chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; felt extremely sick; extreme aches; extreme fatigue; flu-like symptoms but no fever; hot and cold chills.; Even food did not taste right.; extreme nausea; rash around the site of injection site.; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm), ILLNESS (felt extremely sick), PAIN (extreme aches), FATIGUE (extreme fatigue) and INFLUENZA LIKE ILLNESS (flu-like symptoms but no fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm), ILLNESS (felt extremely sick), PAIN (extreme aches), FATIGUE (extreme fatigue), INFLUENZA LIKE ILLNESS (flu-like symptoms but no fever), CHILLS (hot and cold chills.), TASTE DISORDER (Even food did not taste right.), NAUSEA (extreme nausea), INJECTION SITE RASH (rash around the site of injection site.) and VOMITING (vomiting). At the time of the report, INJECTION SITE PAIN (sore arm), ILLNESS (felt extremely sick), PAIN (extreme aches), FATIGUE (extreme fatigue), INFLUENZA LIKE ILLNESS (flu-like symptoms but no fever), CHILLS (hot and cold chills.), TASTE DISORDER (Even food did not taste right.), NAUSEA (extreme nausea), INJECTION SITE RASH (rash around the site of injection site.) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PT experience chest pain, dizziness, and pain upon breathing after vaccination.  These symptoms started about a minute after vaccination. EMTs were called and pt was transported to the hospital for evaluation.
This spontaneous report as received from a registered nurse refers to a patient of unknown gender, age range reported as 9 (units not reported). On 04-NOV-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot number K005180, expiration date 10-APR-2016 (dose, dose number, route and frequency were not reported) which was improperly stored. No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) involved. The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
The day after the shot was administered on 1/22 /21 I had swelling of my left arm it was a hard knot and was red and hot the next day it went away and on the 28th a rash appeared red in nature and the size of a quarter which then developed into the size of a half dollar it was hot and itchy and hurt
a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Feb2021 08:00 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal (ongoing). The following information was reported: PAIN (non-serious) with onset 16Feb2021, outcome "recovered" (17Feb2021), described as "a little sore".  Additional information: The patient has been taking losartan for at least 10 years. The patient has been taking for about 15 years  Men's Multivitamin. The call received the second dose of the Covid-19 vaccine last week. He has been having side effects and is asking if they are unusual. He has heard of headaches and an upset stomach. He has had a headache for a week. He also has an upset stomach. He heard of 24-36 hours but this is dragging.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated with TD developed swelling in gums & roof of mouth, joint achiness including jaw, fever, tingling & numbness in hands. Continues to have dull pain in lt wrist & sore jaw.
Occurred the evening after the vaccines were given 01/19/2006, fever 102, twitching of arms and legs off and on for about 20 minutes, no loss of consciousness. No post ictal sleepiness, no recurrence.
The clinic had just received a new refrigerator, the vaccine was brought back on 4-30-23.  The bag was marked with correct expiration date but the nurse didn't catch that it expired 3-30-23 and administered vaccine
History of left knee pain onset four days after receing Mumps vaccine.Pain started in left knee, progressed to upper back, lower back, worsened in left knee and then pain in feet. Pain gradually subsided but pain in left knee persits when climbing stairs, upon rising from sitting position, sometime when walking.
Patient returned to pharmacy 9 hours later with swelling of the left deltoid, approximately 5inx5in that was hard and warm to the touch with some redness.
Nausea; 3 weeks after, the 2nd dose was given; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced NAUSEA (Nausea) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 weeks after, the 2nd dose was given). At the time of the report, NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 weeks after, the 2nd dose was given) had resolved.            Concomitant medications were not reported. The patient was treated with unspecified medications for nausea.  On an unknown date, the patient had nausea after the vaccination which resolved after 24 hours. 3 weeks later, the patient had  the 2nd dose of the vaccine and since then had nausea. The patient was hospitalized twice due to the nausea and consulted with physician but the medications that were being given to the patient were not helping.  This report refers to a case of wrong schedule of product for mRNA-1273, lot # unknown with associated AE Nausea. Very limited information regarding the event Nausea has been provided at this time. Further information is not expected.   This case was linked to MOD-2021-254392 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This report refers to a case of wrong schedule of product for mRNA-1273, lot # unknown with associated AE Nausea. Very limited information regarding the event Nausea has been provided at this time. Further information is not expected.
PNEUMOVAX site became swollen by 3PM, by 8PM whole arm was swollen. Treated with cold compression and elevation. By Thursday morning symptoms began to resolve.
Woke up at 1:30am feeling weird. Experienced Weakness, body shakiness, inability to move lower extremities (legs), super weak as in can?t put one leg in front of the other, headache from 1:30am- 11pm on 3/4/21. ?Feels like a spike being driven into the heels of my feet up to my knees where my legs would jump?, pain persisted off and on for entirety of the night. Loss of appetite. Still experiencing some weakness and shakiness.
arm swelled so big; fast heart beat; dizziness; shaking really bad; weakness; Itching welts all over it; foggy head; runny nose; sore throat; shortness of breath; cough; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled so big), PALPITATIONS (fast heart beat), DIZZINESS (dizziness), TREMOR (shaking really bad) and ASTHENIA (weakness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm swelled so big), PALPITATIONS (fast heart beat), DIZZINESS (dizziness), TREMOR (shaking really bad), ASTHENIA (weakness), URTICARIA (Itching welts all over it), FEELING ABNORMAL (foggy head), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), DYSPNOEA (shortness of breath), COUGH (cough), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, PERIPHERAL SWELLING (arm swelled so big), PALPITATIONS (fast heart beat), DIZZINESS (dizziness), TREMOR (shaking really bad), ASTHENIA (weakness), URTICARIA (Itching welts all over it), FEELING ABNORMAL (foggy head), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), DYSPNOEA (shortness of breath), COUGH (cough), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Fluarix exposed to a freezing temperature; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number FZ453, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's comments: The nurse had reported that a patient might had been administered a doses of Fluarix after it was exposed to a freezing temperature, 31 degrees Fahrenheit. The reporter stated that they were still investigating if any patients received doses after the exposure. The vaccine administration facility is the same as primary reporter. The reporter had consented to follow-up via email. Additional supportive information: The nurse had reported that a patient might had been administered a doses of Fluarix after it was exposed to a freezing temperature, which had led to Incorrect storage of drug. This was one of the five cases, which was reported by the same reporter.
A non-serious spontaneous report of congestion and running fever was received from a consumer concerning a five-year-old female patient subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 03-Oct-2009. On 04-Oct-2009 the patient began experiencing congestion and on 05-Oct-2009 was running a fever. No further information was provided. The events of congestion and running a fever were ongoing.
Vaccination adverse reaction; WARNING: THE STUDY CONFIGURATION IS MISSING THE STUDY PHASE. PLEASE UPDATE THE STUDY PHASE AND RE-GENERATE THE NARRATIVE AGAIN.    This     The subject received mRNA-1273 (Moderna COVID-19 Vaccine). The report describes a case of VACCINATION COMPLICATION (Vaccination adverse reaction).    Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) for Non-Hodgkin's lymphoma and IBRUTINIB (IMBRUVICA) for Non-Hodgkin's lymphoma.    No Medical History information was reported.  On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), IBRUTINIB (IMBRUVICA) (Oral) and IBRUTINIB (IMBRUVICA) (Oral) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if the patient was enrolled in Covid-19 vaccine trial.  The patient was treated with cetirizine (Zyrtec) .
Soreness near injection site weeks after second dose administered on 5/20/21. Becomes more noticable at night time. Perhaps worse after laying on it.
This spontaneous report as received from a healthcare worker refers to a 19 year old patient. Information regarding concurrent conditions and pertinent medical history was not provided. On 08-AUG-2014 the patient was inadvertently vaccinated with a 0.5ml dose of LIQUID PEDVAXHIB (injection, lot # J016185, expiration date 02-OCT-2016, intramuscular) instead of meningococcal vaccine (unspecified). The healthcare worker stated that writing on bottle had similarities to other vaccine. No adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 16-NOV-2015 at time- 14:42, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.3 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
No adverse effects; intramuscular rather then subcutaneous route; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.     On 29-APR-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot# N02146 has been verified to be non-valid; expiration date reported as 24-SEP-2019) by the intramuscular rather than subcutaneous route for prophylaxis (incorrect route of product administration). No adverse effects reported. The outcome of the event is unknown.
Pfizer-BioNTech Covid Vaccine EUA                                   First vaccine dose was received on Wed 3-31-21. On Thurs 4-1-21 (unsure of exact time and whether it was before or after 24 hours from dose, likely before), I noticed tiny bumps and an uncomfortable feeling along my upper lip, lip was swollen. Bumps are rash-like.  On Friday the lightbulb went off and I thought it might be connected to the vaccine. After some online searching I reported it to Pfizer and am now filling out this form.  I do not currently have a doctor as my doctor left. I called the practice I had last used but was unable to speak to a doctor or get an appt.   (continued below)   The rash/swelling/bumps itself is mostly just annoying and not severe but I was concerned it could be a delayed allergic reaction and concerned about whether it is safe to get the second vaccine.  I did not seek any treatment other than applying topical chapstick and carmex at home.  Today, Sat 4-3 it is somewhat better but not totally resolved.
Pt presented requesting a Pfizer vaccine, after administering the vaccine it was discovered that he had previously received a Janssen  on 05/05/2021. RN, ADM of Health Dept, discussed with nursing staff at rehab center about whether client had had any adverse effects, and that he will not need a  second dose of the Pfizer vaccine.
Not able to get the 2nd within the 2-6 month; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The patient asked if he/she go and receives the second dose, would the immune response be equivalent to the response that would have occurred if he/she had been able to get the 2nd dose within the 2 to 6 month protocol. The follow-up would not possible as no contact details were available.
soreness in injection arm; rash over entire body/looking like mosquito bits/being very itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in injection arm) and RASH PRURITIC (rash over entire body/looking like mosquito bits/being very itchy) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung cancer since an unknown date. Concomitant products included OSIMERTINIB MESILATE (TAGRISSO) for an unknown indication.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness in injection arm) and RASH PRURITIC (rash over entire body/looking like mosquito bits/being very itchy). At the time of the report, VACCINATION SITE PAIN (soreness in injection arm) outcome was unknown and RASH PRURITIC (rash over entire body/looking like mosquito bits/being very itchy) had not resolved.            Treatment medication include ointment.   This case was linked to MOD-2021-253206 (Patient Link).
Severe, debilitating, agonizing pain in left shoulder and numbness and tingling in left arm.
first day I felt nothing...next day about half way thro the day I felt where the shot was given and noticed my my face was a bit puffy around my arch of my nose and under my eyes, I was also a little bit tired.  The next day (Thursday the 18th).  my face was tender and more painful still around the same area in addition everything tasted bad.   I rested and decided to take it easy.  Thursday eve I looked in my mouth because it just tasted so awful.  I saw big sores on my inner cheeks and my tongue was white ish color ...looked like thrush to me.  I took some clovtrimazole troche tablets by mouth for a few days and seems to be helping. My taste is still not back to normal as of yet.   I must include that I also had a mild headache off and on after both doses and after the first dose my upper mouth swelled a bit but resolved after the first day. I  didn't report that.
sore arm/top of arm hurt; pain all in the muscle area; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm/top of arm hurt) and MYALGIA (pain all in the muscle area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/top of arm hurt) and MYALGIA (pain all in the muscle area). At the time of the report, PAIN IN EXTREMITY (sore arm/top of arm hurt) and MYALGIA (pain all in the muscle area) had resolved. Not Provided          No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up Received: Patient denied having fax or email. AE's resolved.
Patient received 3 vaccines and ear piercing on 6-26-2007 after vaccines were given. Patient had reaction hives, rash, swelling, crying on both legs and feet, no breathing problems, 1/2 tsp Benadryl.
the night of the vaccine, headache and arm pain started. On Saturday 1/16/21 vomited started and lasted until Tuesday 1/19/21. Continues to feel fatigue today on 1/20/21.
Mild to moderate urticaria,  severe generalized pruritis both involved mainly both distal extremities of arms some of lower limbs and trunk.  One week moderate to severe especially toward midday and evening;  appeared to being resolution around day 10 with copious antihistamines
Received booster dose of Pfizer vaccine and immediately felt reaction in right arm.  Arm and painful to touch.  Rash developed within 1 day.  Symptoms resolving over last 3 weeks.
Symptomatic COVID-19 infection requiring hospitalization; symptom onset ~10/16/21 per chart notes
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received SHINGRIX (batch number AKJSBDKAJS ?, expiry date 31st March 2019) for prophylaxis. Previously administered products included BCG vaccine with an associated reaction of no adverse event, cholera vaccine with an associated reaction of no adverse event, tuberculosis vaccine with an associated reaction of no adverse event, typhoid vaccine with an associated reaction of no adverse event, smallpox vaccine with an associated reaction of no adverse event and Flu vaccine with an associated reaction of no adverse event (high dose). Concurrent medical conditions included neck injury, penicillin allergy and sulfonamide allergy. On 28th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site warmth, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had lots of vaccinations in the past with no reaction. She was not allergic to latex and she sleeps on right side. The patient received SHINGRIX in the left deltoid. Lot numbers were collected but appeared to be invalid. The patient had not reported the events to her physician. The patient experienced swelling at the injection site, pain at injection site, heat or hot at injection site, almost no redness at injection site of the left deltoid. These events did not restrict her activities in any way and resolved after about 3 days. For tolerance to next dose, refer case US2018GSK144786. The reported batch number AKJSBDKAJS for SHINGRIX does not exist in sales database. Clarification is requested for the same.