chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extremely sick; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 31Mar2021 at a single dose for COVID-19 immunization. Medical history included ongoing Systemic lupus and ongoing Rheumatoid disease. The patient's concomitant medications were not reported. After her first dose the patient got extremely sick on an unspecified date and is scared to get second dose. The patient wanted to know if the vaccine is safe for people with autoimmune disease. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
NO adverse events.   Administration of monovalent COVID-19 #3, not recently approved bivalent COVID-19 vaccine.
pt recv vax & w/in 15min exp blurry vision & had a gen tonic-clonic sz less than 60sec followed by post ictal period lasting 20 to 30min dx sz p/vax;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 3(booster) , single (Lot number: FP4554) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 09Nov2021 as dose 2, single (Lot number: 048C21A), in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 19Mar2021 as dose 1, single (Lot number: 1805020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BMI" (unspecified if ongoing); "Sulpher based antibotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) High; SARS-CoV-2 test: (09Jun2022) Positive; (13Jun2022) Positive; (02Jun2022) Negative; (03Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
can not talk right; having difficulty in talking; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPEECH DISORDER (non-serious), outcome "unknown", described as "can not talk right; having difficulty in talking". Additional information: Reporter stated that, her sister in-law after taking the Pfizer vaccine (further clarified as COVID vaccine) shot, developed a side effect that is, that she can not talk right and she is having difficulty in talking."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
earaches; heart palpitations; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (earaches) and PALPITATIONS (heart palpitations) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (earaches) and PALPITATIONS (heart palpitations). At the time of the report, EAR PAIN (earaches) and PALPITATIONS (heart palpitations) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Consumer reported that they read on the internet that some people experience earaches and heart palpitations after receiving Moderna's COVID-19 vaccine.
I am 29 weeks pregnant with my first pregnancy and due April 22, 2021.   I woke up and felt a tender lump on the right side of my torso. It is 4 inches down from my ribs. It feels soft and hurts to touch.   I contacted my doctor and they said that if it continues to get worse then to come in and get it checked out but as of now - just wait and hopefully it will go down.
Redness, swelling, warmth and bumps on Lt anterior thigh and then spread to Rt anterior thigh.
I have had shortness of breath and tightness in chest. I feel like I cant concentrate. I cant sleep more than 2 hours at a time. I thought it would go away but it has not.
Hives on lower legs and lower arms, began on 1/21 and worsen slightly each day, started with just left leg, then right leg, then in both lower arms starting 1/25. Seems very delayed from time of vaccination but have not used any new products, soaps, detergents, or any other unusual/new foods or medicines.
This spontaneous report as received from a consumer (the patient's father) refers to a 23 year old female patient with OCD. In 2010, the patient received the first vaccination with GARDASIL, administered via intramuscular injection. On unspecified dates, the patient received the second and third dose of GARDASIL. Concomitantly, the patient received unspecified OCD medication. Since the administration of GARDASIL, also reported with a start date of 16-DEC-2012, the patient had been experiencing extreme fatigue, malaise and lack of energy, that "interferes with her quality of life and ability to work in her chosen field" (as stated by the patient's father). In addition, muscle aches were reported with an unspecified start date. The patient's father also reported that his daughter's adverse experience began on an unspecified date with fever and sore throat, after completion of the series. While fever and sore throat diminished, the extreme fatigue, tiredness and muscle aches continued. No treatment was given for the adverse events. On an unspecified date, the patient visited the doctor because of the adverse events. On an unspecified date, blood work for Lyme disease, hormonal imbalance, iron and other unspecified tests were performed. The results of the tests were unknown. The patient's father wanted to know if there had been other reports of similar experience and how best to deal with it. A causality assessment was not provided. Additional information has been requested.
I heard from a nurse practitioner that she had heard there were 2 patients(both at least 65 years old; at least one was female) who had an allergic reaction; tongue swelling; throat closing; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is second of 02 reports. An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 22Jan2021 as unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had allergies and had Epi-pen. On 22Jan2021, the patient had allergic reaction (tongue swelling and throat closing) after taking the vaccine. The patient had own Epi-pens and used them. The adverse reactions were reversed by single use of Epi-pens. The patient was taken to the emergency room to be safe. The events resulted in emergency room/department or urgent care. The patient received treatment with self administered epi-pen. The outcome of events was recovered on an unspecified date in Jan2021.  Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-2021087746 same reporter/ drug, different patient/ similar AE
After the patient's 1st injection her arm was numb the next day. After the patient's 2nd injection her bottom lip swelled and was chapped.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration of vaccine was 07-May-2021. No concomitant product reported by reporter. No treatment medication reported by reporter.
Patient daughter called to report a sudden onset of confusion.  She reports that she left to walk the dogs and the patient's behavior was normal she returned to find him confused for example using the wrong utensils to eat his food and saying things that did not make sense. His speech was clear but once again his responses were not appropriate to the conversation.  Patient's daughter reports he received his 1st COVID vaccine on 3.24.21 at a vaccine facility. Sent to ED for eval and treatment Reason for Disposition ? Very strange or paranoid behavior  Protocols used: CONFUSION - DELIRIUM-A-OH
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had received anti-viral medication; Paxlovid as COVID 19 Treatment. Treatment started on 06Jun2022 and stop date was 10Jun2022. Patient had other medication in 2weeks was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt rcvd vax; pt had fever & lose of appetite; also rash & swollen on body;
pt recv vax; 1hr later became stiff all over for approx 20 sec;no recent illness or fever; f/u exam WNL;
Intense pain on both sides of my torso lasting 3 days, headache, zapped all energy.
Pt c/o sore throat, congested/stuffy nose, on/off slight sob while walking not severe not continuous and loss of taste. Pt concerned its due to possible s/e of covid 19 vaccine J&J that he got on 06/09/21 as all these sx started same day and not getting better still. Pt speech clear, comfortable. Also denies emergency sx at this time. Advised to monitor his sx . was scheduled to speak with urgent care provider for consultation.. Notified pt if any emergency sx arises call 911 or go to nearest ED.
Initial shot was JnJ back in April. This was my second official vaccine shot. I got the Moderna 1/2 dose. Around 11pm I was having extreme fatigue and headaches so bad my vision was fuzzy. Worse than any migraine I?ve had. The following morning I nearly passed out and was having similar or worse headaches and a high fever. To put in perspective,  It felt like I was in a suspenseful movie playing 52 card pickup with a gun to my head, and I couldn?t pick any cards up.  I didn?t go to the doctor or hospital, and after sleeping all day/taking DayQuil the symptoms went away.
A nurse reported that a 45 year old female received Pnu-Imune 23 vaccine (pneumococcal vaccine polyvalent) on 10/30/01. Concomitant therapy included Prozac, Amaryl, Altace and "Lantus", "Altos" and "Aziphex". On 10/31/01, the pt developed an injection site reaction characterized by swelling and tenderness. The area of the reaction measured 4-5" in diameter and resembled a  wheel. No additional information was available as of the date of this report. The reporter noted that 6 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Follow-up information received on 1/11/02, from physician. Pt identified as a 45 year old female. The pt recovered.
my extremities were tingling; I was dizzy; After That I began having symptoms of sore throat; tiredness; coughing; stuffy nose; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medication included baby aspirin [ACETYLSALICYLIC ACID]. No current meds besides baby aspirin. No underlying conditions. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, immediately after receiving the second dose, the patient extremities were tingling and patient was dizzy, after that began having symptoms of sore throat, tiredness, coughing and stuffy nose. It had been well over three weeks now and patient still had symptoms. Event took place after use of product. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected. Information about batch/lot number cannot be obtained.
Covid19 breakthrough infection.  1st Vaccine given 05/25/2021.  Pt presents to hospital with one month hx of abdominal/ back pain and constant fatigue to where he is unable to work.  Alos with progressively darker urine, decreased appetite.  Pt found to have likely colon CA with mets to liver and lungs.  On IV abx.
On November 22, 2022, I had a runny nose all day and late afternoon I began to feel really off.  My skin began to feel like it was crawling and waves of dizziness.  I felt progressively worse very quick.  I had sinus pressure and a tickle in the back of my throat.  I felt fatigued.  I tested positive that evening with a home test.  I had extreme muscle fatigue in my lower legs and my I was unable to stand.  I had chills and fever.  I continued to take fever reducers and Flonase.  I began taking Paxlovid that night.  My muscle fatigue went away but I still had all of the other symptoms the next day for a few more days.  By day 3 I was able to stay awake for a good portion of the day and my fever was now only 100 for a few more days.  My headache was persistent the entire time and my sense of taste and smell was affected.  I began to feel better after a few days but then had a rebound case December 9, 2022.   I finally tested negative on December 15, 2022.  December 15-27th I had daily headaches and continued to lose the rest of my smell.  As of today I have my energy back and almost all of my sense of taste.
Affects her mother's ability to sleep; She developed rashes on the wrists around her body, then her ankle, then her back/had it all over her body at various times; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and 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: RASH (non-serious) with onset 2021, outcome "not recovered", described as "She developed rashes on the wrists around her body, then her ankle, then her back/had it all over her body at various times"; INSOMNIA (non-serious), outcome "unknown", described as "Affects her mother's ability to sleep". Therapeutic measures were taken as a result of rash.  Additional information: Pt received booster dose of the Pfizer-BioNTech Covid vaccine on Oct2021 and a week after, she developed rashes on the wrists around her body, then her ankle, then her back. Reporter mentioned those are just examples and that her mother had it all over her body at various times. Reporter states she never noticed where and when it started. She added that this affects her mother's ability to sleep. Patient had also tried antihistamine but that work and was also prescribed prednisone 3 days ago where she had some relief but was also told it could come back. Reporter wanted to know if there are any reports like this after taking the booster dose and if there are any recommendations from Pfizer. Reporter said she can understand rash is a side effect but generally everything, but the rash was either or localized to site of injection but she haven't seen anything the type of rash her mom has. Reporter wanted to know If something hasn't published yet. if there are other incidents, hopefully there will be more information or not and reporter don't know if its related to the vaccine but because of the timing it seems to be helping for now.  The lot number for bnt162b2 was not provided and will be requested during follow up.
10-28-10 vaccine given. Parent noticed redness/inflammation at night. Parent state she put warm compress on arm; redness/inflammation improved. No fever mom then noticed arm looking purplish. She called clinic to report problem. Was told by medical staff that if problem worsen to bring to clinic right away. But if problem improve to bring child to clinic on 11-8-10.
chronic urticaria began and has not stopped; increase thyroid antibodies; This is a spontaneous report from a contactable other health care professional (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142), via an unspecified route, administered in right arm on 13Jan2021 at 08:00 (at the age of 30-year-old), as second dose, single, for COVID-19 immunization at hospital. Medical history included rheumatoid arthritis. Concomitant medications included ibuprofen (IBUPROFEN) and certolizumab pegol (CIMZIA). The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), via an unspecified route, administered in right arm on 23Dec2020 at 08:00 (at the age of 30-year-old), as single dose, for COVID-19 immunization and experienced mild cough with throat irritation for about 3 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Jan2021, 5 days after the second vaccination, chronic urticaria started and had not stopped as well as increase thyroid antibodies was reported. The events were reported as non serious and resulted in Doctor or other healthcare professional office/clinic visit. At the time of the report the patient was receiving unspecified medications for the events. The outcome was not recovered for the reported events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021575962 same patient, different event, different dose of vaccine
Feeling crampy in my lower abdomen; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (Feeling crampy in my lower abdomen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN LOWER (Feeling crampy in my lower abdomen). At the time of the report, ABDOMINAL PAIN LOWER (Feeling crampy in my lower abdomen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided by the reporter. Concomitant information was not provide by the reporter.
This spontaneous report was received from a Certified Medical Assistant referring to unspecified patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unspecified date since September 2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB (anatomical route of vaccination was not provided) for prophylaxis. It was reported that on 17-OCT-2016, PEDVAXHIB with lot # M025192 with expiration date on 21-MAR-2019, was exposed to a temperature excursion of 47°F to 77°F for 1 hour time range for 1 cycle. Subsequently on 18-OCT-2016, lot # M036056 with expiration date on 18-MAY-2019, was exposed to a temperature excursion of 32°F to 35°F for 30 minutes. On 20-FEB-2017, the vaccines with lot # M036056 and lot # M034188 with expiration date on 20-MAY-2019 were exposed to a temperature excursion of 32°F to 35°F for 1 hour and 30 minutes time frame. On 26-APR-2017, PEDVAXHIB with lot # N000231 with expiration date on 25-OCT-was exposed to a temperature excursion of 32°F to 35°F for 1 hour time frame. It was also reported, that the lowest temperature excursion was of 34.3°F and the highest of 46.6°F. Information was provided due to a data logger. Furthermore, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000715: US-009507513-1707USA000716: US-009507513-1706USA009543.
pt recv vax; very irritable for 8 hr; later same day, inconsolable crying for 5 hr; apap given q/ 4 hr;
Redness and swelling, welt-like, tender to palpation, appears to be extravasated.
No adverse reactions to the first 2 shots. The third shot caused fatigue and a fever with chills. Was easily remedied with 2 extra strength Tylenol.  Lung congestion