chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had palpitations, headache ongoing since he received vaccine. Pt will follow-up with doctor. Pt stated his appointment was on 10/13/00.
Severe body ache; limb stiffness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe body ache) and MUSCULOSKELETAL STIFFNESS (limb stiffness) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN (Severe body ache) and MUSCULOSKELETAL STIFFNESS (limb stiffness). On 17-Jan-2021, PAIN (Severe body ache) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (limb stiffness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Dose administered after the expiration date 05-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after the expiration date 05-Jul-2022) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 prophylaxis.     Allergies (medications, food, and other products) were reported as unknown. It is unknown that patient ever had COVID positive test or diagnosis. Medical History was reported as unknown. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose number) was unknown.     On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after the expiration date 05-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after the expiration date 05-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered with 1st booster dose. No concomitant medications were reported. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. AE caused patient to seek medical care (office visit, Urgent care, ER, hospitalized) was unknown. The patient experienced a similar event in the past was unknown. AE Outcome (recovered, residual effects, ongoing, unknown) was unknown. Symptoms improved or worsened was unknown. No treatment medications were reported.
In March 2022, after tiredness, back pain and brown urine, hospitalized for three days with high liver counts (over 1000) and it took two weeks and a liver biopsy to diagnose with autoimmune hepatitis.  Was put on Prednisone and liver counts have gone down but now have increased BP and now being treated for not only the Autoimmune Hepatitis but Hypertension as well.  Will have to have a total cardiac workup to see exactly what is going on and who knows how long I will have to stay on the Prednisone.  Both of these organs, heart and liver, I never had problems with before and I am attributing to the COVID vaccine.
Large (2") bruise, pain, severe stiffness - pain/stiffness still existing after 14 days, while bruise is now beginning to fade, on 2/23/16.
I lost my sense of smell; The fever and cough that was expected on Saturday; The fever and cough that was expected on Saturday; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809 and Expiration date was unknown), via an unspecified route of administration on an unspecified date in 2021 as unknown dose number, single dose for COVID-19 immunisation. Medical history included Epilepsy, PTSD and traumatic brain injury all from an unknown date and unknown if ongoing. Concomitant medications included lamotrigine (LAMICTAL) taken at a dose of 100 mg; venlafaxine taken at a dose of 150 mg; levonorgestrel (SKYLA) (Intrauterine device) at an unknown dose. Patient stated, she got the Pfizer vaccine on Wednesday and today she lost sense of smell (01Mar2021) and wanted to make sure is that any bit of normal or should she go tested. Stated, the smell was today. The fever and cough that was expected on Saturday (unspecified date in 2021). Patient received treatment for events over the counter thing like Advil and Cough drops and some nasal decongestion. Consumer further stated vaccination date: It was 26. Therapeutic measures were taken as a result of lost my sense of smell, the fever and cough that was expected on Saturday. There was no investigation assessment. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt was given flu shot - The area where flu shot was given was red, feverish, and swollen. Pt went to MD and was given antibiotic for a staph infection (which was diagnosis MD told patient).
ON 10/28/23, PATIENT CALLED THE PHARMACY AND COMPLAINED ABOUT SLURRED SPEECH, HEADACHE, AND TROUBLE WALKING.  PATIENT SAID SYMPTOMS STARTED ON 10/27/23.  PATIENT WAS ADVISED TO SEEK MEDICAL TREATMENT IMMEDIATELY.  PATIENT WENT TO LOCAL HOSPITAL, WAS DIAGNOSED AS HAVING HAD A MILD STROKE, AND WAS ADMITTED.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and PRODUCT STORAGE ERROR (14 patients were vaccinated on 06Apr2022, vaccine Expiration date: 02Apr2022) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (14 patients were vaccinated on 06Apr2022, vaccine Expiration date: 02Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and PRODUCT STORAGE ERROR (14 patients were vaccinated on 06Apr2022, vaccine Expiration date: 02Apr2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not reported.
Patient experienced soreness the following morning (Wednesday the 6th) after the vaccine was given in the left deltoid. That same night, he noticed the swelling, redness and slight warmth to touch in the vaccine site. It was elliptical in shape and was 50 by 100 mm in length. He reported to the Health department in person on the morning of Thursday the 7th.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Apr2021 at 12:00 as dose 4 (booster), single (Lot number: fj9943) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "High blood pressure, controlled" (unspecified if ongoing), notes: High blood pressure, controlled; "arthritis" (unspecified if ongoing); "High blood pressure, controlled" (unspecified if ongoing), notes: High blood pressure, controlled. The patient's concomitant medications were not reported. Past drug history included: Thiomersal, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a pharmacist, via a company representative, concerning a female patient of an unknown age. The patient's concomitant medications included donepezil (ARICEPT). Her medical history, concurrent conditions and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, frequency, route of administration, anatomical location, lot # and expiration date were not provided), for prophylaxis. On an unknown date, the patient experienced shingles (herpes zoster). The patient reported this reaction to the pharmacist on 30-MAR-2017. It was unknown if a treatment was given for the adverse event and if a laboratory diagnostics studies were performed. No product quality complaint was involved. The patient's outcome and the causality assessment between ZOSTAVAX and herpes zoster were unknown. Additional information has been requested.
The patient reported itching around ankles about 5-7 hours after the vaccine was given. She had the expected symptoms of body aches and low grade fever. On 9/15/2020 (one day after vaccine) she developed a rash of both lower extremities which she described as "little blisters" and continued to have itching. She saw me in the urgent care on 9/18/2020 and she had a vesicular rash of bilateral upper and lower extremities with sparing of the face and trunk. She continued to have intense itching, but at the time of visit she had no other symptoms; no fever, sore throat, headache, myalgia, cough, shortness of breath, loss of taste/smell. She felt completely well aside from the itching of rash. She states that she had chicken pox/Varicella at age 32. The rash was vesicular, but there was no erythema of skin (the typical Varicella rash is described as a dew drop on a rose petal). I spoke with her today (9/20/2020) and the rash continues to be just on the arms and legs. She has a few more lesions, but no lesions of face or trunk. Still itching, but no fever. NO other symptoms.
HOT FLUSHES FROM HEAD DOWN BODY, HEART RACING, NAUSEA.
Patient came to walk-in COVID-19 vaccine clinic and reported he did not have the 2nd vaccine. The system used to check was down due at the time of vaccination. Patient attested to never having the 2nd vaccine. The 2nd vaccine administered. Later we found out the patient had both vaccines. His last COVID-19 vaccine was 2 days prior. Our clinic is working to give out gift cards for patients that received the 1st and 2nd dose. No adverse events at this time. Reached out to patient twice but has not returned phone call.
Lethargy, hypotonia, hypoxemia, vomiting over 1 hour after vaccination. Requred O2- fluid bolus, stimulation and had hospital observation.
It started with some fatigue and GI symptoms like nausea, upset stomach and it progressed. To the point where I was extremely fatigued and so I went to the doctor.
No adverse events.; Patient was administered an improperly stored VAQTA.; This spontaneous report was received from a Nurse Practitioner referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, historical drugs, drug reaction and allergies were not reported.  On 23-SEP-2019, the patient was vaccinated with an improperly stored dose Hepatitis A Vaccine, Inactivated(VAQTA) with lot # S007769, expiration date on 24-JUL-2020 (strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis.  The administered dose of vaccine experienced above temperature of 47°F/9°C(11.3°C) °C degrees Celsius, for 9 hours and 55 minutes. There was no digital data logger invloved, and no previous temperature excursion. No adverse effects reported.
mild headache within 24 hours; muscle aches within 18 hours; sore arm within 12 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 24Mar2021 09:30 (Lot number: ER8727) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "sarcoidosis" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LIPITOR [ATORVASTATIN]; PREDNISONE; QNOL. Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EN6205) at 05:30 PM in left arm), administration date: 02Mar2021, when the patient was 60 years old, for COVID-19 immunisation, reaction(s): "diarrhea". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Mar2021 21:30, outcome "recovering", described as "sore arm within 12 hours"; MYALGIA (non-serious) with onset 25Mar2021 03:30, outcome "recovering", described as "muscle aches within 18 hours"; HEADACHE (non-serious) with onset 25Mar2021 09:30, outcome "recovering", described as "mild headache within 24 hours". Therapeutic measures were not taken as a result of pain in extremity, myalgia, headache. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are needed. No further information is expected.
Pt vaccinated at 4:30 pm for first dose. Left CHD did normal daily activities. Went to bed that evening woke up around 3 am on 1/16/21 extreme pain to left arm, diaphoretic, chills, weakness. Went to stand up and started experiencing vertigo. Made it to restroom, was able to void, went to stand up and found herself waking up on the floor. Had redness and swelling to right cheek, ecchymosis to right eye, and found abrasion to left posterior head. Stated it took 48 hours for the weakness and fatigue to go away. Pt did not seek medical attention right away however did contact her PCP and make aware of occurrence. Was given the ok per PCP to receive second vaccine.
LEG CRAMPING; DIFFICULTY BREATHING; SWELLING OF LEG WITH EDEMA; HEAVY LEG; LOSS OF APPETITE; RASH ON LEFT FOREARM; LOSS OF 5 LBS; DIFFICULTY WALKING; DIFFICULTY SLEEPING WELL; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 120 pounds, and height was 170.68 centimeters. The patient's concurrent conditions included chronic obstructive pulmonary disease (copd), asthma, interstitial lung disease, herniated disc at cervical lumbar, allergy to sulfa medications, back injury, and oxygen 24/7.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced loss of 5 lbs. On APR-2021, the subject experienced difficulty walking. On APR-2021, the subject experienced difficulty sleeping well. On 11-APR-2021, the subject experienced leg cramping. On 11-APR-2021, the subject experienced difficulty breathing. On 11-APR-2021, the subject experienced swelling of leg with edema. On 11-APR-2021, the subject experienced heavy leg. On 11-APR-2021, the subject experienced loss of appetite. On 11-APR-2021, the subject experienced rash on left forearm. On 12-APR-2021, Laboratory data included: Ultrasound scan (NR: not provided) No venous clots and no thrombosis. On 20-APR-2021, treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of leg with edema, and heavy leg on 15-APR-2021, and loss of appetite, and rash on left forearm on APR-2021, was recovering from leg cramping, and difficulty breathing, and the outcome of loss of 5 lbs, difficulty walking and difficulty sleeping well was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious.
Red spots in panty area, up sides, underarms, legs, and shoulders. Feels warm.
Vaccine given at 11:20 AM. Patient had nausea/vomiting and diarrhea from mid to late afternoon that same day.
Have very bad body aches and hot and cold sweats . I have been taking ibuprofen 2 times and symptoms get better.
I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen; I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: ER8729) at the age of 41 years as dose 2, single and administered in arm left, administration date 12Mar2021 (Lot number: EN6306) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROBIOTICS; DIGESTIVE ENZYMES; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]. The following information was reported: LYMPHADENOPATHY (non-serious), MASS (non-serious) all with onset 12Mar2021, outcome "recovered with sequelae" and all described as "I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen". The event "i have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen" and "i have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Facility type vaccine was Pharmacy or Drug Store. The patient had no other medical history and no known allergies. The patient had not received any other vaccine in four weeks prior to vaccination. Adverse event reported after each Covid vaccine. Lump took weeks to go down. Recovered with lasting effects. Prior vaccination, the patient was not diagnosed with Covid. Post vaccination the patient was tested for Covid-19 through nasal swab, result was negative. Got an MRI of the area in Aug2021, no cancer detected.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2016US029210, is an initial spontaneous report received from a pharmacist on 06 Nov 2016. This report refers to a 56 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with a single dose of FLUCELVAX QUADRIVALENT (batch number: 185205, Expiry: Apr 2017) 0.5 ml intramuscularly on 05 Nov 2016. It was reported that the vaccine was administered following a temperature excursion of 33.8 Fahrenheit for an unknown duration of time (vaccine was not frozen). No adverse event was reported following this medication error (incorrect storage of drug).
A flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis; A flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis; This is a spontaneous report from a non-contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8734) via an unspecified route of administration in the right arm on 09Apr2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medial history included HTN (hypertension), high cholesterol, CAD (coronary artery disease), depression, allergic rhinitis, all from unspecified dates and unspecified if ongoing and ongoing psoriasis and psoriatic arthritis from unspecified dates. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications included apremilast (OTEZLA) taken for psoriasis and psoriatic arthritis from an unspecified date and unspecified if ongoing. It was reported that no other vaccine was received in four weeks prior to the COVID-19 vaccine and it was also reported that another vaccine was reported in two weeks prior to the COVID-19 vaccine. The patient previously received  the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8730) via an unspecified route of administration in the right arm on 19Mar2021 at 09:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. On 11Apr2021 the patient experienced a flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis. The clinical course was reported as follows: "I take Otezla for Psoriasis and Psoriatic Arthritis. I have been well controlled for over a year. On the 3rd day following the vaccine I developed a flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis." Treatment was not received for the events. The clinical outcomes of the events a flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis were both recovering/resolving. Since the vaccination, the patient had not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
patient had received second shingrix shot and a tdap shot on 9/11/18 after being on a wait list for second dose of shingrix. patient was not taken off the wait list when vaccinated 9/11/18 and was called to get these two shots when we received a shipment 10/16/18. patient then came in and received a third shingles shot and second tetanus shot. patient did not report any adverse events. it was realized at patients next doctors apt that she had received a double dose.
Flare-ups of ulcerative colitis; under the weather; This is a spontaneous report from a contactable healthcare professional and consumer. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunization. Medical history included ongoing ulcerative colitis. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unspecified date as first dose, single dose for COVID-19 immunisation. On May2021, the patient was "under the weather" experiences flare-ups of ulcerative colitis symptoms were "pretty rough" which could be also due to him "loosen up" his diet and he received the second COVID-19 vaccine shot. The outcome the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the available information the reported events were  attributed to  an underlying or  an intercurrent medical condition and  it is assessed as unrelated to the  suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Fever; increased white blood cell count; erythema, warmth, tenderness, edema at injection site.