chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported to hospital on 01/18/2022  with inability to walk and right extremity weakness.  Acute stroke was not seen on CT of brain.  Patient underwent CT MRI EEG and echo, no evidence of acute stroke.  Patient did test positive for Covid-19.  Patient was placed on oxygen for comfort.  Patient was discharged back to long term care facility.  Patient expired on 04/05/2022.
had the shot but still got them/suspected vaccination failure; still got them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 03-MAR-2023  Reporter's comments: This case was reported by the patient via interactive digital media.  The reporter stated that the he/she got the shot and still had them (Shingles). Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.  Follow-up would not possible as no contact details were available.
Ear infection; She has trouble hearing in that ear; Her arm was hurting for a little bit on same day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infection), PAIN IN EXTREMITY (Her arm was hurting for a little bit on same day after receiving 1st dose) and HYPOACUSIS (She has trouble hearing in that ear) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00782LA) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Glaucoma. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Her arm was hurting for a little bit on same day after receiving 1st dose). On 26-Mar-2021, the patient experienced EAR INFECTION (Ear infection) and HYPOACUSIS (She has trouble hearing in that ear). At the time of the report, EAR INFECTION (Ear infection), PAIN IN EXTREMITY (Her arm was hurting for a little bit on same day after receiving 1st dose) and HYPOACUSIS (She has trouble hearing in that ear) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Antibiotic ear drops, steroid ear drops, amoxicillin day.
From time to time I feel a stuffy nose I always do a home test on the 22nd it was negative. Fever, chills, runny nose, fatigue, weak. After going to patient first I started taking over the counter medicine for the fever on the 23rd I was so weak I couldn?t even wake up. On the 25th I stopped taking the meds. Today I have no fever, but I have runny nose, congestion and a weakness and coughing.
Client c/o having blurry vision and splitting headache.  Also felt very hot.  Loss of consciousness.  Able to respond to verbal commands.
a little chest tightness like when I breath deeply; Feels more like I don't know like the start of a cold or cough would; Feels more like I don't know like the start of a cold or cough would; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Aug2021 11:30 (Lot number: FA7485) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Stage 1 heart failure" (unspecified if ongoing), notes: I have stage 1 heart failure.". The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot no: FA7485, first dose was at 4 pm, Anatomical site of injection: Left Arm), administration date: 17Jul2021, when the patient was 25 years old, for Covid-19 Immunization.  The following information was reported: CHEST DISCOMFORT (non-serious) with onset 07Aug2021, outcome "not recovered", described as "a little chest tightness like when I breath deeply"; NASOPHARYNGITIS (non-serious), COUGH (non-serious) all with onset 07Aug2021, outcome "unknown" and all described as "Feels more like I don't know like the start of a cold or cough would". Therapeutic measures were not taken as a result of chest discomfort, nasopharyngitis, cough.  Additional information: Vaccination Facility details consumer stated, I know that it was Pharmacy. When probed if consumer administered any vaccination 4 weeks prior to COVID 19 Vaccine, Consumer stated, No. Family medical history related: Consumer stated, "Not to my knowledge." Confirmed the onset of event as yesterday 4 O'clock. Patient got the vaccine (COVID 19 Vaccine) Saturday. Yesterday I felt okay 'after receiving' it but yesterday evening, she had kind of start feeling a little chest tightness like when she breath deeply and she was feeling the same today. Further stated that like it's not like allergic reaction but it's feels more like I don't know like the start of a cold or cough would. The patient had questions about that because I mean I work with children, that was my concern.  Follow-up attempts are completed. No further information is expected.
10 hours after received Covid and flu shots, developed itchy papules/vesicles on hands and feet, runny nose and mild cough - diagnosed 10-30-23 with Hand-foot-mouth disease
About 2 days after the vaccine headache and sore throat started and I had a site reaction, looked like a bug bite, it got red, swollen, warm to the touch, an inch around, painful for about 2 days it got a little bit bigger and then slowly went away. The headache I took Ibuprofen and Tylenol and felt better by the next day.
Impressive muscular pain after heavy, but normal for me, exercise; odd muscular pain in legs after exercise; This is a spontaneous report from a contactable physician (Patient himself). A 55-year-old male patient received both dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 17Dec2020 12:15 (Batch/Lot Number: EG1685) intramuscular in right arm , second dose on 06Jan2021 (Batch/Lot Number: EK9321) (age at vaccination 55 year) intramuscular in arm,  both as single dose for covid-19 immunisation. Medical history included coeliac disease from 2009 and IgA nephropathy very mild from 2020, both ongoing. The patient had no allergies. The patient's concomitant medications were not reported. The patient has not received any other vaccine within four weeks and not other medication within two weeks.  The patient experienced odd muscular pain in legs after exercise on 10Jan2021 12:00 and on 11Jan2021 12:00 impressive muscular pain after heavy, but normal for patient, exercise.  The patient underwent lab tests and procedures which included COVID-19 (Nasal swab) test: negative on. The outcome of event leg pain was unknown, of other event was recovered. Reporter consider that the Pfizer product had not had a causal effect to the adverse event.   Follow-up (07May2021): Follow-up attempts completed. No further information expected.  Follow-up (PRD 26Apr2021): New information form a contactable physician (patient) included: route of administration, second dose date of vaccine, non serious event myalgia, reporter's causality.  No Follow up attempts needed. No further information is expected.; Sender's Comments: The events event leg pain  and myalgia considered intercurrent conditions and unlikely related to both both dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 17Dec2020 12:15 (Batch/Lot Number: EG1685) intramuscular in right arm , second dose on 06Jan2021 (Batch/Lot Number: EK9321).
This case was reported by a physician to a sales representative and described the occurrence of seizure in a 16-month-old male subject who was vaccinated with Havrix, for prophylaxis. The subject had no prior history of seizure, nor did the subject have a family history of seizure. On 03 February 2006, the subject received the 1st dose of Havrix. On 03 February 2006, the subject also received IPOL (unknown manufacturer) and Varivax (unknown manufacturer). On 03 February 2006, within five minutes after vaccination with Havrix, the subject experienced a seizure. At the time of initial reporting, 07 February 2006, the event was unresolved. The physician considered the seizure to possibly be related to vaccination with Havrix. Comment: Seizure was assessed as medically serious.
rash; pain; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash, general body pain and influenza-like symptoms. On an unknown date, the outcome of the rash, general body pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the rash, general body pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The patient received dose of Shingrix in the left arm. The reporter stated that, after vaccination with dose of Shingrix, the patient had two palm sizes big rash near the injection site, severe body pain and flu-like symptoms. Additional ionformation not provided.
Delirium; mumbling unintelligbly; shaking uncontrollably; not recognizing family members; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient did have COVID prior vaccination and the patient did not test for COVID post vaccination. On an unspecified date, the patient experienced delirium at night of given dose in the morning. The patient was not feverish, but she was mumbling unintelligibly, shaking uncontrollably and not recognizing family members. The patient received ibuprofen and acetaminophen as the treatment for the events. the outcome of events, delirium, mumbling unintelligibly, shaking uncontrollably and not recognizing family members was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event delirium and BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Runny nose; Slight sore throat right side of throat; Tired; This is a spontaneous report received from a contactable other health care professional. A 66-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route and in left arm on 19Mar2021 at 13:45 PM (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient medical history included thyroiditis (thyroid meds (unspecified drugs). The patient had known allergy with Wellbutrin. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route and in left arm on 26Feb2021 as a single dose for COVID-19 immunisation. The patient received other vaccine within four weeks prior to the vaccination (as reported). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other medications within two weeks of vaccination. On 23Mar2021, at 16:45, the patient experienced runny nose, slight sore throat right side of throat and tired. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of runny nose, sore throat and tiredness was not resolved at the time of report. No follow-up attempts are possible. No further information is expected.
Flushing, rapid heart rate and shortness of breath occurred 1.5 hours after H1N1 injection. Seen ED. Rx with prednisone and BENADRYL.
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 18-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-1906USA011674:
Fever Sob Tachycardia Elevate d-dimer  Chest pain Cough
Moderna  booster 10/4/2022, 10/5/2022 had onset R Trigeminal nerve pain R Branchial plexus-mainly ulnar nerve electrical pain. No weakness but  incoordination R hand, can't use the computer , getting better.
Left arm red, swollen warm to the touch. 1st day measured 4.5 x 4 left arm to above elbow. 2nd day 5x5 all around arm. TX BENADRYL, cold compress, antibiotic.
Injection site was swollen on first day and very painful, couldn?t elevate arm. On second day pain was 75 percent better but very swollen. One week after injection the site became very itchy, warm with slight bumps. Feels like an insect bite.  Day 9 the redness is expanding and still itchy.
The day after the vaccine I had high heart rate even after being inactive or 10 minutes. I went to the hospital where everything came back normal but they gave me fluids for dehydration. I have also been experiencing fatigue, headaches and pain/swelling in the lymph nodes in my armpits. I am also still experiencing high heart rate while inactive after leaving the hospital. I have a follow up with my PCP scheduled for Saturday 12/4/2021.
Patient inadvertently administer extra 0.25 ml dose,  previous dose of 0.25 ml was administered in November
This is a spontaneous report from a non-contactable pharmacist via a Pfizer sales representative. A patient of unspecified age, ethnicity, and gender received PREVNAR 13 via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that after they gave the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), the patient fell sick on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
lymph node under left arm became enlarged after 5 days of vaccine. 12 days after vaccine, lump became hard.
severe injection site reaction with bruising and swelling; severe injection site reaction with bruising and swelling; This case was reported by a other health professional via sales rep and described the occurrence of injection site bruising in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site bruising and injection site swelling. On an unknown date, the outcome of the injection site bruising and injection site swelling were unknown.   It was unknown if the reporter considered the injection site bruising and injection site swelling to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced severe injection site reaction with bruising and swelling. No further information reported. The reporter did not consent to follow up.
Patient took 2nd dose of Moderna COVID-19 vaccine on 8/24/2021.  On 8/25/2021, patient started experiencing nausea, vomiting, fever, lack of appetite, and body aches.  On 8/26/2021, patient started experiencing diarrhea and her body aches became more severe (she was still experiencing the other issues from 8/25/2021).
Pt developed chickenpox on 12/28/2000 and was seen by a doctor on 1/3/01.
Received Varivax #1) 1/26/01 #2) 12/12/07 Onset Varicella vesicles-entire body-itchy-afebrile Tx: supportive ie Aveeno baths. Anti-itch topical Benadryl oral prn.
Malaise, fatigue, pain in left shoulder, temp elevation, muscle aches, sweats, Advil.
Face, beginning with upper lip and eventually all of face numbness, started about 45 minutes after receiving the vaccine and lasted about 15 minutes.  Cheeks felt swollen, like a chipmunk, but no real difficulty breathing, very minor if at all.  Facial numbness returned about 8:45pm,  less noticeable than before,  Random itchy spots on arms, scalp, and face, but no noticeable hives. Taking Allegra
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: cellulitis at injection site-Medium, Additional Details: Patient called pharmacy and stated she had redness and swelling at injection site since Saturday. She went to doctor today (Monday 12/20/2021) and was diagnosed with cellulitis. She was given antibiotics.
Drug effect decreased; Patient received first dose on 01-Jan-2021 and second dose on 01-Jan-2022; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 01-Jan-2021 and second dose on 01-Jan-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 01-Jan-2021 and second dose on 01-Jan-2022). On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 01-Jan-2021 and second dose on 01-Jan-2022) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.  Company Comment: This is a Spontaneous case concerns a 81-year-old female patient, with no medical history reported, who experienced the non-serious unexpected event of Therapeutic product effect decreased unspecified days after the second dose of the mRNA-1273 vaccine. Inappropriate schedule of product administration is reported in this case as the Patient received first dose on 01-Jan-2021 and second dose on 01-Jan-2022. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerns a 81-year-old female patient, with no medical history reported, who experienced the non-serious unexpected event of Therapeutic product effect decreased unspecified days after the second dose of the mRNA-1273 vaccine. Inappropriate schedule of product administration is reported in this case as the Patient received first dose on 01-Jan-2021 and second dose on 01-Jan-2022. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Patient's mother yelled "Excuse me! Is this normal?" Patient was leaning forward and appeared pale, sweaty, and was convulsing/groaning. Patient's pupils appeared extremely dilated. If he lost consciousness, it was very briefly (seconds or less).  Mother confirmed that he just had his first Pfizer vaccine, and that in the past he had become dizzy after receiving other immunizations. However, he had never convulsed. When asked if he had a seizure disorder or diabetes, Mom said "No".
This spontaneous report as received from a pharmacist refers to an  unspecified number of patients of unknown age and gender with no pertinent medical history and drug reactions reported. On unknown dates, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (dose, route, lot number and expiration date were not reported) that were improperly stored. Concomitant therapy was not reported. No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.