chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 3/11/01, mid-afternoon, came in house and mother took shirt off to change and noticed his right upper slightly red, no pain per child. Mother did not apply cold compresses as instructed by nurse after giving vaccines. On exam today, site slight pink and warmth; no pain.
States she talked to 2 other people who experienced the same thing; States she talked to 2 other people who experienced the same thing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) 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: BLOOD PRESSURE ABNORMAL (non-serious), HYPERTENSION (non-serious), outcome "unknown" and all described as "States she talked to 2 other people who experienced the same thing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that she can only find 2 other people that this happened to. Her neighbor said it was on tv about this happening, about the vaccine affecting blood pressure medicines. She called Pfizer right after it happened, and all they told her was to contact the CDC.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201361208 Same reporter, same product, same event, different patient;US-PFIZER INC-202201360920 Same reporter, same product, same event, different patient;
Local redness, itching warmth at injection site redness diameter 2 1/2".  Treatment - Benadryl 25 mg with decrease in symptoms.
p/vax pt exp varicella w/mult lesions on trunk, extremities & scalp;the lesions were in different stages;some lesions were papular some umbilicated;some vesicular w/surrounding erythema, some crusty w/enlarging erythema;bacterial infect;
This spontaneous report as received from a physician refers to a 6 month old infant patient. Drug allergies, reactions and medical history were not reported. On 11-DEC-2013 the patient was vaccinated with ROTATEQ (oral, lot # H010052, expiration date 02-NOV-2013, dose 2 ml). No concomitant medications were reported. No adverse effect was reported. This case is linked to the same reporter cases: MARRS 1402USA013045, 1402USA013518 and 1402USA013519. Additional information has been requested.
12./2020:seen by PCP for PE; found to have Hidradenitis suppertiva under arms,breasts; on (3) rounds  1st inj of   Pfizer/FN6207 given subqQ at 11:00am  on 3.23.21; Right upper arm hurt  at needle site.  2nd Inj of Pfizer/EW0150 given subQ at  10:55am on  4.13.21; right arm; no pain at site. Next day, 4.14.2021 woke-up @ 6:00am like a train had just hit my body. Very unsteady on feet, nauseas, no appetite, up a few hrs, took a Deuxis 800/26mg with some relief.   4.15.2021 woke up @ 7am feeling alittle better, able to function more than day prior.  4.17.21 eyelids/ bilateral inner canthus(s) became swollen, reddened. 4.19.21: email sent to PCP with (2) pics of my eyes, still swollen and red .
Back ache; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) and BACK PAIN (Back ache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bladder infection. Concurrent medical conditions included Blood pressure fluctuation (Taking blood pressure pill.).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nauseous). On an unknown date, the patient experienced BACK PAIN (Back ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, NAUSEA (Nauseous) had not resolved and BACK PAIN (Back ache) outcome was unknown.            Concomitantly, patient was taking unspecified blood pressure pills.  Action taken with mRNA-1273 in response to the events was not applicable
Pt returned to clinic 2 days after vaccination with left Deltoid Area swelling, warm to touch & redness.  Also C/o Itching & burning as well as tenderness. Denies respiratory Distress
my torso, arms, neck, and face began to itch/the same symptoms began; this time a rash appeared; my hands swelled twice the normal size; This is a spontaneous report from a non-contactable consumer (patient). This female consumer (patient) reported that: A 38-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 10Apr2021 09:00 (38-year-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history included sulfur allergy and allergy to beauty products (Sulfur of all types in medications, foods, health and beauty products) from an unspecified date and unknown if ongoing. Concomitant medications included calcium (CALCIUM); vitamin d nos (VITAMIN D NOS); fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) all taken for an unspecified indication, start and stop date were not reported. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 20Mar2021 09:00 (38-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunization and experienced pruritus and peripheral swelling. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. The patient received other medications in two weeks. On 10Apr2021 17:00 after the second dose of vaccination, the patient experienced my torso, arms, neck, and face began to itch/the same symptoms began, this time a rash appeared and my hands swelled twice the normal size. The patient received treatment for the adverse events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Pt was only 13 years old and received a booster dose of Pfizer but was not eligible
Patient did not immediately report any issues upon receipt of vaccine. She reported today that she has been having a problem with her Left arm ever since receiving the first dose of Moderna in September 2021. She said at the time of the vaccination, she immediately felt "tingling run down her arm." She reports that since this dose, she continues to sporadically feel "tingling" and her arm will "fall asleep" below the elbow and feel "heavy" from time to time. She has recently consulted a doctor because the symptoms are starting to affect her daily life. The prescriber is researching if she may have a vaccine related injury.
240pm DPT immun Lt arm, 245pm hives to Lt arm, upper chest & back, 250 Seen by clinic MD & given epinephrine SQ by nurse, 310 Hives reduced & redness fading, 410 left clinic as stated. Instructed to use Benedryl liquid as directed by MD
Patient lost consciousness 10-20 seconds following 1st dose Pfizer vaccine. Patient awoke after 5-10 seconds and experienced nausea and vomited.  Patient was referred to urgent care as he refused EMS services.
R57.0 CARDIOGENIC SHOCK 4/10/2023 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC
The patient was administered the vaccine.  We instructed her to sit in the waiting area for observation.  Approximately 10 minutes later, she lost consciousness and fell to the floor.  But she was caught by her husband before that happened.  I instructed my technician to call 911 and then attended to the patient.  She was seizing on the floor and did not appear to be breathing, although her heart was beating.  Just before I began rescue breathing, she abruptly began breathing again and slowly opened her eyes.  She slowly began to regain consciousness although she was very scared.  She did not remember what had happened.  Her husband and I stayed with her on the floor until the paramedics arrived several minutes later.  They took her outside on a stretcher to monitor her vital signs and talk with her.  Some time later I was told that she had recovered fully and wanted to go home.  I will follow up with her doctor tomorrow to inform them of the situation.
Pt called 10/31 complained of pain joint/swelling. (after 30 days). Told to follow up with MD.
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On 18-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Description: Diffuse maculopapular rash of both UE/LE and trunk within 48 hours of anthrax #2 and yellow fever vaccines.  Symptom:  Joint Pain, multiple joints Start: 11/04/1997 Comment: bilateral hands, feet, knees.  Symptom:  Rash, pruritic Start:  06/30/1996 Symptom:  Rash, diffuse Start:  06/30/1996
Pt had occipital occlusion stroke (Rt anterior medial thalamus) and was treated at Hospital and then transferred to level 3 facility. He was in-patient for 4 days at which time he had almost complete resolution of sxs. He was referred to a neurologist with stroke specialty at the Hospital and clinics.
Severe arthritis that gradually got worse. Started in left hip, then right hip, now both hips and both knees and less severe in lower back. I have never experienced arthritis like this! Occasionally I get lower back spasm or sore knee but this is debilitating and nsaids not helping even in high doses.
High Blood pressure spikes lasting for a week. Uncontrollable bleeding right nasal. BP as high as 200/118. Three ER visits. Prescribed Clonidine 0.1 mg daily until it relented. Saw cardiologist. Upped candesartan to 24 mg and Amlodipine to 7.5 mg daily and started Spironolactone 25 mg daily. Off Clonidine as it subsided. Excellent BP all summer and fall. Got the second Pfizer bivalent booster on January 14, 2023 (lot#GL2042) and in 3 days I began the high BP spikes again. 196/115. Still had the Clonidine and started taking to control my BP. Took me a week of use until the BP spikes have subsided. I suspect the Pfizer boosters are interfering with the  ACE inhibitor drug Candesartan. That?s why it takes a few days for my BP to spike. ???? No question in my mind that the Pfizer boosters caused this. People with high BP problems should be warned. I need to find another alternative to help prevent Covid infections now.
rash started not just in her arm, all on her left side, it's a very large rash, it's worst; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash started not just in her arm, all on her left side, it's a very large rash, it's worst) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for an unknown indication.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE RASH (rash started not just in her arm, all on her left side, it's a very large rash, it's worst). At the time of the report, VACCINATION SITE RASH (rash started not just in her arm, all on her left side, it's a very large rash, it's worst) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided.
Patient was given his injection in the right deltoid. Tolerated this well. Approximately 10 to 15 minutes later, his care provider brought him to me and stated that his face was " red and splotchy".  It was noted that Patient had red, raised areas on his face. Patient is non verbal and developmentally disabled, so I was unable to assess if these were itchy. I assessed his neck, chest and arms, no red raised areas noted. I placed a pulse oximeter onto the patients finger, oxygen saturation 95% or greater, heart rate 90-100's no visual signs of distress.
Abdominal cramps; Frequent urination; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal cramps), POLLAKIURIA (Frequent urination) and DIARRHOEA (Diarrhea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramps), POLLAKIURIA (Frequent urination) and DIARRHOEA (Diarrhea). The patient was treated with SIMETICONE (GAS-X) at a dose of 1 dosage form. At the time of the report, ABDOMINAL PAIN (Abdominal cramps), POLLAKIURIA (Frequent urination) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were reported
Intermittent dizziness from 3/28/2021 through April. Since early May have had daily symptoms ranging from foggy head, off balance, lightheaded, dizziness with fatigue and orthostatic intolerance.
shipment of Fluzone QIV 0.5 mL pre-filled syringes was shipped on Monday (11Nov2019) and received on 14Nov2019, shipment experienced an extended time frame and was out of temperature compliance, NO AE; shipment of Fluzone QIV 0.5 mL pre-filled syringes was shipped on Monday (11Nov2019) and received on 14Nov2019, shipment experienced an extended time frame and was out of temperature compliance, NO AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 43 years old male patient who was vaccinated with 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) that had temperature excursion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Nov-2019, patient received 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) (batch number: UJ299AA, expiry date: 30Jun2020) via intramuscular in the Left Arm.   It was reported that vaccine pre-filled syringe that was shipped on Monday (11Nov2019) and received on 14Nov2019. The shipment experienced an extended time frame and was out of temperature compliance (no exact temperature was available).  It was a case of actual medication error due to incorrect product storage and Product shipment delay.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Dizziness that progressed to a syncopal event; unsure of length of time unconscious; also has heat with swelling at injection site with a 4 inch long red area moving toward elbow.
On 1/15/18 headache, flue-like s/y; 0n 1/16/18  headache on and off with onset of warm feeling in the chest and body with numbness and tingling in left arm and l leg. Continuation of symptoms. Until today. 1/20/18 loss of sleep concentration difficulties.
Hot to touch at injection site; Facial swelling; Rapid heart beat; arm swollen and hot to touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site), SWELLING FACE (Facial swelling), HEART RATE INCREASED (Rapid heart beat) and VACCINATION SITE SWELLING (arm swollen and hot to touch at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to touch at injection site), SWELLING FACE (Facial swelling), HEART RATE INCREASED (Rapid heart beat) and VACCINATION SITE SWELLING (arm swollen and hot to touch at injection site). At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site), SWELLING FACE (Facial swelling), HEART RATE INCREASED (Rapid heart beat) and VACCINATION SITE SWELLING (arm swollen and hot to touch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided.  Treatment information not provided.
PATIENTS' MOM  SHOUTED OUT THAT SHE HAD PASSED OUT,  911 WAS CALLED. I RAN OUT AND FOUND THAT SHE WAS CONSCIOUS AND LOOK VERY PALE AND DRY HEAVING , PATIENT STARTED FEELING DIZZINESS AND VOMITED ABOUT 10 MINUTES AFTER VACCINATION ,  TREATED WITH BOTTLE OF WATER TO DRINK AND COLD PACK TO PUT ON NECK, OUTCOME WAS THAT SHE FELT FINE AFTER ABOUT 20 MINUTES AFTER EMERGENCY CREW ARRIVED,  PATIENT WAS ABLE TO GO HOME WITHOUT AMBULANCE
Narrative:  COVID infection following COVID vaccine series 07/22 Pfizer, dose #1 08/12 Pfizer, dose #2 10/08 COVID swab, result: detected 10/06 pt cc: cough, rhinorrhea exposure: unknown 10/08 SARS-COV-2 Variant Sequencing result: pending
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-JUL-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # M000442, expiration date 31-MAR-2018, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 56 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
This case was reported in a literature article and described the occurrence of acute macular outer retinopathy in a 42-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced acute macular outer retinopathy (serious criteria GSK medically significant), scotoma and floaters. On an unknown date, the outcome of the acute macular outer retinopathy, scotoma and floaters were recovering/resolving. The reporter considered the acute macular outer retinopathy, scotoma and floaters to be possibly related to Influenza vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of acute macular neuroretinopathy (AMN) of right eye in a 42-year-old female who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a female. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient had received unspecified seasonal influenza vaccine (administration route and site unspecified; dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient presented with a 2-week history of black spots and a paracentral scotoma in the right eye. Findings on multimodal imaging were classic for AMN. The findings improved but did not fully resolve 4 weeks after initial presentation with observation alone. Treatment was unknown. The author considered the event of AMN possibly related to unspecified seasonal influenza vaccine. The authors stated, "Although a febrile illness or the use of oral contraceptives is most commonly associated with the development of AMN, it is important for clinicians to also consider influenza vaccination as a possible aetiology". The article corresponding to this case is not available for regulatory submission due to copyright restriction.  Lab Comments: Lab tests were performed on unspecified date. Findings on multimodal imaging were classic for Acute macular neuroretinopathy.
fever; chills; booster made him feel horrible half a day or a day; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's 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: PYREXIA (non-serious), outcome "recovered", described as "fever"; CHILLS (non-serious), outcome "recovered"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "booster made him feel horrible half a day or a day".  Additional information: The event started right after the patient received booster. He felt horrible half a day or a day. He felt bad with fever and chills for half a day. The patient did not have any investigations. The caller was assuming everything was good regarding outcome. The patient completely blamed his symptoms on that Pfizer COVID-19 Booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201292854 Same reporter, different drug, different patient;