chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she got ear infection and she was on antibiotic therapy; This is a spontaneous report from a contactable consumer (patient) via regulatory authority (CEP ID: 159558). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Jun2021, as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient got ear infection. She said that her 2nd dose is scheduled today (05Aug2021). She wants to know if it is safe for her to do air travel after getting the 2nd dose. She added that she got the 1st dose of the Covid-19 vaccine last 30Jun2021 and originally, her 2nd dose schedule was on 30Jul2021, but she got ear infection and she was on antibiotic therapy that is why she did not get the 2nd dose on its scheduled date. Submitted a manual AE form because of ear infection after taking the 1st dose of the Covid-19 vaccine. Therapeutic measures were taken as a result of the event with antibiotic therapy. The outcome of event ear infection was unknown.   Follow-up attempts are completed. No further information is expected
This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. The physician stated that her refrigerator and freezer units began to have temperature excursions as of 05-MAY-2014. GARDASIL was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range) since 05-MAY-2014 and also to 49F for 12 hours. On unspecified dates since 05-MAY-2014, an unspecified number of patients received GARDASIL which was improperly stored. No product complaint was reported for GARDASIL. This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004441 and 1411USA004442 (same reporter link). Additional information has been requested.
Approximately 15 hours after, patient began seeing little bumps on body (stomach, thighs, neck) The bumps continued to spread, get bigger(welts), turn red and very itchy. This continued, he could not attend school, he did not participate nor engage in usual activities or behavior...very bothered and uncomfortable. After a couple days, I saw the rash was not going away and made an appointment with his Primary DR. The doc was surprised and agreed it was a reaction and he should refrain from taking 2nd dose. She prescribed Prednisone on 1/18 twice a day...that helped tremendously but now that he is off of it...it seems like its coming back.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 12-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
My daughter had a high fever for 2 to 3 days following the shot (E.R.) said not to worry and I gave her ADVIL and TYLENOL 3 or 4 days later she had a violent seizure. Stopped in - no appointment. (Now has seizures without meds. she is on.)
Severe Migraine; Swollen Lymph node; foggy brain; ear pain; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Severe Migraine), LYMPHADENOPATHY (Swollen Lymph node), FEELING ABNORMAL (foggy brain), EAR PAIN (ear pain) and FATIGUE (fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included IBUPROFEN for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Severe Migraine), LYMPHADENOPATHY (Swollen Lymph node), FEELING ABNORMAL (foggy brain), EAR PAIN (ear pain) and FATIGUE (fatigue). At the time of the report, MIGRAINE (Severe Migraine), LYMPHADENOPATHY (Swollen Lymph node), FEELING ABNORMAL (foggy brain), EAR PAIN (ear pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not provided
Headache, dizziness, malaise, nausea.  12/19/13 fever, anorexia, nausea, headache, loose stool.
Severe chills for 2 1/2 hours with slight nausea  Extremely tired for 22 hours
Moderna Covid vaccine 18 March and 20 April 2021, with no prior history of Covid, mother with thyroid disease, no family history of clotting  18 April 2021 diagnosed with vasculitis due to R eye acute temporal side vision loss, has slowly improved with time, aspirin 81 mg daily and prednisone 20 mg daily with plans for taper have been added and the vision loss continues to improve, she has been evaluated by ophthalmology and a retina specialist and a rheumatologist with a history of a positive ANA greater than 1280 but no clear rheumatologic diagnosis at this time  April 2021 anticardiolipin antibody negative, DRVVT positive on 29 April 2021 at 1.3, CBC normal, she denies any history of exogenous hormones or recent travel or immobility or any drugs likely contributing to her symptoms, LDL has been 125 noted recently, and SPEP has been negative.  She is nulligravida with no prior history of arterial or venous thrombosis, a dye test done during her eye evaluation has shown Retina vasculitis OU + delayed arterial filling OD w/ Visual photopsias suspected to be migraine related and w/ the delayed arterial filling in the right eye, they recommend systemic work up to r/o possible source of emboli through her PCP. Migraine vasospasm is possible explanation of visual symptoms.  17 June 2021 echocardiogram with agitated saline was negative for PFO with normal ejection fraction 63%  Labs June 2021 showed normal protein C, S,  Antithrombin, negative factor V Leiden, negative anticardiolipin antibodies, negative beta-2 glycoprotein antibodies, and negative hexagonal lupus anticoagulant
CHILLS; FEVER WITH TEMP. 99.3 AND 99.6; 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 past medical history included blood donation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.3 F, 99.6 F. On 21-MAR-2021 04:00, the subject experienced chills. On 21-MAR-2021 04:00, the subject experienced fever with temp. 99.3 and 99.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever with temp. 99.3 and 99.6 and chills was not reported. This report was non-serious.   Additional information was received on 22/Mar/2021: The following information was updated and incorporated into the case: Product batch number updated.
10 1/2 hrs after vaccination (during the night) - Chills, sweating, fever. 1 day after vaccination - Chills, sweating, 101.5 fever, neck ache, EXTREME fatigue, nausea; Slept almost all day and night, and could hardly get out of bed. 2 days after vaccination - Nausea, fatigue. Injection site - redness, pain & swelling - grew to the width of about three quarters (the coin); maybe one quarter width high.
pain; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy. Concomitant products included LOVASTATIN, NIFEDIPINE, LEVOTHYROXINE, FUROSEMIDE and VITAMIN B COMPLEX for an unknown indication.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated that the itching happened before her second dose, she took Anti-itch cream (Sheffield) for treatment   This case was linked to US-MODERNATX, INC.-MOD-2021-072899 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072899:1st dose vaccine
Pt began with Abdominal /trunk spasms on 9/18/09 AM, persistant, uncontrollable per pt, fully alert, no past history of spasms or seizures, no fever or illness. Admitted 9/19-24/09 to Hospital due to symptoms as below. Note also had a few spasm night of 9/24, used Benadryl and clonapin as per neurology, few more 9/25/09 AM. stopped Clonapin as did not seem related to stopping and made drowsy per family.  No more myoclonus since when seen at clinic on 9/30/09. Discharge Diagnoses : Spinal myoclonus of unknown etiology / Possible conversion reaction  (note family disagrees with conversion reaction as etiology). Depression treated with Zoloft. Hospital Management: Basics: labs (urine HCG, urinalysis, urine tox screen, electrolytes, thyroid studies, anti-strep O, anti-mycoplasma antibodies, anti-lyme antibodies, ammonia, ANA screen, free metanephrines, ESR, CRP). Special Medications: Clonazepam, valium, one dose Valproate. Imaging: MRI of brain/spine   Consults: Neurology, Physical Therapy, Psychiatry and Health Psychology. Anesthesia: conscious sedation. Special Monitoring: video EEG monitoring 10/26/09:  Hospital records received for dates of service 9/18/09 to 9/19/09 and 9/19/09 to 9/24/09.  Dx:  Spinal myoclonus vs. conversion reaction.  Assessment:  Presents with repetitive spasm of head, arms, neck, legs and trunk.  Not painful, but impaired ADL's.  No alteration in consciousness.  Also c/o slight nausea, denies headache,  some dizziness, had a few bouts of diarrhea on 9/19.  Spasms are myoclonic in nature, and tend to resolve while she is asleep.  Gait slightly unsteady. Romberg Positive.  Upon admission on 9/19 presented with myoclonus of abdominal musculature. Able to talk and text during episodes.  Started on Depakene.  Differential dx's. include infectious or post-infectious, autoimmune, paraneoplastic, or structural (mass) or idiopathic. Exhibits no seizure activity.  Clonazepam seemed to decrease frequency of myoclonic jerks.  Zoloft discontinued, known to cause myoclonus in peds. population. PT was initiated then haulted as there was no evidence of LE weakness.   Discharged to home, slightly improved to follow up with Peds, Psych and Neurology.
fever, chills, muscle aches (mainly in legs and back), fatigue, slight nausea
Mother noticed swollen left arm next morning after vaccine, arm was hot with a blue ring around injection site.  Mom called MD and was instructed to give antihistamine and pain med.  Mom states arm was swollen down to elbow.
Runny nose; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and SNEEZING (sneezing) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Thyroid pill for Product used for unknown indication, LOVASTATIN, OMEPRAZOLE and MELOXICAM for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced RHINORRHOEA (Runny nose) and SNEEZING (sneezing). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL (CORICIDIN HBP COLD AND FLU) ongoing since an unknown date at an unspecified dose and frequency. On 06-May-2021, RHINORRHOEA (Runny nose) had resolved. At the time of the report, SNEEZING (sneezing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment drug include Coricidin  Action taken with mRNA-1273 in response to the event was unknown
pt was crying & screaming from 3PM to 9PM in forty five minute intervals; treated w/APAP w/Codein
some mild diarrhea; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; dry cough; This is a spontaneous report from a contactable consumer reported for himself.  A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot EL3249 via unspecified route on 13Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medications were not reported. On unknown date in Jan2021 the patient developed a dry cough and then some friends of him were tested positive for Covid-19 (further clarification unknown) and so on 22Jan2021 the patient got tested again and the result was positive. On 24Jan2021 the patient had some mild diarrhea and the temperature was normal. Consumer stated that he received as treatment some Zinc and Vitamin E and Vitamin C. The outcome of the events was unknown. The second dose was scheduled for 03Feb2021.
chills, 102 degree fever, headache, joint pains, muscle pains, backache, fatigue, and dry cough - These started  about 12-16 hours after dose  #2 with a mild headache and then mild chills that progressed over a couple of hours to become significant. All of the symptoms became rather intense and lasted approximately 24 hours. They faded rather abruptly, but the fatigue lingered another 24 hours.
numbness, cramps, tingling in both legs & arms; started on 28JUL & was on & off (mostly at noc) then was an everyday thing until 30AUG; now  is on & off; most serious point was unable to walk normally, had no feeling in lower legs;
PATIENT RECEIVED PFIZER DOSE OUT OF AN UNDILUTED PEDIATRIC VIAL.  PT DID GET CORRECT DOSE SINCE THE VIAL WAS NEVER DILUTED.  ATTEMPTED TO CALL PATIENT BUT SHE DID NOT RETURN MY CALL. NO INDICATION FROM HER OF ANY SYMPTOMS OR REACTIONS TO THE VACCINE.
15 out of 17 employees who received FLUZONE Intradermal vaccine developed intense inflammation, pain, and swelling at the site of injection within minutes to hours post injection.
Patient called the weekend after receiving the vaccine (called Saturday 10/21) and asked if it was normal for her shoulder to be in pain. She stated that she could not lift her arm from the shoulder, and any front-to-back motion of the arm hurt as well. She said that she was expecting her arm to be sore, but not expecting her shoulder to be in so much pain/not moveable. She did mention that it felt like the injection "went in to the bone in my shoulder" and that her daughter, when helping to remove the bandaid, questioned why the bandaid was so high on the arm/touching the shoulder joint. Patient also said it felt like her shoulder was burning at the time of injection. I advised patient to rest her shoulder, take ibuprofen, and to let us & her physician know if things got worse (or didn't improve). I am not sure if she ever contacted her physician, but she called again on Friday 11/17 (a month after receiving the vaccine) to inform me that she still could not raise her arm and that any shoulder movement still caused a large amount of pain. I informed patient that I would report her injury/reaction to VAERS and to let me know if she had any other questions/issues.
Had a sore arm and lump day of shot. Pain was gone the next day. Lump gone in 2 days. Last night I noticed the lump was back and warm. By this evening it is itchy and tender to the touch.  Face and neck seem a bit tichy also.
Migraine headache, fever 101.2, full body aches, chills, right side neck pain, fatigue
vaccine was administer to a patient outside the manufactures age range. provider followed up with patient and mother no adverse reactions reported as per provider
Rash to face and lips, periorbital edema, all lasting 1 week, has not fully resolved. Taking benadryl and hydrocortisone cream
Headache Per nursing: "took Moderna on last Thursday on January 31st,2020. C/o migraine headache on Friday morning. States had sore throat and sore tongue since before taking the vaccine but states feels like it's getting worse. Employee also c/o feels like her to Narrative:
Information has been received from an RN concerning an approx. 40 year old male health center employee who was vaccinated with MMRII as a child. Recently, the pt had a negative rubella titer (WAES0112USA02042) and on 11/16/01, received a dose of MMRII. Six days later, on 11/22/01, the pt developed lymphadenopathy at the neck and behind the ears. No rash was noted and the pt was afebrile. The dx from a family physician was mild rubella. The pt was scheduled to see "ENT" during the week of 12/3/01. On 11/28/01, the pt developed a fever and arthritic symptoms, which persisted. Unspecified medical attention was sought. Follow-up information received from the RN indicated that her office did not administer the pt's vaccine or evaluate the pt after the event. No further information is available.
No additional AE reported; got administered VARIVAX dose 2 times on the same day; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 08-NOV-2022, the patient was vaccinated with 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # W011622, expiration date was not reported however upon internal validation it was established as 06-APR-2024, 0.5 ml (route of administration and anatomical location were not provided) as prophylaxis (overdose). No additional adverse event was reported (no adverse event).
pt recv vax 18JAN96 & 22JAN96 pt exp a fever of 102 & vomiting;no further details were provided;
the vaccine was administered after it was stored for 3 days past the 31 days that are labeled; the vaccine was administered after it was stored for 3 days past the 31 days that are labeled; the vaccine was administered after it was stored for 3 days past the 31 days that are labeled; This case is considered as invalid as RA-unidentifiable patient: no patient identifiers reported.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Jan2022 (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: EXPIRED PRODUCT ADMINISTERED (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 11Jan2022 and all described as "the vaccine was administered after it was stored for 3 days past the 31 days that are labeled".  Additional information: Caller is a Pharmacist calling on behalf of a (withheld). She called to ask for guidance of an administration of the Pfizer Biontech COVID 19 vaccine adult formulation (purple cap) after improper handling and storage. Caller stated that in one of the clinics the vaccine was administered after it was stored for 3 days past the 31 days that are labeled. Caller stated 5 patients were involved, however she did not mentioned genders nor ages. Type of dose (first, second or booster) was unknown. She mentioned she assumes the vaccines were administered yesterday 11Jan2022.Responded as per attached document. Under Table 1. Summary of Data to Support Inadvertent Excursions to the Labeled Storage Condition for Frozen or Thawed, Undiluted Vaccine1,3,4. 2 degree C to 8 degree C (35 degree F to 46 degree F). Total time: 32 days = 31 days labeled time described in the Prescribing Information plus 1 day excursion time. No information to support excursion.   Follow-up attempts are completed. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: removed age group "Adult" and reassessed the case as invalid.
migraine; felt awful; Pain; severe flu / flu-like symptoms; This case was reported by a other health professional via sales rep and described the occurrence of pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, influenza-like symptoms, migraine and feels awful. On an unknown date, the outcome of the pain, influenza-like symptoms and feels awful were recovered/resolved and the outcome of the migraine was unknown.   It was unknown if the reporter considered the pain, influenza-like symptoms, migraine and feels awful to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient reported pain and severe flu-like symptoms following receipt of Shingrix dose 1 that lasted about 1 day.  The patient stated a migraine was triggered and she felt awful for about a day, then was fine.  The patient did not experience this severe type of reaction with dose 2. The reporter consented to follow up.
weekend following vax pt devel hives & continued until pt went tubing, then got severe. seen in ER & treated w/IVs
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received BOOSTRIX (batch number 9PD92, expiry date 30th May 2020). On 1st May 2018, the patient received BOOSTRIX (intramuscular). On 1st May 2018, less than a day after receiving BOOSTRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to BOOSTRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient received BOOSTRIX in the right arm. The patient experienced soreness at the injection site along with a round, red area around the injection site approximately 2 x 2 cm in area.