chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash /Hives all over the body. Itchy for approximately 3 days.; Rash /Hives all over the body. Itchy for approximately 3 days.; Rash /Hives all over the body. Itchy for approximately 3 days.; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP6955), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing Type 1 Diabetes, sleep apnoea syndrome from an unknown date and unknown if ongoing Sleep Apnea, drug hypersensitivity sulfa from an unknown date and unknown if ongoing. Concomitant medications included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient experienced rash /hives all over the body, itchy for approximately 3 days. On 10Mar2021 pruritus 20:00, rash /hives all over the body, itchy for approximately 3 days, rash, rash /hives all over the body, itchy for approximately 3 days, urticaria. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
patient filled out all paperwork for vaccine. Was told it was Moderna Vaccine for COVID. Given all Information on Moderna. After vaccine was administer patient Informs pharmacist here needed COVID test not vaccine Pharmacy gave patient a free (BinaxNow) Pharmacy tech assisted Patient with covid test. Test came back negative Event is patient Never stated they were in for Covid test. patient Never stopped Pharmacist from giving them the Moderna Vaccine.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date in April 2019 (reported as last week), the patient received her first dose of GARDASIL 9 injection via subcutaneous route (incorrect route of product administration) for prophylaxis (lot number, expiry date unspecified). The dose of GARDASIL 9 was not administered into her deltoid muscle, it was administered into subcutaneous area in the back her arm. On an unknown date in April 2019 (reported as 4 days later), the patient developed a lump on her arm (limb mass). No product quality complaint (PQC) was involved. The outcome of lump on her arm was unknown. Reporter causality was not provided. No additional information provided.
Moderna COVID-19 Vaccine EUA: patient in clinic for follow-up of  left shoulder/arm pain starting right after immunization. Patient evaluated that day in the emergency department (ED), administered analgesics, and pain improved. Noted to be hyponatremic and blood glucose increased and was administered intravenous fluids. Patient discharged rom ED stable. On follow-up symptoms have resolved.
Pt found sitting in chair, c/o lightheadedness and faint; in approx 20 seconds, pt fell back in chair, eyes closed, unresponsive; pt placed on floor and within 15 seconds was opening her eyes and following commands; pt diaphoretic, warm; Initial VS w/Dinamap were 148/111, HR 192, SaO2 100, RR 20; ausculated HR was 60 and regular about one minute later; ammonia inhalants used and pt became more awake; second set of VS: 90/49, HR 62, RR 18; pt sleepy, responds appropriately, oriented x3; pt helped into wheelchair and placed on exam table; no changes in status; third set VS 94/53, HR 55; sister with pt in exam room; fourth set of VS at 1825 94/53, HR 61, pt now rubbing her chest and states she is feeling pressure there that started approx 15 mins ago, pt in no distress, states that she is still "feeling out of it"; 911 called at 1828; pt states that she has anxiety and has had panic attacks in the past (last one approx one year ago) and that how she is feeling now reminds her of that; pt taken by FD at 1844, report given.
Vomiting. Dizziness about one hour after shot (also after taking medications) (felt better several hours later).
SEVERE shingles: pain, rash around torso from sternum around right side of torso to spine. An additional shingles site occurred on right side of head, behind ear: pain, rash Present symptoms after a month : rash, pain, extensive post herpetic neuropathy Medications: valacyclovir, tylenol with codeine, neurontin, homeopathic, cranial sacral adjustments, homeopathic creams, prednisone, ice
Welt raised, red and hot it was 3 1/2 x 2 inches. this started a week after the injection
This spontaneous report was received from a registered nurse and refers to a currently 16 months old child patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ, lot # M007307, expiration date 30-NOV-2017 ,for prophylaxis (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0.8 degrees Fahrenheit for 24 hours and 30 minutes. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1802USA003853: US-009507513-1801USA013280:
1/29/08 Received phone call from patients father. Patient c/o right arm being sore from where Menactra was administered. Father noted area to be tender, slightly red, warm to touch and appears has a pustule type area in the center. I advised to use warm compresses, and contact physician. Apparently the area had been somewhat tender since administration, but patient had not informed a family member. 1/31/08 Spoke with father. Patient used warm compresses for a very short time. Did not contact physician as of yet. 2/6/08 Contacted by father.  Father contacted family physician's office. They issued patient a script for a 10 day supply of a sulfa based antibiotic on Friday 2/1/08. The spot on her right arm is smaller and is now cool to the touch.  "It looks like it is clearing up" per father's statement.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. There was no product quality issues.  Company comment- This case concerns a 77-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report; Sender's Comments: This case concerns a 77-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report
Red rash on his chest, back, both legs, both arms, groin area; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 20th August 2019, 4 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was not recovered/not resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient started to develop a red rash on his chest, back, both legs, both arms, groin area at the time of reporting. The reporter consented to follow up.
Debilitating pain in left arm (the one that received the shot). Difficulty lifting or using it. Started roughly 2 hours after vaccination and lasted for 2-3 days. Swelling in lymph nodes in left armpit. Started about a week after vaccination and lasted for 2-3 days. There is no personal history of swollen lymph nodes in armpits.
reaction to the second injection a week after; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the second injection a week after) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the second injection a week after). At the time of the report, VACCINATION COMPLICATION (reaction to the second injection a week after) outcome was unknown. Not Provided          No Concomitant medications was provided.  No Treatment medications was provided.
Public Health Nurse gave MD wrong dose/type of H1N1. Patients should have received 0.25 ml preserv free and instead she gave MD 0.5 ml H1N1 with preservative. Sanofi UP013AA multi dose vaccine.
arm get a little sore / feels a little sore; numbing sensation under her underarm that went up to the right side of her neck / right side jaw felt a little bit number; kind of sleepy; a little tired like you just want to lie down and sleep / a little fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm get a little sore / feels a little sore"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbing sensation under her underarm that went up to the right side of her neck / right side jaw felt a little bit number"; SOMNOLENCE (non-serious), outcome "unknown", described as "kind of sleepy"; FATIGUE (non-serious), outcome "unknown", described as "a little tired like you just want to lie down and sleep / a little fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Employee had fevers x 1 day about 12 days post vaccine (given 8/12). On 9/30, pt started a generalized vesicular itching rash - treatment- off duty from work and Calamine lotion, ice antihistamine.
headache; dehydrated; debilitated; sleeping; aching; couldn't eat; 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 ASTHENIA (debilitated), SOMNOLENCE (sleeping), MYALGIA (aching), FEEDING DISORDER (couldn't eat) and HEADACHE (headache) in a patient of an unknown age and gender 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 Multiple sclerosis.    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 ASTHENIA (debilitated), SOMNOLENCE (sleeping), MYALGIA (aching), FEEDING DISORDER (couldn't eat), HEADACHE (headache) and DEHYDRATION (dehydrated). At the time of the report, ASTHENIA (debilitated), SOMNOLENCE (sleeping), MYALGIA (aching), FEEDING DISORDER (couldn't eat), HEADACHE (headache) and DEHYDRATION (dehydrated) outcome was unknown. Not Provided          No concomitant medications provided.   Reporter did not allow further contact
pt recv vax & exp myalgias, fever, rash & fatigue; This is in follow-up to report (s) previously submitted on 10/19/1997, 1/16/1998. Information has been received from a health care professional concerning a 27-year-old female registered nurse who on 06AUG97 was vaccinated with the first dose of VARIVAX vaccine. Concomitant vaccination included MMRII vaccine. On 26AUG97 the patient experienced a generalized rash "over her entire body" which started as "red mosquito-bite-like" papules and some progressed to vesicles "which crusted over". She also developed myalgias, fever, and fatigue. The patient was "potentially diagnosed with varicella manifestation" and was treated as an outpatient with pallative treatment such as antihistamines, analgesics and rest. Subsequently, the patient recovered. It was reported that the plan was to "check antibody levels (serum) before giving booster vaccine". No further details were provided. This is an amended report. Vaccine administration information has been added. The manufacturer of "M-M-R II" was added and the narrative was updated accordingly.
total scalp area, ear to ear became sore to touch. Minor headache was infrequent. Several days later the tender scalp receded to the right side only. Unable to sleep but in one position. The soreness has now traveled to include my right eye socket. Dr unable to determine a fix.
p/vax 1JUN98 T99.4 10AM, awoke 2JUN98 c/o pain in rt deltoid area @ inj site;on exam arm is swollen w/marked erythema;rx elevation, cold compress & advil;
Developed hives on back, itching in pharynx. Oral cavity assessed and normal.  Given benadry 25mg po x1 dose, dose repeated later in the evening.  Hives resolved
vaccine at 10:20am on 2/20/21 temperature, chills, headache, tiredness started 1am 2/21/21 lasted about 24hrs highest temperature 101.4 degrees symptoms not enough to warrant doctor visit May have had COVID19 in January 2020.  Had migraines (never had before), temperature, no taste, smell, extremely tired 2 wk recovery.  No test given due to newness of Covid.
Information has been received from a pharmacist concerning a female patient who on 05-MAY-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine. On 06-MAY-2008, the patient experienced a sinus infection. A second doctor prescribed clarithromycin for sinus infection. The patient sought unspecified medical treatment. Follow up information indicated there was no adverse event, the pharmacist called because he wanted to know if taking the clarithromycin would effect the vaccine.
REDNESS UNDERNEATH EYES AND CHEEKBONES; SWELLING UNDERNEATH EYES AND CHEEKBONES; ITCHY; RASH ON NECK/ARM/DIFFERENT PARTS OF THE BODY; This spontaneous report received from a physician concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high cholesterol, alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-OCT-2021, the patient experienced rash on neck/arm/different parts of the body. On 05-DEC-2021, the patient experienced redness underneath eyes and cheekbones. On 05-DEC-2021, the patient experienced swelling underneath eyes and cheekbones. On 05-DEC-2021, the patient experienced itchy. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on neck/arm/different parts of the body, redness underneath eyes and cheekbones, itchy, and swelling underneath eyes and cheekbones. This report was non-serious.
This case was reported by a physician via sales rep and described the occurrence of facial swelling in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced facial swelling, eye swelling, lip swelling and general body pain. On an unknown date, the outcome of the facial swelling, eye swelling, lip swelling and general body pain were unknown. It was unknown if the reporter considered the facial swelling, eye swelling, lip swelling and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter agreed to be contacted for follow up.
Moderate to severe allergic reaction, arm swelling, itching, redness, difficulty raising arm, fever, chills, nausea, elevated heart rate, and asthma attack.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 27-APR-2018, the patient was vaccinated with a dose of M-M-R II via intramuscular route (dose, lot number and expiration date were not reported) instead of subdermal route. No adverse effects were reported.
Dose administer from punctured vial after 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administer from punctured vial after 12 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administer from punctured vial after 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administer from punctured vial after 12 hours) had resolved.        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 reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional patient and vaccine information received and Reporter information updated
Vx given after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In SEP-2022, the patients received Boostrix. In SEP-2022, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Vx given after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 13-MAR-2023 The reporter reported that Boostrix vaccines had been out of temperature range since September 2022 and had been administered to various patients since. The reporter did not consent to follow-up. Information about patients and lot number for vaccine requested and declined, health care professional said it was not available. At the time of reporting, Boostrix was given to various patients after temperature excursion, which led to incorrect storage of drug.
Some minor pain, redness, and swelling starting about 5 hours after shot and continuing for 1-2 days. Then pain, redness, and swelling went away. Only a small red dot remained at injection site. Then about 1 week later I noticed pain when touching right arm in injection site area with an approximate quarter sized red area and slightly larger than that swollen area around injection site. Now 2 days after noticing that, the red area is getting bigger (about inch and a half diameter) and the swollen area has gotten larger (about two and a half inches in diameter), so I'm having my husband report it for me. I have not used anything to treat this, might try ice today.
Vaccines administered 9/22/03. T 99 this AM and faint erythema, maculo-papular rash trunk and upper extremities.
IMMEDIATELY AFTER GETTING SHOT BECAME LIGHTHEADED - THEN FELT NUMBNESS/TINGLING SENSATION ON TONGUE & THROAT
Patient had a seizure while in the observation area. It was witnessed by staff and EMS was on site. Seizure activity lasted 15 seconds and patient became conscious, alert, and oriented within 5 minutes of being post seizure. Patient refused transport to the hospital after being evaluated by on site paramedics.
dry tickle type cough; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on 30Apr2021 13:30  (at the age of 52 years old) (Lot Number: ER8737) as dose 2, single for COVID-19 immunisation. Medical history included arrhythmia and penicillin allergy from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included esomeprazole magnesium (NEXIUM); metoprolol, Vitamin D; cyanocobalamin (VIT B12); glucosamine; all taken for an unspecified indication, start and stop date were not reported. The patient took the first dose of BNT2B2 on 09Apr2021, administration time: 04:00 PM, anatomical Location: Arm Right, Batch/lot number: ER8737 (at the age of 52 years old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06May2021, the patient experienced dry tickle type cough. Patient felt like it comes from the middle of her chest. The event was reported as non-serious. The patient was not hospitalized. No treatment was given for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.   No follow-up attempts are need. No further information is expected.