chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Arm is really sore and kindy achy; Chills; So cold; Feeling crummy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is really sore and kindy achy) and MALAISE (Feeling crummy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is really sore and kindy achy) and MALAISE (Feeling crummy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm is really sore and kindy achy) and MALAISE (Feeling crummy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Report received on 24-APR-2021 contains no new information.
patient received FLUZONE QIV at 4 months old with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient who experienced patient received fluzone qiv at 4 months old with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2022, the patient received 0.5 mL total of dose 1 of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ878AB and expiry date: 30-Jun-2023) via intramuscular route in the right thigh for prophylactic vaccination.  On 11-Oct-2022, (latency: same day) the patient received fluzone qiv at 4 months old with no reported adverse event (product administered to patient of inappropriate age) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
first shot made my stomach upset; if there is anything I can take that will help with my stomach ache; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced upset stomach and stomach pain. On an unknown date, the outcome of the upset stomach and stomach pain were unknown.   It was unknown if the reporter considered the upset stomach and stomach pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The first shot made patient's stomach upset. The patient just wanted to know if there was anything he/she can take that would help with stomach ache. The patient was nervous about the 2nd dose.
Pt. dev. fever low grade approximately 100 degrees F on the 6th day after vaccines and lasted for 2 days then rash (eryth. maculopapular) dev. on face then spread to body/ext. on 10th day after vaccines given. No conjunctivitis.
Mom brought patient back to office about 20-30 minutes after discharge home.  Child had complained shortly after shot that her hands were tingling and she couldn't move them.  The patient was crying and upset when I saw her.  Both of her upper extremities were quite stiff distally especially the fingers which were extended and quite rigid.  With lots of coaxing she could bend them but was unable to squeeze my fingers.  She was treated with oral diphenhydramine to which she responded and she was discharged home within 45 minutes.
Expired vaccine; 0.3ml given as booster; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine) and ACCIDENTAL OVERDOSE (0.3ml given as booster) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 030B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine) and ACCIDENTAL OVERDOSE (0.3ml given as booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine) and ACCIDENTAL OVERDOSE (0.3ml given as booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (0.3ml given as booster).    It was unknown whether patient had tested positive for COVID-19.  No concomitant medications were reported.  No adverse events reported. No treatment medications were reported.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age. On 11-JAN-2016 the patient was vaccinated with PEDVAXHIB lot # L030865 (expiration date 07-JUN-2018), which was improperly stored at 48.5F for 30 minutes (incorrect product storage). There was no previous temperature excursion. No adverse effects reported. Additional information is not expected as it was not allowed to contact the reporter.
COVID breakthrough infection with hospital admission requiring xfer to ICU. Increasing weakness, frailty in weeks prior to admission on 10/14/21. Significant decline in resp status on evening of 10/16 w/ transfer to ICU lvl of care for  respiratory support. Given remdesivir x5 days. Tocilizumab 8 mg/mg given x 1.
Patient developed numbness of lips within 2 hours and left side of face. patient developed a burning sensation on Left side of head later that day. Right foot started going numb 3 days later and then spread to shin after  3 days  and by 1 week spread to waist and Left side of chest also. Patient then developed numbness in left leg and in perineal area.  MRI lumbar spine was done to evaluate patient's history of herniated disc which had no significant change from previous MRI. So a brain MRI was ordered and patient was referred to a Neurologist
my daughter had 11 vaccines injected into her blood stream that day and she has not been the same ever since. she has been suffering with severe gut issues, allergies, fevers, and sickness like she never had before.  She also shows signs of ADHD which she never had before either. We are still treating her almost 2 yrs later, it will be ongoing until my child is back to normal
Myoclonus (involuntary muscle spasms/jerks) all over body at rest and during movement. No neurological issues prior to Covid vaccine. Muscle jerks have continued to get worse by the day.
pt recv vax 22AUG96 & 27AUG96 pt exp a rash w/one raised bump on stomach & two other blisters;
HIGH FEVER X 5 DAYS, RASH, VOMITING, DEHYDRATION, SEEN IN ER 7/25/08, 07/29/08 PT SEEN IN OFFICE 7/28/08. HOSPITALIZED 7/31/08 TO 08/05/08 DIAGNOSED WITH INCOMPLETE KAWASAKI DISEASE.  09/17/2008 MR received for DOS 7/31-8/5/08 with D/C DX:  Incomplete Kawasaki's Disease. Fever-resolved. Dehydration resolved. Hematemesis resolved. Pt presented initially to ER 7/29/08 with 5 day hx of fever with emesis and decreased oral intake. On exam pt exhibited extreme irritability, increased HR, and vomiting. Erythema of tonsils and cervical lymphadenopathy. Pt developed high fevers in hospital as well as L bulbar conjunctivitis which lead to dx of incomplete Kawasaki's. TX witrh ASA and IVIG with improvement of fevers, activity and po intake. D/C on 1/2 baby ASA with repeat echo and labs as outpt.
I gave vaccines to this patient i began on the right arm and administered a Flu vaccine, then i moved to the patients left arm and administered HPV#2  vaccine. I then told the mother that we usually have patients wait 15 minuets in the room but because we were so busy i was going to have them wait in the lobby. Mother said that was fine and was about to walk out when her daughter just suddenly fell to the ground in a sitting position, I reached for her arm but she still fell to her left side and hit her head on the ground. I quickly pulled her and held her in my arms blowing air to her face, mother stepped out and got help. An MA walked in the room and saw what happened and went to get the provider. Water was given to the patient and then mother and I carried patient onto the bed. Blood pressure and oxygen were then taken, provider then told us she had it all under control and we stepped out. CARDIAC REFERRAL FOR WITNESSED SYNCOPE IN CLINIC after HPV vaccination, likely vasovagal  Patient already saw neurology and cardiology. She is pending a brain MRI with neurology.
Fever 103.6 (Rectal), Stuffy nose. ER 6/15/04PM, office 6/16/04, vaccine rxn vs viral illness. Will follow up
A non-serious spontaneous report of "7 patients were inadvertently administered expired H1N1 LAIV" was received from an office manager/health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medication have been reported for this patient. The vaccine expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
HEADACHE; TIREDNESS; QUEASY STOMACH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced queasy stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, tiredness, and queasy stomach on 26-MAR-2021. This report was non-serious.
Fever up to 101.4,  left arm soreness, fatigue, drowsiness
I broke out into a rash and fever all over my body the day before Thanksgiving, which was two weeks after being  vaccinated and called the dr. office and did a tele visit he then prescribed me a cream for the rash. I also spoke with a dermatologist 2-3 days later and he also confirmed I had the right dermatologist prescription and told me to take the Claritin and use the cream every day for 2 months. The conditions slowly faded away around the end of December.
No sore arm until day 3; Ended up with 5 welts or hive like marks down the arm of the injection site; Being tired first few days; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 15Mar2021 at 09:30 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included childhood asthma, seasonal allergies, allergic to cats, iodine allergy and fruit allergy (bananas and avocado and peaches). Concomitant medications included escitalopram oxalate (LEXAPRO) from unknown date for unknown indication. The patient also had known allergies to morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 17Mar2021 at 02:00, patient experienced pain in arm, hives and tiredness. The patient reported no sore arm until day 3, ended up with 5 welts or hive like marks down the arm of the injection site. And only one on the other arm. There were no other symptoms except being tired for first few days. The hives were still present. The patient did not receive any treatment for reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the reported events pain in arm, hives and tiredness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Arm pain; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 13-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 18:15 (Lot number: EWD177) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "allergy", notes: Known allergies: Tylenol.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  Additional information: It was reported that patient received other vaccine on same date vaccine in right arm. She had no covid prior vaccination. She was not tested for covid post vaccination. The lot/batch number is not available.  Follow-up attempts completed. No further information is expected.
26FEB96 t103.4 ax;LOM;begin cephalexin office visit;28FEB96 seen again w/temp to 105 x 2;26FEB PRN,& 27FEB began devel rash;exam 28FEB morbilliform rash;27FEB 103;28FEB 100;suspect viral exanthem but VAE a poss though timing unusual
the pt received the vaccine and seemed to be doing fine. her sister was next to get a flu shot so patient got up waiting next to her mom. while the sister was getting a shot i heard a tud sound and saw patient laying on the floor. I ran and lifted her legs. the other pharmacist grabbed icepack and I also gave her water and some candy as soon as she came to. she was out for five to 7 seconds. she had a typical vasovagal response.
On 10/2/02 child developed fever. For 10 days child had fever. Parent would give Tylenol and fever would subside. On 10/4/02 child became fussy, irritable and difficult to comfort, especially at night. This continued for 10 days. Child saw MD 10/11/02. Parent states MD diagnosed a virus. Parent requested VAERS report be completed. No treatment other than Tylenol.
Within 24 hours of vaccination, left upper leg had significant swelling, redness, heat and tenderness.
Vaccines given at 9:10. Pt did great. As he & parent were driving out of parking lot he became pale, rigid & unresponsive for 10-20 seconds. Pt monitored for 90 minutes then sent home in stable condition.
swollen arm; bruised arm; hurting arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), CONTUSION (bruised arm) and PAIN IN EXTREMITY (hurting arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm), CONTUSION (bruised arm) and PAIN IN EXTREMITY (hurting arm). At the time of the report, PERIPHERAL SWELLING (swollen arm), CONTUSION (bruised arm) and PAIN IN EXTREMITY (hurting arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Kinrix administered instead of separate DTap & IPV injections. No reaction. Verified no change in schedule with state. MD aware
Patient and Guardian gave the incorrect DOB. Consent form had a date of birth of 12 years but the actual age was 11 years. The error was found after the fact through the Immunization Information system.
pt recv vax & noted paresthesias in lt arm;pt felt faint;pt lost consciousness & began to posture & seize;911 called & raised legs,took BP;down to 60 systolic;pt became conscious a few sec p/& slowly pressure rose to systolic of 80;
1. Fever to 101.6 the night of vaccination. 2. Mild runny nose since 1 day after vaccination.  3. Severe cough since 1 day after vaccination.  Brought up milk and phlegm several times due to forceful loud coughs.
I was diagnosed with an autoimmune disease called Oral lichen planus on March 07, 2023, I was having difficulty eating, and also soreness and redness and shallow sores along my gums and teeth. I was prescribed magic mouthwash and mouth rinse.
fatigued; Dizzy; fatigued, tired was reported as worsened.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration administered in Arm Left on 18May2021 09:10 (at the age of 31-years-old) as single dose for covid-19 immunisation. The patient's medical history included ongoing G6PD deficiency. She says she only found out about it a couple of years ago but she assumes it's a life thing, dust mold and blood deficiency. The patient's concomitant medications were not reported. It was reported that the patient got her vaccine about 9:00 yesterday and a little after, she stayed 30 minutes to be watched because she has some blood disorders, she was fully getting more and more fatigued throughout the day on 19May2021. She says her one concern is part of the severe allergic reaction: she is dizzy on 19May2021. She says the dizzy is not so bad. She says she is tired and wants to make sure she was ok if she would go to sleep would that be an issue. The patient said that her vaccination card was in her car. She does not know the NDC number, LOT number, or expiration date of the first dose. The outcome of the events fatigued and dizzy was not recovered while, the outcome of another event was unknown.  Information on the lot/batch number has been requested.
Kidney infection; Kidney stones; This is a spontaneous report from a contactable consumer. This contactable consumer reported for a patient that stating that received second dose of bnt162b2 (BNT162B2; formulation: solution for injection; Lot number and expiration date were not reported) via an unspecified route of administration, on an unknown as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Consumer reported that two of my relatives developed kidney infection and kidney stones and hospitalization after receiving second dose.  Information about lot/batch number has been requested.
Left thigh 2.5x6cm redness and swelling. Left axillary .75cm redness. Prescription: Duricef 500mg qd 10 days.
Tinnitus - I have developed tinnitus in my left ear.  It started off as a beeping  - at first I thought that something electrical was causing it.  Then it transformed into something that sounds like a cicada, or a shaker, something rattling at a very fast pace.  That sound is constant.  It is always there.  Sometimes I also hear popping and beeping.
Information has been received from a consumer concerning his son who was vaccinated (date, route and site not report) with PedvaxHIB (lot#not reported). The caller stated that his son was administered a recalled lot of the PedvaxHIB and experienced an AE but did not provide the AE description. No additional information is expected.
Information has been received from a Bachelor of Science in Nursing concerning a patient who, "a few days ago", was vaccinated with a dose of VARIVAX (Merck) (lot #, expire date and route not reported). On an unspecified date, the patient could be experiencing an adverse event, but the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from the Bachelor of Science in Nursing who reported that the child patient experienced normal local response, such a redness and swelling but it was no true allergic reaction. Additional information is not expected.
Patient seen in office for right arm pain, onset at time of injection 12-20-07. Pain continued to date of 1/25/08. Right deltoid tender to palp. No heat, Rubur or swelling.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2022 as dose single, unknown (Batch/Lot number: unknown) at the age of 55 years, in left arm 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negetive, notes: After testing negative for 5 days; (23May2022) positive, notes: my COVID came back. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1st shot, no reaction. Second shot, swelling and rash around shot site for about 2-3 weeks, fatigue, and about a month out, rash around abdomen that comes and goes. Still getting rashes intermittently.
general fatigue and diffuse muscle aching that interfered with sleep. All resolved by 10/12/2022 at 7 AM