chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Generalized prickle sensation; Localized injection site urticaria; flushing; profuse sweating; arm pain; loss of motion; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year female patient received BNT162B2 (lot number: EM9899) first dose on 17Dec2020 20:00 Intramuscular on right arm at single dose for COVID-19 immunization. Medical history included Asthma, Sulfa and Reglan allergies, Possible Covid 19 in Mar2020, Extensive cardia workup months following Dx with recurrent pericarditis, Non specific T wave abnormality on colchicinent Pepcid. Previous pericarditis Oct2016. Concomitant medications included Valsartan, amlodipine besilate, spironolactone, formoterol fumarate, mometasone furoate (DULERA), siugular, pristing, clonazepam, pramipexole dihydrochloride (MIRAPEX), Pepcid, colchicine (for pericardins). Patient had Flushing, Sweating (Perfuse sweating head and neck), Pain in arm and Mobility decreased (Moderate arm pain and loss of motion due to pain after both injections), Symptoms occurred 3-4 days after 1st vaccine and lasted 2.5 weeks. Organ involvement: Multiorgan Involvement, Respiratory, Bilateral wheeze/bronchospasm, Upper airway sweeling, Respiratory distress, Tachypnoea, Increased use of accessory respiratory muscles, Recession, Cyanosis, Grunting, Dry cough, Hoarse voice, Difficulty breathing (without wheeze or stridor), Sensation of throat closure, Sneezing, Rhinorrhea, Cardiovascular, Measured hypotension, Shock, Tachycardia, Capillary refill time > 3 sec, Reduced central pulse volume, Decreased level of consciousness, Loss of consciousness, Dermatological/Mucosal, Generalized Urticaria, Generalized erythema, Angioedema, Generalized pruritus with skin rash, Generalized pruritus without skin rash, Red and itchy eyes, Nausea, Vomiting, all were No. Generalized prickle sensation and Localized injection site urticaria were yes. The patient did not require medical intervention, the patient was not seen in the Emergency Department, not hospitalized, not admitted to an intensive care. The event did not require the initiation of new medication or other treatment or procedure. There is not a previous history of any allergies, does the patient take (or have readily available) any specific medication related to this. patient did not receive any recent vaccines for any other conditions prior to the event being reported, patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported, patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. None of the event above consideration serious due to begin life threating, or due to persistent or significant disability/incapacity or any other reason, if yes note below which event and serious criteria. patient not decreased. No treatment required. None of the AEs require a visit to: Physician office. No culture performed. No anti pyretic use. The outcome of the events was recovered.   No follow-up attempts are needed. No further information is expected.
Twenty seven days after my second vaccination I developed Right side of face paralysis and went to ER. After steroids and valcyclovir I was 100 percent recovered.
Patient came to the hospital on 10/13/22 with new onset heart racing and breathing irregularity. He claims 8-9 days prior he had some cough and recently had some diarrhea. He tested positive for COVID on 10/13/22 in the hospital. He was discharged home on 10/24/22.
heart palpitations/flutter, sharp chest pains since the date of the injection.; heart palpitations/flutter, sharp chest pains since the date of the injection.; heart palpitations/flutter, sharp chest pains since the date of the injection.; chills and numbness down entire left side of body.; chills and numbness down entire left side of body.; constant goosebumps since the injection date; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (non-pregnant) received the first dose of BNT162B2 at the age of 43-year-old via an unspecified route of administration, administered in arm left in Aug2021 (Lot Number: AF7484) as single dose for COVID-19 immunisation. Medical history reported as none. No known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced heart palpitations/flutter, sharp chest pains since the date of the injection in Aug2021, chills and numbness down entire left side of body in Aug2021, constant goosebumps since the injection date in Aug2021. Heart rate in Aug2021 showed heart palpitations/flutter. Seriousness criteria of the events was reported as disabling/incapacitating and life threatening. Events resulted in emergency room/department or urgent care. Treatment received for the events that included anti-imflammatory and aspirin. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Pt recv vax on 4/2/99; on same day pt exp swollen/ red/ pain/ bruised rt arm, restless, fever (99.4-100), chills, tingling wrists/ fingers, dizzy, palpitations; tx=cool packs, Benadryl, Ibuprofen
Almost 12 hours after vaccine, started feeling muscle  and joint aches (in hips, arms, legs and neck area), followed by chills for a few hours and then got very hot. I have also had a sore arm since receiving the vaccine. Also, I went to this vaccine clinic with 2 of my neighbors that also had the exact same reactions.
Problem with his knee; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Problem with his knee) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ARTHRALGIA (Problem with his knee). At the time of the report, ARTHRALGIA (Problem with his knee) outcome was unknown.            No concomitant medications were reported.  Not  taken any treatment at the time of reporting. It was reported that the patient will be seeing his doctor on 23 Mar 2021 for a problem with his knee and expects to receive a steroid injection.
This spontaneous report as received from a physician refers to a 66 year old male patient. No medical history and current conditions were reported. On 11-APR-2013, the patient was vaccinated with PNEUMOVAX 23 injection 25/0.5 ml single dose, subcutaneous (lot # H015749, exp 08-JUN-2014). No co suspects or concomitant medications were reported. On 11-APR-2013, the patient experienced muscle weakness and joint pain within 48 hours of receiving PNEUMOVAX 23. The patient was scheduled for a follow up appointment with the physician. At the time of the report muscle weakness and joint pain were not recovered. The primary reporter considered muscle weakness and joint pain to be significant disability. Additional information has been requested.
heart pain at 4am, muscle aches, fever(101) chills, headache, dizzy, Rash on arm
The vial was initially stored in the refrigerator on 06DEC2022 and vaccine administered on 07APR2023; No adverse event; a Pediatric patient received expired 2nd primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a Pediatric patient received expired 2nd primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06DEC2022 and vaccine administered on 07APR2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (a Pediatric patient received expired 2nd primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06DEC2022 and vaccine administered on 07APR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a Pediatric patient received expired 2nd primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06DEC2022 and vaccine administered on 07APR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (a Pediatric patient received expired 2nd primary dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06DEC2022 and vaccine administered on 07APR2023).    No concomitant medications was reported.  Reporter does not have patient's demographics handy, she was sure that the patient was pediatric. Vial size was 2.5 ml. The vial was initially stored in the refrigerator on 06DEC2022. The vial did not undergone any temperature excursions.  No treatment medications was reported.
Feelings of having a fast-beating, fluttering,  or pounding heart.  And tightness in the chest.
Pt received the vaccine on 9/21/23 at 0900 in the left deltoid and stated experiencing a reaction 30 minutes after vaccination.  Initially, she had pain, a burning sensation, and redness at the injection site and could not lift up her left arm. Pt  noticed that the injection site was right through the shoulder bone.  Applied ice and took Ibuprofen which relieved the pain for that day.  Pt stated there is an improvement in her range of motion and there is pain in the Left arm when lifting heavy objects. Denies discharges on the injection site. Denies shortness of breath. Denies swelling. No pain when L arm is not in use. Pt declined to follow up for evaluation.
Syncopal episode. ALS assessment completed . with Sinus on Monitor. Noted elevated BP with Sugar of 97. Refused transport to the Hospital and signed refusal . Vitals signs set #1 175/97, 90 18, Pulse Ox 100%, Set 2 182/20, 84 18, 100%, Set 3 171/83, 82, 18 100%
Swelling of injection site was still visible after eight days. Site is approximately 4 inches in diameter, raised, firm, and warm to the touch. No fever or other noticeable symptoms.
Patient says he had muscle aches and muscle cramps for a long time and says he thinks it still hasn't resolved.
Developed severe nerve pain over entire body. History of Shingles shortly after second dose of vaccine, at the time assumed to be unrelated with intermittent residual nerve pain localized to L arm. Received booster in AM, ~12hrs later sudden intense onset of severe nerve pain over entire body, unrelieved so far.
Medication Error wrong medication administered.  Patient was to receive Prevnar 13 and was given Pneumovax 23.  No adverse reactions noted at time of visit.
Administrative error, Patient fully vaccinated with Janssen and Janssen. Patient received Pfizer booster per request with no adverse effects noted.
Arm very sore. All my body ached, front of head hurt. Felt very sick to stomach, nausea. This was for four days. I never got sick from a flu shot before.
terrible nausea; headache; Was in bed 2 days; very tired; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Lot number: 3248) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Underactive thyroid" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication included: DOXYCYCLINE. Vaccination history included: bnt162b2 (Dose 1, single (Lot number: 3248) in the left arm at 10:00 AM), administration date: Mar2021, when the patient was 56 years old, for COVID-19 immunization, reactions: "Fever", "Chills", "Body aches", "Nausea", "Headache", "Very tired". The following information was reported: NAUSEA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "terrible nausea"; HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "headache"; BEDRIDDEN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Was in bed 2 days"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "very tired". Therapeutic measures were not taken as a result of nausea, headache, bedridden, fatigue.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received doxycycline within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. After second vaccine, the patient woke in the middle of the night with again terrible nausea and headache. She was in bed 2 days - very tired and extremely nauseous and terrible headache.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423929 Same reporter, patient, and drug; Different dose and events
achy; tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achy) and FATIGUE (tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 027821A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-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 PAIN (achy) and FATIGUE (tired). At the time of the report, PAIN (achy) and FATIGUE (tired) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the events were Not Applicable.    This case was linked to MOD21-099585 (Patient Link).
Flushed, warm, malaise, sweating, nausea, dizzy, light headed, elevated blood pressure.
Seem to get a cold and as it progressed turned into bronchitis. 1/6 took a CoVid test rapid (negative) just to make sure and later on 1/12 went to urgent care. There, I got a chest X-ray and oxy levels. Thru the physical exam and prior history doctor diagnosed as bronchitis. Breathing treatment for albuterol, antibiotic, prescription for cough (benzonatate caps), and prednisone. Also, advised to use nebulizer as per usual. Took about 10 days but feel much better and have recovered.
The vaccine was given on 3/7/00. The child developed a fever of 101 that night. Three days following immunization, he developed a skin rash. The skin "shedded" on buttocks, hands, feet, trunk, and legs. The face was red and rash on trunk was "sand paper like".
CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID 19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, and codeine allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 01 total administered on 11-MAR-2021 to the left arm for prophylactic vaccination. On an unspecified date, the patient experienced confirmed clinical vaccine failure (dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. The patient received second dose of Non-company suspect vaccine elasomeran (dose number in series 2) (moderna covid-19 vaccine )(form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 22-OCT-2021 to the left arm for prophylactic vaccination. It was unknown if patient had any adverse events following vaccination with elasomeran (dose number in series 2). The patient additionally received third dose of Non-company suspect vaccine elasomeran (moderna covid-19 vaccine) (dose number in series 3) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 04-JUN-2022 to the left arm for prophylactic vaccination. On an unspecified date, the patient experienced suspected clinical vaccine failure. The patient received paxlovid (form of admin, route of admin, batch number were not reported) administered from 23-Jun-2022 to 27-JUN-2022 for covid-19 treatment. On 28-Jun-2022 , the patient still tested positive after finishing antiviral. Concomitant medications (dates unspecified) included: olmesartan and hydrochlorothiazide. On 28-JUN-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid 19 infection and confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20220715465-covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccine failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient is a 60 y.o. female who received the Moderna Covid-19 Vaccine, mRNA-1273 (PF) 100 mcg/0.5 mL IM Susp, Lot 044A21A on 3/15/2021. The patient experienced the following reaction(s) during the immediate of observation: 11:38am patient c/o numbness/tingling to mouth; lips and tongue. No swelling noted to face or mouth. Patient denies shortness of breath or difficulty breathing Patient was treated/managed as follows:  11:40am VS BP 118/82, HR 65, RR 18, O2 sat 98% on room air. Patient reports numbness and tingling feeling resolving. 11:50am VS BP 116/86, HR 62, RR 18, O2 sat 98% on room air. Reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 11:52am Escorted to car by RN.
Hardness at inj site, considerable swelling, pt indicated her discomfort and malaise incapacitated her for two days. Largely resolved when reported on 10-21-13.
She has been feeling unwell; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  An 74 year-old female patient received bnt162b2 (BNT162B2), administration date 11Apr2021 (Batch/Lot number: unknown) at the age of 74 years 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: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "She has been feeling unwell".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AEs reported; patient received 4 doses of GARDASIL or GARDASIL 9; 1st dose was administered on 12/2014, 2nd dose 12/15/2020, 3rd dose 2/26/2021; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided.  In December 2014, the patient was vaccinated with the first dose of either hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (unidentified Merck hpv vaccine administered (name and lot number not provided)).   Then, on 15-DEC-2020, the patient received the second dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).   On 26-FEB-2021, the third dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was given.   On 22-JAN-2022, a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered (extra dose administered) (0.5 ml, by intramuscular route, Lot #U007652, expiration date on 14-APR-2023).  No additional Adverse Experiences (AEs) were reported.
he reported that he felt lightheaded and also felt confused. HIs vitals were normal. It took about 80 minutes before he reported feeling back to normal. He was awake and interactive throughout, not tachycardic, was able to converse the whole time.
2 febrile sz ! @ approx 4PM & another @ 8PM on 12MAR98;temp @ time of sz was 103.9;unclear of temp @ time of first sz;
After receiving the vaccine; erythema developed 10 days after initial vaccination. No erythema was present until 10 day mark.
1 hour post vaccination, patient developed a rash on her arm that spread slightly to below her neck on the arm she was vaccinated on.  given 2 doses of benadryl. 1 dose at clinic, 1 dose for later.