chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of induration over injection site in a 29-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and accellular pertussis vaccine, absorbed (Boostrix, GlaxoSmithKline) for prophylaxis. The subject's medical history included migraine. The subject had no history of drug allergies. On 13 April 2009 at 10:39 the subject received unspecified dose of Boostrix (0.5ml, unknown route, left arm). On 13 April 2009 at 13:00, approximately 2 hours after vaccination with Boostrix, the subject experienced 3.75 centimeter induration at injection site, headache, neck stiffness and soreness and tingling in distal part of left arm. The subject was treated with ibuprofen and ice (Ice pack). At the time of reporting the events were unresolved.
The medication was not mixed with the clear liquid that needs to be mixed with the medication, instead diluent was used in the medication. Contacted parent and is aware. Parent is bringing patient back for re immunization.
Within initial 6 hours, patient experienced slight swelling at the injection site which progressed over the next several hours and was red, tender and warm to the touch approx tennis-ball sized.  Patient called pharmacy following day and was instructed to use acetaminophen and ice on the affected site to reduce swelling.  Patient called pharmacy again on the second day to report improvement at site and reduced swelling, but still red and tender to the touch and now excess skin in the previously swollen site.  Spoke with patient on day 3 and she reports it is continuing to decrease in swelling and tenderness.
Hospitalization for acute hypoxemic respiratory failure due to COVID-19 infection, encephalopathy, possible UTI on dates 9/7/23- 9/20/23. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
first dose of the Moderna COVID-19 vaccine on 15Apr2021 and the second on 16Aug2021; pressure headache; swelling where the injection was given; Rash the size of an eye patch where the injection was given; sweats; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (pressure headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04C21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). On 17-Aug-2021, the patient experienced HEADACHE (pressure headache), VACCINATION SITE SWELLING (swelling where the injection was given) and VACCINATION SITE ERYTHEMA (Rash the size of an eye patch where the injection was given). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 15Apr2021 and the second on 16Aug2021). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. On 17-Aug-2021, HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved. At the time of the report, HEADACHE (pressure headache), VACCINATION SITE SWELLING (swelling where the injection was given) and VACCINATION SITE ERYTHEMA (Rash the size of an eye patch where the injection was given) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 15Apr2021 and the second on 16Aug2021) had resolved.            No concomitant medications were provided by reporter.
Hemiplegic migraine; Forgetful; Peeing more often; Heavy tongue; Slurred speech; Aura; Bleary vision; Left eye twitching on and of; black and blue eye; Hands shaky; swollen black and blue eyes; Depth perception problem on right side; Headache; Fatigue and very tired; This is a spontaneous report from a contactable patient. A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: unknown) via unspecified route of administration on 04Mar2021 at 10:30 am (at the age of 53- years) as a single dose for COVID-19 immunisation. The patient's medical history included asthma, seasonal allergy, Transient Ischemic Attack (TIA) in 2014 and migraine. The concomitant medication includes erenumab aooe (AIMOVIG) for migraine from unknown dates. Patient previously took botulinum toxin type A (BOTOX) for migraine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Mar2021 at 08:00 am, the patient experienced fatigue for 1-3 days, headache, until she had gone to urgent care. The patient also reports swollen black and blue eyes, tiredness, left eye twitching on and off, blurred vision, slurred speech, was forgetful, depth perception problem on right side and heavy tongue, hands shaky, aura, peeing more often (sometimes she had to sit longer) and hemiplegic migraine. It was also reported that, the events migraines and headache she had after the vaccine was intolerable. At the time of report the events of mild headache and blurred vision was ongoing. The adverse events resulted into healthcare professional office/clinic visit and emergency room/department. Therapeutic measures for the reported adverse events included treatment with metoclopramide, methylprednisolone and "nr" from unknown dates. The clinical outcome of the events of fatigue, headache, swollen black and blue eyes, tiredness, left eye twitching on and off, blurred vision, slurred speech, was forgetful and heavy tongue, hands shaky, aura, peeing more often and hemiplegic migraine was reported as recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated reporter details (reporter name, for correspondence contact in slide#2, Health care professional leave blank; Protect confidentially and Correspondence contact was checked). Patient details added (Patient's first name and age/units). For concomitant drug "amogiv" was considered as typo and coded as Aimovig. Concomitant therapy leave blank since the concomitant drug was coded via WHO drug in product tab already. Deleted duplicate reported Indication of BNT162B2. Lot# UNKNOWN was removed from dosage regimens tab. Best doctor/Health care professional information such as phone number and email were added in vaccine administration tab. Treatment received was ticked as Yes for events. Physician Office Visit and Emergency room visit were checked. "Depth perception problem on right side" was added as AE.
employee had flublok influenza vaccine in left arm on 10/26/2022.  employee verbalized on 10/27/22 his eyelids bilaterally became red and swollen.
No Adverse Event; Received an expired Moderna COVID19 booster; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired Moderna COVID19 booster) and NO ADVERSE EVENT (No Adverse Event) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 006m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired Moderna COVID19 booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received an expired Moderna COVID19 booster) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that patient received an expired Moderna COVID19 booster.  Caller stated the vaccine expired on 16 Sep 2022, Vial expiration checker showed that the expiration date was 15 Sep 2022.  Treatment information was not provided.   This case was linked to MOD-2022-660008 (Patient Link).
CHILLS, HEADACHE, DIARRHEA, FATIGUE SYMPTOMS LASTED 48 HR
tenderness left armpit, progressed to pain & lump in left axilla approx 2in x 3in per staff (kiwi sized)
The pt experienced 8 x 4 1/2 cm erythema on the left deltoid.
Patient temporarily experienced a vagal response resulting in gently falling to ground, within minutes after receiving vaccine injection. This occurred 10 seconds of ambulating after vaccine receipt. She opened her eyes per parent report within 3 seconds of the event, and was responsive. I evaluated her as a provider within a few minutes after the event.
31AUG shaking all over as cold; crying w/h/a discomfort; fever 100; APAP given q 4 hrs by 1SEP95 completely recovered;
immediate rash over much of outside upper left arm, some itch, swelling, pain, not very serious or debilitating, subsided in ten days.  New rash with edema in upper extremities, fever 98-103F, fluid in lungs; June 10-16, 2021.  ER administered prednisone, tapering off on June 30.  July 3 rash returned aggressively, no fever, no edema; taking prednisone again.
Felt achy; Low grade fever; Headache; This case was reported by a consumer and described the occurrence of pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received Shingrix. On 22nd July 2019, 13 days after receiving Shingrix, the patient experienced pain, low grade fever and headache. On an unknown date, the outcome of the pain, low grade fever and headache were unknown.   It was unknown if the reporter considered the pain, low grade fever and headache to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. 2 weeks ago from the reporting date, the patient received Shingrix. The day before the reporting date, the patient felt achy, had a low grade fever and headache. The patient was fine tidy and was curious and asked could that had been from the vaccine.
Pediatric 3+ yrs. administered instead of pediatric 6 mos. to 36 mos.
Arm red, swollen and tender at injection site. Advised to try Motrin, Ice and call if worsens.
This spontaneous report as received from a licensed Vocational nurse refers to a 75 years old patient with codeine allergy. The patient was vaccinated with ZOSTAVAX (dose, route and frequency unknown) (lot number reported as #0071AE and expiry date reported as 03-APR-2013) (expiry date also reported as 03-APR-2020) on 12-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in September 2012 the patient experienced redness and soreness and the injection area became swollen about the size of an egg. The patient took BENADRYL as treatment. Medical attention has been sought by office visit. The outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. This is one of the several reports received from the same reporter. Additional information has been requested.
IMMEDIATELY 5 MINUTES AFTER HE WAS VACCINATED HE BEGAN TO COUGH ANTHE COUGH INCREASED EVERYDAY. THREE WEEKS LATER HE HAD TO BE HOSPITALIZED AND HE WAS OPERATED AS EMERGENCY WITH PERICARDITIS AND HE HAD 980 MILITERS OF LIQUID SUBSTANCE BETWEEN THE PERICARDIO AND HIS HEART . He was operated as an emergency.
Site: Pain at Injection Site-Medium, Additional Details: Patient states he has "throbbing pain when pressing injection site 10 days after being vaccinated"  States it was a "very painful" injection. States "no redness, no swelling, no pain unless touching site or physical exertion".  Pt called and spoke to nurse at primary care dr who told him vaccine may have been giving in "shoulder cap".  Office told him to wait a week and call back if still in pain.  I told pt I would call to follow up with him next week.  I advised him to take motrin if needed.
elevated Kinase level reaction; This is a spontaneous report from a contactable pharmacist.  A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported, Pharmacist said that son took 1st dose of Covid vaccine and had an elevated Kinase level on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood creatine phosphokinase: elevated on. Information about lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.
Moderna COVID-19 Vaccine EUA Patient was given dose after puncture vial expiration had been reached.
Pain in all joint : stronger in both. Knees right ankle. Elbows. Congestion with head with ringing in right ear.
The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.; Temp Excursion - Yes; No adverse event; erroneously vaccinated  clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes).    No concomitant drug was provided by reporter. No treatment drug was provided by reporter.
Fever 100 degrees Fahrenheit, chills, weakness, headache, tiredness, left shoulder pain
Patient was scheduled for Moderna # 2 injection at 2 pm, she came to the COVID clinic early for injection since she was in the building for another appt and received Pfizer instead of Moderna inadvertently by CMA as Pfizer was being administered in AM and Moderna in PM today.  Patient remained in clinic at least 15 minutes before leaving free of any adverse reactions.  After patient left clinic and documentation was being done it was identified that she received PFIZER COVID vaccination.  CMO notified and review of CDC guidelines done. VAERS report done. RN Practice Manager has reached out to the patient via phone to inform of issue and at time of documentation has not been able to make contact.
4/1/2021 routine lab work done for follow up Dr. visit, 4/2/2021 Dr.office called stated platelet count is 14,000 go to ER. Patient was admitted to the hospital and as of this entry still a pt. because the Drs can not get his platelet count up or to stay up ( range has been from  approx. 7,000 to 30,000) Patient is in declining health.  As I understand it labs from Jan /2021 the platelets were 77,000. He has been treated with IVIG, prednisone, NPlate, platelet infusions-please contact Drs. and the hospital  Patient displayed NO outward bleeding of any kind. He had only1 small bruise about the size of a dime on the base/web of his left index finger
Epileptic Feed; Dizziness; Chills; Fever; Vomiting; Feel like vomiting (Nausea); Headache; Pain at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (Epileptic Feed) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mitral valve prolapse. Concurrent medical conditions included Hypertension and Thyroid disorder.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). On 27-Apr-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever), VOMITING (Vomiting), NAUSEA (Feel like vomiting (Nausea)) and HEADACHE (Headache). On 28-Apr-2021, the patient experienced EPILEPSY (Epileptic Feed) (seriousness criterion medically significant). At the time of the report, EPILEPSY (Epileptic Feed), DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever), VOMITING (Vomiting), NAUSEA (Feel like vomiting (Nausea)), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She also developed dizziness headache, felt bad and today 28Apr2021 she developed an epileptic feed about 3 hours ago. She has never had an epileptic feed before. She has a history of mitral valve prolapse and was currently on treatment for hypertension of thyroid disease. She wanted to know what she can do to treat these symptoms.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
This is a spontaneous report from a non-contactable nurse via a Pfizer sales representative. A female patient of an unspecified age and race received TRUMENBA on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was a high school senior going to school with the reporter's daughter. She was a very active student playing soccer and horse-back riding. After vaccination, she claimed she was unable to walk for several weeks due to the numbness and tingling in her legs. She also experienced migraine headache (started 7 hours after vaccination), tingling in arms and legs with some numbness in her legs. She was better at the time of report, walking and returning to school. Outcome of migraine headache was unknown. No follow-up attempts possible. No further information expected.
Information has been received from a physician concerning a patient who on an unspecified date, was vaccinated with 0.65 ml dose of ZOSTAVAX (lot# not reported). The physician stated that the patient developed shingles after having been vaccinated with ZOSTAVAX. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
pt devel a pea sized lump @ the inj site;the lump turned into a dimpled indentation which lasted 3wk;addtl info was recv 25OCT95;pt recovered;
16 hrs. after receiving vaccine, after sleeping for 6 hours awakened with severe right ear tinnitus and nearly complete loss of hearing. Right cervical anterior nodes extremely swollen, difficulty swallowing on right. Right ear pain and fullness like Eustachian tube blocked but could not open it. Tinnitus still present 42 days later. Hearing loss resolved now. Right glands still swollen. Saw ENT 10/18. Advised NSAID X 2 weeks. October 25 developed extremely swollen right anterior inferior neck papillary dermal fibrosis that had to be removed for biopsy.  Still have ear fullness, right gland swelling and significant right tinnitis.
2-3 days after MENACTRA vaccine pt developed a confluent pustular/folliculitis rash over back & chest.  Some runny nose & congestion.
Fever, Joint stiffness, Brain Damage (diminished white and grey matter), loss of mobility (can no longer walk), seizures, twitching, loss of ability to focus with eyes sometimes, extreme fatigue.
02 yom dependent with ongoing 1: DERM COMPLAINT: Pt has had multiple Sxs after receiving a Flu shot 05 weeks ago; the week of 08JAN2013. He first presented with N/V/D 01 week after his shot with loss of appetite and occasional irregular breathing pattern. However father and mother both deny any changes in bowel movements, urination, or dietary changes. 01 week later he began to develop a rash on the posterior aspect of bilat his elbows that has since spread to his lower extremities and is painful to the child. Parents deny any knowledge of allergies, or any family members with similar Sxs, any change in detergents. Parents also claim that all vaccinations are up to date and diet has since improved. Mother states that for home treatments they have tried Epsin salt baths, NEOSPORIN, Cortisone cream, and MOTRIN only seeing minor help with the Pt sleeping from the MOTRIN. Pt does not currently have N/V/D/F/C. Pt last seen on 07FEB2013 by and diagnosed with Molluscum. Pt was referred and told to follow up as needed.
I had a headache, body ache, chills, fever, sore throat, cough, fatigue.