chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful swelling; Painful swelling in my Underarm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (painful swelling) and LYMPHADENOPATHY (Painful swelling in my Underarm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (painful swelling) and LYMPHADENOPATHY (Painful swelling in my Underarm). At the time of the report, AXILLARY PAIN (painful swelling) and LYMPHADENOPATHY (Painful swelling in my Underarm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported. Concomitant medication were not reported
Child had itching of ears and itching of eyes mild macular rash. Within one hour of receiving vaccine. Foster mother called NP Benadryl given. Child recovered without complications.
seizure; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Is Bivalent: False), for COVID-19 Immunization. The following information was reported: SEIZURE (medically significant) with onset May2021, 2 hrs after the suspect product(s) administration, outcome "recovered". Patient woke up from a nap having a seizure 2 hours after receiving 2nd dose of Pfizer COVID-19 vaccine. It was unknown if patient had COVID or COVID tested prior vaccination. Therapeutic measures were not taken as a result of seizure. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported event Seizure cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Within 2 hours, my left arm turned kinda pinkish red, about the size of a navel orange and it started itching, and it was slightly raised. It had an itchy sensation. I started having really severe body aches. I did not take my temperature, I figure this was part of it. 34 hours later, I woke up in a pile of sweat and my symptoms were gone.
Left-sided facial nerve palsy with bilateral paresthesias that progressed from 8/4-8/10. MRI and LP support diagnosis of Guillain-Barre. Symptoms followed an acute mono-like illness that started on 7/29. Testing to diagnose preceding infection still pending.
Tachycardia, hypoxia but normal bp while lying down noted on vitals, sense of impending doom. Epinephrine given, transferred to ED. No observed loc, but had amnesia from portions of stay.  In ER, intiial vitals showed ipmroved heart rate but bp in 90s after epi. Then recurrent sense of impending doom, tachycardia to 140s again, fluids and steroids given. Watched for few hours, dc home with epi and famotidine and benadryl.
DIDN'T SLEEP WELL; BODY ACHES; FATIGUE; HEADACHE WITH NO FEVER; FELT LIKE NOT ABLE TO TAKE DEEP BREATH; FELT LIKE HEAVY WEIGHT ON CHEST; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced felt like not able to take deep breath. On MAY-2021, the subject experienced felt like heavy weight on chest. On 11-MAY-2021, the subject experienced didn't sleep well. On 11-MAY-2021, the subject experienced body aches. On 11-MAY-2021, the subject experienced fatigue. On 11-MAY-2021, the subject experienced headache with no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from didn't sleep well, body aches, fatigue, and headache with no fever, and the outcome of felt like not able to take deep breath and felt like heavy weight on chest was not reported. This report was non-serious.
I felt numbness on the rt lateral aspect of my rt foot as well as pain in the calf & thigh so I took Aleve & went to bed & then the next day I went to urgent care.
To ER on 07/24/04 after receiving TD on 7/19/04. Tingling in arm, weakness, sharp dull pain, heat sensation upper arm. Used Motrin for some relief. Weakness now resolving in arm. Physician reported not sure from TD.
Leg swollen; Foot swelling; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Right on 18May2021 (Batch/Lot Number: ER8736, Expiry Date: 31Aug2021) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. NDC and UPC number of vaccines is unknown. On 20May2021 patient experienced leg swollen- peripheral swelling, foot swelling 2 days after taking shot. The outcome of the events was unknown. The outcome of events unknown.
Skin red and warm to touch there is no drainage or hardness presented. Applied cool pack to site. Dr assessed site and stated it looked like a local reaction. She couseled pt mother and told her to return tp the clinic or emergency room if redness spread or patient developed fever.
Pt recv vax on10/14/98; on 10/16/98 pt exp sore arm w/ bubbling & red line, fever; tx=Keflex & warm compresses
Weakness in upper leg; Weakness in upper leg and hip area; Could not walk; This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had his Pfizer vaccine (unspecified vaccine) on Monday and about 18 hours after the vaccine, he developed weakness in his upper leg and the hip area to the point where he could not walk for a short period of time. The other factor is that he had a transdermal anti-nausea patch (unspecified medication) at the same time and we don't know if that contributed to the reaction and it really only lasted maybe 30 minutes, the actual inability to walk was maybe 30 minutes and then gradually over the next 24 hours he was almost back to normal. The patient was almost 36 hours now and he is feeling like pretty close to normal strength wise, almost 90%. So, the patient want to know if this weakness is a reaction. The patient is now becoming concerned about taking the second portion of the vaccine because of the reaction that he had but don't know if it was transdermal patch that might have contributed to this. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Severe sciatica and joint pain on the right and left sides of body within 24 hours of shot.
chills; fatigue; severe muscle pain generally; severe joint pain in the left hip; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 11Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Hip replacement" (unspecified if ongoing); "IV Contrast" (unspecified if ongoing), notes: known allergies: IV Contrast. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for covid-19 immunization; Covid-19 vaccine (dose 3, manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (dose 4, manufacturer unknown), for covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 12Oct2023, outcome "recovering"; FATIGUE (non-serious) with onset 12Oct2023, outcome "recovering"; ARTHRALGIA (non-serious) with onset 12Oct2023, outcome "recovering", described as "severe joint pain in the left hip"; MYALGIA (non-serious) with onset 12Oct2023, outcome "recovering", described as "severe muscle pain generally". Therapeutic measures were not taken as a result of chills, fatigue, myalgia, arthralgia.  Additional information: On 12Oct2023, the patient felt chills, fatigue, severe muscle pain generally, severe joint pain in the left hip. No fever. The patient was not tested for COVID post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Nausea, vomiting, diarrhea, fever, chills, muscle aches, runny nose
All fine after shot until about 9 hours after shot cold aches in back and the fever all body sweating nausea, no vomiting, in bed got up to go to bathroom and passed out falling have lots of bruising multiple areas from fall. felt better after came to. No seeing medical prof for this treatment has been bed rest.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses VARIVAX (lot number L041206 and expiration date 20-OCT-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I had a sore arm for 5 days after the shot. It hurt to move, and I could not raise it above my shoulder. After that it calmed down. On the 9th day, it got sore again. I'm on day 11 now and it is still very sore.
Pain; Blisters on his tongue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and TONGUE BLISTERING (Blisters on his tongue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain) and TONGUE BLISTERING (Blisters on his tongue). At the time of the report, PAIN (Pain) and TONGUE BLISTERING (Blisters on his tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication included an unspecified high blood pressure medication.   No treatment information was provided.
Fever fluctuations; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever fluctuations) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Neosporin and Polysporin). Concomitant products included LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]), ATORVASTATIN, FISH OIL, LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) and COLECALCIFEROL (D3) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever fluctuations). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever fluctuations) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Followup received on 24-apr-2021. Past medical history was updated. 1st dose details were updated. Concomitant medications were updated.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Patient was administered the vaccine that underwent temperature excursion; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered the vaccine that underwent temperature excursion) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 5:25 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Nov-2021 at 5:25 PM, the patient experienced PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered the vaccine that underwent temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered the vaccine that underwent temperature excursion) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. No treatment medications were provided.
RAISED RED RASH WHICH WHENT AWAY BUT NOW SHES BRUISED, TENDER AND FEELS AN INDENT AT THE INJECTION SITE
fever + 1.6 degrees over normal that lasted for 24 hours.  pain at injection site that lasted for3 days  red rash at injection site that lasted for 6 days.
The evening after receiving 12 month immunizations pt. developed 102.5 fever, unable to roll over, swollen face & extremities, jerking of extremities, gagging, lethargic.
Information has been received from a physician a 14 year old female who on 25-JUL-2007, at 10:00, was vaccinated into the right deltoid with a first dose of Gardasil (656051/0244U). Concomitant therapy included Menactra. On 25-JUL-2007, immediately after receiving the vaccination the patient became lightheaded, had a syncopal episode (approximately 5 second), developed stiffening of arms and eyes rolled back. Blood pressure measurement after syncope was 90/60 (sitting). At 11:30, blood pressure measurement was 100/68 and pulse was 76. There was no seizure activity and the patient was no post-ictal. On 25-JUL-2007, the patient recovered. No further information is available.
Patient has been experiencing tingling of forearms/hands and lower legs/feet since 1 week after his first dose of the Pfizer vaccine
PATIENT COMPLAINED OF TROUBLE BREATHING, TIGHT THROAT, TINGLE IN LIPS, EARS & THROAT 10 MINUTES AFTER VACCINATION.  HAD PATIENT CONTROL THEIR BREATHING, 25MG DIPHENHYDRAMINE LIQUID ADMINISTERED ORALLY.  SYMPTOMS REMAINED & PATIENT WENT TO URGENT CARE.  UPON RETURN FROM URGENT CARE (1 HOUR LATER), SYMPTOMS WERE RESOLVED & PATIENT FWAS PRESCRIBED HYDROXYZINE 25MG TABLETS FOR ANXIETY.
1 of 5 pts (out of 40) pts vaxed from the same lot who devel a local rxn consisting of rash surrounding site;rash appeared w/in 3 days of vax (varying in size in all 5 pts;largest from shoulder to elbow;area sore & tender;no fever;
Extreme Vertigo; went to ER , they gave me an antihistamine and it helped.  Have not lost dizziness or vertigo since I took vaccine. Extreme brain fog
PT COMPLAINED OF REDNESS AND ITCHING OF RIGHT UPPER ARM FOR 10 MINUTES.  AFTER 10 MINUTES, THE RASH AND REDNESS BEGAN TO SPREAD DOWNWARD TOWARD ELBOW WITH INCREASED ITCHING THAT EXTENDED INTO THE AXILLA AREA.  WAS TRANSPORTED TO URGENT CARE FOR FURTHER TREATMENT AND EVALUATION.  URGENT CARE - 9:00 AM
I experienced a breakthrough case of COVID-19 with headache, cough, slight fever, chills, congestion and very runny nose.
pt recv vax 17OCT97 & the next day pt was unable to lift the lt arm (vaccination side);this has persisted to the time of the 14NOV97;dx lt upper trunk brachial plexus injury which had been improving @ that time;
ON OCTOBER 7, 2011 PATIENT RECEIVED A THIRD DTaP VACCINATION. HER LEFT LEG IMMEDIATELY SWELLED UP AND STAYED SWOLLEN FOR 5 DAYS. IT HAD A RASH AND WAS ALSO VERY ITCHY IN THE AREA WERE SHOT WAS GIVEN. PATIENT LIMPED AROUND FOR 5 DAYS SHE COULDN'T PUT MUCH PRESSURE ON HER LEFT LEG. ON THURSDAY OCTOBER 13, 2011 I NOTICED HIVES IN THE AREA WHERE SHOT HAD BEEN GIVEN. IT WAS NO LONGER A RASH BUT HIVES ONLY IN AREA WERE SHOT HAD BEEN ADMINISTERED. PATIENT HAS ALSO BEEN VERY IRRITABLE SINCE SHOT WAS ADMINISTER.
Fatigue, shoulder pain, heaviness in the head, chest discomfort, blood pressure a little high and I gave him 2 TYLENOL.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium, Additional Details: she passed out about 2 minutes after injection.  we elevated her feet and placed an ice pack on the back of her neck.  she came to within a few seconds.  sat in our consultation area for about 20 minutes with her mom.   she was able to walk out unassisted.
Loss of hearing. Muscle pain in lower back and legs. Chest pain.  Consistent fatigue. Headache. Eye Pressure with occasional splotchy eyesight
Injection site soreness and urticaria beginning at 3:30pm.  Took 50mg of liquid Benadryl followed with 25mg four hours later.  Urticaria disappeared.  Six days later, the injection site soreness is worse with tenderness and heat extending to the elbow and shoulder blade.  Am taking Naproxen.
Patient felt a hair like sensation in throat. Difficulty breathing. Felt like throat was closing. Thinks it was caused from Varicella vaccine that was administered 3 days prior. Patient did not feel well after Vaccines were administered on 10/22/15. She called Vaccine hot line and was instructed to see physician.
Injected Moderna vaccine and within a few minutes, felt rushing feeling in center of chest, followed by dryness in throat, "like something caught in my throat."  Administered liquid oral benadryl 50 mg.  Hypertensive initially,130-140s/100s,  HR 80-100.  After 30 minutes, symptoms improved, returned to work at pharmacy on the same site where she received the vaccine.  Symptoms in the afternoon were dull substernal chest discomfort.  Denies hx of GERD.    Repeated benadryl at 1626.  Little improvement in substernal chest discomfort. Gave NTG 0.4  mg SL, with 324 chewable baby asa, initially felt flushed/hot, but then symptoms began to improve.  Very resistant to go by ambulance to ER.  Son able to provide transportation from clinic directly to another facility. Ambulatory upon d/c from clinic.
1. Ten hours after injection, intense muscle pain and soreness. 2. Ten hours after injection, strong headache.  3. Ten hours after injection, fever and chills.  4. Ten hours after injection, inability to sleep.  5. 18 hours after injection, terrible joint pain in upper body. 6. 18 hours after injection and ongoing, sore deltoid muscle at injection site.
24 hours after receiving second dose of Covid Vaccine presented with soreness in the area of shot, muscle aches upper back/neck, fever at max of 100.3. Ibuprofen or acetaminophen managed fever from baseline to 99.3 degrees.  Fever and aches present day after vaccine. Second day after vaccine, aches and fever present but not as significant. Third day after vaccine, side effects subsided. Temp back to baseline.
Large, hard swollen area around injection site, about 3" in diameter.  Red in color, warm to the touch.  Appeared last night.
1/8/7 rcv'd vaccine; by 1/9 had pain @ site, by 1/10 site was fire red w/"50 cent"-size knot that was movable. Pt treated herself w/warm compresses.  The knot was decreasing by 1/13 and today 1/16 the knot is dime size but still tender to the touch.
Large hive at injection site, pruritis, erythema, severe local reaction (>120mm).  No systemic symptoms.
Information has been received from a physician and a registered nurse concerning a 14 month old male with a history of asthma who on 13-JUL-2007 was vaccinated with a dose of MMR II. It was noted that 3 weeks prior to vaccination the patient had pneumonia which was treated with amoxicillin. By the end of August 2007, the patient developed a very low grade fever, generalized rash all over the body, kopliks spots and nasal drainage. At that time the patient was hospitalized and placed into isolation with the diagnosis of viral illness, IGM positive for measles. The patient was hospitalized for 2 days received unspecified treatment and was released. The nurse states the case was not life threatening and there was no significant disability. No further information was provided. There was no product quality complaint involved. The patient's events were considered serious for hospitalization. Additional information has been requested. This is one of several reports from the same source.
Constant headache. feel pain in stomach, ache on joints and muscle, dizzy spell. Blood pressure - high, blood count - low white, concentration trouble, depression, digestive gastric ulcer, digestive problems. Fatigue and pain. Gastritis.