chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 4 years old patient with no pertinent medical history and drug reactions or allergies. The patient was vaccinated with dose 1 MMR II (Lot # not reported) on 18-MAR-20122 (no adverse events reported) and 2 of MMR II (Lot # 0134AE expiration date 10-OCT-2014) on 10-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on 10-JUL-2012, the patient had an injection site reaction described as a large white area (seemed to be fluid filled) formed immediately after the vaccination was given and then became a 2 by 2 inch area of redness, 1 day after onset of therapy. The injection site reaction was resolved within 30 minutes of vaccination. This is one of several reports received from the same source. Additional information has been requested.
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 10-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-1906USA011674:
MUSCLE SORENESS AT INJECTION SITE; SPILLED DOSE DURING ADMINISTRATION; This spontaneous report received from a patient concerned a male of unspecified age. 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 13-MAR-2021 for prophylactic vaccination at left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced spilled dose during administration. On 14-MAR-2021, the subject experienced muscle soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle soreness at injection site and spilled dose during administration was not reported. This report was non-serious.
Vertigo and generalized feeling of weakness developed within hours of vaccine. Normal exam. No redness or swelling at injection site. Some tenderness of muscles in axilla on side of the injection.
Patient received Arexvy vaccine 8/23/23 IM in her left arm. Starting 8/24/23 she had large swelling/redness around the injection site, and swelling in her underarm believes it to be a lymph node. She states she had similar reaction to all of the covid vaccines. She is doing at home ice packs and ibuprofen to help with pain.
Large lympadenopathy axillary on right side- the size of a softball, tender, pronounced swelling
Approximately 4 hours after receiving vaccine I developed a strong metallic taste in my mouth. This has persisted for 7 days. Neither brushing teeth nor using mouthwash alleviates strong metallic taste.
BREATHING DIFFICULTIES; DIFFICULTY WALKING; FATIGUE IN LEGS; MUSCLE PAIN; INCREASE IN HEART RATE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on left arm on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced increase in heart rate. Laboratory data included: Heart rate (NR: not provided) Increased heart rate. On 06-MAR-2021, the subject experienced muscle pain. On 07-MAR-2021, the subject experienced breathing difficulties. On 07-MAR-2021, the subject experienced difficulty walking. On 07-MAR-2021, the subject experienced fatigue in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle pain on MAR-2021, and had not recovered from fatigue in legs, breathing difficulties, difficulty walking, and increase in heart rate. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Patient received: JJ on 9/1/20 Mod 12/1/21 Mod 2/2/22 (extra booster)
Patient presented to his PCP for a follow up.  Patient was offered covid booster and flu.  Patient was given Moderna Monovalent instead of Moderna Bivalent for booster dose.  No adverse reactions.
Initial report was received from a healthcare professional on 15 November 2011. A female patient had received an intramuscular FLUZONE; lot number UT425AA in right deltoid on 06 October 2011. On the same day of the injection in the evening, the patient developed chills, body aches and neck ache. On 07 October 2011 in the am, the patient experienced nausea, arm swelling, pain at right deltoid and difficulty using her arm. The symptoms progressed and she was seen in the emergency room (ER) prior to office visit. No further information was available at the time of the report. The patient outcome was not recovered/not resolved. Documents held by sender: none.
More pain/redness at the injection site; More pain/redness at the injection site; This is a spontaneous report from a contactable pharmacist via a sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced more pain/redness at the injection site then normal on an unspecified date. Outcome of the events was recovered on an unspecified date.
itching over their legs and their arms (both of each); have some raised surfaces, It's constantly annoying; sleeping has been hard at times; expected little pain in the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (expected little pain in the injection site), VACCINATION SITE PRURITUS (itching over their legs and their arms (both of each)), VACCINATION SITE SWELLING (have some raised surfaces, It's constantly annoying) and SLEEP DISORDER (sleeping has been hard at times) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LISINOPRIL, HYDROCHLOROTHIAZIDE, SIMVASTATIN and AMLODIPINE for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (expected little pain in the injection site). On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching over their legs and their arms (both of each)), VACCINATION SITE SWELLING (have some raised surfaces, It's constantly annoying) and SLEEP DISORDER (sleeping has been hard at times). On 03-Feb-2021, VACCINATION SITE PAIN (expected little pain in the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching over their legs and their arms (both of each)), VACCINATION SITE SWELLING (have some raised surfaces, It's constantly annoying) and SLEEP DISORDER (sleeping has been hard at times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included topical lotions.
This case was reported by a healthcare professional and described the occurrence of dizziness in a 28-year-old female subject who was vaccinated with HAVRIX. Concurrent medications included oral contraceptives and concurrent vaccination included ADACEL given on 21 August 2007. On 21 August 2007 the subject received 1st dose of HAVRIX at 1 cc in the right deltoid. On 22 August 2007, 1 day after vaccination with HAVRIX (the following morning), the subject experienced dizziness while in the shower. The event resolved the same day with no treatment. The subject did go to her primary care physician regarding the dizziness. An EKG was performed, but was negative. On 4 March 2008 at 09:08, the subject received 2nd dose of HAVRIX at 1cc in the left arm. Six hours after vaccination with the 2nd dose of HAVRIX, at 15:00 on 4 March 2008, the subject developed severe fatigue that improved without treatment. The event had resolved by 5 March 2008. Both event s of dizziness and fatigue were systemic reactions. The healthcare professional considered the events were possibly related to vaccination with HAVRIX.
Patient was in the observation area and report feeling dizziness and blurry vision. Patient was  sweeting.  At this point we take the vitals of the patient  sugar was 100, O2% 83% at 4:40pm, 120/90 blood pressure.  The paramedic put the oxygen 2units and repeated the vital. The was transfer to the hospital.
5/20/21 - States sore arm Experienced nausea, fatigue, Head ache, and chills. Symptoms x48 hours
chills /get so chilly; pain in his arm for 24 hours at the injection site; difficulty lying; This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced chills, injection site pain and movement disorder. On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the injection site pain and movement disorder were unknown.   It was unknown if the reporter considered the chills, injection site pain and movement disorder to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. He claims that he has had a flu shot every year and he would experience pain in his arm for 24 hours at the injection site but he described the pain and experience as negligible and infrequent. Occasionally, after receiving the flu shot it would be difficult for him to lie on his left shoulder to sleep but that experience only happened once or twice. He mentioned during the phone conversation that in the military he would receive 5 to 6 vaccinations in one day and he would get so chilly that he had to take a shower and the chills resolved. He didn't clarify which vaccinations he received in the military. The reporter consented to follow up.  This case has been linked with US2020021556, reported by same reporter.
TEMPERATURE EXCURSION, MINIMUM TEMPERATURE WAS MINUS 0.41 DEGREES CELSIUS TO MINUS 1.46 DEGREES CELSIUS AND MAXIMUM TEMPERATURE WAS MINUS 1.99 DEGREES CELSIUS WHICH WAS BELOW MINUS 2 DEGREES CELSIUS; INCORRECT STORAGE OF VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 10-MAY-2022) dose was not reported, administered on 24-MAR-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On an unspecified date, the patient experienced temperature excursion, minimum temperature was minus 0.41 degrees celsius to minus 1.46 degrees celsius and maximum temperature was minus 1.99 degrees celsius which was below minus 2 degrees celsius, and incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion, minimum temperature was minus 0.41 degrees celsius to minus 1.46 degrees celsius and maximum temperature was minus 1.99 degrees celsius which was below minus 2 degrees celsius and incorrect storage of vaccine was not reported. This report was non-serious.
High fever for approximately 24 hrs after second injection and coughing for a week after; High fever for approximately 24 hrs after second injection and coughing for a week after; dose administration date=14Dec2021, dose administration time=12:00 PM, dose number=1/administration date=29Mar2022, administration time=12:00 PM, dose number=2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. A 9-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2022 at 12:00 as dose 2, single (Lot number: FL8094) at the age of 9 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (dose product= COVID-19, dose brand= Pfizer, dose brand unknown= False, dose lot number= FK5127, dose lot unknown= False, dose administration time= 12:00 PM, dose number= 1, vaccine location: Left arm), administration date: 14Dec2021, when the patient was 9-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Mar2022, outcome "unknown", described as "dose administration date=14Dec2021, dose administration time=12:00 PM, dose number=1/administration date=29Mar2022, administration time=12:00 PM, dose number=2"; PYREXIA (non-serious), COUGH (non-serious) all with onset 31Mar2022 at 07:00, outcome "recovered" (2022) and all described as "High fever for approximately 24 hrs after second injection and coughing for a week after". It was unknown if therapeutic measures were taken as a result of pyrexia, cough. Additional information If other vaccine in four weeks was no. If Covid prior vaccination was no. If Covid tested post vaccination was unknown. The patient did not have known allergies. High fever for approximately 24 hrs after second injection and coughing for a week after   No follow-up attempts are possible. No further information is expected.
caught a cold: sniffles, sneezing, sore throat, a lot of congestion; caught a cold: sniffles, sneezing, sore throat, a lot of congestion; caught a cold: sniffles, sneezing, sore throat, a lot of congestion; caught a cold: sniffles, sneezing, sore throat, a lot of congestion; caught a cold: sniffles, sneezing, sore throat, a lot of congestion; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 04Jun2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced caught a cold: sniffles, sneezing, sore throat, a lot of congestion. Caller wants to know if she can take the second dose of the Pfizer Covid vaccine as scheduled or should she wait until after the cold resolves. Caller states she does not think it is from the vaccine tho, her brother was sneezing or whatever and thought it was allergies and then her boyfriend, daughter, son, sister, brother, mother, everyone got it. Caller was speaking fast and clarified that everyone got a cold. It started off as a sore throat then it was sneezing and that was it, no fever, but a lot of congestion. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.  Follow-up #01 (25Jun2021): This is a Follow-up Spontaneous report from a contactable consumer female(patient) reported that: Updated in narrative.
Patient began having soreness around the injection site around 2 hours after it was given. Her use of the arm was restricted and limited. After treating with over the counter ibuprofen and naproxen and using ice on  the arm, the range of motion has returned after about a week. However, she still has pain that she describes as tendinitis like pain in the arm.
Per the Life Services Manager: Suffering with pain from her vaccine. She has seen her doctor and started therapy. Her doctor and therapist explained that it?s an inflammation of the shoulder bursa.
A few minutes after receiving the vaccine, patient complained of becoming light-headed and having some tunnel vision.  He also became diaphoretic and sat down in a chair.  A few minutes after sitting down, patient lost consciousness and slumped downward off of chair.  Pharmacy staff were able to protect his head  from injury as they assisted in gently laying him on his back.  Patient regained consciousness about 10 seconds later.  Patient's mental status was not altered and he was able to walk out of the pharmacy on his own strength.  Patient also stated that he had a history of vasovagal fainting in the past with needles.
Felt sick; Hefty reaction; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick) and VACCINATION COMPLICATION (Hefty reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt sick) and VACCINATION COMPLICATION (Hefty reaction). At the time of the report, MALAISE (Felt sick) and VACCINATION COMPLICATION (Hefty reaction) had resolved.            No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter   Reporter did not allow further contact
experiencing moderate injection site pain and erythema; experiencing moderate injection site pain and erythema; This spontaneous report has been received from a physician, concerning a 30-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 07-JUN-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T025370 with expiration date 01-DEC-2022, intramuscularly in the right arm (dose and frequency were not provided) for prophylaxis.  On an unknown date in June 2021, the patient reported that was still experiencing moderate injection site pain and erythema (vaccination site pain and vaccination site erythema). The patient did not received treatment for the adverse events.  The outcome of vaccination site pain and vaccination site erythema was reported as not resolved at the reporting time. The reporter did not provide a causal relationship between the adverse events and the therapy. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025370; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
After vaccines had arm pain and dizziness, felt tired. Experiencing bilateral arm pain, dizziness and tiredness after returning to office 2-2.5 hrs post visit.
Two days after pt received several vaccines, she presented with a 10cm x 7cm edematous erythematous welt posterior R arm.
MOP reports raised with patch like marks that is hot to touch , as well as red. Diagnosed with cellulitis. Pt was prescribed with cephalexin QID for 7 days.
54M PMH?HTN, HLD, diastolic cardiomyopathy with biventricular pacemaker. Received third COVID vaccine on 10/18/2021. Patient last seen running with his show dogs. Found down undetermined amount of time by RN who initiated CPR. Patient presented with EMS in ER with ventricular fibrillation. ACLS and intubation followed with ROSC. Pupils fixed with myoclonic upper extremity motions noted by providers prior to paralytic and intubation. Patient transported to Cath Lab where coronaries found to be without lesion.
ringing in ears; sensation of needing to relieve pressure in ears.  Intermittent, lasting 7-10 days.  Sore arm at injection site.
Fever 99.9; Bronchial congestion; Tenderness in lower right abdomen; Pain in lower back both right and left side; Severe pain in lower right abdomen; Severe joint  pain (pain level 9); Muscle pain (pain level 9); Wheezing; Body aches; Nausea; Spike in BP; Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 24Mar2021 at 11:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP), asthma, arthritis. The patient was allergic to egg whites, bananas and fish (fresh water). Concomitant medications included losartan/hydrochlorothiazide 100/12.5 (MANUFACTURER UNKNOWN) received on unspecified date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on unspecified date (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 24Mar2021 at 12:00, the patient experienced spike in BP, dizzy, nausea. On 25Mar2021 the patient experienced body aches, wheezing. On 26Mar2021 the patient experienced events of severe joint and muscle pain (level 9), bronchial congestion, severe pain and tenderness in lower right abdomen, pain in lower back both right and left side while event of wheezing persisted. On 27Mar2021, the patient experienced fever of 99.9 (unspecified units) and while events of severe joint and muscle pain (level 9), bronchial congestion, severe pain and tenderness in lower right abdomen, pain in lower back both right and left side and wheezing persisted. On 28March2021, pain and tenderness in lower right abdomen persisted. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for events. The clinical outcome of rise in BP, dizzy, general body pain, bronchial congestion, lower abdominal tenderness, low back pain, lower abdominal pain, wheezing, nausea, joint pain, muscle pain and fever was recovering at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.