chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling in underarm of left arm where shot was administered; Pain with swelling and has not decrease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Jan2022 15:45 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown. Did not receive, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 06May2021, when the patient was 43 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Did not receive, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 15Apr2021, when the patient was 43 years old, for COVID-19 Immunization.  The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 08Jan2022 07:30, outcome "not recovered", described as "Swelling in underarm of left arm where shot was administered"; PAIN (non-serious) with onset 08Jan2022 07:30, outcome "not recovered", described as "Pain with swelling and has not decrease". Therapeutic measures were not taken as a result of peripheral swelling, pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
The patient woke with visual disturbances on 3/14.  He was seen by and eye doctor 3/16 and referred to the ER.  MRI in the ER showed right occipital lobe infarct.  He was discharged home on 3/17.
Patient reports he received flu vaccination at his place of business at 2:15 pm on Monday,  11/03/2008. The same evening at 8:00 pm his arm developed a "softball size hive" which he described as being "raised, red, swollen, hard, itching, and warm to touch" at site of administration (LD). Hr reports that when he woke up the following morning at 7:00 am on Tuesday, ll/4 his arm was "normal." On Tuesday evening (11/4) at 9:00  pm he developed a "tennis ball." sized "hive" on his mid back area that progressively spread to his entire back and a large area of both thighs. He denied any SOB or airway obstruction. He took 2 OTC Benedryl tablets at 3:00 am and states when he awoke the following morning on Wednesday, 11/5 at 7:00 am the "hives" had resolved. He had carpel tunnel surgery on Thursday, Nov 6 on his R wrist and reports no episode of hives on the day of surgery, but on the same evening (Thursday) he again developed  a hive on his outer left thigh which he described as golf ball in size, raised, warm and itchy. He again took 2 OTC Benedryl tablets. On Friday, Nov. 7 at 7 am he reports having hives on both buttocks and thighs which progressively spread to both of his entire thighs and to back of both knees. By 12:15 on Friday, Nov. 7 the hives had resolved.I checked back with him on Wednesday, Nov. 12 and he reports no further problems since Friday, Nov. 7. He reports he has received the flu vaccine annually for the last 10 years without adverse effects.
Patient began complaining of right shoulder joint pain and presented to the clinic with right shoulder joint swelling and pain 5/8, the morning after the injection. The swelling subsided within 7 days after the injection was given. Continues to have pain in the joint.
Severe headache, and fever for two days and chills.  Prolonged headache and brain fog four days after vaccine.  Fatigue still lingering
pt slumped in chair and fainted about 5 minutes after vaccine, was unconscious for about 10 seconds, came to suddenly, very disoriented.  Very sweaty and continued to drift in and out of consciousness.  No sign of andioedema or swelling of any kind.  He was able to communicate mostly, just very drowsy and disoriented.  EMT was called and was assessed.  He refused going to hospital, remained at store for about 45 minutes after incident.  Went home with family still somewhat dazed.
Severe Headache with blister rash on left side of face, head, neck, and shoulder area.
This spontaneous report as received from a pharmacist refers to a 53 years years old female patient. The patient was vaccinated with one vial ZOSTAVAX (Lot number reported as 0070AE, expire date 03-APR-2013) subcutaneously on 15-SEP-2012. There were no pertinent medical history or drug reactions/allergies. No concomitant medications were received. On 20-SEP-2012 the patient developed redness and swelling at the injection site after receiving a dose of ZOSTAVAX. No treatment was received. No lab diagnostics performed. The outcome was reported as not recovered/not resolved. The patient had sought medical attention via saw the pharmacist. Additional information is not expected.
This patient had received vaccination and was scheduling next appt in observation area. Medical alert called overhead. RN responded to alert. Pt conscious, but per RN, in observation area, she stated he had a loss of consciousness and although she tried to break his fall, he did hit his head on the wall. Pt was sitting in chair, vitals attempted to be assessed, no reading, but patient alert. Before vitals were repeated,16:18 pt eyes drifted left and closing, another loss of consciousness, followed by convulsions and gasping sounds from the throat. Pt convulsed and left leg /foot turned inward torsion. Pt was removed from chair by 3 RN's to floor safely. approximately 15-30seconds of convulsion. pt regained consciousness AOX4. Pt remained laying, head propped on cushion. vitals taken 16:24 BP 108/69 86bpm, 100%O2Sat. MD assessed and pt stable. MD provided recommendation for pt to be evaluated at ED for further evaluation due to the convulsions. Pt accompanied by friend, friend agreed to drive pt to ED. Blood Glucose 90, which was taken at 1630.  Wheelchair was provided for patient, RN rolled pt out to car and friend designated driver.
Lost control of bladder; Could not walk; Paralyzed from the waist down for about 24 hours; Received the 2nd dose on 22Jan; Diarrhea; Vomiting; A spontaneous report was received from a consumer, concerning a 67-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced paralyzed from the waist down for about 24 hours/PT: Paralysis, received the 2nd dose on 22 Jan 2021/PT: inappropriate schedule of product administration,  lost control of bladder/PT: urinary incontinence, could not walk/PT: gait inability, diarrhea/PT: diarrhoea, and vomiting/PT: vomiting.  The patient's medical history was not provided.  Concomitant medications included omeprazole, fluoxetine hydrochloride, propranolol, colestipol, acetylsalicylic acid, and calcium.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) on 28 Dec 2020. On 22 Jan 2021, the same day as the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, following the second vaccination, the patient experienced vomiting and diarrhea. On 23 Jan 2021, the patient could not walk, was paralyzed from the waist down for about 24 hours, and lost control of her bladder.  Treatment information for the events was not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the event, paralyzed from the waist down, was considered recovered/resolved on 24 Jan 2021. The outcome of the event, received second dose on 22 Jan 2021, was considered resolved on 22 Jan 2021. The outcome of the events, vomiting, diarrhea, could not walk, and lost control of bladder, was unknown.; Reporter's Comments: This case concerns a 67 year old female subject, who experienced a serious unexpected event of paralysis after second dose of mRNA1273 (Lot# 032L20A). Very limited information regarding this event has been provided at this time.  Further information has been requested.
Severe convolutions/involuntary movements lasting 9 hours. temperature up to 103.3 that persisted >24 hours. One episode of emesis without nausea. Headache, dry mouth, fatigue, joint pain lasting >5 days.
At 2:18pm the pt states "Not feeling well" at 2:23pm assisted pt to lay on the floor. Pt states that he fekt dizzy and might pass out. He stated he had blurry vision and felt fast heart rate. BP 120/80, P: 68. Placed cold packs to neck front and back. At 2:25pm pt stated feeling better. At 2:27 R-20, P 68 BP 120/80 02 Sat 99% and temp 96.4. At 2:33 placed pt upright in chair. Pt felt better and was cleared.
Pt reported bumps on wrists, elbows and neck. Bumps appeared day after vaccination. Bumps were not spreading. They itched but no pain.
Patient developed a welt at injection site almost immediately. He was given 0.05mL of the pediatric dose per facility instructions. He was supposed to be given 0.20mL after 30 minutes of observation time but it wasn't given because of the immediate reaction.
Pt. after the fact disclosed she had another vaccine 7 days prior to the second does of COVID-19 vaccine. She stated that her PCP said it would be okay to still receive the COVID-19 in a week.  PCP notified that no vaccine should be given prior to or post vaccine for 14 days and no vaccine should be given in between the two doses.
PATIENT FAINTED AND LOOSE CONSCIOUSNESS FOR ABOUT 30 SECONDS AND THEN REGAIN CONSCIOUSNESS BUT WAS VERY PALE AND WEEK. EMS TOOK PT TO HOSPITAL.
Headache, Fever, cold hands and feet, scratchy throat,  Narrative:  Other Relevant History:
Flu; Lost ten pounds; very sick; This non-serious case was reported by a consumer and described the occurrence of influenza in a 76-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza (Verbatim: Flu), sickness (Verbatim: very sick) and weight loss (Verbatim: Lost ten pounds). The outcome of the influenza and weight loss were not reported and the outcome of the sickness was resolved (duration 11 days).   It was unknown if the reporter considered the influenza, sickness and weight loss to be related to Shingles vaccine.     It was unknown if the company considered the influenza, sickness and weight loss to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-JUN-2023 The patient received shingles vaccine and had extreme flue, lost ten pounds and very sick for eleven days. The patient asked that , need to compensated for the misery. The reporter was requested for consent to follow up
Bones aching, - elbows, arms and hands numb - nausea, diarrhea, no appetite - sleeping all the time - depressed , excessive sweating on the left side of face and neck - excessive phlegm production as well as left eye buringin
Initial report received from a healthcare professional on 08 February 2007. A 40 year old, male patient developed cellulitis at the site of vaccination and fever after he received an injection of Adacel (lot number "C62644AA", route of administration not reported) on 29 January 2007. Additional information was not provided.
Patient received 3 vaccines on 12/5/2014 and had full body seizure on 12/6/2014 mid day. Was denied being seen by neurologist because mom mentioned the vaccines. Neurological symptoms continued for months following- including head-banging/spinning- other sensory symptoms- that were no present prior.
Shaking/tremors of arms and legs.  Frequent apnea episodes.  Does not respond to verbal stimuli.  Obtunded.  911 called.  Patient sent to ER. 8/1/08-records received for DOS 6/20-6/22/08-Assessment:complex febrile seizure, presenting in status epilepticus. Morning of admission developed tactile fever, runny nose and increased drooling and later that same day received his vaccinations. Soon after began to experience generalized tonic-clonic activity lasting 45 minutes. Temp in ED 101.5.
2 days after the vaccine, patient developed N/V x6 episodes, and had a couple of loose stools. Then developed a slight sense of throat constriction, left jaw area swelling/warmth, bilateral periorbital edema, followed by perioral edema and lips swelling/tenderness. The facial swelling resolved, but it was followed by migratory large joint pains/warmth: knees, hips, shoulders and neck. Also, she had a headache, fatigue and tactile fever. Entire syndrome lasted about 3-4 days.
she has "Sjogren's" Syndrome; Caller mentioned she has an autoimmune disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy to other ingredients like dairy" (unspecified if ongoing), notes: allergy to other ingredients like dairy; "allergy to other ingredients like dairy or citrus" (unspecified if ongoing), notes: allergy to other ingredients like dairy or citrus. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "she has "Sjogren's" Syndrome"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Caller mentioned she has an autoimmune disease".  Clinical course: Patient stated that she had the original and booster last Nov and was waiting for the new vaccine to come out. She asked was it true that the original booster would be discontinued, for the "original booster" and the vaccine for the two shots (primary), was it the same vaccine and was asking how long the protection would last. Reporter mentioned she could not find anywhere online the full list of ingredients of the bivalent vaccine and was really could not find that distinctively online. Reporter asked for her allergy. Reporter stated: she could not take the Moderna because it had citric in it and could not take flu or pneumonia shots because of allergy to other ingredients like dairy or citrus. She was thrilled when Pfizer's did not have any of that. Reporter mentioned she had an autoimmune disease, and that her doctor advised against getting flu, shingles, and pneumonia shots. Reporter stated she had Sjogren's Syndrome, explained that her immune system was barely functioning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No adverse event; First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine; First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 IMMUNISATION (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 12-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 23-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2022, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced COVID-19 IMMUNISATION (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, COVID-19 IMMUNISATION (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine).    Concomitant product use was not provided by the reporter.  The patient had also received several other vaccines at the same time as the Pfizer vaccine.  No treatment information was provided.
Pt complained of feeling dizzy after vaccine was administered, approx. 11:10, while pt seemed to be fainting (falling over while sitting in chair), her extremities became ver stiff. Pt responded to verbal stimulation after 1 minute.
VARlVAX and M-M-R II given intramuscular (IM) instead of subcutaneous (SC); Caller reported no further AE. No PQC reported.; This spontaneous report was received from a nurse practitioner, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.      On 15-JUL-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T032932, expiration date 28-SEP-2022) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# T013725, expiration date 21-APR-2022) (0.5 ml; strength and frequency were not provided) via intramuscular (IM) route instead of subcutaneous (SC) route for prophylaxis (incorrect route of product administration). No further adverse event (AE) or product quality complaint (PQC) was reported.
his pulse shoot up to 125; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in left arm on 05Mar2021 21:30 (Lot Number: EN6206) as single dose for covid-19 immunization. Medical history included covid-19 from 26Jan2021 to 10Feb2021. There were no concomitant medications. The patient received dose 1 intramuscular left arm on 12Feb2021 07:30 (Lot: EL9266) for covid-19 immunization. The patient experienced his pulse shoot up to 125 on day after 2nd Vaccine. None received prior vaccinations (within 4 weeks). None family medical history relevant to AE. The outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Aneurysm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 43 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: ANEURYSM (non-serious) with onset 04Apr2021, outcome "unknown", described as "Aneurysm". The event "aneurysm" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of aneurysm.  Additional information: Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Prior to vaccination the patient was diagnosed with COVID-19, any other medications the patient received within 2 weeks of vaccination no. Prior to vaccination, the patient was diagnosed with COVID-19. Reported stated that Another report was of a local anesthesiologist having any aneurysm immediately after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to a 20 unspecified patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of an improperly stored ROTATEQ (lot #, expiration date and dose were not reported), route default as oral. Secondary suspects and concomitant therapies were not reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent to contact Health Care Professional was given.
No fever; both arms & legs jerked-occurred 12APR92 & again 15APR92; pt taking Demitane for cough; Amoxicillin started 13APR for URI;
Local erythema and edema, fever 103.6 vomiting, generalized myalgia for 5 days supportive care, ibuprofen, ice, topical hydrocortisone.
Patient experienced shaking and shivering of the entire body as well as extreme achy and tiredness that last about 2 weeks. Several days after the injection she developed a raised, red rash at the injection site. At this time she has recovered fully.
tested positive for COVID-19; chills; fever; lost of appetite; tiredness; feel bad; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), DECREASED APPETITE (lost of appetite), FATIGUE (tiredness) and FEELING ABNORMAL (feel bad) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever), DECREASED APPETITE (lost of appetite), FATIGUE (tiredness) and FEELING ABNORMAL (feel bad). On 23-Jan-2021, the patient experienced COVID-19 (tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) at a dose of 1 dosage form. At the time of the report, CHILLS (chills), PYREXIA (fever), DECREASED APPETITE (lost of appetite), FATIGUE (tiredness), FEELING ABNORMAL (feel bad) and COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.