nausea; Headache; A spontaneous report was received from a consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, headache, pain in sinuses, tingling of the lips/paresthesia oral, dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Jan 2021, immediately after receiving the vaccine the patient experienced the events nausea, headache, pain in sinuses, tingling of the lips, dizziness.  Treatment details included diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported.   On 8 Feb 2021 the outcome of events, nausea, headache, pain in sinuses, tingling of the lips, dizziness was resolved.
within minutes, I felt dizzy and my whole body felt heavy, like gravity had increased on me.  my skin felt hot and firey for about 1 minutes, and I took off my jacket.  my eyesight went a little into tunnel vision - but I did not feel faint... just completely off.  i felt like I had to walk it off so I did.  I go thome, but had the chills for 2 days.  Then the left side of my neck hurt like I had pulled something and my arm selled and was so painful I had to walk with it in a sling and NOTHING could touch it for the next 2-3 days.  Now its 9 days later nad I have a 3 in diamter rad spot, its dry and itchy, swollen and hurts again.  And I feel tired and crampy again.
PCV13 & Hep B yesterday at 8-14-12 at 4:30. Fever of 103 degrees last night. 102 degrees all day today. No symptoms other than fussiness. Mom home from work with him. 8/16/12 fever decreased. Went back to school per mom.
Event occurred after 2nd dose. Patient was diagnosed Covid Tylenol, Remdesivir Inpatient
EIGHT BLOOD CLOTS; This spontaneous report received from a patient via a company representative through social media concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, and expiry: UNKNOWN) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient got eight blood clots. Reported stated that ''I am vaccinated and that's how got 8 blood clots, thank you very much for being a genius". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of eight blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220547431-COVID-19 VACCINE AD26.COV2.S-Eight blood clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
8/14/21: admitted. initially presented to ED with a chief complaint of near syncope, shortness of breath, generalized weakness. tested positive for COVID 19 last Monday.  Note, he was vaccinated against COVID-19 with Johnson and Johnson on 3/13/21.  Diagnosed with acute hypoxic respiratory failure, covid-19 pneumonia 8/26/21: discharged
Pt had redness and swelling on right arm, the site of injection of MMRV 9 cm by 8.1 cm on 8/7/15 @1545.
Information has been received from a pharmacist concerning a co-worker who was a female pharmacy student that administered Zostavax (Oka/Merck) to patients at another pharmacy.  The pharmacy student developed herpes zoster, a couple of months ago in 2007.  This is one of several reports received from the same source.  Additional information has been requested.
never got the second dose of the vaccine; sore arm; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PRODUCT DOSE OMISSION ISSUE (never got the second dose of the vaccine) and MYALGIA (sore arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced LETHARGY (lethargic) and MYALGIA (sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never got the second dose of the vaccine). At the time of the report, LETHARGY (lethargic) and MYALGIA (sore arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (never got the second dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    treatment medication were not provided.
ADACEL was given 4-3-12 and re-vaccinated on 8/21/2012.
Cold sweats, fatigue, feeling faint, nausea. Stayed for extra observation time until I was well enough to drive but had to lie down as soon as I got home an hour later. Felt extremely tired and had chills. Still have them. Will hopefully feel better tomorrow. Didn?t expect the first dose to hit me this hard.
Small raised bumps on the top of both arms now spreading to neck. Not itching, mild redness.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The nurse noted that on multiple unspecified dates, multiple unspecified patients were administered with improperly stored VARIVAX (lot # K007979 with expiration date 03-JUN-2016, lot # L021211 with expiration date 10-JUN-2017; dose and frequency not provided) (incorrect product storage). The vaccines were stored at 29 Fahrenheit (F) for 4 hours. The vaccines were previous stored at 39 F for 3 hours as well as 33 F for 3 hours. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/13/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Immediate Tightness in chest, Blood Pressure Spike, Arm Pain, general muscular pain, exhaustion.  Chest Tightness and Blood Pressure spike lasted 4 days.
pt recvd 1 dose of Engerix-B & w/in 30 days of the dose devel elevated triglycerides;
My Vaccination record card I got on the day lists Janssen 1808609 and I filled out a disclosure form on the day for Johnson and Johnson.   But 2 days later I received a txt with a picture of a COVID 19 vaccination record card from hospital  stating I got the first dose of MODERNA 1808609, the CDC logo is blocking the patient number so I cannot provide .  I have tried to contact hospital by calling the number that txt me but it's not a working number. I have called many different hospital numbers that I have been passed to and even tried the school who hosted the vaccine but everyone just passes me on to someone else and says it doesn't fall under them. At this point I do not know which vaccine I have received. I have had no fever or symptoms whatsoever following my shot. I do not know if this means I likely got the moderna short vaccine 1 or I had J&J and was lucky.   I need to know which shot I got so I can travel.
Myalgia, Fever, CHILLS, INJECTION SITE DISCOMFORT Narrative:
This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, balance disorder and light headedness. On an unknown date, the outcome of the influenza-like symptoms, balance disorder and light headedness were unknown. It was unknown if the reporter considered the influenza-like symptoms, balance disorder and light headedness to be related to SHINGRIX. Additional details were received as follows: This case was received from web form submission. The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The healthcare professional (HCP) reported that, they had a patient who developed flu like symptoms after a dose of SHINGRIX as this was a common. However, the patient also had a feeling of light headedness and off balance.
I had diarrhea for 2.5 days, pain on injection site, no fever. I just hydrated myself  and ate my normal meal.
PATIENT REFERS THAT AFTER THE VACCINE ADMINISTRATION, SHE FELT A BURNING SENSATION, AND SHE NOTICED HER RIGHT ARM WITH EDEMA, SWOLLEN, RED, AND HOT TO THE TOUCH. SHE RECEIVED ANTIBIOTICS IV (ROCEPHIN) FOR ONE WEEK.
At 1620, pt. received Pfizer vaccine administered by RN at clinic. Pt. was sent to observation area, which is in the cafeteria. At 1625, Support staff checked on pt. and pt. reported he felt dizzy and immediately informed RNs. Pt. was sitting on the chair and drinking water when this incident occurred. During assessment, pt. was found diaphoretic, pale in skin color, pt. reported blurry vision, and trouble breathing. Pt. respirations rate was 16 breaths per minute, non-labored, no signs of any distress. Pt. stated no prior medical history. After a few minutes, pt. started to recover. Pt. skin color started to improve and less diaphoretic. At 1629, EMS called by RN. Pt was moved to another area away from other patients. Pt. was able to ambulate, follow commands/ directions without any deficits. At 1637, EMS arrived, pt. vitals was taken BP=100/50's and stable. Pt. refused to go to the hospital for further observation. RN stayed with pt. until 1700. Pt. was given some snacks and drinks (gatorade and water). Pt. was moved across the nurses' vaccination table for further monitoring. Pt. fully recovered and left to go home at 1732.
(L) arm SQ injection, varicella redness welling, redness warm at site.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Lot number: ER2613, Expiration Date: Jul2021) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01, Lot number: EN6202, Home test positive), administration date: 25Feb2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "COVID-19", "experienced only mild arm soreness with the vaccinations as well as minimal fatigue", "experienced only mild arm soreness with the vaccinations as well as minimal fatigue". The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "experienced only mild arm soreness with the vaccinations as well as minimal fatigue".