chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt sluggish the next morning/early afternoon; soreness & feeling in heaviness in arm where vaccine was injected the evening of the vaccination; soreness & feeling in heaviness in arm where vaccine was injected the evening of the vaccination; This is a spontaneous report received from a contactable reporter. The reporter is the patient.   A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 10:30 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies_Environmental" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE DISCOMFORT (non-serious) all with onset 03Mar2021 20:00, outcome "recovered" and all described as "soreness & feeling in heaviness in arm where vaccine was injected the evening of the vaccination"; SLUGGISHNESS (non-serious) with onset 04Mar2021, outcome "recovered", described as "felt sluggish the next morning/early afternoon". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site discomfort, sluggishness.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. Events did not result in physician office visit or emergency room visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Per MD, persistent fever, 8 hours post vax. Decreased mobility on 11/4/01. Mosquito bite looking lesion on right lower leg. On 11/5/01, right lower leg discolored and swollen. To ER. On admit to ER, temperature 39.3C, tachycardia and right lower leg cyanotic, purpuric and cold below the knee. Only pulses present in right leg was femoral; others absent. Bleeding profusely from mucous membranes and puncture sites. Rapidly deteriorated and despite very aggressive CPR, reports child expired. Cause of death dx'd as toxic shock syndrome. Per F/U 4/29/02-Pathologic dxs cellulitis on the right lower extremity; petechial rash on the skin of the head, neck, torso and extremities, hospital blood cultures grouwing out beta-hemolytic Streptococcus Group A bacteria, Meningitis due to: Streptococcus pyogenes, Group A, Beta-hemolytic streptococcus; pulmonary congestion and edema; bilateral hydrothraces; ascites; eosinophilic gastroenteritis. COD: Septic Shock and Bacterial Meningitis due to bacteremia due to cellulitis.
My tinnitus has reached a level it has never been before. I can?t sleep and I have rarely heard it in the day before now. It won?t go away at all and has started intermittently in the ear it was not in before.
Hives first noticed on left wrist and also had a headache. The hives continued to spread to other parts of her body. She reports she had a brief wheezing episode on 7/11/12. She has been taking oral Benadryl since 7/10/12 and sought medical help on 7/16/12. The doctor prescribed an antihistamine. The patient first informed our clinic about her event on 7/16/12 after seeing her doctor.
Almost immediately after given vaccine client began to feel nausea, tingling in both arms and weakness, client placed in anti-gravity chair and water client began to feel better.
soreness; redness; discomfort; This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, erythema and arm discomfort. On an unknown date, the outcome of the pain, erythema and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the pain, erythema and arm discomfort to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced redness, soreness and arm discomfort with the 1st dose. This case has been linked to US2020002546, reported by the same reporter.
Dose #2 given Left deltoid @ 9:04am. 3 welps noted on Right deltoid approx. 15 minutes later at site of previous dose. Denies shortnes of breath no facial of lip swelling. No other s/s Denies food of drug allergies observed 30 minutes no other s/s
PULSATING PAIN IN PALM OF HAND. HARD TO TOUCH, SWELLING/REDNESS ON THE AREA. RECOMMENDED PT TAKE SOME IBUPROFEN
Skin bright red from neck down to below buttocks back and front; Down both arms; Very lethargic the entire day; This is a spontaneous report from a contactable consumer or other health care professional (patient herself) of 79-years-old female non pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810, Expiration number: not reported) via an unspecified route of administration on 04Feb2021 14:45 (at the age of 79-years) in left arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not known to allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Feb2021, patient experienced skin bright red from neck down to below buttocks back and front, down both arms and patient felt very lethargic entire the day. No therapeutic measures were taken for the events occurred. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history included chronic obstructive pulmonary disease (COPD), asthma, hospitalisation from Feb through Mar and pneumonia. Concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of recovering. Before vaccination, she was in the hospital from Feb through Mar and they sent her home on steroids and two kinds of antibiotics. Subsequently she had the vaccine shot, but she still came down with it. This was the 2nd time she experienced pneumonia and was worse. She complained of difficulty breathing and a high fever. No follow-up attempts are possible, information about lot number cannot be obtained.
Pt recvd vax 22SEP91 c/o vague malaise beginning 25SEP but not enough discomfort to interfere w/daily activities; 26SEP91 @ home 5AM severe episodes of respiratory difficulty p/3 home ventilation treatments pt drove self to hosp ER;
Rash from knees to chest with itching,.Relieved by taking Benadryl 50 mg; still some itching 12 hours after Benadryl but has improved "75%" according to patient. Rash has resolved.
I starting having aches, headaches diarrhea, lethargic and swollen tongue. I didn't know what was happening, I started brushing my teeth and use hydrogen peroxide. My mouth was so dry I could even brush my teeth, I contacted my doctor he gave me steroids,  I couldn't taste food or feel if it was hot or not. It did improve but I still have weird sensations with different foods.
Patient with COVID detected PCR found upon admission after ground level fall.  Provider d/c note:  "71-year-old female past medical history of lung cancer and dementia she presented for chief complaint of ground level fall.  Emergency department workup notable for hypertension tachycardia leukocytosis and anemia.  Shoulder x-rays obtained showing impacted humeral neck fracture.  Orthopedic was consulted recommending closed reduction nonweightbearing and shoulder immobilizer with outpatient follow-up.  Urinalysis was notable for pyuria/bacteriuria.  Patient was started on Levaquin and treated for urinary tract infection.  Patient's initial workup concerning for sepsis received IV fluids and clinically improved prior to discharge.  Patient completed course of IV antibiotics prior to discharge."
This spontaneous report as received from a healthcare worker, clinic manager refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 11-MAR-2016 the patient was vaccinated with expired dose of VARIVAX (Merck) 1350 U (dosing details were not reported) lot # K003406 with an expiry date: 06-MAR-2016. The patient did not experience any adverse effects. No concomitant medications were reported. There was no product quality complaint involved. Additional information has been requested.
Tingling in the legs starting about 1 hour after injection and continuing on an irregular basis for several days. Mild fever and flu symptoms starting 10 hours after vaccination and lasting for 24 hours.  Faster than normal resting heartbeat, easily excitable heartbeat (over 100 just with standing up, eating, drinking...). PALPITATIONS and IRREGULAR HEARTBEAT, especially noticeable when resting ever since this second dose of Moderna (it's been more than a month).
numbness and tingling sensation on both legs, redness on face and neck with mild rash on face and neck
Scratchy throat, watering swollen eyes. Extreme fatigue, body chills and aches.
5 days after the shot I started getting a rash/itching on my face. Under my right arm (armpit) was sore. I also had a sore throat. 8 days after the shot my arm (where the shot was) starting turning red. It ended up growing  about 5 inches wide and was very warm and tender for a few days.
Renal failure; She then got really sick; This is a spontaneous report from a contactable consumer (patient) via a Pfizer- Sponsored Program. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On unspecified dates the patient experienced renal failure, which was serious for hospitalization, and she then got really sick. The patient called to report that she received the first dose of the COVID-19 vaccine on 04Mar2021 and then got really sick after having 11 teeth pulled. She stated that she went into renal failure and was hospitalized and was unable to receive second dose. She wanted to know if she could still receive the second dose of the vaccine. The patient asked how she could schedule her second dose because she missed her appointment on the 23rd due to being admitted to the hospital with renal failure. She did not believe the side effects were due to the vaccine, but rather due to the extensive dental work. The clinical outcomes of the events renal failure and she then got really sick were both unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The company considered there was no plausible mechanism implicating suspect BNT162B2 to the reported events based on the drug known safety profile. The patient got really sick after having 11 teeth pulled, due to an underlying condition, and the renal failure was related to an concurrent condition.
mom states that pt had onset of high fever & diff breathing approx 7-8hrs p/vax;pt was taken to ER w/temp of 106 on arrival & had a sz shortly p/;according to MD pt was treated for bronchospasm, viral pneumonitis & asthma;
About 4-5 days later I began feeling a little nauseous.  By day 6-7 I had excessive diarrhea. By day 9-10 I have had to leave work because I can?t go more than an hour without having to run to the restroom, and now there is also sharp bowel pain which radiates to my back.  My nausea is extreme and I?m barely eating.  My fatigue is such that I can barely keep my eyes open- not sure if it is related to the diarrhea and lack of eating out the vaccine, and my migraine which I usually get once a week have been more like every other day for the past week.
5/19/11 PM pt developed itchy painful rash around (L) ear & spreading up to (L) forehead & into scalp, associated with ear pain. No fever, no otitis media. I thought it looked like early varicella (Ramsay Hunt Syndrome) & sent pt to dermatology who concurred. Pt started on acyclovir & prednisolone.
Back pain, swollen right arm, face swollen, right side, neck pain, nausea went to ER - Diagnosed with local reaction Taken within Demerol, amonicillin. For spider bite on foot 10 days old (left foot). Went to ER also on 10/20/2001. Taken with phenerean and Demerol.
Right sided jaw pain and discomfort. I constantly feel like it's swollen and sometimes dislocated. I feel like I have difficulty moving my jaw on the right side.
Patient received the Moderna Bivalent vaccine instead of the Regular Moderna vaccine for her 1st dose in the primary series.
This spontaneous report was received from a Nurse via field representative refers to a male patient of an unknown age. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 injection for prevention of human papilloma virus (HPV) (lot#, expiry date, route, anatomical location and dosage details were not reported). On 28-AUG-2018, the patient was vaccinated with second dose of GARDASIL 9 injection for prevention of human papilloma virus (HPV) (lot#, expiry date, route, anatomical location and dosage details were not reported). On the same day, an unspecified amount of time later, while at the office, the patient "was not feeling well and felt sick" (malaise). The reporter at the office "believed the patient had a syncopal episode". The patient sought medical attention. The outcome of the events was unknown. No product quality complaint (PQC) was involved. The reporter did not provide any causality assessment.
Pt's mother reports Edema, Erythema, and Urticaria on (L) Leg going outward from injection site. Symptoms started 24hrs after injection. Provider recommended stopping Hib series going forward.
Pt is having "pins and needles" feeling in arm around injection site that is interfering w/ ADL's.
Received INFUENZA vaccine 10/01/2009 pm. 10/21/2009 site discomfort. 10/3-4 swelling under arm (left) tender to touch. 10/5 swelling decreased less tender orange size.
Pain around vaccination site; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8734) via an unspecified route of administration in the left arm on 08Apr2021 at 15:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included iron (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) and clarithromycin (CLARITIN) all started on an unknown date for an unknown indication. The patient had no past drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 19:00, the patient experienced pain around vaccination site. The clinical outcome of the event pain around the vaccination site was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Immediately after injection, the patient had a local reaction noted at the site. The injection site was red, with a raised rash above the injection site with one pustular area below the injection site. Treated with Benadryl.
Five hrs after receiving GARDASIL became "feverish" didn't take temp. Dizziness, near syncope hot all over, felt "fluey" for several hrs. No symptoms next day. No site reaction.
PT DID NOT DISCLOSE PREVIOUS VACCINATION AND WAS GIVEN A FOURTH DOSE (INSTEAD OF WHAT WE WERE TOLD WAS THE FIRST DOSE)
I took the J&J shot roughly at 11:50a, and naturally felt the immediate burn, and swear I felt the liquid moving through my arm. My arm was immediately tingly and numb simultaneously, and I felt...light and weird. Around 2p, I began feeling feeling lightheaded and weak, and at 6p, I had chills, severe weakness, dizziness and nausea. I couldn't stand up longer than 2 minutes without wanting to vomit and faint. I couldn't even stand up long enough to wash dishes, prepare a bowl of grapes to eat or shower. Throughout the night, I sweated so terribly from the chills to the point that my bed was soaked to the mattress pad, and currently at 2:02p on April 6th, I'm still experiencing the extreme weakness, nausea, and chills.
5NOV95 130AM t105 oral temp;6NOV95 101-102 oral temp;7NOV95 102;8NOV95 100;
demyelination; activated rheumatoid; there is a lot of inflammation; couldn't walk; fingers and hands lock up; It seems to have activated her rheumatoid; This spontaneous case was reported by a consumer and describes the occurrence of DEMYELINATION (demyelination) and RHEUMATOID ARTHRITIS (activated rheumatoid) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included CARVEDILOL, LOSARTAN, DULAGLUTIDE (TRULICITY), DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), GLIPIZIDE, LEVOTHYROXINE SODIUM (LEVOXYL), PRAVASTATIN and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-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 experienced DEMYELINATION (demyelination) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (activated rheumatoid) (seriousness criterion medically significant), INFLAMMATION (there is a lot of inflammation), GAIT INABILITY (couldn't walk), TRIGGER FINGER (fingers and hands lock up) and CONDITION AGGRAVATED (It seems to have activated her rheumatoid). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at a dose of Prednisone 7 day Medrol pack for three rounds and ADALIMUMAB (HUMIRA) at an unspecified dose and frequency. At the time of the report, DEMYELINATION (demyelination), RHEUMATOID ARTHRITIS (activated rheumatoid), INFLAMMATION (there is a lot of inflammation), GAIT INABILITY (couldn't walk), TRIGGER FINGER (fingers and hands lock up) and CONDITION AGGRAVATED (It seems to have activated her rheumatoid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) demyelination.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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. However, patient's underlying disease and advanced age remains a contributory factor.   This case was linked to MOD-2021-083671 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Added Events Demyelination, rheumatoid arthritis, gait inability, trigger finger, , Added medical history rheumatoid arthritis, Added additional information in the I Narrative field and Added treatment information in product tab.; Sender'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. However, patient's underlying disease and advanced age remains a contributory factor.
Did not receive second dose on recommended window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive second dose on recommended window) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive second dose on recommended window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive second dose on recommended window) had resolved.            No concomitant medications were provided. Treatment information was not provided.   Reporter did not allow further contact
Approximately 3-4 minutes after the above inoculation, child became pale with transient perioral pallor. Responded immediately to manual stimulation. Cried, but remained on and off lethargic. No loss of consciousness, no advertent muscular movements. Responsive throughout. O2 given by tube; EMT summoned. Child taken to hospital and admitted. Reported to be totally recovered by doctor.
Migraine that was so sever just moving my head would make me cry or cause me to throw up.  Extreme nausea and chills Lasted for one day
Patient calling RN triage line. Patient reports receiving Pfizer COVI19 vaccine at hospital on 4/20.  Patient reports onset of widespread rash directly after vaccine on face, beck, chest, and back of hands.  She denies SOB, tongue swelling, difficulty breathing or airway involvement.  She notes that she had a severe reactions to CT contrast in the past, and had similar widespread rash symptoms that required IV benadryl to treat. Today, 4/26, she still confirms widespread rash with increased itching and burning. She also reports severe body aches, particularly right sided flank pain.  Per protocol, RN advised immediate evaluation in ED. Patient will leave now, and go to hospital.
Lymph node swelling in neck, armpits and groin. Difficulty swallowing.
11/15/2021 34-year-old female who presents for fever, fatigue, cough, loss of appetite with body aches.  Fully Covid vaccinated.  No known sick or Covid positive contacts.  Denies any chest pain or difficulty breathing.  Has not used anything over-the-counter to help. 11/20/21-Regeneron infusion
An empty syringe not filled vaccine, MAY HAVE BEEN utilized to "vaccinate" this patient.  This possible error was identified within 24-hours of the event and the parents were informed of the potential error.  The parents have decided to re-vaccinate on 11/18/2021.