chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath, lightheaded, feeling of throat closing (able to communicate with no drop in spo2), unsteady on feet, elevated heart rate (90-115)
I did not have an adverse reaction to the vaccine. I started having diarrhea in 12/2022. I have seen my doctor and I was referred to a gastroenterologist. I have had multiply test but they are unable to determine the cause. I am on a restricted diet and prescribed a prescription and I am to wait for about 3 months. Currently I am trying to stay with the diet to control the diarrhea.
Became dizzy and pale almost immediately post vaccination. Gave cool water and snack, symptoms resolved within 5 minutes. Observed in clinic until 0840, reported zero symptoms, released with adult.
The patient went to bed 3-4 hours after that time; fever; swelling in the arm extending down to the wrist; finger in the same arm have become numb; Pain in Palm/Pain On Top of Hand; The injection site is also warm to the touch; pain at the injection site (left); Swelling on inside of injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the arm extending down to the wrist), HYPOAESTHESIA (finger in the same arm have become numb), PAIN IN EXTREMITY (Pain in Palm/Pain On Top of Hand), VACCINATION COMPLICATION (The patient went to bed 3-4 hours after that time) and VACCINATION SITE WARMTH (The injection site is also warm to the touch) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DASATINIB MONOHYDRATE (SPRYCEL), ETHINYLESTRADIOL, LYNESTRENOL (OVOSTAT), FLECAINIDE, METOPROLOL, LORAZEPAM (ATIVAN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced PERIPHERAL SWELLING (swelling in the arm extending down to the wrist), HYPOAESTHESIA (finger in the same arm have become numb), PAIN IN EXTREMITY (Pain in Palm/Pain On Top of Hand), VACCINATION SITE WARMTH (The injection site is also warm to the touch), VACCINATION SITE PAIN (pain at the injection site (left)) and VACCINATION SITE SWELLING (Swelling on inside of injection arm). On an unknown date, the patient experienced VACCINATION COMPLICATION (The patient went to bed 3-4 hours after that time) and PYREXIA (fever). The patient was treated with NAPROXEN at a dose of 500 mg; MENTHOL (ICE [MENTHOL]) at an unspecified dose and frequency and EUGENOL, MENTHOL, METHYL SALICYLATE (HEAT) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in the arm extending down to the wrist), HYPOAESTHESIA (finger in the same arm have become numb), PAIN IN EXTREMITY (Pain in Palm/Pain On Top of Hand), VACCINATION COMPLICATION (The patient went to bed 3-4 hours after that time), VACCINATION SITE WARMTH (The injection site is also warm to the touch), VACCINATION SITE PAIN (pain at the injection site (left)), VACCINATION SITE SWELLING (Swelling on inside of injection arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Published information has been received concerning a 25 year old male who was vaccinated with a booster dose of Hepatitis B virus vaccine rHBsAg (yeast)(manufacturer unknown).  Seven days later, he presented to the ER with diffuse skin lesions and bruises of his extremities of 24 hour duration. The pt was subsequently hospitalized. His initial labs showed WBC count of 2200/uL, hemoglobin 14.6g/dL, hematocrit 40%, and platelet count 4000/uL. The only positive physical findings were petechiae of oral mucosa and petechiae of the upper and lower extremities with occasional ecchymoses.  Liver function tests showed SGPT 747, SGOT 222, bilirubin 0.8, and alkaline phosphatase 49. Follow up lab tests showed decreasing liver function tests over a 2 week period. Initially he received prednisone and IVIG for ITP, but there was no improvement in his counts so on the 4th hospital day, a bone marrow biopsy was performed, which showed hypocellular marrow with 15% cellularity.  The number of megakaryocytes was markedly decreased. Diagnosis was consistent with aplastic anemia. After a month, a repeat bone marrow biopsy was performed which again showed 5% cellularity.  He ultimately received an allogeneic bone marrow transplant.  Further work up showed negative HIV tests. Serology study for parvovirus, CMV, IgM and ANA was negative. Hepatitis A as and Hepatitis A Ab (ACVPCR), Hepatitis A core Ab, and Hepatitis B surface Ag tests were negative. Hepatitis B surface Ab titers was high (>150).  It was hypothesized that an underlying immune predisposition might have enabled the vaccine to trigger the vigorous cytotoxic T lymphocyte response that possibly led to aplastic anemia.  Additional information has been requested. Follow up 01/05/05: Follow up information from the physician indicated that the patient was seen as a consultation approximately 2 years ago. A bone marrow biopsy was performed as a second opion and confirmed the aplastic anemia diagnosis. He received a bone marrow transpalnd and was doing well. The physician stated that he does not know or have the ability to find out which Hepatitis B product the patient received. Additional information is not expected. Follow up 03/03/05: Patient's recovery status is unknown. Per follow up report received on 06/14/2005:  Patient's recovery status is still unknown.
Pt. complains that two days after receiving flu shot that his left arm started itching and he noticed a rash developing where shot was given (rash size of quarter). He reports he applied hydrocortisone cream and takes BENADRYL at night. He shows up at pharmacy on 10/12/11 10:46 with a rash at same site as large as a fist but no itching as of this date.
Severe Abdominal pain starting 3/24/21.  Went to ER 4/13/21 due to abdominal pain..  Admitted to hospital due to very low platelet count of 4,000, Also very low WBC and ANC. While in hospital, received three infusions over three days of platelets.  Platelets came up and then dropped.  Day 4 and 5 started on high doses of steroids with Gamma globulin infusions both days.  Discharged on 4/19/2021.  Continued follow-up  and care through Cancer care specialists with Dr. Platelets stable but continue in low range. WBC/ANC still critically low. Considered very high risk for infection Receiving Retuximab infusions.  Once a week for 4 weeks.  Have completed one.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: 8737), in right arm, on 28Apr2021 as dose 2, single (Lot number: EW0170), in right arm and on 07Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 41 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: by day 11 solid positive on rapid antigen test; Positive, notes: COVID 19 Treatment; Negative, notes: Tested negative on Day 10, by day 11 solid positive on rapid antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.
This spontaneous report was received from a registered nurse, and refers to a 16 year old male patient. The reporter did not have information on the patient's medical history or concurrent conditions. On 07-JUL-2016, the patient was vaccinated with a properly stored first dose of GARDASIL 9 (dose, route of administration, lot number and expiration date not reported). Subsequently, on 20-OCT-2016, he received a properly stored second dose of GARDASIL 9 (dose, route of administration, lot number and expiration date not reported). Finally, on 17-DEC-2016, he received his third dose of GARDASIL 9 (dose, route of administration, lot number and expiration date not reported). All the vaccines were administered for prophylaxis. No concomitant medication was reported. In December 2016, following his third dose of GARDASIL 9, the patient "was running a temperature of 101" (units not reported). At the time of the report, the outcome of body temperature abnormal was unknown. Additional information is not expected as the reporter did not wish to be contacted.
sore throat; achy for a couple of days; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and PAIN (achy for a couple of days) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced PAIN (achy for a couple of days). On 16-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and PAIN (achy for a couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.
After receiving Flu shot, customer passed out and struck head on shelves near front of store. Patient stated he was lightheaded, dizzy and thirsty. Also stated he had not eaten today. EMS arrived w/in 5 minutes and took over care.
The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM; No adverse event; 3 pediatric patients received doses >12 hour post puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 pediatric patients received doses >12 hour post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Aug-2022 at 8:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 pediatric patients received doses >12 hour post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 pediatric patients received doses >12 hour post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (3 pediatric patients received doses >12 hour post puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM).    No concomitant medication was reported. The vial was stored in the fridge for 2 weeks after puncture, was reported. It was reported that the vial was initially stored in the refrigerator on 03-Aug-2022. The vial was first punctured on 04-Aug-2022 at 8:15 AM. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-635840, US-MODERNATX, INC.-MOD-2022-635851 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-635840:Patient 2 US-MODERNATX, INC.-MOD-2022-635851:Patient 3
CC: Rash upper chest, started 4/03/12 evening burning, itching, painful. Exam: B/L erythema with small papules C4 dermatome.
Ended up getting COVID at the beginning of February.  Difficulty breathing and taking in deep breath sxs started 02/26/2022
Child was brought in for office visit two days after immunizations d/t fever and localized rash to L thigh. Described by NP as tennis ball sized, raised, red, circular, warm rash at injection site (L thigh). Treated w/ ice and benadryl. No other treatment needed. Note this office also reported another local reaction w/ the same Dtap lot number.
very dizzy; shortness of breath; fever; aching joints; This is a spontaneous report from a contactable healthcare professional (the patient).  A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3247), intramuscular in the left arm on 20Jan2021 at 13:45 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included gastroparesis, low thyroid, iron anemia; and allergies to latex, apples, kiwi, and avocado. The patient did not have COVID prior to vaccination. The patient had a nasal swab COVID test on 13Jan2021, which was negative. The patient was not pregnant at the time of vaccination. Concomitant medications included: omeprazole, pantoprazole, levothyroxine, ethinylestradiol/ ferrous fumarate/ norethisterone acetate (LO LOESTRIN FE), bifidobacterium infantis (ALIGN), cetirizine hydrochloride (ZYRTEC ALLERGY), duloxetine hydrochloride (CYMBALTA), folic acid, and colecalciferol (VITAMIN D). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 30Dec2020 at 15:00 (at the age of 39-years-old), in the left arm as a single dose for COVID-19 immunization, and experienced fever, dizziness, aching joints, headache, shortness of breath, swollen and painful lymph nodes in left armpit only, 24 hours after shot, lasted two weeks. The patient had not received any other vaccine within 4 weeks prior to the vaccine. In Jan2021, the patient experienced very dizzy, shortness of breath, fever, and aching joints about 8 hours after the shot. The patient did not receive any treatment for the events. The clinical outcome of very dizzy, shortness of breath, fever, and aching joints about 8 hours after the shot was not recovered.
10 minutes after receiving vaccination, patient reported rapid heart rate, fatigue, felt weak, hot, and palpitations. Patient reported tachycardia with heart rate 160-170's. Transient numbness to hands and perioral region. Presented to ED, was monitored with resolution of symptoms.  On 1/4/21 patient presented to ED with tachycardia with HR up to 160s, Episode was severe, causing lightheadedness, "throat squeezing", with bilat UE paresthesias. Episode lasted 20 minutes. Patient evaluated in ED and discharged with outpatient follow up with cardiology and endocrinologist.
shortness of breath; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (shortness of breath) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  No treatment of events was reported.
Vomiting A non-serious spontaneous report of vomiting has been received from a registered nurse concerning a four-year old patient subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history or medication history was reported for this patient. The patient received FLUMIST on 21-Oct-2008. The patient vomited within a couple of hours after receiving FLUMIST. Per the reporter, approximately 500 doses were administered at the site; she does not believe "the product is bad" and does not want to return "the last five doses" at the site. The outcome of the event is unknown.
Patient called pharmacy an hour after injection her lips started to swell and tingle she did not do anything about it but problem continued over next couple of days. She went to urgent care on 9/22/2017 and was told to take BENADRYL.
her body is being faint 3 to 4 times a day; Her oxygen drops from the 99 to an 83; her muscles she is suppose to get numb and then she just controls her muscles and she faint; her brain is awake you know close to get an electric shock (further clarification unknown hence not captured in tab) following new things episode; This is a spontaneous report from a contactable consumer reporting for sister. An unspecified age female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on 11May2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her body is being faint 3 to 4 times a day on 16May2021, her oxygen drops from the 99 to an 83, her muscles she is supposed to get numb and then she just controls her muscles and she faint, her brain is awake you know close to get an electric shock (further clarification unknown hence not captured in tab) following new things episode on 16May2021. She stated that patient got vaccinated on 11May2021 and completed 5 days after her first vaccine, she started getting, and was not sure if it was side effect which is why reporter called and not sure if it had been reported before. But patient body was being faint 3 to 4 times a day, but it was quite a little episode when patient faint for second and wakes up, faint wakes up faint there was seconds between 2 and 1 and last sometimes less than a minute sometime a few minutes after 5 minutes. Patient oxygen drops from the 99 to an 83 and basically her muscles she was supposed to get numb and then she just controls her muscles and she faint, but she can still here on brain is aware her brain is awake you know close to get an electric shock (further clarification unknown hence not captured in tab) following new things episode. So, reporter was calling to ask if this was the possible side effect if it was reported before. Reporter confirmed that patient only had her first dose. She stated that patient had MRI scan an EEG scan and 'AFib' (further not clarified hence not captured in tab) and they all came out normal which was why reporter was assuming it was a side effect. It was reported that second shot was not scheduled yet and reporter was not sure. On further probing, reporter stated that did reporter need to because reporter was in a kind of a rush right then. Product details and pharmacy details could not be probed as the reporter was unwilling to complete the report. Hence limited information available over the call. The patient underwent lab tests and procedures which included atrial fibrillation, electroencephalogram, magnetic resonance imaging on unspecified date which resulted normal and oxygen saturation decreased to 83 on 16May2021. The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.
Pt. states that after receiving the 1st dose of Phizer 10/20/2021, started experiencing symptoms within an hour of chest pains and shortness of breath. Primary visit 11/2021, EKG (Normal). Still experiencing symptoms, Emergency Room visit 11/13/2021 (estimated) with no diagnoses.
severe ipsilateral shoulder pain. After second dose developed bilateral pain, then developed migratory polyarthritis. By the time I met him 2 months later he had inflamed joints, ESR 118. Rheumatology eval is in progress, but he has responded to steroids.  No prior history of an inflamatory arthritis
Red  itchy Bumps all over Torso/Face /Neck/Extremities  5ish hours after Moderna Booster
pt recv vax & immed had sz that lasted approx 20secd;placed on floor, feet elevated, pulse good, BP 130/60;EMS came to hlth dept;adm to hosp for observation & testing;MD stated not pathologic sz & not rxn to vax;
Patient stated itching and redness did not start until 1 week after vaccine. Large area approximately 4in by 4in
Function kidney decreased; Pain in arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 21K-163-4167928-00.  A 55 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single, intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at unknown dose (citrate free) for moderate to severe rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL IMPAIRMENT (medically significant), on an unknown date, outcome "not recovered", described as "Function kidney decreased"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Pain in arm". The action taken for adalimumab was dosage not changed. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "function kidney decreased" and "pain in arm" related (reported as probable) to bnt162b2. The reporter considered "function kidney decreased" and "pain in arm" unrelated (reported as no reasonable possibility) to adalimumab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a nurse referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with one dose of GARDASIL 9 (dose, route and lot number not provided) after the completion of the entire three-dose series of GARDASIL (extra dose administered and off label use). This was outside the labeled recommendations in both the GARDASIL 9 and GARDASIL Prescribing Informations. No adverse effect was reported. There was no product quality issue (PQC) involved. Additional information has been requested.