chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "ex-smoker" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "known allergies: Keflex"; Septra, reaction(s): "known allergies: Septra". Vaccination history included: Pneumovax23, reaction(s): "known allergies: PneumoVax23". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received anti-viral treatment nirmatrelvir/ritonavir (PAXLOVID) from 25Jul2022 to 30Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Mildly sore arm at injection site. Flu-like symptoms: fever, chills, body aches, headache, malaise, fatigue, weakness x 24hours.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A patient of unspecified age and gender receive PREVNAR 13, (Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for for pneumonia vaccine. The patient's medical history and concomitant medications were not reported. The patient experienced bad swelling on arm which lasted for a week. It was reported that event took place after use of product. Outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested.
no adverse event; an expired dose ofM-M-R II was inadvertently administered to a patient today; This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 14-APR-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S006051 with expiration date on 27-FEB-2021, therapy type: rHA (exact dose, route of administration were unknown) for prophylaxis. No adverse events were reported.
Metal/tin taste in mouth immediately after, for about 10 minutes; Tingling and numbness on left side of mouth and face immediately after; Tingling and numbness on left side of mouth and face immediately after; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 15:45 (Lot number: ER8734) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 10Apr2021 15:45, outcome "recovered" (2021), described as "Metal/tin taste in mouth immediately after, for about 10 minutes"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 10Apr2021 15:45, outcome "recovered" (2021) and all described as "Tingling and numbness on left side of mouth and face immediately after". Therapeutic measures were not taken as a result of dysgeusia, paraesthesia, hypoaesthesia.  Additional information: The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient received Prevnar 20 on 07/29/2023 in her right deltoid. She came into the pharmacy today 08/04/2023 informed us about local injection site reactions: swelling, redness, tenderness, soreness. We recommended her to apply ice compress and take tylenol to help with sorness because she has history of stomach ulcer and if it gets worse she should inform and see her PCP.
A report has been received from a Physician concerning a 11 year old, male subject, who ha been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 24-OCT-2014. The patient experienced tested positive for  Flu A which started during NOV-2014. The outcome of the event of tested positive for Flu A is unknown. The report was considered to be non-serious.
This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, since 05-SEP-2014, the patients were vaccinated with GARDASIL (dose, lot# were not reported) which were exposed to an unsupported temperature excursion of 59F for a cumulative total of 132 hours. On 05-SEP-2014, total excursion time was 63 hours. On 16-SEP-2014, total excursion time was 15 hours. On 18-SEP-2014, total excursion time was 24 hours. On 23-SEP-2014, total excursion time was 15 hours. On 29-SEP-2014, total excursion time was 15 hours. No Product Quality Complaint (PQC) was involved. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Redness, itching, pain, warm, spreading. Pain got worse each day-went to visit her PCP 10/14/13.
The excursion expiration date of 7 days thawed in refrigerator was followed because of the Pfizer email approving the 7 days. Policy was to follow the expiration of 5 days.
pt recvd vax 2MAY95 & 11MAY95 exp lightheadedness & fever;12MAY95 reported to employee hlth dept c/o joint pain in neck;rt lower abd pain & constipation
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot # R003114, expiration date 27-SEP-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 74 degrees Fahrenheit for 72 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA000365.
Fever, headache, chills, nauseous, and drowsy. I took Tylenol and slept for 16 hours.
The patient reports the following: "So about 30 min -1 hour after my vaccine shot, I got extremely light headed and fatigued. I couldn't keep my eyes open. I was driving and must have lost consciousness for a really short time but enough for someone to report my driving/or cop seeing me. When the police officer was talking to me I didn't have any energy to speak, generally fatigued, and couldn't remember basic Information. The police officer issued me a ticket after I told him I didn't feel well after receiving vax. "  The patient was advised by co-workers to report the event to the vaccine provider.
TOOK THIRD DOSE ON DAY 6; This spontaneous case (PVX2019-1066) was received from pharmacist on 01-May-2019. It describes a 58-year-old female consumer who "took third dose on day 6", while being on Vivotif for an unknown indication.  Case report: The consumer took the third dose on day 6. The doses were taken on 25-Apr-2019, 27-Apr-2019, and 30-Apr-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took third dose on day 6" was unknown.  Company's Comment: The causality of the event "took third dose on day 6" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 6" was considered as not applicable.
soreness of the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of the vaccine".  Additional Information: Caller is asking about the fall vaccine that just came out this afternoon, she had all the other vaccines before. She would like to know if she could take Tylenol before she takes the vaccine to eliminate the arm soreness. Created manual AE form as she gets soreness in her arm whenever getting the vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vaccine in an unknown thigh; cellulitis; This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. In July 2021, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the cellulitis to be related to Kinrix and Kinrix Pre-Filled Syringe Device. 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 reported. The pediatric patient received Kinrix in an unknown thigh which led to vaccine administered at inappropriate site.  Less than a week after receiving Kinrix, the patient developed cellulitis.  The reporter consented to follow up. The reporter and healthcare professional gave permission to contact them for further information. No other information was shared. This was 1 of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR154890:Same reporter US-GLAXOSMITHKLINE-US2021AMR154892:Same reporter US-GLAXOSMITHKLINE-US2021153977:Same reporter
This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a 57-year-old female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On 11th March 2018, less than a year after receiving SHINGRIX, the patient experienced fatigue, malaise and pain. On an unknown date, the outcome of the fatigue, malaise and pain were unknown. It was unknown if the reporter considered the fatigue, malaise and pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced severe fatigue, general malaise and body aches. This case was linked to the case US2018GSK080273, reported by the same reporter.
sore arm (no pain medication taken for it) fatigue ( has not improved since injection) night sweats (has not improved since injection)
This spontaneous report was received from a medical assistant and refers to a 8 months old female patient. No information regarding the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was provided. On 02-AUG-2016 at 14:30, the patient was vaccinated with an improperly stored third dose of ROTATEQ lot # L039141 and expiration date 16-AUG-2017, (Strength and dose were not reported), via oral. It was reported that the vaccine was exposed to a temperature excursion described as a minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The healthcare worker also stated that the MIN and MAX were not cleared previously. No previous temperature excursion was noted. Patient's concomitant medication was not provided. No adverse effects were reported. A product quality complaint was not involved. This is one of the several reports received from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Initial report received on 27-September-2013 from a reporter. A number of patients whose age, medical history and concomitant medications were not reported, received a dose of FLUZONE QIV (route and site of vaccination was not reported). The reporter stated that after immunizing the staff, everyone was complaining of severe arm pain, radiating from the shoulder to the elbow. One employee stated that the pain was so severe it was keeping her from sleeping and she considered going to the emergency room. List of documents held by sender: none.
Headache; Tiredness; Fever; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 09Feb2021 at 17:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 09Feb2021 at 19:00, the patient experienced headache, tiredness and fever. Patient received Acetaminophen as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered on an unspecified date. The events were considered non-serious.
positive COVID test result; positive COVID test result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 06Apr2021 at 14:00 as dose 1, single (Lot number: ER8737), in left arm and on 04May2021 at 15:00 as dose 2, single (Lot number: ER8734) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: seafood" (unspecified if ongoing); "Known allergies: dairy" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing); "Known allergies: Beef" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC D. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "positive COVID test result". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (10Jan2022) Positive.  Clinical course: No other vaccine in four weeks. No covid prior vaccination. Patient tested for covid post vaccination. No Other medical history.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300297624 same patient, different dose;
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "Mild asthma" (unspecified if ongoing), notes: Mild asthma; "Known allergies: Sulfa based drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin antibiotics, reaction(s): "Known allergies: Drug allergy", notes: Augmentin Antibiotics. The following information was reported: COVID-19 (medically significant) with onset May2022, outcome "recovered", DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical Course: Reported event: red rash from head to chest, throat swelling while taking COVID symptoms were mild after taking first dose on 05May2022 and stopping the medication on 07May2022, COVID symptoms came back worse than before taking the medication. COVID symptoms started again on 10May2022. reaction from 07May2022 13:00 to 08May2022. Treatment was received for the adverse event BENADRYL.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
numbness in both hands; tired; light headache; hands turning numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (hands turning numb), FATIGUE (tired), HEADACHE (light headache) and HYPOAESTHESIA (numbness in both hands) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HYPOAESTHESIA (hands turning numb). On 11-Mar-2021, the patient experienced FATIGUE (tired) and HEADACHE (light headache). On 12-Mar-2021, the patient experienced HYPOAESTHESIA (numbness in both hands). At the time of the report, HYPOAESTHESIA (hands turning numb), FATIGUE (tired), HEADACHE (light headache) and HYPOAESTHESIA (numbness in both hands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Soreness at the injection site. Mild on the first day, More pronounced on days 2 and 3. Starting to fade on day 4  Extreme shivering starting on day 1 about 13 hours after the injection, followed by strong fever. Unable to sleep much that night. Symptoms subsided by about 20 hours after the injection.  Mild nausea accompanied the shivering.    It should be noted that this was the second shot in the series. I only had injection soreness after the first shot (about 3 months previously)
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 25-JUN-2007, a healthcare provider at a clinic administered ZOSTAVAX to the patient (dose, route, and lot # not provided).  The patient was inoculated with ZOSTAVAX to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 15-OCT-2013 and in June 2014, the patient was treated by a physician at the same clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with zoster vaccine live (ZOSTAVAX) and suffered serious physical, emotional, and economic damages as a result of the patient's injuries.  As a direct and proximate result of ZOSTAVAX, 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
several pt from this facility recv vax & 1 day later devel inj site rxn characterized by a small, bluish purple area, redness, warmth & swelling;redness, warmth & swelling extended to the elbow;
This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used), PRODUCT STORAGE ERROR (Given after 30 day expiration from freezer to fridge) and NO ADVERSE EVENT (No adverse event) in a 17-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine.      Total 3 patients were administered with the Moderna Bivalent booster dose. No concomitant medications were reported. No treatment details were reported.
Sudden onset.  Chills, low-grade fever.  Myalgia, arthralgia I did have the Covid virus in June.  I still have adequate IgG.  This began while I was seeing patients today.  I do not feel very good.  No cough, nasal congestion, no fear of contamination.
excruciating pain in the legs; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (excruciating pain in the legs) and FATIGUE (fatigued) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (excruciating pain in the legs) and FATIGUE (fatigued). At the time of the report, PAIN IN EXTREMITY (excruciating pain in the legs) and FATIGUE (fatigued) outcome was unknown. Not Provided      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.   No treatment information was reported.   This case was linked to MOD-2021-116655 (Patient Link).
The day before vaccination 4-26-2022, I went to a family funeral and was exposed to Covid. Two days after vaccination of dose 4, I woke up with a slight fever up to 101.0, swollen neck gland, runny nose, headache and sore throat. I took a home test for Covid with positive results. It was reported to the nurse at the assisted living facility. The doctor who rounds at the facility reviewed my record and ordered Paxlovid bid x 5 days and it was started on 4-30-2022. I am feeling better now and I am reporting my breakthrough case of Covid.
Prior to 01/04/2023 about 10 days prior I started to experience warm reddish veins near my right knee. I went to the doctor on 01/04/2023 and needed a duplex ultrasound of the right lar extremity veins. I had a right lar extremity vein and swelling .  It was found that the upper right calf contained Thrombus.
rash onset on 7/24/99 lasted 5 days had little over 50 bumps;had fever for 3 days;no temp taken w/thermometer;no complications;no rx medications given;