chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had your basic congestion, cough, and fever symptoms; but the worst of it all was that my throat was on fire and super scratchy and itchy. It was intense burning sensation going through my throat. I had sneezing, runny nose, cough, and body aches. I had a painful neck spasm for some time. I had mild nausea but no vomiting as well as a low-grade fever. I was really fatigued. I took several at-home COVID-19 tests; on 12/09/2022, it came back negative. So the next morning on 12/10/2022, I took another one which instantly came back positive. So I took TYLENOL to try to calm my symptoms. As of now, I took another COVID-19 test today which came back today. As of now, most of symptoms has settled except the body fatigue and congestion.
Information has been received from a pharmacist, (who was told by the sister of a patient) concerning a female patient who was vaccinated on an unspecified date with a dose of zoster vaccine live (Oka/Merck) (dosage and route unspecified). Subsequently, on an unspecified date, the patient experienced redness and induration at the site. There were no other symptoms reported, although the patient's sister stated that the patient was bothered so much that she left church early on Sunday, 28-OCT-2007. The patient took an unspecified antihistamine for the reaction and called her physician. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 27-AUG-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
7 yo female was visibly anxious about the vaccination. no problem during administration, minor bleeding after which caused pt to become lightheaded and fall back in fathers arms and hit head on wall, consciousness was not lost for any extended period of time, minor vomiting ensued, pt was given water, a cold compress for warm head, and laid down, after some time and deep breathing, she felt well enough to go home with her father
REDNESS AT INJECTION SITE; PAIN; HEAT AROUND RIGHT ELBOW.
Bell's Palsy- right side. Drooping started in eyebrow, progressed to mouth and cheek. went to urgent care 4/6/2021, prescribed prednisone and rest, sent home.
At around roughly 7:00 pm my regular achy arm became body aches followed by chest pain and shortness of breath. I know I do not have COVID 19 I haven?t left my house since March 2020 until October 2020 to have my baby and since then haven?t been out again except to get vaccinated in March 2021. I also do not have any underlying conditions I?ve had full check ups because I had a baby 6 months ago.  The only side effect concerning me are the shortness of breath and chest pain.
This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FA7480), at the age of 47, in left arm, on Aug 18, 2021, at 20:30, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient developed arthralgia (in right ankle), onset Aug 19, 2021, at 06:30, with outcome of not recovered. Arthralgia in right ankle was evaluated at a physician office visit and emergency room visit. Relevant laboratory tests and procedures available in the appropriate section. Therapeutic measures were taken as a result of arthralgia. Additional information: Treatment received for adverse event was Medrol-dose pack. Event resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications taken in the past two weeks. COVID-19 tested post vaccination. No follow-up attempts possible. No further information expected.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient has a PMH significant for Chronic Ischemic heart disease, AF, HF, HTN, restrictive lung diseas, malignant neoplasm of bladder. Was seen in March with a CC of SOB and chest pain. Enrolled with hospice of county. Pt was 89 YO
Neuropathy gets worse; Loss of appetite; Feels crampy after meal; Lost 5 lbs; Nausea; Chills; Arm soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy gets worse) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pre-diabetic.  Concomitant products included ESCITALOPRAM for Antidepressant therapy, GABAPENTIN for Neuropathy, VITAMIN D2 for Vitamin D deficiency.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 08-Apr-2021, the patient experienced CHILLS (Chills) and MYALGIA (Arm soreness). On 19-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy gets worse) (seriousness criterion medically significant), DECREASED APPETITE (Loss of appetite), ABDOMINAL PAIN (Feels crampy after meal), WEIGHT DECREASED (Lost 5 lbs) and NAUSEA (Nausea).   On 10-Apr-2021, CHILLS (Chills) and MYALGIA (Arm soreness) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy gets worse) and ABDOMINAL PAIN (Feels crampy after meal) had not resolved and DECREASED APPETITE (Loss of appetite), WEIGHT DECREASED (Lost 5 lbs) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Ondansetron 4 mg for nausea. patient mentioned that she is Pre-diabetic. Anti-emetic drug was prescribed by her Physician from Cymbalta reaction.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Myalgia, chills and nausea are consistent with the product safety profile
Chest pain; LBBB (left bundle branch block); NSTEMI (non-ST elevated myocardial infarction); angioplasty & bypass done 1/11/21; discharged home 1/12/21 with referral to radiation oncology and f/u with interventional cardiology.
This spontaneous report was received from a pharmacist referring to a 57 year old female patient with seasonal asthma, penicillin allergy and cephalosporin allergy, who on 02-JAN-2015, was vaccinated with a dose of ZOSTAVAX (lot # K010967, expiration date 06-NOV-2015), 0.65 ml, subcutaneously in the right arm, Concomitant therapies included VENTOLIN, omeprazole (manufacturer unknown) and acetaminophen, NORCO. The pharmacist stated the patient came into the pharmacy and told him that within 24 hours post vaccination (in January 2015), she developed a rash, 5 to 6 inches long, 3 to 4 inches wide, at the injection site which was the back of her right arm. Pharmacist stated that the patient used cortisone cream as treatment. The rash was gone within one week time. The patient recovered on an unknown date at the time of this report. Additional information is not expected because no further details provided.
MS; Fibromyalgia; headache; muscle & joint pain; muscle & joint pain; diarrhea; nausea; just not feeling well; tiredness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 18Oct2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Oct2021, the patient experienced multiple sclerosis, fibromyalgia, headache, muscle & joint pain, diarrhea, nausea, just not feeling well and tiredness. The patient was treated with Baclofen and Tylenol as a therapeutic measure of ms and fibromyalgia. The outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a pharmacist refers to 2 patients of unknown age. The patients were vaccinated with PNEUMOVAX23. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that 3 unspecified patients had swelling (2 patients had unspecified swelling and 1 patient had swelling the size of a baseball at the injection site shortly after administration of PNEUMOVAX23, sometime that week. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested. This case in linked to case 1302USA002092 (same reporter link).
tested covid positive by PCR on 5/23/2021, may  have pneumonia, mild, unclear if covid or bacterial cause. Patient presented with a seizure after binge drinking, relapsed alcoholism
Left upper arm had shoulder pain and swelling. Rash was red on arm for a few days.
The patient was vaccinated on 6/23/22.  On the afternoon of Friday, June  24th, expired Moderna Covid-19 Vaccine was discovered in the refrigerator.  Lot 54A22A was placed into the refrigerator on 5/19/22 and expired 30 days after on 6/18/22.  The expired vaccine was immediately removed from inventory.  A clinic pharmacist then called the manufacturer, Moderna, to report the incident and inquire about the stability of the expired product.  The pharmacist from Moderna submitted a ?lot analysis? request to evaluate the effectiveness of the affected lot against Covid-19 past the 30 day expiration date.  On Tuesday, June 28th, Moderna responded and stated that: ?The vaccine administered on June 22 and June 23, 2022 from lot number 054A22A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  No patient harm resulted.
pt recvd vax given 17SEP93 parotitis p/17 days from inject, cold, cough, inc temp, swollen parotid gland;
Burning Nostrils; Severe migraines; nausea; spine pain; blurred vision in right eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (First dose, MANUFACTURER: UNKNOWN), for Covid-19 immunization. The following information was reported: NASAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Burning Nostrils"; MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "Severe migraines"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; SPINAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "spine pain"; VISION BLURRED (non-serious) with onset 2021, outcome "unknown", described as "blurred vision in right eye".  Additional information: It was reported that, the patient was not on any Medications prior to receiving the Pfizer vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient received Prevnar-13 vaccine on 1/29/2020 Itching and rash onset 5 hours after injection; he denies started new medications or eating new food items or being outdoor prior to onset of symptoms. Prednisone 10 mg- take daily 5 tablets on day 1. 4 tablets on day 2, 3 tablets on day 3, 2 tablets on day 4, 1 tablets on day 5, Disp #15/0 refill Hydroxyzine 25 mg one tablet Q6H PRN Itching, #30/0 refill Take prescribed Medications as prescribed Avoid hot shower- take tepid warm shower, use mild soap or Aveeno body wash Avoid prolonged sun exposure or heat or very cold temperature Ok to use Calamine lotion OTC as needed Report to the nearest emergency room for worsening symptoms or any respiratory symptoms such as shortness, throat tightness or discomfort or chest pain Patient voiced understanding and agreed to plan of care
Severe osteoarthritis of the glenoclavicular joint, with joint space narrowing, cartilage loss, (unknown) formation and (unknown) of large osteophytes (right shoulder). The follow up states 12/12/02 lot # not recorded for LYMErix vaccines.
exposure on her right eye to Kinrix Vaccine; exposure on her right eye to Kinrix Vaccine; This case was reported by a other health professional and described the occurrence of accidental occupational exposure to product in a female employee while administering DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 27th October 2021 10:53, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced accidental occupational exposure to product and exposure via eye contact. On an unknown date, the outcome of the accidental occupational exposure to product and exposure via eye contact were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The other health professional reported that on 27th October 2021 at 10.53 AM, employee had exposure on her right eye to Kinrix Vaccine, which led to accidental occupational exposure to vaccine and exposure via eye contact. The reporter informed that the employee had rinsed her eye for 15 minutes after the exposure, and she's requesting additional medical advice. The patient suffered an exposure on her right eye, resulting in no symptoms. No further information reported. The reporter consented to follow up. This case has been linked with case US2021091657, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021091657:same reporter
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EP7533), in left arm and on 22Apr2021 as dose 2, single (Lot number: ER8735) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild hypothyroidism" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (02May2023) Negative; (03May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid..; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180817 same patient, different drug/event;
patient received the vaccine post excursion with no adverse event; Initial information received on 22-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2022SA519157.  This case involves a 13 years old male patient who received the IPV (VERO) [IPOL] Poliomyelitis Vaccine (Inactivated) post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella Zoster Vaccine (Varicella Vaccine) for Immunisation.  On 21-Sep-2022, the patient received 0.5 ml Total (1 X) (Dose 2) of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (lot number: V1A024M, expiry date: 17-Feb-2024, Strength: Standard, Frequency: once) via intramuscular route in the left deltoid for immunization.  On 21-Sep-2022, the patient received the Poliomyelitis Vaccine (Inactivated) post excursion with no adverse event (poor quality product administered) (Latency: same day)  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
2 episodes of eyes rolling back in head and generalized increase in tone, no shaking, mild headache, subjective fever, pt taken to ER temp = 99 degrees given fluids, ibuprofen.
This spontaneous report as received from a Doctor of pharmacy refers to a 2 days old patient of unknown gender. The patient was vaccinated accidentally with 2 doses of RECOMBIVAX HB (route and lot # not reported) instead of 1 dose, on 20-JAN-2013. Additional information has been requested.
I received my Covid-19 vaccine on 10/22/2022. On 01/10/2023 I woke up with a sore throat, headache, body ache, chills, pain in sinus area and fatigue. I went the next day to do a PCR test for Covid-19 and were positive Covid-19. After testing positive I reached out to my doctor and was prescribed PAXLOVID. Symptoms started to resolve within 48 hours with still ongoing symptoms (runny nose and fatigue).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, he was treated at a hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapies were reported. On 26-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA lot # L009445, expiration date 01-JUN-2017 (dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
17APR95 c/o body aches, joint aching, fever 100.6; extreme dizziness & fatigue; 24APR95 devel fine red rash over entire trunk of body, arms, stomach & legs, body ache, h/a; t99.6; As of 27APR95 feeling much better, but off work;
Had thyroid cancer after vaccine admin all of a sudden from a scan a year before no lumps or cancer. Now I have tumors in my breast that grew significantly over the past few months and a new jump in my left breast that wasn?t there in march
Three patients have been seen in follow-up visits and have reported mild injection site pain; fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An elderly patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Oct2023, outcome "unknown", described as "Three patients have been seen in follow-up visits and have reported mild injection site pain"; FATIGUE (non-serious) with onset Oct2023, outcome "unknown". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  Additional information: It was reported that the RSV older adult vaccine was prescribed to approximately 7 patients. Three patients have been seen in follow-up visits and have reported mild injection site pain and fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300362628 Same product and event; different patient;US-PFIZER INC-202300362807 Same product and event; different patient;
The pt experienced crying, crankiness, fever, treated with Tylenol the same day of vax. The pt had a strep infection with ER treatment in fall of 1987. Bronchitis in the fall/winter of 1987, limping in the summer of 1988 and in the Fall of 1997, JRA was diagnosed. Per doc 214443, annual follow-up: JRA juvenile rhumetoid Arthritis. Do not feel it was one specific vaccination that caused the response, but caused from the combination of vaccines over a period of time.
After the administration of the vaccine, the Patient turned very pale, her lips were very blue, was very dizzy and almost fainted.
I was diagnosed with type I diabetes on 2/14/2020 and I believe it is a direct result of the Flu shot that I received that year.  The first symptoms (frequent urination, increased thirst) that I can recall started on 11/15/2019,  but symptoms could have started sooner.  It's hard to say for sure but I know I didn't have any prior to 10/7/2019.
Muscle and joint achiness for 3 days, resolved; chills for 2 days, resolved; pain, redness, and swelling around site of injection for 4 days, ongoing, pain is diminishing, area of redness and swelling has expanded to about 2 inches in diameter.
pt recvd vax & exp swelling knees 24 hrs p/vax;elbow & wrist pain & swelling resolved 2-3d;nostianzth(?)-cannot sleep;fingers swollen & painful;numbness both extremities;
swollen lymph node in right arm pit area nickel size, noticed evening of 1/4