chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9 month old male patient received an expired dose of Fluzone vaccine,No AE; Initial information received on 07-Jul-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a nine month old male patient who received an expired 0.5 mg dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number not reported and expiry date: 30-Jun-2020) via an unknown route at an unknown administration site for prophylactic vaccination.  Past vaccination included flu vaccine (with first dose at his 6 month visit in April).  Medical history, concomitant therapy, medical treatment and family history were not provided.  It was a case of an actual medication error due to expired vaccine used. It was reported that a 9 month patient visit yesterday and he received the flu vaccine. After he received the dose they found that the vaccine was expired.  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.  There will be no information available on the batch number for this case.
Patient has delayed reaction from vaccine. Patient presents with worsening intermittent pain to left arm that comes in waves and in addition to the pain, arm heaviness.
I was Vaccinated on 9/4. On 9/8 in the evening time, I began having rib pain. I assumed I had dislocated it (I have before)and tried to fix it at home. After a few days of pain, I went to the urgent care and they saw a rash that indicated shingles. After talking with the doctor about what could have triggered this, I meantioned I had been vacinated a few days before symptoms started. The doctor stated that the shingles were liekly triggered by the vaccine.
After receiving the vaccine I had multiple near syncopal episode both while standing and while laying supine. The near syncopal episodes occurred randomly and were not provoked by exercise or any other activity.  These symptoms subsided after about 2 weeks.   Sub-sternal chest pains occurred for one week after receiving the vaccine. The pain ranged from minor to moderate and again was unprovoked and subsided on its own.   12 lead EKG shows a first degree heart block. I have never had any abnormal EKG results in my life. Having them routinely for my job
This spontaneous case reported by a consumer, describes the occurrence of paresthesia (tingling in his left arm), movement disorder (left arm does not swing when walking), limb discomfort (left arm felt weird) and illness (severely sick the next day) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 044B21A and 016B21A) for COVID-19 immunization. No medical history reported. On Apr 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On May 11, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On May 11, 2021, patient experienced limb discomfort (left arm felt weird). On May 12, 2021, patient experienced illness (severely sick the next day). On an unknown date, patient experienced paresthesia (tingling in his left arm) and movement disorder (left arm does not swing when walking). At the time of the report, paresthesia (tingling in his left arm), movement disorder (left arm does not swing when walking), limb discomfort (left arm felt weird) and illness (severely sick the next day) outcome: unknown. The patient already consulted his physician and CT scan done. They are going to do nerve conduction study as well. No concomitant medications or treatment information provided.
diarrhea; vomiting; Upset stomach; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: ELO142), via an unspecified route of administration on 15Jan2021 13:00 at a single dose in left arm for COVID-19 immunization. Medical history included Hodgkin lymphoma, thyroid cancer, breast cancer and hypothyroidism, known allergies: allopurinol. There was no other vaccine in four weeks. Concomitant medications: There was other medications in two weeks, but unspecified. The patient experienced upset stomach about 2 hours after vaccination was administered (15Jan2021 15:00), then diarrhea and vomiting both on 16Jan2021 15:00 (as reported) (about 14 hours after vaccine was given). No treatment received. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No COVID prior vaccination and no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021.
Patient reported soreness that started about 5 hours after the shot and still lingers even after 3 weeks of getting the shot. Patient said she has difficulties lifting her arms to put her clothes.
Been in and out of the hospital all year and with it's pressure to the roof; Haven't been able to work; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Been in and out of the hospital all year and with it's pressure to the roof) in a male patient of an unknown age 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 was provided by the reporter.  Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) for Diabetes, LISINOPRIL DIHYDRATE (LIZINOPRIL), AMLODIPINE BESILATE (NORVASC), PROPRANOLOL, PRAVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), FISH OIL and ARGININE HYDROCHLORIDE (L ARGININ) for an unknown indication, IRON.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced HYPERTENSION (Been in and out of the hospital all year and with it's pressure to the roof) (seriousness criterion hospitalization) and MALAISE (Haven't been able to work). The patient was treated with METOPROLOL for Hypertension, at an unspecified dose and frequency; CLONIDINE for Hypertension, at an unspecified dose and frequency and HYDRALAZINE for Hypertension, at an unspecified dose and frequency. On 21-Jan-2021, HYPERTENSION (Been in and out of the hospital all year and with it's pressure to the roof) outcome was unknown. At the time of the report, MALAISE (Haven't been able to work) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Blood pressure measurement: 187/83 (High) 187/83.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 18 Jan 2021, the patient was admitted to the hospital and discharged on 21 Jan 2021. Since then, the patient reported he has been to the emergency department (ED) 4 or 5 times.  Treatment medications also included Clonidine patch.  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. Further information has been requested.; 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. Further information has been requested.
Patient arm swelled to the middle of the forarm,the injection site is very hoved up, can not move arm, at the E.R. they could not get a pulse on that arm. Came home gave her BENADRYL & ibprophen. She tried to move it, was very swollen on 6/6/06-went back to ER-injection site was infected. BEADRYL was given 6/7/06-went to family MD-it was still hard, swelling is subsidizing.
pfizer bivalent booster was expired on 12/5/22. vaccine was given on 12/16/22
approx 9 days following pt devel fever,rash;fever rose to 104.5 & pt was very lethargic mom was unable to reduce fever using APAP;pt was taken to PMD & assessed thoroughly-no other problems found;approx 18hrs p/vax fever reduced to 101
Strep throat; This is a spontaneous report received from a contactable reporter. The reporter is the parent.  A 21 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "Strep throat".  Additional Information: The caller  said that her children received the 1st dose of the vaccine on 15Apr and they are scheduled to get the 2nd dose on 05May, however, they developed Strep throat. She would like to know if they can still go and get the 2nd dose as scheduled.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 02-AUG-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # M007763, expiration date 15-SEP-2017), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with GARDASIL. Subsequently, following vaccination, the patient fainted.  The patient fully recovered.  No further details were provided.  No further information is available.
Headache Nausea Fever Body aches Fatigue Swelling double the size and redness Lymph nodes swelling and achey
Patient found in EMT observation area diaphoretic and sitting hunched over 10 minutes following her vaccine. EMT assisted her to floor, laying supine with legs elevated over head. Patient states she is "feeling really good" 10 minutes following event. Patient left site at  10:33 am with steady, balanced gait.
A thirteen-year-old minor accompanied by his father, reported chest pain ten minutes after the first dose of vaccine at 1600 hrs. in the vaccine clinic yesterday, 08/05/21. He reported pressure pain 5/10 on the sternum area,  consistent and localized, guarding it with right hand periodically. VS within normal limit, including rhythm during assessment. At registration, the patient was noticed reluctant and nervous to have vaccine and exhibited fear of getting it one then . However, his father was seen convincing him for the vaccine. During assessment,  the patient stated ? See, I told them , I won?t get one, this is what happened?. He stated that he was brought to the clinic straight from the school by his father. Meanwhile, the parent of the minor denied the patient of having any underlying health condition, hx of taking medicines or recent hospitalization.  911 was called and the Fire Department was at the site @ around 1603 hr. The paramedic performed EKG and VS which were normal as per them. I gave option and suggested the father that it be better for the safety of his child to be seen by the medical providers in a nearby hospital. The father took my suggestion positively and consented to send his son to the hospital. The Paramedic ambulated him at around 1630 hrs.
Since the vaccination my periods have gone from 4-5 day average to 7-8 days in length.  In addition my cycle has gone from 28-29 days between each one to 20-21 days the last 3 months.  Nothing else in my life has changed, I am not taking hormonal replacement, birth control, or any other medications.  I am not trying to be nor have I been pregnant within the last 20 months.  I noticed the changes because I track my cycles and recognized first the extended length and then the shortening of time between cycles.
All adverse events occurred within 24 hours of receiving the vaccine. Irritability/fussiness, and high pitched and unusual cry and scream, diarrhea, and gastrointestinal pain, lasted for 5 days. Sleepiness and significantly decreased response to his environment lasted more than a week. Did not respond to lights, noise, etc., like he had before the vaccine.
After getting vaccines became pale, complained of feeling dizzy. Laid down on exam table. BP 68/42 - Later 30/60, Mom states the entire family has low Blood Pressure. Placed cold compress on forehead and back of neck.
Pain started within 2 hours of imm's. lethargy and drooling. Seen on 3/20/2010 with classic Coxsachive infection. Felt viral immun. cause of sx's. Dad requested VAERS reporting.
Day 1-Moderna vaccine (Feb 2, 2021) Day 2-pain at injection site, red size of half dollar Day 3-injection site swollen, hot, and itching but no pain Day 4-injection site enlarged doubled in size no pain Day 5-injection site enlarged to 7" long x 3.5" wide, itching painful to touch, skin red and hot (took 100 mg Benedryl, used CeraVe cream Day 6-injection site continues red,  hot and  intense itching  (took 100 mg Benedryl, used CeraVe cream ) Day 7-injection site continues to grow in size, red, hot painful, raised bumps, most intense itching I've ever had  (used CeraVe cream) Day 8-left arm (site of injection) is red from near shoulder stretching to within 1" of elbow, wrapping around arm about 6" (used CeraVe cream) Day  9- redness fading, itching  and pain subsiding some (used CeraVe cream) Day 10- redness continues to fade, itching getting better - no pain (no treatment) Day  11-no redness, rash remains rough, but little itching no pain (no treatment) Day 12-no itching, redness, pain or signs of rash (no treatment)
No adverse effects were reported; The nurse reported that the patient was administered PROQUAD by intramuscular injection; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 28-MAY-2018, the nurse reported that the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dosage, frequency, lot number, and expiration date were not reported) for prophylaxis, by intramuscular injection (incorrect route of product administration). No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA012997:
Patient received 1st Pfizer vaccine at 3:10pm on 4/20/21 and felt only numbness/tingling in arm within the first hour, then felt fine rest of day into the following day 4/21/21, until about 2:00pm when she developed a headache that got worse with time. Headache turned into pain that radiated to her ears, jaw, and neck. When patient got home close to 6pm that evening (4/21/21), she looked in the mirror and noted her face looked droopy. She went to go speak to her husband, who realized immediately that her speech was slurred. He took her to hospital where she was admitted for observation and tests were run.
This spontaneous report was received from a pharmacist and refers to a 31 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In December 2013, the patient was vaccinated with the first dose of RECOMBIVAX HB, then, in September 2017, the patient received the second dose of RECOMBIVAX HB, and in October 2017, the patient received the third dose of RECOMBIVAX HB(dose, route, lot number and expiration date were not reported) all for prophylaxis. No adverse effects reported.
Bilateral Tinnitus-ongoing, lymph node swelling (Right) under armpit- 1 week to dissipate
The patient was at the end of her 30 minuet observation post IM injection. Patient stated, "I feel funny, my lips and tongue are tingling. My tongue is starting to feel thick." Patient was taken to a private room where vitals were taken ( stable vital signs), patient stated, "I feel like it is getting worse." Patient was given IM EPI. EMS was called and patient was transported to the ED.
Patient received J&J COVID vaccine on 4/9/21 at pharmacy . Today (4/22/21), patient is admitted to our facility with VTE, submassive, unprovoked, with bilateral high-burden PE and LLE DVT, and right heart strain / acute cor pulmonale; in patient with H/o R PE, provoked 2014 after transcontinental flight, s/p Warfarin x 6 months, reportedly negative hypercoagulable panel; with strong family history of venous thrombosis in mother and sister. Heparin drip started, plan to start DOAC tomorrow. Anticipate hospital admission for at least 2 nights.
The day after I received the 2nd dose of the covid shot I experienced fever, extreme muscle fatigue, chills, sore throat, extreme fatigue, and headache. 2 days after the shot these symptoms lessened to minor instead of severe. 3 days after the shot my headache turned into an extremely painful migraine that did not go away until 5 days after the shot.  I have never experienced a headache or migraine before that did not go away after getting a night's rest. I had to take zofran to keep from vomiting from the migraine. I had to take off work until the migraine went away. I could not tolerate light or sound, my head throbbed and was intolerable.
the patient later found out that she was pregnant at the time of administration; This spontaneous prospective pregnancy report was received from a nurse referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 25-MAR-2019, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported. After the vaccination the patient found out that she was pregnant at the time of the administration (exposure during pregnancy).    The patient estimated date of delivery (EDD) was 16-MAR-2019. Their last menstrual period (LMP), gestational age and trimester of exposure were not provided.  The pregnancy outcome was outcome pending. The outcome of exposure during pregnancy was unknown.
3rd GARDASIL injection given at 8:15.  Went home with baby sitter.  Felt fine.  Laid down @ 2:45 and woke up @ 3-3:15.  Complained of severe abdominal pain, pain in injection site and H/A.  Temperature 101 F.  Baby sitter gave 2 Tylenol.  Fever went down.  At 7:30 rash on face, temperature of 99.9.  Saw doctor.  Had sinus drainage.  Was given teaspoon Zantac and 2 Tylenol.  6/4/08, still has rash.  Feels tired.
Patient was administered a second booster dose of Moderna on 4/5/22 but the vial had expired on 4/4/22. Incident was reported to Moderna and a lot analysis was completed. Results showed the vaccine "maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration".
Excruciating pain on my arm (vaccine arm) can?t move, raise the arm, can?t sleep due to pain. Will contact family doctor on Monday if it does not get better
This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 12-DEC-2014, patient was vaccinated with an improperly stored dose of MMR II (lot# J016232, Expiry: 19-DEC-2015, therapy type: HSA, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Patient received 2nd dose of Pfizer vaccine today.  The patient's mother asked for assistance as daughter was "having a reaction."  Vitals/assessment at this time: 62, 16, 82/54, 99% on room air. Patient looks pale, diaphoretic, says "my vision is blurry". Questioned mother and patient, mother said "this is the first time this has happened." When asked about if she had anything to eat, she said she had not eaten breakfast.  OJ given. Patient awake, alert, oriented X3. Sitting in chair. Skin warm to touch/ looks flushed. Vitals  Reassessment- 72, 92/59, 95% room air. Repeat vitals taken x 2. Patient noted feeling better. Patient drank all orange juice, moving extremities, talking, walking with steady gait. Home with parent.
RN gave MMRV instead of MMR and Varicella separately. This was out of approved age range Foster home notified. no adverse effects. 0 adverse event! Med was given (MMR/VARICELLA) outside of age range.
Employee experiencing increasing pain, spasms and slowly loosing ability to use left shoulder. Discomfort radiating to shoulders and back. Saw Provider at clinic for check up who diagnosed a muscle injury and recommended an MRI and PT.
Information has been received from a registered nurse concerning a 12 year old female who on 18-JAN-2007 was vaccinated IM with a first dose of Gardasil. No other vaccinations were administered. On approximately 18-JAN-2007, the patient experienced soreness at injection site, fatigue, musculo-skeletal pain, and joint pain. The following laboratory tests were performed on the patient: complete blood cell (CBC) count; erythrocyte sedimentation rate (sed rate); rheumatoid factor (RF); antinuclear antibodies test (ANA); creatine kinase (CPK); "strep test"; influenza A and B; Lyme disease enzyme-linked immunosorbent assay. All lat test results were reported as normal. The patient was not prescribed any treatment. By 20-FEB-2007, the patient was fully recovered. Additional information is not expected. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Follow-up from a physician indicated that approximately 10-14 days after the patient was vaccinated, she developed shoulder, hip and ankle pains. On 07-FEB-2007, the patient had a shoulder x-ray, right knee x-ray, and hip x-ray. All were normal. On 07-Feb-2007, the patient's ESR was 41. On 17-FEB-2007 the patient recovered from the shoulder, hip and ankle pain. Additional information is not expected.
Child started running temp,, not eating, not playful.  Started 7/15/03, went to ER on 7/17/03, was told by ER doctor child had a virus.
Primary spontaneous pneumothorax experienced almost four months after second Pfizer covid vaccination. No covid-19 diagnosis during, or prior to the lung collapse.
Shortness of breath, dry cough, and chest pain 10 minutes after getting the vaccine.   Dry cough, sore throat, headache, mucus, tiredness, COVID arm from day 7 after vaccination.
12 x 13 cm induration. Localized reaction right deltoid home medications ADVIL for comfort. Ice area. CLARITIN 10mg 1 po in AM, BENADRYL 50mg 1 po PM, ZANTAC 150mg BID with CLARITIN & BENADRYL.
Received 5 vaccines on 2/17/2012, had reaction later same day had 3.5 cm raised hive on right arm had 9 cm raised hive on left arm.
Urticarial rash, right thigh-worse at injection site-Had approx 4 cm erythema at site and one urticarial lesion
30 min. after injection i had really bad muscle and back pain, and got the chills.  15 min. after that i got the chills again and just totally felt horrible.
Bloody breast fed stools began 5/8.  Diarrhea developed 5/9 with mucousy bloody stools 12 times a day.  Developed fever 101.5 5/10.