chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from the nurse and refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 20-JUN-2015, the patient was vaccinated with expired dose of 0.5 milliliter (ml) PNEUMOVAX 23 (lot # K009809 and expiry date: 16-MAY-2015) injection once through intramuscular route. No concomitant medications were reported. No adverse events were reported. The outcome of expired product administered was unknown. No product quality complaint (PQC) was filed. No further information available. Additional information has been requested.
Pt's  friend stopped by pharmacy 7/29/21 stating that she was hospitalized 7/28 , the day after receiving her 2nd Covid vaccine.  Pt received 2 units of blood and is feeling much better.  She has an ongoing history of anemia.  Unsure if this was related to vaccine but reported due to timing of vaccine/ hospitalization.
Fever to 101.5, shaking chills, extreme lethargy and fatigue. Started approx 14 hours after injection. Lasted 36 hours. In bed , unable to eat, shower, do any activity. Took Advil for fever and drank water
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 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Feb2023 as dose 5 (booster), single at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2022 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Aug2023 to 08Aug2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rashes on one half of her body, the leg and the arm, she does not remember which side.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes on one half of her body, the leg and the arm, she does not remember which side.) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Lactose) and Inflammatory bowel disease (takes Linzess to treat this illness) since 2018. Concomitant products included LINACLOTIDE (LINZESS) from 2018 to an unknown date for Inflammatory bowel disease.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced RASH (Rashes on one half of her body, the leg and the arm, she does not remember which side.). At the time of the report, RASH (Rashes on one half of her body, the leg and the arm, she does not remember which side.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment Information were provided by the reporter.  Patient experienced rashes on one half of her body, the leg and the arm and she does not remember which side. This rash appeared a couple days after the vaccine was administered. Patient consulted her schools medical facility and the rash went away without medication a couple days after.   This case was linked to MOD-2022-486107, MOD-2022-486076 (Patient Link).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date (reported as a long time ago) the patient was vaccinated with ZOSTAVAX vial, 19400 PFU (dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On an unknown date, four days after administration, the patient experienced varicella like rash. The patient did not seek medical attention. The outcome of varicella like rash was unknown.  The relatedness between ZOSTAVAX and the event was not reported.  Additional information is not expected because reporter refused additional contact.
Patient has been experience a grade-3 type reaction since administration on 1/15/19. Patient complained about pain and soreness that occurred around the time of administration. On the same night of vaccination, patient experienced malaise, including muscle pain, headache, shivering, and fever. Within the next 24-48 hours after administration, swelling had developed at the site of administration, which spanned several inches in diameter and was warm to the touch. Patient also reported having a "rock-hard" arm with muscle pain that prevented her from being able to life her arm and use her left arm throughout the day. Note: Symptoms peaked around 24 to 48 hours after vaccine administration. Patient's symptoms have been improving as of day 4 (1/18/19) when symptoms were actually reported. Patient was able to move arm easily, but swelling and pain still existed.
Fever up 105 + stomach cramps treated with Tyenol and Ibuprofen
Symptoms started 11/27, states she had holiday facilities with her family the few days prior.She lost her sense of taste and smell.  She has been feeling weak and not able to take in much p.o. intake. COVID-19 (+) on 12/5 with pneumonia.  Hypoxia/78% on RA on admission.
missed the Infanrix dose/ Use of Kinrix as the 4th DTaP; Wrong vacine administered/missed the Infanrix dose/Use of Kinrix as the 4th DTaP; This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a child male patient who received 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.   Previously administered products included Pediarix (received already the 3 doses of pediarix).   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered 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 reported. The patient was 4 to 5 years of age. The nurse practitioner reported that, the patient received already the 3 doses of Pediarix and missed the Infanrix dose and probably would be administered Kinrix as 4th DTaP dose, which led to inappropriate schedule of vaccine administered and wrong vaccine administered. The reporter did not consent to follow up.
Arm became red, swollen, hot. Got worse by Saturday morning. Went to urgent care. Doctor gave her antibiotic (sulfa) and antihistamine (hydroxyzine).
Developed heavy bleeding and golf ball size clots on next menstrual cycle. I have never had clots during a menstrual cycle before. Menstrual cycle lasted 17 days. This continued with each following cycle with a decrease in severity with each consecutive cycle. At this time I am 7th menses since the vaccination. This cycle had normal flow but continued to last 10 days (vs a normal 6 days). I did not allow administration of the second vaccination shot after experiencing the scary complications of the first. I had a tubal litigation performed 7 years ago and was not pregnant.
Developed significant lymphadenopathy L axilla, L clavicle area, L breast with L breast swelling (3 inch increase in chest circumference).  Pain and tenderness.
headache, stomach ache, nausea, vomiting, left lower leg muscle pain, injection site soreness first day; flu-like symptoms lasting 2-3 days; treated with ibuprofen
This spontaneous report was received from a physician via a company representative concerning a male patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On 11-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX vial (dose number, route, dosage schedule, lot number and expiration date not provided). Concomitant medication was not reported. On an unspecified date in November 2014, after receiving ZOSTAVAX the patient developed retinal necrosis. The patient sought medical attention and was admitted at the hospital for an unspecified reason when he was diagnosed with the retinal necrosis (dates of admission and discharge were unknown). The outcome of retinal necrosis was unknown. Causality assessment was not reported. Upon internal review the event retinal necrosis was considered to be medically significant. Additional information has been requested.
This is a reaction based on technician error: 3 year old boy receiving 4th dose of PREVNAR 13 (catching up). According to technician, child moved his leg. The needle came out of the initial injection site, cutting across his leg, and reentering at another point. Vaccine components spilled out so it is unclear exactly how much the child received. Child is unable to walk without pain and has a hematoma. Watching for signs of infection or other illness.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  In 2011, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot#, dosage and route unknown) for long-term prevention of shingles and zoster-related conditions.  Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (date unspecified) and was treated by a healthcare provider at a clinic and was hospitalized due to the event (date unspecified). As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Shoulder to her elbow, her arm is red and itchy from all over; Shoulder to her elbow, her arm is red and itchy from all over; Reaction on her arm with it being itchy, red, and swollen; Sore; Itchy; Sleepy; Sluggish; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Shoulder to her elbow, her arm is red and itchy from all over), PRURITUS (Shoulder to her elbow, her arm is red and itchy from all over), SOMNOLENCE (Sleepy), SLUGGISHNESS (Sluggish) and PERIPHERAL SWELLING (Reaction on her arm with it being itchy, red, and swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced SOMNOLENCE (Sleepy), SLUGGISHNESS (Sluggish), PAIN (Sore) and PRURITUS (Itchy). On 21-Feb-2021, the patient experienced ERYTHEMA (Shoulder to her elbow, her arm is red and itchy from all over), PRURITUS (Shoulder to her elbow, her arm is red and itchy from all over) and PERIPHERAL SWELLING (Reaction on her arm with it being itchy, red, and swollen). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Shoulder to her elbow, her arm is red and itchy from all over), PRURITUS (Shoulder to her elbow, her arm is red and itchy from all over), SOMNOLENCE (Sleepy), SLUGGISHNESS (Sluggish), PERIPHERAL SWELLING (Reaction on her arm with it being itchy, red, and swollen), PAIN (Sore) and PRURITUS (Itchy) outcome was unknown.
First noticed a diaper rash in the evening of the same day she received vaccinations. It was red with little bumps in the crease of bottom, the creases around her genitals and on her genitals, with a few satellite red bumps around her waist. She is exclusively breast fed and this is the first occurrence of diaper rash. I applied zinc oxide whenever she wore a diaper and tried to leave her without a diaper whenever possible. It cleared up in 3 days.
leaked and an underdose was given; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 2459T, expiry date 8th October 2023) for prophylaxis.   On 20th February 2023, the patient received the 2nd dose of Shingrix. On 20th February 2023, unknown after receiving Shingrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.   Additional Information: GSK Receipt Date: 22-Feb-2023 Reporter's Comments:  The patient went to receive the 2nd dose of Shingrix, but the vaccine leaked and an underdose was administered. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient received 2nd dose of Shingrix, but the vaccine leaked, which led to underdose.
This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 61-year-old female patient received BNT162b2 (BNT162B2), on 29Sep2021 at 11:02 as dose 3 (booster), single (Lot number: EW0183) at the age of 61 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "Neuropathy", start date: 2017 (ongoing); "Allergies" (ongoing); "Asthma", start date: 2000 (ongoing); "seasonal allergies", start date: 1990 (ongoing); "Celiac Dx", start date: 2017 (ongoing). Concomitant medication(s) included: GABAPENTIN oral taken for neuropathy peripheral (ongoing); XYZAL oral taken for hypersensitivity (ongoing). Vaccination history included: BNT162b2 (DOSE: 1, First Dose: 08Jan2021, Time: 11:00, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL0140), administration date: 08Jan2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Pyrexia"; BNT162b2 (DOSE: 2, Second Dose: 29Jan2021, Time: 11:00, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL9261), administration date: 28Jan2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Pyrexia"; BNT162b2 (Dose 1), administration date: 08Jan2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "rash"; BNT162b2 (Dose 2), administration date: 28Jan2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "rash". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; RASH (non-serious), outcome "unknown", described as "rash on R buttock". Additional information. Patient did have a fever for 2 days after injection and also got a rash on R buttock. This reaction occurred after all 4 vaccines. The reporter considered the Pfizer product had a causal effect to the adverse events.; Sender's Comments: Linked Report(s) : PFIZER INC-PV202200024801 same patient/reporter, different dose; PFIZER INC-PV202200024802 same patient/reporter, different dose;
Improperly reconstituted administration.; Improperly reconstituted administration.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) for prophylaxis.   Co-suspect products included mmr vaccine pre-filled syringe device (Priorix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Priorix and Priorix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Priorix and Priorix Pre-Filled Syringe Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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 Information: GSK Receipt date: 30-Dec-2022. Reporter's Comment: Reporter stated that Pharmacy technician calls today December 30th to report an improperly reconstituted administration of Priorix occur. HCP was asked about information of the patient and batch number, expiration date and vaccination date for the vaccine but information was declined, hcp stated she didn't have that info. The reporter consented to Follow-up via email. Additional supportive information: The patient received improperly reconstituted administration of Priorix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a registered nurse concerning a female patient who on 06-OCT-2009 was vaccinated with the second dose of GARDASIL (lot number not reported). "Shortly after", the patient experienced Bell's palsy. The date of the first dose unspecified. Unspecified medical attention was sought. At the time of the report, the outcome of the patient was not reported.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 08-FEB-2017 (also reported as 09-FEB-2917), the patient was vaccinated with an improperly stored dose of ROTATEQ per oral, lot # M031650 with expiration date 16-MAR-2018, for prophylaxis (dose was not reported). The vaccine was exposed to a temperature between 5 and 25 Celsius degrees in 4 cycles. The cumulative time was 1.5 hours. A data logger was used to log temperatures. No adverse effects were reported. A product quality complaint was not involved.  This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA011981: US-009507513-1702USA011982: US-009507513-1702USA011983: US-009507513-1702USA011984: US-009507513-1702USA011985: US-009507513-1702USA011986: US-009507513-1702USA011987: US-009507513-1702USA011988:
Rash; Fever; 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 RASH (Rash) and PYREXIA (Fever) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and PYREXIA (Fever). At the time of the report, RASH (Rash) and PYREXIA (Fever) outcome was unknown.            No treatment information was reported.  No concomitant medication ere reported.
pharmacist gave an Expired dose of covax; This is a spontaneous report from Pfizer sponsored program. A contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. First time caller was a pharmacist gave an Expired dose of covax, they were following medera guidelines and administered to patient puntured vial 12 hrs since recontitution. This was a Pfizer covax. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Couldn't sleep all night; Terrible pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep all night) and PAIN (Terrible pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INSOMNIA (Couldn't sleep all night) and PAIN (Terrible pain). At the time of the report, INSOMNIA (Couldn't sleep all night) and PAIN (Terrible pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.; Sender's Comments: Very limited information regarding these events of pain and insomnia has been provided at this time.  Further information has been requested.
Narrative:  Patient is a 74 year old MALE died in home hospice care from progression of Hepatocellular carcinoma previously followed by Primary Care also with past medical history of HTN, DM, PTSD, CAD s/p PCI, HFrEF, history of GAVE and multiple gastric polys, Iron deficiency anemia, ITP. PROBLEM LIST: *Full care by hospice * Cirrhosis of liver *Ascites Allergic Rhinitis Vitamin D Deficiency HCC - Hepatocellular carcinoma CHF - Congestive Heart Failure Chronic kidney disease stage 3 OA - Osteoarthritis Hypomagnesemia Seen by palliative care medicine service Interstitial lung disease Cough Gastric polyp Thoracic aortic aneursym without rupture Type 2 diabetes mellitus Recurrent major depressive episodes, mod History of operational stress reaction Essential hypertension Idiopathic thrombocytopenic purpura Gastroesophageal reflux disease Iron deficiency anemia due to blood loss History of polyp of colon Adjustment disorder with mixed emotional features Coronary artery disease Mixed hyperlipidemia Obstructive sleep apnea of adult Falls Pt had received covid vaccines on 3/9/21 & 4/5/21. This death caused by cancer and is not related to covid vaccines.