chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My tolerance for any spicy food has change to a significant status.  i have always been able to eat  spicy foods, not super hot, just regular spice level, now anything with any kind of spice I cannot eat. I cannot have Spearmint, Hot & Sour soup, mild Taco sauce as an example and I have been eating these kinds of foods for well over 20 years with no problems. When I consume these kinds of foods my mouth immediately starts burning intensely and I have to stop eating that kind of food. The burning does stop when I stop consuming the food.
Information has been received from a registered nurse referring to a 15 year old patient of unknown gender. On 30-JUN-2015 the patient was vaccinated with GARDASIL (lot # K008931, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2014US017903 is an initial spontaneous report received from the pharmacist on 04 Sep 2014. This report refers to a 61 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145221) subcutaneously at a dose of 0.5 ml on 03 Sep 2014. It was reported that on the same day after vaccination, she experienced swelling under arm. The event outcome was unknown. The seriousness and causality were not reported.
We are not sure if it's due to the vaccine or not (since it has been 4 months since the 2nd dose). But here are symptoms: a. Persistent Low-grade Fever (on and off between 99.5 - 100.5, since last 30 days and counting) b. Extreme Tiredness/Fatigued c. Dizziness d. Pain in Head, Neck, Chest, Abdomen e. Chills
He had received a PNEUMOVAX shot on November 5th, in the right arm. yesterday it was red and swollen, he felt achy all over and had a bit of chest congestion and cough. He took ADVIL PM and is noticing that he is better today. I does look like an allergic reaction. He has benefited already from some ADVIL PM he took so I
Skin at site seems to have tightened or hardened under the rash; Red rash approximately 4 inches in diameter at injection site on left upper arm.; Rash started about 2-3 days after injection and is continuousl itchy; Red rash approximately 4 inches in diameter at injection site on left upper arm.; This is a spontaneous report from a contactable consumer (patient). An 80-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6204), via an unspecified route of administration, administered in arm left on 27Feb2021 09:00 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included low platelet count, heart valve transplant from a cow, bladder cancer with surgery removing cancerous tumour (no recurring signs), tendency for increased blood pressure from unknown date and unknown if ongoing. Concomitant medications included n-plate, amiodarone, amlodipine, aspirin and atorvastatin taken for an unspecified indication, start and stop date were not reported. No covid prior vaccination. Not tested for covid post vaccination. No known allergies. No other vaccine in four weeks. The patient experienced red rash approximately 4 inches in diameter at injection site on left upper arm. Rash started about 2-3 days after injection and was continuously itchy. Skin at site seems to have tightened or hardened under the rash on 04Mar2021. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information was expected.
Soreness at the injection site, muscle soreness over whole body, overall feeling fo malaise.
SICK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no previous immunization and no patient medical history. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sick. The action taken with covid-19 vaccine was not applicable. The outcome of sick was not reported. This report was non-serious.
Infection; Diverticulosis episodes; Shivers; Shattering; 2 small blood clots one in each lung; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (2 small blood clots one in each lung), INFECTION (Infection), DIVERTICULUM (Diverticulosis episodes), CHILLS (Shivers) and FATIGUE (Shattering) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced PULMONARY EMBOLISM (2 small blood clots one in each lung) (seriousness criteria hospitalization and medically significant), DIVERTICULUM (Diverticulosis episodes) (seriousness criterion hospitalization), CHILLS (Shivers) (seriousness criterion hospitalization) and FATIGUE (Shattering) (seriousness criterion hospitalization). On an unknown date, the patient experienced INFECTION (Infection) (seriousness criterion hospitalization). At the time of the report, PULMONARY EMBOLISM (2 small blood clots one in each lung), INFECTION (Infection), DIVERTICULUM (Diverticulosis episodes), CHILLS (Shivers) and FATIGUE (Shattering) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information included high blood pressure medication (unspecified).  At the time of report, the patient was at the hospital.  Treatment information included medication for blood clots (unspecified).  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt received yellow fever vaccine about 10-15 min prior to coming to office. Pt presented with diffuse mild rash on inner forearms bilaterally and localized redness at injection site. Pt denies SOB, chest tightness, throat swelling, difficulty breathing. Provider consulted and recommended benadryl and monitoring. Pt agreeable.
One hour after immunization, local rash developed at injection site. Rash spread to legs, belly, back, ears, chin. Faded within 48 hours. Temp up to 102 rectal during that time. Date of vaccine saw N.P. who stated diaper rash and localized rash. Mother states diffuse rash occurred following visit to N.P. Received 4 month vaccinations - 11/2/17 - DTP, HIB, Polio, Hepatitis B. Rash started on chest and over his body. Presently on NUTRAMIGEN - stools with streak of blood. Stools are watery. Diaper rash. Using diaper rash cream with every diaper change. Boils bottles. Does get a tsp. of Rice cereal for 2 months. Low grade fever a couple of days ago 99 after immunizations - resolved. Teething. Small rash after 2 month immunization at site of injection - oatmeal bath recommended did not help but baking soda paste and did help. Right thigh most pronounced and where initial rash started and then progressed to remaining body. Face was swollen and rash all over body on 11/3/17. Rash has resolved since immunization except now has a diaper rash. Mom has hives from tetanus injection. Has lost weight since immunizations - down 6 oz. Has increased vomiting. Has pediatrician managing formula intolerance - diagnosed milk intolerance - believes he has been seen by GI in the past and had GI testing per Mom. Increased fussy.
Local left deltoid area swelling redness tender about 3" area. Sistemic mild to moderate fever, low grade at home.
Patient fainted after receiving the Covid 19 vaccine. The patient also reported not having eaten much during the day. The patient had not been unconscious for long and came to. The pharmacist and one other staff member had the patient lay on the floor with her feet elevated until she felt less dizzy. The patient was also given juice to drink. After approximately 25 minutes, the patient was able to get up and walk to go home
very lethargic on Sunday. Felt hot (no fever) all day Monday, with headache, also lethargic. In the evening I was changing my shirt and I noticed there was a large raised, hot welt on my left arm around the injection site. Called a family member who is a nurse and they told me to go to Urgent care. Went to Urgent care that night around 5:30pm, the Physicians Assistant (did not get her name) told me it looked like a delayed reaction to the covid 19 vaccine and she told me not to get the second shot. She also told me to report the side affect.
Woke up second day after vaccine and notice lump under right arm in armpit area. Went to a quick care locally and was told most likely a Lymph Node
Patient was given Moderna vaccine via off label use. Patient 17 years old at time of vaccination.
8 hr p/vax pt devel fever of 104 & inj site rxn swelling, redness, hardness & pain; pt was unable to move leg;pt was tx w/APAP & advil;next afternoon temp 105.5;on the way to MD ofc exp sz;slumping,limp;eye rolling back in head;tummy hurt
I95.9 HYPOTENSION 12/2/2021 ADENOCARCINOMA, RIGHT LUNG LOWER LOBE J96.00 ACUTE RESPIRATORY FAILURE 12/2/2021 ADENOCARCINOMA, RIGHT LUNG LOWER LOBE
stay hot; keeping headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (stay hot) and HEADACHE (keeping headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (stay hot) and HEADACHE (keeping headache). At the time of the report, FEELING HOT (stay hot) and HEADACHE (keeping headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Inconsolable crying for approximately 4 hours. TYLENOL 0.4ml - 2 doses 4 hours apart.
This spontaneous report as received from a certified  medical assistant refers to a patient of unknown age. On an unknown dates, unspecified number of patients were vaccinated with 0.5 ml doses of PEDVAXHIB (Lot # not reported) IM which was unsupported due to lack of stability for the temperature storage conditions. No adverse effect was reported. Additional information has been requested.
Felt a little sick right after shot but was still functional. Got worse over next two days Tested positive for Covid 3 days after vaccination
Patient given COVID booster vaccine.  0.5cc to right deltoid.  Within a minute of administration, patient was noted to have swelling and induration to right arm about the size of a half dollar.  Patient was given 50 mg of benadryl and Ice was applied to injection site.  Patient monitored for half hour.  Symptoms did not worsen.  injection site had decreased swelling and induration, but still some palpable induration.
6/26/07 Child received booster Varicella vaccine on 6/28/07 RTC for red swollen L arm at injection site 1 1/2 cm ecchymosis around site, 2" redness around site. Advised to ice area and take Ibuprofen
Patient complained that she got a huge bruise where the injection was administered and her arm was incredibly sore for several days after the administration of injection. Patient says that the injection was administered in the wrong area on the arm, missing the deltoid muscle. Healthcare professional who administered the injection maintains that injection was administered correctly in the deltoid muscle, however patient maintains that injection was not given at the correct site.
This spontaneous report as received from a physician refers to an unknown number of unspecified patient's (information about the patients' gender and age was not reported). Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On unknown dates in 2016 (reported as starting in February 2016), the patients were vaccinated with improperly stored ROTATEQ (lot # L035510, expiration date: 14-MAY-2017; lot # L033694, expiration date: 16-JUN-2017; doses were not reported) orally. The vaccine was stored at 51 degrees Fahrenheit for a time frame of 126 hours and 34.3 degrees Fahrenheit for at time frame of 19.94 days. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 94-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that no treatment was given on the patients. No concomitant medications were reported.
REDNESS AROUND INJECTION SITE OF 5CM WITH INDURATION OF APPROX. 3CM. RAISED INDURATION OF APPROX. 1CM. AREA WAS WARM TO TOUCH AND THE ARM WAS SORE FOR 3 DAYS. REACTION OCCURED ABOUT 12-16 HRS AFTER INJECTION (OVER NIGHT) AND LASTED APPROX. 3-4 DAYS. PT. WAS TREATED WITH IBUPROFEN AND COLD COMPRESSES.
Pt complained of hip pain on 6/21/03 - seen by MD on 6/23/03 - Dx with ?toxic synoitis - Motrin was prescribed - spoke with pt's mother 6/25/03. Child is "doing a lot better".
Bruise at injection site; Headache off and on; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise at injection site), HEADACHE (Headache off and on) and FATIGUE (Fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included AMITRIPTYLINE, METOPROLOL and VITAMIN 15 for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Bruise at injection site), HEADACHE (Headache off and on) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Bruise at injection site), HEADACHE (Headache off and on) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
racing of the heart; This is a spontaneous report from a contactable consumer, reported for a 63-year-old female patient. A 63-year-old female patient received BNT162B2( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient has experienced racing of the heart (palpitations) on 2021. Clinical course of events includes; stated that, she has to report her racing of the heart. States that she didn't put 2 and 2 together, and that this has been waking her up at night. Has been occurring since Mar when she got the vaccine. She states that she has noticed it got more intense; now is calming down again. Asked, is that normal, as she says she couldn't figure out what was happening, that it was more intense and faster. Reports that it just sped up like it would be irregular and then continue beating really fast. She is hoping this week she can see if they (HCP) can figure something out. Also asked that, her 17 year old nephew, who received his last dose of the Pfizer BioNTech Covid-19 vaccine on 07Aug2021. 18 hours after, he took ibuprofen, and she is asking if that was ok to do. The outcome for the event palpitations was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Day 6 after the first injection my arm became itchy, the next day it is red, swollen, itchy, and kind of hard. Also hurts, like it did the day after I got it. After I got it, it only hurt for one day, so this is after the arm went back to feeling fine for a week.
606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 03OCT2021; The product was refrigerated on 08OCT2021 beyond expiration date 03Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 03OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 08OCT2021 beyond expiration date 03Oct2021) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 03OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 08OCT2021 beyond expiration date 03Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 03OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 08OCT2021 beyond expiration date 03Oct2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  On 08-Oct-2021, the vial was placed in the refrigerator. The vial did not undergo any temperature excursion and the patient had no adverse event.  The reporter also said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  No treatment information was provided.   This case was linked to MOD-2022-491837 (Patient Link).
pt recvd vax;exp high fever of 104.3 day p/ vax;did not eat;fussiness,did not sleep much;to er 17feb95;hosp x 3 days;tx w/ atb's,O2 per cannula; spinal tap neg;
prior to the Pfizer vaccines, she had the Moderna Covid-19 Vaccine; Caller said that she had an allergy couple days ago.; eyes foggy; second dose it got worse,; cloudy vision; difficulty to see at distance; not to see things that are close; eyes are kind of funky/she needs to have an eye surgery; prior to the Pfizer vaccines, she had the Moderna Covid-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 73 years, in arm for covid-19 immunisation; levothyroxine sodium (SYNTHROID), (ongoing) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna coviD-19 vaccine (1st Dose, Lot: 028L20A, NDC/Exp: Unknown, Anatomical Location: Arm), administration date: 21Jan2021, when the patient was 73-year-old, for Covid-19 immunization; moderna coviD-19 vaccine (2nd Dose, Lot: Unknown, NDC/Exp: Unknown, Anatomical Location: Arm), administration date: 18Feb2021, when the patient was 73-year-old, for Covid-19 immunization; BNT162b2 (3rd Dose, Lot: 301458A, NDC/Exp: Unknown, Anatomical Location: Arm), administration date: 26Oct2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "eyes foggy". The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "prior to the Pfizer vaccines, she had the Moderna Covid-19 Vaccine"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Caller said that she had an allergy couple days ago."; VISION BLURRED (non-serious), outcome "unknown", described as "eyes foggy"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "second dose it got worse,"; VISION BLURRED (non-serious), outcome "unknown", described as "cloudy vision"; MYOPIA (non-serious), outcome "unknown", described as "difficulty to see at distance"; HYPERMETROPIA (non-serious), outcome "unknown", described as "not to see things that are close"; EYE DISORDER (non-serious), outcome "unknown", described as "eyes are kind of funky/she needs to have an eye surgery".
patient received Quadracel subcutaneously that was intended in the left vastus lateralis (intramuscular)/No AE; Initial information received on 26-Dec-2019 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 year old male patient who received received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] subcutaneously which was intended in the left vastus lateralis (intramuscular) (incorrect route of product administration).  Medical history, past medical treatment, vaccination and family history were not provided.  The patient received concomitant therapy with MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) [PROQUAD]  On 16-Dec-2019, the patient received a dose of 0.5 mL suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5635AA, expiration date: 18-JUN-2021] via subcutaneous route in unknown administration site.  It was a case of actual medication error due to incorrect route of product administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.