chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FJ5682), 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: "Diabetic" (unspecified if ongoing); "known allergies Statins" (unspecified if ongoing), notes: known allergies Statins. 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 which included PAXLOVID from 31Jan2023 to 04Feb2023.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
body ache; High grade fever (102); rigors; malaise; This is a spontaneous report from a Non-contactable Physician. A 34 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 05Jan2021 12:00 at the second single dose (lot number EL0142), via an unspecified route of administration on 15Dec2020 17:00 at the first single dose (lot number EK5730) for covid-19 immunisation.  Vaccination location was Left arm. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced body ache, high grade fever (102), rigors, malaise on 05Jan2021 18:00. The patient did not receive any treatment for the events. The outcome of events was recovered in Jan2021.    No follow-up attempts are possible. No further information is expected.
Could hardly raise his arm; Injection area felt like he was hit with a hammer in the arm; Fatigue; Muscle pain; Nausea; Joint pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could hardly raise his arm), VACCINATION SITE PAIN (Injection area felt like he was hit with a hammer in the arm), FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (Nausea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Heart disorder.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Could hardly raise his arm), VACCINATION SITE PAIN (Injection area felt like he was hit with a hammer in the arm), FATIGUE (Fatigue), MYALGIA (Muscle pain), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and CHILLS (Chills). At the time of the report, HYPOKINESIA (Could hardly raise his arm), VACCINATION SITE PAIN (Injection area felt like he was hit with a hammer in the arm), FATIGUE (Fatigue), MYALGIA (Muscle pain), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient taking medicines for heart problem and high blood pressure No treatment information was reported by reporter   This case was linked to MOD-2021-290283 (Patient Link).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 16-MAR-2012, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 12-DEC-2016, the patient was treated by a physician at a medical clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with 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.
Pain at injection site. Large (2 inch diameter) area that is red, hard and warm to touch.
Slight dizziness, 100.8 fever, joint pain, chills, extremely tired.   Rotated Tylenol and Motrin every two hours overnight.  Still have a low-grade fever 20 hours later but feeling better.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-FEB-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. Digital data logger was involved. There was no involvement of Product quality complaint (PQC). This is one of the several reports received from the same reporter.
Moderna vaccine was administered outside of source - reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------ J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/23/2022 SHORTNESS OF BREATH R09.02 HYPOXIA 6/23/2022 SHORTNESS OF BREATH J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/23/2022 SHORTNESS OF BREATH R09.02 HYPOXIA 6/23/2022 SHORTNESS OF BREATH J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/23/2022 SHORTNESS OF BREATH R09.02 HYPOXIA 6/23/2022 SHORTNESS OF BREATH
pt recv vax 24MAY96 & w/in 10 days pt devel a gen papular rash;
sore and warm arm at site of injection, fever to 100.1F, achy joints.  just lasted a few hours the day after the vaccine.  all resolved now.
Low grade fever and chills for approximately 6 hours; Headache on and off for 2 days; Fatigue for approximately 2 days; Pain (moderate) at injection site for 2 days; Swelling at the injection site (mild) for 3 days; Slight dizziness
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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: Er8735), in right arm and on 20Apr2021 as dose 2, single (Lot number: Ew0161) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Nov2021 as dose 3 (booster), single (Lot number: 051f21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; VYVANSE; ADVAIR, stop date: 26Jul2022; PROAIR RESPICLICK; ROSUVASTATIN, stop date: 26Jul2022; FLONASE [MOMETASONE FUROATE], stop date: 26Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Paxlovid was started as therapeutic measures for vaccination failure, covid-19 from 27Jul2022 to 01Aug2022.  Clinical course: Symptoms of covid reappeared 2 days after completing Paxlovid, with the addition of respiratory and lung congestion on 02Aug2022 10:00 PM  No follow-up attempts are possible. No further information is expected.
approximately 12 hrs after reaction, patient experienced localized bright red egg sized swollen area at injection site, itchy, soreness, and firm swollen arm
Spotting, possible early menstrual period. Began on cycle day 11, so far has continued through cycle day 12.
covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 07F21A, 023M20A and 031L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication and treatment provided
We called the patients mother and let her know what had happened and asked if patient has had any signs or symptoms the patients mother said no.
pt was given vax @ 11AM & pt became blue, stopped breathing for about 1/2 min @ 6PM; no reoccurrence;
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021 at 4:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of the patient was reported as 27.62. No concomitant medications were reported. On 03-Apr-2021, 20 vials were moved to clinic. The vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021. On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 03-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided. The occupation of reporter was reported as clinic manager. This case was linked to MOD-2022-566976 (Patient Link).
Flu-like symptoms for about 8 hrs; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms for about 8 hrs) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-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 experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms for about 8 hrs). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms for about 8 hrs) had resolved.            No Concomitant product use was reported. No treatment information was provided.   The reporter who was calling on behalf of their husband reported that the patient after receiving their Moderna Covid vaccine for the second dose experienced flu-like symptoms till next day from the onset of symptom.   This case was linked to MOD-2021-368071, MOD-2021-360778 (Patient Link).
Child was vaccinated with varicella and MMR and IPV vaccine on 12/3/02. Child was diagnosed with chicken pox at hospital ER on 1/29/07.
I got COVID after Dose 3. I started with a slight fever on March 17, 2022 and on March 18, 2022 experiencing congestion, low oxygen level was 88, brain fog and fever was 103. I went to the doctor was tested for Flu was prescribed Paxlovid for 5 days finished on March 22, 2022 was diagnosed with COVID pneumonia and bacterial pneumonia (was treated for both).
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of PROQUAD with lot/batch # L033698, expiry date 28-FEB-2017 (dose, dose number, strength, vaccination site and route of administration not provided). Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Got the Pfizer vaccine for shot 2 on 27 Mar 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Got the Pfizer vaccine for shot 2 on 27 Mar 2021) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Got the Pfizer vaccine for shot 2 on 27 Mar 2021). At the time of the report, INCORRECT DOSE ADMINISTERED (Got the Pfizer vaccine for shot 2 on 27 Mar 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant was not provided. patient treatment information was not provided.
Fevers to 100, dizziness, red, painful, swollen L arm at injection site.  Tx - MOTRIN & BENADRYL.
severe anaphylactic reaction; This is a spontaneous report from a non-contactable consumer (parent). A 15-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was a healthy person and had 7% body fat and very athletic. The patient experienced severe anaphylactic reaction. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient went to Emergency Room @ 5PM day following vaccine with difficulty moving eyes and drooping cheek.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Shakiness-Medium
tested positive for Covid virus; tested positive for Covid virus; This is a spontaneous report received via a Pfizer-sponsored program, from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned there were also 2 children and 2 adults who were positive. Clarified later in call that they were all at a dinner party together with 4 adults vaccinated and 2 unvaccinated children, one being her daughter (adult) and niece and they both also tested positive for Covid virus, which she finds profound. Stated her daughter received the Pfizer Covid vaccine, but her niece was not vaccinated and was just positive for Covid virus. Mentioned she just read that the CDC is only interested in post vaccination serious cases. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Further information is expected.
After giving the injection the patient had severe pain at the injection site. A few minutes later she struggled to make a fist with her same hand and reported having pain going up her neck. The injection site did swell up a few minutes after the injection as well and she felt tingling in her hands shortly after. Patient was given 25 mg of benadryl after she reported the tingling in her hands. She did not have any difficulty breathing though. She was able to stand up and walk with her parent to the car and was driven to ER by parent to be checked out.
"THICK TONGUE"/"THROAT DRY"  INCREASED PULSE 90-100 BPM
ADMINISTRATION OF DOSE OF 0.25ML; This spontaneous report received from a health care professional concerned multiple patients. 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: 211A21A, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 10-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of dose of 0.25ml. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of dose of 0.25ml was not reported. This report was non-serious.
Left arm injection site of DTaP. Large red area size 2.5" x 2.5". Swelling and hot to touch.
Parent reported that five days after receiving H1N1 vaccine he developed cough, fever 101.9 - URI. Student taken to PCP who said it may have been reaction to vaccine.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild
01/04/22 presents to ED for "Intentional Ingestion" "altered mental status". PMHx of "Disorder of thyroid, Hypothyroidism, IBS (irritable bowel syndrome), Incisional hernia (10/2020), Kidney stone, Non-intractable vomiting with nausea (12/12/2015), and Thyroid disease"
Within 5 min., itching/cough. She took PO BENADRYL and use Epi pen at office approximately 15 min later given Epi 1/1000 0.3, BENADRYL and 40 prn.
lupus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus". Additional information: Caller's daughter received the first and second dose of the Pfizer COVID-19 vaccine. Caller's daughter received the vaccine "when she was 15" years old. Caller mentioned that her daughter "now has lupus" and the vaccine "gave her Lupus".  Caller also added that "no one in her side or her husband's side of the family has that type of auto-immune disease". Caller also mentioned that she read from the government's website that the "Pfizer vaccine causes this type of auto-immune disease". Caller is frustrated that her "daughter is sick" and that her daughter's "life is flipped upside down". Caller added that her daughter's "dreams of her future, of what she wanted to do is totally gone because now she won't be medically fit for it". Caller was also concerned with the medical bills and her daughter's "life long treatment". Caller asked if it is possible to be given the first and second dose of the Pfizer COVID-19 vaccine with the same lot numbers. Caller asked if Pfizer is going to help with the medical bills and her daughter's life-long treatment related to her daughter's experienced as described. Follow-up attempts are completed. No further information is expected.
Patient discharged after (4) day inpatient admission from 11/18-11/22/2021.  Patient is a 90 y.o. female with pmhx relevant for HTN, CKD 3a, hypothyroidism, essential tremor, and GERD admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. She is vaccinated x2. Symptoms started 11/10. Received dexamethasone from 11/19, Remdesivir was declined by the patient. Is discharged without home oxygen, she has been weaned back to room air. Due to no longer requiring oxygen dexamethasone is discontinued at discharge. CT-A chest without evidence of PE. Due to worsening respiratory status relatively late in viral course and weakly elevated procalcitonin she was covered for community acquired pneumonia with ceftriaxone and doxycycline from 11/19. Will prescribe augmentin 875 mg BID for 3 more doses (tonight and tomorrow) to complete five days of therapy. Patient has been cleared from COVID isolation requirements due to time from symptom onset. Her home chronic conditions were well controlled and medications unchanged at discharge. A RUQ US was obtained on admission for concerns of abdominal pain which subsided. The imaging did demonstrate cholelithiasis without evidence of acute cholecystitis, and expectant management is indicated. She did have some wheezing on auscultation and nebulizer treatments were initiated.