chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body ache; Fatigue; Swollen lymph nodes under left arm; Chills; low grade fever; bruise on left arm just under injectionsite.; This is a spontaneous report from a contactable healthcare professional, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 25Mar2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa (sulfonamide drugs). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included norethisterone acetate, ethinylestradiol, ferrous fumarate (BLISOVI 24FE) taken for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 04Mar2021 at 10:30  (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 26Mar2021, the patient experienced chills with low-grade fever after 14 hours of vaccination. On 27Mar2021 after 18 hours of vaccination, the patient experienced fatigue and body ache, a swollen lymph node under the left clavicle. On an unknown day in Mar2021, the patient had a bruise on the left arm, just under the injection site which was present about 20 hours after vaccination. Therapeutic measures were taken as a result of chills with low-grade fever, fatigue, body aches, swollen lymph nodes, bruise on the left arm and included treatment with ADVIL. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events low-grade fever was resolved on 27Mar2021 after a duration of 6 hours and bruises was recovered on an unknown day in Mar2021; chills was recovering; while the events of fatigue, body ache, swollen lymph nodes were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
HOSPITALIST HISTORY AND PHYSICAL  DATE OF ADMISSION: 3/15/2021   DATE OF H&P:  3/16/2021   PATIENT DEMOGRAPHIC: 71 year-old female  MODE OF ARRIVAL: EMS. _____________________________________________________________  CHIEF COMPLAINT: Dyspnea and mild cough.  HISTORY OF PRESENT ILLNESS: 71 year-old T2 diabetic female who presented to the ED late yesterday for evaluation of increasing shortness of breath. Also, reports she's had a nonproductive cough for several days. Yesterday, her breathing just sufficiently severe that she could not walk through the house without stopping to catch her breath. No chest pain. She ultimately decided to summon EMS. They reported that her initial SaO2 values to be in the low to mid 80% range. She was placed on 2 L/min of supplemental oxygen and given a SABA updraft in route.  When she arrived at the ED, her SaO2 registered 92%. She denies any prior history of asthma or COPD.  No ischemic or valvular heart disease. No history of CHF. No orthopnea. No pedal edema. No high fever. Of note, she completed her second COVID19 vaccination approximately 10 days prior to onset of her chief symptoms as described. In the ED, her chest x-ray was felt to show no evidence of acute cardiopulmonary disease. Her d-dimer was normal. However, a CTA of the chest revealed extensive centrilobular ground-glass nodularity throughout the lungs. No pulmonary embolus or signs of right heart strain. Patient admitted with atypical pneumonia/pneumonitis and associated dyspnea, cough and hypoxemia.  ASSESSMENT: 71-year-old T2 diabetic with hypertension presents with increasing shortness of breath and nonproductive cough, onset approximately 10 days post second COVID-19 vaccination. CTA of chest reveals an atypical pattern of extensive centrilobular ground glass nodularity. Clinically she has associated mild bronchospasm and hypoxemia.
Restlessness, extreme muscle fatigue, physical exhaustion. Partial loss of mental clarity.
Severe Reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE REACTION (Severe Reaction) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced ADVERSE REACTION (Severe Reaction). At the time of the report, ADVERSE REACTION (Severe Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were received by the reporter. Treatment medication for these events were not reported by the reporter.
Myalgia, Fever, severe fever despite tylenon excedrine and nsaids and intractable myalgias and pain led to a 4/15 ER visit. Patient was treated with ivf, tyleno and improved with steroids Narrative: Employee developed a fever of 102 despite antipyretics, had severe very painful myalgias not allowing sleep and generalized pain. She was seen in the ER 4/15 , diagnosed with a strong immunologic reaction and improved after additional tylenol, iv fluids and steroids. She was issued a prescription for more steroids and informed that she has a stong inflammatory reaction. No other conditions identified. feeling better currently
pt recvd vax & 12-15 hrs & exp asthma & bronchospasm;
pediatric patient that inadvertently received a second dose of influenza vaccine this season, no adverse event; Initial information received regarding an unsolicited valid non-serious case received from a pharmacist and was transmitted to Sanofi on 06-Nov-2019.  This case involves a pediatric patient who inadvertently received a second dose 0.5 ml of influenza quadrival a-b vaccine [Fluzone Quadrivalent], pre-filled syringe UT6645LA via intramuscular route in arm on 05-Nov-2019. The patient had received first dose of Influenza vaccine (unknown manufacturer) (dosing details unknown, batch number not reported) via unknown route an site on an unknown date this year.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to Inappropriate schedule of vaccine administered.   No adverse event reported.  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 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.  Information on the batch number was requested.
super numb and tingling everywhere; muscles in her face were kind of frozen; sore arm at the injection site; feel strange throughout body; right side of body felt tingly, numb, and paralyzed; swollen neck glands under jaw and right side of neck; Blood pressure elevated; Right side of her neck hurt; Arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site), FEELING ABNORMAL (feel strange throughout body), HYPOAESTHESIA (right side of body felt tingly, numb, and paralyzed), LYMPHADENOPATHY (swollen neck glands under jaw and right side of neck) and BLOOD PRESSURE INCREASED (Blood pressure elevated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism (The patient has a past medical history of Hypothyroidism.) and Rubella (The patient has a medical history of Rubella several times.). Concurrent medical conditions included Blood pressure increased (The patient reported elevated blood pressure after vaccination.), Allergy to plants (Tree), Allergy to nuts (Brazil nut) and Fruit allergy (Cantaloupe). Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site), FEELING ABNORMAL (feel strange throughout body), HYPOAESTHESIA (right side of body felt tingly, numb, and paralyzed), LYMPHADENOPATHY (swollen neck glands under jaw and right side of neck), BLOOD PRESSURE INCREASED (Blood pressure elevated), NECK PAIN (Right side of her neck hurt) and PAIN IN EXTREMITY (Arm pain). On an unknown date, the patient experienced PARAESTHESIA (super numb and tingling everywhere) and MUSCLE DISORDER (muscles in her face were kind of frozen). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Pain, at an unspecified dose and frequency. On 23-Jan-2021, VACCINATION SITE PAIN (sore arm at the injection site), FEELING ABNORMAL (feel strange throughout body), HYPOAESTHESIA (right side of body felt tingly, numb, and paralyzed), BLOOD PRESSURE INCREASED (Blood pressure elevated), NECK PAIN (Right side of her neck hurt) and PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, LYMPHADENOPATHY (swollen neck glands under jaw and right side of neck) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Blood pressure measurement: elevated abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-13282, MOD-2021-138693 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Recovery date of lymphadenopathy updated.
swollen, firm, and there was a lump; red rash that was itchy on her injection arm just below the site of injection; red rash that was itchy on her injection arm just below the site of injection; red rash that was itchy on her injection arm just below the site of injection; swollen, firm, and there was a lump; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE NODULE (swollen, firm, and there was a lump), VACCINATION SITE PRURITUS (red rash that was itchy on her injection arm just below the site of injection), VACCINATION SITE ERYTHEMA (red rash that was itchy on her injection arm just below the site of injection), VACCINATION SITE RASH (red rash that was itchy on her injection arm just below the site of injection) and VACCINATION SITE SWELLING (swollen, firm, and there was a lump) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE NODULE (swollen, firm, and there was a lump), VACCINATION SITE ERYTHEMA (red rash that was itchy on her injection arm just below the site of injection) and VACCINATION SITE RASH (red rash that was itchy on her injection arm just below the site of injection). 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (red rash that was itchy on her injection arm just below the site of injection) and VACCINATION SITE SWELLING (swollen, firm, and there was a lump). At the time of the report, VACCINATION SITE NODULE (swollen, firm, and there was a lump), VACCINATION SITE PRURITUS (red rash that was itchy on her injection arm just below the site of injection), VACCINATION SITE ERYTHEMA (red rash that was itchy on her injection arm just below the site of injection), VACCINATION SITE RASH (red rash that was itchy on her injection arm just below the site of injection) and VACCINATION SITE SWELLING (swollen, firm, and there was a lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided.
9 doses were administered post excursion; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported. Storage condition at the time of the excursion was frozen. Temperature noted in that condition was -2 to -18 C. Excursion duration was for 2hrs. The vial belongs to one of the following batch numbers AR9236B, Exp date: 22-Aug-2023 / AS1903B, Exp date: 14-Jun-2023 / AS7170B, Exp date: 09-Jun-2023.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Live Significant follow-up received: New events added and Narrative was updated
Site: Bruising at Injection Site-Mild, Additional Details: when the shot was given little bit of blood came out and pt reported that she was about to faint and had some water, so I called the minute clinic nurse practioner she checked her pulse and blood pressure, 1st her blood pressure was low and then after 5 to 10min her blood pressure was good, her vitals are ok. Then she returned home , called and checked on her after sometime and she said she is doing good, she said she excerises and bike a lot, so her heart rate is usually low.
Injection site looked like she got burned in her arm; Injection site was red; Hot injection site; She believed vaccination was not given in center of her deltoid; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot injection site), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (She believed vaccination was not given in center of her deltoid), VACCINATION SITE SWELLING (Injection site was swollen), VACCINATION SITE PAIN (Injection site looked like she got burned in her arm) and VACCINATION SITE ERYTHEMA (Injection site was red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 VACCINATION SITE WARMTH (Hot injection site), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (She believed vaccination was not given in center of her deltoid), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site was red). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site looked like she got burned in her arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and MEFENAMIC ACID (ADVIL [MEFENAMIC ACID]) at an unspecified dose and frequency. On 26-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (She believed vaccination was not given in center of her deltoid) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE SWELLING (Injection site was swollen), VACCINATION SITE PAIN (Injection site looked like she got burned in her arm) and VACCINATION SITE ERYTHEMA (Injection site was red) had not resolved.            No concomitant medications were reported  The symptoms lasted for 3 or 4 days before it subsided. A week later, the symptoms returned.  Action taken with mRNA-1273 in response to the events was not Applicable.    This case was linked to MOD-2021-059689 (Patient Link).
3-4 days after the first vaccine I had itchy neck and slight redness. Also, under the eyes I had small red patches that were mildly itchy. It went away after about a week.   4 days after the 2nd vaccine, in those same spots I experienced swelling, redness, itch.  6 days after the 2nd vaccine shot, my primary physician prescribed 3 doses of prednisone and Benadryl to alleviate the itch. Swelling and redness subsided but very mild itch was till there. On 04.05.21 (18 days after the 2nd shot) my face and neck swell up and are red and itchy. I also feel itchy ob my legs and beck. Benadryl did not help.
This case was reported by a healthcare professional and described the occurrence of burning feeling in cheek in a 27-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included upper respiratory infection. There were no concurrent medications. On 14 January 2011 at 10:00 the subject received unspecified dose of ENGERIX B (unknown route, left deltoid). On 14 January 2011, less than one day after vaccination with ENGERIX B, the subject experienced burning sensation of cheeks. There was no further information provided at the time of reporting. At the time of reporting, the outcome of the events was unspecified.
No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker referring to a 21-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-FEB-2023, the patient was vaccinated with 1 dose (dosage form) of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #w020525, expiration date: 14-DEC-2023 for prophylaxis (strength and route of administration were not provided) (product storage error). The vaccine was exposed to 30 degrees Fahrenheit for 3 hours 15 minutes. There was no previous excursion. No additional adverse events (AEs) were reported (no adverse event).
Within 2 min after administering vaccine (IXIARO), pt complained of pain at injection site and dizziness. Blood pressure was measured to be 72/48 and pulse 40 and temp. 97.9. Patient laid on ground and was given water, glucose (INSTA-GLUCOSE) and recovered approximately 30 min later. Follow up BP 103/67, pulse 53.
BRUISE IN LEFT GROIN; BUMP IN LEFT GROIN; MIGRAINE; HAMSTRING AND QUADRICEP PAIN; MAJOR ARM PAIN; INTERMITTENT HEADACHES; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031,expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included norethisterone.  On APR-2021, treatment medications included: acetylsalicylic acid, ibuprofen, and paracetamol. On 09-APR-2021, the subject experienced intermittent headaches. On 09-APR-2021, the subject experienced sore arm at injection site. On 14-APR-2021, the subject experienced major arm pain. On 19-APR-2021, the subject experienced migraine. On 19-APR-2021, the subject experienced hamstring and quadricep pain. On 24-APR-2021, the subject experienced bruise in left groin. On 24-APR-2021, the subject experienced bump in left groin. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 20-APR-2021, major arm pain on 17-APR-2021, and sore arm at injection site on 16-APR-2021, was recovering from hamstring and quadricep pain, bruise in left groin, and bump in left groin, and had not recovered from intermittent headaches. This report was non-serious. This case, from the same reporter is linked to 20210458898.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
After the vaccine I had the normal side effects sore arm and slight fatigue. I went to have my schedule labs done my iron levels start dropping and I am at risk for becoming a anemic.
9-5-14 c/o of "knot" of (R) deltoid 1-2 days then swollen lymph gland near (R) collar bone 5-6 days post vaccine. T=98.9. No other systemic side effects.
Vesicles & papules, itchy, developed on rt anterior chest and upper arm.Seen 12/2 & 12/6; appears to be a mild case of shingles.Zovirax was given on 2nd visit.
Pt. states received the Moderna 1st shot 05/12/2021, 3 weeks later started experiencing difficulty walking, muscle mass narrowing. Fell in home 07/04/2021 ER visit. 21 days hospitalized and diagnosed with Lou Garrett Disease. Prescribed HBP pills, muscle relaxers.
arm is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient had the shingles vaccine about a month ago. The patient reported that the patient's  arm was killing. The patient's asked how long should it hurt for?
48 hours post vaccination, injection site grew red, raised, itchy, and warm to the touch. 48 - 60 hours later the injection site had flattened out and had a slight purple "bruise like" coloration. After an additional 48 - 60 hours after injection site had flattened, redness, warmth, itchiness, and raised appearance returned.
Shingles- developed on 1/2/2021.  I did not know that I had the shingles when I took the vaccine on 1/5/2021.  I have never had the shingles, I thought it was a rash. I have allergies, have been known to develop dermatitis occasionally. Diagnosed with shingles by my primary care provider on 1/6/2021.  Also went to Ophthalmologist as a precaution since the  area around my left eye was affected.  Primary care doc prescribed Valtrex (7 day regimen).  As of today 1/29, I have residual nerve itching, skin is healed. Some nerve pain.