chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness on arm; Sleepy; swelling in that arm; hot to touch; hardly lift my left arm; Fatigue; Chills; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jun-2021 and was forwarded to Moderna on 13-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on arm), SOMNOLENCE (Sleepy), SWELLING (swelling in that arm), SKIN WARM (hot to touch) and LIMB DISCOMFORT (hardly lift my left arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine (swelling in arm; redness at  the site for about 3 weeks; 4 inch diameter; hot to touch) in 2008 and Flu vaccine (swelling in arm; redness at the site for about 2 weeks; 3 inch diameter; hot to touch) in 2020. Concurrent medical conditions included Wasp sting (stung on bottom of right foot and leg was swollen and red to the knee in 5 mins; required emergency room visit and follow-up care/rx) since 1985, Bee sting (stung on left forearm; arm swelled really quickly and was taken to doctor immediately; treated and rx) since 1984, Hypersensitivity reaction, Hay fever, Hives, Hypertension since 1994, High cholesterol since 2003 and Drug allergy (allergic reaction verified by doctor; rash/hives on stomach) since 2011. Concomitant products included SIMVASTATIN for High cholesterol, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) and METOPROLOL TARTRATE for Hypertension.    On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness on arm), SOMNOLENCE (Sleepy), SWELLING (swelling in that arm), SKIN WARM (hot to touch), LIMB DISCOMFORT (hardly lift my left arm), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (fever). On 13-Jun-2021, ERYTHEMA (Redness on arm) and FATIGUE (Fatigue) had resolved. At the time of the report, SOMNOLENCE (Sleepy), SWELLING (swelling in that arm), SKIN WARM (hot to touch), LIMB DISCOMFORT (hardly lift my left arm), CHILLS (Chills) and PYREXIA (fever) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ERYTHEMA (Redness on arm), SOMNOLENCE (Sleepy), SWELLING (swelling in that arm), SKIN WARM (hot to touch), LIMB DISCOMFORT (hardly lift my left arm), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (fever) to be possibly related.    As treatment medication, the patient started taking Benadryl (25 mg/8 hours) on April 28, 2021. The patient still continues to take Benadryl.     Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Nonsignificant FU Appended
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-DEC-2014 the patient was vaccinated with ROTATEQ (oral dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
30 mins after injection arm pits on fire (lasted 12 hours) Chills and body aches started 4 hours after injection and lasted 2 days.  NO fever. 2 days after injection developed rash on chest, back, arms and head.  Rash lasted 2 days.  NO hives.  Rash was itchy
Information has been received from a healthcare professional concerning a 45 month old female with no known medical history or allergies who on 2/1/02 was vaccinated in her right leg with a first dose of varicella virus vaccine live (lot # 638249/0426L). Concomitant vaccination that day included a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (lot # 484202) in her left leg. There was no illness at the time of vaccination. On 10/29/04, the patient experienced low grade fever and a rash. The patient was seen in the office on 10/30/04 with 50 to 80 lesions. No treatment was required. The patient had no adverse events following prior vaccination. There was no product quality complaint involved. Follow up information from a healthcare professional indicated that on 10/28/04 the patient developed a pustule looking rash on her back, arms, and legs with approximately 50 which began drying up the following day. It was reported that she was afebrile. Subsequently, thee patient recovered. Additional information is not expected.
This spontaneous report was received from a nurse and refers to a female patient of 5 years old. No information regarding the patient pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-AUG-2016, the patient was inadvertently vaccinated with improperly stored doses of VARIVAX (lot # M005971 and expiration date: 02-FEB-2018) (dose and route of administration were not reported). No adverse event reported. Additional information is not expected.
Suspected vaccination failure; still have it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In August 2021, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles a week ago from the date of reporting. The patient was on the 2nd round of Antiviral. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
This is a spontaneous report from a contactable nurse (patient). A 43-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0151), at the age of 43, via an unspecified route of administration, in the left arm, on Apr 30, 2021, at 10:15, single dose, for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6206), at the age of 43, via an unspecified route of administration, in the left arm, on Apr 9, 2021, at 16:00, single dose, for COVID-19 immunisation. The patient did not receive other vaccines within four weeks prior to the vaccination. On May 1, 2021, at 21:00, patient experienced sore arm, sore armpit, one episode of nausea, vomiting, generalized body aches, fatigue and tender enlarged supraclavicular lymph node. The events did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of sore arm, sore armpit, one episode of nausea, vomiting, generalized body aches, fatigue and tender enlarged supraclavicular lymph node: resolving (at the time of this report). No follow-up attempts needed. No further information expected.
03-19-19 received vacc. - c/o itching x 2 days. 03-21-19 - c/o localized redness, hot to touch and sensitive to touch - increased swelling (size of softball) also c/o light headedness - mild blurred vision went to ER - Dx with cellulitis - started KEFLEX 500 mg QID.
Moderna COVID-19 Vaccine EUA chills, shivers (shaking so hard couldn't hold anything),  102 degree fever,  face felt like it was burning, headache so bad that head felt like it would explode... lasted 9 hrs
fell, hit head, confusion, memory loss, balance disorder, tremors and shaking, vomiting, headache, high blood pressure, TIA, CVA, aneurysm
In June 2021, I started experiencing multiple extended periods (2 or more hours) of sinus tachycardia with chest pain, shortness of breath, dizziness, weakness, and exhaustion. Prior cardiologist increased beta blocker Metoprolol ER Succinate (was already taking for SVT) for one week and then increased Midodrine the following week. After nonresponsive office I contacted a new cardiologist who ran tests and ordered a 48 hour monitor and continued the higher dosage of both medications. Referred to a Cardiac Electrophysiologist and am now on a 30 day monitor, will review results on December 6th.
Impulsive, easy to anger, out of control, aggressive, fever up to 104 degrees farenheit, fatigued, dizzy, feeling abnormally cold even without fever, headache, anxious, tachycardia, severe nightterrors, insomnia
12/21/2021: 72-year-old female with a history of multiple sclerosis presents to the ED today for weakness and difficulty with her ADLs.  Patient states "I cannot take care of myself anymore "she has had worsening weakness at home. She denies any recent illness, chest pain shortness of breath nausea vomiting diarrhea or difficulty urinating or recent fevers.  And states that she is coming into the ED today because she wants to get placement and cannot take care of herself anymore.
lymphedema in right axilla starting 1 day after second COVID vaccine. Presents to PCP for evaluation and tx. Hasn't been to work due to swelling and pain.
Generalized seizure without fever; went on to have 3 seizures without fever.  Hospitalized.  All tests normal except EEG.  Discharged on Keppra.
fever-low grade starting 8 hrs after injection lasting 36 hrs-99.3-100.5 bilateral axillary tenderness lymph node swelling bilaterally-neck lasting 36 hrs mild headache  eye swelling/itch all symptoms relieved with Benadryl 50-75mg x2 doses and Tylenol 500mgx2
SEVERE PAIN AT INJECTION SITE. PATIENT COULDN'T LIFT ARM WITH LIMITED RANGE OF MOTION. PATIENT FELT BETTER 1 WEEK AFTER IMMUNIZATION, BUT STILL COMPLAINS OF PAIN AND LIMITED RANGE OF MOTION ON ARM RECIEVED VACCINATION ON TILL THIS DATE. PATIENT WILL BE SCHEDULING FOR PHYSICAL THERAPY.
Severe rash and hives occurring all over body: abdomen, belly button, ears, neck, face, front and back of hands, forearms, back, thighs, ankles, feet, scalp.  Itchy, dark red.  Ranging in size from small pinpricks, to watermelon sized splotches. Lasting 2-4 hours in each location, some reoccurring daily in same locations (forearms and hands being most common). Started 12/17/21 and continuing.  Have taken Claritin during daytime, Benadryl at night.  Calamine lotion to help with irritation, but it's not sufficient.  In addition to rash starting on day 11 after Booster shot, side effects from booster on day of vaccination included: arm so severely sore it couldn't be lifted, migraine lasting 20 hours, chills/hot flashes (fever unknown), nausea, vomiting, weakness, swollen lymph nodes under left arm (injection site).  Soreness and swollen lymph nodes lasting 5 days after booster.
ITCHING, REDNESS AND SWELLING AT INJECTION SITRE STARTING 11/6/2014.
respiratory reaction; This spontaneous report was received from a consumer,  referring to a female patient of unknown age. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route, lot# and expiration date were unknown) for vaccination.         On an unknown date, the patient experienced respiratory reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome of respiratory reaction was unknown. The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and respiratory reaction was related.     This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA003984:
On 11/1/00, the pt noticed arm was red and warm to the touch. Pt was recommended treating area with cool compresses and Tylenol.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 63-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 20th February 2018, the patient received the 1st dose of SHINGRIX. On 21st February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling and injection site bruising. On an unknown date, the outcome of the injection site swelling and injection site bruising were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the case for one of his patients. The age at vaccination was not reported. The pharmacist said that the symptoms developed at the site of injection and it was a pretty large area. The symptoms went away in about 4 days.
Information has been received from a physician concerning his mother, a 76-year-old female with sulfonamide allergy who was vaccinated on an unspecified date with a dose of Zostavax. Subsequently, on an unspecified date, about 5 days post vaccination, the patient developed shingles on her lower right flank. The area was about 16"x8" in size. She also had a temperature of 102 degrees fahrenheit, malaise and myalgia. She went to her physician, and fainted in his office. she was hospitalized and diagnosed with shingles, impetigo and fungal super infection. It is also reported that the vaccination caused overwhelming sepsis and bacterial super infection. She was treated with anti-virals, anti-biotics, and anti-fungals. She was released from the hospital after 5 days. It is reported that she is still recovering. No product quality complaint was involved. Shingles, fungal super infection, and impetigo were considered to be disabling, immediately life-threatening and were thought to be other important medical events. Additional information has been requested.  10/26/07 Reviewed hospital nedical records which reveal patient experienced right sided back & shoulder pain followed by rash eruption c/w shingles.  Seen by pcp when developed increased pain & cellulitis secondary to bacterial infection.  Admitted 8/7-8/12/2007.  Tx w/IV antibiotics & antivirals.  ID consult done.  Neuro consult done for near syncopal episode.  Cardiology consult done.  Improved & was d/c to home on continued oral antivirals & antibiotics. FINAL DX: shingles; secondary bacterial infection; electrolyte imbalance; HTN; near-syncope; GERD; fever. READMITTED: 9/14-9/16/2007 as direct admit from pcp offfice s/p labs revealed elevated creatinine. TX w/IVF.  Diuretic d/c'd.    FINAL DX: dehydration, resolved; hypokalemia, resolved; renal insufficiency secondary to dehydration, resolved; anemia, stable; GERD, hyperlipidemia; contact dermatitis (laundry detergent). 11/2/07 Received vax info from pcp & VAERS database updated w/same. Per 60 day follow up: I still have pain in my back where I had the outbreak of shingles. The discoloration on my back is getting a lighter color, but is not completely gone. Please advise me how I might recover the $200.00 I paid form y vaccines-my medical bills and medication was ver expensive.
With initial shot, blood rolled down my arm to my elbow.  I iced my arm every two hours for 15 minutes 4 times.  Arm turned red  at injection point and almost all the way around my arm on the first day.  Huge bruise above the injection point also appeared the first day.  Arm is sore but flexible.  Redness is still there.  This is the fourth day.
Client had no adverse effects from this vaccine. However age indication for this vaccine is 18-64 and client is 72 years of age. Reason for VAERS report is simply due to the fact that client was outside recommended age for vaccine. No adverse effects were experienced by the recipient.
serious reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (serious reaction) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (serious reaction). At the time of the report, VACCINATION COMPLICATION (serious reaction) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.   Reporter did not allow further contact
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Mar2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 05Sep2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05Mar2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received treatment for events with antiviral Paxlovid from 08Aug2022 to 13Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Anaphylactic Shock about 1 hour post vaccination; Hives all over the body; Swollen Throat; Itching all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic Shock about 1 hour post vaccination) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced URTICARIA (Hives all over the body), PHARYNGEAL SWELLING (Swollen Throat) and PRURITUS (Itching all over the body). On 04-Jun-2021 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic Shock about 1 hour post vaccination) (seriousness criteria hospitalization and medically significant). The patient was treated with EPINEPHRINE (EPIPEN) on 04-Jun-2021 for Anaphylactic shock, at a dose of 2 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 04-Jun-2021 for Hives, at a dose of 25 milligram every six hours. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic Shock about 1 hour post vaccination) and PHARYNGEAL SWELLING (Swollen Throat) outcome was unknown and URTICARIA (Hives all over the body) and PRURITUS (Itching all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that as of 07 JUN 2021, the patient still had hives and itchiness.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Tinnitus - significantly increased Brief total failures of hearing in left ear, twice, on the evening of April 21st Swelling in hands - April 26th so swollen was unable to bend right index finger fully Manual dexterity affected - difficulty working with small parts Swelling in ankles and feet - difficulty getting shoes on
N17.9 - Acute renal failure, unspecified acute renal failure type (CMS/HCC) E87.1 - Hyponatremia N17.9 - Acute kidney injury (CMS/HCC)
Flu shot on 12-18-2017. On 1-2-2018, brain fog/brain tightness, low body temperature avg 97.4, eyelid dermatitis. Lab tests on 1-15-2018 revealed elevated alkaline phosphatase of 121 which then normalized by next lab test in 4-2018. Body temperature never rises above 97.8 to present (always had normal body temps before).  Brain fog is constantly present since the flu shot.  MRI of brain was normal on 9-18-2018. CT scan of liver on 7-28-2021 revealed hepatomegaly of 17.5 cm (was normal years earlier).
I feel like I am coming out of a Novocain feeling. my face was numb and in my ear, jawline, nostrils, left eye... everything feels numb.
On 6/21/2019 and was "seen for sore throat, fever from an unspecified cause, and a pruritic rash, with an unspecified etiology"; On 6/21/2019 and was "seen for sore throat, fever from an unspecified cause, and a pruritic rash, with an unspecified etiology"; On 6/21/2019 and was "seen for sore throat, fever from an unspecified cause, and a pruritic rash, with an unspecified etiology"; This spontaneous report was received from a nurse practitioner and refers to a 49-year-old non-pregnant female patient. The patient's pertinent medical history and concomitant therapies were not provided. She had no drug reactions or allergies.  On 07-JUN-2019, the patient was vaccinated with a one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, subcutaneously (lot # R031628 has been verified to be a valid lot number, expiration date was reported as 01-NOV-2020 and was confirmed to be valid expiration date; albumin status: rHA; exact dose and anatomical location were not reported) for measles, mumps, rubella protection. On 21-JUN-2019, she experienced sore throat, fever of unknown origin (reported as unspecified cause) and pruritic rash with an unspecified etiology. On the same date, the patient visited clinic where she received treatment and on the same date, was released. On 22-JUN-2019, the patient was on follow up visit and reported similar complains. During this visit, she was treated and on the same date, was released. On the same date later, the patient visited emergency room (ER) and was admitted to the hospital (the reporter did not know what treatment was given upon admittance). On 25-JUN-2019, she recovered from reported symptoms and was discharged from the hospital.  Causality assessment was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA010772:
Immune mediated thrombocytopenia. Presented with altered mental status, found to have Platelets at 10,000.