chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had redness, swelling, hot to touch, pain in arm. I recommended to Patient to use an ice pack on the area every 2 hours for 10-15 minutes. Patient went to walk in clinic with PCP on 3/6. Patient was instructed to alternate between heat and ice. The swelling and pain started to reduce into the weekend on 3/7.  I saw patient today on 3/10 and no signs of redness, swelling, or pain.
Palpitations. BP 142/95 (pulse 160), 100% O2 sat. Follow-up BP 134/91 (pulse 104), O2 sat 100%. Of note, had COVID-19 pneumonia in December 2020.
This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Non Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA via Pharmajet-Stratis on 07-Oct-2015, Batch no: not provided, Route of administration: not provided, Dose: needle free flu shot. No additional drugs suspected. On Oct-2015, after starting treatment with AFLURIA the patient experienced The bandage was very bloody when I took it off, so much that it stuck to my skin (injection site), Bruise/Bruising/still bruised in context of injection site, It is still very tender (injection site)/Tenderness (injection site). For relevant test results see appropriate report section.
Client called local health department on 7/31/09 and reported that after she received the Td booster on 7/28, she left the clinic and when she arrived home, approximately 20 minutes later, a family member remarked that her lips were very red. She reported that her lips felt swollen and then became slightly numb over the next several minutes.  She took Benadryl and the symptoms subsided and did not recur. No previous episode after Td booster.  PHN had encouraged Tdap, but client wanted the Td.
METALLIC TASTE IN MOUTH, RINGING IN THE EARS, RASH ON FACE, BODY ACHES, BODY HURTS, FEELS LIKE RIB CAGE IS TIGHT
2 weeks after the vaccine, patient had a complete coronary artery occlusion of 3 of the 4 vein grafts with an ejection fraction of 15-20% and resulting vfib.
Patient presented with back pain. Was found to be in A fib RVR, new onset, also found to have cardiomyopathy with EF 20%. Patient was having DOE for 1 month prior off and on. Further imaging showed Mediastinal mass. Patient presented to me to receive anesthesia. I asked patient if he had been vaccinated and he said he received moderna shot a few months ago and did not remember the exact date. These finding are new since receiving the vaccine. Unknown if related
pt recv vax & cried inconsolably for more than 4hr;pt was seen by MD the next day & recovered;
Patient indicates receiving vaccine (flu) at around 3pm on 11/2, at about 10pm she developed hives all over body and dizziness, symptoms lasted 2 hrs. Was taken to emergency department for observation. No medications prescribed. Has had flu vaccine in previous years with no adverse results.
Once I got home from work I started feeling nauseous, throbbing headache, soreness in my arm with a welt on the injection site. Around 11pm I started vomiting violently through the entire night with sweats and chills.
Patient describes soreness at the injection site lasting several weeks.  She also says there is a hard area that she can feel under the skin.  There is no other swelling.
Rash all over body. Red circle, areas pustules on abd, back, legs and diaper.
pt recv vax;devel d,n,v & high fever;was delirious w/ fever on 3rd noc;on 4th day still weak;general malaise & fatigue cont through 12feb96;
After bandage removed dime size redness at injection site (left arm).  8-10 hours after injection. Next morning noticed warm to touch - Upper (equal palm) was warm.
Received 20 mcg instead of 10 mcg dose for his age as diluent was not added
2 of the 5 patients immediately passed out; headache; upper GI pain; vomiting; This spontaneous report has been received from a nurse referring to a pediatric patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T007024 with expiration date of 23-APR-2022 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis.    On an unknown date, the patient experienced headache, vomiting, gastrointestinal pain and passed out (loss of consciousness). The outcome of headache, vomiting, gastrointestinal pain and loss of consciousness was unknown. The reporter considered headache, vomiting and gastrointestinal pain to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).  Upon internal review, loss of consciousness was determined to be medically significant.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007024; expirationdate: 23-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA014407: US-009507513-2011USA014406: US-009507513-2011USA014408: US-009507513-2011USA014405:
Light headedness; This is a spontaneous report from a non-contactable pharmacist. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 24May2021 as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 24May2021, the patient experienced light headedness. She had relaxed for 30 minutes and felt better. Therapeutic measures were not taken as a result of the reported event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event light headedness was resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Product Removal Update Pfizer Pediatric 5-11 Years. Per email received, Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19. Dose was administered 10/01/2022. Expiration 10/19/2022.
Patient received flu shot 10/1/13 at 9:45 AM without complaint. On 10/1/13 at approximately 10:30 AM patient complained of chest pressure, dizziness, soreness at injection site, feeling jittery and flushed; and nausea. Patient appeared to be in moderate distress. Was given comfort measures-carbonated drink for nausea, cool moist towel to back of neck, and ice pack. An emergency cart and personnel was brought to patient's office. Blood sugar was assessed via finger stick and was in the 200's. Patient verbalized understanding from this writer of the following: if symptoms become worse and /or if patient developed shortness of breath, difficulty breathing, severe chest pain to call 911 and/or go to the nearest emergency center immediately. Call private provider as soon as possible and explain events of today. Call this writer after the patient felt better for follow up. Patient given this writer's contact information. Patient was driven home by patient's spouse. On 10/8/13 this writer contacted patient via phone call. The patient stated the following: "on 10/2/13 patient went home and symptoms decreased but still had mild body aches, headache, and felt jittery. On 10/3/13 patient went to her provider who said patient had a moderate reaction to receiving the flu shot. On 10/3/13 that evening the patient spoke with Workman's Compensation nurse who advised patient to call nurse if patient needed to see a Workman's Compensation provider. Patient filled prescriptions for an Albuterol inhaler to be used twice a day for three days, and then as needed; and oral Prednisone which she is taking at present.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX injection, lot # L023594 with expiry date 26-JUN-2017 and lot # L026405 with expiry date 15-JUL-2017 (dose, route of administration and anatomical location were not specified). It was unknown which lot # each patient was administered. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there was no consent for further contact.
arm very sore; severe dizziness; very sick; as if she has the flu; fever (over 100 ° F; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm very sore), DIZZINESS (severe dizziness), ILLNESS (very sick), INFLUENZA (as if she has the flu) and PYREXIA (fever (over 100 ° F) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm very sore), DIZZINESS (severe dizziness), ILLNESS (very sick), INFLUENZA (as if she has the flu), PYREXIA (fever (over 100 ° F), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm very sore), DIZZINESS (severe dizziness), ILLNESS (very sick), INFLUENZA (as if she has the flu), PYREXIA (fever (over 100 ° F), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 100 f degree (plane angle) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a registered nurse refers to one of current 18 years old female twins. The patient was vaccinated with the first, second and third doses of an unspecified hepatitis B vaccine (manufacture unknown, lot number unknown) on 18-MAR-1994, 18-APR-1994 and 14-DEC-1994, respectively. No other co-suspects were reported. No concomitant medications were reported. The patient was going into college and blood titers for the anti-HBs were below the acceptable range. No other adverse effect has been observed or reported. The patient sought medical attention via physician examination. The outcome of adverse event was unknown. Additional information has been requested. This is one of several reports received from the same reporter.
Patient immediately started feeling  anxious, heart palpitating, dizzy, and soon started feeling nauseous. She thought maybe it was a panic attack or low blood sugar as she had not eaten this morning, so we continued to monitor her, blood pressure and effects, for 45 minutes until we felt necessary to call.
PATIENT CALL A DAY AFTER AND COMPLAINS OF DIFFICULTY IN BREATHING, HEAD PAINS, SWOLLEN TONGUE/THROAT, AND LEFT SIDE WEAKNESS ABOUT 15 MINUTES AFTER VACCINE WAS GIVEN.  PATIENT RETURN TO FOLLOW-UP A DAY AFTER VACCINE WAS GIVEN. PATIENT WAS ADVISED TO DRINK MORE WATER AND PRESCRIBED SINGULAIR 10MG QZ AND PERIACTIN 4MG TID.
tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt. received the vaccine and 1-2 seconds later, she passed out. She came-to almost immediately and began to feel normal. She was very anxious prior to the vaccine. She was treated by lying down supine. Her BP came up to normal and she felt normal again. She received 1 other vaccine prior to this one and 2 after.
Trigeminal surgery had left sensitivity to my right lower lip and small part of my tongue.  After the shot, I experienced swelling in those two areas.   By the next morning, everything was back to normal.   No medications were taken nor treatments applied to the area.
Patient developed eczema patches within a few days of her vaccinations.  We returned to her doctor after a month and were given a topical steroid cream.  Patient later developed an adverse reaction, also classified as an addiction to the steroid cream and suffered raw, bleeding, oozing, crusty skin for about a year of her life.
Hard, red, hot, painful lump at injection site approx 1 1/2 inches.
Heart palpitations, shortness of breath.  Diagnosed in the ER with bigeminy. Symptoms began within 1 hour of the vaccination and increased over a week.
Had physical exam and vaccinations at 2:30pm. Non consolable crying and fussiness from 9pm to 2am.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other 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 52-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 4:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, 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 52.98 on 03-Apr-2021. Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021 (Batch number: 030B21A).   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  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  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.
body aches fever (temp 101) localized injection site pain without erythema or swelling
On day of second vaccination, she "felt like she got hit by truck" (typical reaction).  Over next two days she developed worsening shortness of breath with hypoxia, O2 sats down to 82-84% on room air at home.  On presentation to hospital, she is noted to have severe new bilateral diffuse ground glass opacities on CXR, leukocytosis of 15, no fever, no hypotension, negative lactate, negative BNP, no other organ failure.  No wheezes or edema on exam, no edema by CXR/CT, no PE by CT.  No cough, no phlegm.  She continues to have severe hypoxemic respiratory failure, on bipap, not yet intubated.  No vaping history, no THC history.
Dizziness occur first about 2 mins after shot it lasted about 15 mins and after that I became light headed, tireness and some shortness of breath
Headache, Diarrhea, NauseaVomiting & HYPERtension Narrative:  SIDE EFFECTS, post first vaccination:  12/30 - day of vaccine: N/V, diarrhea, increased BP, chest pain, HA 1/7 - more symptoms of severe HA, N/V, chills, menstruation like cramps and discharge.
This spontaneous report has been received from a healthcare worker referring to unspecified number of patients. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with ROTATEQ (dose, frequency and route not reported, lot # K015816, expired date: 29-MAY-2016; K010221, expired date: 12-MAY-2016). No adverse event were reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 69 year old patient who on 04-NOV-2010 was vaccinated with a dose of VARIVAX (Merck) (lot number 666854/0163Z) instead of ZOSTAVAX (Merck) due to a human error. There was no adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Swelling of left arm; "Raised area over bottom of body" , itching red rash noticed after 1 week after shots were given. Called Dr. but did not get seen that day and no treatment was even done.
No additional AEs reported. No additional information available or provided.; VARIVAX was reconstituted and then stored in the refrigerator for 2 or 3 hours before being administered to a patient.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-NOV-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot # U007472, expiration date: 08-MAR-2023 (dose number and route of administration were not reported) for prophylaxis.  The dose of the vaccine was reconstituted and then stored in the refrigerator for 2 or 3 hours before being administered to the patient (wrong technique in product usage process). No additional adverse events were reported (no adverse event). No additional information available or provided.
Patient states she woke up and she had 101.5 fever and chills.  She also described the injected area as scarlet red and swollen.  No pain. She applied hydrocortisone 1% on the area for a few days and the rash went away along with the fever.
pt recvd vax;devel an 8"x6" area of induration of the muscle,a small nodule,edema,erythema & pain at the inject site; also exp lymphadeno; hosp on 5jun94;
Huge welt developed at site of injection extremely tender and painful. Did not happen at 1st dose.
Patient woke up from a nap and our of nowhere had an extremely high temp of 104 and shortly after he fell and had a seizure. He has shown no signs of being sick prior to that and was seem by a Dr before getting vaccinated and he was perfectly fine. He got rushed to the ER and the Dr says he has strep throat.
Patient received SHINGRIX then worked for 4 hours without incident. On her ride home her legs became extremely painful. She has experience this before with her spinal stenosis but described the pain as more severe. She took a tramadol for the pain. The next morning she awakened at 4am and upon rising, she felt very dizzy and fainted. She fell to the floor and was discovered by her husband. She reports being sore and experiencing some bruising on her finger.
After administration developed rash, wheezing, tender, given Epinephrine, Dreadron, Albuterol, Benadryl
pt recv vax & devel inj site pain, crying & fever;no further info was available @ the date of this report;this is one of three children from this site to have an adverse exp following receipt of vax;
Severe Body ache, severe Fatigue, Oxygen level good but breathing felt labored, severe headaches, chills/hot flashes, nausea,  swelling of left arm, swollen red & itchy injection site, left side of face numb, cough, runny/stuffy nose, sore throat, mood swings, no appetite, constant thirst, upset stomach, chest congestion, coughing up mucus, ear ache, facial pain/ sensitivity, hives that lasted multiple days, fever of 99.7 and above for 2 days, increased resting heart rate, red dry eyes, constant sneezing, change of taste and smell.
No adverse event; Patient received a Moderna Covid-19 vaccine first dose after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna Covid-19 vaccine first dose after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Morfin allergy). Concomitant products included LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]) for Anticoagulant therapy.    On 14-Sep-2022 at 9:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna Covid-19 vaccine first dose after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna Covid-19 vaccine first dose after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna Covid-19 vaccine first dose after 30-day Use By Date).    The patient does not know the history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  HCP explained she did not have any other medical history information since she was not a facility regular patient.  The patient never ever had COVID positive test or diagnosis.  Patient did not receive other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  It was reported that HCP called because a patient received a Moderna Covid-19 vaccine first dose after 30-day use by date.  HCP confirmed that no side effects had been yet reported. HCP asked if she needed to call the patient or re-vaccinate her.  On 15-Aug-2022 7:50 am EST time, the vial was initially stored in the refrigerator.  The vial does not undergo any temperature excursions.  Treatment information was not provided.