chrisvoncsefalvay/vaers-outcomes huggingface dataset:
large (2-inch diameter) round red swollen place on upper left arm, several inches below the actual injection site, exactly one week after the injection.  By the next day, my entire upper arm on dorsal side was swollen and aching.  This swelling and pain lasted for two weeks afterward.  I used diphenhydramine and ibuprofen to alleviate symptoms.  The swelling diminished over the first week, was gone after two weeks.  I still have some vestigial achiness.
upset stomach; fever; dry vomit-restless; back & neck ache; did not feel well;
12/21/2020 2:20PM Facial spasms, left side of face-- eye, nose,  lip (prominent) - occurring for minutes at time, symptoms have not resolved
red, itchy, warm lump quarter size 1/19 grew to golf ball size 1/20
At 2:15 right wrist locked up. Unable to bend wrist, symptoms lasted one minute. Wrist was sore for hours. Right wrist locked up again at 3:00pm and lasted for one minute. Patient is also complaining of soreness to right clavicle and extends into right side of neck. No decreased ROM to neck. Patient complaints of fatigue and 'heaviness' to entire right arm.
positive covid test on 14Jun2022; positive covid test on 14Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (COMIRNATY), on 20Apr2021 as dose 1, single (Lot number: ER8731) and on 11May2021 as dose 2, single (Lot number: EW0165) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "cataract surgery", start date: 14May2022 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "positive covid test on 14Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (14Jun2022) Positive, notes: Relevant Tests: None except positive covid test on 14Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Prior Vaccinations (within 4 weeks) was none. Patient medical history (including any illness at time of vaccination) was none pertinent or relevant per the caller. Family medical history relevant to AE(s) was none. Additional vaccines administered on same date of the Pfizer suspect reported as none. AE(s) did not require a visit to emergency room or physician office visit.
Onset swelling same evening in (R) arm. Itching, reddened. Notes she had mild itching with prior varicella vaccine 1 month ago.
30 minutes after injection, numb cheeks for 1 hour after. For 2 days, sore arms.
pt recv vax 8OCT96 & on 9OCT96 w/in 12hr of vax pt devel gen hives &  pruritus & a tightness in chest;tx w/DPH;chest tightness resolved & the hives & pruritus cont;
This spontaneous report as received from a nurse refers to a newborn patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient missed a dose of RECOMBIVAX HB lot # J007946, expiration date 24-MAR-2016 and lot J012567 expiration date 30-JAN-2016, because the medication appeared gray and cloudy. Vaccination was rescheduled for the next day. No adverse event was reported PQC involved. This is one of several reports from the same reporter. Additional information has been requested.
12/17/2020 patient self reported that the Shingrix vaccine of 10/9/20 left him with extremely sore and partially usable affected arm.  After initial injection site irritation and swelling, he feels that he cannot lift that arm past about 45 degrees without incurring pain.
Twenty minutes after the shot, hissing developed in my ears.  There is pressure in my ears.    These symptoms arrived after the vaccine , were not present before the vaccine.
gets sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (002591). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), at 11 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "gets sick". The action taken for tofacitinib citrate was unknown.  Additional information: Offered to transfer patient to the Inquiry line she declined and will contact her doctor. Patient called to inquire about the Pfizer vaccine. She stated that she got the Pfizer shot and has been receiving the booster shots. She advised she is on her fifth month without the booster and every time she takes it she gets sick. Patient was prescribed Xeljanz XR 11mg. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-JAN-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 320, 232, 88, and 40 hours, with the lowest recorded temperature of 29, 33, 30, and 34 degrees Fahrenheit (-1.66, 0.55, -1.11, and 1.11 degrees Celsius) respectively; and lasting for 64 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
COVID Symptoms: severe sore throat & cough one day after returning from eight-day river cruise. Home test for COVID & phone visit w/ MD Prescriptions: Codiene/guaifenesin, Benzonatate, Lageviro  Symptoms reduced to occasional coughing after 36 hours Home test negative on 10/08/2022 and 10/10/2022
Patient tolerated shots well, patient received first dose in April when he was 17, we noted the error prior to the second dose, reviewed CDC guidelines and administered second dose off label.  Discussed with family the error and they wanted to preceded with second dose
whole body aches/ dull pulsing pain on both sides of torso; chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 04Mar2021 (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: CHILLS (non-serious) with onset 08Mar2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 09Mar2021, outcome "unknown", described as "whole body aches/ dull pulsing pain on both sides of torso". Therapeutic measures were taken as a result of chills, pain. Additional information: The patient took paracetamol (TYLENOL) as treatment for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a Registered Nurse concerning a multiple unspecified patients of unknown age. The nurse reported that on unknown date, multiple unspecified patients were vaccinated with improperly stored PNEUMOVAX 23, RECOMBIVAX HB (MARRS # 1501USA003586), M-M-R II (MARRS # 1510USA010025) or ROTATEQ. (MARRS # 1510USA010026). No adverse effects were reported. No further information was provided. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 29-JUN-2015, the patient was vaccinated subcutaneously with an expired 0.5 ml dose of M-M-R II (therapy type: rHA) (batch # J006139; lot # 1684AA; expiry date: 17-APR-2015). No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Ear ringing bilaterally/soft ringing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ear ringing bilaterally/soft ringing) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ear ringing bilaterally/soft ringing). At the time of the report, TINNITUS (Ear ringing bilaterally/soft ringing) outcome was unknown.            No relevant concomitant medications were reported.  The patient noticed ear ringing bilaterally 3 weeks before this report. Soft ringing, only heard when all else was quite. The patient went to ear, nose, throat specialist  (ENT) and was told she had healthy ears. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: No new information
Rash developed within hours of vaccination which gradually evolved into severe eczema over 2 months and has since persisted. Has history of mild eczema prior to this, but was described as moderately - severe 2 months before vaccines.
J and j COVID vaccine EUA Light headed and shaky - within 10 minutes Nausea - within 10 minutes Headache - within half an hour Fatigue - 2 hours post Fever - reached peak of 101.5 - 6 hours post, lowered to 100 steady by 20 hours and has not subsided Advil taken - 7 hours post Dizziness - cannot walk for more than 100 ft without rest - 6 hours post, worsened with fever, has not subsided  Muscle aches - 8 hours post, strongest in both shoulders, has not subsided Abdominal cramps - 20 hours post, has not subsided Overall confusion -  extremely ?out of it?, processing time is slow and focus is nonexistent, cannot answer simple questions easily or do basic tasks like reading or typing for extended periods - 4 hours post, worsened with fever and catatonic by 8 hours post, comes in fits and has not subsided
Rashes and itching of the skin by breast, stomach, arms and hands. Headaches, chills, Body aches and fatigue.
With needle stick, had severe pain, increased with injection of fluid on 10/10/22.  Since injection has had pain and limited ROM.  Burning sensation to right arm at rest, increased pain with activity. Has tried ice, heat and topical NSAID, no improvement.  Team member will be seen in occupational health.
Blood clot behind his eye; He started not being able to see and went blind the other day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (hospitalization, disability, medically significant), outcome "unknown", described as "Blood clot behind his eye"; BLINDNESS (hospitalization, disability, medically significant), outcome "unknown", described as "He started not being able to see and went blind the other day". Therapeutic measures were taken as a result of thrombosis, blindness.   Clinical course: The patient got the vaccine and by the time he got home he started not being able to see and went blind the other day. His wife is a nurse and started filling him full of Aspirin and got him to the hospital. When she got him to the hospital, they found he had a blood clot behind his eye. He had to have surgery and remove the blood clot. He can see now, but not like before. He can't work. They said he will have to placed on disability because he has to be able to see to drive.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt inadvertently sprayed self on neck & clothing w/rubella vax on 24FEB91; The next evening pt devel red, pruritic rash on neck; pt treated w/DPH & HCL cream; w/in next 48 hrs rash was resolving; Pt als given Rhuligel for pruritis;
Could not use her left side; She cannot talk properly; Headache; Injection site was swollen; Injection site was red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (Could not use her left side), SPEECH DISORDER (She cannot talk properly), HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site was red) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04015214) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Naproxen).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site was red). On 15-Apr-2021, the patient experienced HYPOKINESIA (Could not use her left side) and SPEECH DISORDER (She cannot talk properly). At the time of the report, HYPOKINESIA (Could not use her left side), SPEECH DISORDER (She cannot talk properly), HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient could not hold phone with her left hand. The patient had been to doctor and was given a cream.
Patient felt some discomfort swallowing and disorientation. He asked for some Benadryl and a dose of 10 ml was provided . He felt better after a few minutes and then left . He did not want any further treatment. I called patient later in the day and he was fine.
This is a serious spontaneous case initially received from other health professional on 06-Mar-2019, concerning a neonate female patient of body weight 4366 gm. The mother was 30-year-old female with body mass index 44.8. The mother had previous one pregnancy with full term live birth. The mother's current conditions included anaemia, anxiety, hypertensive disorder, depressive disorder and asthma. The mother's concomitant medications included hydrochlorothiazide for hypertension, Proair [salbutamol sulfate] for asthma and Prenatal Vitamins [minerals nos; vitamins nos] for obstetrician (OB) care. The mother's last menstrual period (LMP) date was 26-May-2018. The type of pregnancy was singleton. On 08-Oct-2018, at 19 weeks of gestation, the foetus was exposed to FLUCELVAX QIVc [route of administration: transplacental, batch number: 252226, dose, anatomical location and expiry date: not reported] (explicitly coded as fetal exposure during pregnancy) for an unknown indication. On the same day, the mother underwent a prenatal ultrasound in which no congenital malformation was noted. On 03-Dec-2018, the foetus was exposed to a non-company suspect vaccine TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid, dose: 0.5 ml, patient's route of administration: transplacental, parent's route of administration: intramuscular, batch number, anatomical location and expiry date: not reported] for an unknown indication. On 02-Jan-2019, 2 months and 25 days after vaccination, the mother experienced migraine aura without headache and was treated with Zofran [ondansetron, 8 mg, every 8 hours, prn, oral from 02-Jan-2019]. On 27-Feb-2019, at gestation age of 39.6 weeks, the mother delivered a live female infant, vaginally. Pregnancy complication was noted which included chronic hypertension in the mother and shoulder dystocia in the infant. No congenital malformation was noted. The appearance, pulse, grimace, activity, and respiration (APGAR) score was 8 at minute one and 9 at minute 5. The mother's estimated delivery date (EDD) was reported as 02-Mar-2019. This case is linked to 201902538 (mother case).; Reporter's Comments: A female neonate patient experienced shoulder dystocia during vaginal delivery, 4 months 19 days after maternal exposure to FLUCELVAX QIVc (company suspect vaccine) at 19 weeks of gestation (considered as fetal exposure during pregnancy) and more than 2 months after receipt of TDAP vaccine. Time to onset is considered implausible. The event shoulder dystocia is due to the mechanical obstruction during vaginal delivery, hence role of company suspect vaccine is ruled out and assessed the causality as not related. Maternal BMI (44.8) is considered as known risk factor. The event fetal exposure during pregnancy assessed as not related considering the intended use of vaccine. The TDAP vaccine is considered as co-suspect. The company assessed the event shoulder dystocia as serious (medically significant).
Information had been received on 04-APR-2017 from a pharmacist who reported that a patient (age and gender not reported) was inadvertently administered a single dose of M-M-R II (lot# L009544, expiration 19-MAR-2017) subcutaneous with diluent on 03-APR-2017. Pharmacist reported that M-M-R II had expired on 19-MAR-2017. No adverse effects reported. No further information provided. Pharmacist did not want to be contacted. Additional information is not expected.
PATIENT HAD RECEIVED THE PFIZER VACCINE ON 3-12-21 AT PHARMACY. PATIENT TOLD US THIS WAS HIS FIRST COVID-19 DOSE. WE STARTED AND FINISHED A COURSE OF THE MODERNA VACCINE. CONTACTED THE PHARMACY OF THE ERROR IN ADMINISTERING THE VACCINE. THE PATIENT NEVER REPORTED A PROBLEM OR ADVERSE REACTION TO THE VACCINE TO OUR KNOWLEDGE.
hasn't received a second dose yet; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first dose in June 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hasn't received a second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-Aug-2023 During the call nurse declined to provide more information. The reporter consented to follow-up via email. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Patient received ZOSTAVAX injection 10/3/12 seen PCP office 10/11/12 for rash right side ABD Dx: Zoster - treated with Famciclovir.
3 days after1st dose of Pfizer vaccine patient had sudden onset of sharp chest pain with strength of 6/10 along with sensation of something pressing on chest. Parent called office and was instructed by the medical assistant on duty to go to ER immediately. Parent verbalized understanding. The next day the office heard that patient did not go to ER but that pain had fully resolved after 24 hours. No remaining chest pain or discomfort reported. I as the medical provider was not aware of incident until patient came into the office 7/29/21 for acute viral pharyngitis unrelated to the vaccine. Heart sounds were regular with no concerning sounds or rhythm noted. Patient has had no recurrence of chest pain since 6/13/21 reportedly. Denies any shortness of breath at time of episode or since. Patient no-showed 2nd Pfizer vaccine appointment and has only received 1 dose of the Pfizer COVID vaccine.
Crippling flare up of CPPD ( pseudo gout) 5 days in the hospital.
I noticed swelling of the lymph nodes under my left armpit, when i called my doctor's office the nurse told me to put ice for 20 minutes.  Ice was applied every day for 20 minutes, the swelling finally went down some today but the vein under my left arm is still tender.
Headache- woke up with it on 03/23/2021 Muscle pain began around 10:30 am. Tried back stretching exercises and heating pad. That seemed to help. "Covid arm" began around 4:15 pm. My right arm is sore  with a rash that is itchy and warm to the touch. I put Calamine lotion on my arm. The rash is just below the injection site of the vaccine.
1 week ago yesterday I had first dose of Moderma.  No huge side effects,  but a screaming stiff neck that sent me to the chiropractor.  This morning,  I woke up and my neck feels 99% better, but my injection site is red, hot, painful and swollen.  My arm feels and looks like a stuffed sausage.  Is this normal or should I be concerned?
DIARRHEA; CHILLS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAY-2021 10:00 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 08-MAY-2021, the subject experienced diarrhea. On 08-MAY-2021, the subject experienced chills. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from chills, and diarrhea. This report was non-serious.
Patient returned at 9:36am after receiving first dose at 8:41 complaining of nausea and dizziness.  Vital signs taken and assessment determined Benadryl needed. Patient was given 0.4mL =(20mg) . Patients vitals checked every 5 minutes. At 10:16 patient felt better and reposted symptoms better and no dizzy spells. Pt released at 10:38. Patient called for update on 2/5/21. Patient reported feeling better this day but reports that nausea returned with cramping and lasted until 2:30 pm day of shot. Dizziness and confusion lasted until 9:00pm day of injection, disoriented until 6pm day of injection and diarrhea that lasted until 4pm day of injection. Per medical director, Dr, patient should not get second dose of Pfizer vaccine.
Information has been received from a nurse referring to a patient of unknown age and gender. On 30-JAN-2015, the patient was inadvertently administered a dose of improperly stored VARIVAX (Merck) 0.5 ml, (lot number and expiry date were not reported), subcutaneously. No adverse effects reported. This is one of two reports received from the same reporter (linked to 1502USA004548). Additional information has been requested.