chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hypercholesteremia" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN (E.C.), start date: 12Oct2022; ROSUVASTATIN, start date: 01Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Feb2023) Negative, notes: Covid test was negative on day 5 after completing paxlovid; (26Feb2023) Positive, notes: today 4 days after testing negative patient tested positive today. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 17Feb2023 to 22Feb2023.
Patient in observation area for a 30 minute observation period. Patient upon sitting down began to cough.  Patient given water with no resolve to coughing.  Patient stated she has a history of asthma  attacks and has to occasionally use her epinephrine pen to aide in breathing due to a new onset of an allergy to salad dressing.  Patient taking to first aid area assessed by Medic. Lungs were clear to auscultation and patient O2 sat was 95% on RA.  Patient denied any difficulty breathing.  Provider evaluated patient and at 1240 patient given 4 puffs of albuterol inhaler-patient's personal inhaler used. After reassessment/observation provider released patient home.
Prominent orbicularis oris (upper lip)  muscle tightness; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 09:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in 2021 as a single dose for COVID-19 immunisation. Medical history included HTN (hypertension), hypothyroidism, lumbar spinal stenosis and season allergies to grass. The patient had no known drug allergies (NKDA). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 30Apr2021 at 15:00, three weeks after she received the first dose of the COVID-19 vaccine, the patient experienced prominent orbicularis oris (upper lip) muscle tightness that was yet to resolve. The patient reported that there was no change of muscle tightness described with second dose of vaccine and the bottom lip was not affected by this. There was no inflammation or irregularities to upper lip. The patient reported that the adverse drug event (Ade) was yet to resolve. The patient reported that no treatments like otc (Over-the-counter), medications or home remedies were implemented. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event prominent orbicularis oris (upper lip) muscle tightness was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician via sales representative refers to a female patient of unknown age. Medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, dosage, route and lot number were not reported) for prevention of HPV. Concomitant therapy was not reported. The physician informed that on an unknown date the patient experienced headache after being administered the GARDASIL vaccine. The outcome of the event was unknown. Additional information is not expected because the reporter refused to be contacted.
My adverse event started on 12/12/2022 in the morning. I had a headaches, runny nose, fatigue, body aches, chest congestions and post nasal drip. On 12/15/2022 I went to an urgent care where they tested  me for COVID-19 Infection, Flu, and Strep. All the tests were negative. I've noticed something new was happening with me. All of a sudden I had a rising heart rate. My resting heart rate increased by 10 since I wear a heart  monitor I noticed it. I get heart palpation which slowly would stop. I also experienced chest pressure. I would start to breath faster. It happens all of a sudden I feel the chest pressure and then increased heart rate afterwards. On 12/15/2022 I went to an urgent care for symptoms of COVID-19. They advised me to care ibuprofen since I tested negative for COVID-19 infection. On 02/09/2023 when I started feeling the chest pressure and increased heart rate. I messaged my doctor since she doesn't work that day she told me to go to the urgent care. I went to the urgent care on 02/09/2023. When I explained to them about the issue I was experiencing they again tested me for COVID-19 infection, Flu and Strep. I was negative again. So, they told me to go see a Cardiologist. I scheduled an appointment for tomorrow 02/15/2023 at 12:30PM.
Patient had no adverse effects or symptoms from this dose; Caller is a medical assistant who reports six expired doses of VAQTA were administered; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported.  On 15-JUN-2022, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 milliliters (ml) once (lot number: T031201, which was determined to be valid, with an expiration date on 14-JUN-2022) as prophylaxis (route and anatomical location of administration were not reported) (expired product administered). The hepatitis A vaccine inactivated (VAQTA) mentioned did not have any prior temperature excursion and the patient had no adverse effects or symptoms from this dose.
Muscle pain, headache. I took Acetaminophen. Pain reduced to a manageable level.
Received on Thursday, on Saturday patient reported redness around the site. Around the arm that extends up to the shoulder and that area was very warm to the touch. Patient advised to consider taking BENADRYL, Ibuprofen and to have area examined by a doctor.
Stopped babbling, stopped eating regular foods, ignored parents when name was called. This started sometime between 12-17 months of age. Had been saying some one word things. 06/12/2003: "Onset of autistic symptoms. Diagnosis: Autism Spectrum Disorder."
12-24 hrs after vaccine given, pt. reports L deltoid very red, swollen and painful, later noticed rash down arm to elbow-resolving by 12/16/09.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Medium
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Nov2021 as dose 1, single (Batch/Lot number: unknown), on 17Dec2021 as dose 2, single (Batch/Lot number: unknown) and on 07Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Clotrimazole, reaction(s): "Known allergies: Clotrimazole"; Tobramycin, reaction(s): "Known allergies: tobramycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment with Paxlovid from 29Jul2022 to 02Aug2022 for COVID-19. The patient received other medications/products within 2 weeks of starting COVID-19 treatment. Patient reported metallic taste (onset 45 minutes, duration 4-6 hours), insomnia (slept 3-4 hours first 2 nights versus 8 normally and more when she was sick, missed a dose last night and slept completely normally. She expected that this will reoccur tonight after her last night time dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile and temporal association, there is reasonable possibility of causal association reported between the events and the suspect drug BNT162B2
This spontaneous case initially received on 12-Jan-2017, was reported by a health authority and concerns a(n) female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for Indication not reported. Dose regimen: Not reported, site: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Hives (outcome: Not Reported), Itching (outcome: Not Reported), Rash (outcome: Not Reported).
covid worked itself in; covid worked itself in; This is an initial spontaneous report from a contactable consumer. A female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via unspecified route of administration on 19Feb2021 as a single dose for covid-19 immunization. Patient was weaning of methotrexate for rheumatoid arthritis due to the side effects of the methotrexate. She missed the second dose of the vaccine because she was experiencing things from withdrawing from the methotrexate and covid worked itself in. She is no longer on methotrexate. Second dose of the vaccine was cancelled on 19Mar2021 because of being very sick due to taking Methotrexate and immunosuppressant drugs for Rheumatoid arthritis. She said she was also advised by the Facility that she can get her second dose of the vaccine 40 days after the first dose. The outcome of the events were unknown.  Follow up (13Apr2021): This is a follow up spontaneous report from a Pfizer Sponsored Program COVAX Support. Contactable female consumer (patient) reported treatment details, suspect drug information added clinical information.  Information on the lot/batch number has been requested.
Service member is  29 year old Army Captain. She reports swelling and redness at the injection site area about nickel size the evening of the day she received her injection (Jan 3  07). The next day it had progressed to 'quarter size' until today (Jan 5 07) the swelling and redness has increased to 'golf ball size' with some itching. Past medical history positive for allergies to fire ants, codeine, dust mites, grass and some tree pollens. Also reports having large local reaction to 'bug bites'. Erythema start 01/03/2007; Edema at injection site 30-50mm Start 1/03/07 comment: 'nickel size'; symptom: Edema at injection site 50-120 mm Start 1/05/07 comment: 80 x 80mm. Symptom: Erythema Start: 1/05/07; Symptom: Pruritis start: 01/05/07
Received @ 2 DOSAGEON 10-14-21 - c/o hives,   ITCHING,  REDNESS  AND MIGRAINE  THE NEXT DAY   10-15-2021  -NOT REPORTED UNTIL 10-25-2021,  TOOK  3-4 DOSES OF BENADRYL -RESOLVED  IN  ONE DAY , NO SOB
left chest pain; left chest pain/It was sharp and seemed to get worse with movement so assumed it was musculoskeletal; woke up in the early morning with severe pain; pain even sitting up and especially with taking in a little larger breaths than usual; body aches; This is a spontaneous report from a non-contactable consumer reported for self. This 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EC1284) via unspecified route of administration on 25Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. About 18 hours after injection (Dec2020), the patient started having left chest pain when she went to sleep. It was sharp and seemed to get worse with movement so assumed it was musculoskeletal. The patient fell asleep and woke up in the early morning with severe pain. It again was worse with certain positions but was extremely painful. The patient couldn't find a comfortable position. There was pain even sitting up and especially with taking in a little larger breaths than usual. Could not pinpoint the area of pain, but it seemed anterior in the lower left chest. No other symptoms otherwise, no shortness of breath. The pain improved with paracetamol (TYLENOL), and she was able to fall back asleep. The pain continued throughout the day and then the patient developed body aches that afternoon. By the next day, symptoms improved and were nearly resolved by the following day. The patient was not diagnosed with COVID-19 prior to and since the vaccination. The patient recovered from the events.   No follow-up attempts are possible. No further information is expected.
She's feeling a little tired; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable Female consumer reported for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she's feeling a little tired on 13Feb2021. It was reported that caller received the Pfizer Covid-19 vaccine yesterday and wanted to ask if it was okay to take a glass of wine. She was feeling a little tired. The outcome for event was unknown.   Follow-up attempts are completed. No further information is expected
Pt with anxiety, shortness of breath, weakness, lightheaded, palpitations. EKG suggest ischemic changes. Troponin 0.006. BNP elevated.   Is an 89-year-old female that presented to the outside facility with palpitations and more frequent episodes of anxiety as well as some mild shortness of breath.  During the course of their evaluation she was found to be hypokalemic.  We discussed replacement.  She does have a mildly elevated troponin.  Icon Lab Tests Completed
I was having a tickling cough on the 4th by the 8th I could not even talk. I had no voice and the cough has not stopped. I had a fever from the 7th to the 8th. I have taken COVID-19 home tests and went in for a PCR test and that was negative. My healthcare provider gave me a cough medicine and an inhaler and have me doing a gargle. At this point I still have the cough but I am not fully recovered at this point.
No additional AEs reported; VARlVAX that expired on 23JAN2022 was administered on 28JAN2022; This spontaneous report was received from a consumer, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 28-JAN-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number T002842, expiration date reported and validated as 23-JAN-2022) as prophylaxis (expired product administered). No additional adverse events (AEs) reported.
Pt c/o feeling warm and weak. Vital signs at 12:15, BP 110/60, HR 86, spO2 95%. Pt refused further care.
2 Days after recieving injection, pt reports experiencing upper arm muslce soreness and pain.  Pt has difficulty moving arm back, and moving arm up. putting pressure on arm, unable to sleep on arm, unable to push down on seatbelt buckle button.
Pfizer-BioNTech COVID-19 Vaccine EUA injection site soreness
Presents to ED the day after 2nd covid vaccine with nausea, abdominal pain, body aches, fever to 102.7 - normal immune response. D/C'd home in stable condition.
BAD HEADACHE; PRETTY FATIGUED; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced bad headache, and pretty fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad headache and pretty fatigued was not reported. This report was non-serious.
Pt after flu vaccine developed pustules in the mouth - (roof & sides of mouth). Went away after 24 hours.
I just noticed a painless swelling in my left jaw one wek after vaccination . It could have been there sooner without me noticing. Lump is about 1" wide and is very firm but not rock hard. Does not affect jaw function and feels like a lymph node. Location is exactly where a salivary gland would be. I have never had this type of swelling before. I feel fine otherwise except for being tired from physical exertion and a stressful week. Arm was sore for 4 days after vaccine.
Child received 2 month vaccines, within days of receiving those vaccines the child began having infantile spasms. Since that began the child has been in and out of the hospital, developmentally significantly delayed and has received multiple drugs in order to try to combat the severe seizure disorder.
About 3 to 4 inches below injection site a silver dollar size welt showed up and over next few days it became about 4 times bigger. It is warm to touch and sore.
This case was reported by a physician and described the occurrence of high fever in a child male subject who was vaccinated with KINRIX (GlaxoSmithKline), haemophilus influenzae type b vaccine (non-gsk). Concurrent medications included Vitamin D (Vitamin D supplement). On 31 January 2012 the subject received 1st dose of KINRIX (.5 ml, unknown route) and experienced inappropriate age at vaccination administration, and the subject received 3rd dose of Haemophilus influenzae type b vaccine (Non-GSK) (unknown route). It was reported that the subject was younger than the indicated age for KINRIX administration. On 31 January 2012, "that evening" within hours of vaccination with Haemophilus influenzae type b vaccine (Non-GSK) and KINRIX, the subject experienced high fever of 102.0 degrees. The subject was seen at the physician's office "yesterday" (1 February 2012) with continued fever. The physician reports the fever was decreased, but the subject was not afebrile. The physician reported that he was unsure which vaccine may have caused the reaction. At the time of reporting the outcome of the events were unknown. The physician considered the events were possibly related to vaccination with KINRIX and Haemophilus influenzae type b vaccine (Non-GSK). Follow up information received from the physician on 13 March 2012. The physician reported that on 01 February 2012, one day after vaccination with KINRIX, the 6-month-old subject experienced fever. The fever resolved on 03 February 2012. The only diagnosis was fever. The physician noted that the events could have been associated with the erroneous administration of KINRIX. The subject was younger than the indicated age of KINRIX. The physician noted that the event was not serious.
Patient had itching at injection site - when observed site saw red looking rash - look like shingles - referred patient to MD.
This spontaneous report as receive from a registered nurse (R.N.) refers to an unspecified number of patients of unknown age and gender. Medical history and drug allergies were not provided. It was reported that on an unknown date, the patients were late receiving their third dose of GARDASIL (dose, route of administration, lot# and expiration date were not reported). Information regarding the patient's first and second dose of GARDASIL was not provided. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
This spontaneous report has been received from a nurse (L.V.N.) refers to one of twin sisters who in February 2010 was vaccinated with first dose of GARDASIL. The patient's mother said her draughts might have received the second dose of GARDASIL. Vaccine in March or April 2011 but the office could not provide official documentation and twins might received additional dose of GARDASIL. Vaccine for second dose again. No adverse effects reported. At the time of report, the outcome was unknown. This is one of several reports received from same source. Additional information has been requested.