chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L006181 with expiration date 13-DEC-2016, lot# L039141 with expiration date 16-AUG-2017, dose unknown) orally. The vaccine had been stored under the temperature of -0.6 Celsius degree for 361 hours and 35 minutes. Digital data logger was involved. It was unknown if there was previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report has been received from a consumer refers to the consumer's mother, a 78 years old female patient, with no drug allergy or concomitant medical history who was vaccinated SC with a 0.65 ml dose of ZOSTAVAX on an unspecified day in approximately MAY-2012 (reported as about two months ago). Concomitant medications included some unspecified medications. In approximately MAY-2012 (reported as about two months ago) the patient experienced a burning sensation throughout her body since having a ZOSTAVAX. The patient sought medical attention and physician had given the patient BENADRYL and LYRICA (manufacture and strengthen unspecified). Blood work and other unspecified tests were performed. At the time of report, the patient was not recovered. Additional information has been requested.
Client received her second Moderna vaccine at 1155. At 1202 client complained of feeling hot and heart beating fast. Palpated pulse was 130. client then put on the wheelchair to the corner . At 1205 BP 168/100, 02 sat 98% on RA, HR 89, RR 22. At 1208 HR 74, 02 sat 98% on RA BP 150/90.Client denies any symptoms at this time. Client denies feeling hot or any fast heartbeat or palpitation. No further treatment is needed. Client will be driving self-home. Symptoms where resolve in 4 min. Total observation time is 45min. Client left at 12:40.
itching on Sunday;next day rash on arms, trunk legs;Monday swelling w/dyspnea;Tues AM EPi, Solumedrol, Pred, Medrol
bleeding in colon; MARKETING PROGRAM  This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4339989-00.  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 06Dec2020 (Batch/Lot number: unknown) at the age of 31 years as dose 1 , single, intramuscular, administration date 21Jan2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) as dose 3 (booster) , single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: LARGE INTESTINAL HAEMORRHAGE (medically significant), outcome "not recovered", described as "bleeding in colon". The patient underwent the following laboratory tests and procedures: colonoscopy: unknown result, notes: Bleeding in colon. The action taken for adalimumab was unknown.  The reporter considered "bleeding in colon" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the event large intestinal haemorrhage and the 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.
9 x 9 cm red and indurated patch, right upper outer thigh. Benadryl 1tsp Q 6 hrs.
Information has been received from a nurse practitioner concerning a 34 year old female certified medical assistant who on 02/28/2003 was splashed in both eyes with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported). The pt reported that her eyes felt numb. Unspecified medical attention was sought. The pt's outcome is unknown. Additional info has been requested.
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The date of vial initially stored in the refrigerator was unknown. Number of doses/vials were 168. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant live follow-up: Additional reporter added.
Pt was fully vaccinated with the Pfizer COVID-19 vaccine (on 1/28/2021 and 2/18/2021).  Pt tested positive for COVID at her LTC facility on 8/24/2021.  She was then subsequently seen in the ED on 8/28/2021.  On 9/5/2021, she was seen again in the ED and admitted for COVID 19 complications and pneumonia.  She was discharged on 9/7/2021
rash all over body; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash all over body) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A(Sor5)7147B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Covid19 vaccines (previous had all Pfizer Covid19 vaccines.). Past adverse reactions to the above products included No adverse event with Pfizer Covid19 vaccines.    On 06-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over body). The patient was treated with TRIAMCINOLONE ongoing since an unknown date at a dose of 0. 1 percent. At the time of the report, RASH (rash all over body) outcome was unknown.            Patient had no known allergies. Patient was not taking any other medications for any health conditions.  Patient went to a dermatologist and they prescribed Triamcinolone Cream 0.1 percent..
Large red area surrounding location of vaccine, swollen, hot to touch, soreness, lasted about 4 days.
NauseaVomiting sore red arm, nausea, sweats 8 days after second dose
7 days after my first Pfizer COVID vaccine, I developed mastitis. It began in the morning with mild generalized muscle and joint pain and progressed to moderate to severe joint pain, a fever of 102 degrees, and localized redness and swelling of the left breast over the course of 12 hours. Treatment with Cephalexin 500 mg PO QID for 14 days was initiated within 12 hours of onset. The systemic symptoms resolved within 24 hours of treatment onset and the breast redness and swelling resolved within 72 hours.   While I am aware that an infectious mastitis is likely unrelated to the vaccine, I opted to report this incident because I have breastfed 3 children and have never had mastitis prior to this event  and because of the limited information available on this vaccine in lactating women.
Fever 6/27-6/30 to max 104. Onset rash 7/1 with numerous erythematous papules, vesicles and erosions by 7/6, appearing secondary in face. Prescribed Keflex with improvement. Seen again for rechecks on 7/8 and 7/27; Healing.
Weakness in legs, headache-both symptoms lasting until the following morning. Area of injection warm, firm and itchy. Itchiness gone today but still warm and firm.
HPV #3 adm yesterday. Mother reports today pt has headache, some nausea & sore arm. Mother insists on reporting.
reaction to DT rash, bruising;rxn to MMR bruised, red;monitor for rx to other inj/components;referral to allergist @ later date;
Child received Pre-K immunizations in our office on 8/14/03. Mom returns a call to our office on 8/15/03. Describes child's arm, left upper, deltoid area as very red, swollen and warm to touch. Denied any pain or itching. Localized reaction apparently to the DTaP vaccine. Instructed on care and to notify the office or ED if condition worsened.
This spontaneous report was received from a 52 year old female patient (who was also a company representative) reporting on herself via a company representative. Information about the patient's medical history, concurrent conditions, drug reactions or allergies was not provided. On 11-JAN-2017, the patient was vaccinated with ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported) for prevention of shingles. No concomitant therapies were administered. On 11-JAN-2017, the patient experienced injection site redness, swelling and a small bump in the center of injection site. The injection site was slightly warm to the touch. No treatment was given for the events. Laboratory diagnostics tests were not performed.    The outcome of the events was reported as not recovered/not resolved (the patient stated that at the time of the report, the symptoms had not gone away). The causality between the events and ZOSTAVAX was not reported. The patient did not seek medical attention. Product quality complaint was not involved. Additional information  is not expected as there were no contact details provided.
came to the pharmacy on 7/30/2021 requesting his first dose of the Pfizer COVID-19 Vaccination. He filled the consent form completely and stated that this is his first COVID vaccine. The vaccine was administered to him and he was asked to return to the pharmacy 3 weeks later for the 2nd dose. He made no mention of being administered any other COVID vaccine to the pharmacist and did not present any other record to the pharmacy staff. He came back to the pharmacy 3 weeks later on 7/30/21 and when he was asked to present his COVID vaccination record card, the pharmacist noticed 2 cards. One card was the one filled out at our pharmacy for the first Pfizer vaccine and upon inspection, the other card was for a Johnson and Johnson COVID vaccine that he was administered in May 2021. The pharmacist questioned this other card to which replied that his wife was very concerned about COVID and he thought that getting more would be better. He later stated that he didn't mention getting the Johnson and Johnson vaccine when he got the first Pfizer vaccine. The pharmacist on duty did not administer the 2nd Pfizer vaccine and called Pfizer to get guidance. Pfizer did not have a specific recommendation of whether or not to give the 2nd dose. It was decided not to proceed with the 2nd dose and the patient was made aware.  No adverse events have been reported from the patient.
Fever, chills, muscle aches, extreme fatigue, shortness of breath, chest pain
This spontaneous report was received from a registered pharmacist and refers to a 69 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 03-AUG-2017, the patient was vaccinated with an improperly stored ZOSTAVAX, lot number M041087 with expiration date 03-JAN-2018 (dosage schedule, anatomical location and route of administration not provided) for prophylaxis, reconstituted with properly stored diluent (MRK INJ). The administered vaccine was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour. Previous temperature excursion was reported as 6 degree Fahrenheit to 14 degree Fahrenheit for 45 minutes. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010696: US-009507513-1708USA010732: US-009507513-1709USA014569: US-009507513-1709USA014570: US-009507513-1709USA014571: US-009507513-1709USA014572: US-009507513-1709USA014573: US-009507513-1709USA014574: US-009507513-1709USA014576: US-009507513-1709USA014577.
One day after Anthrax shot #3, noted pain and tingling in right arm (same as shot) from axilla to IV & V fingers. Has continued off and on since then and seemed to be exacerbated by subsequent Anthrax shots, of arm. No other local reaction.
Diarrhea after second vaccine, and booster; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2 and dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the past drug BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced diarrhea after second vaccine, and booster on an unspecified date. It was reported that the patient was reading the post vaccine instructions and it said diarrhea as a side effect. She also had the effect with the second vaccine. Caller stated that with the second vaccine, she had diarrhea for one day, and with the booster, the diarrhea had lasted two days. The outcome of the event was recovered on an unspecified date.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
9JUN92 p/last shots took to ER; t104-mom doesn't remember what med MD gave pt; rt leg swelled & had generalized rash; had cry cont p/shot;
Received injection 11/3/09 at 12:30pm states on drive home became very dizzy and confused and heart started racing and then starting fluttering like it was missing a beat. Felt like she was not getting O2 to brain. Left arm became cold and joints in both fingers ached. Eyelid felt very heavy. Lasted 3 1/2 hours.
Large raised, hard, red welt on leg below injection site. Apprx 2" x 3" in size, visible for 3-4 days. 4 days later 101 deg F temp. First ever fever, resulting in ear infection.
Information has been received from a medical assistant referring to a 4 month old female patient. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
High fever up yo 103.7 for the first 24 hours. Now fluctuates between 101 and 102.5. Severe body aches. Nausea, dizziness, off balance. I've fallen twice going to the bathroom.
6:30 pm 12/3 sore arm 3:44 am 12/4 chills, fever 99.8F, muscle aches, headache, nausea, body pain took 2 regular strength Tylenol 12/4 all day same symptoms and noticed swollen lymph nodes under left arm, fatigue, stayed in bed all day 12/ 5 same symptoms as 12/4 but noticed a red patch at the injection site (didn't look at it on 12/4), by mid afternoon I noticed i had trouble catching my breath and felt chest heaviness, this cleared up 12/5 night 12/6 went to work for 2 1/2 hours and saw my dr at 2 pm 12/6 I was concerned about my bodies reaction to the booster After 1st Moderna dose I had a headache the next day. After 2nd Moderna dose I was in bed for a day and 1/2 with the same symptoms After booster by reaction was much more severe than after my 2nd dose.  My reaction scared me enough to seek medical advice. I'm afraid if I need another dose of how my body will react. I was told the booster was 1/2 a dose and any reaction would be the same or less severe than what I had after the 2nd dose. This was not the case for me.  I was very sick with it. 12/ 7 all symptoms are gone except the arm is still tender at the injection site.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient did not have other medication in 2 weeks. Anti viral details product: COVID 19 Treatment, Brand: paxlovid, Treatment start date: 08Oct2022, Treatment stop date: 09Oct2022, Lot number: GF3187, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Complete fatigue, chills, headache for 2 days, then continued weakness still occuring.
Information has been received from a 70 year old male physician who in 2006 was vaccinated with a dose of Zostavax. On 11-APR-2007 the physician experienced pain on right flank area and right abdominal area. Unspecified medical attention was sought. A CAT scan on the affected area showed no abnormalities. There were no zoster-like lesions present. At the time of the report the physician had not recovered. There was no product quality complaint involved. The physician considered his pain on right flank area and right abdominal area to be disabling. Additional information has been requested.
shingles; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.   Reporter did not allow further contact
9 DAYS POST VACCINATION EXPERIENCED SORE THROAT, MILD DRY COUGH, CHILLS W/O FEVER, GENERALIZED FLU LIKE MUSCLE ACHES.
No additional AE/PQC.; improperly stored administered PROQUAD; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 26-JUL-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliters (ml) for prophylaxis, lot# reported as X01111 (this is an invalid lot number for varicella [oka-merck] virus vaccine live [PROQUAD]), expiration date reported as 18-JUL-2024 (dose, anatomical location, and route of administration were not reported). The vaccine was stored at a temperature of -14.23 Celsius (C) degrees (-14 C up to -10 C) for 0 hours, 15 minutes, 0 seconds (product storage error). No adverse event was reported.
Cellulitis at site of injection, redness, swelling, warmth. Spreading of redness. Was seen on 11/21/18 for assessment of problem. Put on KEFLEX and problem resolved.
After dose 1 and dose 2 of my  initial vaccines I  started having  pain in my lower part of the body   including legs, limbs,  arms, lower back, toes and muscles cramps.  I never had this pain before.  It wasn't severe . As time went by after getting my 3rd dose the pain increased  I went to  my doctor to tell him that it is very painful. My doctor told me that there is nothing to worry about the pain is not related to the vaccine. He just told me to relax and the pain will go away by it's own.  I never had this pain before so, I decided to see an Orthopedic because my toes was hurting . The Orthopedic  prescribed me diclofenac  and also advised me to take Tylenol as needed .
Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my throat. I was taken to the ER.  The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea and feeling very unwell.
Two days after the 3rd shot I started with swollen throat,  swollen sinuses, extreme fatigue , taste and smell has reduced 90% and my period hasn?t started and was due the day after my shot. I still am having the same symptoms almost two weeks later
Dizziness, Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, Localized pain, redness; chills, fatigue Narrative:
Fever 100 degrees, headache, stomache upset, extreme pain at vaccine site, muscle soreness, lethargy
Arm at vaccine site swollen like a grapefruit, painful, & red.Severe migraine that did not go away after 2 days even using Naeproxin sodium & Tramadol. Low blood pressure & fainting & fever.