chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives all over her body Post Antibiotic; Swollen Lips post Antibiotic; Pain in the left hand; Swollen Left Hand; Red Thumb on the Left Hand (Similar to Gout); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left hand), PERIPHERAL SWELLING (Swollen Left Hand), GOUT (Red Thumb on the Left Hand (Similar to Gout)), URTICARIA (Hives all over her body Post Antibiotic) and LIP SWELLING (Swollen Lips post Antibiotic) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 09-Apr-1998 and Drug allergy (patient remembered that she did have doxycycline about 20 years ago and she had a reaction to the doxycycline about 20 years ago.). Concomitant products included ATENOLOL, PRAVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID] and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM D3) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left hand), PERIPHERAL SWELLING (Swollen Left Hand) and GOUT (Red Thumb on the Left Hand (Similar to Gout)). On 04-Feb-2021, the patient experienced URTICARIA (Hives all over her body Post Antibiotic) and LIP SWELLING (Swollen Lips post Antibiotic). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the left hand), PERIPHERAL SWELLING (Swollen Left Hand), GOUT (Red Thumb on the Left Hand (Similar to Gout)), URTICARIA (Hives all over her body Post Antibiotic) and LIP SWELLING (Swollen Lips post Antibiotic) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-090658 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: significant follow up received, patient demographics updated, concomitant medication updated
she started with swelling in hands; SWELLING FACE; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (she started with swelling in hands) and SWELLING FACE (SWELLING FACE) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALLOPURINOL and PROPRANOLOL HYDROCHLORIDE (INDERAL) for an unknown indication.    On 26-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 PERIPHERAL SWELLING (she started with swelling in hands) and SWELLING FACE (SWELLING FACE). The patient was treated with CHLORPHENAMINE MALEATE (CHLOR-TRIMETON) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (she started with swelling in hands) and SWELLING FACE (SWELLING FACE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-238930 (Patient Link).
12:30 am (~8 hours after vaccines) that night, employee stated she had fever/chills sensation (hot/cold) and was unable to sleep. She also had nausea and anorexia.  It was improving by the next day.
Pt recvd vax in MAR90 & devel idiopathic thrombocytopenia purpura.
Day 1: nausea; Day 2: nausea; Lethargic; Fever between 99.8 - 103
Patient received 2nd Pfizer vaccine on 02/05/2021. Patient was exposed to COVID-19 on 09/07/2021. Patient developed shortness of breath and low O2 saturations on 09/09/2021 and tested positive for Covid-19 on 09/09/2021. Patient was admitted to the hospital on 09/09/2021.
P 130, BP 108/78 at 19:40. Pt. complained of feeling hot and dizzy a few minutes after getting vaccine. Given 25 mg BENADRYL. Felt a little better. Some wheezing in lungs. Still felt dizzy. 25 mg more BENADRYL at 19:45. Pt said dizziness still comes in waves.
No Adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.   Suspect product dosage text was reported as unknown.  The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medication was reported.   It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. This case contains information for patient 2 out of 16.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Mother noticed childs arm warm and swollen compared to other arm, which was also vaccinated, with no reaction.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with the unspecified number of improperly stored doses of GARDASIL (lot# K008931, exp. date: 04-MAR-2017) (strength, dose and frequency were not reported). The doses of GARDASIL were in temperature minus 1.2 Celsius degree for 18 hours and 32 minutes. There was no previous temperature excursion available. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Typical symptoms presented as fatigue and chills. Then my heart started beating 120-165bpm sitting still and started palpitating 4-5 times per minute for 2 hours. Hospital gave me Ativan, beta blockers, minerals to get my heart to start beating properly again. I was in the hospital for about 8 hours, my heart eventually returned to normal. Normal CT scan for heart. Covid vaccine probably amped up an immune response and caused my heart rate to spike and not pump efficiently. Released from the hospital with fatigue but my heart is fine.
This spontaneous report as received from a medical assistant via a company representative refers to a 15 month old female patient. On 15-APR-2014 the patient was vaccinated with VARIVAX (Merck), (lot# and strength unknown) 1 single shot, subcutaneous injection. On an unknown date after receiving the VARIVAX (Merck) the patient developed chickenpox. The patient sought unspecified medical attention. Immunoglobulin G (IGG) and immunoglobulin M (IGM) lab tests were performed but the result was not provided. The outcome of the event was reported as not recovered. The causality of the event and VARIVAX (Merck) was not provided. Additional information has been requested.
Rapid heart beat- 2 brief instances within 15-20 minutes of vaccine administration; Light headed feeling; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on left arm on 23Dec2020 07:30 at single dose for COVID-19 immunization. Medical history included high blood pressure (HBP), supraventricular tachycardia (h/o SVT), h/o breast cancer, and sulfa drugs allergies. The patient was not pregnant. Concomitant medication included famotidine, metoprolol succinate, and tamoxifen. The patient experienced lightheaded feeling and rapid heartbeat- 2 brief instances within 15-20 minutes of vaccine administration on 23Dec2020. No treatment was received for the events. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination via nasal swab on 24Dec2020, results was pending. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Admitted to hospital 2/12 with chest pain and elevated cardiac enzymes. ECG changed; Cardiac Cath negative. Diagnosis: myocarditis secondary to smallpox vaccination. Other viral studies pending.
Patient called pharmacy on Sunday morning  6/30/2019 complaining about red sore arm, that felt warm and said it felt like the pain was traveling up his ear.
Pt experienced diarrhea, neck stiffness, ringing in ears, nausea, chills, body aches, injection site pain, malaise, abd pain.
Right arm was achy and painful to move less than a week after vaccination. I couldn't sleep on my right side and had extreme pain when lifting my arm above shoulder. No inflammation or bruising.
Patient reports right shoulder pain not relieved by NSAID and ice therapy. We are treated her as muscle strain or rotator cuff injury with rehab and continued NSAID use. Will order MRI of shoulder for no improvement and give steroid injection in 2 weeks if needed.
Swollen lymph node above right collar bone. Painful and hard to sleep with pain.  It is noticeable and didn?t show itself right away but definitely by next day it was there
Fatigue, cold sweats, muscle twitches in arms, severe cramping in body, severe headache persisting up to this date of reporting adverse reactions (10/13/21).
Pt. received Pneumococcal and Td vaccines in left arm on 2-18-04. On 2-19-04 pt. developed large swelling at site of Pneumococcal vaccine with enlarged lymph nodes in left axilla and muscle soreness in left deltoid extending to left upper back. Temp 97.8, Blood pressure 120/70, P 72
Some aches; Chills; Tired; This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received Flu vaccine on an unknown date, not had a reaction to the annual flu shot).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain, chills and tiredness. On an unknown date, the outcome of the pain, chills and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had not had a reaction to the annual flu shot. The patient reported that she had a slight reaction some aches and chills in the evening and tired the next day.. The patient asked she was female if that makes a difference. The case has been linked with case US2019AMR229177, reported by same reporter for same patient.
A second Covid booster dose was given in error. The patient had already received his second Covid booster on 6/7/2022, and then received another booster dose on 6/28/2022. Both were Moderna 0.25ml.
A total of three  patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A total of three  patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A total of three  patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (A total of three  patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications reported. The Moderna Covid-19 vaccine was removed from the freezer on 09-Dec-2021 and was assigned a beyond use date of 08-JAN-2022. A total of three patients received the Moderna Covid-19 vaccine after the vaccines beyond use date.    This case was linked to MOD-2022-451537, MOD-2022-451522 (Patient Link).
Patient opted not to stay for 15 minutes after vaccination given.  She left immediately and about 10 minutes after vaccination was driving and felt a "thud" in her heart,  about 10-15 minutes later it happened again.   Then she started noticing it happening every few minutes.  Arrived home and noticed her heart accelerating and having an irregular "thudding". Denies any other symptoms.  She drove her self to Emergency room.  She says it stopped "thudding" as she was entering the ER.  Upon arrival her BP was elevated to 200+/100+ (did not recall exactly. ) She was placed on heart monitor and no irregularities were seen.   Covid test was negative, other labs (could not recall specifically) .  Was told be ER physician that CXR and labs were normal and heart monitor found no abnormalities.   She was held in the ER for about 4 hours.  Upon discharge BP was 120/? (she could not recall. )  The following day she went to urgent treatment center for BP check and it as 155/?  .  She was not having further symptoms, just wanted to see if her BP was back to normal.  She has f/u with her PCP scheduled for 12/9/21 to reassess BP.   No further cardiac symptoms.
Growth at base of neck, eventually diagnosed as multinodular goiter after continued growth until found during routine physical in April 2019.
Starting 9/17 she got a welt in the shot site and it became red and painful fairly quickly, continued to get larger and spread and turn very hot to the touch. On 9/18 today there is now a small blister where the shot was given and her arm is swollen and very painful and some (minimal) itching.
Patient developed red rash neck, chest and arms. Bilateral Eye swelling. Chest tightness. Denied difficulty breathing. Benadryl 25mg IM administered and transferred to Emergency Room for further treatment.
Cellulitis, bright red, itching, fever, rt deltoid.  Hands bilaterally numb up to her neck.  Still has problems under arm and around elbows itching and minimal swelling.
Patient received Gardasil while on Bactrim Ds on Dec fifth. On Dec. 6 at approx. 6 pm developed a sudden rash covering his entire trunk and extremities. He has a history of allergy to Cipro with similar reaction to the Cipro.
Warm to Touch - Near Injection Site; Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE WARMTH (Warm to Touch - Near Injection Site), INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and INJECTION SITE SWELLING (Swelling - Near Injection Site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to Touch - Near Injection Site), INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and INJECTION SITE SWELLING (Swelling - Near Injection Site). At the time of the report, INJECTION SITE WARMTH (Warm to Touch - Near Injection Site), INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and INJECTION SITE SWELLING (Swelling - Near 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) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.
Received second dose of Pfizer vaccine. The next day had a mild headache and axillary lymph node swelling
Swelling of hands and feet starting 6/5/2021  Started with right pinky, then the full hand. Extreme pain on wrist. On 6/10/21 feet started to swell up...a week later my other hand started to get swollen
She has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: other - warmth feeling on her frontal and left parietal area 10 mins post vaccination. Pt endorsed it's the same feeling when she get's the hot flashes because of menopause. Denies headaches, dizziness, focal numbness/weakness, nausea/vomiting, cp, sob. Physical exam unremarkable. vital signs stable. neuro intact. sent home stable.
Patient here for 1st dose. At 3:15, patient complained of itching L upper arm and 5 minutes later itching to back and neck area. Patient self administered Benadryl at 2:40 and additional 50 mg of Benadryl at 3:53 PM. Patient is alert X3, speech at baseline, breath sounds clear to A&P no stridor, no wheeze noted. BP 130/80, HR 95, Temp 98.4, O2 Sat 99 %. Patient was refusing to have Epi Pen administered by RN X3 attempts. AIDE was called to assess. Patient alert, no visual swelling or difficulty breathing. 3:20 patient ambulated to the bathroom. 3:33 patient advised by medics to call a family member to drive her home. Patient agreed and called family. Reports her itching is improving and continues to be alert. VS are stable. 5 PM patient left with friend driving via private car. Patient was advised to consult with doctor prior to next vaccine.
Headache, sweats, low grade temperature (99.3), fatigue, and myalgias. These resolved within 24 hours with two separate doses of 650mg tylenol, but the fatigue persisted for 48 hours.
This spontaneous report was received from a pharmacist refers to an unspecified patient of unknown gender and age. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose: 0.65 ml, lot # L039094, expiry date: 08-JAN-2017). Pharmacist reported that the vaccine underwent temperature excursion at 6 degree Fahrenheit for 24 hours. No adverse effects were reported. Additional information has been requested.
pneu,monia - steroids possible satellite lesion generalized rash Follow up information: Pt states that he received "asthma" after being vaccinated for smallpox.
This is a 74y.o. male with a PMH of CAD s/p PCI to LAD, HFrEF 20%, atrial fibrillation on Eliquis, ICD s/p BiV, DM type 2, OSA, CKD stage 3, who presents to WBH-RO for evaluation of two days of shortness of breath and fatigue. Was found to be covid +.  Started on tx by ID for 3 days. Was also hypotensive so we held his entresto and bumex. Pt still hypotensive sometimes. He was also found to be in AKI with creatinine 1.57  (baseline ~1.3-1.5). AKI- resolved upon discharge.  We kept holding his Bumex and Entresto given low BP.  On daily assessment patient was euvolemic.  His urine output was good and daily weight was not concerning for fluid retention.  We decided to discharge him with instruction not to take his
Arm vaccinated was very sore and non-movable. Pt had a fever and was nauseated X 24 hours.
Unbearable pain in entire body. Tylenol had no effect. 101 degree fever
a little bit of sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (a little bit of sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 4), Pfizer vaccine (Dose 3) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included Pain in arm with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Hypertension.    On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little bit of sore arm). At the time of the report, PAIN IN EXTREMITY (a little bit of sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking medicine for hypertension. It was reported that patient had no other reaction after vaccination. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-725143 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725143:same reporter
Pt was in her usual state of health. Received COVID booster (3rd shot) the morning of admission. Patient remembers acute onset abdominal pain morning of admission, also dizziness x 2 days. Otherwise denies chest pain or other symptoms including lightheadedness.    Patient became unusually somnolent early afternoon, and was breathing at a very slow rate with foam around her mouth. Legs and hands were also unusually cold.  She was brought to the ED by concerned family members and found to have a VBG with pH 7.0 and pCO2 in the 90s. She was placed on Bilevel positive airway pressure for a few hours with recovery in her pH and pCO2. She was also started on ertapenem and eventually narrowed to doxycycline by day of discharge after 2 days.   On ROS, denies any fevers, cough, chest pain, shortness of breath, dysuria, urinary incontinence, new rash. + abdominal pain that is now improved. + ongoing dizziness. Endorses chills. Declines headache. Patient denies any confusion though patient's family feels that patient is more confused.
Fever one day after vaccine for few days. Swollen tonsils for few days. Rash on both sides of neck starting 1 day after vaccine and spreading for 2 weeks after vaccine.
2nd trimester missed miscarriage detected on 10/29/2021 (18th week of pregnancy). Fetal demise is believed to have occurred at 16 weeks. Treated with dilation and evacuation procedure on 11/5/21.
Swelling, erythema and pain in right anterior thigh starting 20 hrs after injection and worsening over next 24 hrs. No fever, drooling or shortness of breath.