chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown age and gender. Information on the concurrent conditions and medical history of the patients were not reported. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD lot #L034930, expiry date, 03-MAR-2017, Lot # L027634, expiry date 21-JAN-2017 (incorrect product storage). Concomitant medication were not reported. No adverse event were reported. There were no Product Quality Complaint (PQC) involved. Temperature at which the vaccine was stored was 6.5 degree Centigrade, for a time frame of 3 hours. There were no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
Pregnant at time of vaccination, confirmed by 8wk ultrasound with heartbeat on 1/29/21. Due date was . Missed miscarriage discovered at a routine ultrasound (nuchal translucency) at 13w2d on 3/8/21. Baby was a few days behind on measurements (so died within that week). No cause found but also no genetic testing done. No maternal illness or symptoms.
Pt received TDaP vaccine on 12/14/17 11:36 after screening questions indicate she had not had previous adverse reaction to this vaccine and no hx of allergy to the vaccine. Pt notifies clinic via phone call on 12/15/17 at 1536 that she was experiencing pain site of vaccine since am. States she is unable to move right arm. Offered patient follow-up appt with provider. Pt declines. Advised to use cold compress/NSAID to manage pain & to report if sx persist or worsen. Advised pt of Urgent Care hours available. 12/19/17 placed call to patient to f/u. Pt reports that is experiencing burning pain right shoulder which limits mobility of right arm. Pt has not scheduled follow-up on problem or gone to Urgent Care for re-evaluation of symptoms. Patient did have appointment with gynecologist 12/18/17 and communicated problem to provider. Provider gave Rx for NORCO to manage Rt shoulder pain. Pt states she has not taken this Rx. PCP notified. PCP places call to patient 12/19/17 and advises patient to come for exam in clinic, offered same day appt. Pt declines stating it is too difficult to get to clinic. 12/20/17 Pt comes to Urgent Care for exam reports Rt arm pain and numbness in fingertips right hand. Exam reveals no erythema, warmth or skin changes in deltoid area. Pt reported moderate to severe tenderness to palpation at mid humerus around biceps/triceps. No redness, warmth, at site of tenderness. Pt told passive ROM by provider but is unable to actively move her right arm. No evidence cellulitis. Advised to continue ice, NSAID, Alpha lipoic Acid Supp, Arnica cream, and sling. Advised to follow-up in one week. Pt received temporary handicap placard for 3 wks at her insistence. 12/26/17 Pt calls to report arm is not getting better. Appointment scheduled for f/u PCP 12/28/17. 12/26/17 pt calls to cancel appt and reschedules with another provider 01/05/18. On 01/03/15 Pt calls to report her right arm is still in pain with burning sensation and limited mobility. She cancels appt 01/05/18 stating she has not had labs drawn yet. She believes she has nerve damage related to Tdap administration 12/14/17. 01/11/18 Pt has appt with new provider and requesting referral to neurology. Full exam completed. Xray Rt shoulder ordered: negative exam. Rt shoulder/arm appearance normal. Exam notes state pt has limited ROM, full strength, 2+ reflexes, sensation to light touch. Gabapentin therapy ordered. Referrals initiated to physical therapy and neurology. Pt advised to continue ice/heat & ADVIL PRN.
Diarrhea; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Mar2021 08:45 (Lot number: Unknown) at the age of 53 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "COPD" (unspecified if ongoing); "heart disease (CABGx3 2018)" (unspecified if ongoing). The patient took concomitant medications for diabetes, COPD, and heart disease. The following information was reported: DIARRHOEA (non-serious) with onset 26Mar2021 22:30, outcome "unknown", described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient has no known allergies and did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After obtaining consent to give vaccine and vaccine was given, while completing paperwork in medical record, it was noted that the pt. had received a dose of the same flu vaccine 1 month prior on 11/4/21
MS; legs were very tired; could not walk; very unbalanced; very weak; bedridden; fall; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 4018565.  A female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; SIMVASTATIN; CALCIUM; VITAMIN 15; BIOCAL; PROBIOTIC 10; SKELAXINE; RELAFEN. Past drug history included: Kenalog allergy, reaction(s): "Allergy"; Cipro allergy, reaction(s): "Allergy". The following information was reported: BEDRIDDEN (non-serious) with onset 23Mar2021, outcome "recovered"; GAIT INABILITY (non-serious) with onset 23Mar2021, outcome "recovered", described as "could not walk"; FALL (non-serious) with onset 23Mar2021, outcome "recovered"; FATIGUE (non-serious) with onset 23Mar2021, outcome "recovered", described as "legs were very tired"; BALANCE DISORDER (non-serious) with onset 23Mar2021, outcome "recovered", described as "very unbalanced"; ASTHENIA (non-serious) with onset 23Mar2021, outcome "recovered", described as "very weak"; MULTIPLE SCLEROSIS (medically significant), outcome "recovered", described as "MS".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
GBS with ascending polyneuropathy causing paresthesias and weakness treated with IVIG at discharged to rehab had aspiration and worsening weakness again then brought to MGH, requiring intubation
unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose; unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In December 2021, the patient experienced ACCIDENTAL UNDERDOSE (unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  It was reported that it was 5 months after her first booster and she was immunocompromised. It was also reported that the patient was under 50 and needs a second booster.  No treatment medications were reported by the reporter.
Exactly one week after taking the vaccine, I broke out with a small rash on my right arm. Within two days, the rash spread from my shoulder down to my elbow. The rash hurt so bad that I had to cut the sleeves off shirts to even be a little comfortable. I went to the doctor and they ran blood tests and skin tests and they said I was possibly allergic to an ingredient in the vaccine. Until this day, I still have the rash but the pain has subsided. I decided to get the second vaccine in the left arm and I did have a reaction, but it was not as bad as the first vaccine. I still broke out with a small rash but it was nowhere near the one I experienced on my right arm after the 1st vaccine.
Mild headaches; Rash on right arm below injection site 10 days after vaccine administration.  Rash was red, raised, itchy.   It resolved in a few days but some mild itching remained on right arm.
Bell's Palsy with transient R-sided facial weakness and notable weakness involving forehead for 4d
Pt was admitted to hospital for post smallpox vaccine, generalized vaccinia.  Had vaccine 9 days prior to symptoms of vaccinia.  Case analysis indicates pt experience macular rash and a hypersentivity reaction.
UNCLEAR TIME FRAME BUT DAY OF VACCINATION SHE WAS OBSERVED FOR 25 MINUTES WITH NO REACTION, REPORTS HOURS LATER SHE HAD DIZZINESS AND PAIN INTO HER NECK AND A MILD HA. SHE BEGAN TO FEEL PALPATATIONS. WENT TO URGENT CARE AND WAS IN AFIB.NOW ON OBSERVATION STATUS ON TELEMETRY UNIT. HAS H/O OF AFIB AND DIABETES
Patient received Prevnar 20 on 4/16/22 here in the pharmacy in his left deltoid. On 4/30/22, he noticed facial drooping on his right side.  He presented to his physician on 5/2/22 where they diagnosed it as Bells Palsy and started him on a course of Prednisone in hopes to resolve it
2 1/2 days p/vax pt devel hives on face, scalp, lt breast, abd & back;itching of feet & legs;took DPH & hives resolved by 0600 20APR96
A  4 inch red rash appeared on 2/13/21. continued both sides of arm to elbow and then inside of arm above wrist by 2/20/21. disappeared by 2/24/21.
Mother states child received 1st hepatitis B vaccine 12-17-01. That evening she developed a red rash. The rash progressed and on 12-19-01 was evaluated at Hospital. Diagnosed with hives and placed on Benadryl and oral steroids for four days. (Mother states there was also some eye swelling that resolved while waiting for doctor). On 1-5-02 developed hives again, was seen in the ER again and put on Benadryl. I saw her on 1-7-02.
When I was just administering the vaccination she jerked her arm quickly away so that the needle fell out and some of the vaccination was not administered. Recommended that she ask her primary MD if she should get another shot
soreness starting 10 days later in lymph node underarm of same arm where vaccinated.  Lasting at least 1 week.  Doctor examined with no apparent swelling.
My daughter recieved the flu vaccine on 11/8/2019. She currently has a very large red patch at the injection sight. No bruising, just redness. Does not seem to irritate or bother her.
Headache (waning); Tiredness; Arm muscle pain; Clammy; hot and cold flashes; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Jul2021 at 16:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any concomitant medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jul2021 at 00:00 the patient experienced headache (waning), tiredness, arm muscle pain, clammy, hot and cold flashes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache (waning) was recovering and the clinical outcome of the events tiredness, arm muscle pain, clammy and hot and cold flashes was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given Johnson and Johnson vaccine as a booster dose (third dose). 0.5 ml was given. No reactions./side effects.
1st Moderna, sore arm for a few days..2nd Moderna 30 days later, sore arm within an hour, begin body aches 19 hours later, 24 hours chills, next day fine except felt like a little hungover.... Then, 30 days later, wake up at 3 am, go to bathroom, get back in bed, feel like I?m falling 20 stories, then like I?m in a fighter jet like I?m shot down spinning pulling 7 G?s, I finally stop the spinning, feel nauseous, head wet with sweat, get outta bed, go on couch, spins a little more, but make it to work, but since then have felt a little ?off?...a little ?foggy??
Discontinued Pfizer Monovalent 6mo-4yr, No Adverse reactions reported by parent.
Upon standing post inoculation, reports feeling lightheaded.  Syncope episode while sitting in observation area.  Epinephrine 0.3mg IM administered & transferred to ED for observation. No medications administered in ED. Dx: vasovagal syncope - stable
Extreme muscle pain, tightness, and joint stiffness in upper arms, wrists, and shoulders (both right and left), neck, back (T and L areas) and hips.  Began approximately 24 hrs following injection.  Lasted for about 48 hrs. Tylenol/Ibuprophen alternating doses every 6-8 hrs provided some relief
Day Of (3/24/21) - None Second Day (3/25/21) - Fatigue, soreness at injection site, feeling feverish (though temp was only 97.6 degrees F) 6 Days later (3/30/21) - Lymph node swelling (large painful bump) in Left armpit 7 Days later (3/21/21) - Lymph node swelling hardened and pain increased, redness/swelling/rash/warmth/soreness at injection site 8 Days later (4/1/21) - Lymph node swelling decreased but injection site soreness slightly worse
A week after the injection, I developed cellulitis at the injection site that started as a small area and over 3 days tripled in size
Mother stated 01/27 left arm red and bigger over area that the shots were given.  On 01/28 area looked worse.  Hard to touch and he complained of pain. She called her pediatrician, the receptionist told her he needed to be seen.  She told me that she took him to the ER at a hospital.
Tiredness, body aches, chills, watery eyes, swelling in throat that lasted a couple days   Very large, swollen and itchy rash around the injection site.  Rash improved after several weeks.
BODY ACHES; SKIN SENSITIVITY; CHILLS; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, 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 subject experienced body aches, skin sensitivity, chills, and vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, skin sensitivity, and chills, and the outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.
I had abdominal pain for 2 to 3 days.  I also was light headed,  weak and had some dizziness for 2 to 3 days.  I also had a headache the evening of 3-11-21 and the morning of 3-12-21
Information has been received from a consumer concerning her 25 month old son with allergy to eggs and oatmeal, patient's mother with Sjoren's syndrome and the patient had a history of a hot, red face, limping gait, decreased urination, loose stools, increased drooling and "unusual behavior" such as staring and rocking as well as hitting his arms and legs seven days after vaccinated with the first dose of measles virus vaccine live (Enders-Edmonston) (MSD) (WAES # 0902USA04542) who on 21-JAN-2009 was vaccinated with the first dose of VARIVAX (Merck).  On 28-JAN-2009, "seven days after receiving his first dose", the patient exhibited stuttering, tooth and eye pain, as well as banging his head on the floor.  The patient was examined by his physician and the physician had ordered unspecified tests to rule out auto-immune disease, especially Sjogrens syndrome.  The test results were pending at the time of the report.  The consumer reported that her son's symptoms resolved slowly over the course of the last month and completely resolved as of 25-FEB-2009.  No further information is available.
Inability to urinate- minimal flow. Tx: sulfa 9/3/10 office visit.
vaccine booster received 10/23/2021.  10/27/21 experienced chest pain, went to ED, STEMI verified.  Transferred to cath lab and had 2 stents place in R coronary artery.  Definite heart disease prior to MI but concern that vaccine may have accelerated occlusion with a clot.
Severe Nausea, Vomiting, fatigue, Abdominal Cramping, Body Aches
The patient has a history of ESRD on dialysis and type II diabetes. He was seen in the ED on 4/3/23 for bilateral leg swelling for the past two weeks. He also reported right arm swelling for the past three days as well as shortness of breath. A COVID PCR test performed in the ED resulted positive. Ultimately the patient was admitted 4/3/23 - 4/8/23. On admission, he was noted to have poor oxygen saturation on room air and required 2L O2. He was unable to wean off O2 upon discharge so went home with supplemental O2. Discharge diagnoses include renal failure, COVID-19, among other diagnoses. He was treated with Decadron. Of note, the patient has received the primary COVID vaccine series and the bivalent vaccine.
Local site reaction, swelling, pain, erythema, itching, approximately 8cm diameter
NONE-  AGE-APPROPRIATE BIVALENT MODERNA WAS ADMINISTERED ONE AFTER FDA WITHDREW AUTHORIZATION FOR USE
She suffered a UTI on the 17 of Nov and saw a physician on the 18th. They gave her nitrofurantoin 6mgs four times a day.
At 12 hours after vaccine, chills and severe muscle aches. Took 1000mg tylenol. At 18 hours after vaccine, mild headache and muscle aches. Around 22 hours, severe epigastric pain and vomiting. For the next 24-36 hours after vaccine mild muscle & headaches and fatigue. 1000mg tylenol taken around every 8 hours.
BLISTERS, RED HURTS AT TOUCH. NO TREATMENT. MOTHER DOES NOT WANT CHILD TO GET SEEN.
I did not have an adverse reaction to the vaccine. On 02/13/2023, I felt like I was coming down with a cold. On 02/14/2023, I had a fever, cough, runny nose, congestion and no appetite. I tested positive for COVID-19 on 02/14/202. I contacted my doctor and got a prescription for Paxlovid. I tolerated the medication and was able to take it. As of today, I still feel fatigued.
The patient did notice a very sore arm and small rash the day after the vaccine.  It was accompanied by a slightly  enlarged lymph node.  The swelling went down after 2 days.
Fever, mild congestion, intermittent cough, Rash that began today 5/29/2015 that started at the nape of the neck and
The next day mom noted 1/2 inch lump at site of injection with 2 inches of surrounding "redness and puffiness". Itching of site noted.
monitor for 45 min, vaccine at 1845, felt flush, NO HX OF PREVIOUS REACTIONS REPORTED, LEFT AT 1930
Didn't get sick at all, but on second day felt soreness under armpit and had golf ball sized swollen lymph node.  Painful, made it hard to sleep, lasted about a week.
I was not pregnant when I got the vaccine. I think I found out on 2/10 and 2 weeks into the pregnancy, I started bleeding. I called my doctor and was told to come in. I had an ultrasound and there was not sign of the pregnancy, so I had to have a Rhogam shot due to being B-. I bled about 5-7 days afterwards.
broke out into hives after receiving the FLUBLOK 3 years in a row; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (Healthcare professional).  This case involves a 62 years old female patient who experienced hives after receiving vaccine  Influenza quadrivalent recombinant vaccine  [Flublok ].  The patient's past vaccination(s) included Flublok in 2019 and FLUBLOK in 2020. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing allergy to Sulfa (Drug allergy).  In October 2021, the patient received a dose of suspect Influenza quadrivalent recombinant vaccine lot number not reported via unknown route in the arm and developed a non-serious broke out into hives (urticaria) (latency: 1 day). She broke out in hives in lower extremity above ankle and below knee and hives on upper arms between elbows and shoulders lasted 1 week.  She is concerned with receiving Flublok this year and she wanting to know if there was another flu product that she could get instead of the Flublok.  Caller states she also received the Flublok between the months of September and October in 2019 and 2020 and had the same reaction all 3 years   Action taken: not applicable.  The patient was treated with Benadryl [Diphenhydramine hydrochloride]) for Urticaria.  At time of reporting, the outcome was Recovered / Resolved in 2021 after week for the event.
Swelling and itching in upper lip and inside nose. Still swelled on each side of nose at 8:00 AM on 10/21/2016.
GOT COVID POSITIVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got covid positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000202909.