chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT RECEIVED PNEUMOVAX RIGHT DELTOID INTRAMUSCULAR ON 10/18/2006. PATIENT IS IN CLINIC TODAY WITH COMPLAINTS OF SLIGHT TENDERNESS/SORENESS AT SIGHT OF INJECTION THAT BEGAN THIS MORNING. PATIENT ALSO HAD TWO DISTINCT RED AREAS MEASURING 20 CENTIMETERS IN LENGTH AND 7 CENTIMETERS WIDE EXTENDING LATERALLY ACROSS THE RIGHT BICEP.  EDUCATED PATIENT ON VACCINE AND POSSIBLE SIDE EFFECTS AND TO SEEK MEDICAL ATTENTION IMMEDIATELY IF SYMPTOMS WORSEN OR BECOME LIFE THREATENING.
FROM ABOUT 4-9 PM ON 6/27/19 SHE EXPERIENCED FEVER + CHILLS ARM WAS ALSO RED + PAINFUL
Diagnosed with COVID19 after 1st dose of Moderna COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID19 after 1st dose of Moderna COVID19 vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced COVID-19 (Diagnosed with COVID19 after 1st dose of Moderna COVID19 vaccine). At the time of the report, COVID-19 (Diagnosed with COVID19 after 1st dose of Moderna COVID19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 37 year old male. The patient's height, and weight were not reported. 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: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received DTPa (DTaP vaccine) for prophylaxis. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant), fever and cough. On an unknown date, the outcome of the vaccination failure, whooping cough, fever and cough were unknown. It was unknown if the reporter considered the vaccination failure, whooping cough, fever and cough to be related to DTaP vaccine. Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported high fevers for weeks and intractable coughing and whooping. At the time, the patient did not know what the whoop was and kept going back to the physician and they never told her what was wrong with her, but one physician yelled at her because she had assumed she had pneumonia. The patient reported that do not forget to quarantine yourself for several weeks after you get the vaccine, as you might become an asymptomatic carrier. This case was considered as a suspected vaccination failure case as the time to onset of the event and lab confirmation for whooping cough were unknown.
Had 4 vaccines given 8/8/05. Looked red, mildly itchy for 2 days on both upper arms, seen by MD on 8/10/05 and given Rx Benadryl and Tylenol for localized reaction.
pt recvd vax & 5 days post vax exp intermittent hives on legs & arms,& itching;MD prescribed DPH & a skin lotion;prompt resolution of hives w/in 24hrs;
a 8 years old male patient was given an expired dose of Ipol vaccine/No AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an eight years old male patient who was given an expired 0.5 ml dose of (VERO) [IPOL] lot N1J451M, expiry date: 05-Oct-2019via subcutaneous route in the left arm on 29-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A).  It was an actual medication error due to expired vaccine used.  There were no side effects observed.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Ever since the first dose, I have been experiencing EXTREME/SEVERE tiredness. I am ALWAYS tired and I WAS NOT having this problem before the vaccination. I cannot stay awake for a full day. I always fall asleep. I now require naps just to get through each day. I have been drinking drinks with vitamin B complex for energy but I am STILL tired.
Awoke to sore, "hot," red arm (expected from previous years) and a swollen, "hot," extremely painful right knee replacement - latter unexpected. Couldn't bend leg at all. Treated with alternating heat/cold packs, compression knee brace, and low dose of Vicodin on night of 10/25/2016 for pain relief and sleep. Awoke at 6:00 AM on 10/26/2016 with no further arm soreness and greatly improved knee pain and stiffness...not entirely resolved, but I can bend my leg enough to sit comfortably and  the "heat" appears to have disappeared overnight. I expect the remaining discomfort and swelling to continue resolving itself within the next day or two.
Felt like a foreign object was in my right eye (sometimes caused by dry eye). Not sure of onset timing after vaccine. 4 weeks after injection, eye swollen, sore and severely bloodshot. First diagnosis by optician at that time was eyelash in eye. Given antibiotic eyedrops. Little improvement. Following week seen by ophthalmologist who diagnosed herpes infection in right eye. Prescribed Zirgan eye drops, Valtrex capsules (for 14 days) and Pred Acetate (steroid) eye drops. Currently tapering off Pred Acetate. Ophthalmologist said last week only 1 cell remaining (so almost over it).
had generalized aches for 3 days; h/a for 5 days, p/h/a wrist, ankle joints felt frozen; rt foot swelling then rash devel extending from rt knee to rt ankle; rx feldene caused GI distress; lt breast mass; skin had red spots w/pustules;
Soreness at injection site; headache; fatigue; This is a spontaneous report from a contactable consumer. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration, in left arm on 19Feb2021 13:15 (at the age of 29-years-old) as single dose for covid-19 immunisation. Patient historical vaccine was first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), an unspecified route, in left arm on 29Jan2021 13:15 (at the age of 28-years-old) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), Centrum multivitamin. The patient had not received any other vaccines prior to the COVID vaccine. The patient experienced soreness at injection site, headache, fatigue on 19Feb2021 16:00. No treatment received for reported adverse event. Patient not tested for COVID-19 after the vaccination. The outcome of the events was resolved.
Raised, red, itchy injection site reaction  approximately 2-3 inches diameter  Narrative: Reaction appeared yesterday, is still  present.
Aching muscles,  fever, chills, low energy, loss of appetite, dull headache.  Took 3 Tylenol over a 24 hour period. Vaccine administered on Saturday evening.  Symptoms started just after noon on Sunday.  Went to bed early Sunday and felt fine on Monday morning.
Pt reports numbness/tingling in hand and fingers on the right. Pt received 2nd dose of COVID-19 in right upper arm approximately 5 minutes prior to time of RRT. Observed pt from 1146 to 1205. Pt maintained stable vital signs throughout observation period, maintained a strong regular pulse ranging from 80 - 90 bpm. Maintained oxygen saturation on room air between 98-100%. At time of release, pt was still exhibiting numbness in fingers and palm of right hand. Good range of motion with right arm. Denies any symptoms other than the above stated. Provided pt of option to be seen in the emergency department, but pt declined, and stated that she would like to wait and if her symptoms persisted or worsened, she would come back to the ER.
Vaccine given at 1030 am.   At approx 5pm patient started noticing burning of both hands and feet along with body chills.  Next day burning and chills were absent however patient had 101.2 fever lasting 1 day.  Approximately 10 days later burning in bilateral hands and feet returned with worsening symptoms calling GP on Sept 4th 2002.  GP instructed patient to make an appointment with Neurology.  Patient was in extreme pain in hands and feet resulting in ER visit on 9/11/20.  ER did CT scan and blood work with no notable findings.  Patient went to neurology on  9/16/20 and was referred to an allergy immunologist who at appointment ran test with no clinical findings.   Patient went to GP on 10/20/2020 and MD had patient stop Crestor CoQ10.  She was put on b12 and Folate.  Patient also stopped celexa and started Duloxetine and take gabapentin as  needed up to 3 times daily.  This combination helped burning of hands and feet.  Patient was referred to Neurology and was seen on 3/15/2021.  Workup done including 3 punch biopsy.  Neurology is trying to determine if neuropathy is from Shingrix due to onset of symptoms, or from pre diabetes.
Developed hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Nov-2021, the patient experienced URTICARIA (Developed hives). At the time of the report, URTICARIA (Developed hives) was resolving.            Concomitant information was not provided.  Treatment information included antihistamine, which helps clear the hives.
soreness in arm so great and right after the shot was heavy and now upper arm still very sore; pain; fatigue but unsure if from vaccine since she suffers from migraines; Feels like the muscle is damaged,more than muscle being effected to where she couldn't lay on that arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm so great and right after the shot was heavy and now upper arm still very sore), PAIN (pain), FATIGUE (fatigue but unsure if from vaccine since she suffers from migraines) and MYALGIA (Feels like the muscle is damaged,more than muscle being effected to where she couldn't lay on that arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concomitant products included MELATONIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm so great and right after the shot was heavy and now upper arm still very sore), PAIN (pain), FATIGUE (fatigue but unsure if from vaccine since she suffers from migraines) and MYALGIA (Feels like the muscle is damaged,more than muscle being effected to where she couldn't lay on that arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm so great and right after the shot was heavy and now upper arm still very sore) had not resolved and PAIN (pain), FATIGUE (fatigue but unsure if from vaccine since she suffers from migraines) and MYALGIA (Feels like the muscle is damaged,more than muscle being effected to where she couldn't lay on that arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatments were reported.  Patient was planned to reach out to HCP on 11-MAR-2021.
Swelling at injection site for five days. Large ?golf ball? sized lump. Hot to the touch and painful.
patient said he felt dizzy immediately after receiving Gardiasil. . .he had a syncopal episode with sweating for about 2 -3 minutes and he also had about 10 seconds of clear vomitus.   He never completely fainted .   He never lost consciousness.   After about 15-20 mins patient said he was feeling fine and he walked out of the clinic
Immediate pain in right calf, proceeding to numbness, coldness, and pain in right foot. Blood clot (no vascular disease) discovered, subsequent amputation below the knee.
PATIENT HAD SEVERE BODY ACHES AND HEADACHE. TYLENOL WAS NOT HELPING. PATIENT STATED THEY FELT LIKE THEY COULD NOT GET OUT OF BED AND THAT THE LEFT SIDE OF THEIR BODY FELT WORSE THAN THE RIGHT.  PATIENT ADVISED TO CONTINUE TYLENOL AND SEEK CHECK UP WITH PCP ON MONDAY
Unsteady/had to hold onto the wall to keep upright; Forever to write a simple email/weired things; No appetite but able to eat after 10 pm; Slept and woke up delirious; Woke up with 101.6 degrees fever; Tremendous itching; Soreness/pain; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Slept and woke up delirious) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness/pain) and SWELLING (Swelling). On 25-Jan-2021, the patient experienced PRURITUS (Tremendous itching). On 19-Feb-2021, the patient experienced DELIRIUM (Slept and woke up delirious) (seriousness criterion medically significant), GAIT DISTURBANCE (Unsteady/had to hold onto the wall to keep upright), ABNORMAL BEHAVIOUR (Forever to write a simple email/weired things), DECREASED APPETITE (No appetite but able to eat after 10 pm) and PYREXIA (Woke up with 101.6 degrees fever). On 19-Feb-2021, DELIRIUM (Slept and woke up delirious), GAIT DISTURBANCE (Unsteady/had to hold onto the wall to keep upright), ABNORMAL BEHAVIOUR (Forever to write a simple email/weired things), DECREASED APPETITE (No appetite but able to eat after 10 pm) and PYREXIA (Woke up with 101.6 degrees fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness/pain) and SWELLING (Swelling) outcome was unknown and PRURITUS (Tremendous itching) was resolving.            No relevant concomitant medications were reported.  Treatment for events included 3 paracetamol.; Reporter's Comments: This case concerns a 66 Y/O F with a serious unexpected event of delirium, and nonserious unexpected abnormal behavior, pain in extremity, pruritus, and expected swelling and pyrexia.  Serious event onset was 2 days after second dose mRNA-1273. Delirium resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Painful rash in right temporal region, from right eye, to hairline, to ear (a triangle)
Rash developed at injection site 9-1-06.  Patient developed Varicella on 9-12-06 received injection 8/25/2006. Patient had the varicella vaccine administered at a different fascility.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, therapy start date were not reported, administered 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 31-DEC-2021, the patient experienced suspected covid-19 infection and thus had suspected clinical vaccination failure. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The reporter stated that "tested positive two days ago, but if not for a 30 minute fever I would have never suspected or gotten tested". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209770.; Sender's Comments: V0: 20220100917-covid-19 vaccine ad26.cov2.s- Suspected clinical Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M018810, expiry date 28-MAY-2016 (route and site of administration, dose and strength were not reported). The temperature was 0.9 Celsius degrees for 20 hours 47 minutes. Previous temperature excursion was no performed. Data logger was involved. Additional information has been requested.
Started feeling nauseous and laid down. After eating dinner I started to run a fever (temp unknown), I went to bed and woke up at 3:30am covered in sweat with soaked bedding. The evening before I had spoken on the phone as well as text messaged someone and have no memory of the events.
Pt received IZ on 7/18 on (R) thigh. Mother reports site swollen to softball size on 7/19. Denies, fever, rash or redness. On 7/20 site swollen to size of golf ball. No leg impairment, no change in energy level. On 7/23 swollen to size of a quarter. Will continue to follow.
high fever (100-102); chills; severe fatigue; sweats; joint pain; malaise; lassitude
This spontaneous case, initially received on 18-Oct-2018 from other non-health professional (consumer), concerns a 33-year-old, adult, female pregnant patient. The patient had 4 previous pregnancies in which the patient had 2 miscarriages. The patient had no relevant maternal and paternal medical history. The patient did not use any contraceptive method. The patient had no birth defects and congenital anomalies were occurred in previous pregnancies. The patient's current condition included hypothyroidism (since an unspecified date). It was reported that patient's husband did not used any medications prior to conception and the patient took levothyroxine for an unknown indication prior to pregnancy and during the pregnancy. The patient's last menstrual period date (LMP) was 16-May-2018. On 17-Oct-2018, at gestational age of 22-weeks (second trimester of pregnancy) the patient was administered FLUCELVAX QIVC [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported] (explicitly coded as vaccine exposure during pregnancy). No treatment measures were taken. It was reported that, after vaccine administration, the patient did not experience any adverse event. There was no evidence of defect or adverse finding from a prenatal test and no birth defect or congenital anomalies were noted. The patient's estimated delivery date (EDD) was reported as 20-Feb-2019. The reporter assessed this case as non-serious.
breathed in it burnt and the back of her throat feels swollen and it hurts; breathed in it burnt and the back of her throat feels swollen and it hurts; headache; joint pain; fever; breathed in it burnt and the back of her throat feels swollen and it hurts; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), ARTHRALGIA (joint pain), PYREXIA (fever), THROAT IRRITATION (breathed in it burnt and the back of her throat feels swollen and it hurts) and PHARYNGEAL SWELLING (breathed in it burnt and the back of her throat feels swollen and it hurts) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 24-Mar-2021, the patient experienced HEADACHE (headache), ARTHRALGIA (joint pain), PYREXIA (fever) and THROAT IRRITATION (breathed in it burnt and the back of her throat feels swollen and it hurts). On 25-Mar-2021, the patient experienced PHARYNGEAL SWELLING (breathed in it burnt and the back of her throat feels swollen and it hurts). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (breathed in it burnt and the back of her throat feels swollen and it hurts). On 25-Mar-2021, HEADACHE (headache), ARTHRALGIA (joint pain) and PYREXIA (fever) had resolved. At the time of the report, THROAT IRRITATION (breathed in it burnt and the back of her throat feels swollen and it hurts), PHARYNGEAL SWELLING (breathed in it burnt and the back of her throat feels swollen and it hurts) and OROPHARYNGEAL PAIN (breathed in it burnt and the back of her throat feels swollen and it hurts) outcome was unknown.
ON 2/11/21, DEVELOPED BODY ACHES, HEADACHE, NAUSEA, SORENESS AND SWELLING AT INJECTION SITE, AND CHILLS
Information has been received from a health professional concerning an 18 year old female with no previous medical history or no known drug allergies, who was vaccinated with 3 dose series of GARDASIL.  The patient received the first two doses in an other location (lot# not provided).  She also received MMR and DTAP (manufacturer unknown) with the first dose.  The patient was vaccinated IM with a 0.5 ml third dose of GARDASIL at this location (lot# 655620/0171U).  No concomitant medication.  After this she experienced amenorrhea.  The same happened after the second dose and she was given a PROVERA challenge to restart the menstrual cycle, which it did.  The patient's mother called the office to report the patient had amenorrhea again after receiving the third dose.  Unknown medical attention was sought via phone.  The patient's outcome reported as not recovered.  Additional information has been requested.
hemiparesis is reported in a pt poss receiving 1 dose of flu vax; MD was not sure whether recvd Parke-Davis fluogen; pt exp sx w/in 24 hrs of vax;