chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"rash" (red area) around the triceps on the right arm.; chills; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), RASH ERYTHEMATOUS ("rash" (red area) around the triceps on the right arm.) and CHILLS (chills) 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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness). On 03-May-2021, the patient experienced RASH ERYTHEMATOUS ("rash" (red area) around the triceps on the right arm.) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and CHILLS (chills) outcome was unknown and RASH ERYTHEMATOUS ("rash" (red area) around the triceps on the right arm.) had not resolved.            Concomitant product information, if any, was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-101553 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101553:First Dose Case
SEVERE REACTIONS; SICK; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced severe reactions, and sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe reactions and sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220200753.
Fever, body aches all over including arm pits and groin area, headache, numbness in fingers and toes, neck pain.
Per Mom-lLft deltoid was red, swollen and warm, Progression to purple with increased warmth. Denies fever or SOB, Tender to touch. Take to ER for evaluation, Given Benadryl and encouraged warm packs to area.
Patient felt faint, lightheaded, nauseous approximately 5 minutes post vaccination.  Tx: Laid supine, EMS evaluation, vitals Pt refused EMS transport and further care, pt recovered
Patient felt warm and did not feel well.   The pharmacy staff gave the patient a bottle water and ice pack.  After 30 min, the symptoms significantly decreased and the patient felt fine.
her arm is sore; This is a spontaneous report from a contactable consumer reporting for his mother in law. An 87-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced her arm was sore on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
Was tested for COVID this past Wednesday and was called with positive result on Thursday.  Notes she has had sx for about a week  Now.  Notes she had fever on the first day.  Has since had cough, wheeze and shortness of breath.  States PCP placed her on abx and steroids which she is still taking.  Notes her blood sugars have been elevated with steroid use.  Has had some chronic diarrhea.  No abd pain, n/v/c.  No dysuria.  No leg swelling or rash.  Here now w/ worsening cough and shortness of breath.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 2:50 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021 at 2:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patients were given doses from vials that were stored in an ultracold freezer which was colder than should had been. Vaccine was stored in an ultra-cold freezer at minus 82 degrees Fahrenheit. Storage condition at the time of the excursion was frozen storage and excursion duration was 1 month.  Date when vials moved from freezer to refrigerator was 19-Nov-2021 and Moderna COVID-19 vials went from the super cold freezer to the refrigerator. No vaccine state changes were noticed, and vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. No treatment information was provided.      This case was linked to MOD-2021-402935 (Patient Link).
at 545 PM patient reported feeling warm and flushed  vitals at 550 PM 192/88 O2 97 HR 72  given IM Benadryl 50mg left deltoid at 552 PM  repeat VS @ 6 PM manual BP 164/82 and rest of VS WNL  monitoring for 10 mins by nurse and paramedic  VS @ 610 PM 97%O2  68 HR 150/86 BP on D/C  stable and will monitor,  to go to ED if SOB, or any signs of distress develop
back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and rheumatoid arthritis medicine for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced BACK PAIN (back pain). At the time of the report, BACK PAIN (back pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-073846 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073846:Dose 1 of vaccine
Breakthrough case admission after 3 vaccines Moderna 3/26/21 Lot# 017B21A;  Moderna 4/23/21 Lot# 037B21A;  Moderna 12/1/21 Lot# 933909
Evaluated by Dr. on 9/20/18, determined patient was experiencing Alien Hand Syndrome (AHS). Physician associated disorder with previous influenza immunization, FLUZONE QUAD. Patients symptoms are subsiding at present time.
eye lids burned after each shot. Pretty badly.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2022 as dose 3 (booster), single (Lot number: 33025BD) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex. There were no concomitant medications. Past drug history included: Albuterol, reaction(s): "Known allergies: Albuterol", notes: Known allergies: Albuterol. Vaccination history included: BNT162b2 (Dose 2; lot number: EW0173; dose vaccine location: Right arm), administration date: 07May2021, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "My eye lids burned after each shot. Pretty badly."; BNT162b2 (Dose 1; lot number: EW0164; dose vaccine location: Left arm), administration date: 16Apr2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "My eye lids burned after each shot. Pretty badly.". The following information was reported: EYE IRRITATION (non-serious), outcome "not recovered", described as "eye lids burned after each shot. Pretty badly.". Additional information: Patient's eye lids burned after each shot. Pretty badly. 1st occurrence, they made her sit with the paramedics for a bit. After each subsequent shot, the patient knew it would pass so did not report. Now, all this time later, every single time she cry or her eyes get watery, her tears still burn her eyelids. Pretty significantly, to the point that she have to wipe them away or it's unbearable.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300247349 Same patient, same event, same product, different dose (Dose 1);US-PFIZER INC-202300247350 Same patient, same event, same product, different dose (Dose 2);
Sore body, headache, dizziness, fever, feeling cold and hot at the same time
Of note, after 15 minutes of observation, patient felt sensation of carotid pulse racing. I was called by support staff to evaluate patient. Patient was directed to chair and I interviewed patient. She reports history of low blood pressure at baseline, and not eating food today. She reports a coffee on her way to the vaccine site. Nursing staff available and assisted with collection of vitals.  Vitals were SpO2 98%, HR 70-78, Blood Pressure  98/70, RR ~16. Patient reports this is her blood pressure baseline. I auscultated heart and lungs, with a RRR, no murmurs, and CTAB. I checked patient's right carotid pulse, at the location she felt it was quick, and it matched pulse oximetry heart rate of ~70. Patient self-checked behind me and agreed that it felt back to normal. Patient denied presyncopal sensation, and denies any other symptoms and agrees she feels back to normal. At this point patient seems medically stable, and differential diagnosis of symptoms includes mild vagal response, dehydration/caffeine intake-induced tachycardia (transient), or anxiety component. Discussed these possibilities with patient, who agrees. Patient was discharged from the vaccination site.
pt recv vax 1APR99 mom & child to clinic 14APR99 & to report local swelling in lt upper arm;14APR99 area is non tender w/o warmth; area is approx twenty five piece in size & is indurated;
Vaccine of MMR was given (L) arm (upper) SQ. When pt. got to our check out window her arm was swollen & red & some pain. Dr. instructed ice & BENADRYL after seeing the reaction on (L) arm.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs were not provided. On 18-JAN-2019, two patients were vaccinated with improperly stored doses (also capture in case # 1901USA007807) of  VARIVAX Lot # R022116, expiration date 02-AUG-2020, subcutaneously (strength, dose, dose number, and anatomical location were not provided) for prophylaxis. The sterile Diluent used to reconstitute the VARIVAX was stored properly. The vaccines were exposed to a temperature of 15 Fahrenheit degrees to 46 Fahrenheit degrees (18.9 Fahrenheit degrees) for 30 minutes. There was a previous temperature excursion from 15 Fahrenheit degrees to 46 Fahrenheit degrees (16.7 Fahrenheit degrees) for 30 minutes, 15 Fahrenheit degrees to 46 Fahrenheit degrees (23.3 Fahrenheit degrees) for 50 minutes, 6 Fahrenheit degrees to 14 Fahrenheit degrees for 30 minutes, 15 Fahrenheit degrees to 46 Fahrenheit degrees for 30 minutes, and 15 Fahrenheit degrees to 46 Fahrenheit degrees (25 Fahrenheit degrees) for 50 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This is one of two cases reported, received from the same reporter. Sender's Comments: US-009507513-1901USA007807: Same reporter.
5 days post vax pt experienced nausea, vomiting and abdominal pain. Pt was diagnosed with reflux esophagitis and was treated with lansoprazole.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB (Lot #, dose and route were not reported). No symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
7 patients devel large welt (approx 1 1/2 inches), redness, swelling, & pain @ inj site;all pt had negative allergy hx to eggs;
This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequently adverse events. On an unspecified date on or after 21 October 2001 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.
Received a phone call from the pts mother around 2:50 pm on 03/04/2002. He informed out translator that the pt started breaking out in a rash and her face was swellling. Nurse instructed her to go to the ER. At 4pm that day, the reporter received a call from ER physician. He stated that the mother told him that the pt started with rash about 10 mins after receiving immunizations. He stated that he diagnosed as an allergic reaction and gave her Benadryl.
Neuropathy in right leg down to my foot. Have been to ortho, did physical therapy that didn't help and had MRI today. Have follow up with neurologist coming up.
I broke out with a rash on my legs following all 3 vaccination doses. Clears up in a week. Still have the current rash from the shot I received 9/30/21
Subsequent Covid-19 infection resulting in Hemorrhagic Myocarditis and death.
Information has been received from a nurse practitioner concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not available). Subsequently, on an unspecified date the patient experienced seizures after the vaccination. Unspecified medical attention was sought. It was unknown if there were lab studies performed. The outcome of the patient was not reported. Upon internal review, seizures was determined to be an other important medical event. Additional information has been requested.
A physician reported a 62-year-old female was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis and subsequently tested positive for the hepatitis B surface antigen. The pt's medical history and concurrent conditions were not reported. Concurrent medications included estrogen, testosterone, vitamins and Gingko. The pt experienced no adverse events following previous immunizations. On 10/21/2002, the pt received her 1st injection of Engerix-B (lot #ENG5354A2) consisting of 2 injections of 10 mcg to provide the adult 20 mcg injection. On 10/22/2002, she attempted to donate blood and was told she tested positive for the hepatitis B surface antigen. On that date, she tested negative for hepatitis B core antibody, and hepatitis C antibodies. On 12/30/2002, she tested non-reactive for hepatitis B core IgM, hepatitis B surface antibody and hepatitis B surface antigen. The reporting physician indicated that the pt will receive the remaining Engerix-B immunizations.
Missed second dose, past the 42 day mark; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose, past the 42 day mark) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Wheelchair user.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose, past the 42 day mark). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose, past the 42 day mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided.
She had a bad feeling in receiving the second shot adn so, did not take it; hives all over the body, , waist, shoulders, thighs, feet, check, face; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She had a bad feeling in receiving the second shot adn so, did not take it) and URTICARIA (hives all over the body, , waist, shoulders, thighs, feet, check, face) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concomitant products included TRAMADOL for Stenosis, FENOFIBRATE, RIVAROXABAN (XARELTO), LEVOTHYROXINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MAGNESIUM and VITAMIN B COMPLEX for an unknown indication.    On 25-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 PRODUCT DOSE OMISSION ISSUE (She had a bad feeling in receiving the second shot adn so, did not take it) and URTICARIA (hives all over the body, , waist, shoulders, thighs, feet, check, face). The patient was treated with PREDNISONE for Allergy, at an unspecified dose and frequency; FAMOTIDINE at a dose of 20 milligram; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 10 milligram and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (She had a bad feeling in receiving the second shot adn so, did not take it) had resolved and URTICARIA (hives all over the body, waist, shoulders, thighs, feet, check, face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient  used bone joint supplement for arthritis as concomitant medication Treatment medications includes Antihistamines. Patient reported 1st shot Expired date not written on vaccination card.
I had typical vaccine side effects. I went in for a regular check up and had an ultrasound on 02/07/2021 that showed a low heart beat at 107 which is slightly low for 7 weeks gestation.  On 03/05/2021 we repeated the ultrasound and had no heart beat.
102 Fever for 12 hours Headache Muscle aches Vomiting Nausea Chills Fatigue
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 (CLUSTER) and 2023SA057309 (CLUSTER).   This case involves an adult of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  Action taken: Not applicable.  Outcome:  Unknown for both the reported events.  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 the 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
8/3-hard knot and swelling 8/4- swelling and rash that spread around arm
dizziness; weakness all over; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness and weakness generalized. On an unknown date, the outcome of the dizziness was recovered/resolved and the outcome of the weakness generalized was unknown.   It was unknown if the reporter considered the dizziness and weakness generalized to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR045208  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced weakness all over and dizziness. The patient was referred to HCP (health care professional). The patient had no HCP (health care professional) currently. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR045208:2nd dose case - same reporter same patient