chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hpv vaccine used as treatment for bilateral plantar warts; This literature marketed report has been received from the authors of the published article, concerning a 36 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, salicylic acid, candida albicans and curettage. The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacture unknown) for bilateral plantar warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several records received from the same literature .
Under arm pain; Dizziness; Brain fog; Neck pain; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 25May2021 at 11:00 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. Medical history included anemia, since unknown date. The patient did not have any allergies to food, medications, or other products. The patient did not receive any medication within two weeks of vaccination. 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 vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on an unknown date, as a single dose for COVID-19 immunisation. On 26May2021 at 12:00, the patient experienced under arm pain, dizziness, brain fog, neck pain and fatigue. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events under arm pain, dizziness, brain fog, neck pain and fatigue were not recovered 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.
had anaphylactic reaction after 12 days; itching; ringing in her head; wooziness; disorientation; trouble swallowing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (had anaphylactic reaction after 12 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (History of reactions to food). Concomitant products included DIPHENHYDRAMINE for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced ANAPHYLACTIC REACTION (had anaphylactic reaction after 12 days) (seriousness criterion hospitalization), PRURITUS (itching), TINNITUS (ringing in her head), DIZZINESS (wooziness), DISORIENTATION (disorientation) and DYSPHAGIA (trouble swallowing). The patient was hospitalized on 14-Feb-2021 due to ANAPHYLACTIC REACTION. At the time of the report, ANAPHYLACTIC REACTION (had anaphylactic reaction after 12 days), PRURITUS (itching), TINNITUS (ringing in her head), DIZZINESS (wooziness), DISORIENTATION (disorientation) and DYSPHAGIA (trouble swallowing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Several days after the first Moderna vaccination on 14Feb2021, the husband reported that after dinner the patient experienced itching, ringing in her head, wooziness, trouble swallowing, and disorientation.  We called 911 and the ambulance came and took her to the hospital. time. At the emergency department, they did lot of tests, but negative result. On an unspecified date the patient was seen by an allergist and food allergies were ruled out by the allergist.  No additional treatment information was provided. Action taken was reported as unknown.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-081674 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Anaphylactic reaction captured in event tab as medically significant and the emergency department did lot of tests, but negative result.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-081674:Dose 1
Headache, Myalgia, Arthralgia, CHILLS, EXTREME SWEATING Narrative:
vaccinated 3 days ago and am still tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (vaccinated 3 days ago and am still tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (vaccinated 3 days ago and am still tired). At the time of the report, FATIGUE (vaccinated 3 days ago and am still tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
40 patients administered with vaccines that have undergone temperature excursion; on 31Jan2022 temp range: positive 34.7F to positive 41.2F for 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (on 31Jan2022 temp range: positive 34.7F to positive 41.2F for 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (on 31Jan2022 temp range: positive 34.7F to positive 41.2F for 12 hours). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (on 31Jan2022 temp range: positive 34.7F to positive 41.2F for 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  The vials had Maximum or minimum temperatures reached, as applicable (specify temp is in C or F). On 28Jan2022 temp range: positive 34.7F to positive 41.2F; on 30Jan2022 temp range: positive 34.7F to positive 41.2F which occurred approximately for 48 hours; on 31Jan2022 temp range: positive 34.7F to positive 41.2F for 12 hours and on 04Feb2022 temp range: positive 35.2F to positive 41.7F for 12 hours.  The vial was thawed on 28-Jan-2022.
pt devel abd pain 8/25/99 & adm w/pancreatitis on 8/26/99; disch on 8/30/99;rx w/NPO, IV fluids, Zantac 150mg IV bid;
Increased temperature, arthralgia, fatigue. Ruddy rash, arms and thighs. Jaundice, nausea, vomiting. Mild renal damage-resolved, dark urine.
Large (4") diameter red warm patch surrounding the site injection - Tx with BENADRYL and Ice at site.
calcium 1500; right coronary blockage; clotting; fainted, like syncope events; electrical blood issues; electrical in nature; Fatigue; Dizziness; in the triceps area in the upper arm near the shoulder; This is a spontaneous report from a contactable consumer (patient). This 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8727) via an unspecified route of administration in the triceps area in the upper arm, near the shoulder on 22Mar2021 (at 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or relevant family history. Concomitant medications included pitavastatin calcium (LIVALO) taken for 3 or 4 years for cholesterol and zolpidem tartrate (AMBIEN) from an unknown date for sleep. The patient previously received the first dose of BNT162B2 on 03Mar2021 (lot number FN6206) in the triceps area for COVID-19 immunisation. The patient had no prior vaccination within 4 weeks. The patient stated he was calling regarding the Pfizer Covid vaccine and reporting some side effects that had occurred. The patient reported it started probably in Apr2021. He started to have fatigue and was kind of curious. He went to the internal medicine doctor and had an annual physical that was probably in Jul2021. He was referred to a cardiologist and it looked like he was going to have to have a stent put in his heart and also some other diagnostic monitoring, a LINQ device. It looked like somewhat electrical in nature, along with a right coronary blockage. The patient stated there were a lot of other complications with the right coronary blockages, electrical blood issues, those kinds of issues. The clotting was identified in Jul2021 but probably started before then, he couldn't say; the clotting was identified in Jul2021 but that was usually what causes blockages. Now (as of 28Sep2021), he had to have a LINQ device that was "kind of like" a Holter monitor. The LINQ device was "like" an internal Holter monitor and they were going to monitor his electrical activity. Also, based on a computerized tomography (CT) scan yesterday (as of 28Sep2021) of the heart, it looked like he was going to have to have a stent placed in the right coronary. The patient reported no new medications were started regarding the reported events. The patient reported he fainted in Apr2021 and again in Jul2021; further reporting they were like syncope events preceded by dizziness, which he reported still experiencing and had not gotten better. The patient reported needing an emergency room visit when he fainted, during which he was admitted to the emergency room and did not have to stay overnight. The clinical outcomes of fatigue and dizziness were not recovered; the outcomes of the other events were unknown.
After the vaccine pt experienced some numbness and tingling in her tongue, then a tightness in her chest and then found it difficult to breathe.  Developed a facial rash and periorbital edema.  These symptoms waxed and waned.  Pt given PO Benadryl as well as epinephrine by EpiPen.
Patient reported sharp pain radiating from neck to r. shoulder blade that she believes is from the vaccine.  FLUHD in R ARM, pneumovax23 in left arm.  Pt notified pharmacy of reaction, gave her suggestions of icing area, treating with APAP and follow up with her primary care physician.  Additionally, I contacted DR office and let them know of the reaction (4pm 9/24/19).  Will be filing VAERS today.
Patient reported to pharmacy on 9-10-18 that starting on 9-2-18 she had a redness on side of arm opposite injection site and a rash that spread to her chest.
Fever 102, Severe Chills, Feeling hot,  Aches & Pains, Extreme Tiredness (thursday 3/11), Sore Arm where it was difficult to lift (only lasted 4 hours), Extremely weak unable to reach for my cell phone, Headache, Very bad neck pain,  Feeling like I had the flu, Sweating, nauseous and couldn't eat. Did not sleep at all Wednesday 3/10 night  due to the aches and pains, could not get comfortable.  Couldn't lie down or sit up comfortably and barely able to stand. I slept most of the day on Thursday 3/11 and was so tired I would fall asleep in mid sentence. Took ibuprofen 200mg and helped SLIGHTLY and wore off very quickly. Couldn't wait to get to the four hour mark to take more. I was so sick my husband wanted to take me to the ER.  I woke up on Friday 3/12 feeling back to myself.  I was told by my Rheumatologist to stop take HP Acthar Gel and Xeljanz for one week after the vaccine.
Redness. Pt watched it for a while, improving steadily. Afebrile BP 150/40, pulse 80, R 16. Fairly linear oval 4 cm longest dimension, slightly raised. Pt given Dicloxacillin. Pt to f/u in office on 1-31-08.
Patient was given TDAP in right deltoid. following injection patient has pain at site and decreased mobility in the right upper extemity. unable to lift arm above head.
Initial misuse report received from a healthcare professional on 30 July 2013. A child had only received DTaP/IPV component of PENTACEL and did not receive ActHIB component. No adverse event was reported. List of documents held by sender: none.
Pt received Moderna vaccine, later that day pt complained of having a productive cough with blood-tinged sputum.
following administration of booster dose. Patient reports tongue senation (swelling and tingling) and tickling back of the throat. patient was assessed by onsite provider at 11:28. Lung sounds normal and no wheezing.  Epi given to patient at 11:31. EMS was called 11:38 for patient. Pt stable when paramedics arrive.
Dizziness, intense nausea, disoriented all within 15 minutes. After 2 +/-  hours, symptoms continued, but now pain in arm, body feels like I got run over by a truck, disoriented like I?m on a treadmill upside down, at fast pace, feeling of heat and cold, intense headache, heart fluttering, GI symptoms getting a bit worse.
Generalized aching; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching), PYREXIA (Fever) and FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Plaque psoriasis.  No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced PAIN (Generalized aching), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, PAIN (Generalized aching), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown. Not Provided    mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.    No concomitant medications were reported No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for the event(s) of BODY ACHES, FEVER and FATIGUE with HUMIRA(ADALIMUMAB) was no  reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot number N010115 and expiration date of 24-SEP-2018 for prohylaxis (dose, route of administration, lot number and expiration date were not reported) reconstituted with sterile water diluent lot number (lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 15°F to 46°F with a time frame of 15 hours and 50 minutes, while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved. There was not product quality complaint involved. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1712USA002600:
sore arm, nauseous, diarrhea, fatigue, loss of appetite, lower back pain, upper thigh muscle ache, mild headache, joint pain
Allergic reaction; Itchy; Breaking out all over the body; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Breaking out all over the body), HYPERSENSITIVITY (Allergic reaction) and PRURITUS (Itchy) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ACNE (Breaking out all over the body). On 27-May-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction) and PRURITUS (Itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy and Acne aggravated, at a dose of 1 dosage form. At the time of the report, ACNE (Breaking out all over the body), HYPERSENSITIVITY (Allergic reaction) and PRURITUS (Itchy) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided.   This case was linked to MOD-2021-207609 (Patient Link).
At approximately 2:30pm, patient sustained an abrasion to the bridge of her nose and a bloody lower lip as a result of an apparent unwitnessed syncope. She was found by the nurse sitting on the exam table crying and upset. I examined her and noted the abrasion & lower lip lacerations. I examined her 2 more times before patient left fully recovered at 3:35.
Pt had mild dementia prior to vaccine.  Was able to walk, toilet herself, feed herself,.  After Vaccine pt became bedbound within 12 hours, markedly confused, and anorexic
1st dose JANSSEN,2nd dose Pfizer; 1st dose JANSSEN,2nd dose Pfizer; really sick; Dizziness; No appetite; joint pain; nausea; in bed for 7 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20211229790(0) (JANSSEN).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Janssen Covid-19 vaccine (Covid-19 vaccine AD26. COV2.S) (Suspension for injection) (Covid-19 Vaccine)), for Prophylactic vaccination. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "1st dose JANSSEN,2nd dose Pfizer"; ILLNESS (non-serious), outcome "unknown", described as "really sick"; BEDRIDDEN (non-serious), outcome "recovered", described as "in bed for 7 days"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; DECREASED APPETITE (non-serious), outcome "unknown", described as "No appetite"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Additional information: It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov.s (dose number in series 1). The patient received non-company suspect booster vaccine: BNT162 (from of admin, route of admin, and batch number were not reported), 1 dose and total, start therapy date were not reported for prophylactic vaccination (dose number in series 2). On an unspecified date following BNT162 (Pfizer) vaccination, the patient got really sick. From the next day, the patient was in bed for 7 days with joint pain, Nausea, Dizziness and no appetite (Dose number in series 2). As per reporter relatedness between BNT162B2  and reported events was reported as unknow. As per reporter and manufacturer relatedness between BNT162B2  and reported events was reported as possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tested positive for covid-19; tested positive for covid-19; sore throat; fatigue; 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 34-year-old male patient received BNT162b2 (COMIRNATY), on 13Apr2021 as dose 1, single (Batch/Lot number: unknown), on 04May2021 as dose 2, single (Lot number: EW0153) and on 21Dec2021 as dose 3 (booster), single (Lot number: FD8448) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid-19"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive, notes: via 2 at-home rapid tests; (13Jun2022) Positive, notes: today via 2 at-home rapid tests. Clinical course: It was reported that, having been fully vaccinated (2 doses) and boosted (1 dose), I tested positive for covid-19 today via 2 at-home rapid tests. So far, my symptoms are relatively minor, and include sore throat and fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1st day thru 3rd day intermittent shortness of breath occurred about 4 hours after vaccine dose, some lymph swelling under left arm 2nd day, fatigue for a couple of days, light chills first night, on the 15th day pulsing tinnitus in both ears and intermittent rapid heartbeat and anxiety and feeling unwell, temp of 99.4 went and had covid test returned negative, pulsating tinnitus still happening on day 16 post 1st dose of vaccine.
Fever of 101 for 2 days. Felt ill and dizzy for several days. Had an episode of Vertigo - which I never had before.
headache shivers freezing  pain arm and whole body nausea intense fatigue dizziness
Patient developed large egg sized welt at the site of injection 1/26/2020, 9 days after administration. Raised, erythematous lesion accompanied by pruritus ("Covid arm.") Pruritus was controlled by topical cream (Sarna). This subsided by 2/4/2020, but the following day patient developed rash at site of injection with punctate, erythematous lesions (bumps) accompanied by severe pruritus. Was given diagnosis (remotely) of shingle.  Patient has had both doses of shingles vaccine (Shingrix). Pruritus resolved within 4 days. Lesions persisted for 10-12 days.