chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Throbbing and painful to move/lift; After first dose:  extremely sore injection site arm (deltoid) that woke me the first 2 nights even with Tylenol use.  Throbbing and painful to move/lift.  I also had a runny nose the day after first; After first dose:  extremely sore injection site arm (deltoid) that woke me the first 2 nights even with Tylenol use.  Throbbing and painful to move/lift.  I also had a runny nose the day after first; This is a spontaneous report from a non-contactable health care professional (Patient, self-reported). A 50-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EH9899, Expiration date: Not reported) via an unspecified route of administration, administered in left arm on 18Dec2020 18:15 as 1st Dose single for covid-19 immunization. Medical history included hypertension, blood cholesterol, latex sensitivity and GI upset from eggs and soy. Concomitant medications included atorvastatin; fexofenadine hydrochloride (ALLEGRA); hydrochlorothiazide/losartan potassium (LOSARTAN HCTZ). Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. Patient received bnt162b2 (Batch/Lot number= EL3249), via an unspecified route of administration, administered in left arm on 08Jan2021, 06:15 PM, 2nd DOSE, SINGLE. On an unknown date, after first dose patient had extremely sore injection site arm (deltoid) that woke me the first 2 nights even with Tylenol use. Throbbing and painful to move/lift. I also had a runny nose the day after first dose. Symptoms resolved by 3rd day after injection. Treatment received with Tylenol, Ibuprofen and Benadryl. Outcome of the events was recovered.   No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021090292 similar report from same reporter
soreness in the arm; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender receive pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported soreness in the arm for two days. The pharmacist stated that this is a typical occurrence and the pharmacist sees a lot of patients.  No follow-up attempts are possible, information about batch number cannot be obtained.
pt recvd vax & 1 hr later exp urticaria of the neck & face; No further details are available;
Within 15 min of vaccine face flushed, felt a little light headed, and felt tingling in jaw/mouth/throat. Intermittently worse and a little better. Was on way home from store and had to return. Ended up seeing doctor. Was given 2 Benadryl and told to monitor and not receive second shot.
This case was reported by a healthcare professional and described the occurrence of turned blue in a 1-day-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the 1 day old subject received a dose of ENGERIX B while already in the hospital. Soon after vaccination, the subject experienced excessive crying, breath holding and he turned blue. This case was assessed as medically serious by GSK. The healthcare provider gave the subject oxygen and suction. The subject was discharged from the hospital as it was planned which was the day after vaccination. It was reported that the baby was doing fine at the time of reporting; however, the outcome of the events was not specified.
Syncopal Seizure Event; Syncope; This case was reported by a nurse via call center representative and described the occurrence of seizure in a 18-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced seizure (serious criteria hospitalization and GSK medically significant) and syncope (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the seizure and syncope were unknown.   It was unknown if the reporter considered the seizure and syncope to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Fluarix Quadrivalent 2019-2020 season on left deltoid. The patient experienced syncopal seizure event and was hospitalized due to it. The reporter consented to follow up.
More than 36 days has passed since first dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days has passed since first dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021.    On 26-Apr-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 (More than 36 days has passed since first dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days has passed since first dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Information has been received from a nurse practitioner concerning a 30 month old male with no relevant medical history and no known allergies who on 05/01/03 (previously reported as 05/06/03) was vaccinated in the right arm with a SC first dose of varicella virus vaccine live (Lot # 643768/1063M). Concomitant therapy on 05/01/03, included an IM fourth dose in the left arm of Hib conj vaccine (crm197) (Batch # UA816AA), an IM fourth dose in the left arm of DTAP (Tripedia)(Batch # C1354BA) and an IM fourth dose of in the left arm of Prevnar (Batch # 493-187). There was no illness at the time of vaccination. Subsequently, the pt developed "12-15 varicella-like lesions", also described as "12-15 insect bite like lesions on back". There were no relevant lab or diagnostic studies performed. It was noted that no hospitalization or treatment was required. Unspecified medical attention was sought. Subsequently, the pt recovered. There was no product quality complaint involved. No additional information was provided. No further information is expected.
On 7/29/2021 patient was suppose to receive Janssen COVID vaccine. Patient was  injected with empty need of the Janssen vaccine that her husband received.  Vaccine was postponed to identify signs of infection. Patient declined blood draw for her and husband for infections disease because "it is her husband".  No infection or adverse reaction to needle stick. Patient was given Janssen Vaccine 8/11/2021. Has tolerated well as of this time.
Redness and itching; red erythema area on left arm measured 5inches in diameter.
Hx of being COVID 19 long hauler in medical record; admitted to hospital with aspiration pneumonia, GIP Respiratory Distress; DNR; Comfort Care; pt passed away in the hospital; no record of when pt tested positive for COVID; PCP not identified
COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Pfizer  on12/30 and 1/21 . Patient is admitted to hospital on 3/7 for atrial fibrillation with rapid ventricular rate
Bells palsy; Metal taste in mouth, mild on first afternoon but stronger tasting on next two days; her body started to feel strange/ just felt weird; This is a spontaneous report from a non-contactable consumer (patient). A 43-years-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 left arm, on 12Mar2021 at 02:30pm (at age of 43 years old), as a single dose, for COVID-19 immunisation. Medical history included migraine and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications included ondansetron (ZOFRAN) and oxymetazoline hydrochloride (CLARITIN ALLERGIC), Nurtec and allergy immunotherapy; all started on an unspecified date and for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the BNT162b2 vaccine. On 12Mar2021 (at 6:00pm), the patient experienced a metal taste in her mouth, mild on first afternoon but stronger tasting on next two days. On Day 2, it was reported that her body started to feel strange, could not quite describe feeling, further described as it was not really a tired feeling or a painful feeling, just felt weird. On 25Mar2021, the patient experienced Bells palsy. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the events metal taste in her mouth, body started to feel strange/just felt weird. The clinical outcome of the events, metal taste in her mouth, body started to feel strange/ just felt weird, was recovered on an unspecified date. The clinical outcome of the event Bells palsy was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
leg cramps severe; mild chills; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 01May2021 at 16:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no known allergies. 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. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration on 10Apr2021 at 12:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 02May2021, about 24 hours after 2nd shot, the patient experienced leg cramps which were severe and mild chills. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events leg cramps severe and mild chills were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Red bumps all over body/rash. Afebrile. Mom applied BENADRYL cream to rash and it was gone the next day. Child did not complain about itching.
12/31/2020:  vaccine given 1/17/2021: symptom onset and subsequent hospital course: dyspnea, hypoxic, tachypnea, afib w/RVR, septic, NSTEMI
Received 1st dose covid vaccine 4/8/2021. Few days after c/o fatigue, muscle aches, headache, drowsiness and dizziness which overall resolved after 1 wk but still mild headache, muscle aches and still some drowsiness and dizziness did not resolve. After 2nd dose, 2d after started experiencing drowsiness and dizziness, still ongoing, improved while sitting or resting. 1 wk after 2nd dose, muscle aches resolved. Also 2 weeks after 2nd dose, dry mouth, 8/10 throat pain which is now 2-3/10. He feels it is improving every day.
"Bladder trouble"; "First dose back in March"; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER DISCOMFORT ("Bladder trouble") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-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 BLADDER DISCOMFORT ("Bladder trouble") (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE ("First dose back in March"). At the time of the report, BLADDER DISCOMFORT ("Bladder trouble") and PRODUCT DOSE OMISSION ISSUE ("First dose back in March") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not provided. No treatment information was provided.  Company comment This report refers to a case of product dose omission issue for mRNA-1273 (lot # unknown) with AE of Bladder discomfort reported. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: This report refers to a case of product dose omission issue for mRNA-1273 (lot # unknown) with AE of Bladder discomfort reported. Very limited information regarding this event has been provided at this time. Further information has been requested.
Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient's husband called to report baseball size swelling in axillary region of arm where COVID vaccine was given. Assessed via phone and recommended to monitor since swelling had decreased slightly in last 12-18 hours. Recommended they monitor and check for any increasing size, redness, and warmth and refer to urgent care for evaluation if occurring. Husband verbalized understanding and agreed to plan.
Rash - The afternoon of Friday, October 12 he developed a rash that his mom said looked like hives on his chest. Over the next few days, this urticarial rash spread down his abdomen, then spread to his face, and then spread down his legs. Over the past few days, it has transitioned into a generalized redness of the skin. She says the skin feels warm and is irritated. The rash was been consistently itchy. On exam the rash is warm to touch area of erythema and macular rash on right lower arm and left upper arm with lighter diffuse papules and macules on background of erythematous skin of lower extremities that has persisted over five days. No pustules, no papules, no vesicles. Flushing redness across much of back that improved over several days. Erythematous blanching patches over nasal bridge and cheeks. Does have periorbital erythema which mom says is not his baseline. Some dermatographism noted on exam. Severe chest pain and pain in his back. 10/18 /18 - 1 day of low-grade fever (Tmax = 38.4 C) Episodic pain (sometimes severe) to palpation of epigastric area and right lower quadrant of abdomen 1-2 days of dry cough, runny nose, mild pharyngitis, mild abdominal pain. 10/18/2018 - dryness and pealing of lips 10/17/2018 - placed on diphenhydramine 50 mg every 6 hours and lactobacillus rhamnosus probiotic BID 10/18/18 - placed on sucralfate PO QID and ranitidine 75 mg BID 10/19/2018 - placed on ursodiol 300 mg BID Received acetaminophen, ibuprofen, tramadol, morphine, and ondansetron as needed during hospitalization.
Patient said 9 hours after administration she experienced fever (101.0 F), chills, joint, neck and eye pain. Said arm hurt for 48 hours.
Inability to lift arm (muscles in left upper arm became very painful and could not be lifted more than a few inches from my side, problem began about 4 hours after injection and lasted approximately 24 hours). Tinnitus (ringing in both ears increased steadily each day after injection, ringing reached a peak at approximately 1 week after injection and still persists)
Injection site pain; Slight fever; muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198, Expiration Date was not reported), an unspecified route of administration in left arm on 24Feb2021 at 10:15 (at the age of 74-years-old), as dose 1, single for COVID-19 immunisation. Medical history included dry eye, migraines, scoliosis, thyroid, osteoporosis and arthritis. The patient had allergies to food, medications, or other products. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine (MANUFACTURER UNKNOWN), vitamin D2 (ergocalciferol) (MANUFACTURER UNKNOWN) and Ciclosporin (RESTASIS) all taken for unspecified indication with stop and start dates not reported. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Feb2021, next day of vaccination, the patient experienced injection site pain, slight fever, and muscle pain. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events injection site pain, slight fever, and muscle pain was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Extreme head and ear pain with seizure-like episodes, temporary vision and memory loss, agitation, and nausea. Lasted 72 hours. Diagnosis of confusional migraine, currently in treatment.
pt said their arm hurt so much they can barely move it. reccomended tylenol and ibuprofen
Mother reported on 03/20/2018 child did have on the evening of 12/20/2017 facial drooping, red rash all over body. Then on the following days that followed child suffered a fever of 101.4. Mother did also state the child became fussy and and sluggish after receiving the vaccines.
Patient reports weakness in the legs that started a few days after receiving the vaccine that led to the inability to walk. She reports falling around 5 times due the weakness in her legs. She has notified her PCP and is seeing a specialist.
suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; migraine; This is a spontaneous report from a contactable consumer (patient's mother). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 20Apr2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled to have surgery on an unspecified date (Thursday) and on 23May2021 for an unspecified reason and the reporter would like to know how long can the second dose scheduled for second dose 21May2021 be delayed. It was reported that on an unspecified date after the first dose, patient had mild symptoms similar to COVID infection symptoms, except with a migraine. The reporter did not feel it was out of the ordinary. The outcome of the events was unknown.   Information on lot/batch number has been requested.
Mild Head ache, so far I have not taken anything for it but I may take some advil.
This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA (lot: N005274: expiry date: 03-APR-2018) (incorrect product storage). The vaccine was stored at 32F to 35F for 15 hours. No adverse effects were reported.  There was no prior temperature excursions. This is one of the three reports received from the same reporter. Additional information has been requested.
Shortly after KINRIX and PROQUAD were administered, patient began to complain of itching, especially on the palms of his hands. Palms of his hands turned red as well as his ears. Next a rash was noted on his arms, chest, back and abdomen.
One day after immunizations patient presented with redness, pain, swelling left deltoid area. Treated with oral Clindamycin 300mg 4 times a day plus IV Clindamycin 600mg on 10/3/07, 10/4/07; seen again 10/5/07 - sent to for admission due to lack of resolution. 10/30/07-records received for DOS 10/5-10/06/07-DC DX: Cellulitis. C/O worsening cellulitis left arm after receiving flu shot 3 days ago. Swelling, warmness and tenderness at injection site of posterior left deltoid, spread to posterior arm and tracked down to anterior cubital fossa.
Information has been received from a physician concerning a 13 year old female with a history of invasive meningococcal disease who on 27-JUL-2007 was vaccinated with the first dose of Gardasil (lot # 658490/0802U). Concomitant vaccination included Menactra. On 28-Jul-2007 the patient experienced rash within 24 hours of vaccination with Gardasil. The patient's outcome was not reported. There was no product quality complaint. Additional information has been requested.
24 hours post vaccination pt RTC with c/o edema, redness to L del, where vaccine administered. Denied any c/o of pain to site.
Patient received vaccination in the afternoon of 08/19, she reported to the pharmacy on 08/20 with significant erythema and a small amount of heat to the area. The erythema extended from shoulder to elbow area. Patient did not report any pain, but did have mild soreness around the injection site.  Spoke with the patient several hours later and erythema/pain did not increase.
big itchy; red/pink patches /rash like bumps in patches/patches on body, side, legs and forearms; had blurry vision but it is worse; blood sugar too high after shot; A spontaneous report was received from a Consumer concerning a 81-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events big itchy(Pruritus ) red pink patches, rash like bumps in patches, patches on body, side, legs and forearms(rash), had blurry vision but it is worse(Condition aggravated), blood sugar too high after shot(Blood glucose increased).  The patient's medical history as provided as type 2 diabetis. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  Patient experienced big itchy red pink patches, rash like bumps in patches, patches on body, side, legs and forearms, had blurry vision but it is worse, blood sugar too high after shot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, big itchy red pink patches, rash like bumps in patches, patches on body, side legs and forearms, had blurry vision but it is worse,  blood sugar too high after shot was not reported.