chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 21May2022 at 16:00, outcome "recovered" (22May2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: Tested positive for Covid 19 on 08May2022; (18May2022) Negative, notes: Tested negative on 18May2022 and 19May2022; (19May2022) Negative, notes: Tested negative on 18May2022 and 19May2022; (21May2022) Positive, notes: tested positive again on 21May2022; (22May2022) Negative, notes: Tested negative again on 22May2022. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course of the events: Other medications in two weeks: No. Anti-viral details: Paxlovid. Treatment start date: 11May2022. Treatment stop date: 15May2022. Indication: treatment of Covid-19. Administrator route: oral. Adverse event: Tested positive for Covid 19 on 08May2022. Started taking Paxlovid on day 3. Took full course of treatment. Tested negative on 18May2022 and 19May2022, but then tested positive again on 21May2022 and had mild symptoms. Tested negative again on 22May2022. Adverse event start date: 21May2022. Adverse event start time: 04:00 PM. If patient recovered: Recovered. Adverse event stop date: 22May2022 . If treatment ae: No. Known allergies: unsure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and drug ineffective.
Fluid buildup around the heart and rapid fluid retention; administration date=20Aug2021,dose number=2;prev dose administration date=03Aug2021, prev dose dose number=1; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 20Aug2021 (Lot Number: FC3181) as single for COVID-19 immunization (age at vaccination 42-year-old). Medical history included high cholesterol and obesity from an unknown date and unknown if ongoing. Concomitant medications included gabapentin; amitriptyline; lovastatin; tizanidine; and fluoxetine hydrochloride (PROZAC) all taken for an unspecified indication, start and stop date were not reported. The patient previously received (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Aug2021 (Lot Number: FC3180) as single for COVID-19 immunisation (age at vaccination 42-year-old). The patient did not receive other vaccine in four weeks. The patient experienced fluid buildup around the heart and rapid fluid retention on 02Sep2021 with outcome of unknown. Event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life threatening illness (immediate risk of death from the event). The patient experienced inappropriate schedule of product administration on 20Aug2021. The patient underwent lab tests and procedures which included Sars-CoV-2 test (Covid test type post vaccination=Nasal Swab): negative on 01Oct2021. Therapeutic measures were taken as a result of fluid buildup around the heart and rapid fluid retention includes pericardial window. The patient was not diagnosed with covid prior vaccination.
Pt vax w/Pneumococcal developed 105 oral fever by hx (documented 102.5), severe headache, photophobia, mild neck stiffness, large local rxn (6x9.5cm), hyperactive reflexes w/ankle clonus started approx 12 hrs p/shot. Improving 21JAN.
This spontaneous report was received from an office manager and refers to an unspecified amount of patients of unknown demographics. The patients' pertinent medical histories and drug reactions or allergies were not reported. From 01-JAN-2017 to 25-SEP-117, the patients received an improperly stored doses of PNEUMOVAX 23 (lot # N011491 with expiration date at 04-NOV-2018; dose, route of administration and anatomical location were not reported), for prophylaxis. There were previous temperature excursions (unknown by reporter). The reporter did not know the ranges of temperature excursions and their time frames. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012746: US-009507513-1709USA012745: US-009507513-1709USA012747: US-009507513-1709USA012635: US-009507513-.
Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A, 031A21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment informations were reported.   This case was linked to MOD-2021-336875, MOD-2021-337387 (Patient Link).
VERY MILD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced very mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from very mild headache. This report was non-serious.
FEELING COLD; MILD CHILLS; SCRATCHY THROAT; HEADACHE; FATIGUE; SORE AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.. No concomitant medications were reported. On 01-APR-2021, the subject experienced sore at injection site. On 01-APR-2021, the subject experienced fatigue. On 02-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced scratchy throat. On 08-APR-2021, the subject experienced feeling cold. On 08-APR-2021, the subject experienced mild chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore at injection site on 01-APR-2021, and headache on 05-APR-2021, had not recovered from fatigue, and scratchy throat, and the outcome of mild chills and feeling cold was not reported. This report was non-serious.
Patient received H1N1 11/9/09. States 11/10 started itching and broke out with rash all over body. Now on BENADRYL states help itching but rash still there.
Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Mild, Additional Details: 10 minutes after administration patient came to Pharmacist complaining of feeling lightheaded and dizzy.  Patient soon fainted afterwards and was in and out of conciousness for <2 minutes.  Able to respond to questions during that time.  BP 62/40, had pt lay down feet up. 10 minutes later Bp 108/82 and patient felt much better.  Follow up a few hours later and patient felt completely normal.
Chills, fever of 100.3; headache, body ache, slight nausea
Large red area extending downward from injection site. 4.5in x 4.5inch in diameter. Swollen nodule.
Phlegmy throat, BP 191/110(137), 98 % o2, 86 pulse. 10 mg Zyrtec given per MD orders, Pt transferred to FM.
development of red, itching, swollen, painful area left posterior upper arm.  pt sought care ED & f/u office visit
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 18:30 as dose 4 (booster), single (Lot number: Glt9702) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 at 14:00 as dose 1, single (Lot number: EN6208), in right arm, on 31Mar2021 at 13:45 as dose 2, single (Lot number: ER8734), in right arm and on 21Dec2021 at 17:30 as dose 3 (booster), single (Lot number: FE3594), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Chronic Fatigue Syndrome" (unspecified if ongoing), notes: Other medical history: Chronic Fatigue Syndrome; "POTS" (unspecified if ongoing), notes: Other medical history: POTS. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received paxlovid for COVID 19 treatment since 07Dec2022 till 11Dec2022. The patient reported that other medication in 2 weeks were unknown.
This is a serious post marketed study case from a physician in the USA of BELL'S PALSY considered medically important (OMIC). The reporter causality is probably related to FluMist. On 2/1/05 a 48 year old female received FluMist and on 2/4/05 the patient reported hyperhydrosis of hands. On 2/6/05 the patient developed left facial tingling for which she presented to the medicine department on 2/9/05. At the exam table, she was unable to close her eyes completely and had a left facial droop. The patient has a history of Bell's palsy since in her 20's. She also complained of hyperhydrosis of hands without relief with Drysol. The patient was treated with prednisone taper, acyclovir (400mg TID for ten days), artificial tears, and her eyes were taped shut at night. The patient completed course of treatment prescribed on approximately 2/19/05. The patient's clinical outcome was unknown.
We gave the patient an expired dose. Dose was drawn up 3/31 about 3:00 PM and was left on the counter overnight. Patient received dose the next day at about 1:30 PM
So on 2/23/2021 I have hives at 1:30AM and took Clariton. 3AM tongue was still itchy. I woke up uncomfortable both times. I went to the DR 2/23/2021, just took Benadryl. On 3/12/2021 in the evening I had my eyes and tongue swollen at about 9PM. I have consistently had intermittent swelling on m tongue. I have been seen by an allergist as well on May 27th , I had a skin prick test and allergy tests. I now have to carry Benadryl, steroid pills and an EpiPen wherever I go.  There was tongue on 2/23/2021 that was really bad, I did not have eye swelling or anything like that. Starting 2/24/2021 I was on steroids and 2x a day Benadryl but none of that really alleviated the swelling either.
Caught covid, not sure if it?s related directly to the vaccine but I took the vaccine and now I have covid
A VACCINE WAS ADMINISTERED AT ROOM TEMPERATURE 5 HOURS AFTER FIRST PUNCTURE; This spontaneous report received from a pharmacist concerned a 47 year old male. 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: 1855191 expiry: UNKNOWN) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-DEC-2021, the patient experienced a vaccine was administered at room temperature 5 hours after first puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a vaccine was administered at room temperature 5 hours after first puncture was not reported. This report was non-serious.
Legs tingling; back of legs all red; muscles aching going into her feet; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Legs tingling), ERYTHEMA (back of legs all red), and MYALGIA (muscles aching going into her feet) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALLEVESS for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PARAESTHESIA (Legs tingling), ERYTHEMA (back of legs all red), and MYALGIA (muscles aching going into her feet). At the time of the report, PARAESTHESIA (Legs tingling) outcome was unknown and ERYTHEMA (back of legs all red), and MYALGIA (muscles aching going into her feet) was resolving.        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.   Concomitant medicine include Alleve  Treatment drugs were not included  Action taken with mRNA-1273 in response to the event was unknown       Reporter did not allow further contact.
Vaccine administered after an excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received HAV (Havrix) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   On 28th February 2022, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The nurse reported a patient received havrix vaccine in left thigh after an excursion, which led to incorrect storage of drug.  The reporter consented to follow up. This is 1 of 6 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039273:same reporter US-GLAXOSMITHKLINE-US2022039271:same reporter US-GLAXOSMITHKLINE-US2022039274:Same reporter. US-GLAXOSMITHKLINE-US2022039275:Same reporter. US-GLAXOSMITHKLINE-US2022039277:Same reporter.
-Diagnosed with Shingle Opthalmicus in the left eye on 11/12/2021 (symptoms started 11/06/2020) -Prescribed Valacyclovir HCL 1 gram tablet, Gabapentin 300 mg and increased to 600 mg, Erythromycin 0.5% eye ointment, and Prednisolone AC 1% eye drop -Progressed to Optical Neuritis (admitted to the hospital 12/18/2021 and discharged on 12/22/21). -MRI also showed involvement with the back of the sclera. -Prescribed Acyclovir 822 mg via IV with 0.9% sodium chloride.
Prenatal ultrasound revealed a fetus with no heartbeat or blood supply. My OBGYN diagnosed a miscarriage.  11/24 and 11/24/09 Medical records received for DOS 11/16/09.  Final DX: Missed abortion, spontaneous abortion.   Planned Cytotec, but spontaneously aborted w/cramping and bleeding w/clots.  U/S revealed empty uterus.   ICD9 Code:  632.0., 637.10
Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness of arm) outcome was unknown. Not Provided          No relevant concomitant medications were reported. Other treatment medications include Warm Compress.
Before the vaccines rolled out, I had 3 styes that year. When I got my vaccine in January, I had one in the spring and then in the fall. Around 09/15/2021- I noticed that a painful stye had developed on the bottom lid of my right eye. First, I went to urgent care- they gave me an antibiotic cream and the doctor said it should heal in 2 to 4 weeks. I administered it for 2 weeks, my bottom eyelid was very red and my bottom eyelid was raised. It was not getting better. The doctor said it might be chalazion. He said it can take up to 2 months to heal. Then I went to my eye doctor. She said it was the immune system when it is healing this can occur. It is typical for it to be an immune reaction for my eyelid to have gotten this bad. She prescribed a steroid drop and it has gone down a lot. If it does not go down she said it may need to be surgically removed. Note: A week before the stye appeared, my mother developed shingles on her arm a week prior to when I my stye appeared. I have to go back and the doctor and she will tell me if I would require surgery to have it removed.
diagnosed with nerve damage; Neuropathic pain; rash was located on patient's left torso extending to his back (spinal cord); 2nd dose of Shingrix received on 03-Jul-2023; Shingles rash/diagnosed with shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number P45M9) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number L7F7E, expiry date 22-NOV-2020) for prophylaxis.   On 03-JUL-2023, the patient received the 2nd dose of Shingrix (injection, right deltoid). On 02-SEP-2018, the patient received the 1st dose of Shingrix (injection, right deltoid). In APR-2023, not applicable after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles rash/diagnosed with shingles). On 03-JUL-2023, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose of Shingrix received on 03-Jul-2023). On an unknown date, the patient experienced nerve damage (Verbatim: diagnosed with nerve damage), neuropathic pain (Verbatim: Neuropathic pain) and rash (Verbatim: rash was located on patient's left torso extending to his back (spinal cord)). The patient was treated with gabapentin. The outcome of the shingles, nerve damage and rash were not reported and the outcome of the neuropathic pain was not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles, nerve damage, neuropathic pain and rash to be related to Shingrix.  It was unknown if the company considered the shingles, nerve damage, neuropathic pain and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-JUL-2023 The case was reported by patient's wife. The reporter stated that that the patient was diagnosed with Shingles approximately 3 months ago and was experiencing neuropathic pain, nerve damage and shingles rash. The patient was diagnosed by a dermatologist and was currently taking Gabapentin for neuropathic pain with no improvement.  The rash was located on patient's left torso extending to his back (spinal cord). The patient stated that the patient was diagnosed with nerve damage. The reporter consented to follow up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 02-FEB-2018, the patient received both PROQUAD, subcutaneously (dose, lot# and expiration date were not reported) and M-M-R II (dose, route of administration, lot# and expiration date were not reported). Concomitant therapies included sterile diluent. No adverse effect was reported.
multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-MAY-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Heart started fluttering and continued through the night. Called primary doctor and was told to urgent care. Urgent care sent me to ER. Fluttering. Irregular heartbeat and chest pressure has continued. Waiting for appointment with cardiologist
17 month old child broke out into weal rash at vaccine site. Also fine maculopapular itchy rash on her body. Extremities. Mom noticed 24 hrs later.