chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 month after vaccine patient developed bilateral upper and lower extremity weakness, blurry vision which progressed to the point of not being able to walk. She was admitted and diagnosed with Guillain-Barre which persisted despite treatment with IVIG. Now, 6 months later, she continues to have symptoms at has diagnosis of CIPD "chronic inflammatory demyelinating polyradiculopathy". She has been in and out of inpatient rehab and still requires assistance with walking and multiple ADLs. She is getting IVIG monthly which does help but after a few weeks symptoms return. She had no other illnesses that patient or family remember around the time of the development of these symptoms.
PATIENT HAD SWELLING, ITCHING, REDNESS, WARMTH, AND SORENESS AT THE INJECTION SITE 2 DAYS AFTER IMMUNIZATION.
Acute Headache, Dizziness, Tiredness, Hot flash in left arm from sholder to finger tips, Facial tingling, moving sensation under the skin on left side of face and neck.
This spontaneous report was received from a medical assistant via a company representative refers to a 2-year-old (age estimated from date of birth is 6 months but narrative in the source document states 2 years) male patient. On 10-APR-2013 the patient was vaccinated with a 0.5 milliliter (ml) of GARDASIL (lot# H017898, expiration date July 2015)subcutaneously. Concomitant therapies included PEDIARIX, PREVNAR, ROTATEQ and TYLENOL. The GARDASIL dose was accidentally given to the patient who was supposed to get Hib which was due next week. The GARDASIL had been drawn up for a teenage patient who did receive GARDASIL due to an unrelated seizure condition. The 2 year-old patient did not experience any adverse event. The patient received TYLENOL in office for unknown reasons. Additional information has been requested.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZ0A) for COVID-19 vaccination.     Family history included Congenital heart disease NOS ((sister)) since an unknown date. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 29-Sep-2020 and the estimated date of delivery was 06-Jul-2021. On 05-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy. The vaginal delivery occurred on 24-Jun-2021, which was reported as Full-term. For neonate 1, the birth weight was 3024 grams (6lbs 11oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Unknown. No problems during delivery and no fetal/infant abnormalities at delivery or at one month post-partum. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Amniocentesis: normal (normal) normal. On 26-Feb-2021, Ultrasound scan: normal (normal) Normal.     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.   Patient underwent Microarry test results were normal.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Additional information added - Reporter details added. Concomitant medication added, patient details and details related to pregnancy added. Lab data added.
Patient reporting have a high BP with systolic values around 170. She went to the doctor where the doctor checked her out and sent her home. This happened 2 days after the vaccination. Patient called and wanted me to report this.
right wrist swollen after getting the shots.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (right wrist swollen after getting the shots.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (right wrist swollen after getting the shots.). At the time of the report, JOINT SWELLING (right wrist swollen after getting the shots.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication were not reported. Concomitant products were not provided.  Patient reported that his doctor said he saw other patients experiencing similar symptoms as the ones described.
MODERNA use for COVID-19 under Emergency Use Authorization (EUA): Patient has 2nd dose of moderna on April 15, 2021. 2 weeks after injection she was talking to a friend at 8:00AM, as she was trying to talk, she could not get the words out. There was confusion. She reports feeling "funny" and went to lay down, she dozed on and off for 2 hours, she could not remember names, her sister's husband and boyfriend's family. "funny" feeling is described as not thinking right. Afterwards she was tired and slow for the rest of the day. Has not had episode in the past or since. 2 weeks following she went on a trip, she reports she could walk 2 miles, used to be able to walk 3-4 miles. She complains of apathy and excessive napping. She denies dizziness, balance difficulties, headache, visual changes, head trauma, concussion, medication change, bug bites. 2nd COVID dose was April 15th. She complains of lack of motivation. She has a history of insomnia. She reports memory has been consistent. She complains of short attention span and lack of patience. She denies history of stroke and seizure, tobacco and alcohol use. She can fall asleep very easily now.
The patient received his flu vaccine and left the pharmacy to do some shopping. The patient returned to the pharmacy 10-15 minutes later having shortness of breath, chest pain, and elevated heart rate. The patient said he had a heart stent placed on 9/14/2023. An ambulance was called and the patient was taken to the hospital by EMS.
Information has been received from a physician concerning several hundred patient who on unspecified dates were vaccinated with doses of GARDASIL (lot number, route and site not reported). It was reported that the products had been predrawn and stored in the refrigerator for up to one week. No adverse effect reported except"it always stings". As of this report time, the outcome was not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information regarding the patient's concomitant medication, pertinent medical history, drug reactions or allergies was reported. On 26-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot# K019386, expiration date: 09-JUN-2016, one shot, once, intramuscularly in an arm. The vaccine was expired. No adverse events were reported. Additional information has been requested.
Odd Tightness in his Throat/same type pressure in his throat; Arms and Legs Shaking, Trembling and Quivering; Face turned a little bit red; Arms and Legs Shaking, Trembling and Quivering; This is a spontaneous report from a contactable consumer (patient, self-reported). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9269 and expiry date was not reported), via an unspecified route of administration, on 10Mar2021 at 14:15 (age at vaccination: 55 years), as a single dose for COVID-19 immunization. The patient's medical history included multiple sclerosis (MS) and bee venom allergy. Concomitant medication included fingolimod hydrochloride (GILENYA) for multiple sclerosis. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 13Feb2021 (age at vaccination: 55 years), as a single dose for COVID-19 immunization and had odd tightness in his throat. Vaccine was not administered at Military Facility. The patient stated that on 10Mar2021, he had his second dose. At that point, it was within 2 hours, he had odd Tightness in his Throat/same type pressure in his throat and his arms and legs were shaking and quivering. He stated that he went to the emergency room and the doctor there gave him medication and he ended up getting discharged. He stated that he woke up this morning and had the same thing, trembling in his arms and legs. The patient stated that his question was, how common was that and when did that go away. He stated that steroids took care of that and a corticosteroid. When he woke up and took it, it had been such a long time since the last dose he took of prednisone. He has waited 2 hours and 10 minutes to talk to call handler, so he did have time. He didn't have the pressure in his throat yesterday because he had prednisone late in the day, so Thursday he didn't have it and today as of this morning he has it. He stated that things were getting better, he was not in the ER, stated he guesses once he gets thorough this and arms and legs weren't shaking, so for now unknown. He will find out tomorrow if his arms and legs weren't shaking. The patient's face turned a little bit red which occurred after both the first and second vaccine and only lasted a short time. The patient took Prednisone once a day, Benadryl every 6 hours by mouth. Outcome of the event odd tightness in his throat/same type pressure in his throat was recovering, face turned a little bit red was recovered on 10Mar2021, and for all other events, it was not recovered.  Follow-up attempts are completed. No further information is expected.
Constant pressure in head at the top, back,, and forehead between the eyes,drainage in throat, fatigue, ear pain at times, dizziness, aches in shoulders and upper back at times.
This is a spontaneous report from a contactable consumer (patient). A 28-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EP7534) (age at the time of vaccination was 28 years and non-pregnant at the time of vaccination) via an unspecified route of administration on 16Mar2021 16:30 in right arm as dose 1, single for COVID-19 immunisation. The patient medical history included allergy to metals and had reactions to magnesium and was not sure if there was any in the vaccine. Concomitant medication was not reported. No other vaccine in four weeks. On 16Mar2021, the patient experienced she had gone to the emergency room for a migraine and she got rash on her. On 17Mar2021, the patient noticed today a big red rash that formed on her stomach. Therapeutic measures were taken as a result of she had gone to the emergency room for a migraine. The outcome of the event for big red raised rash on stomach was not recovered. The outcome of the event for migraine and she got rash on her were unknown. No follow up attempts are possible. No further information was expected.
Case number PHEH2013US013158, is an initial spontaneous report received from a nurse on 13 Jun 2013, with a follow-up received on 16 Oct 2013. This report refers to an adolescent male patient. He was vaccinated with MENVEO, batch number: M11082/A11082 at a dose of 0.5 ml intramuscularly into left deltoid on 05 Aug 2013 (09:45). The reporter stated that, MENVEO was stored in refrigerator that dropped to 32.6 F for less than one hour on 19 Apr 2013 (vaccine compromised due to refrigeration malfunction). He was vaccination with another dose on 07 Aug 2013. No adverse reaction was reported following this administration error. Follow-up was received on 16 Oct 2013: Patient demographics, vaccination date, site and revaccination information was updated. Report type was changed from incomplete to spontaneous upon follow-up.
Patient developed a diffuse, erythematous, confluent macular rash on the face, chest, abdomen, arms, and legs 12 days after vaccine administration. Rash was not pruritic. No pustules or vesicles. Associated mild congestion. No cough, vomiting, diarrhea, fever. No treatment at home. Recommended topical emollients for comfort and the use of benadryl if itching developed.
Local injection site rash occurred 1 and 2 days post-injection. Also reported shortness of breath. Nurse advised patient to visit ER. ER doctor prescribed prednisone 40mg daily x 4 days. Provider to follow up.
Booster; Tightness in chest; Mild trouble breathing; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Oct2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 15Oct2021, the patient experienced tightness in chest and mild trouble breathing. The events did not result in doctor or other healthcare professional office/clinic, 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 tightness in chest and mild trouble breathing were unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a Registered Nurse refers to a 19 year old patient of unknown gender. It was reported that on 22-FEB-2012 the patient received the first dose of GARDASIL (route, lot number and expiration date not reported), then the patient received the second dose on 24-MAY-2013 of GARDASIL (route, lot number and expiration date not reported). There was no concomitant medicaiton reported. The nurse reported that the patient recieved doses of GARDASIL outside of the recommended dosing schedule. It was reproted that at the reporting time the third dose of GARDASIL had not been administered yet. No adverse effects reported. Additional information is not expected.
"Starting at 8:00pm same evening start felt like getting fever and developed some redness inch or 2 below injection site.  Drank glass of water every hour during night because so thirsty. Arm was aching underneath, couldn't raise arm and hurt down my side. Following day stayed in bed due to not feeling well. Nausea, slight headache, "just didn't feel good". Saturday morning still not better so went to urgent care and was told that her arm looked like it was cellulitis developing in arm. Was told very angry and red and having a bad reaction. given Prednisone but pt never took medication.  Today, 4/22/19, redness gone, no fever but still feels weak and feels groggy. "
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 24-APR-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported; lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
The vial was initially stored in the refrigerator on 08-Sep-2022 and was administered on 10-Oct-2022; No adverse event; Patient received a vaccine past 30 days in the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past 30 days in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Sep-2022 and was administered on 10-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included LEVOTHYROXINE, FLUOXETINE, MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), OMEPRAZOLE and SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for an unknown indication.    On 10-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 10-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past 30 days in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Sep-2022 and was administered on 10-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past 30 days in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Sep-2022 and was administered on 10-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past 30 days in the fridge) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Sep-2022 and was administered on 10-Oct-2022).    Patient was taking other medication. The vial size was 5.5 ml. The vial did not undergo any temperature excursions. No treatment medication was reported.
Patient received her second dose of Moderna vaccine, Lot number 12374008 at 1605. Approximately 5 minutes later she reported having "itching" to the extremity she was injected on. A small amount of hives around the site is noted. Lung sounds are clear. No stridor indicated. Dr informed. Verbal order for 10 mg of Cetirizine received at 1616, and administered to the patient. She tolerated this well.    VS stable 1615 152/77 97% on RA HR 69 Resp 16-18 Temp= 97.8F    Verbal order also obtained for Albuterol inhaler, and epinephrine.03 mg PRN anaphylaxis.    VS remain stable= 1625 BP= 151/79 P= 63 O2= 98% on RA Temp 97.8 Resp=16   Patient declines any further symptoms and states the, "itching is getting better."    Follow up VS 1635 BP= 130/78 HR= 64 O2= 98% on RA Resp= 14-16   Symptoms continue to improve. Rash is gone. Patient denies itching at site. Dr updated. He cleared the patient to go home. She passed the walking test. Lung sounds remained clear. No indication of stridor, patient able to swallow water well. Disposition, home.
Right upper thigh-3 days later with 3.5 inches X 2.5 inches erythematous  tender reaction. Advised Ibuprofen, cold compresses
acute perforated appendicitis; symptom onset approximately 5:00 PM on 8-13-2022; laparoscopic appendectomy 8-15-2022
This spontaneous report was received from a pharmacist referring to a 64 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
abscess @ lt arm; next day pink around area; next day painful; then pain in lt arm & chest-pink ring around area; had to have drained & packed; On Duricef;
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L018500, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I have the shot didn't work./Suspected Vaccination Failure; I have shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have the shot didn't work./Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date:11-MAR-2023 The case was received from the patient interactive digital media. The patient had Shingles shots and it did not work.  The patient had shingles. 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. The follow-up could not be possible as no contact details were available.
Patient started with pain in his lower back thought it was muscle spasm .Kept working with the pain rash started still didn?t think anything about it March 29 he went to family doctor said it was a muscle spasm gave him muscle pills March 29 he was taken to the emergency room in excruciating pain emergency room doctor did test bloodwork CT scan urine sample came back that he has shingles he has the rash. His wife also had the same shot and she also has rash on her side no pain.Do not know if this has anything to do with the shots but wanted to report us because he never had it before he got the shot or neither did she
rash and itching - Benadryl, acetaminophen, loratadine