chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt stated she had a regular appt w/ her Cardiologist on 2/1/2021 which did blood work.  She was told her platelets were high.  They are usually normal but after taking the covid vax they were elevated with a reading of 605.
Information has been received from a health professional concerning a 12 month old female who on 10/09/2001 was vaccinated with varicella vaccine live. On 10/30/2001, the pt developed bumps all over, a vesicular, pustular rash for "a few days." The registered nurse reported that the pt had one symmetrical dark, scaly, 1cm lesion on her back and multiple 10-15 blisters, some crusted, on her trunk, scalp, and legs. Additional info has been requested.
Patient received only the powder vial of this two part vaccine.  It was inadvertently diluted with sterile water diluent instead of the included part two liquid vial.  This dose was deemed invalid and was repeated on 12/1/21  The root cause of this error is due to the packaging by manufacturer.  Unlike all other vaccines, this two part vaccine must be mixed together in order to be effective.  It is not a sterile water diluent like our other vaccines.   Other vaccines packaged this way come as 10 vials in a box = 10 doses.  Menveo is 5 vials each of the liquid and powder therefore only 5 doses.  The two vials do not come "attached" in any way.  GSK knows this is an issue and therefore has created bands that we can pair the vials to each other after opening.  In a busy clinic, or new staff when the box is opened its easy for staff to pull just one vial - if its the powdered vial - reconstituting with sterile water diluent like other powedered vaccines is a common error.  If the liquid vial is pulled, its easy to administer just this liquid without mixing.    When this happens, its difficult to trace to one patient therefore often the entire 5 doses need to be tracked and revaccinated since its difficult to know who may have received the correct dose vs incorrect.   In this instance an inexperienced MA administered the powder only, diluted with water to a total of 4 patients before the error was discovered.      Recommended packaging change so that it is very clear that its a two part vaccine , perhaps a peel pack with the two vials together or apply the band before packaging instead of having the end user apply the band.  Better yet. similar to solumedrol vials - its one vial with two chambers, that when the lid is pushed down, it pushes the rubber stopper and the two parts mix together.  This would also prevent unnecessary access to the vial with needles to remove and inject into the other.
product storage error; This spontaneous report was received from the administrator from the doctor's office referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.       On 20-OCT-2020 the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot # S027467, expiration date 02-MAR-2021, for prophylaxis(dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).         The vaccine was stored in a temperature of 17.2 degree Fahrenheit (°F) for 1 hour and 30 minutes as recorded by a data logger. There was a previous temperature excursion of 12.2F for 1 hour.
On the second day after getting the second dose, I started having chills, general malaise like a cold, this increased to an internal fever, a lot of nasal mucus, sore throat, and now in the chest.
approx 15days p/vax pt exp generalized rash. addl in for requested
2 red spots on right breast- faded 3 spots on left breast- very itchy, faded then returned Scattered spots on torso- itchy, faded then returned
Patient reports received J&J vaccine on 4/9. Later that day developed a minor headache and dizziness. Woke up on 4/10 still feeling dizzy, and this has been persistent since.  Patient states it comes in waves, and at times feels her vision is a little blurry.  Denies vomiting, diarrhea, headaches today. Patient states also feels chest may be a little heavier today- "sensation of wearing a shirt that is too tight"  but denies difficulty breathing or SOB.  Pt denies any leg pain/redness/swelling/warmth.
patient reported swelling in the injection arm, located more specially in the bicep region and swelling down the trunk of his torso. patient reported no redness but swelling. patient to this day (06-25-2019) is still experiencing swelling in his arm.
got the flu every time; Initial information regarding this unsolicited valid non-serious social media  from  consumer (patient) and transmitted to Sanofi on 12-Dec-2020.  This case involves an unknown demography patient who got the flu (influenza) every time, while he/she received INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route on an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza, non-serious event) every time unknown latency following the administration of INFLUENZA VACCINE.  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Soreness at injection site, redness in three areas surrounding shot.  It was hot and itchy.  Put ice pack on, bacitracin ointment.  The soreness went into my arm pit.  Still dealing with issue.
Patient was in for appointment with a primary care provider and received the HPV, meningococcal, and the flu vaccines during that appointment. Patient was sitting on the patient couch in the exam room and became pale, diaphoretic, and fainted approximately 1 minute after being given the HPV vaccine. The patient had already received the meningococcal and influenza injectable vaccines a minute prior to receiving the HPV vaccine. The nursing staff and primary care provider responded to the nurse call for assistance within seconds and the patient was already starting to say a few words and was still seated on the couch in the exam room. Patient's father was also present. Patient did not sustain and injuries. Blood pressure was 149/80, pulse 82 with initial assessment at the time of the fainting episode. Patient was assisted to lie down and elevated feet above level of heart. Patient was observed, provided oral fluids and allowed to rest in a supine position over the next hour, patient was able to progress to a sitting position and stand briefly. He was able to drink 2 (6 ounce) cans of apple juice and 3 (8 ounce) cups of water without difficulty. The patient was alert and oriented, with normal color and feeling better, but still very tired out upon discharge to home with father. Patient's vital signs were stable at 118/79 (blood pressure) and 87 (pulse). Patient was escorted by wheelchair with nurse to his father's car and was dismissed to the care of his father. The patient's primary care provider was notified of the patient's stable condition at the time of discharge from the clinic to home. The patient's primary provider was notified of the emergency response actions taken.  The emergency response actions taken were discussed with the family members present at the event.
This case was reported by a consumer and described the occurrence of fever in an adult female patient who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified), pneumococcal vaccine (non-gsk). A physician or other health care professional has not verified this report. The patient's medical history included foot surgery and hospitalization. Concurrent medical conditions included asthma and ulcerative colitis. Co-suspect medication included ATIVAN multi dose powder inhaler, ADVAIR HFA inhaler and SYMBICORT. Concurrent medications inculded PROVENTIL HFA, Symbicort, VENTOLIN HFA, DULERA, Probiotic and Prednisone. On an unknown date, the patient started ADVAIR multi dose powder inhaler 500/50 Diskus (inhaled) at 1 puff (s), variable dosing. The patient stated that she has taken ADVAIR DISKUS for many years. She stated that she has had thrush while on ADVAIR, even after rinsing her mouth. The patient stated that she takes ADVAIR DISKUS one puff in the morning and two puffs at night. She used to take ADVAIR 500/50 mcg; however, her physician decreased the strength of ADVAIR to 250/50 mcg which helped decreased the thrush. She said that she normally gets thrugh within 24 hours of her first dose of ADVAIR and her physician prescribes fluconazole tablets for 10 days to treat the thrush. The patient was currently taking Fluconazole and a generic mouth rinse to treat the thrush and her physician advised her to eat yogurt after taking ADVAIR to prevent thrush. She stated that when she has thrush. She stated that her prescriber sometimes switches her from ADVAIR DISKUS to ADVAIR HFA. She does not have thrush on ADVAIR HFA, but she said that her physician stated that ADVAIR HFA is not as effective. The patient provided very limited information. At the time of reporting, the oral thrush was unresolved. In October 2013 the patient received a dose of Influenza vaccine unspecified (unknown, unknown arm) and unspecified dose of Pneumococcal vaccines (Non-GSK) (unknown, unknown arm). The patient reported she date in 2013, within months after vaccination with Influenza vaccine unspecified and Pneumococcal vaccines (Non-GSK), the patient experienced oral fever of 103 degrees and walking pneumonia. The fever resolved after three days. At the time of reporting the oral thrush was unresolved and the outcome of the walking pneumonia was unspecified.
Stomachache; Agitated; Shaking; Upper back pain; Neck pain; Chills; Achy muscles; Headache; Tachycardia; A spontaneous report was received from a consumer, concerning a 58 year-old female who developed tachycardia, chills, achy muscles, headache, neck pain, upper back pain, shaking, stomachache, and agitation. The patient's medical history and concomitant medication lists were not provided.  On 22Jan2021, the patient received her first dose of mRNA-1273 (batch number: 01362019) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 22Jan2021, post vaccination, the patient experienced chills, achy muscles, headache, neck and upper back pain. On 22Feb2021, the patient experienced tachycardia and shaking in the morning and subsequently the patient went to the emergency room (ER) and was later released. The patient underwent unspecified series of tests.   Treatment included administration of acetaminophen, lansoprazole, and diazepam.  The outcome of the events, tachycardia, chills, achy muscles, headache, neck pain, upper back pain, shaking, stomachache, and agitated were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Office visit 6/12/06 F/U on lump on right deltoid, Disc options including surgical removal and doing nothing.
Difficulty breathing, referred to ER. Mother reported in ER that pt broke out in hives and face is swelling.  Mother thought pts blood pressure was elevated, but not sure.  Tx was 2 shots, mother said pt felt better.
Pt recv vax on 3/9/99; 1 hr post vax pt exp nausea, dizzy, tender/ sore/warm/ bruised LA, tingling left fingers, achy; tx=rest &Ibuprofen
Chest pain, High blood pressure, Heart rate was fast and i also had tingley hands . It  happened about 45 Minutes after i had the vaccine. I was then sent out to the hospital.
Information has been received from a health professional concerning a 15 week old female patient who on 03SEP2002 was vaccinated with a dose of varicella virus vaccine live On 03APR2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine live and developed break through chickenpox. Additional information has been requested.
Child awoke the day after vaccination and his upper arm was swollen, hard, warm and painful.  He had pain trying to flex or extend at the elbow.  He returned to our office on 07/15/2010 for treatment.  Not febrile or otherwise ill.
First Dose of Moderna Vaccine was administered on 09-Mar-2021 and second dose of Moderna vaccine was administered on 01-Apr-2021; Dry eyes; STUNG; SORE THROAT; Felt Dizzy; COVID SHOT CAUSED SORE MUSCLE; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (Dry eyes), PAIN (STUNG), OROPHARYNGEAL PAIN (SORE THROAT), DIZZINESS (Felt Dizzy) and MYALGIA (COVID SHOT CAUSED SORE MUSCLE) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Rheumatoid arthritis. Concomitant products included INFLUENZA VACCINE for Flu vaccination.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose of Moderna Vaccine was administered on 09-Mar-2021 and second dose of Moderna vaccine was administered on 01-Apr-2021). In 2021, the patient experienced DRY EYE (Dry eyes), PAIN (STUNG), OROPHARYNGEAL PAIN (SORE THROAT), DIZZINESS (Felt Dizzy) and MYALGIA (COVID SHOT CAUSED SORE MUSCLE). At the time of the report, DRY EYE (Dry eyes), PAIN (STUNG), OROPHARYNGEAL PAIN (SORE THROAT), DIZZINESS (Felt Dizzy), MYALGIA (COVID SHOT CAUSED SORE MUSCLE) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose of Moderna Vaccine was administered on 09-Mar-2021 and second dose of Moderna vaccine was administered on 01-Apr-2021) outcome was unknown.    Concomitant product use was not provided by the reporter. In 2021, the patient experienced that Moderna covid vaccine shot caused sore muscle, stung, felt dizzy, dry eyes, and sore throat.  No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. This case was linked to MOD-2021-624984 (Patient Link).   Reporter did not allow further contact
Left injection site swollen (thigh); warm to touch and very sore. Swollen from 5cm below left inguinal area to lower part of left knee (left thigh 31cm circumference, right thigh 29cm)
Fever for 14 hours. 102.5 and when on Motrin and Tylenol could get down to 99.6, but nothing less. Full body aches, unable to get out of bed. Fever, chills, full body aches. Headaches.
Patient states that injection site started itching/burning/tingling. Area was very red and hard. She cam to the pharmacy 2 days later to show me. And indeed, I felt the area and it was hard, raised, feverish feeling and maybe 2 inches across. I advised her to take BENADRYL by mouth and use cool compress. Injection site reactions arm common. But this RXN appeared worse than most.
At  5 weeks pregnant dose 1 was administered  at 8 weeks a complete spontaneous miscarriage occurred
72 year old female came to get dose # 2 of Hepatitis 3 dose series.  She as given the pediatric dose instead of the adult dose.
Dose Given After Excursion; Initial Report Received on 11-Oct-2021  A registered nurse reported that a 42-year-old male (race, and ethnicity unknown) were administered HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after a temperature excursion occurred.  No medical history was reported.  No relevant concomitant medications were reported.    On 25-Aug-2021, the patient received a dose of HEPLISAV-B (Lot #s, expiration dates, NDC #s, and serial #s unknown) at the clinic.  The HEPLISAV-B had a temperature excursion. No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Itching, wheal. No induration. No SOB, no tongue swelling. Advised Diphenhydramine 25mg now & q 6 hours prn.
LESS THAN 24 HOURS AFTER GETTING VACCINE SHE GOT A RED RASH AT SITE OF INJECTION AND IT FELT HARD BENEATH THE SURFACE OF THE SKIN. IT WAS ITCHY. SHE SAID IT WAS WARM TO TOUCH. SHE HAS ALWAYS RECEIVED FLU SHOTS IN THE PAST AND NEVER GOT A REACTION LIKE THIS SO SHE WANTED TO REPORT IT. ON 9/30/17 SHE CAME TO THE PHARMACY TO REPORT IT AND IT WAS STILL RED AND LOOKED A LITTLE BRUISED. SHE SAID IT WAS GETTING BETTER BUT STILL HURT.
AT 10 pm on 11/5, I had severe uncontrollable shivering for at least 1 hr.  At 7 am on 11/6 I had severe headache, muscle pain in legs, unsteady upon walking, high blood pressure 160/76, pulse 106
Within 4 hours of the vaccination, Postherpetic Neuralgia, replicating the same nerve pain associated with a prior (5 year) incidence of shingles. Pain was level 7-8 and made it extremely difficult to move at the torso (stand up from toilet, sit down into an automobile seat).
Patient was given a Pfizer Pediatric Dose instead of an Adult Dose.  Patient had no reaction
This spontaneous report as received from a physician assistant refers to a patient of unknown age. On 25-AUG-2014, the patient was vaccinated with a expired dose of PNEUMOVAX 23 (lot # J009827, expiration date 10-AUG-2014, route not reported). No adverse effect was reported. Additional information has been requested.
Shoulder aches, hard to lift arm, going on 4th week now.  I get the flu shot every year (I work in the hospital) and never had a reaction, but this year, I felt it was strange the minute she gave it to me, I felt it was too high.  I think better education needs to be given for administrators.
The patient was very nervous of the vaccine and of needles & informed the certified technician of this. She talked to her to calm her prior to administering the vaccine. Said patient was shaking during the administration. The technician informed her we would have her sit & wait for 15 minutes & when she got up she was shaking and said she was going to pass out. The technician called for assistance & told the patient to sit back down. Pharmacist came and patient did faint in the chair. We tapped her a few times and held her up in the chair for a short time until patient came to. Patient called her mom & we gave her crackers, orange juice and held ice packs on her and talked with her until her mother came.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 13:00 as dose number unknown, single (Lot number: EW0158), in left arm and on 12Nov2021 as dose number unknown, single (Lot number: FH8020) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (06Jul2022) Negative, notes: negative Covid tests after 5 days of Paxlovid treatment (06Jul2022 to 10Jul2022); (10Jul2022) Negative, notes: Home Covid tests stayed Negative from 10Jul2022 to 14Jul2022; (14Jul2022) Negative, notes: Home Covid tests stayed Negative from 10Jul2022 to 14Jul2022; (15Jul2022) Positive, notes: on 15Jul2022 and tested Covid positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective, covid-19.
Information has been received from a physician concerning a 7 year old female with no allergies or pertinent medical history who on 22-DEC-2000 was vaccinated with a first 0.5 ml dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 03-AUG-2007 the patient developed shingles. Unspecified medical attention was sought. No lab studies were performed. The patient was recovering. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Headaches, stomach pain. Possible seizure. Sent to Neuro 5/22/18 for a follow up.
sore arm started at 2pm-still have have it. Chills and fever-10pm day of shot-5am 2/26 Headache-10pm 2/24-9am 2/26  Body aches and muscle weakness-3am 2/25-10am 2/26 Nausea 3am 2/24-9pm 2/25
Caller states that 5 deaths, from that vaccine was reported; This is a spontaneous report from a contactable consumer. This is the 1st of 5 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date, Consumer stated that 5 deaths, from that vaccine was reported and over 50% of people reported a debilitating disease, or cannot function, and have thousands of dollars in medical bills. The outcome of event was fatal. Autopsy was unknown.  Information on the lot/ batch number has been requested. ; Reported Cause(s) of Death: Caller states that 5 deaths, from that vaccine was reported
Left neck pain/soreness radiating to mastoid and down to left chest.  Had difficulty swallowing/eating due to pain now improved.  Drank 1 alcoholic beverage of 1 oz alcohol and symptoms increased significantly.  Left neck still stiff and has hypersensitivity to cold and hot temps.  Pt tried ibuprofen w/o relief.  Exam on 10/27/2010 showed left ant/post cervical adenopathy only and tenderness to left SCM muscle and paraspinous muscles of neck.  No lesions ever noted at injection site on left deltoid.