chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received bivalent Moderna Covid-19 vaccine booster dose and 0.25ml of the dose escaped the needle and trickled down the patients arm; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (The patient received bivalent Moderna Covid-19 vaccine booster dose and 0.25ml of the dose escaped the needle and trickled down the patients arm) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AF7144B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (The patient received bivalent Moderna Covid-19 vaccine booster dose and 0.25ml of the dose escaped the needle and trickled down the patients arm) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (The patient received bivalent Moderna Covid-19 vaccine booster dose and 0.25ml of the dose escaped the needle and trickled down the patients arm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (The patient received bivalent Moderna Covid-19 vaccine booster dose and 0.25ml of the dose escaped the needle and trickled down the patients arm).    No concomitant medication were reported. No treatment medication were reported.  The patient received bivalent Moderna COVID-19 vaccine booster dose and 0.25ml of the dose escaped the needle and trickled down the patients arm.  The pharmacist did consult CDC guidelines and another 0.25ml dose was administered to the patient to equal a 0.5ml dose.   This case was linked to US-MODERNATX, INC.-MOD-2022-641683 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-641683:Same reporter
she lost strength in her left hand or more in the arm; She said she can't pick up nothing; Her hands also feels cold sometimes; she can't stand up right; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 35-years-old female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/ lot number: unknown, Expiry Date: unknown), via an unknown route of administration in left arm on an unknown date as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient lost strength in her left hand or more in the arm, she said she can't pick up nothing, her hands also feels cold sometimes and she can't stand up right. It was explained that the patient had the first dose of the vaccine and lost strength in her left arm and right arm, where she was vaccinated; especially in the left arm where the caller got the vaccine. Right hand also lost some strength but not like the left hand. She can't pick up nothing. She said the caller reported that the symptoms were gone and the caller was getting ready for the second dose this week. She said sometimes it get worse, especially in the shower: she can't stand up right or or that some days she wakes up and it's worse than others, can't pick up anything. The patient also reports that her hands and feet feel cold. She is asking if this is normal. Should she get the second dose or not. The outcome of the events was unknown.   Information about batch/Lot number has been requested. No further information obtained.
11.25.10 presented to urgent care. Diagnosed with a cellulitis to (L) deltoid. Treated with KEFLEX antibiotic.
Extremity impairment/lost grip of her hand, unable to feed herself, and unable to hold a spoon; Extremity impairment/lost grip of her hand, unable to feed herself, and unable to hold a spoon; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 93 year-old female patient received bnt162b2 (BNT162B2), administration date 21May2021 (Lot number: EW0183) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Lot/batch number: EW0167, No events reported), administration date: 21May2021, when the patient was 93 years old, for Covid-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 18Jun2021, outcome "not recovered" and all described as "Extremity impairment/lost grip of her hand, unable to feed herself, and unable to hold a spoon".  Additional information: Caller (Patient's son) wanted to know if the extremity impairment that his mother was experiencing was among the listed side effects after getting the Pfizer BioNTech Covid-19 Vaccine. The report was not related to a study or program. The patient was not the reporter. Reporter stated he was calling on behalf of his mother. Reporter sated he just wants to go over some side effects that maybe his mom has because she was 93 years old. Reporter stated after his mom got the second vaccine on Wednesday that next done on Thursday and ever since she lost the use of her hands where she cannot feed herself and hold a spoon or whatever. Reporter stated he was wondering if this was something from the vaccine or if he should be concerned. Reporter confirmed vaccine he was referring to the COVID 19 vaccine. Reporter declined to complete report at this time wished to be transferred to MI for his question. Investigation assessment was not provided.  Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
Patient after 5 minutes of administration got light headed and sweaty. He hadn't eaten since morning. Gave some orange juice and water and in 10 minutes he was feeling better.
Starting about 2 hours after injection until 42 hours after injection Faintness - mild Headache - mild Fatigue - severe Injection site pain - mild Chills - Severe Brain fog - moderate
This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 02-JUL-2014 the patient was vaccinated with third dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Information has been received from a consumer concerning his 24 year old wife with no medical history or drug allergies who on approximately 15-SEP-2009 (3 months ago) was vaccinated with the first 0.5ml injection of GARDASIL (lot# not reported). There was no concomitant medication. Subsequently the patient didn't get her menstrual period from two months (approximately on 15-Oct-2009) after getting GARDASIL three months ago. Blood and urine test was performed but the results not provided. The patient sought medical attention via physician. Additional information has been requested.
Lip swelling and pain/swollen to 4x the regular size of lip; Lip swelling and pain/swollen to 4x the regular size of lip; This is a spontaneous report from a non-contactable consumer (patient, herself). A 31-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0178 and expiry date was not provided), via an unspecified route of administration, administered in Arm Left on 19May2021 13:15 (at the age of 31-years old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19. No known allergies. No other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 21May2021 12:00 AM, the patient experienced lip swelling and pain, swollen to 4 times the regular size of lip. No treatment received for the events. Seriousness of the events was reported as non-serious. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
heat and tenderness at injection site, starting morning after the injection and stayed the same the rest of the day
After administration of a subcutaneous MMR vaccination using a VanishPoint syringe, a black dot appeared on the site of injection.
Some soreness at injection site the evening after the injection. 20 hours later noted itching and selling at the site. 44 hours later stated that all symptoms had resolved
Right upper arm red and swollen; about 2 inches wide and 4 inches long; Hot and painful; Doctor prescribed Generic BACTRIM DS 1 tablet po bid for 10 days.
So, on the Thursday, on my job I was doing a training, and the right side of my face from my ear to my job line, it went numb. It felt like I could not speak, I tried to, but I could not figure out how. I also had a fever that day as well. I told my manager I needed to go home I was not feeling well, I did not go to the doctor I just went home to lay down. I also had a headache at this time as well. So that night I slept and waited to see what would happen the next day. So, when I got up, I did not have the numbness anymore but still had the headache so that is when I went to the urgent care. I was getting messages from the CDC at this time and when I talked to the doctor. at the urgent care because she listened to all my symptoms and knew at the time all the things that had went wrong with the vaccine after hearing all my symptoms, she felt I was having the right symptoms and sent me immediately to the ER. At the ER they took some neurological assessments and took some blood work, and everything came out normal, doctor told me what to look out for and released me.
Symptoms: fever (100.8), body aches, nausea, headache. Treatment: Tylenol, Naproxen, Ondansetron
Sudden twitching, tremors, loss of vision, dry mouth, trouble swallowing. The tremors and twitching started first, initially with my eye, then cheek, then arm, then leg. The loss of vision and dry mouth happened about an hour after the twitching started and happened very suddenly. I went to urgent care and all of my vitals were normal, slightly elevated BP, no anaphylaxis.
I was diagnosed with Postural orthostatic tachycardia syndrome. I was given medication. Currently on treatment. I passed out and had tachycardia. That would cause shortness of breath and dizziness. I was diagnosed in March and I am currently on medication treatment.
At 2:50 pm patient came to observation area, after 5 minutes of observation RN observed patient becoming pallor, eyes closed and loss consciousness for few seconds. Patient regained consciousness right away. RN elevated legs, vital signs initiated. No signs of respiratory distress. Water was provided. Patient stated he has history of vasovagal and didn't eat  anything before getting the vaccine.
7/26/07 routine exam, TD & Zostavax immun given, 7/28/2007 reported to family members aches, chills, "can't get warm", did not contact medical personnel nor feel need to seek emergent care. retrospective report from family member.  7/29/2007found by family member in AM within a few hours after death.  8/3/07 Received pcp medical records which reveal patient seen 7/5 & 7/26 in office for right foot pain, RUQ abdominal pain. X-ray of right foot revealed arthritic changes. US of gallbladder revealed sludge.  Labs revealed decreased kidney function c/w chronic kidney disease III.  Urine c/s neg.  Lipids significantly increased as patient had stopped on her own the statin drug presribed.  CXR was WNL w/streaking due to scarring.  EKG unchanged from prior tracings revealed right axis deviation & borderline R-wave progression.  Last seen by nephrologist 4/06 & was d/c from service due to resolution of condition.  Records include vax records which confirm dose & lot #s as reported. 9/11/07 Received Autopsy Report which states COD as hemopericardium w/cardiac tamponade due to acute MI w/cardiac rupture due to arteriosclerotic heart disease.  Pathological diagnoses included: I. Arteriosclerotic heart disesae    A. Atherosclerosis of coronary arteries w/acute thrombus.    B. Acute MI w/cardiac rupture.    C. Hemopericardium w/cardiac tamponade. II. Systemic atherosclerosis    A. Atherosclerosis of cerebral arteries.    B. Atherosclerosis of aorta. III. Nephrosclerosis. IV. Fibroma of ovary. V. Hyperlipidemia by clinical history. VI. IBS by clinical history. VII.  Osteoporosis by clinical history.
SECOND DOSE OFCOVID-19 MODERNA VACCINE  WAS ADMINISTERED 10 DAYS AFTER FIRST DOSE. ( 18 DAYS TOO EARLY) PATIENT RECALLS FEELING ILL DUE TO THIS.
lt arm DTAP shot reddened area, warm to touch not tender 2x2 size;
I had the following symptoms following my first shot of the COVID-19 vaccination: loss of appetite (lasted for about a week), fever, migraine, extreme fatigue and weakness, body aches, and chills.  My left arm also felt very sore for a few days.
pt exp sudden onset of pain 14OCT97 in lt arm (deltoid area into lt shoulder) restricting mobility-pain radiated neck down arm-pain progressively worsened;15OCT97 firm lumps in biceps & tricep;dx myofasiculitis d/t allerg rxn;
Thousands of people went blind; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Thousands of people went blind) 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 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 BLINDNESS (Thousands of people went blind) (seriousness criterion medically significant). At the time of the report, BLINDNESS (Thousands of people went blind) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  This is a spontaneous report received through medical information. A male of unknown age reports that ¨thousands of people went blind after Moderna vaccine".  Very limited information regarding the events has been provided at this time. Further information has been requested as per the verbatim of the patient is a generalization.  Neither product administration nor events are clearly stated. Until further information is received, the case is retained as valid.   This case was linked to MOD-2021-307513 (Patient Link).; Sender's Comments: This is a spontaneous report received through medical information. A male of unknown age reports that ¨thousands of people went blind after Moderna vaccine¨ .  Very limited information regarding the events has been provided at this time. Further information has been requested as per the verbatim of the patient is a generalization.  Neither product administration nor events are clearly stated. Until further information is received, the case is retained as valid.
Initial report was received from a healthcare professional on 15 December 2011. A 53-year-old female patient had received an Intradermal (ID) injection of FLUZONE INTRADERMAL; lot number UT4164AA in left arm on 13 December 2011. On the same day of the injection, the patient developed a blister 13mm in diameter, pain and erythema at the vaccination site left arm. The patient was seen on 15 December 2011, and received corrective treatment with ALEVE and ice. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Follow-up information received on 27 February 2012 from a nurse. The reporter spoke with the patient and the patient stated the blister opened and healed which took about 2 weeks, and then she had a residual knot at the site of injection that was non-tender. The patient sought no further treatments and recovered on 27 December 2011. The reporter reviewed the case and has no additional information at this time. Documents held by sender: None.
Local reaction (redness, pain, swelling) x 2 wks at injection site followed by 2 wks of redness, swelling, itching upper chest.
Patient has a known needle anxiety and faints with any vaccine or blood draw.  His doctor recommended pre-medicating with diazepam 5mg to reduce anxiety and hopefully prevent  syncope.  He initially did well for a minute or two, then fainted for a few seconds, woke up, felt nauseous, vomited,  then fainted again for a few seconds.  Once he woke up, he felt much better.  He waited a few extra minutes and went home.
Sudden appearance of significant amount of eye floaters, flashes and blurriness in the right eye about 20 hours after the 2nd shot of Pfizer Covid-19 vaccine.  First started to notice sporadic floaters and mild blurriness during the 3-week period between the 1st and the 2nd shot of Pfizer vaccine.  Diagnosed with Central Retinal Vein Occlusion (CRVO) with macular edema in the right eye within 48 hours of the 2nd shot of the vaccine.  Confirmed by second opinion. Right eye vision is currently 20/50.  Received Eylea injection in the right eye.   Antiphospholipid panel, Protein S, Protein C, Factor V, Homocysteine and Antithrombin all come back normal from lab testing.  Blood pressure normal, no diabetes, no known systematic disease.  34 year old female.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant therapies were not reported. On 08-AUG-2015, the patient received an expired dose of ZOSTAVAX (lot: K000326; expiration: 27-FEB-2015) (dose and frequency were not provided) subcutaneously. No known adverse effects were reported. Additional information has been requested.
Moderna COVID-19 Vaccine EUA  About 8-10 hours after my wife and I first noticed that my left (vaccinated) arm was sore. Within a few hours, my left hand began to tingle and my right leg felt stiff. I experienced a loss of balance that made walking difficult.  For the next 24 hours I became very fatigued. But two days after the vaccination, I have begun to regain my strength.
Developed blisters that erupted, were non-purulent, on palms and fingers of both hands.  They were non-painful or itchy.  The new skin was tender.
It was reported that a patient (2 of 6) received a Fluzone SV 2001/2001 vaccination (administration date and site was not provided). Sometime after the vaccination (exact date not specified), the patient developed a local reaction at the injection site. Further information is requested. Linked cases: U200101055, U200101226, U200101227, U200101228 and U200101229.
dizziness; distortion of vision; migraine headache accompanied by vomiting; migraine headache accompanied by vomiting; distortion of Speech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Aug2021 08:30 (Lot number: FD0809) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Allergy: erythromycin", notes: Allergy: erythromycin; Hydroxychloroquine, reaction(s): "Allergy: hydroxychloroquine", notes: Allergy: hydroxychloroquine. The following information was reported: DIZZINESS (non-serious) with onset 31Aug2021, outcome "recovered" (2021), described as "dizziness"; VISUAL IMPAIRMENT (non-serious) with onset 31Aug2021, outcome "recovered" (2021), described as "distortion of vision"; MIGRAINE (non-serious), VOMITING (non-serious) all with onset 31Aug2021, outcome "recovered" (2021) and all described as "migraine headache accompanied by vomiting"; SPEECH DISORDER (non-serious) with onset 31Aug2021, outcome "recovered" (2021), described as "distortion of Speech". The events "dizziness", "distortion of vision", "migraine headache accompanied by vomiting", "migraine headache accompanied by vomiting" and "distortion of speech" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, visual impairment, migraine, vomiting, speech disorder.  Additional information: The patient did not receive any other vaccine in four weeks and other medications in two weeks. It was reported that shot received on Saturday (28Aug2021), Tuesday (31Aug2021) morning experienced dizziness distortion of vision and speech which accelerated into a migraine headache accompanied by vomiting. AE treatment with iv fluids and pain killer. The patient had no covid prior vaccination. The patient tested covid post vaccination.  Follow-up attempts are completed. No further information is expected.