chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 27-OCT-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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. On or about 05-JUN-2017, the patient was treated by a physician, for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate 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. Additional information has been requested.
side effects after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after second dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after second dose). At the time of the report, VACCINATION COMPLICATION (side effects after second dose) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.    This case was linked to MOD-2021-398710 (Patient Link).
Administered Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
When I woke up 3/18/2019 at 5 AM I noticed that my neck, chest & under the breasts were all red. It went all the way up the back of my neck & in the hair and all the front of my neck. It was hot to touch but didn't itch. I felt very warm all day but did not have a fever. I put a cold wash cloth on my neck when I got home from work at 3:30 PM. My neck was still red the next day but better but my noon it started to itch alittle. On 3/20/2019 it wasn't as red and was feeling better. Arm was sore & red at the site on 3/17/2019. Little tender still on 3/20/2019.
hardness at the site; swelling on that arm from the vaccine but it is a little bit improved; soreness that lasted for a couple days and that was a little more severe then the usual flu shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness at the site), VACCINATION SITE SWELLING (swelling on that arm from the vaccine but it is a little bit improved) and VACCINATION SITE PAIN (soreness that lasted for a couple days and that was a little more severe then the usual flu shot) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling on that arm from the vaccine but it is a little bit improved) and VACCINATION SITE PAIN (soreness that lasted for a couple days and that was a little more severe then the usual flu shot). On 22-Mar-2021, the patient experienced VACCINATION SITE INDURATION (hardness at the site). At the time of the report, VACCINATION SITE INDURATION (hardness at the site), VACCINATION SITE SWELLING (swelling on that arm from the vaccine but it is a little bit improved) and VACCINATION SITE PAIN (soreness that lasted for a couple days and that was a little more severe then the usual flu shot) had resolved.            No concomitant medications were reported.  No treatment related information was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: event outcome updated
This spontaneous report as received from a nurse practitioner refers to a 20 month old female patient with no medical history and no drug allergies. On 14-JUN-2013 the patient was vaccinated with a dose of VARIVAX dose, route and lot # not reported. Concomitant therapies included albuterol. The patient developed a red, itchy rash after receiving VARIVAAX. The rash started on 17-JUL-2013 (approximately two days before the date of report) and started on the back of the right shoulder and spread to right scapula. The reporter mentioned there were no clear vesicles and the rash looked like folliculitis. No lab diagnostics studies were performed. The patient was treated with unspecified steroid cream. The patient sought medical attention by office visit. The outcome of adverse event was reported as not recovered/not resolved. The relatedness between adverse event and VARIVAX was not reported. Additional information has been requested.
The day after the vaccine, experienced muscle pains, aches, join pain.  Had fever chills, headache, nausea, diarrhea, dizziness.  Prolonged symptoms of muscle and joint pain still ongoing as of 3/15.
Red rash to RUE (approx 3? x 2?). Noted at approx 1805 after work shift. Applied Benadryl Itch Cooling Spray daily for 2-3 days, took Signature Care Levocetirizine Dihydrochloride 5 mg qAM as usual. Rash cleared by 1/25-26
This spontaneous case was reported by a consumer and describes the occurrence of SKIN BACTERIAL INFECTION (A bacterial skin infection), ERYTHEMA (Arm turned red), PERIPHERAL SWELLING (Arm turned swollen), PRURITUS (Arm turned itchy) and RASH (Rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, SIMVASTATIN, CENTRUM SILVER WOMEN 50+ and CALCIUM CITRATE TETRAHYDRATE, COLECALCIFEROL (CITROCALCIO) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021 at 2:28 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced SKIN BACTERIAL INFECTION (A bacterial skin infection), ERYTHEMA (Arm turned red), PERIPHERAL SWELLING (Arm turned swollen), PRURITUS (Arm turned itchy) and RASH (Rash). The patient was treated with SULFAMETHOXAZOLE;TRIMETHOPRIM for Bacterial infection, at an unspecified dose and frequency. At the time of the report, SKIN BACTERIAL INFECTION (A bacterial skin infection), ERYTHEMA (Arm turned red), PERIPHERAL SWELLING (Arm turned swollen), PRURITUS (Arm turned itchy) and RASH (Rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient was pot on a safe barrier bandage, circular bandage, thick around outside and bandage part in the middle, where the vaccine was injected.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Patient demographics, concomitant medications, treatment medication and additional event updated.
Still hospitalized. This is a 75-year-old  immunocompromised female with a PMH of breast cancer on tamoxifen, HFpEF, IDDM2, HTN, GERD, and ESRD who presented to the  ER 1/11/22 with a CC of generalized weakness x 1 week and a positive home COVID test.  CXR showed mild bilateral patchy opacities.  Pt was given Tylenol, Decadron, 500 mL IVF bolus and transferred to facility for hospital admission. On interview, telephone interpreter was utilized throughout.  Pt states she has been progressively weak with shortness of breath, cough, fever and chills x 1 week.  she states she was too weak to get up and ambulate with her walker as she typically would.  She states she fell and hurt her right knee trying to walk up steps yesterday.  She states she was started on hemodialysis approximately 2 weeks ago.  She states she cannot recall the name of her nephrologist or cardiologist.
APPENDICITIS; This spontaneous report received from a patient via a company representative via concerned a patient of unspecified age, sex, race and ethnicity. 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 not reported, batch number: Unknown) dose was not reported, frequency was one total administered on 06-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced appendicitis and had to have emergency surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of appendicitis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210931861-Covid-19 vaccine ad26.cov2.s-Appendicitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Information has been received from a physician assistant concerning a 23 year old female, who on 21-OCT-2008, was vaccinated, IM, with the first dose of GARDASIL, 0.5 ml ( Lot # 0152X). Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). On 21-OCT-2008, a few hours after receiving her first dose of GARDASIL, the patient experienced localized area of redness, swelling, numbness and a raw feeling on her chin. The patient's localized are of redness and swelling and numbness and a raw feeling on her chin persisted. It was reported that the patient sought medical attention: contacted the office by phone and an appointment in the office had been scheduled. Additional information was received from a physician assistant stating that the patient received GARDASIL in the morning and later that afternoon/evening, patient experienced swelling tin the jaw and chin. This was patient's first dose of GARDASIL. AE reported back around 22-OCT-2008. The patient had no significant medical history and no concomitant medication. Additional information has been requested.
always administered Fluarix to their pregnant patients; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in an unspecified number of female patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2020-2021 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The reporter mentioned that, they had always administered Fluarix to their pregnant patients, which led to vaccine exposure during pregnancy. No other information was provided. The reporter consented to follow up.   Follow up information received on 2nd March 2021: The reporter stated that none of the patients had experience adverse reaction. The reporter asked if GlaxoSmithKline need records of all patients given Fluarix Quadrivalent 2020-2021 even if no reaction.  Follow up information received from other healthcare professional on 9th September 2021: The reporter reported that he/she did receive this form earlier this year but there was no patient information on it. He/she do not show in their records that any patient called them with an adverse reaction, so without patient information from GlaxoSmithKline, he/she was not sure who this was for. The pregnancy outcome was considered lost to follow up.
At approximately 18:00 on 01/05/2021 I noticed my hearing was hypersensitive. At about 20:00 I experienced hearing loss in my left ear like I had an ear infection. This morning I woke up and it is worse. I can barely hear out of my ear and I have tinnitus. I am dizzy and feel cautious.
vaccine brand other: Moderna, vaccine dose number: 4; vaccine brand: Pfizer / BioNTech, vaccine dose number: 3; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8132), in left arm, on 25Apr2021 as dose 2, single (Lot number: RW0170), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: 3302680) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Sep2022 as dose 4 (booster), single (Lot number: AS7162B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "obese" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other: Moderna, vaccine dose number: 4; vaccine brand: Pfizer / BioNTech, vaccine dose number: 3". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid treatment from 27Aug2023 to 01Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296454 same patient different drug/event;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 20-NOV-2014, a healthcare provider at a county health department administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-OCT-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
patients have received DAPTACEL past expiration date with no reported adverse event; Initial information received on 12-Jul-2023 regarding an unsolicited valid non-serious case received from physician.  This case is linked to cases 2023SA214127, 2023SA213484, 2023SA214713, 2023SA214480 and 2023SA213445.  This case involves a 5 years old and unknown gender patient who had received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] past expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine inact 3V (vero) (IPOL); measles vaccine, mumps vaccine, rubella vaccine (MMR); and varicella zoster vaccine live (OKA/MERCK) (Varivax) for Prophylactic vaccination (immunization).  On 13-Mar-2023, the patient received 0.5 mL dose 5 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: C5829AA; Expiry date: 01-Mar-2023) via intramuscular route in unknown administration site for immunization past expiration date with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patients have received daptacel past expiration date with no reported adverse event.  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.
Shortness of Breath Extreme fatigue Dizziness/Brain fog Body aches and pains
After the vaccination, for both doses, there was a significant sensation of pressure in chest.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 46-years-old non pregnant female patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, batch/ lot number: ER8733) via an unspecified route of administration on unspecified date in 2021 (at the age of 46 years) as dose 1, single dose for covid-19 immunization. It was reported that no covid prior vaccination and no known allergies. The patient's medical history and concomitant medication were not reported but reported that patient took other medication in 2 weeks from vaccination and no other vaccine administered in four weeks. On unspecified date in 2021, immediately after the vaccination, patient experienced significant sensation of pressure in her chest that lasted approximately 3 to 5 minutes, then went away. No other side effects. It was reported as non-serious. Not tested for covid post vaccination. No treatment received for the events. The outcome of the event was recovered on unspecified date in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
2-3 days after I had hives (itchy) show up on my hands and it's spreading. I've also had recocurring migraines which started on Friday April 9th and have continuted to occur. When I bend or tilt my head, the pain gets worse and I'm unable to cook, move around or function. It feels much worse than a headache.
He developed herpes zoster 2-3 days after receiving first dose of SHINGRIX.
left upper arm with erythematous warm, tender lesion at site of varicella vaccine, no drainage. Dr. diagnosed reaction as cellulitis and patient was prescribed AUGMENTIN 875-125 MG TABS
Presented to ED with fever, chills. Infectious disease dx allergic reaction to one of the vaccines, no active infection.
Chills, body aches, feeling warm(  normal temp), fast heart rate, headache unable to sleep. 12 hours  after receiving vaccine.  sypmtoms lasted x 3 hrs.  with Tylenol
Soreness of the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness of the site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015621A or 0512H) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced VACCINATION SITE PAIN (Soreness of the site). At the time of the report, VACCINATION SITE PAIN (Soreness of the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information were reported by the reporter.   This case was linked to MOD-2021-270210 (Patient Link).
Patient received a moderna vaccine per his and his guardians request rather than receiving a Pfizer vaccine.  No adverse reactiond
Covid arm (upper left arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm (upper left arm)) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038-A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LIOTHYRONINE for Thyroid disorder.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE REACTION (Covid arm (upper left arm)). On 22-Apr-2021, VACCINATION SITE REACTION (Covid arm (upper left arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2021-114437 (Patient Link).