chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain in left armpit lasting for more than one day (still painful at time of reporting); Pain down entire left arm for about 12 hours after shot but this has subsided; Dose received: 3; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Dec2021 at 14:45 (Lot number: FF2589) at the age of 39 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included None. Concomitant medication(s) included INFLUENZA VACCINE taken for Immunization, start date: 01Dec2021, stop date: 01Dec2021; MUCINEX and AZITHROMYCIN. Vaccination history included Bnt162b2 (DOSE 1, SINGLE; Lot number: EN5318; Anatomical site: left arm; Route of administration: intramuscular; Administration time: 15:00), administration date: 28Jan2021, when the patient was 38 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EN5318; Anatomical site: left arm; Route of administration: intramuscular; Administration time: 15:00), administration date: 18Feb2021, when the patient was 38 years old, for COVID-19 immunisation. The following information was reported IMMUNISATION (non-serious) with onset 03Dec2021 at 14:45, outcome unknown; AXILLARY PAIN (non-serious) with onset 03Dec2021 at 16:00, outcome recovering; PAIN IN EXTREMITY (non-serious) with onset 03Dec2021 at 16:00, outcome recovering. Therapeutic measures were not taken as a result of axillary pain and pain in extremity.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Pain woke her up in the middle of the night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Felt fine night of 11/06/03 .  10 am (11/07/03) had donut for breakfast and hands began to itch and swell.  Face and lips swelled like a balloon.  Pt's face and chest became bright red.  Pt was driven to the medical clinic where she was treated by a MD.  Pt became "shocky" and was treated with injectable epinephrine, benadryl and cortisone.  She was observed for 1/2hour and was sent home with oral Benadryl for 3 weeks and oral cortisone for 10 days.
Patients arm was red, painful and swollen. We treated her for cellulitis of left upper extremity. She was started on cephalexin 500mg capsule and was sent for a ultrasound of her arm to rule out blood clots in arm.
Received her H1N1 at 11:09 on 11/3/09 and 20 minutes later started to have pruritus and hives. Patient with history of asthma and eczema. Patient reports slightly feeling of scratchy throat as well. Patient was seen here by Dr. and sent home.
Fever, Joint Pain, Nausea, Diarrhea, Headache, Redness Swelling at injection site.
Very strong tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and a little prone to blood clots. 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 medications included fosinopril (MANUFACTURER UNKNOWN), rivaroxaban (XARELTO), carvedilol (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN); all for unknown indication since an unknown date and unknown if ongoing. On 21Apr2021, the patient experienced very strong tinnitus which patient had never experienced before. Therapeutic measures were not taken as a result of the event very strong tinnitus which the patient had never experienced before. 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 very strong tinnitus was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Light headed,dizzy,nausea, chills, sore arm where shot was placed.. an hour after the shot given, chills started 4 hours after shot was given
Patient with a reported history of anaphylaxis to several things and carries her own EpiPen. She was brought to monitoring room at 1835 With complaints of cough and at that time had taken two puffs of albuterol inhaler. Patient also reports some medicating with 50 mg of Benadryl two hours prior to vaccine. O2 sats were 99% heart rate 69 and lungs CTA. At 1845 patient self dosed another 2puffs ofalbuterol. At 1845 HR 130 and sats 98%. At 1850, BP 173/139 HR 127. Patient continued to develop a progressive cough and SOB. Consulted Dr. by phone. We dosed with Zyrtec 10 mg po and assisted pt with administration of her own epi-pen.  Followed up with ED next day. Pt had been escorted there from vaccine clinic after epi-pen administration and progressive SOB. ED reported pt remained hemodynamically stable and A&O x 4. Treatment consisted of Benadryl 50 mg IV, Pepcid 20mg,IV, solumedrol 125 mg IV, fluids 1L, and racemic epi. Discharged home after 3 hours.
At 4:39pm, pt stated, "he felt dizzy and the room was spinning." VS 142/92, 78, 18, O2 stat-97% on RA, Apical pulse listened for 1 full minute, HR at 78, bilateral lung sounds clear.  No respiratory distress noted.  Pushed fluids, assessed VS, gave oranges as snacks. Encouraged pt to stay by nurse's side, remain calm, and deep breathing technique. Reassessed pt at 5pm, pt stated, 'he feels better, denies dizziness/room spinning'.  Reassessed VS upon clearance of 130/86, 72, 18, O2 stat-99% on RA.
MOM CALLED WITH CONCERNS ABOUT HER DAUGHTER.  SHE SAID HER DAUGHTER HAD  A SMALL RASH ON HER STOMACH ON SAT. 5/30/09 AND THEN DEVELOPED BIG RED BUMPS ON HER AMDS AND LEGS ON TUES. 6/2/09 MOM STATES ON 6/4/09 "RASH IS GOING AWAY" PT SEEN AT HEALTH DEPT SMALL RAISED RED RASH FINE SIMILAR TO MEASLES RASH.
multiple blood clots in lungs; multiple blood clots in legs; feeling chest pain; short of breath; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), via an unspecified route of administration in left arm on 06Feb2021 at 18:00 at single dose for covid-19 immunisation. The relevant medical history included DCIS Breast cancer from 2016, Known allergies: pencillin from an unspecified date. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient previously received first dose of BNT162B2 on 16Jan2021 at the age of 68 years old (lot number: EL3249, at 06:15 PM, in Left arm) for covid-19 immunisation. The patient received 2nd Pfizer vaccine dose on Sat, 06Feb2021. On Wednesday 10Feb2021 she became short of breath. On 11Feb2021, she began feeling chest pain. On 12Feb2021, she was advised by primary care Dr to go to the emergency room. She was admitted on 12Feb2021 to ICU with multiple blood clots in her lungs and legs. She was told by the emergency Dr this was a sign of Covid, they did a Covid test, came back negative. She remained in the hospital till 18Feb2021. She was at the time of the report on Eliquis (10 mg/d). A hereditary blood clot test was done that came back negative. She had never had an issue before the vaccination with blood clots nor anyone in her family and she was in good health before the vaccination. Dr didn't think the vaccine caused the blood clots but her primary care Dr thought it did-which was why she was reporting it. The patient also stated that event multiple blood clots in her lungs and legs resulted in Emergency room/department or urgent care, Hospitalization and Life threatening illness. The patient had hospitalization for 7 days. Treatment Heparin 25,000unit in .45% NaCl Premix, Narcan received. No covid prior vaccination. The patient underwent lab test included Nasal Swab which showed negative on 12Feb2021; Hereditary blood clot test which showed negative on an unspecified date in 2021. Therapeutic measures were taken as a result of all the events. The outcome of the events was recovered with sequel.
Heat in injected site. Swelling at injected site. Severe pain at injected site. Unable to raise arm.
arm swelled up; arm swelled up, and was hot and heavy; arm swelled up, and was hot and heavy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up), FEELING HOT (arm swelled up, and was hot and heavy), LIMB DISCOMFORT (arm swelled up, and was hot and heavy) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Dialysis since an unknown date. Concomitant products included HYDROXYZINE, ALLOPURINOL, RENA-VITE, VITAMINS NOS (GERITOL [VITAMINS NOS]) and LABETALOL HCL for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (Headache). On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (arm swelled up), FEELING HOT (arm swelled up, and was hot and heavy) and LIMB DISCOMFORT (arm swelled up, and was hot and heavy). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 16-Mar-2021, PERIPHERAL SWELLING (arm swelled up), FEELING HOT (arm swelled up, and was hot and heavy) and LIMB DISCOMFORT (arm swelled up, and was hot and heavy) had resolved. At the time of the report, HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
&J COVID-19 VACCINE  ADMINISTERED 28 DAYS AFTER  MODERNA COVID-19 VACCINE  ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included kidney disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 042121A, and 042A21A expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On an unspecified date, the subject experienced &j covid-19 vaccine administered 28 days after moderna covid-19 vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of &j covid-19 vaccine administered 28 days after moderna covid-19 vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210419970.
BP 140/82, HR 90, oxygen sat 97%. Patient allowed to rest and stated that she felt better.,Patient came to observation stating that she felt a little short of breath. She was running late for her appointment and started to feel anxious about missing her Fatigue ** Pt reported SOB**
No adverse event but did receive the incorrect vaccine. Should have received the Pfizer Bivalent Booster
It was realized after the vaccination that YF-Vax was contraindicated due to the patient takes Revlimid; Initial information received on 05-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 53 years old male patient who realized after the vaccination that yf-vax was contraindicated due to the patient takes revlimid after receiving yellow fever vaccine - [YF-VAX].  The patient's past medical history included Stem cell transplant.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included lenalidomide (Revlimid).  On 05-Oct-2023, the patient received a dose of suspect yellow fever vaccine - Solution for injection (lot- UJ829AA) via subcutaneous route in the back of the left upper arm (dose, strength and expiration date: not provided) for Immunisation.  On 05-Oct-2023, it was realized after the vaccination that yf-vax was contraindicated due to the patient takes revlimid 5 mg qod (with no reported adverse event) (contraindication to vaccination) (latency- same day) following the administration of yellow fever vaccine.  They have a client who was administered a YF-VAX but it turns out the patient is on an immunoregulatory medication called Revlimid. A patient was administered a dose of YF-Vax today around 15:00. Product used: Used First time product used: Yes Still using product: No.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 30-MAR-2016, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L025598, expiration date 13-JAN-2017 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 hours. This is one of several reports received from the same reporter. Additional information has ben requested.
Patient felt dizzy and fell down 5 min after receiving immz. He felt light headache and mild pain on (L) arm.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 10/14/2022 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY  ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 9/7/2022 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 10/14/2022 DM 2 W CATARACT  ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 9/7/2022 DM 2 W CATARACT
immunocompromised condition; has been sick; This is a spontaneous report received from contactable reporter (Nurse) from a sales representative.  A 5-year-old patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM 197 protein) (PREVNAR 13), as dose 4, single (batch/lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 (dose 1), for immunization; Prevnar 13 (dose 2), for immunization; Prevnar 13 (dose 3), for immunization. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised condition"; ILLNESS (non-serious), outcome "unknown", described as "has been sick". The patient underwent the following laboratory tests and procedures: titer test: neither patient had titers of Prevnar.  Additional information: The nurse was describing 2 recent patients at the age of 5 years of age that has been sick and titer tests were conducted and neither patient had titers of Prevnar. She felt both had 4 doses as infants. Thought was strange that they had no titers. One of the patients also had no titers of Hep B. The patients were going to have further testing to uncover if why been sick and/or if they immunocompromised condition or another condition.  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 temporal relationship, the association between the events "immunocompromised condition" and "has been sick" with PREVNAR 13 can not be completely 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.,Linked Report(s) : US-PFIZER INC-PV202300011939 same reporter/product/event, different patients;
Swelling around injection site -3" diameter, hardness, red color, hot. Painful to touch. Fever - 99 degree.  Ice pack, Neosporin with pain relief, ibuprofen
Redness at injection site; A spontaneous report was received from a nurse (patient), a female patient of unknown age, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced redness at injection site (injection site redness).   The patient's medical history was not provided. No concomitant medications were reported.  On 23 Dec 2020, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown), intramuscularly for prophylaxis of COVID-19 infection.   The patient reported that still today on 01 Jan 2021, she has redness at the site that was very localised at the injection site was about an inch to inch and a half in size and almost square sort of shape. The patient does not have any other symptoms or discomforts. No treatment information was provided.  Action taken with second dose mRNA-1273 in response to the event was not reported.   The outcome of the event, redness at injection site, was not recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Approximately after two weeks after vaccination a bad head cold, tingling in hands & feet. 48 hrs after had no feeling in leg muscles.
Patient received her Moderna vaccine 0.5 ml IM at 2:20 PM this afternoon. Around 02:35 PM, she started to complain of dizziness, lightheadedness, and tingly sensation to the fingers. Vital signs were taken as follows: BP: 135/98,  T: 99.8, HR: 79, SPO2: 99%. He was evaluated by Dr. at 02:49PM with order to administer Benadryl 50 mg IM x 1 now, given to the Right deltoid at 02:56 PM. Additional order to monitor DSP for an hour given by Dr. At 3:25 PM, DSP complained of seeing spots with noted visible trembling/shivering. Vital signs rechecked: 141/108, HR: 83, T: 99.8, SPO2: 99%. Dr. informed of her status with directive to send to Clinic if symptoms persist with no improvement in vital signs. At 04:05 PM, continue with complaints of dizziness and weakness, Vital signs: 134/97, HR: 80, T: 98.8, SPO2: 99%. Dr. informed with order to send staff to ER via State Van. Staff sent to  Medical Center at 04:15 PM accompanied by Residential Clerk. At around 06:15 PM, was sent home from ER due to improvement of symptoms.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were 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 (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) 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 (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) 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 (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case contains information for the 63rd of 100 adult male patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  Nurse reported that an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again. The 100 adult male patients were involved.  Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Today he took a covid home antibody test which came back positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Today he took a covid home antibody test which came back positive) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (He has received every pfizer dose available to him prior to a Moderna Spikevax vaccine). Past adverse reactions to the above products included No adverse event with Pfizer.    On 12-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (Today he took a covid home antibody test which came back positive). At the time of the report, COVID-19 (Today he took a covid home antibody test which came back positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2023, SARS-CoV-2 antibody test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       He had received every Pfizer dose available to him prior to a Moderna Spikevax vaccine on 12 OCT 2023, lot number unknown. He started experiencing symptoms 2 days ago, feeling like he had a severe cold with a runny nose. On 20 Oct 2023 he took a covid home antibody test which came back positive. He had not taken any medications or treatments for his symptoms.