chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax 120PM pt was very concerned about getting a shot w/ a needle;wanted to use gun;lightheaded dizzy, SOB, very hot, blurred vision, weak in the knees;hyperventilation;
Two days post vax, the pt had intermittent and inconsolable crying for over two hours. Further information requested.
R ARM-RED, SWOLLEN, WARM, TENDER, UNABLE TO MOVE ARM, TEMP 103.
Dec 13 th  irregular heart beat d. with PVCs. Never had this arrhythmia before no history of high blood pressure. Dizzy and lightheaded periods of feeling faint .Medications to treat were no successful due to reaction to medication. May 17 2022 had successful cardiac ablation
shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th May 2019, the patient received the 1st dose of Shingrix. On 14th May 2019, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and developed shingles, which was diagnosed on 14th May 2019 by a physician. The reporter consented to follow up.
Left arm cellulitis, redness with induration at injection site started the day after injection.  Chills and sleepy.  Given Rocephin IM 12/30/2020.  Prescribed clindamycin 300mg 2 tab q8 for 7 days.
(+) Varicella following vaccine x 2 #1 11.02.03 Merck 0545N. #2 6.19.09 Merck 0471Y.
Floater in eye; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (Floater in eye) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history was not reported .  Concomitant products included LEVOTHYROXINE and AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VITREOUS FLOATERS (Floater in eye). At the time of the report, VITREOUS FLOATERS (Floater in eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Swelling & joint pain on left side of the body with whole body muscle weakness.  Muscle weakness lasted 5 days.  Joint swelling and pain was primarily in knee, elbow & lower leg/heel.  This pain started within 24 hours of vaccination and has been ongoing.  I stared a round of steroids.  This inflammation is totally new and unlike and previous episode of reactive arthritis.  I have not had a reactive arthritis event in over 10 years and take no related medication.
This spontaneous report as received from a 23-year-old male healthcare student refers to himself. No medical history was reported. On an unknown date (patient reported "as an infant"), the patient was vaccinated with two doses of M-M-R II (dose, route of administration and lot number were not reported). No concomitant medications were reported. On approximately 23-OCT-2015 (reported as "three weeks ago"), the patient had titers drawn and the results for the measles, rubella and mumps antibody tests were negative. On an unknown date, the patient was diagnosed with psoriasis and was treated with STELARA. The outcome of psoriasis, rubella antibody negative, mumps antibody test negative and measles antibody negative is unknown. The relatedness between the events and M-M-R II was not reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 24-NOV-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (Lot # L013192, dose and route of administration not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was reported. This is one of the several reports from the same reporter link. Additional information has been requested.
Fever 1 day after Fever 7 days after  Fever 14 days after  Fever 21 days after with febrile seizure
Patient stated he had a headache. Water and crackers are given. Patient stated he felt a little better Without acute distress noted. Rest is advice to take. Tylenol if needed. Resident observed for 30 minutes in observation area
shoulder pain/swelling/redness, fever;?septic arthritis & cellulitis;
This is a spontaneous report from a contactable consumer or other non HCP. A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 3 intramuscular, administered in arm right on 15Oct2021 13:00 (Batch/Lot Number: FH8020) (at the age of 66-years-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included, 2 heart valves replaced from an unknown date and unknown if ongoing , atrial fibrillation from an unknown date and unknown if ongoing , cardiac failure from an unknown date and unknown if ongoing , thyroid from an unknown date and unknown if ongoing , high cholesterol increased from an unknown date and unknown if ongoing. Concomitant medication(s) included allopurinol taken for an unspecified indication, start and stop date were not reported; carvedilol taken for an unspecified indication, start and stop date were not reported; digoxin taken for an unspecified indication, start and stop date were not reported; sacubitril valsartan sodium hydrate (ENTRESTO) taken for an unspecified indication, start and stop date were not reported; simvastatin taken for an unspecified indication, start and stop date were not reported; tamsulosin taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; torsemide taken for an unspecified indication, start and stop date were not reported; warfarin taken for an unspecified indication, start and stop date were not reported; potassium chloride taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had no known allergies. The patient had previously received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 2 via intramuscular, administered in arm right on 27Feb2021 03:00 PM (at the age of 65 years) (Batch/Lot Number: EL9266) and also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via intramuscular, administered in arm right on 28Jan2021 03:00 PM (Batch/Lot Number: EN5318) for covid-19 immunization. The patient previously received influenza vaccine (INFLUENZA VACCINE) for immunisation on 06Oct2021. On 16Oct2021 14:00 the patient experienced Headache, fatigue, and vomiting. The patient not received treatment for the events. The outcome of the events (Headache, fatigue, and vomiting) was recovered on an unknown date in Oct2021.    Follow-Up (26Oct2021): Follow-up attempts are completed. No further information is expected.
on the Paxlovid/had a breakthrough infection; on the Paxlovid/had a breakthrough infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient 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 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "non-smoker" (unspecified if ongoing); "non-alcohol user" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "on the Paxlovid/had a breakthrough infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient stated, he took the Pfizer COVID vaccine first and second and 2 boosters and everything was fine. Unfortunately, despite all that, he had a breakthrough infection, because of his age, his doctor put him on the Paxlovid, the 5-day regimen, he had 2 pills a day 1 yellow and 1 white, he tolerated this fine. After day 3 he was instructed to do a nasal swab, but it was still showing positive, he wants to know how long it takes for it go away after taking Paxlovid. He states that he was feeling better, he just did not know, after 3 days he was still getting a positive result, he asks this agent how long he had to quarantine. He asks how widespread this is.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Was treated for blood clots in my right lung. There was a cluster of blood clots in my lower right lung. I am on blood thinners now. Eloquis is the blood thinner I am on now.
skin reaction on her face that is red and inflamed; skin reaction on her face that is red and inflamed; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (skin reaction on her face that is red and inflamed) and DERMATITIS (skin reaction on her face that is red and inflamed) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ERYTHEMA (skin reaction on her face that is red and inflamed) and DERMATITIS (skin reaction on her face that is red and inflamed). At the time of the report, ERYTHEMA (skin reaction on her face that is red and inflamed) and DERMATITIS (skin reaction on her face that is red and inflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
10/18/2010- rapid heart rate and elevated blood pressure required Emergency Room visit and admission to Cardiac Surgery Intensive Care Unit for two nights at Hospital.  Treated with blood pressure medications.  Discharged from hospital with medications on 10/20/2010.  Symptoms slowly progressed to numbness, tingling, and weakness in extremities and then progressed further to difficulty walking and total paralysis of left side of face.  Was diagnosed with Guillain-Barre Syndrome on Monday, November 22nd 2010.  Treated with four infusions of IV Immune Globulin.  Currently enrolled in physical therapy three times per week.  Slowly improving symptoms.  Still unable to work or drive.
Nickel size redness to left arm check out itchiness. Denies hardness or pain. Explained need to keep clean, covered and put Bacitracin on.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild
arm is red at injection site; Arm is swollen at injection site; Little bump; big circle at injection site; hot; Swollen lymph nodes on left side of under armpit and neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm is red at injection site), VACCINATION SITE SWELLING (Arm is swollen at injection site), VACCINATION SITE MASS (Little bump), VACCINATION SITE REACTION (big circle at injection site) and FEELING HOT (hot) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included THYROID (ARMOUR THYROID), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and BACITRACIN, POLYMYXIN B SULFATE (ANTIBIOTIC [BACITRACIN;POLYMYXIN B SULFATE]) for an unknown indication.    On 09-Jan-2021 at 2:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm is red at injection site), VACCINATION SITE SWELLING (Arm is swollen at injection site), VACCINATION SITE MASS (Little bump), VACCINATION SITE REACTION (big circle at injection site), FEELING HOT (hot) and LYMPHADENOPATHY (Swollen lymph nodes on left side of under armpit and neck). At the time of the report, VACCINATION SITE ERYTHEMA (arm is red at injection site), VACCINATION SITE SWELLING (Arm is swollen at injection site), VACCINATION SITE MASS (Little bump), VACCINATION SITE REACTION (big circle at injection site), FEELING HOT (hot) and LYMPHADENOPATHY (Swollen lymph nodes on left side of under armpit and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Received a pneumonia vaccine on 10/5/09 in my right. That night I was terrible pain in that arm. On Wed, 10/8/09 I noticed redness and swelling. I returned to the clinic that I had either an adverse reaction & was given steroids & an antibiotic (cellulitis).
Patient received 0.2ml of undiluted Pfizer (5-11yr) Covid-19 vaccine. Spoke with patient's guardian when error was discovered. Situation explained to parent and all questions answered to their satisfaction. Dr. was notified. Parents encouraged to reach out to PCP or health facility for further questions or concerns. Parent verbalized understanding and has no further concerns at this time.
STRONG SMELLING URINE; STRONG SMELLING SWEAT; DARK URINE; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy (rash at age 11/12 years old), hyperlipidemia, attention deficit hyperactivity disorder (adhd), post-traumatic stress disorder (ptsd), drinks 4 glasses of beer once a week, and non-smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. Patient's water intake was normal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced strong smelling urine, strong smelling sweat, and dark urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from strong smelling urine, strong smelling sweat, and dark urine. This report was non-serious.
Pt concerned site of recent Tdap vaccine (11 days ago 4-12-13) left upper arm, constant pain rating 3-4/10 with movement, states, it's like it's in the joint, it doesn't hurt when I touch the skin. Denies any redness/swelling, fever/chills. Arthralgia. Acetaminophen 650 mg UD.
I went to the doctors clinic and had my 2nd Covid test waiting my 15 minutes and went home. I had my grand daughter over for the holidays and they tested positive for Covid on October 27th, 2021. I tested and was negative. Then in December I tested again and was positive due to that my granddaughter came home and she was positive. I was coughing a lot for days. I was very fatigue barely awake. No fever and but I was having a lot of problem breathing, I had no appetite and very nausea. This lasted about 1 month.
I had a very sore throat, fever, chills, runny nose, tonsil stones, cough, congestion, loss of energy for 2 weeks and it took well over a month to go back to normal. I was diagnosed with strep a week in and took antibiotics for 10 days.
Pt states eyesight was blurry, then itchy and watering w/swelling of eyes followed by throat tightening up and choking-all this started 10 hours after vaccine.
10/25/11, client reports receiving vaccine approx. 0930. At approx 1230pm her "throat felt like it was closing, muscle aches, headache, and felt hot". Client check temperature at 1745 and was 103.9 degrees. Took OTC NYQUIL and TYLENOL approx. 1830. Today, 10/26/11, temp 98 degrees and throat feels "fuzzy when swallowing".
headache; This is a spontaneous report from a contactable consumer or other non-Health Care Professional via Pfizer sponsored program. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 29Jul2021 as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported.On 29Jul2021 the patient experienced headache. The outcome of event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
hives from the neck to legs; Face redness; tightness in the chest; unable to take a deep breathe; This is a spontaneous report from a contactable nurse. A 36-year-old female patient  received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscular in left arm on 12Jan2021 11:00 to at a single dose for COVID-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On 12Jan2021 11:00, hives from the neck to legs, face redness and tightness in the chest, and was unable to take a deep breathe. The outcome of the events was recovered with sequelae. The events resulted in an emergency room/department or urgent care. Treatment for the events included Benadryl, Ativan, Pepcid, NS Bolus and EpiPen. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested with COVID-19 post vaccination.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of hives from the neck to legs, face redness and tightness in the chest, and was unable to take a deep breathe due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including physical examination with vitals and chest x-ray, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Extreme fatigue, HA, sensitive to the light, red and warm and the site of the injection, confusion.
no symptomatic adverse events were reported/ no additional AE; PROQUAD and VARIVAX concomitantly instead of MMR-II and VARIVAX; accidently administered PROQUAD and VARIVAX; This spontaneous report was received from a nurse referring to a 12-month-old patient of unspecified age. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was unknown.   On 01-SEP-2023, the patient was administered varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (ml) (route of administration was not reported; lot number W021740 has been verified to be valid, expiration date reported and established as 10-JUL-2024) as prophylaxis. On the same date, the patient accidentally received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) 0.5 ml (route of administration was not reported; lot number W036929 has been verified to be valid, expiration date reported and established as 19-MAY-2024) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (wrong product administered, accidental overdose).  No symptomatic adverse events were reported (no adverse event).
Information has been received from a nurse referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M017982, expiration date 13-SEP-2017, dose and route were not provided), which were exposed to 50 Fahrenheit (F) for 40 minutes. It also underwent previous temperature excursion at 50.2 F for 1 hour and 10 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Upon wakening, I noticed she was hot and took her temperature rectally (103.1). She was administered 1/875mL of Motrin. An hour later, her fever was reduced, but came back quickly and at 10:45AM it was 102.3 again. She was lethargic with puffy eyes.
It was reported that a female patient received a TriHibit (combination of Tripedia and ActHib) and an IPOL vaccination on 03/15/00. Reportedly sometimes after the vaccination the patient developed a local reaction. No specifics provided. Additional information is being requested. From corrspondence received on 04/25/99, it was reported that the patient developed an erythematous area around thre injection site and swelling up to the elbow. The reaction lasted 48-72 hours. The patient was placed on hymenitis for possible cellulitis, Patient did well after reaction resolved. From mailed correspondence received on 06/12/01 started that the patient recovered from this experience. The patient's age and the adverse evrent onset date was also provided.
Patient passed out and had seizure-like reaction before falling out the the chair he was waiting in and hitting his head on the the floor. Fire/Paramedics were called to the scene and took over. Pt left with emergency services