chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site hot to touch; developed a rash; Vaccination site very swollen; her arm is still sore; red and blue arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCOLOURATION (red and blue arm), VACCINATION SITE WARMTH (Vaccination site hot to touch), RASH (developed a rash), VACCINATION SITE SWELLING (Vaccination site very swollen) and MYALGIA (her arm is still sore) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No medical history for the patient was reported.  Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM 24HR) for an unknown indication.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced VACCINATION SITE DISCOLOURATION (red and blue arm), VACCINATION SITE SWELLING (Vaccination site very swollen) and MYALGIA (her arm is still sore). In July 2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site hot to touch) and RASH (developed a rash). The patient was treated with PARACETAMOL (TYLENOL) on 08-Aug-2021 for Vaccination site erythema, at an unspecified dose and frequency and LORATADINE on 08-Aug-2021 for Vaccination site erythema, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (red and blue arm), VACCINATION SITE WARMTH (Vaccination site hot to touch), RASH (developed a rash) and VACCINATION SITE SWELLING (Vaccination site very swollen) was resolving and MYALGIA (her arm is still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
ROUTINE MANDATORY INFLUENZA VIRUS VACCINE (88, NOS).  SYMPTOMS RESULTED IN RAPID THROAT AND TONGUE SWELLING, SPASMS, FATIGUE/SLEEPINESS, RASH, ITCHING, VERTIGO.  TREATED WITH EPI-PEN AND BENADRYL.
Pt received Flu Vaccine.  Within 30 minutes she developed hives, prescribed with BENADRYL & Prednisone.
Received the second Shingles vaccine:  Shingrix 50 Mg Inj(IM)Sngdse VL 10Pk  Broke out in hives, swollen face, hand, foot and in severe pain.  Went to a different pharmacy to talk to the pharmacist and was told to go immediately to family doctor and that this reaction needs to be reported.
Injection site reaction such as sore arm; Injection site reaction such as sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction such as sore arm) and PAIN IN EXTREMITY (Injection site reaction such as sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Injection site reaction such as sore arm) and PAIN IN EXTREMITY (Injection site reaction such as sore arm). At the time of the report, VACCINATION SITE REACTION (Injection site reaction such as sore arm) and PAIN IN EXTREMITY (Injection site reaction such as sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information were reported.   This case was linked to MOD-2021-333451, MOD-2021-333533 (Patient Link).
Pediatric (5-11) age children given Pfizer 12 and up dose at  Vaccine Clinic.  RN Site lead contacted Dr. to notify and discuss next steps. Informed by Dr.  there is no new symptoms are concerns to worry about at this time but to call and notify the parents of the adverse event.  RN Site lead notified the parents of the adverse event.
Tired, nauseous and slight body aches. These went away about after a few hours maybe three of taking over the counter pain reliever acetaminophen.
Around 12:00 I started having trouble blinking my right eye and had numbness and tingling around lower orbit. This lasted about 5 hours intermittently. I do have a history of bells palsy and my face never returned back to normal. (first started 2015 with my first pregnancy). I am currently pregnant. This is my third pregnancy, due date 05/03/2021.
Patient stated she was in extreme pain during the injection and after. Pain was tolerable after ice pack was given and 5-10 minutes had passed
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/28/2021 and 4/25/2021. Previously admitted 10/19 - 11/3 for sepsis w/prosthetic valve endocarditis (E. faecalis). Presented to ED on 11/19/2021 c/o difficulty breathing, per EMS COVID positive w/unknown date of diagnosis. Admitted for hypoxemia requiring 3L NC, progressed to acute hypoxemic respiratory failure requiring noninvasive positive pressure ventilation, c/b pneumothorax requiring chest tube. 11/20 noted to be lethargic w/left facial droop. Tx included anticoagualation, IV steroids, remdesivir and tocilizumab x1. 11/23/21 experienced rapid desaturation and developed PEA and expired.
Chills; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 12:00 at single dose at left arm for covid-19 immunization. Medical history included TAVR, blood pressure, acid reflux from an unknown date and unknown if ongoing. Concomitant medications included lisinopril for blood pressure, atorvastatin, omeprazole for acid reflux, hydrochlorothiazide for water pill, spironolactone; all ongoing. The patient experienced chills, nausea, diarrhea all on 09Feb2021 with outcome of recovering. These symptoms were still there, but they're almost gone. Stated it seemed like they all came on together. No additional vaccines administered on the same date of the Pfizer vaccine considered as suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Stated she had never had a reaction after previous vaccinations.   No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Diffuse swelling of entire L thigh to knee.  Blotchy erythema.
Patient had memory losses and was seen first at our facility and then transferred to Emergency Room.  Was diagnosed with "transient global amnesia"
Involuntary head shaking side to side occuring throughout the day and night; each episode lasting 5-10 seconds.  Started the morning after vaccine was given.
I contracted COVID-19 two months after my vaccination (4th dose (3 of Pfizer, one of Moderna)
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 18-AUG-2016, the patient received a dose of improperly stored VARIVAX (strength, dose, and frequency were unknown; lot number and expiration date were M004662 and 28-JAN-2018). No adverse reactions reported. This is one of the several reports received from the same source. Additional information has been requested.
Menstrual cycle changes- period began 8 days early (no memory of such a drastic early start happening before)
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Incredible body aches), ARTHRALGIA (joint pain), TACHYCARDIA (Fast heartbeat), PYREXIA (fever) and HYPERHIDROSIS (Sweats) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced MYALGIA (Incredible body aches), TACHYCARDIA (Fast heartbeat), PYREXIA (fever) and HYPERHIDROSIS (Sweats). On 23-May-2021, the patient experienced VOMITING (threw up). On an unknown date, the patient experienced ARTHRALGIA (joint pain). On 24-May-2021, VOMITING (threw up) had resolved. At the time of the report, MYALGIA (Incredible body aches), ARTHRALGIA (joint pain), TACHYCARDIA (Fast heartbeat), PYREXIA (fever) and HYPERHIDROSIS (Sweats) outcome was unknown. Patient  threw up on Sunday morning on 5/24/21 but he wasn't sure if it was from the chicken he ate the night before. Treatment medication was not  provided. Concomitant product use was not provided by the reporter.
Patient received vaccine, went to waiting room and sat down.  Patient started to get hot, not feel well, and started swearing.  EMT staff noticed beads of sweat on upper lip, patient stated her stomach was in knots.  EMT gave patient water, placed an ice pack on her back, and had patient do deep breathing.  Patient was wheeled to the doorway for cool air.  Patient ate before the event.  EMT gave patient an orage juice.  Patient stated she was dizzy and vision was full of colors.  EMT sat with patient.  EMT did an eye test  by using a test that evaluates a person's level of consciousness- passed.  Patient started to feel extremely better = color pinked up.  EMT walked patient to car after 15 minute wait.
approx 4 weeks after shot, symptoms and pain of pericarditis. took 1000 mg of aspirin for 7 days to clear pain symptoms.  Felt pressure in chest, as well as heart pain with any exertion
c/o feeling itchy from head to toe "even my eyes" last NOC was awakened from sleep- denies rash. Phoned ER- took OTC Benadryl as advised. Itchiness resolved, slight difficulty breathing going up and down stairs.
Information has been received from a certified medical assistant concerning a 78 year old male patient with diabetes, high cholesterol, hypertension and no drug reactions or allergies who on 20-JUL-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 666639/0564Z, expire date 09-OCT-2011), 0.5 ml, subcutaneously.  Concomitant therapy included metformin, GLYPRIDE, DIOVAN, simvastatin (manufacturer unknown), CELEXA, aspirin, minerals (unspecified) (+) CENTRUM SILVER, cholecalciferol and omeprazole.  Certified medical assistant stated that on 20-JUL-2010 post-administration of PNEUMOVAX 23, the patient complained of right arm swelling at and around the area of the injection site.  The area was hot, red and sore to the touch.  The nurse practitioner assessed the area.  She noted that there was 17 cm of heat and bright to little pink skin under the ulnar aspect of the arm to a few inches below the axilla to a few inches past the elbow.  The patient stated that he had to sleep in a recliner chair because the pain was so intense.  There were no laboratory diagnostics studies performed.  The patient was treated with antihistamines of unknown origin and the patient recovered fully the beginning of August 2010.  Right arm swelling at and around the area of injection site, 17 cm of heat and bright to lite pink skin under ulnar aspect of the arm to a few inches below the axilla to a few inches past the elbow, red and sore to the touch were considered to be disabling "for a few days" by the certified medical assistant.  This is one of two reports received from the same source.  Additional information has been requested.
Information has been received from a nurse practitioner concerning a female with a history of hep A exposure (date unknown) who on 03/29/2001 was vaccinated with hep A vaccine. The nurse practitioner reported that "now" in approximately April 2001, the pt has symptoms of hep A. The pt sought unspecified medical attention. Additional info has been requested.
high temperature, respiratory illness ,flu,running nose. 1/15/09-per vaccine provider phone call-patient presented to office 4 days after vaccine C/O flu-like symtpoms, examined and discharged from office. krk 1/16/2009 ER records received for DOS 1/13/2009 with DX: URI-viral. Presented to ER with c/o fever, sore throat, runny nose, ear pain. Temp 98.2'F. Suspected febrile response from MMR.
exhaustion; Fever; Chills; Headache; Badly swollen arms; Aches and pains; Were feeling awful; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and PERIPHERAL SWELLING (Badly swollen arms) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced FATIGUE (exhaustion), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Badly swollen arms), PAIN (Aches and pains) and VACCINATION COMPLICATION (Were feeling awful). At the time of the report, FATIGUE (exhaustion), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Badly swollen arms), PAIN (Aches and pains) and VACCINATION COMPLICATION (Were feeling awful) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
pt recv vax 17FEB95 1130AM & 930PM pt had t104; pt taken to ER; pt was also having some diarrhea; pt was treated for bronchitis/croup & given ATB
Localized Redness, swollen, warm to touch, itchy rash at injection site.
This case was reported by a nurse via sales rep and described the occurrence of pain in a 17-year-old female patient who received BEXSERO. On 20th March 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. The reporter considered the pain to be probably related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. Concomitant medications were unknown. The patient received BEXSERO on right arm. The patient experienced 4 weeks of pain. The patient received the 2nd dose of BEXSERO on 17th May 2017. No other vaccines were administered. This case was linked to case US2017073554, reported by the same reporter.
Covid Arm - redness, soreness, swelling around injection site about the size of a softball
CHILLS; SEVERE JOINT PAIN ESPECIALLY IN THE KNEES; HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pulmonary embolus, and other pre-existing medical conditions included patient had not pregnant at the time of reporting. patient had extensive allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included warfarin for pulmonary embolus. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced severe joint pain especially in the knees. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, nausea, and fatigue on 10-APR-2021, and was recovering from severe joint pain especially in the knees. This report was non-serious.
Swelling in my hands and feet, skin irritation, full body hives, and blood clots in my lungs
4/30 - Throat Swelled/extremely soar 5/10/2021  GBS like symptoms.  Throat completely swelled. Given steroid shot and prescribed dexamethasone. 5/24/2021 Rash boils.  Diagnosed with first case of shingles.  6/4/2021  Shingle bacteria infection.  Prescribed sulfamethazole
Fever 102 deg F, myalgia, 3 days post fax. treated with Naprosyn and Tylenol
Pale, diaphoretic rigid, twitching, unconscious, syncope episode,  EMS was called and patient was transported
Pt developed 2 blister lesions over the left thigh area of induration. Discharge is clear and drying.
Chills, malaise and general body aches. 7/12: 3.5"x1" red welt on lateral side of arm below deltoid, hot to touch and tender. 7/25: area is light pink but no longer hot or raised.
She experienced achiness in legs; Weakness; Slight headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She experienced achiness in legs), ASTHENIA (Weakness), HEADACHE (Slight headache) and MYALGIA (Sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0031821A and 025B21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, BENAZEPRIL, OXYBUTYNIN, OMEPRAZOLE, PRAVASTATIN and SALBUTAMOL (VENTOLINE [SALBUTAMOL]) for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (She experienced achiness in legs), ASTHENIA (Weakness), HEADACHE (Slight headache) and MYALGIA (Sore arm). At the time of the report, PAIN IN EXTREMITY (She experienced achiness in legs), ASTHENIA (Weakness), HEADACHE (Slight headache) and MYALGIA (Sore arm) had resolved.            No Treatment medication were reported.
fever up to 103.4, chills, aches, fatigue that started night of the vaccines
weak; no appetite; tired; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (weak), DECREASED APPETITE (no appetite) and FATIGUE (tired) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #045A21A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ASTHENIA (weak), DECREASED APPETITE (no appetite) and FATIGUE (tired). At the time of the report, ASTHENIA (weak), DECREASED APPETITE (no appetite) and FATIGUE (tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: negative (Negative) Lumiradx SARS-CoV-2 AG Test, nasal swab.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include sinus and allergy unspecified medication and an unspecified cough medication.  No treatment medications were  provided by the reporter.
This spontaneous report as received from a registered nurse, via a company representative, refers to two patients of unknown age. On 18-MAR-2014 two patients were vaccinated with ZOSTAVAX, single dose, in the arm. The patients were also administered Tdap in the same arm on 18-MAR-2014. This case refers to patient two of two patients. In March 2014, the patient developed "localized reactions". This patient developed swelling that extended to the elbow. The patient sought medical attention and visited the office. The outcome of the events and causality assessment were not provided. This case is linked to case 1403USA010921 (patient one of two patients). Additional information has been requested.
one year later patient approaches the counter and gives statement as an FYI.  within days after receiving the vaccination he reports chest pains which while diminished are still on-going.  he went to hospital had EKG's and other evaluations over time as he was concerned it was heart attacks.   He has stopped the sulfasalazine and is not getting more vaccinations.
primary said she thought I had gotten covid before I got the second shot; This spontaneous case was reported by a nurse and describes the occurrence of SUSPECTED COVID-19 (primary said she thought I had gotten covid before I got the second shot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CALCIUM, VITAMIN D NOS, ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN CALCIUM (LIPITOR), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LORATADINE (CLARITIN [LORATADINE]), MONTELUKAST SODIUM (SINGULAIR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and DENOSUMAB (PROLIA) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SUSPECTED COVID-19 (primary said she thought I had gotten covid before I got the second shot). At the time of the report, SUSPECTED COVID-19 (primary said she thought I had gotten covid before I got the second shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided   This case was linked to MOD-2021-341159 (Patient Link).; Sender's Comments: This case concerns a 68 year old female with no reported medical history , who experienced the unexpected event of Suspected Covid 19 which occurred on an unknown date after vaccination with the 1st dose of mRNA-1273 (Moderna). The rechallenge is not applicable since only information of the 1st dose is reported. The age of the patient may be considered as a confounder( since the elderly group are prone to Covid 19 infection) for this case. The benefit-risk relationship of mRNA-1273 (Moderna ) is not affected by this report.
The vision in my right was blurred for about 6 hours. When it started to get better it was inconsistent.  I would close my left eye and at first my right eye would be blurry for about 2-3 seconds then would be able to focus. As of now 13 hours after first noticing the problem upon waking, my vision is almost 20/20 again from what I can tell not having a doctors visit.
This spontaneous report has been received from an unspecified source via a company representative referring to "a couple" of patients of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patients were vaccinated with GARDASIL 9 (strength, dose, frequency, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patients developed headache, which lasted for 2 days. The outcome of headache was reported as resolved. The causality assessment was not provided. Follow up information has been received from the medical assistant on 02-OCT-2018. The primary reporter reported that, the 2 patients were teenage girls. The reporter further mentioned, "When it came time for the patients to get their second dose, the mothers for the girls didn't want the patients getting anymore doses due to the really bad headaches that lasted one to two days." The reporter had no knowledge of the dates it occurred or treatments or any further patient specifics. Upon receipt of follow-up information it was determined that this case is now valid as the patient identifier was received.