chrisvoncsefalvay/vaers-outcomes huggingface dataset:
short of breath; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do so; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do so; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) via an unspecified route of administration in the left arm, on 03Jan2021 at 10:00, at a single dose, for covid-19 immunization. Medical history included known allergies (unspecified). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a doctor's office/urgent care. The patient experienced 3 "waves" or what her many coworkers were describing as "whooshes". The first two occurred minutes apart approximately 4-5 minutes post vaccine-last less than one minute each. The 3rd wave occurred after lunch approximately 3 hours later-lasted approximately 2 hours but not as intense as the first times. The patient further described the symptoms as "felt like a rush" (unspecified) experienced when receiving epinephrine. She was short of breath, lightheaded, dizzy, like pre-syncope as she felt like she could pass out but did not do so. The events occurred on 03Jan2021. The patient did not receive treatment for the events. The patient recovered from the events on an unspecified date. The patient has not been tested for COVID-19 since vaccination.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Patient administered the vaccine that underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered the vaccine that underwent temperature excursion) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 4:13 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 4:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered the vaccine that underwent temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered the vaccine that underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Patient received vaccine which was stored in an ultra-cold freezer at minus 82 degrees Fahrenheit.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
Vaccine administered 10/30/08. Diagnosis of shingles made 11/14/08. (1) with onset of symptoms 11/6/08. (2) with onset of symptoms of rash 11/8/2008.
swelling, redness from site of vax to shoulder area down to elbow w/swelling, n/v, fever;no fever when pt seen next day;
pt recv vax 3FEB97 & pt exp rash w/eruptions that @ the time of the report were still oozing/varicella;
Patient had a bruise develop about 2 days afterwards, about 2 inches in diameter. She reports pain and swelling at the site, and flu-like symptoms (as patient expected). This did not happen with first dose. The bruise and erythema has improved some since then but is still present. Patient was referred to physician if does not continue improving.
Woke up shaking violently throughout my whole body, at first I thought it might be because I was cold but my blankets were notably warm and my body temperature was at a good level.
Patient was accidently given Pfizer monovalent instead of Bivalent. patient was informed of the administered  vaccine . no reported adverse events.
Painful, red, swollen rash at site of injection about 5 cm in diameter. Rash was not present at bedtime 05/17/2021 at 10:30 PM, woke up in the morning, noticed it 05/18/2021 at about 08:20 AM.
pt recv vax & began to exp R UE numbness & paresthesia (pt does not recall which arm was injected)also began to exp tongue paresthesias, frontal h/a, lightheadedness;no SOB or swallowing difficulty;
Dx unprovoked bilateral pulmonary emboli on 2/9/2021, started having right flank pain on. 2/6/2021.  Admitted to hospital on 2/9/2021. Lack of recent surgery, travel and DVT.  Given 11 hours of IV heparin, and discharged from hospital, and I am now on the oral blood thinner (eliquis) apixaban for life.
Upper left arm pain following booster and continuing to current date (over 4 months) .  there is no inflamation or redness,  Primary care provider could do nothing except to tell me to contact cdc.
Headache, Myalgia & Arthralgia Narrative: Body aches and headache day after injection. Took Tylenol.
I had a slight scratchy throat that went into sinus congestion. I used chloroacetone and TYLENOL. I called the doctor on Monday and was advised to use MUCINEX and FLONASE and wear a mask. My symptoms did not improve greatly. I am feeling better, but I am slightly tired. My nose is stuffy, and I am hawking up stuff out of my throat. I opted not to take any prescribed medications. I am still in the process of recovering.
h/a, nausea, malaise, sl diarrhea, blurred vision, watery eyes;
Erythema and pain around injection site (left buttock) that was first noticed in the afternoon of 1/4/16.  Redness and pain spread over the next 36 hours.  Decreased in size by time of examination on 1/6/16.  Associated symptoms was also small area of induration around injection site and itching.
relapse of PMR with CRP eventually hitting 253 (normal is 0 - 9) This necessitated increasing my prednisone dose to 60mg/day starting October 26, 2022.  As of February 02, 2023 I have tapered to 13mg/day.  My CRP is still elevated at 15.4.  On September 27, 2022 my CRP was 6.5.  (My booster was on September29, 2022) On October 13, 2022  my CRP was 106.9.  On Oct. 18, 2022 my CRP was 190.  On Oct 25, 2022 my CRP was 253
Child received DTaP vaccine onto left deltoid on 4/4/03 #5. Mother was instructed to give child Tylenol post vaccination. Mother brought child today 4/17/03. Left upper arm noted to be slightly swollen and red, warm to touch and with flat rashes. Mother claims cold compress was applied on and off but noted no improvement. Mother was advised to bring child to his MD. Alert, conscious and responsive; ambulatory; not in any distress.
Injection site became Red again and a little Itchy; Had chills; Injection Site Red again; Rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site became Red again and a little Itchy), INJECTION SITE RASH (Rash on the injection site), CHILLS (Had chills) and INJECTION SITE ERYTHEMA (Injection Site Red again) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 20-Jan-2021, the patient experienced INJECTION SITE RASH (Rash on the injection site).   On 28-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site became Red again and a little Itchy), CHILLS (Had chills) and INJECTION SITE ERYTHEMA (Injection Site Red again). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.   On 22-Jan-2021, INJECTION SITE RASH (Rash on the injection site) had resolved. At the time of the report, INJECTION SITE PRURITUS (Injection site became Red again and a little Itchy), CHILLS (Had chills) and INJECTION SITE ERYTHEMA (Injection Site Red again) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Injection site redness, Injection site rash, injection site pruritus and chills are consistent with the known safety profile of the vaccine
Large raised welt at vaccination site, about 3 inches by 2 inches. I have had the welt for 4 days, it is still large, red, hot to the touch and itchy.
This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route of administration were not reported, lot # L045954 with expiration date: 17-NOV-2017). Concomitant therapy was not reported. No adverse effects were reported. Administered vaccines experienced the temperature excursion of 24.8 degrees Fahrenheit for 13 days 4 hours 45 minutes on an unknown date. Data logger was involved. Additional information has been requested.
sweeling/ redness/hot/itching on bicep, on left arm but below injection site
Pt. rec'd PNEUMOVAX, flu vaccine & meningitis vaccine about 4:00 PM 9-30-10. When he woke up 10-1-10, had diarrhea, chills & achiness all over.
Rash on the chest and abdomen; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash on the chest and abdomen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced RASH (Rash on the chest and abdomen). At the time of the report, RASH (Rash on the chest and abdomen) had not resolved.        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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
On 09/10/21:  Patient is a 57 y.o. male with recent COVID infection, HFpEF, NASH cirrhosis, CKD IIIb, and IDDM2 who presented to ED via EMS post-code after PEA arrest. According to patient's wife, he developed acutely worsening shortness of breath early this morning. Wife called EMS after his shortness of breath did not improve upon resuming his home oxygen 3L NC which he had discontinued two days prior due to subjective improvement. Family estimates he stopped breathing less than 5 minutes prior to EMS arrival. EMS reports patient was apneic and in wide-complex PEA on arrival. He was coded for 20 minutes before ROSC. He arrived intubated and on levophed.    Cardiogenic etiology considered due to transient hypoxia; however troponins without significant delta, EKG did not show ST abnormalities concerning for ischemia, or MI. Bedside echo without concerning findings. Infectious workup negative. Aggressively diuresed patient with minimal renal recovery. On exam patient was lacking gag reflex and pupils unreactive. Due to concern for severe anoxic encephalopathy and PVS, all sedation was stopped. Patient remained without any purposeful movement, without gag reflex, and without reactive pupils after >48 hours of complete cessation of sedating agents. Poor prognosis discussed with wife (NOK) and daughter. They both stated he has previously said he would not want to continue with current measures in this type of situation. Wife (NOK) ultimately decided to withdrawal care and pursue comfort care. Patient was terminally extubated and discharged to inpatient hospice
Soreness at injection arm/the injection arm is extremely sore; not able to sleep; not able to move or lift the arm above the head; fatigue; fever; extreme muscle cramps; arm was tender to touch; restless; felt more sleepy; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (not able to sleep), TENDERNESS (arm was tender to touch), RESTLESSNESS (restless), SOMNOLENCE (felt more sleepy) and MUSCULAR WEAKNESS (not able to move or lift the arm above the head) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Past medical history not provided). Concomitant products included PANTOPRAZOLE and VITAMINS NOS for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced TENDERNESS (arm was tender to touch), RESTLESSNESS (restless), SOMNOLENCE (felt more sleepy), MYALGIA (extreme muscle cramps) and PYREXIA (fever). On 08-Apr-2021, the patient experienced INSOMNIA (not able to sleep), MUSCULAR WEAKNESS (not able to move or lift the arm above the head) and FATIGUE (fatigue). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at injection arm/the injection arm is extremely sore). At the time of the report, INSOMNIA (not able to sleep), TENDERNESS (arm was tender to touch), RESTLESSNESS (restless), SOMNOLENCE (felt more sleepy), MUSCULAR WEAKNESS (not able to move or lift the arm above the head), MYALGIA (extreme muscle cramps), FATIGUE (fatigue), PYREXIA (fever) and VACCINATION SITE PAIN (Soreness at injection arm/the injection arm is extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment activities for event was done with ibuprofen.
pain tenderness at injection site; chills; muscle pain; sinus congestion and drainage causing a cough
This spontaneous report was received from a medical assistant, regarding an 18 year old female patient. The patient did not have historical conditions or medications, drug reactions, allergies or concomitant medication. On 18-SEP-2017, the patient received the first dose of GARDASIL 9 injection for Human Papilloma Virus vaccination, via intramuscular, lot # N019923 and expiration date 28-APR-2019. The dose and anatomical location of the injection were not provided. On 27-SEP-2017 the patient called to the physician's office to inform that from an unknown day in September 2017 she had pain and swelling at the injection site. An unspecified Health Care Professional informed the patient to take acetaminophen (TYLENOL) or ibuprofen (ADVIL) and use warm compresses to treat the events and to return to the office if there was no improvement. On 02-OCT-2017, the patient returned to the physician's office unable to lift the left arm, with urticaria at the injection site (reported as small welt, 4mm, at injection site) and swollen lymph nodes on the left side of the neck. No lab diagnostics or studies were performed and the patient was not recovered at the time of the reporting. The reporter did not mention if there is an association between the adverse events and the use of GARDASIL 9.
Moderna COVID-19 Vaccine EUA After the first dose, my upper left arm around the injection site was red, slightly swollen, and itchy for about a week. After the second dose I had a 102F fever, chills, all my joints ached to the point that I could barely walk because I wasn't sure my legs would hold me up. This lasted for approximately 24 hours and was then followed by a severe headache that lasted approximately 24 hours
Fever, chills, body aches, heart racing which lasted about 6 hours.  Slight fever the following morning.
This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Non Health Professional and concerns  61 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA via the Pharmajet Statis device o 07-Oct-2015 - unknown stop date, Batch no: not provided, Route of administration: intramuscular, Dose: no information provided.  No additional drugs suspected. On 07-Oct-2015, after starting treatment with AFLURIA the patient experienced bled a lot in context to injection site, a very large raised (red) area in context to injection site, a very large (raised) red area (that is sensitivity to touch)/redness in context to injection site, a very large (raised red) area that is sensitive to touch/slight sensitivity when touched in context to injection site. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Patient was fine and breathing normally for the first couple of minutes after the vaccine.  About 2 minutes after his eye started to loose focus and his body went from limp to very stiff. Patients mother helped assist moving the patient to the floor until he got color back in his face about 5 minutes later. Patient remained laying down for about 30 minutes and slowly moved from sitting to standing over the next 10 minutes.
Medical Assistant drew up and gave the wrong immunization. Provider ordered MMR. MA drew up and gave MMRV. Patient received 2 doses of the varicella vaccine at the same time because of this error. No adverse events occurred at the time of the reporting.
Pt received FLUZONE then began having diaphoresis, dizziness, SOB, and dilated pupils. EMS called. Pt refused transport to ED. F/U call on 11/4/16 pt states no further complications.
Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  In a case series, patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and with results of post-vaccination tests were collected from existing health records within the specified health system.    Patient received an initial hepatitis B series at 59-years-old and a second hepatitis B series at 60-years-old.   A total of 6 doses of the standard hepatitis B vaccine were administered.  The patient was considered a non-responder.  At 61-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
2nd dose received more than 35 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 35 days after 1st dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 35 days after 1st dose). On 17-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 35 days after 1st dose) had resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   The patient wants to get an appointment for the booster dose.
Very Fatigued; Fevers; Chills; Headache; Pressure in head; Muscle aches; soreness in whole body; Weakness; Stomach ache with diarrhea; Stomach ache with diarrhea; Injection site pain; Armpit pain & swelling; Armpit pain & swelling; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3246) solution for injection intramuscular in the left arm on 18Jan2021 at 03:30 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included chronic spontaneous urticaria. Concomitant medications included omalizumab (XOLAIR), lisdexamfetamine mesylate (VYVANSE), famotidine (PEPCID AC), fexofenadine hydrochloride (ALLEGRA), valacyclovir, fish oil, probiotic, medical marijuana. The patient had no known allergies. Historical vaccine included BNT162B2 (Pfizer, Lot EJ1685) in Dec2020 at 06:15 intramuscular in left arm for COVID-19 vaccination for 1st dose with no adverse event. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 18Jan2021 at 11:00, the patient experienced very fatigued, fevers, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling. No treatment was provided for the events fatigued, fever, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling. The outcome of the events fatigued, fever, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
Noted to have tremors where it is difficult to hold items. Tremors are intermittent, not consistent. Self resolves. No exacerbating factors.
Information has been received from a physician concerning an 81 yr old female who in 1994 and on 07Dec04 was vaccinated with a first and 0.5 milliliter second dose of pneumococcal 23v polysaccharide vaccine, respectively (second dose lot number 647681/0986N). On the day of immunization, the pt experienced a local injection site reaction of swelling and redness accompanied by body aches, chills and a fever. Unspecified medical attention was sought. The pt's outcome was unk. No product quality complaint was involved. The physician requested an investigation into the lot number. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. It was also reported that a male pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also experienced adverse events (WAES0412USA03121).