chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling in her head; equilibrium is off; Low grade fever; left side hotter than the rest; making her nervous; electrical zaps behind her left eye; Headache; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 22Mar2021 14:45PM (age at vaccination 57-years-old) as first dose single for covid-19 immunization. The patient medical history included hypertension, asthma (she has an asthma pump she uses as needed, her asthma was diagnosed 7 or more years ago), overweight, surgery from an unknown date and unknown if ongoing (Caller says she has had several surgeries in her lifetime) along with Caller said that she was on disability right now, and has been for the past few years (disability is unknown). Concomitant medications were not reported. On 23Mar2021 patient experienced that when she walks she had zaps or tingling in her head that are throwing her equilibrium off. She says she had a low-grade fever, her left side is hotter than the rest of her head and neck area. She says that the girl that was giving her the injection said oh you are a bleeder, she must have hit a vein. She says that this was making her nervous, she does not like feeling off balance and does not trust herself to drive today. She asks does she need to go to the doctor or emergency room. She says she felt ok on her way home yesterday from getting the vaccine, then when she got home her head started feeling weird, like a tingle. She says she wants to make sure she was not going to die here. She says that her left side, where she was injected in her left arm, feels hotter, and her right side feels normal. She says if she does her temperature on her left side it was 100.8 then sometimes 101. She says she needs to know what to do from here, she does not want to croak while being home and she does not trust herself driving. She says having the weird sensation throws her off, when she turns her neck or stretches and gets up she has electrical zaps behind her left eye for her head. It was reported she was on disability right now and has been for the past few years. She asks if the people giving vaccines, are they phlebotomists or certified to give vaccines, she should have asked, they were supposed to hit a muscle, not a vein. It was reported she also has a heavy too headache. She says that the vaccine was given in her non-dominant arm. The patient underwent lab tests and procedures which included body temperature found to be unknown result on unspecified date of 2021. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
No AE/ PQC reported at this time; HCP called in to report a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 26-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # T030944, expiration date 09-MAR-2022 (dose number, dose and route of administration were not reported) for prophylaxis.  The vaccine was stored improperly in the temperature between 14 degrees Fahrenheit (F) and 46 degrees Fahrenheit (26.6 F) for the time frame of 3 hours and 20 minutes. There was no previous temperature excursion. Digital Data Logger was not involved.  No adverse event was reported.
Vaccine administered on 3/26/21. First symptom of fatigue noticed on 3/28. Late evening 3/29/21 had early indication of sore throat on left side. Awoke 3/30/21 with continued fatigue and sore throat that only indicated when swallowing with pain extending to behind left ear. Started and continued salt water gargle to date. Visited Primary Care Provider on 4/1/21 for evaluation. PCP evaluated and said to continue gargle and Ibuprofin as needed for discomfort. Fatigue and sore throat while swallowing has continued with some periods of lesser indications. Contacted PCP office on 4/7/21 to report continued conditions and asked if there was a possibility of a recurrence of Mononucleosis (diagnosed in 1986) PCP ordered Mono Test which came back positive today 4/8/21
12 cm x 10 cm area of redness on left arm onset date 6-24-08. Treatment: BENADRYL prn, cold compresses
Sudden itch near site started 2/21; rash visible near site, continues today. Glands also swollen in previous three days
This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient accidently received a booster instead of a first dose 0.5ml dose of the bivalent Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 27-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043h22a) for COVID-19 prophylaxis.     No Medical History information was reported.       No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Blood clots in right leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots in right leg) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots in right leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots in right leg) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Very limited information regarding the event has been provided at this time.  No further information is expected.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received provided no new information; Sender's Comments: Very limited information regarding the event has been provided at this time.  No further information is expected.
A nurse reported that a 73 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 07/03/00. On 07/06/00, she developed an injection site reaction characterized by soreness, swelling, redness, and warmth. A diagnosis of cellulitis was made. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated lot # 471-637.
Symptoms were severe headache, leg cramps, low fever, chills.  These lasted approximately 16 hours.
Face red, hot; face flush; A report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced face hot an face flush.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the patient reported that her face was red, flushed and hot. She denied fever. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, face hot an face flush, were unknown.   The reporter did not provide an assessment for the events, face hot an face flush.; Reporter's Comments: This case concerns a female patient of unknown age. The patient's medical history was not provided. The patient experienced NS, unexpected event of face erythema and flushing. The events occurred the day the first dose of mRNA-1273 was administered. She denied fever. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
tested positive for COVID today; tested positive for COVID today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Apr2023, outcome "unknown" and all described as "tested positive for COVID today". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99, notes: 99; SARS-CoV-2 test: (02Apr2023) Positive, notes: tested positive for COVID today 02Apr2023. The patient was fully vaccinated with Pfizer COVID-19 vaccine according to the schedule (received the vaccine shortly after it was announced for patient age group) and tested positive for COVID on 02Apr2023. The patient had a mild temperature (99), headache, cough, sore throat and feeling generally unwell.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Jynneos vaccine was pre-drawn into syringe for administration . Vaccine was in the syringe for up to an hour. The CDC does not recommend pre-drawing immunizations due to lack of stability data for this vaccine.  There are no documented adverse effects.
Soon after receiving flu shot her arm starting aching and she had limited range of motion, progressing to a stabbing sharp pain and extreme difficulty in moving her arm.
Severe ringing and buzzing in the ears, nausea, headache, lightheaded,  diarrhea, insomnia.
Since then, mouth is uncomfortable; Numbing in the mouth/around inside my mouth at the beginning of my throat; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Since then, mouth is uncomfortable) and HYPOAESTHESIA ORAL (Numbing in the mouth/around inside my mouth at the beginning of my throat) in a 50-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL DISCOMFORT (Since then, mouth is uncomfortable) and HYPOAESTHESIA ORAL (Numbing in the mouth/around inside my mouth at the beginning of my throat). At the time of the report, ORAL DISCOMFORT (Since then, mouth is uncomfortable) and HYPOAESTHESIA ORAL (Numbing in the mouth/around inside my mouth at the beginning of my throat) outcome was unknown.            No concomitant medication were reported.  Patient had her booster shot from Moderna 2 to 3 weeks ago and events started a week after the shot.  Since then, she noticed that in her mouth, it's so uncomfortable, like when you go to the dentist and the numbing medicine is going away. It's around inside her mouth at the beginning of her throat.  Patient visited doctor on 06 Jan 2022.  No treatment medication were reported.
a few days after immunization, began having swelling/tenderness in the area of the HPV shot, not itchy
Patient describes the event as the same as given during a stress test (internal flushing), nausea, headache, has felt generally ill since the time of the vaccine (>6 weeks).
45 yo female s/p Pfizer COVID vaccination: dose 1 on 3/5 and dose 2 on 3/26.  Past medical history significant for  anemia of chronic disease, anxiety, ESRD on PD, depression, T1DM, HTN, GERD, gastroparesis, s/p kidney + pancreas transplant. Presented at the time of admission on 8/22 with shortness of breath and cough.   Hospital course described: Septic shock 2/2 MRSA bacteremia: In setting of immunosuppression (cyclosporine). Growth of staph aureus on 8/22 and 8/23 cultures. MecA positive. Treated with vancomycin, meropenem, caspofungin, tobramycin. Clindamycin added 8/24. Respiratory failure thought secondary to COVID ARDS with potential bacterial pneumonia superimposed. Initially satting to 96% on RA, with quick increase in oxygen requirement overnight 8/22-8/23. Intubated and transferred to the MICU. CT PE without PE, but with bilateral pneumonia and findings concerning for necrosis in LLL and some cavitation medially in the right lung, possibly abscess formation. Concerning for development of an aspiration PNE. Treated with Remdesivir and Dexamethasone. CRRT for volume removal.    Severe metabolic and respiratory acidosis: Gap (lactate) and non-gap (renal dysfunction) contributions. Thought secondary to septic shock and renal failure in setting of missed dialysis and acute infection. Required concentrated bicarb drip. She was also hypoglycemic as low as 37 treated with Dextrose infusion.    She developed atrial fibrillation with rapid ventricular response evening of 8/24 with HR increased to 180s. This was treated with amiodarone bolus + drip as well as fluid resuscitation. HR responded to interventions however she remained hypotensive requiring addition of phenylephrine to her pressors. She required phenylephrine, levophed, and vasopressin for much of the evening as well as albumin, LR, bicarb pushes, and increasing rates of dextrose infusion.   Transitioned patient to comfort care evening of 8/24. Palliative extubation performed that evening and all life sustaining medications were withdrawn. Patient was pronounced dead 8/24 at 2339.
Moderate Nausea; Body Aches; Lethargy; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 08Feb2021 at 11:30 AM (at the age of 36 years old) (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation.  Medical history included asthma.  No known allergies. The patient has unspecified concomitant medication. The patient also received first dose of BNT162B2 on 18Jan2021 at 11:00 AM (unknown lot number and expiration) via intramuscular in left arm for COVID-19 immunization at the age of 36 years old.  The patient experienced moderate nausea and body aches on 08Feb2021 at 15:00; and lethargy within 12-16 hours following 2nd shot on 08Feb2021 that lasted for 24 hours. The patient did not receive treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. No other vaccine in four weeks. The patient recovered from lethargy on 09Feb2021; and recovered from nausea and body aches in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt had generalized rash on chest/abdomen morning of 2/8/18, Mom did not take patient to provider.
Trouble sleeping; Pain in hands, legs, and feet; numbness in hands, legs, and feet; tingling / electric shock sensation in hands, legs, and feet; This spontaneous report was received from a female patient of unknown age referring to herself.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 04-MAR-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly (dose, lot #, and expiration date not reported) for prevention of disease.   On 17-MAR-2021, The patient experienced numbness, tingling, and pain in hands legs and feet. She also stated feeling electrical shocks in those areas, and troubling sleep. Consumer stated that she had made contact with planned parenthood who gave her the vaccine, and they had instructed her to get additional bloodwork completed. Consumer stated that she had not taken the those steps as of yet. The patient did not receive treatment for the events. At the reporting time, the patient had not recovered from the events.  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Extended period bleeding; Severe arm pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-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 the left arm on 30Mar2021 at 17:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN); both for unknown indication from an unknown start date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced extended period bleeding and severe arm pain. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events extended period bleeding and severe arm pain were recovered on an unknown date in 2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient reports rash, red splotchy area. Got almost to the size of a baseball. No difficulty breathing-right arm.
Pfizer: First dose 3/30/21 (lot # ER8733 - LD) Patient had no PMH, presented on 4/2/21 with progressive numbness, ataxia, dysarthria, and weakness. Neurologist was consulted. Per neurologist's notes, he was concerning with GBS variant such as AIDP vs AMSAN. He did mention COVID vaccine was given 2 weeks prior. It wasn't sure if it was confirmed diagnosis COVID reaction, however we would like to report for record keeping.
Skin is still discolored on left arm at injection site from 25Mar2021 injection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: EP6955) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Celiac disease" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Generalized Anxiety Disorder" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten/Wheat; "Known allergies: wheat" (unspecified if ongoing), notes: Known allergies: Gluten/Wheat. Concomitant medication(s) included: LORAZEPAM; DESVENLAFAXINE. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious) with onset Mar2021, outcome "not recovered", described as "Skin is still discolored on left arm at injection site from 25Mar2021 injection.". Therapeutic measures were not taken as a result of vaccination site discolouration.  Additional information: The patient did not receive any other vaccine within 4 weeks. The patient received Lorazapam, desvenlafaxine, eye fatigue vitamin medications within 2 weeks of vaccination. The patient reported that the events did not cause any serious consequences. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, an unspecified number of patients received an improperly stored dose of VARIVAX (lot # M006722, expiration date 08-FEB-2018; dose and route were unknown). No adverse effect was reported. Additional information has been requested.
After 8 days of receiving the vaccine, on Jan 28th at 8am, I developed a dizziness that stayed the whole day with me.  On Jan 29th, I still have the dizziness and at 1pm on Jan 29th, I developed a new soreness in my left arm where the shot was taken. I have soreness in my left arm and dizziness still and it is currently 10:55pm CST on Jan 29th.
The patient has an itchy, red bump around the injection site 01/19/01. No fever, size 4x9cm. Treated with Tylenol and Benadryl.
Initial and follow up information has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The medical history, drug reactions and allergies of the patients were not reported. On unknown dates, the unspecified patients received improperly stored doses of RECOMBIVAX HB, lot # K026666, expiration date 22-OCT-2016 (dose, frequency and route were not reported. No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Complained of soreness at injection site at 7:30 PM on day of injection (9/13/17). On morning of 9/14/17, prior to school at about 6:55AM, complained of soreness and heaviness, stated she was unable to lift arm. Mom looked at site, stated there was no redness or swelling, not hot to touch. At 12:30PM on 9/14/17, communicated with mom via text that arm was "a little" better, still felt heavy and could not lift. Stated that she was staying for basketball open gym.
induration, redness-3" @ inject site & cervical lymphadenopathy the following day p/2nd day; 10FEB92 f/u recovered; lot numbers not known;
Diarrhea with fecal urgency and incontinence lasting for 5+ days starting 2-3 days after the injection.
One hour after receiving immunization, felt weak, soreness of throat, tender neck nodes. That night felt very tired and weak. Temp of 100 degrees with chills and body aches, headache. Took ASA at 12m and Tylenol at 7AM on 6/14. Saw Dr. at 11AM on 6/14/02. Dr. prescribed Allegra. Temp up to 101 degrees on 6/14/02. Continued Tylenol for body aches, headache, tender neck nodes. Very tired. On 06/15/02 symptoms continued. Slightly improved on 6/16/02 AM; considerably improved 6/16/02 PM. 6/17/02 Back to work. Symptoms resolved.
Client has pink rash that is tender to the touch about 2cmX 2.5cm on right arm where vaccine was given. No fever, no signs of infection noted. HPV was given 5.5 weeks after 1st dose. Vaccine given during school outreach.
Two days following vaccination. pt. experienced soreness and redness at vaccine site -9 x 12 cm - no itching - no infection - no bulls eye, no petechia.
Within one month of the vaccine, my Granulosum Annulare re-emerged on both hands. It had completely resolved for more than two years after abstaining from TB skin tests.