chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient was received vaccine. The patient was received other medication in 2 weeks. No known allergies. No treatment was received in response to the adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling in left armpit, same side as injection. Lasted about 6 days.
Initial report received on 27 September 2013 from a health care professional. A 65-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number U41714AA, Expiration date 04-Apr-2014 route was unknown and site of vaccination was left deltoid) on 25-Sep-2013. It was reported that a 65-year-old female patient have received the FLUZONE HD. On 26-Sep-2013, patient had 4-5 inch echymotic, tender, afebrile at the injection site. List of documents held by sender: none.
Narrative: The patient developed diaphoresis and hypotension within 5 min of administration of J&J COVID vaccine. He was given 12.5 mg diphenhydramine. No difficulty breathing, itching/hives or pain. He improved after monitoring.
According to parents child had decreased babbling after admin of PCV7 vaccine. Resolved on its own. Not witnessed by anyone in this office
got sick the same day; got crazy nightmares.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick the same day) and NIGHTMARE (got crazy nightmares.) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced ILLNESS (got sick the same day) and NIGHTMARE (got crazy nightmares.). On 15-Jul-2021, ILLNESS (got sick the same day) and NIGHTMARE (got crazy nightmares.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The concomitant and treatment medication were not reported.  The patient got sick the same day and got crazy nightmares.   This case was linked to MOD-2021-360843 (Patient Link).
11 days after my vaccine I woke up with hives from head to toe mainly on my hands, feet and back. Four weeks later I went to the doctor and they ran a CMP test, antigen and general lab work. The doctor recommended that I take Claritin, Allegra, Benadryl, coligyl and hydrocortisone, all over the counter medicine. None of the over the counter products worked so I am just going to ride it out without seeing a allergist.
Patient diagnosed with Polyethylene Glycol sensitivity; patient developed a mobiliform rash that continued to worsen; patient developed a mobiliform rash that continued to worsen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 05Feb2021 (Lot number: EL9264) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,, Product: COVID-19, Brand: Pfizer,, Lot number: EL3247,, Anatomical site of injection: Left shoulder, Route of administration: Intramuscular), administration date: 15Jan2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious) with onset 26Feb2021, outcome "recovered with sequelae" (2021), described as "Patient diagnosed with Polyethylene Glycol sensitivity"; RASH MORBILLIFORM (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 26Feb2021, outcome "recovered with sequelae" (2021) and all described as "patient developed a mobiliform rash that continued to worsen". The events "patient diagnosed with polyethylene glycol sensitivity", "patient developed a mobiliform rash that continued to worsen" and "patient developed a mobiliform rash that continued to worsen" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash morbilliform, condition aggravated.  Additional information: The patient had received any other vaccines within 4 weeks prior to the COVID vaccine. Three weeks after second injection, patient developed a morbilliform rash that continued to worsen. Rash improved after a round of steroids. Patient diagnosed with polyethylene glycol sensitivity. The patient had received treatment with two rounds of steroids for adverse event rash. Prior to vaccination, was the patient was not diagnosed with COVID-19. AE required visit to: Physician office.  Follow-up attempts are completed. No further information is expected.
Became ill with the Shingles on March 20, 2021 on the left side of my back and left side/front.
next day i had swollen area in upper left arm (arm i got shot in) and one round lump on the underside of my upper arm close to armpit area which was quite large.  when i went to dr at first she felt it was vaccine related at that time and it was all swollen on upper arm and warm to touch. the one swelling round lump area didnt go away and I still have it but now dr (at my follow up) is saying maybe that lump was there before? and i need to have an ultrasound. i do worry somewhat that this lump could have been from vaccine as i am needing to take the second vaccine soon.  also within days i got a period when I wasn't due for it and it was the heaviest i ever experienced. it was very very heavy, more than one tampon per every hour twenty four hours even in the overnight this went on for a few days then was normal. I also developed cyctic acne on my face that was awful during this time which was not typical but went away. i also had muscle type pain for a week perhaps, that was mostly on left side, same side as vaccine but i thought that symptom was perhaps normal.
Resident reported shortness of breath, severe fatigue/weakness, new onset confusion, sore throat, body aches, runny nose
After vaccination had pimple bump. Felt uncomfortable, lethargic. Bump never resolved. Mentioned it to doctor but did not result in any action. Did not have fever, normal blood tests. On 4/15 bump got larger than golf ball. Went to medical center on Saturday. Doctor lanced it, clear fluid came out as well as 15 mm mass came out. The consistency of mass was like collagen -- it was harder rather than softer. Like hardened plastic. It seems like vaccine was administered IM rather than SC so it was never absorbed. Doctor gave doxycycline to prevent infection after bump burst. The liquid was clear not puss-like. After bump was cleaned had best night sleep, comfortable sleep, for 1 year.
Fever the following morning (which broke later in the day), along with a lot of pain throughout arm and shoulder (continuing after 3 days). A lot of swelling in armpit (continuing after 3 days). Fatigue.
Developed Pityriasis Rosea.   Severe rash  currently on going for at least the last 4 weeks.
12 hours later I was freezing enough to have teeth chatter. Next day my whole body ached. Everything hurt.
The patient is a middle aged female (of unknown weight) that developed a persistent cough two hours after receiving the flu vaccine. Her eyes were red with purulent discharge and she had a headache that lasted the entire evening. The following day, here eyes were "scratchy" but she was otherwise okay.
Patient had presented to office for COVID-19. Patient was administered dose of COVID-19 at 1415. At 1430, she notified staff in waiting room that she was concerned she was having an allergic reaction. She was brought back to an exam room and I was immediately notified. Patient was sitting next to her husband. Reports prior allergic reaction to shellfish but never to any medication/vaccine or other substance. Described a globus sensation but speech clear and respirations easy. Denied any itching of her mouth/face. Ordered Benadryl 25mg orally which I observed patient to take without difficulty, administered at 1435. Advised that I wanted patient to lay on exam table as she reported feeling very tired and for 2-3 seconds had acted like she might have syncope. Able to get to exam table on her own power without difficulty. Advised patient to rest. Reviewed symptoms/signs of concern to alert staff, with patient's husband. Left patient in room with door open and pule oximetry in place. Within 1-2 minutes, husband called me back into the room.  Patient was found laying on exam exam in decorticate posturing. Teeth clenched, back arched. Advised a call to 911. Patient able to speak through her clenched teeth telling me "No ambulance, this is normal for me". EMS was still paged per my order. I remained with patient throughout her seizure like activity which occurred twice. She was not only verbal throughout the episode,  but was able to answer questions appropriately through her clenched teeth. Has been experiencing this type of posturing for years.  Is under care  neurology who last saw patient 05/27/2022 and was diagnosed with involuntary movements.  Throughout episode, patient's heart rate ranged between mid 80s to as high as 130 when involuntary movements at full effect. Sats were in the high 90s throughout episode. Pulse oximetry was left in place at all times. Patient's husband present at all times. He also reports that patient has had this type of movements for years. Patient tells me that she is more tired today and thinks that this is why she has reacted in such a way to her COVID-19 vaccine.  Patient was never post-ictal. No urinary incontinence today or with any prior episode. When medics had arrived, decorticate posturing had lessened; hands and teeth were still clenched.  Advised patient be taken to hospital via medics; after discussion with EMS, patient and husband, patient agreed to transport. At 1524, RN made intake note at ER. Per RN note, patient had two additional episodes en route to hospital.
Initial information received on 20-Feb-2019 regarding an unsolicited valid serious case received from an other healthcare professional via other company (Pfizer) (MFR control number: 2018325036). This case involves a female patient of unknown age who walked off and fainted, passed out for at least 2 minutes and right arm is painful and significantly swollen, while he/she received vaccines MENACTRA and TRUMENBA. The patient had no medical history also did not take any concomitant therapy. On 08-Aug-2018, the patient received a single 0.5 ml injection of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5984AC Expiry date: 14 Aug 2019 via intramuscular route in the left deltoid. On 08-Aug-2018, the patient received a single 0.5 ml first injection of suspect TRUMENBA not produced by Sanofi Pasteur lot S58877 (Expiry date: 01 Feb 2019) via intramuscular route in the right deltoid. On 08-Aug-2018, The patient developed a serious walked off and faint (syncope) 5 minutes following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant (IME). On 09-Aug-2018, the patient's right arm was painful and significantly swollen (inflammation) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant. Lab test was not performed (The patient will come back in a week and an ultrasound will be done if the arm doesn't go down.). Final diagnosis was arm was painful and significantly swollen and faint. It was not reported if the patient received a corrective treatment. Reporter causality: causality of fainted with MENACTRA was assessed as unknown and for inflammation localized was assessed as unrelated. TRUMENBA: fainted: Unknown and inflammation localized: Related. The patient outcome is recovered for faint (duration: 2 minutes), Recovered / Resolved With Sequelae for inflammation (outcome was reported as Recovered with lasting effects). List of document held: none; Sender's Comments: A female patient experienced syncope (latency 5 minutes), swelling and painful right arm after vaccination with MENACTRA and TRUMENBA. Time to onset is compatible for syncope and unknown for other events. Patient had no medical history nor taken any concomitant therapy or done any lab test. To be noted that swelling and pain was observed at other company site hence it is considered unrelated to MENACTRA. Moreover, concomitant administration of two vaccines preceded the events. Based upon the reported information, the role of the vaccines cannot be individually assessed for syncope.
Patient is a 77 y.o. male patient of MD with history of cataract, dementia, ambulatory dysfunction, hyperlipidemia presented to Doctors Hospital with fall. Problem based management in the hospital is as follows:   Sepsis w Covid-19 Virus Infection w hypoxia, POA, now resolved Generalized weakness w mechanical fall  Acute metabolic encephalopathy, resolved Late onset alzheimer dementia w behavioral disturbance Presented w generalized weakness, mechanical fall and encephalopathy Likely 2/2 worsening dementia with COVID-19 infection   Date of covid positive test: 01/28/23 Vaccination status: vaccinated Imaging: Chest x-ray with no acute process Was initially hypoxic, 87% on room air, requiring 2 L.  Now more than 90% on room air Medical therapy: Was given dexamethasone, remdesivir and tocilizumab per ID recs ID following Anticipated special isolation end date: 02/7/23   Acute metabolic encephalopathy, improved Late onset alzheimer dementia w behavioral disturbance Acute decompensation due to COVID CT head and C-spine did not show any acute process Continued memantine, Trazadone and zoloft Admitted under delirium precautions PT/OT/utilization management consulted   Hyperlipidemia Continued statins   After 4 days of hospital stay, patient was doing well so he was discharged in stable condition
Had vaccine one January 19, 2021, February 19, 2021 and booster (Moderna) November 8, 2021.  Tested positive on PCR test on April 29, 2022 (results April 30, 20222) , messaged physician on May 2, 2022.  Received Paxlovir on May 2, 2022.  Taking prescription currently.    Symptoms, headache, congestions, sore throat, cough, chills.
The night following administration, patient awoke due to pain spreading down the inside of the right arm. Patient presented to pharmacy the day following administration with painful swelling and a raised red rash down the inside of right arm. The rash was not localized to the area where the vaccine was administered, but spread from lymph nodes by armpit down to just below the elbow. I instructed patient to see a medical provider for treatment, and to inform me of the outcome; 24 hours later, however, I have not heard back from patient. Of note, the patient has had PREVNAR and has received FLUZONE HD in the past, both without issue; therefore, I suspect the PNEUMOVAX is the culprit.  Although both vaccines were administered in the same arm by patient request, they were spaced out by approximately 1 inch.
Intense headache; All over body pain; Chills; Sweating; Nausea; Chest feels tight; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 13Apr2021 at 17:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 vaccine. On 14Apr2021 at 05:00, the patient experienced intense headache, all over body pain, chills, sweating, nausea and chest feels tight. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported event. The clinical outcome of the events intense headache, all over body pain, chills, sweating, nausea and chest feels tight was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Immunization given 04/25 8am, started fever that night pain at leg. On 04/26 AM eyes swollen shut. 04/26PM, rash all over body + "asthma" taken to Urgent Care. On 04/29 1pm, called PHD, child continuing fever face chapped, blisters in mouth, referred to CDA. Mom gave Benadryl. Saw a pediatrician and treated with Zyrtec. Complete recovery.
42-year-old patient presented on 10/8/21 for follow-up first coronavirus vaccine complaints. Most symptoms were resolved within 3 days of getting the vaccine last Thursday include fatigue upstairs, chills, headache, dizziness, decreased concentration. one that hasn't resolved as of his shot 8 days ago are 30 seconds to 1 minute nightly palpitations spontaneously resolve when lying in bed. Denies muscle pain, sore throat, new rash cough vision problems chest pain shortness of breath GI symptoms or loss of taste or smell.
Have gotten 6 doses today/patient got 6 doses of unreconstituted Pfizer Covid-19 Vaccine; Have gotten 6 doses today/patient got 6 doses of unreconstituted Pfizer Covid-19 Vaccine; This is a spontaneous report from a contactable pharmacist via Medical Information Team. A 12-year-old received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0167, Expiration Date- Aug2021) via an unspecified route of administration on 14Jun2021 14:30 as dose 1, single (at the age of 12-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. A nurse gave what was believed to be a full dose of un-reconstituted vaccine.  Pharmacist stated there was only a minute amount left in vial, so patient was believed to have gotten 6 doses today (14Jun2021) around 14:30 CST.  It was the patients first dose. Pharmacist stated it looked like he did not see anything much measurable left in it so it looked like they got 6 doses of un-reconstituted Pfizer Covid-19 Vaccine. The reporter seriousness for the adverse events was serious (medically significant). The adverse events resulted in the emergency room visit. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: There might be a causal relationship between patient got 6 doses of un-reconstituted vaccine and Resulting the patient to visit an emergency room visit.
Patient received the Pfizer Vaccine. Mild rash was noted on the forearms by the patient
This is in follow-up to report (s) previously submitted on 5/16/2000. Information has been received from a certified medical assistant concerning a 46 month old female with a history of early onset of delivery and no drug reactions/allergies, who on 14-OCT-2005 was vaccinated SC with a 0.5 mL dose of VARIVAX vaccine(Merck) (lot number: 648083/0072P). Concomitant therapy included measles-mumps-rubella vaccine (MSD) and influenza virus vaccine (unspecified). On 06-JAN-2008, the patient was diagnosed with chickenpox. No other information was available at the time. There were no lab diagnostic studies performed. Unspecified medical attention was sought through a telephone call from the patient's mother. There was no product quality complaint. Follow-up information indicated that the patient was examined by the physician on 14-JAN-2008 and it was determined that her rash was not varicella. No further information was available. Additional follow-up information received indicated that it was determined not to be chickenpox. No additional information is expected.
FluLaval administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: A pharmacist called to ask for information about the administration of Flulaval to 7 staff members.  The Flulaval vaccines that were administered were exposed to room temperature for a few weeks.  The reporter did not provide exact data about time and temperature of the excursion, but mentioned that vaccines were out of refrigeration approximately from 15th September 2022 to 10th October 2022 and then vaccines were administered to the staff members. The reporter did not provide either the exact date of administration nor the identifiers of the 7 people that received this vaccine.  The reporter asked about the stability of Flulaval when exposed to temperatures higher than recommended and asked if the staff members had to be re-vaccinated. The reporter consented to follow-up. This case was for 1 of 7 linked patients reported by same reporter. Additional supportive information: The patient was administered Flulaval after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR157003:Same reporter US-GSK-US2022156225:Same reporter US-GSK-US2022AMR157001:Same reporter US-GSK-US2022AMR157005:Same reporter US-GSK-US2022AMR157002:Same reporter US-GSK-US2022AMR157008:Same reporter
Light headiness when I get up from lying down or sitting down. Started 3 weeks after the COVID-19 vaccination and has not diminished since. No other symptoms.
Systemic: Confusion-Severe, Systemic: Dizziness/Lightheadedness-Severe, Systemic: Fainting/Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Seizure-Medium, Systemic: Weakness-Severe.
1. L arm- redness, heat, ache, + itching 2. Gross hematuria that has persisted x 2 d