chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My son is troubling by the stomach ache; He feel everything like hot; Body itch; This is a spontaneous report received from a contactable consumer (patient's mother). This consumer reported similar event for 2 patients. This is the second of two reports.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was troubling by the stomachache, he felt everything like hot, and body itch. The reporter's concern was the patient's stomachache. The outcome for the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021550808 same reporter/drug, similar event, different patient.
8 days after injection started having itching and a bump on my arm, 9 days after woke up with a large red lesion / reaction at the injection site
11/17/15 Had hospital F/U O.V. today with PCP. Patient is a 76-year-old female who presented to the hospital on November 10, 2015 for generalized weakness. The patient is alert and oriented x3, however she does not recall the details of yesterday and she does not recall all the details leading up to her presentation to the hospital today. She is able to provide some meaningful history which is supplemented by her husband. Yesterday the patient was in her usual state of health. She went to a dentist appointment on a routine primary care visit appointment with Dr. On that appointment she was administered the pneumonia vaccine. She typically wakes up around 0700, however this morning she woke up at 0830. Her husband noted that she wasn't up during her usual time and was listening out for her, and he heard her weakly calling for him. He went to her bedside and she stated that she had an episode of urinary incontinence and also bit her tongue during the night and bled onto the pillow. Nothing like this has ever happened to her before. She denies any previous seizure. He noted that she was slow to answer, he also asked her to smile and noted that she had some overall facial weakness but did not note asymmetry. He also remarked that she had difficulty concentrating on his questions. She had generalized weakness and he noted her to be "limp". Baseline, she ambulates independently. She is typically very responsive and conversant. She does add that she was previously seen by a cardiologist for possible atrial fibrillation. She states that she had had very rare palpitations and around one year ago and was evaluated by a cardiologist. At that time she was evaluated with presumably an event recorder or loop recorder but states that no intervention ever came of her evaluation. She thinks that a blood pressure agent was suggested but opted to not take any new medications. She has never been on anticoagulation. She denies any personal history of hypertension, dyslipidemia, diabetes mellitus, MI/NSTEMI, CVA/TIA, thyroid disorders. She notes a residual headache since waking up that is "all over my head," without photophobia or vision change. She has chronic LUE shoulder pain for which she had a cortisone injection last week and has some baseline ROM limitations. She denies any chest pain, difficulty breathing, vaginal bleeding, hematuria, hemoptysis, hematochezia, melena, bright red blood per rectum, tingling or numbness. She is currently continent and asking for the bedpan.
Patient received first dose 48 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose 48 days ago) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose 48 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose 48 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported. Concomitant medication were not reported.
About two or three weeks after the vaccine, I got what I thought was a bad cold. A killer sore throat and a ton of congestion. I had a horrible cough with wheezing. I thought I had COVID but was negative. That lasted for a few weeks but the cough has never stopped. I cannot get rid of the cough since it started after my booster. I have been checked by my doctor and we got chest X-rays- this led to me be put on a Z-pack and prednisone. I may gradually get better but within two weeks I am back to it being bad again but it never goes away only gets a little better.
Rash to neck and lower face. Symptoms included feeling warmth in same. Had same reaction to first dose and premedicated with claritin. Responded to diphenhydramine with first reaction. 50mg diphenhydramine administered IM today with almost full resolution. Ice pack to area also provided relief. Observed for 75 minutes with no further reaction and patient sent home with prescription for epi-pen and instructions for seeking care.
I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the male nurse that was present and he said that had Epinephrine, I had benadryl and he said that I could take one. Half an hour later my rash got worse and I took 20 mg prednisone that I had for my asthma. During the next two days I have had palpitations, fatigue and tiredness. Today my blood pressure was high and I have never had it like that before.
A non-serious spontaneous report of inadvertent administration to pregnant woman was received from a physician concerning a female of unknown age. No relevant medical and obstetrical history has been reported for this patient. The patient was eight to nine weeks pregnant at the time of vaccination. No concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 26-Jan-2010 for an unknown indication. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The outcome of vaccine exposure during pregnancy was considered resolved.
48 hr after immunization with tdap and pneumovax in same arm, pt came to the urgent care with headache, swollen red arm, fever of 104-105f and body aches and swollen lips.  pt was treated with acetamenophen with resolution.
This is a spontaneous report from a contactable consumer. A 34-year-old female (patient) (pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734), via an unspecified route of administration administered in left arm on 10Apr2021 as single dose for COVID-19 immunisation. The patient LMP Was on 24Feb2021 and 5 weeks of gestational period. Patient medical history included Known Allergies: Penicillin. Concomitant medications included Prenatal vitamins within 2 weeks of vaccination. There were no allergies to medications, food, or other products. Known allergies to Penicilin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12 Apr2021, 48 hours after the vaccine patient started bleeding that has progress from a brown color to a bright red and from a small amount to a moderate amount for 5 days. The adverse event resulted in emergency room. The outcome of the event hemorrhage was not recovered and other event was unknown.
right after getting injection, my left arm started getting swollen, warm and my arm felt heavy and numb it was hard to move my arm. I had to take a Benadryl for the allergic reaction.  but the reason why my arm got swollen was because the person who gave me the injection put the vaccine really close to my shoulder so most probably he poke a vein or nerve and injected the medication directly in my vein because in just seconds of getting the vaccine that started happening.  and the next day i also got normal side effects pain to my arm, bodyaches, fever, nausea, headache but i took tylenol for the fever and muscle and body aches and severe cold and flu medication
Quarter size bald patch (alopecia areata ) on left side of scalp; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 28Oct2021 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication taken within two weeks of vaccination included multivitamin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 20Nov2021, the patient experienced quarter size bald patch (alopecia areata) on left side of scalp. The patient had no previous history of "AA" (alopecia areata). It was reported that the patient had a dermatologist appointment the next day of this report so it was unknown if treatment would be available at that time. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event quarter size bald patch (alopecia areata) on left side of scalp was unknown at the time of this report.
5 days p/vax pt had rash on back, forehead, cheeks & around eyes;no other symptoms;
Later that eveing around 10pm I developed muscle pains and chills.  A headache came about 2 hrs after and a little later I developed a fever and the headache went from light to mild.  Throughout the night I could not sleep because the headache had gotten so severe and I had uncontrollable chills and shakes and a fever.  3/6 I did start around the clock Tylenol which did reduce the fever and make the headache less as intense but for about 2 days the headache so bad with pressure  associated it felt as if my eyes were going to bulge out of my head.  By day 3 I woke up feeling better but was in a fog which lasted the remainer of that day and by day 4 all symptoms had subsided
Symptoms consistent with pericarditis. Sharp pressure exclusively at the breast bone that increases with deep breathing. Sensation of wearing clothing that is too tight. Symptoms occur sporadically but can last anywhere from 30 min-2hrs. Although there is a history of Costochondritis, pain associated with Costochondritis is isolated to the left side of the upper abdomen.
Patient calls on phone 2-26-08 stating she had hives several hours after injection.  She took Benadryl and used hydrocortisone cream.  By the next morning these were better.  She then developed some intermittent chest discomfort and shortness of air.  Instructed patient to go to ER.  Patient did not go.  Spoke to her on 2-27-08, was better.
Fever,nausea,dizziness and pain at itcing at injection site for 6 days.
Patient has had prior left stapes in 1990s. Her hearing has been stable. She got her 2nd Pfizer vaccine on Feb 1 and around the same time or shortly after she noticed her hearing has worsened mainly in the right ear.
Vials that was put in the fridge and after that refrozen and thawed again for adult male patient; No Adverse Event; Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient).    This case is for 11th  patient out of 100 patient's case. Concomitant product use was not provided by the reporter. Patient received additional booster dose. 100 male patients were received bivalent booster dose. Moderna COVID19 vaccine bivalent, dosage given was in ml but was unknown to the healthcare practitioner. Also, lot number was unknown to the healthcare practitioner. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
SUSPECTED HEART ATTACK; This spontaneous report received from a company representative concerned a 60 year old male patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was reported that, the patient was fit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknow) with frequency as 1 total for prophylactic vaccination. Dose and therapy start date were not reported. The batch number was not reported. Per Procedure, no follow up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the patient was suspected with heart attack. On an unspecified date, the patient died from suspected heart attack. It was reported that, the patient died within 30 days of receiving vaccine and cause of death was unknown however suspected as heart attack. It was unknown if the autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210832457- covid-19 vaccine ad26.cov2.s-suspected heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SUSPECTED HEART ATTACK
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose Number 1, 2 ; Moderna, Dose Number: 3, 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 at 10:30 as dose 1, single (Lot number: EN6204), in right arm and on 07Apr2021 at 09:30 as dose 2, single (Lot number: ER8732), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Dec2021 at 12:00 as dose 3 (booster), single (Lot number: 031H21A), in right arm and on 19Nov2022 at 19:00 as dose 4 (booster), single (Lot number: as7166B) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "obese" (unspecified if ongoing), notes: obese; "thyroid disease" (unspecified if ongoing), notes: thyroid disease. Concomitant medication(s) included: LEVOTHYROXINE, start date: Mar2007, stop date: 09Feb2023. Past drug history included: Codeine, reaction(s): "known allergies codeine", notes: known allergies codeine. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Dec2021, outcome "unknown", described as "Pfizer / BioNTech, Dose Number 1, 2 ; Moderna, Dose Number: 3, 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Course of events: Patient received COVID-19 anti-viral treatment with Paxlovid from 09Feb2023 to 15Feb2023,
A few days after receiving vaccine,  I experienced rash and itching on my left shoulder area.  The next day, a smaller rash area developed in right shoulder, but it does not itch.  Today, I noticed the rash had spread to my upper chest area.
Product beyond use date was 11/9/2022 and this product was used on 12/14/2022.  Writer contacted Pfizer and CDC.  No adverse reactions expected, advised to repeat dose ASAP.
No additional AE reported.; the patient was initially scheduled for the 2 dose regimen and was concerned since the 2nd dose was received earlier than expected; This spontaneous report was received from a pharmacist, referring to a 12-year-old female patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.     On an unknown date in May 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) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis. On 03-JUL-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis. The patient was initially scheduled for the 2 dose regimen and was concerned since the 2nd dose was received earlier than expected (inappropriate schedule of product administration). No additional adverse event reported.
My whole body ached and it gave me chest pressure that lasted 4 days and missed 1 day of work because of it.
On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; Received booster from expired vial; Aches; Fever; chills; Headache; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Aches), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headache) and ACCIDENTAL UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE injection for an unknown indication.    Concurrent medical conditions included High cholesterol since 04-Jan-2017.   On 29-Oct-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started INFLUENZA VACCINE (Intramuscular) 1 dose. On 29-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) and EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial). On an unknown date, the patient experienced PAIN (Aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache). On 29-Oct-2021, ACCIDENTAL UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) and EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) had resolved. At the time of the report, PAIN (Aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache) had resolved.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
my left arm (the arm I got theshot in) got very cold; Tingle from elbow all the way down to  ringfinger and pinky finger; tingle from elbow all the way down to ringfinger and pinky finger. A short time after that area became numb and remained numb; This is a spontaneous report from a contactable consumer, the patient. A 56-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 14Apr2021 at 13:15 (at the age of 56-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, blood pressure high, suspected covid-19 on unknown date. The patient was allergic to penicillin, sulfur and clindamycin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 13:45 roughly 30 minutes after receiving the vaccine the patient experienced felt left arm  very cold and the under side of it started to tingle from elbow all the way down to ring finger and pinky finger. A short time after that area became numb and remained numb for roughly 5/6 hours. The patient described it as a similar sensation to when hit the funny bone in elbow however, this lasted for 5/6 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received any treatment for the events. The clinical outcome of the events left arm got very cold ,tingling and numbness  resolved with the duration of 5/6 hours on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.