chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itch a lot; rash on right arm, and a little bit on left one as well, and mainly on back; swelling of the injection site; red circle around the area the size of a baseball; lump/knot in the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE MASS (lump/knot in the injection site), PRURITUS (itch a lot), RASH (rash on right arm, and a little bit on left one as well, and mainly on back), VACCINATION SITE SWELLING (swelling of the injection site) and VACCINATION SITE ERYTHEMA (red circle around the area the size of a baseball) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE MASS (lump/knot in the injection site), VACCINATION SITE SWELLING (swelling of the injection site) and VACCINATION SITE ERYTHEMA (red circle around the area the size of a baseball). On 02-Mar-2021, the patient experienced PRURITUS (itch a lot) and RASH (rash on right arm, and a little bit on left one as well, and mainly on back). On 02-Mar-2021, VACCINATION SITE SWELLING (swelling of the injection site) had resolved. At the time of the report, INJECTION SITE MASS (lump/knot in the injection site), PRURITUS (itch a lot), RASH (rash on right arm, and a little bit on left one as well, and mainly on back) and VACCINATION SITE ERYTHEMA (red circle around the area the size of a baseball) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: No specific follow-up information recorded.
running nose; Cough; throat is bothering her; Headache; Small bumps inside nose; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 56-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: WPSTT) via an unspecified route of administration on 27Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 30Apr2021 the patient experienced running nose, cough, throat is bothering her, headache and small bumps inside nose.  The events outcome was reported as not recovered.   No follow-up attempts are needed. No further information is expected.
Havrix given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old male patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix 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: 16-FEB-2023 Reporter's Comment: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient. The reporter stated that below temperature excursion had happened in October. The vaccine administration Facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient, which led to incorrect storage of drug. This was 1 of 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023026692:Same reporter US-GSK-US2023026694:Same reporter US-GSK-US2023026695:Same reporter US-GSK-US2023026696:Same reporter US-GSK-US2023026698:Same reporter
Blood clot left leg, ankle and foot. weight loss ended up resulting in weakness and breaking the same foot.  Almost 3 months on crutches so far.
Immediately, when injected into upper left arm, extreme muscle pain, swelling and redness occurred. Within 15 minutes, ringing in ears, slight dizziness occurred. Within 35 minutes nausea, headache, severe stomach cramps, extreme pain in my knees, arm froze (could not move joints, could wiggle fingers), chills, dry mouth and drop in body temperature with shallow breathing at night. These symptoms persisted for the next 5 days with loss of appetite. From days 6-9, stomach was better, chills only at dinner time, and my arm unfroze gradually, finally reaching 100% mobility by 10/20/21. Itching at injection sit persisted until 10/21/21.
In 2016 she had a reaction to the FLUZONE flu vaccine. This year the office ordered preservative free vaccine for her and she had a reaction to it also. Within a few minutes her arm was starting to swell and itch. Within 2 hours her reaction site was about a 4" x 6" area, raised, red, hard and very hot to touch. She was given BENADRYL and Ibuprofen routinely for the weekend. This was severe until Sunday at that time she said it didn't hurt as bad. Prior to that she c/o itching, pain and throbbing. She also had a rough feeling petechiae rash that was approx. 1" x 2" around injection site. It is not completely well, but almost completely well. She was taken back to Health Center within 1 hour of injection for Doctor to look at it. She advised BENADRYL, ibuprofen, cool compress.
Onset of mild headache at approximately 2:00AM on 12Jan2021, with headache getting progressively worse since onset. Onset of chills, body fatigue, and muscle/joint aches at 4:00AM on 12Jan2021. Low grade fever (99 degrees F) reported at 5:00AM on 12Jan2021.
I have had constant ringing in my ears for the past few days. It has not gone away yet and has been especially noticeable at night. I also noticed a sudden pain in my chest around noon on 5/1/21 that felt like someone had punched my sternum and bruised it. That has also not gone away yet. It hurts to put any pressure on my palms or lift anything heavy.
Heart pain; Fever; Headache; Stomach ache; Difficulty to sleep; This is a spontaneous report received from a contactable consumer (patient).  A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 28-years-old), administered in Arm Left on 03May2021 10:00 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 28-years-old), administered in Arm Left on Apr2021 10:00 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient experienced the normal symptoms like fever but it was just a mild fever, headache, stomach ache, and difficulty to sleep but the reason he is calling is because he was experiencing heart pain. He received the vaccine for protection on 03May2021 and for all the symptoms he had all started the same day he got the vaccine which all the symptoms started that night. The heart pain was only 10 minutes to 15 minutes that the pain lasted and it was painful but he relaxed himself and the pain went away by itself and he was not scared. He just laid down until the pain relieved and he took no medication. The outcome of the event heart pain was recovered on 03May2021, while for the rest of the events was recovered on 04May2021. The events were considered as non-serious by reporter. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional administered vaccines. No prior vaccinations (within 4 weeks).  Information on the lot/batch number has been requested.
45 mins post vaccination patient experienced severe dizziness, nausea, extreme vomiting, headache behind eyes, tachycardia (bpm 120), elevated BP (190/120), PVCs. Patient was an on-duty EMT and received Zofran and Benadryl in the ambulance. Patient presented to Emergency Room and received fluid bolus, acetaminophen, and metoclopramide. Symptoms resolved within an hour but some residual nausea existed 24 hours later.
Immunocompromised patient received 1st booster dose of Moderna Covid-19 vaccine with 0.5ml dose instead of correct 0.25ml dose after initial primary series of 3 doses of 0.5ml.  Patient has been contacted and voicemail message left asking patient to return our call.
Pt had an urticarial rash within 10 min of injection followed by swelling of the lips, then tongue followed by full anaphylactic reaction requiring epi and transport to ED.
Could not stop trembling/shaking for about half hour, felt feverish but had no fever.  He did feel warm. He thought he was going to vomit, but did not, only spit up a little.
Redness, pain, swelling, warmth @ inject site for approx 12 hrs; fever (not measured) for several days. would not eat for 6-8 hrs; screamed continually for more than 3 hrs.
She developed symptoms 4 days later and tested positive and positive test after completion of series; She developed symptoms 4 days later and tested positive and positive test after completion of series; This is a spontaneous report from a contactable Nurse. This contactable nurse reported for a 38-year-old female (patient 4 of 11) consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EH9899), via intramuscular route of administration, administered in deltoid left on 08Jan2021 (at the age of 38-year-old) at a 2nd dose, single for COVID-19 immunisation. Medical history included immunosuppressive disorder rheumatoid arthritis from 2020 to an unknown date (Onset Date: Spring 2020) and She was exposed to a COVID 19 patient during the course of her work. Concomitant medication included methotrexate (METHOTREXATE) at an unknown dose weekly via oral route of administration taken for rheumatoid arthritis from an unspecified start date and ongoing. The patient did not receive any other vaccines prior to the COVID-19 vaccine within 4 weeks. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EK9231) via intramuscular route of administration, administered in deltoid left on 18Dec2020 at a 1st dose, single for COVID-19 immunisation. Patient had completed the vaccine series on 1/8/2021. She was exposed to a COVID 19 patient during her work. She developed symptoms 4 days later and tested positive and positive test after completion of series on 19Mar2021. A repeat test was performed > 24 later and was also positive on 22Mar2021. Patient experienced respiratory: congestion, cough, rhinitis during the COVID-19 illness. The patient was not hospitalized, not admitted to an intensive care unit, and did not receive supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation for the events. The patient underwent lab tests and procedures which included COVID-19 PCR/Nasal PCR/ SARS-CoV-2 by PCR, or other commercial or public health assay: positive on 19Mar2021 abnormal, SARS-COV-2 test: positive on 22Mar2021 (abnormal, retest for confirmation). Patient did not receive any additional therapies, new medication or other treatment or procedure for COVID-19. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported vaccination failure and COVID-19 cannot be ruled out.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:42 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:42 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month. On 03-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened. The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.   This case was linked to MOD-2021-402935 (Patient Link).
So back in June 2021 I had some pain where the TMJ is located so I saw my PCP who is located out of oh god I forget his office name. He told me to see my dentist, so I did that last month, in September 2021. I am now getting a night guard and a TMJ specialist and I did. The specialist's concern is that it is a bite issue, due to continued growth and my teeth have shifted out of treatment. Just today (10/26/2021) they shaved down the teeth a little bit to make the bite a little better. The cause of the TMJ is completely unknown at this time. Also, back in July I had some bacterial infection, but I work at a summer camp so who knows about that - It felt like pneumonia. It was hard to breath; I could not go to work and the medic on site at work checked me out. The day of rest did not fix it and my mother who is an RN said it was probably an infection of some kind. I got Z-pac and that seemed to clear it up within a few days.
allergic reaction at vaccination site.  large reaction approx 8x8 cm in size red, itchy area started about 1 week after receiving covid vaccine
pt recv vax & exp blisters in the mouth, swollen tongue & lips;encouraged to notify MD;
Trihibet vaccine should not have been given. - To young for this combo, - when it was given.
Injection site pain, sore arm, fatigue after about 4 to 5 hours, getting worse through the night. I took 2 doses of ibuprofen, one at start and another 4 to 5 hours layer before bed. At 4 am I woke up with stomach pain and nausea. Eventually began vomiting and had diarrhea. Muscle aches, chills, headache, and joint pain followed shortly after.  Effects still continuing
Approx 6 hours after  vaccine developed a headache and sore arm which was to be expected . Headache continued for 2 days . Approx 48 hours after vaccine diarrhea , nausea , dizziness and cold spells started . Approx 72 hrs post vaccine chest was very tight and very watery cough, sore throat and slight red rash on chest and arm. Went to ER . They tested for Covid and sent me home with medication to treat symptoms ( anti nausea , anti diarrhea , anti histamine , cough mixture) , more cold spells in the evening and woke up very achy this morning . Also had slight tremor in my leg this morning . Went to my GP in the afternoon as chest still felt tight . Advised to use asthma pump and anti histamines .
10/6/99, 24 hours post vax, pt experienced fever, chills, muscle aches, erythema, warmth @ site of injection. Pt taking cephalaxin. 10/9/99.  10/21/99, pt continues to have left axillary edema and malaise.
No adverse events.  Patient called and set up an appointment for a flu shot with a technician.  After the vaccine was administered he presented a Covid Vaccine card.  He had intended to request a Moderna vaccine and had already received a flu shot earlier in the season.
On Thursday 5Sep2013 at 4:30am awaken with fever oral temperature 102.0 chills, severe headache and right upper arm swollen, red, warm to touch and hard to move. Treated with ice packs to deltoid muscle and alternated tylenol & motrin for two days. Symptoms lasted two days.
local rxn, 8cm red swollen hive on rt deltoid, sore itching, hurts to move arm
Cerebellar stroke; blockage of the blood vessel at the back of his neck; extreme vertigo; Headache; Sleepiness; unable to walk; he can't stand; he can't go to the bathroom on his own; rapid eye movements left to right; Numbness in face; Numbness of tongue; vomiting; This is a spontaneous report from a contactable consumer (patient's son-in-law) via medical information team. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm on 22Aug2021 (Batch/Lot Number: FC3182) as dose 1, single for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was a healthy person before the vaccination and always had good blood pressure. On 13Sep2021, the patient had a cerebellar stroke involving blockage of the blood vessel at the back of his neck. On 13Sep2021, patient had extreme vertigo, headache, and sleepiness. On an unspecified date in Sep2021, unable to walk, he can't stand, he can't go to the bathroom on his own, had rapid eye movements left to right, numbness in face, numbness of tongue, and vomiting. The patient went to the emergency room for the events. On 18Sep2021 the patient was hospitalized for cerebellar stroke involving blockage of the blood vessel at the back of his neck and was given an unspecified treatment. The reporter says his father in law probably had other symptoms but he is not sure what those are, his step mother in law is at the hospital visiting with him, he hasn't been able to see him due to only one person being allowed to be there due to COVID restrictions. The outcome of the events cerebellar stroke involving blockage of the blood vessel at the back of his neck was not recovered while for the rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.
68-year-old female presenting with a cough, generalized weakness, one episode of diarrhea, and fever.  The patient has been sick since about a week ago.  She has spent the last 4 days in bed, unable to get up.  She has a known history of multiple sclerosis and generally uses a walker.
Initial report received on 17 April 2007 from a health care professional. An unidentified female patient, whose medical history was not provided, had received a dose of YF-VAX vaccine on an unspecified date. The lot number, route and site of administration were not provided. At an unspecified amount of this later, the patient developed a "low grade fever" (temperature reading not provided) that subsequently resolved; and a headache. "In a few days", the patient was admitted to the hospital for twenty-four hour observation due to fever (temperature not provided). A spinal tap, MRI, and MRA were negative. Laboratory testing was not provided. It was reported that the patient's headache continued to persist two weeks after the administration of the vaccine. At the time of this report, the patient had not recovered.
01/29/22 presents to ED for "increased confusion". PMHx of "MG/HTN/CHFHTN//colon ca s/p resection 12/18/21/recent covid/malignant pleural effusion"
Case number PHEH2013US024973 is an initial spontaneous report from the physician received on 26 NOV 2013. This report refers to a 01-year-old female patient who was accidentally vaccinated with FLUVIRIN 2013/2014 (batch number: 1309801) intramuscularly on 21 NOV 2013. No adverse event reported following this medication error.
Patient's 1st dose of COVID vaccine was Pfizer MV and then was given a Moderna MV dose for a 2nd dose.
This case was reported by a nurse and described a female patient in her 40's who did not respond to Hep-B vaccine.   On an unspecified date in 2004, the patient received the third dose of Energix-B.  On an unspecified date in SEP 2004, a Hep-B surface antibody titer was "negative".  The reporting nurse considered the event to probably be related to vaccination with Energix-B
After flu shot, experienced soreness in arm for 2 wks, then it began to throb occasionally and she started experiencing weakness in the shoulder/arm. She can't lift her arm over her head. Has had several weeks of physical therapy.
Normal reaction on day one with some swelling in the evening. On day 2 to 3 more swelling and redness. Could not sleep due to swelling. Came to see flight Doctor on day 4.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Lot number: 011L20A), in left arm, on 09Feb2021 as dose 2, single (Lot number: 013M20A), in left arm, on 31Oct2021 as dose 3 (booster), single (Lot number: 939903), in left arm and on 06Sep2022 as dose 5 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Slightly high blood pressure" (unspecified if ongoing), notes: Slightly high blood pressure; "high cholesterol" (unspecified if ongoing); "seborrheic dermatitis" (unspecified if ongoing). The patient had no drug allergy. Concomitant medication(s) included: OLMESARTAN, start date: 07Aug2021; EZETIMIBE, start date: 06Aug2021; AMLODIPINE BESYLATE, start date: 13Aug2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 30Jan2023, 6 days after testing positive.