chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was vaccinated Oct. 27th 2021 with the second dose of the Moderna shot, two days later Oct. 29th 2021, I started getting migraines so bad I could not open my eyes, and the pressure in my head was crippling. 10 days after the second shot, I woke up Nov. 7th and my entire right side of my face was paralyzed, I was taken to the salt Lake VA emergency room, and they told me I had bells palsy a side effect from the covid shot.
sneezed; lost her voice; cough; post nasal drainage; sinus headache; itchiness at the injection site; arm soreness; chills; really tired; achy all over; pain all over; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE PRURITUS (itchiness at the injection site), ARTHRALGIA (arm soreness), CHILLS (chills), FATIGUE (really tired) and PAIN (achy all over) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchiness at the injection site), ARTHRALGIA (arm soreness), CHILLS (chills), FATIGUE (really tired), PAIN (achy all over) and PAIN (pain all over). On 27-Jan-2021, the patient experienced COUGH (cough), RHINORRHOEA (post nasal drainage) and SINUS HEADACHE (sinus headache). On 28-Jan-2021, the patient experienced APHONIA (lost her voice). On an unknown date, the patient experienced SNEEZING (sneezed). At the time of the report, INJECTION SITE PRURITUS (itchiness at the injection site), ARTHRALGIA (arm soreness), CHILLS (chills), FATIGUE (really tired), PAIN (achy all over), PAIN (pain all over), COUGH (cough), RHINORRHOEA (post nasal drainage), SINUS HEADACHE (sinus headache), APHONIA (lost her voice) and SNEEZING (sneezed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided. Treatment included Aleve   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No new information reported.
This is a spontaneous report from a contactable other healthcare professional. A 39-years-old female patient (non-pregnant) received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in left arm on 20Jan2021 14:00 (at age of 39-years-old) as dose 2, single for COVID-19 immunization at hospital. Medical history included adenomyosis, allergies to egg, peanut and clarithromycin allergy. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 20Jan2021 14:00, the patient experienced bleeding every day and have been having extremely heavy nonstop menstrual cycles since getting the vaccine. On an unknown date, the patient experienced disrupted my mental health and disrupted my life in such a way that i have stopped exercising. It was reported as she was having extremely heavy non stop menstrual cycles since getting the vaccine. She was placed on progesterone to make it stop then was placed on a progesterone iud to make the bleeding stop and it still has not stopped. It has been 6 months and the patient was still bleeding every day since getting the vaccine. To the point that it has disrupted her mental health and disrupted her life in such a way that she had stopped exercising and/or been able to wear clothes that she used to for fear that she was going to bleed through them or ruin her clothes. Laboratory tests included polymerase chain reaction on 25May2021: negative (nasal swab). The patient received treatment with progesterone pills and iud replacement. The clinical outcome of the events bleeding every day and have been having extremely heavy nonstop menstrual cycles since getting the vaccine was not recovered and the events disrupted my mental health and disrupted my life in such a way that i have stopped exercising was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Hemorrhage and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from a medical assistant refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 14-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
Presented to the ED on 10/4 due to worsening fevers, cough and fatigue. Patient was noted to be Covid positive. Throughout his hospital course patient was requiring high levels of oxygen. Infectious disease was consulted and assisted with management.  Treatments received included high-dose steroids, remdesivir and baricitinib.  Additionally he was treated for pneumonia with Rocephin and azithromycin. His pro-Cal was noted to be negative and antibiotics were later discontinued. Despite treatment, patient did not improve and was still requiring oxygen at baseline. Palliative care was consulted and upon discussion with patient's son and patient, pt decided to change his CODE STATUS to DNR/DNI. Oxygen requirements did decrease down to 5 L but he continued to be deconditioned and was unable to tolerate much activity. Palliative team continued to follow throughout hospital course and had additional discussions with patient regarding continued clinical decline. Patient decided that he preferred to focus on comfort.  Hospice consult was placed and patient was noted to be eligible for services. Patient wanted to go home with hospice, which was arranged for him.
Mom states patient developed red, generalized rash to face 1 hour after administration of vaccine.  No fever no respiratory distress, encouraged to observe home care advice given.
Started a week after he took the Flu shot and it started with a small rash around his ankle. It started to moved up his leg and it was blotchy redness and itchy. It moved all the way to his arms and chest. He called the Urgent Care dr and they told him to take prednisone and it started to subside.
15 minutes after vaccine was administered, patient experienced tightness and closing up of the throat and difficulty breathing. Symptoms worsened in the next 5 to 10 minutes. Pharmacist administered Epipen 0.3mg 1 syringe to the left thigh, Patient immediately gasped for air and said he felt much better.  Paramedics were called, and they came to examine both the patients. They were stable and doing well.  They gave their mother the choice to have them taken to the hospital or for them to go home.  The mother chose to have them be taken to the emergency room hospital, so the paramedics took them from the premises.
nosebleed/2nd episode of nose bleed after receiving 1st dose of Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EPISTAXIS (nosebleed/2nd episode of nose bleed after receiving 1st dose of Moderna vaccine) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced EPISTAXIS (nosebleed/2nd episode of nose bleed after receiving 1st dose of Moderna vaccine). At the time of the report, EPISTAXIS (nosebleed/2nd episode of nose bleed after receiving 1st dose of Moderna vaccine) outcome was unknown. Not Provided      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.   Treatment include applied pressure for nose bleed 2nd time.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: AE information reported. Contact information updated. Significant follow up appended. Concomitant drug was updated.
Client reported itchiness over entire body. Treated with 50 mg diphenhydramine. Monitored additional 30 minutes, and client's symptoms almost completely resolved. No redness/ hives/ rash.  Client declined transport and left.
3/22/2021 at 12:00 p.m.  Intense headache relieved somewhat with Tylenol. Ended around midnight on 3/23/2021.   3/22/2021 at 1:00 p.m. mild diarrhea which lasted until 3/23/2021 7:00 a.m.  3/23/2021 1:00 p.m. overall weakness and fatigue. Resolved 3/24/201 at 7:00 a.m.  3/22/20221 7:00 p.m. left arm pain at injection site.  Almost completely resolved 3/24/2021 at 7:00 a.m.
The patient is a 68 y.o. female with history of ESRD, DM 2, bipolar 1, asthma, anemia, HTN, schizoaffective schizophrenia, presented to the medical center with cough.   Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 12/9 Symptoms present on admission: Cough, shortness of breath Date of covid positive test: 12/12 Vaccination status: vaccinated Imaging: CXR shows pulmonary vascularcongestion Oxygen requirements on admission: Room air Current oxygen requirements: RA saturating 94-95% Medical therapy: Decadron x 10 days Anticipated special isolation end date: 12/20 if afebrile off antipyretics (not a candidate for short isolation as symptoms are not improving)    ESRD Pulmonary vascular congestion Hyperkalemia Is compliant with HD, most recent HD on day of admission Typically receives HD on T/R/S Patient is anuric, pulm vascular congestion will be best managed by HD Consult Nephro, s/p HD 12/17   Poorly controlled hypertension BP as high as 213/90 Resume home meds As needed labetalol and hydralazine Outpatient follow-up   Anemia of chronic disease At baseline No active bleeding Monitor   Hyperlipidemia Continue statin   Schizoaffective disorder Continue Cogentin   GERD PPI
AFTER PATIENT RECEIVED THE JANSSEN VACCINE, PATIENT WENT TO GO SIT DOWN FOR 15 MINUTES. ABOUT 1 MINUTE LATER, PATIENT FELT DIZZY, BLACKED OUT AND FELL ONTO THE GROUND FROM THE CHAIR. PATIENTS BROTHER WAS WITH HIM AT THE TIME AND PATIENT REGAINED CONSCIOUSNESS A FEW SECONDS LATER. PATIENT WAS SWEATING AND FELT WARM TO THE TOUCH. WE HELPED HIM BACK TO THE CHAIR AND I ASKED SEVERAL TIMES IF I CAN CALL EMS FOR HIM, PATIENT REFUSED MULTIPLE TIMES AND STATED HE FEELS A LOT BETTER AND WILL HAVE HIS GIRLFRIEND DRIVE HIM HOME. I HAD PATIENT SIT DOWN FOR ANOTHER 20 MINUTES BEFORE LETTING HIM GO HOME. I ADVISED PATIENT IF HE FEELS ANY SYMPTOMS AT ALL, WHILE AT HOME, TO CALL EMS IMMEDIATELY. PATIENT AND HIS BROTHER UNDERSTOOD AND THEY LEFT.
This spontaneous report was received from a pharmacist concerning to a 38-year old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 28-NOV-2018, the patient was inadvertently vaccinated with a dose of M-M-R II (therapy type: recombinant human albumin (rHA)) via subcutaneous route (lot # M045394, expiration date: 14-NOV-2018) after it's labeled expiration date for prophylaxis (expired product administered). No adverse effect was reported in the patient. No product quality complaint was involved.
Disease aggravation; COVID-19; COVID-19; This is a solicited report from the marketing program per Regulatory Authority based on information received by Pfizer from the Regulatory Authority. (MFR Control No. # 21K-163-4089689-00).   A contactable consumer (patient) reported that a 47-year-old female received bnt162b2 (BNT162B2 also reported as COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot unknown), intramuscular on 12Feb2021 as dose 2, single; bnt162b2 (BNT162B2 also reported as COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot unknown), intramuscular on 21Jan2021 as dose 1, single for Covid-19 immunisation (age at vaccination: 46-year-old); adalimumab (HUMIRA, lot unknown), subcutaneous from an unspecified date to Aug2021, at unspecified dose for an unspecified indication. Medical history included Penicillin allergy, contrast dye allergy, had Covid-19 on 02Feb2020 was in the hospital for about a month, had influenza on 2020. The patient's concomitant medications were not reported. The patient previously took Remicade and gabapentin and had reaction of drug allergy; Humira for unspecified date to Aug2018 and had an unknown disease flare up. The patient experienced Covid-19 on 29Jul2021 and disease aggravation on an unspecified date. The patient underwent laboratory test which included Sars-cov-2 test: positive on 29Jul2021. The action taken in response to the events for adalimumab was not applicable. The outcome of events was unknown.   Causality for Humira (ADALIMUMAB): The reporter's causality for the event(s) of Covid-19 onset 02Feb2020, Flu, Unknown disease flare up and Covid 19 onset 29Jul2021 was not provided. (withheld) opinion is that there is no reasonable possibility that the events of COVID-19 onset 02Feb2020, Flu, Unknown disease flare up and Covid 19 onset 29Jul2021 are related to Humira (ADALIMUMAB).  Causality (Humira and events):  1)  Covid-19 (Covid-19): Causality as per reporter (Drug/Vaccine) : Not Reported , Causality as per Mfr.(Drug/Vaccine):No reasonable possibility 2)  Flu: Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility   3)  Disease aggravation: Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility   4)  Covid-19: Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility    Causality (PfizerBioNtech covid-19 vaccine and events):  1)  Covid-19 (Covid-19): Causality as per reporter (Drug/Vaccine) : Not Reported   2)  Flu: Causality as per reporter (Drug/Vaccine): Not Reported   3)  Disease aggravation: Causality as per reporter (Drug/Vaccine): Not Reported   4)  Covid-19: Causality as per reporter (Drug/Vaccine): Possible  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events vaccination failure, COVID-19, condition aggravated and suspect drug BNT162B2 cannot be excluded.
cerebral palsy in my left hand and it seems to be a better; left hand started hurting; couldn't move fingers; my whole hand swelled a little bit; hand had like a slight fever to it, it was warm; chills my whole hand like it's going down; little jerks in my hands; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 (at the age of 55years) as single dose for Covid-19 immunization. Medical history included Chronic obstructive pulmonary disease (COPD), heterotaxia (Situs inversus), ankylosing spondylitis, back problem, and cerebral palsy; all from an unknown date and unknown if ongoing. Concomitant medications included diazepam, methocarbamol, meloxicam, salbutamol (ALBUTEROL), and unspecified muscle relaxant; all taken for an unspecified indication, start and stop date were not reported. The patient reported side effects that has official after taking the COVID shot (confirmed as Pfizer COVID Vaccine). The patient stated "I've got cerebral palsy in my left hand and it seems to be a better connection in my left hand, I can now, it's easier for me to pick up small objects and I used to have problems doing that. It is like, I am messenger pain is eating my nerve endings. But here's what happened, 2 days after taking the shot around 26th, I took the shot on 24thMarch, 2021; I took Diazepam, Meloxicam and muscle relaxer (captured as unspecified medication) for back problem. I don't even know if it had anything to do with it, might be just been all the shot, but methocarbamol too. I took those 3 drugs, 2 hours after that, my whole hand, my whole left hand, just my left hand started hurting (further clarification unknown hence captured as suspect conservatively). In my left-hand kind of after feeling and I couldn't move my fingers as well. And afterwards it was in March, it started hurting, my whole hand swelled a little bit. It had like a slight fever to it, it was warm, and it swelled up just slightly not up here, nothing big. I still can't put in my ring, but it was slightly bigger than what it is today, and this hurt. It felt like, I've chills my whole hand like it's going down. So, I work it out, I stretched it, that helped the pain so I could work with them during my fingers stopped working it out. And then afterwards I found out I could, my hands were moving better, it works better. Before I've like little jerks in my hands, you know my hand wouldn't do what I wanted it to do. What I wanted to do more, I can press button, I can pick up smaller objects. It's not 100 percent better, it's not as good as my right hand which had no cerebral palsy in it but it's a lot better than it was. So, I just wanted to report that." The outcome of events was unknown.
28 y/o male experienced a syncopal episode approximately 10 min following janssen vaccine left deltoid. He suffered an abrasion to outer left pattela. He struck to left side of his head on the floor. No signs of abrasion or swelling that area. approximately 3 minutes after syncope, he vomited. x3 h= His pupils
pt recvd vax;devel allergic rxn characterized by tenderness & swelling;no evidence of cellulitis;tx w/ analgesics;
Client was mistakenly administered a Moderna, Dose #2, rather than the Pfizer, dose #2 . After it was given and the mistake was realized, client was notified of the  incident, information was corrected on her imm. card, and advised her that she would not need another dose of Pfizer, that her series is complete.
Soreness, not pain, at injection site on upper left arm for approximately 24 hours, tiredness beginning one hour following injection, but resolved after approximately 3 hours of sleep.
Rash across lower back and upper chest. Sores in my hair with clear fluid coming out. Urgent care visit around 3/18/2021 and there I had a physical and was given a cream. After a time using that didn't seem to work, sought care from a dermatologist. Was given two topical solutions for rash and head. Clobetasol Propionate 0.05% and Triamcinolone Acetonide 0.1% and been taking them since June. Works when I use them but have been seeing it return when I can't.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 12:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 12:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 30.35.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021.18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
c/o red spot/bump on back of neck-noticed spots on chest that noc; states felt very fatigued; 8AUG noticed larger red spot on shoulder (size of quarter); c/o lt side neck gland swollen-neck painful; 9AUG seen in ER; dx herpes zoster?