chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about concomitant medications, pertinent medical history and drug reactions was provided. On unknown dates, an unspecified number of patients had been subcutaneously administered improperly stored (since 22-APR-2015) doses of PROQUAD (Merck) (dose, frequency, route of administration not reported), (lot # K020747, expiration date 30-APR-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from Pfizer (manufacturer control number 2014331640) on 12-DEC-2014. A nurse practitioner reported a patient (age, gender and ethnicity not reported) had an allergic reaction to PNEUMOVAX 23 last year (2013). The outcome of the allergic reaction was not reported. Additional information is expected.
Vaccination failure; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 11Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 24Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Anti viral details: product=COVID 19 Treatment, brand=Pfizer Paxlovid, treatment start date=20Jun2022, treatment stop date=23Jun2022, indication=Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Body aches, low grade temp, fatigue lasted about 24 hours occurred the same day of administration, and lasted about 24 hours.
On 28-Feb-1021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting), HEADACHE (headache) and BACK PAIN (Pain back). At the time of the report, VOMITING (vomiting), HEADACHE (headache) and BACK PAIN (Pain back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: patient within 3 minutes of receiving vaccine felt dizzy and blacked out for a few seconds right after the vaccine.  After 5 minutes patient felt better.  Patient stayed for 30 minutes before leaving the pharmacy.
Sudden loss of vision, "seeing dark circles", not being able to feel legs and hands, was reported by patient within seconds of vaccine administration. Pt diaphoretic, pale and trembling. 3-5 minutes after that, patient reported being able to see clear without problem, was able to feel legs and hands, except for some numbness on (R) leg. Vital signs monitored for 30-40 min. Patient taken to family doctor.
With first two covid-19 vaccines my arm got soar; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (With first two covid-19 vaccines my arm got soar) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Avocados make him nauseous), Diabetic since 2010, Vitamin D deficiency (Low vit D) since 01-Jan-2015, Iron deficiency (Low iron) since 01-Jan-2015, Kidney function abnormal (Protect kidney) since 01-Jan-2012 and Stomach discomfort (Protect stomach) since 01-Jan-2012. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 01-Jan-2012 to an unknown date for Allergy, GLIMEPIRIDE from 01-Sep-2021 to an unknown date and METFORMINE [METFORMIN] from 01-Jan-2012 to an unknown date for Diabetic, IRON from 01-Jan-2015 to an unknown date for Iron deficiency, LISINOPRIL from 01-Jan-2012 to an unknown date for Kidney function abnormal, OMEPRAZOLE from 01-Jan-2012 to an unknown date for Stomach discomfort, MULTIVITAMIN [VITAMINS NOS] from 01-Jan-2011 to an unknown date, ASCORBIC ACID (VIT C) from 01-Jan-2015 to an unknown date and FISH OIL from 01-Jan-2015 to an unknown date for Supplementation therapy, COLECALCIFEROL (VIT D3) from 01-Jan-2015 to an unknown date for Vit D resistant rickets.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-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 VACCINATION SITE PAIN (With first two covid-19 vaccines my arm got soar). At the time of the report, VACCINATION SITE PAIN (With first two covid-19 vaccines my arm got soar) outcome was unknown.            The treatment information was unknown. Patient height was 5' 11".   This case was linked to MOD-2021-400010, MOD-2021-403175 (Patient Link).
The following day (20 hrs after vaccine) I lost sense of smell to coffee and tuna only. All other taste/smell was ok. By the end of that day, taste/smell of tuna recovered but coffee did not. Also developed low grade fever and arthralgia about 30 hours after dose. Fever and arthralgias resolved overnight but loss of taste/smell of coffee ONLY persist. Has rapid Ag and PCR tests done 28hrs  hrs after vaccine and and both negative.
received the second dose of Shingrix by subcutaneous route; Redness in the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number L7S74, expiry date 27th March 2022) for prophylaxis.   On 25th February 2020, the patient received Shingrix (subcutaneous). In February 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema. On 25th February 2020, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix subcutaneous, incorrect route of vaccine administration. The reporter consented to follow up.
This spontaneous report was received via sales representative from a medical assistant refers to her daughter, a 33 year old female patient. Medical history was not reported. In 2006 (also reported as sometime in 2006) the patient was vaccinated with all the three doses of GARDASIL injection (lot number, expiration date, route and dosage were not reported) for prevention of HPV. Concomitant therapy was not reported. The medical assistant informed that on an unknown date the patient was diagnosed with HPV. A PAP smear was performed. The patient sought medical attention by an office visit and was on an unspecified treatment for the adverse event. The outcome of the event was resolved on unspecified date. Additional information has been requested.
Pt vaccinated with Engerix-B developed hemolytic anemia. Treated w/seven pints of blood.
Multiple Blood Clots in Right Lung,  clots  passed through his heart and caused his death
Caused bursitis in my right shoulder. Started the night of the vaccine, lasted 6 weeks. I ended up getting a steroid injection to the shoulder since it wasn?t getting better.
Information has been received from a registered nurse concerning an approximately 11 year old patient who was deficient in pneumococcal antibodies and on approximately 4/5/05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649912/0529P). Subsequently, the patient developed swelling and erythema. Unspecified medical attention was sought. The patient was treated with unspecified oral antibiotics. The patient was hospitalized and treated with unspecified IV antibiotics. The patient was reported to be recovering. No product quality complaint was involved. Additional information has been requested. It was also reported that another child was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649912/0529P; same lot number but different vial) and developed adverse events (WAES0504USA01899).
ON TUESDAY 3/24 AT ABOUT 1 PM I BEGAN TO FEEL HOT AND SWEATY. THAT EVENING I STARTED TO RUN A FEVER. MY WHOLE BODY AND HEAD ACHED BADLY. ALSO AREA OF INJECTION WAS SORE AND RED AND WAS THROBBING. I WAS VERY AWAKE, COULDN'T RELAX I TOOK NYQUIL BECAUSE MY NOSE WAS STUFFED UP TOO. I BEGAN TO SHAKE A LITTLE AND MY WIFE TOOK MY TEMP IT WAS 102. THAT WAS AT ABOUT 10 PM. I WASNT ABLE TO FALL ASLEEP. I GOT UP TO USE THE BATHROOM AT ABOUT MIDNIGHT AND I HAD LIQUID DIARRHEA..BY THIS TIME MY BACK AND NECK WERE KILLING ME ALSO I WENT BACK TO BED AND DRANK SOME WATER....I BEGAN TO BREATHE VERY HEAVY FOR SOME TIME..I FINALLY GOT TO SLEEP AT 3 AM. 5 AM I WOKE TO VOMIT THE WATER AND THE SOUP I HAD FOR DINNER. ALL DAY THE 25TH I WAS IN PAIN. MY BACK HURT MY NECK HURT AND I WAS VOMITING AND STILL HAD THE LIQUID DIARRHEA..MY BREATHING WAS HEAVY AND FAST I HAD TO BREATHE HEAVY BECAUSE I HAD A PAIN RIGHT IN THE MIDDLE OF MY FOREHEAD THAT FELT BETTER WHEN I PANTED I TRIED TO DRINK FLUID BUT IT WOULDN'T STAY IN..THIS WAS THE SAME FOR THURSDAY. BUT IT FELT WORSE I GUESS. I DONT REMEMBER MUCH OF THURSDAY I TRIED TO SLEEP AS MUCH AS I COULD BUT MY WIFE SAYS IT WAS WORSE THEN WENDSDAY. MY CUT ON MY LEG DIDN'T HURT BUT EVERYWHERE ELSE HURT. MY TEMP STAYED STEADY AT 102.3 FOR 1 DAY THEN 101. FOR TWO DAYS AND FRIDAY MORNING IT WAS 99 I FELT BETTER FRIDAY NIGHT BUT WAS STILL GROGGY FOR A FEW DAYS. I HAVE NEVER EVER FELT THIS BAD IN MY LIFE!!!! IT FELT 5x THE FLU ON YOUR NUMBER SCALE IT WAS A 9 FOR PAIN AND DISCOMFORT.
Sore arm; Pain in Left Cheek; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FACIAL PAIN (Pain in Left Cheek) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Herpes genital since an unknown date. Concomitant products included LEVOTHYROXINE, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), OLANZAPINE (ZYPREXA), FLUOXETINE HYDROCHLORIDE (PROZAC), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), VITAMIN D3 and VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FACIAL PAIN (Pain in Left Cheek). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FACIAL PAIN (Pain in Left Cheek) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Within 15-minutes of vaccination, the patient reported dizziness, but they did not syncopize. EMS evaluated the patient on-site. The patient was slightly hypertensive (147/92). EMS transported the patient to Emergency Department. In the ED, the patient presented with dizziness and confusion. Physician administered 1L normal saline bolus. Labs and imaging were unremarkable. Physician spoke with patient's mother who stated that the patient is at baseline given significant psychiatric history. Patient was discharged with a diagnosis of dizziness.
Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Confusion-Severe, Systemic: Hypotension-Severe, Additional Details: Suspected Vasovagal Reaction and loss of conciousness
One thing I experienced was back pain while sleeping at night. I was diagnosed with Type 2 diabetes (out of nowhere), an enlarged heart  and I was told that I had a fatty liver. I did not have any complications with anything like this prior to receiving my vaccine. I am now off the medication for Type 2 diabetes because it's not necessary. I do suffer from rheumatoid arthritis. My test results showed that my liver enzymes were normal, but serotine was elevated. I received a notice and I need to have an abdominal sonogram to check my liver. I had to take metformin. I was told that I needed to see an Endocrinologist. Out of nowhere, I had to start seeing a bunch of different doctors for different problems. I had an abnormal kidney study, bone spur in my foot, I had elevated blood glucose, levels of liver transaminase were elevated and I have uterine fibroids.
Vaccinatino was Sat 10/10/15 - patient had pain at site, but Sun. Had swelling, redness, fever and soreness down arm. By Tuesday better. (MOTRIN relieved fever/pain).
passed away(death); temperature 99.7F; tired; left arm swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (passed away(death)) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Asthma ((but everything was under control).).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (left arm swelling) and FATIGUE (tired). On 31-Jan-2021 at 10:30 AM, the patient experienced PYREXIA (temperature 99.7F). The patient died on 25-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PERIPHERAL SWELLING (left arm swelling), PYREXIA (temperature 99.7F) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Body temperature: 99.7 f (abnormal) elevated.         On 31 Jan 2021, the patient was tired and went to bed early. At 10:30 pm, the patient's wife reported the patient's temperature as 99.7 degrees Fahrenheit and was given acetaminophen. The patient's left arm had swelling. The patient's son (doctor) prescribed antibiotic for treatment.  On 01 Feb 2021, the patient was taken by ambulance to hospital. He was at hospital for 24 days and was on a ventilator.  Treatment included Tylenol antibiotic.  Company comment: Very limited information regarding the events has been provided at this time.  Further information has been requested..; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested..; Reported Cause(s) of Death: Unknown cause of death
Painful arm with rash that is also hot, swollen, and itchy. Painful exactly one week after injection, then more of a rash appeared on day 8. Spread a bit down my arm on day 9, which is the day I am reporting.
hot flashes, heightened sense of smell to the point of nausea, lightheadedness
Pt experienced dizziness & nausea after receiving, MMR & varicella.  Vital signs taken - WNL.  Pt rested for 10 mins & was improved.
I felt extreme tightness in my chest making it very difficult to breathe. I became very hoarse and I felt extremely dizzy.
Wheezing, tight chest, hard to catch breath.   Feeling of passing out, very hot, dizzy, weak.
Diagnosed with bradycardia and an irregular heartbeat. Received a pacemaker on 8/20/12.
Systemic: Fainting / Unresponsive-Mild, Additional Details: She got fainted for 10 second and then regained conciousness. Store called 911 , and they come and checked her
All of a sudden I started having uncontrollable chills with shaking and a pounding headache.  Really bad aches all over body, trying to get out of bed was really difficult as was staying on my feet.  After two Tylenol is was only mildly better and managed to wait 6 hours before taking two more that didn't help a lot.  I was like this right through about 4pm on Saturday, Dec 25.  That monring I had to switch to an aspirin as the Tylenol just wasn't working.  I still didn't feel a whole lot better until the next morning, Dec 26 at which point I was well enough to drive into another city to see my daughter and grandchild.
Two weeks later on February 28, 2021 my left arm was red and slightly swollen and very warm to the touch.  I applied a cool cloth and it improved but was red for a couple of days.  Doctor examined on 3/2/2021 and symptoms subsided.  Arm is still achy.
Had shot years ago, have them now/Suspected vaccination failure; Have them now, had them  number of time; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had them a number of time).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shot years ago and had them now. The patient guessed he/she will get the new shot when he/she can. The patient stated that hoped it helps. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per narrative, dose number was not clear which patient got years ago and for which dose patient was guessing to get, therefore the case was kept valid with single dose without dose number and along with suspected vaccination failure and shingles.
The patient had pain on her right deltoid approximately 1-2 hours after receiving Hepatitis IM. She complains of itching at the site of injection to the elbow. Seen in HS, no redness or swelling at site, no rash noted, no dyspnea. (Treatment- ice and Ibuprofen)
Patient said at first she had pain, swelling, and fever which were consistent with vaccine. However, on Tuesday, March 12 the pain and redness in her shoulder increased and she said she was diagnosed with cellulitis. She said the cellulitis is from the site of injection and has been on 2 days worth of IV antibiotics.
Information has been received from a physician, concerning a 25 year old female patient who on 13-FEB-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #655503/0012U). There was no concomitant medication. The physician reported that "shortly after her first dose of Gardasil," the patient experienced nausea and vomiting. At the time of this report, the physician confirmed that the patient had recovered (date not specified). The patient sought unspecified medical attention. Additional information has been requested.
Headache started about 4:00 p.m. Muscle aches and ears hurting - 9:00 p.m. Diarrhea and throwing up at 4:00 a.m. took TYLENOL, ADVIL and PEPTO BISMOL.
A non-serious report of influenza, temperature of 103 degrees, cough and vomiting was received from a physician concerning a five-year-old female.  No medical or drug history was reported for this patient.  The patient received an initial dose of FLUMIST in October and a booster on 16-Nov-2007.  She had not received influenza vaccinations in previous seasons.  On 18-Dec-2007, the patient presented with a temperature of 103 degrees F with a slight cough and vomiting.  The rapid flu test was positive for both A and B.  Last January, the patient had Flu A with similar symptoms and a positive rapid flu test.  The event outcome is not available.  Additional FLUMIST dosing for this season is not indicated.  The reporter did not provide a causality assessment for the adverse events reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
the patient was administered an improperly stored dose of PROQUAD on 1/25/2019; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 25-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S013715 and expiration date for 01-NOV-2020 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The temperature and the time frame was unknown by reporter. There was a digital data logger involved, but there was no previous temperature excursion. The vaccine was reconstituted with sterile diluent, which was properly stored, lot # S026378 and expiration date 15-MAY-2022.
20-40 minutes after injection; tightness in chest, similar feeling as asthma attack; however, no wheezing. Lasted about 5 hours.
NO ADVERSE EVENT. PATIENT INTENDED TO RECEIVE THE MODERNA BIVALENT BOOSTER.
left eye was twitching like crazy, the eyelid & eyebrow was constantly twitching all day long; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLEPHAROSPASM (non-serious) with onset 04Apr2021, outcome "unknown", described as "left eye was twitching like crazy, the eyelid & eyebrow was constantly twitching all day long".  Additional Information: Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine last 03Apr2021. Starting 04Apr2021, her "left eye was twitching like crazy, the eyelid & eyebrow was constantly twitching all day long". By 08Apr2021, it went away, but came back less noticeable than the first few days. From 09Apr2021 up until 16Apr2021, the eyelid is still twitching "on and off"; not whole day long. Patient tried to manage it with her sleep, coffee, stress management, and also spoke to her doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant referring to two patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M024702, expiration date 18-MAY-2018; lot # L044524, expiration date 09-NOV-2017, dose not reported) subcutaneously. No adverse effects were reported. Additional information has been requested.