chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Light headedness; Soreness in arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), PAIN IN EXTREMITY (Soreness in arm) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light headedness), PAIN IN EXTREMITY (Soreness in arm) and CHILLS (Chills). At the time of the report, DIZZINESS (Light headedness), PAIN IN EXTREMITY (Soreness in arm) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
STATES DIAPHORETIC, DIZZY, PALE AFTER RECEIVING VACCINE.  RECEIVED 1 LITER OF NORMAL SALINE IN ER ON 12/23/20
spasm in thigh and burning acute pain that last for two weeks in lower back and upper leg.
Muscle pain in right arm at onset of vaccine, unresolved. Chills, sweats, tingling and numbness of all hands, feet and limbs, 8-12 hours after shot, resolved within 24 hours. Chest pain, chest tightness, weakness and irregular heartbeat, onset +/- 48 hours after vaccine, unresolved.
injection site pain, on 1/29/2021 employee experienced tiredness, muscle pain, chills, joint pain, etc. Employee also has swelling of the face, and fast heartbeat
Swelling in the right armpit, close to side of breast.; About 24 hours later a little bit of swelling and aching transferred to left armpit as well.; Low grade fever -elevated just 1 above normal; Fatigue; Shooting pains in ankles and knees; Lessened appetite; slight nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 27Mar2021 at 16:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included overweight, fatty liver and  latex allergy. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), one dose one week prior and lansoprazole (MANUFACTURER UNKNOWN) on an unknown date; both for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 06Mar2021 at 15:45 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 17:45, the patient experienced swelling of the right armpit close to side of breast and the swelling was painful. It was significant enough to be obvious through clothing. About twenty-four hours later a little bit of swelling and aching transferred to left armpit as well. The patient also experienced low grade fever (elevated just 1 degree above normal), fatigue, shooting pains in ankles and knees, lessened appetite and slight nausea. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events axillary mass, axillary pain, low grade fever, fatigue, shooting pain, decreased appetite and nausea was recovering at this time of this report.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
pt recv vax; tests revealed elev SGOT of 55 & elev SGPT of 68;10jun95 SGOT =45 & SGPT =51; lab analysis on 21jul94 SGOT=41 & SGPT=51; all oth eval nl;
Patient's father stated that patient's birthday was 07/21/2009, confirming that she was 12 years old at the time of administration. When the date of birth was not working with the insurance coverage, father was repeatedly asked for the correct date of birth and continued to give the pharmacy staff the 7/21/2009 birthdate for patient. Patient herself, was asked to confirm her birthday prior to administration, and confirmed her birthdate was 07/21/2009. The vaccine was administered without incident and there were no noticeable adverse effects of vaccine administration. It was then discovered by pharmacy staff that the pharmacy was given the incorrect birthday and it appears, per the State Immunization Information System, that patient's actual birthday is different then what was given, indicating that she was 11 years old at the date of administration.
left-sided facial numbness and left-sided mastoid pain - diagnosed with Bell's Palsy
Fever tmax 102; chills; muscle aches; fatigue; sore throat; headache; cough; This is a spontaneous report from a contactable other healthcare professional (patient). A 32-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 02Feb2021 14:00 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. Medical history included anxiety, allergy to sulfa drugs and Scallops. Patient didn't have COVID prior vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported, in two weeks. No other vaccines were administered in four weeks. The patient previously received the first dose of bnt162b2 on 13Jan2021 01:00 PM at 32 years old, on Right arm for covid-19 immunization. The patient experienced fever tmax 102, chills, muscle aches, fatigue, sore throat, headache, cough, all from 02Feb2021 08:00 PM. No treatment was received for the events. The patient underwent lab tests and procedures which included COVID test (Nasal Swab): negative on 05Feb2021. The outcome of the events was recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. 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 not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 26-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported at the time of reporting. On NOV-2021, after about 6.5 months after vaccination, the patient did the antibody test for protective antibody. The result was zero (confirmed immunological vaccine failure). The patient spoke to primary care physician (PCP) and the PCP did not believe it and said that might be a mistake. He suggested to repeat the test. The patient did the antibody test again and the result came out to be zero. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000202301.; Sender's Comments: V0: 20211133438-COVID-19 VACCINE AD26.COV2.S- confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Swelling of left arm - pt called in the pm on 2/2 - she said she would seek care at clinic or hospital shortly after our conversation.
Initial report received 19 February 2009 from a health care professional. A 14-year-old male patient with a medical history of environmental allergies and acne, had received an intramuscular right deltoid injection of FLUZONE SV 2008-2009, lot number U2762AA on 29 October 2008 and three days later, he developed pain in his legs. The patient was evaluated on an unspecified date by his family physician who diagnosed the patient has having Guillain Barre Syndrome (GBS). The patient had no illness at the time of vaccination and he had been receiving ZYRTEC, tetracycline, multivitamin, TYLENOL (prn), and allergy shots concomitantly. At the time of the report, the patient's recovery status was unknown. No additional information was provided. Documents held by sender: None. 3/6/09-records received-office visit 9/23/08-seen for evaluation upon awakening feeling "woozy". Suddenly fainted to the floor and after 20-30 seconds appeared fine. Feels hot and cold expecially when changing positions, felt hot last week. Assessment:vestibular dysfunction. Presented on 11/10/08 after ED visit 2 days prior. DX:Probably mesenteric adenitis. Small amount of tenderness to firm palpation in right lower quadrant. 11/21/08-Parent called stating weakness in legs is getting better. Did not return for additional visits.  3/12/09-records received for ED visit 11/8/08-C/O lower right quadrant pain, aching, loss of appetite, nausea.
No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 14-OCT-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature/ was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.
This 68 year old white  male received the Covid shot on  2/06/21    and went to the ED and admitted on 2/08/21    with the following diagnoses listed below. U07.1 - COVID-19
pain at the vaccination site after his first Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the vaccination site after his first Moderna Covid-19 vaccine) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the vaccination site after his first Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (pain at the vaccination site after his first Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient has misplaced his vaccination card and does not have the exact dates of administration or the lot numbers. No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-416982 (Patient Link).
Patient received her SECOND dose of the moderna covid19 vaccine, a few minutes following the immunization the patient began feeling "weird." Patient stated she felt her throat closing up, difficulty breathing, fast heart rate, redness on chest and arms that were not present prior to vaccine, and that she felt like she was going to faint at any second. Asked patient if she had ever felt that way before, she said she had not. Asked the patient if she had ever received an EpiPen shot before, she had not, asked her if she is ok with us administering an EpiPen while the EMS was on their way and she said "Yes".
received a Fluzone Quadrivalent after 2 days of shipping, vaccines were nonviable, no adverse event; received a Fluzone Quadrivalent after 2 days of shipping, vaccines were nonviable, no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist on 05-Nov-2019.  This case is linked to 2019SA310489 and 2019SA310491.  This case involves a 39 year old female patient who received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ270AA, Expiration date 30-JUN-2020) via intramuscular route in the left deltoid on 04-Nov-2019 after 2 days of shipping, vaccines were nonviable.  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  No other vaccine was given.   It was a case of actual medication error due to product storage error and product distribution issue.  it was reported that patient received a Fluzone Quadrivalent after 2 days of shipping which were not viable.  At the time of report no adverse events were observed.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: 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.
Patient walked into clinic - left arm from elbow to shoulder red, swollen, warm to touch.  Seen by physician - child treated with TYLENOL and antibiotics - child to follow up in clinic tomorrow.
fever of 100-103 degrees Fahrenheit lasting 48 hours, measles-like rash predominantly on forehead and cheeks. spread slightly to chest, back, and stomach.
with first injection muscle was toxic for 36 hours, T t 100, diffuse myalgias, arthritis, felt miserable, slept 36 hours as couldn't lift head even to drink water.  Second injection was toxic for 36 hours  , T t 100, diffuse myalgias, arthritis, felt miserable, slept 36 hours,also temp of 100.4. When I could drink I took a tylenol.   questionaire did not  ask, but I had covid in mid August
ON 11/14/21 IN THE EVENING CLIENT NOTICED HIVES ON NECK AND SCALP.  ON 11/16/21 CLIENT HAD INTENSE HIVES ALL OVER HER BODY, FELT TIGHT IN THE CHEST, HAD SWOLLEN JOINTS.  WENT TO THE ER TREATED WITH IV SOLU MEDROL, BENADRYL.  ZYRTEC AND PEPCID.  DISCHARGED ON PEPCID AND PREDNISONE.  REFERRED TO AN ALLERGIST. HAS APT DEC 3RD. WASN'T AWARE OF ANY NEW FOODS OR PRODUCTS THAT COULD HAVE CAUSED THIS REACTION.  SAID SHE DID HAVE SOME SWOLLEN GLANDS IN HER NECK AFTER HER SECOND MODERNA.  11/05/2021  DOSE WAS A BOOSTER, 0.25 CC.
bumpy, raised, red rash at injection site; bumpy, raised, red rash at injection site; Injection site redness; Injection site warm; Injection site sensitive to the touch; Discomfort; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2019, 1 days after receiving Shingrix, the patient experienced injection site rash, injection site swelling, injection site erythema, injection site warmth, injection site hyperesthesia and injection site discomfort. The patient was treated with non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site rash was recovering/resolving and the outcome of the injection site swelling, injection site erythema, injection site warmth, injection site hyperesthesia and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site rash, injection site swelling, injection site erythema, injection site warmth, injection site hyperesthesia and injection site discomfort to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on right arm. The caller reported that an evening before the reporting date, she experienced a bumpy, raised, red rash around the injection site area that was warm and sensitive to the touch. The caller reported that she used cold compress on it and that helped with discomfort. The caller reported that rash had improved some on the reporting date but was still present. The reporter consented to follow up.
PATIENT CAME TO THE PHARMACY TO INFORM THAT AFTER GETTING THE SHINGRIX VACCINE HE HAD ACHES AND PAIN, NAUSEA, FEVER, DIASTOLIC BLOOD PRESSURE OVER 200 AND RASH AT THE SITE OF INJECTION. HE WENT TO THE ER AND GOT TREATMENT. NOW HE IS DOING WELL.
Pregnant at 8 weeks, 5 days at time of second dose. 10:45am 4/15/21: Received 2nd dose.  7pm 4/15/21: 102 fever, restlessness. 2-3 max doses of Tylenol were taken.  Fever kept at 102  5am 4/16/21: fever broke  4/16/21: Exhaustion, achy lasted for the day 4/17/21: vaginal bleeding for the day 4/18/21: no symptoms 4/19/21: visited obgyn: baby checked, no signs of complications  Evening 4/19/21: vaginal bleeding began again 4/20/21: visited Obgyn: ultrasound, found sub chorionic hematoma
Muscle aches, fever, headache, chills, fatigue, nasal congestion and cough. Symptoms developed and worsened over 3 days. Tested positive on day three (August 5). Had a virtual visit with PCP who prescribed Paxlovid. Started Paxlovid on day three of symptoms (August 5) and felt better within hours of first dose. Completed a five day course of Paxlovid treatment on August 9. Continue to feel tired, have occasional cough and nasal congestion.
Fatigue, Nausea, sweats.  No improvement with acetaminophen.
allergies; she had sneezing; her nose was running; sinus problems on her right side; headache/ bad headache on her right side by her right eye the headache was about a 10 on the pain scale; arm discomfort; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergies), SNEEZING (she had sneezing), RHINORRHOEA (her nose was running), SINUS DISORDER (sinus problems on her right side) and VACCINATION SITE PAIN (arm discomfort) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary biliary cholangitis. Concomitant products included SIMVASTATIN (ZOCOR), DILTIAZEM, LEVOTHYROXINE, URSODIOL, ISOSORBIDE and OBETICHOLIC ACID (OCALIVA) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm discomfort). On an unknown date, the patient experienced HYPERSENSITIVITY (allergies), SNEEZING (she had sneezing), RHINORRHOEA (her nose was running), SINUS DISORDER (sinus problems on her right side) and HEADACHE (headache/ bad headache on her right side by her right eye the headache was about a 10 on the pain scale). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergies), SNEEZING (she had sneezing), RHINORRHOEA (her nose was running), SINUS DISORDER (sinus problems on her right side), VACCINATION SITE PAIN (arm discomfort) and HEADACHE (headache/ bad headache on her right side by her right eye the headache was about a 10 on the pain scale) 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.   Fist vaccine was given on 28APR2021, the same day she had arm discomfort. A few days later patient reports she has headaches and sinus problems on her right side. Is this normal? Last Friday, 21MAY2021, the patient got a bad headache on her right side by her right eye, the headache was about a 10 on the pain scale. She took a baby aspirin and the pain went away. Yesterday, the patient went to her family doctor, for her allergies, she said she had sneezing, and her nose was running.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI followUp
PATIENT FELT FAINT, SHAKY AND NAUSEOUS.  BP 81/38 PULSE 99. PT LOST CONCIOUSNESS, (OVER 5 TO 10 MINUTE TIME)
did get shingles after those shots/ Suspected Vaccination Failure; get shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: did get shingles after those shots/ Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: get shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 05-MAR-2023 This case was reported by a patient friend via interactive digital media. The reporter reported that, one can still get shingles with the vaccine, but it is usually a very milder case. The reporter had three friends who did get shingles after those shots. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting This case had been linked with US2023AMR038930, US2023AMR038934 reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR038930:Same reporter
Very high blood pressure,sagging of left eye and mouth.  Facial bruising and vision problems with facial numbness.
Patient states felt some feeling in her mouth. Itchy throat. No shortness of breath. vital signs were stable. Slightly diaphoretic and hot. Had on coat and head scarf. Opened coat. Observed for 15 minutes. Symptoms resolved.
Received Tdap 01-07-19 on 01-09-19 noted redness, itching, swelling below injection site. Using Ibuprofen as needed for pain/edema. ZYRTEC as well. Advised to also add famotidine as needed. Apply ice. Notify office if any worsening SSX.