chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles outbreak on right side of head above right eye with pain; pain; Headache; Fever; This is a spontaneous report from a contactable consumer or other non-health care professional, the patient himself. A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0182) via an unspecified route of administration on 27May2021 (age at vaccination: 14-years-old) as dose 1, single for covid-19 immunization, at Pharmacy or Drug Store. Medical history included asthma from an unknown date and unknown if ongoing. No known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included as the patient received medications within 2 weeks of vaccination reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28May2021, patient experienced shingles outbreak on right side of head above right eye with pain, headache and fever. The events were reported as non-serious. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The patient received treatment for the adverse events which included Valacyclovir, Prednisone, Ibuprofen and Tylenol. Patient underwent lab tests with nasal swab for Sars-Cov2 results negative on 02Jun2021. The outcome of the events was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
Immediate urticarial rxn 3cm x 1cm at MMR site. No anaphylaxis (-) cyl.
Raised bump on injection site. It?s itchy, warm, swollen with mild pain and tenderness. I noticed tenderness when I laid on my arm ans by the end of the day it was swollen and uncomfortable to use. A Google search suggests ?Covid Arm?
Administered Anthrax #2 one month ago and still has raised hardened area from it. Not painful to touch. Anthrax #3 given on on 6 Feb 2003 VAERS date 10 Feb 2003 has raised area that is 2 inches in diameter and is still having itchy reaction.
Arm was sore, hot, red, swollen 12 hours after vaccination.. Redness resolved after 3 days. On 7th day, arm started to itch badly. Then arm became very red, swollen, hot. Arm swelling and redness continued to grow. After 2 more days, redness was 3" in diameter. Saw doctor, who diagnosed as cellulitis. Started me on Keflex 500 mg 4 x day and Benedryl. After 1 more day, redness was 4" in diameter, hot, swollen. Saw doctor again after 4 days (11 days since vaccination) and redness starting to dissipate. Doctor not sure if allergic reaction to vaccine or bacterial infection due to puncture wound from injection. After 14 days from vaccination, redness is almost gone.
I noticed minor digestive problems before the 2nd shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 17Feb2021 13:15 (Lot number: EN6199) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lactose intolerance" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "mild allergy of eggplant & food ingredients" (unspecified if ongoing); "mild allergy of eggplant & food ingredients" (unspecified if ongoing); "normal colonoscopy 2 years Prior" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Augmentin, reaction(s): "Allergic to Augmentin". The following information was reported: DYSPEPSIA (non-serious) with onset 2021, outcome "recovering", described as "I noticed minor digestive problems before the 2nd shot". The event "i noticed minor digestive problems before the 2nd shot" was evaluated at the physician office visit. Therapeutic measures were taken as a result of dyspepsia.  Additional information: The patient had no covid prior to vaccination and was not tested for covid post vaccination. No prior vaccination. The patient did not receive any other vaccine in in four weeks. Other medications in two weeks included OTC multivitamin one per day. The patient received treatment with unspecified medication.  No follow-up attempts are possible. No further information is expected.
received vaccine 9am. started feeling under the weather 10pm. woke up next day 3am with headache. fainted on his way to the bathroom to get Tylenol.  hit his head.
High fever one hour afterwards, headache & tired next day, fever persists 24 hrs later.
Pt said high fever and dizziness. Self medicated w/TYLENOL. Symptoms started that evening and subsided in the morning.
pt. recvd. vax & developed T-102.swollen glands,sore throat,weakness,& fatigue.
Pain, swelling, tenderness to bilateral axilla for 5 days and chills lasted 12 hours.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 and expiry: Unknown) dose was not reported,1 total administered on 09-MAR-2021 to the left arm for prophylactic vaccination. The patient received infliximab, recombinant (solution for infusion, route of admin not reported, batch number: Unknown) dose and frequency were not reported from 02-MAR-2021, dose and frequency were not reported from 31-MAR-2021, dose and frequency were not reported from 28-APR-2021, dose and frequency were not reported from 26-MAY-2021, and dose and frequency were not reported from 23-JUN-2021 for an unspecified indication. No concomitant medications were reported. The patient was complaining about three negative spike protein antibody tests that she has received since receiving JNJ COVID-19 vaccine on 09-MAR-2021. On 31-MAR-2021 the first negative antibody test was performed and after four weeks later on 28-APR-2021 second negative antibody test done and the last negative antibody was done on 23-JUN-2021(confirmed immunological vaccine failure).Remicade doses were given on 02-MAR-2021 which was a week before obtaining the JNJ vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of infliximab, and recombinant was not changed. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality number 90000184875.  Additional information was received from product quality vigilance on 02-JUL-2021. The following information was updated and incorporated into the case narrative: PQC number added, narrative updated. Upon review following information was amended: The event onset date added.; Sender's Comments: V1 - This version is created to amend and update additional information received from product quality vigilance on 02-JUL-2021: PQC number added ; event onset date added. This does not change causality of previously reported events.  20210667208-covid-19 vaccine ad26.cov2.s-Confirmed immunological failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS  20210667208-Remicade-Confirmed immunological failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Redness, swelling , soreness and numbness tingling to fingers on left hand. Redness and soreness spread  from upper left arm (site of injection)  to left shoulder  blade. Difficult to move are very sore.   Lasted 4 to 5 days.   Took "Benadryl" four tablets "two in the morning and two in the evening".  "Helped  a lot.
Weakness, extreme pain all over, limitation of movement, chest pain. Symptoms began about 1 mo post second vaccine and became progressively worse over time.   I went to the ER 5/11/21.  Then again on 5/17/21.  I was admitted to the hospital on 5/17/21 and DX with pericarditis.   I also went to the ER on 5/24/21 for pain related to the pericarditis.
Rash & UrticariaPruritus Narrative: Generalized hives to arms/legs bilaterally anteriorly/posteriorly with excessive itching
Severe tiredness and feeling sleepy even after 12 days of 1st dose.; Severe tiredness and feeling sleepyeven after 12 days of 1st dose; Hot flashes; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 01Mar2021 at 15:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer and radiation in 2014. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included CLINDAMYCIN from an unknown date for unknown indication and unknown if ongoing. On 02Mar2021, at 14:00, the patient experienced severe tiredness and feeling sleepy even after 12 days of 1st dose, hot flashes and nausea where she was not feeling like getting up from bed. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe tiredness and feeling sleepy even after 12 days of 1st dose, hot flashes and nausea not feeling like getting up from bed was not resolved at the time of this report.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Student seen at local hospital ER about 36 hours post vaccine for "maculopapular rash noted to the anterior/posterior trunk and all four extremities". Vital signs were: T-99.0, HR=80. Student was given Visteril 25 mg po PER and discharged with prescription for Atarax 25 mg PO TID for 3 days.
Patient started having low fever and itchiness at vaccine site during evening, a day after receiving vaccine. The itchiness at the site then progressed to a rash which spread to her chest after another day.
24hr after vaccines he developed fever 103.2, stiff neck, bloodshot eyes, dizziness, nausea and couldn't lift his arms. He was not seen by medical personnel. Symptoms resolved in 2 days.
Symptoms of sore arm for 2 days and hives for 3 days all over body about 1 1/2 hours noticed after shot extreme itching. Followed up with Benedryl and creme.  Never felt well after but every once in a while felt feverish and achy.  On September 20th I began feeling these symptoms again and on September 26th 10 AM my eye started to droop.  By 12:00 I went to emergency room Hospital and was admitted with a diagnosis of Bells Palsy.
first broken syringe/broke in half; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 27Jan2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, 0.5ml single (Lot number: FY2475, Expiration Date: Dec2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious) with onset 10Jan2023, outcome "unknown", described as "first broken syringe/broke in half". Additional information: When one of the nurses went to give the vaccine, it broke in half. She doesn't know about patient or not, they said it broke when they went to administer it. No patient got the broken vaccines.  No follow-up attempts are possible. No further information is expected.
Patient received the vaccine at 9:30am.  Approximately 10 minutes after receiving the vaccine she notified us that she was feeling hot and dizzy, and she may pass out.  I gave her a cool pack to put on her back, she was sitting down, and breathing heavy.  She stated that she was feeling very nervous and has a history of panic attacks.  She slumped into her chair and started shaking, her head fell backwards.  I held her head up , kept her head to the side, and removed her mask for air.  Her entire body shook, including her legs.  She came to about a minute later, and was very calm.  She knew she had passed out, and that EMT's were en route.  The EMT suggested that she may have had a vasovagal reaction, and was not convinced it was a seizure.  She did not go to the hospital , but she did have a friend pick her up and drive her to her primary care.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 18-MAR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date: 28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II would had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, fatigue, slight fever, chills, sweats, diarrhea, dehydration
6/29/21: 2nd COVID19 (Moderna) vaccine on 6/30/21:  fatigue, muscle aches, cough, congestion, heavy menstrual cycle began, diarrhea 7/1/21: unproductive/dry cough, voice became hoarse, congestion, diarrhea, extreme fatigue and body aches in PM 7/2/21: laryngitis/voice completely gone, continued unproductive cough, congestion, diarrhea 7/3/21: continued unproductive cough, chest tightness, diarrhea, went to urgent care and was diagnosed with bronchitis and prescribed prednisone  7/4/21: continued all symptoms as noted above 7/5/21: continued symptoms as noted above + nausea  7/6/21: continued symptoms as noted above, continued nausea, progressively worsening cough  7/7/21: continued all symptoms as noted above 7/8/21: woke up feeling extremely fatigued, eyes red, global feeling of weakness, new onset of tingling and pressure sensation left side of face, neck, and left upper arm, new onset tinnitus, high BP prompted ER visit and diagnosis of adverse effects of vaccine
Soreness injection site, fever 102, 5:30-6 PM took two Goody Powders. Muscle aches up and down arm, joint pain left arm numbness and tingling fingertips developed night of injection and next day. 11/30/2001 symptom free.
No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine on 2/7/2022; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 07-FEB-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (recombinant Human albumin) (PROQUAD) 1 dose, lot # U002532, expiration date 24-07-2022 (dose number, exact dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The vaccine was stored improperly at the temperature of -12.3 Celsius degrees for 1 hour on an unknown date. Previous temperature excursions included -13.3 Celsius degrees for 30 minutes, -11.1 Celsius degrees for 1 hour 15 minutes, -8.9 Celsius degrees for 1 hour 30 minutes and -14.4 Celsius degrees for 6 hours on unknown dates. No additional adverse events were reported (no adverse event).
pt devel fever 100-101 & malaise, myalgia;pt also exp tenderness @ site of inj;
2nd shot (L arm) - various purpura; This is a spontaneous report from a contactable other health professional (patient). A 61-year-old non pregnant female patient received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8733) intramuscular, in the left arm on 03Apr2021 at 10:35 (at the age of 61-years-old) as dose 2, single for covid-19 immunisation. Medical history included restless legs syndrome (RLS), attention deficit hyperactivity disorder (ADHD), mitral valve prolapse (MVP), fracture clavicle (R ORIF clavicle) from 2009, and Raynauds from young age and ongoing. Patient has reported family history of cancer epiglossal breast cancer, diabetes, COPD (chronic obstructive pulmonary disease), stroke (was in 90s age group), HTN (hypertensin), alocholism, meningioma and carpal tunnel. Allergies were not reported. The patient's concomitant medications were reported as none. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6207) intramuscular, in the arm right on 13Mar2021 at 10:35 (Lot Number: EN6207) at the age of 61 years old, as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested with COVID-19 post to vaccination. On 05Apr2021, the patient experienced 2nd shot (left arm) various purpura. 2nd shot Left arm various purpura, individual ones resolving, but the purpura not totally resolving / more unusual bruising. Started after the 2nd vaccination could be coincidental or not. Purpura Never as history of purpura prior to second vaccine in various locations. The patient did not receive any treatment for the event. Seriousness criteria reported as not serious. Adverse event required visit to physician office. Relevant tests included COVID test with result: Negative. Test: COVID antibodies with result: Negative. The outcome of the event was unknown.
Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. An 87-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 10Feb2021 at 16:30 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. The patient had a medical history of cancer survivor. The patient had no known allergies to medications, food, or other products. The patient did not take any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 22Jan2021 at 16:30 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 12:00, the patient experienced dizziness and nausea. The adverse event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient had received any treatment for reported events. The clinical outcome of the events of dizziness and nausea was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
It was reported that  a 55 year old female received Fluzone SV 98-99 USP on 10/14/98. Reportedly the evening after the injection the pt broke out in  hives on trunk of body now all over all of body. Has been seen by MD and in ER . Reportedly the pt still has hives.
Information has been received from a registered nurse concerning a 61 year old female patient with seizure disorder, chronic anemia, gastroesophageal reflux disease , aguegenic myeloid metaplasia and seasonal allergy who on 05-OCT-2005 was vaccinated intramuscularly in her left arm with a first dose of pneumococcal 23v polysaccharide vaccine.  There was no concomitant medication.  On 06-OCT-2005 the patient developed cellulitis at an area other than injection site.  The cellulitis developed in her left arm but in the axilla area.  The patient sought medical attention and was prescribed antibiotics and ibuprofen (ADVIL).  Patient's outcome reported as not recovered.  There was no product quality complaint involved.  Follow up information received on 25-OCT-2005 from the physician's office indicated that the patient's complaint was not related to the vaccine.  No further information is available.
Patient received initial Janssen vaccine and while sitting in observation area with mother, patient started getting "Sweaty" and dizzy. During assessment patient was diaphoretic, pale, had complaints of dizziness. Attempted to take vitals, unable to retrieve BP while patient was sitting, HR-38, O2- 100% on RA. Temp of 98.0 F. MD stat called. simultaneously patient fainted and lost consciousness while in wheel chair, patient was transferred to gurney. Patient resumed consciousness, Bp -119/73 (88), HR: 85, SpO2: 100%, Temp: 98.0 F. MD present and completed assessment, patient was transferred to ED. Prior to transfer last vitals- 147/88 (104), HR:83, SpO2:100%, temp: 98.0 F
2mo old male infant received 2mo vaccines and 10 hours later awoke with a 102.1 fever. No decreased alertness, no unusual crying, not limp, no rash, no emesis. TYLENOL given, after 1 hour Fever went down to 100.5, baby fed well, normal diapers, no change in behavior; vaccine injection sites unremarkable. Mother of patient was instructed to continue to dose TYLENOL q6-8 hours for comfort, cool compresses to injection sites for comfort. Later at 9:59 AM the mother reported the baby was doing well, temperature normal, normal feeding, diapers and behavior.
Fell asleep and woke up with hoarsy cough. Next day, noticed hives on lower extremities.
Information has been received from a nurse practitioner (NP) concerning a 5 year old female who in June 1999, was vaccinated with a 0.5 ml dose of VARIVAX (Merck). The NP reported that in March 2005, the patient developed an ear ache and was diagnosed with otitis media. The patient was seen by the NP and treated with AMOXIL. The patient was not getting better and was changed to AUGMENTIN X 2 days. Seven days later, the patient subsequently developed an itchy papular rash from pin point to eraser head size all over. The NP indicated that he was unsure if the patient's rash was a drug reaction vs. varicella. Additional info has been requested.
vaccinated at 1:46, 30 minute after observation, client reported feeling "drunk" and experiencing altered mental state with dizziness and nausea, became clammy and lost color in face, aid called to client and VSS were HR 144, BP palp 154, blood glucose was 96.  Client drank drank juice and water and reported improvement of symptoms. A friend came to drive her home to rest.
swelling, redness, heat, & tenderness @ site; lasting 5 days dec as time went on;