chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AE reported for patient.; RECOMBIVAX HB was administered to one patient on 03Nov2020 after undergoing a temperature excursion; This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-NOV-2020, the patient was vaccinated with an improperly stored dose of thimerosal free hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 milliliter, one time, lot # S022584, expiration date 31-OCT-2021 (anatomical location and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature please move to the previous line excursion of above 47 (49.1) degrees Fahrenheit for 3 hours and 16 minutes. The vaccine was previously exposed to the temperature of 48 degrees Fahrenheit for 30 minutes and to temperature of 47.3 degrees Fahrenheit for 45 minutes. Data logger was involved. There was no adverse effect reported. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Warm to touch, itchy and hives 2 weeks later. Nothing but muscle soreness the first day until now.
Started having menstrual bleeding that is still occurring as of 10/20/2021. Massive clots which I've never had before. Had dizziness that started during the evening and last two days, nose bleeds and a dull headache that lasted 8 days.
I had a lingering head for 4 days, chills, sweats , lost of appetite, rash on my arm, hives, swollen arm for 3 days, I couldn?t lift my arm,  extreme exhaustion for  13 days.
it has been 6 or 7 weeks since they received their first dose (>35 days); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (it has been 6 or 7 weeks since they received their first dose (>35 days)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it has been 6 or 7 weeks since they received their first dose (>35 days)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (it has been 6 or 7 weeks since they received their first dose (>35 days)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were reported.   No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-JUNE-2021, no new information On 30-Jun-2021: Follow-up information received on 30-Jun-2021 contains no new information On 31-Jul-2021: Follow-up received on 31 Jul 2021 contained no new information.
Went unresponsive at home after experiencing diarrhea.  Pulses were lost at home and regained by EMS prior to transport to the emergency room.  Pulses lost again in the emergency room.  ACLS performed for approximately 40 minutes before pronouncement of death was made.
Post vaccination client complains of feeling light headed and loss consciousness for 3secs. Vital signs initiated taken 3X, legs elevated , icepacks provided, observation time extended.  After 20 mins. client stated she was feeling better and advised she hasn't had anything to eat or drink since in the morning. Client left the facility ambulating with no signs of distress at 6:30pm. Client educated to call EMS if symptoms persists. Client confirmed understanding.
vertigo; dizziness in the head; off balance type things; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizziness in the head) and BALANCE DISORDER (off balance type things) 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo), DIZZINESS (dizziness in the head) and BALANCE DISORDER (off balance type things). At the time of the report, VERTIGO (vertigo), DIZZINESS (dizziness in the head) and BALANCE DISORDER (off balance type things) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
Within moments of injection, the site became very sore and irritated.  Within24 hours the site was very swollen, red, and tender to the touch.  The swelling was almost twice the size of the muscle on the arm.
Soreness on injection site on right arm. Gravitated towards "sore neck" on same side. Both lasted about a week.
Patient felt pain at the onset of injection.  There is swelling, inflammation, numbness in the right arm along with pain and weakness.  Patient was treated with ibu 600mg and awaiting blood work to start antibiotic levaquine 500mg.  CBC and venous Doppler was ordered by his MD.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 24-MAY-2011 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot # not reported) IM. On 25-JUL-2011 the patient received a second 0.5 ml dose of GARDASIL (Lot # 668670/0476AA) IM. There was no concomitant medication. The patient came in to the office on 05-AUG-2011 for pregnancy test and test result was positive. Patient's last menstrual period was on 22-JUN-2011 and her estimated delivery date was on 28-MAR-2012. Follow up information has been received via telephone call from the registered nurse who reported that on an unspecified date the patient had a spontaneous abortion at 8 weeks of gestation. The patient did not need a Dilation and Curettage (D and C), she miscarried naturally. At the time of the report the outcome of the event was unknown. Additional information is not expected.
reporting vaccine error...pt received first dose of boostrix 9/20/2018 and another dose 5/21/2022 not in the recommended 10 year time frame...no adverse reaction reported
Patient developed localized induration and erythema of approximately 5 cm over a period of 3 -5 minutes and mild generalized non pruritic non urticaric rash.  He developed mild diaphoresis . There were no other respiratory symptoms or cardiac symptoms.  Patient was treated with PO Benadryl 25 mg.  Over the course of an additional 30 minutes observations period all symptoms resolved with the exception of a minimal erythema of 1-2 cm peri-insertion site.
chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) 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 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) 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 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.
Pain at injection site the night after injection. Swelling, pain, heat in the muscle around the injection site the next day.
Cold sweats, chills, headache,  fever (100.4) onset at 3:30a...  Took ibuprofen at 8a. Symptoms lasted until 1:30p-2p, felt 100% after.
Developed severe body aches, headache, dizziness, convulsive chills, and a large baseball size welt at the site of the injection. The welt was red and hard to the touch. The patient treated with home cares. His symptoms are now resolved, except for the welt, which is improving.
Rash since 36 hours after vaccination and progressively worsening. Patient had taken OTC Benadryl prior to coming to our office. Prescribed prednisone 10mg dose pack on 3/2/21. Patient just seen in our office this afternoon.
This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 29-APR-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
I had a return of a superficial thrombophlebitis on my left arm above where a catheter had been when I had surgery 7 weeks before.  The blood clot returned again to the same level of pain and the same; I had a return of a superficial thrombophlebitis on my left arm above where a catheter had been when I had surgery 7 weeks before.  The blood clot returned again to the same level of pain and the same; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 01Mar2021 13:30 (lot/batch number was not reported) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure. The patient had no known allergies. The patient's concomitant medications were not reported. On 04Mar2021 07:30, the patient had a return of a superficial thrombophlebitis on her left arm above where a catheter had been when she had surgery 7 weeks before. The blood clot returned again to the same level of pain and the same. No treatment was received for the events. Patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and not tested for COVID post vaccination. Vaccine facility type was other. There was no other vaccine in four weeks and there was other medications in two weeks. The outcome of the events were not recovered.  Information on the lot/batch number has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-MAR-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset date unknown). On or about 11-FEB-2014, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as post herpetic neuralgia. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Information has been received concerning a male patient who was vaccinated with hepatitis B virus vaccine, and subsequently developed multiple sclerosis following receipt of the hepatitis B virus vaccine. This report was originally reported by a consumer, the patient's brother, who declined to provide any additional information, and stated his brother would report the information directly. Upon internal review, multiple sclerosis was determined to be an other important medical event (OMIC). Additional information has been requested.
Clinic manager notified me-pharmacist- that they believe that a MENVEO vaccine was diluted with sterile diluent vs. the provided liquid component. Unsure of which pt it happened. There was a report requested of the dates that the vaccine could have been given. After the report was provided it was narrowed down to a 13 yof that the product use error occurred on.
Severe chest pain, upper back/shoulder pain, fatigue?? dx. Acute Myocardial Infarction? angioplasty with stent
837 patients received expired dose; variable"; typically 20 day cycle outside; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (837 patients received expired dose) and PRODUCT STORAGE ERROR (variable"; typically 20 day cycle outside) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (837 patients received expired dose) and PRODUCT STORAGE ERROR (variable"; typically 20 day cycle outside). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (837 patients received expired dose) and PRODUCT STORAGE ERROR (variable"; typically 20 day cycle outside) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Event verbatim : include Per Moderna Lot analysis, regarding doses administered on 25Oct2021, 26Oct2021, 27Oct2021: Moderna cannot guarantee patients received full protection against the COVID-19 Virus started on 04-Nov-2021. No concomitant medications are provided. No treatment medications are provided.  Company comment include This case concerns a patient of unknown gender and age with no details on relevant medical history, who experienced Expired product administered and Product storage error with no associate adverse events after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax) booster dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received on 04-NOV-21 contains non significant information. On 10-Nov-2021: Follow up received on 10-NOV-21 contains no new information; Sender's Comments: This case concerns a patient of unknown gender and age with no details on relevant medical history, who experienced Expired product administered and Product storage error with no associate adverse events after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax) booster dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report
Patient received 0.2ml of the Adult formulation instead of the pediatric vaccine. Vial stored in the incorrect location.
Shortly after receiving the vaccine the patient started complaining of itching/rash near the injection site. She initially thought it was due to the clindamycin that she was taking for her ongoing dental procedures. She followed up with her primary care provider. She mentioned that the Dr. did biopsy the lesions in an attempt to determine what they were as the rash and itching were not going away. The patient is still having the same issues she had in March of 2018 of itching/rash near the injection site but also burning. Her provider is now treating her as if she may have shingles. She has recently filled a prescription for ZOVIRAX 5% cream and Acyclovir 800mg tablets.
On 1/4/22 right temporal intraparenchymal hemorrhage (STROKE).  1/5/22 right craniotomy for evacuation of intraparenchymal hemorrhage. 3/22/22 More blood clots in right leg, surgery to remove  Permanently disabled and legally blind.  Unable to work, unable to drive, must have 24x7 care to help dress, eat, take medication, etc.
This infant had immunization on 12/29/2000. On 12/30/00, at 3 AM, he had a temperature of 104.7; given Tylenol. On 12/30/00, at 8 AM, he had a temperature of 103.1. On 1230/00, at 1 PM last temperature was 101. The infant was irritable, decreased appetite (nursing for shorter periods).
A male patient age 49 received TD vaccine and pneumococcal vaccine on 12/31/09 as routine; no illness at time of vaccination. On 01/01/10, the pt experienced severe pain, redness, swelling and warmth in this right arm at and around the injection site. The pt returned to the clinic on 01/04/10 and was treated with warm-packs and Ibuprofen. Follow-up on 1/19/10: pt resolved with no further complications.
At 16:25 pm patient was given Moderna vaccine after sitting in observation area patient began to vomit. Also c/o dizziness and became diaphoretic. Patient was given water and V/S we're taken BP 122/76, 115 HR, 94 % SO. Patient stated that she has no other health problems. After waiting 30 minutes V/S we're retaken and patient was reassessed. After assessment patient stated that she was no longer having symptoms. At approx. 1700. i told patient she was free to go if all symptoms we're gone.
Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Injection site swelling) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE SWELLING (Injection site swelling). At the time of the report, INJECTION SITE SWELLING (Injection site swelling) outcome was unknown. Not Provided          No concomitant medications reported. No treatment information provided.
Information has been received from an office manager concerning a 17 year old female with no pertinent medical history and no drug allergies, who on 06-NOV-2009 was vaccinated with the first dose of GARDASIL (lot # 659054/0315Y) and on 08-JAN-2010 the second dose (lot #660612/0229X).  There was no concomitant medication.  The patient passed out immediately after the first vaccination and "cracked her head on the floor".  After the second vaccination, the patient passed out again while lying down in the office.  The patient also received seasonal flu vaccine (manufacturer unknown) after the second dose immediately after recovering from the GARDASIL vaccination.  There were no labs or diagnostic tests performed.  The patient sought medical attention while the events happened in office.  At the time of the report, the patient recovered.  Follow up information had been received from a physician concerning a 17 year old female with no pertinent medical history, illness at time of vaccination and no drug allergies, who on 08-JAN-2010 in the afternoon at approximately 3:00 pm was vaccinated with the second dose of GARDASIL (lot #660612/0229X) in the right deltoid.  Concomitant medication included a first dose of FLUZONE, (Sanofi Pasteur, lot # U3240AA) on 08-JAN-2010 in the afternoon at 3:00 pm in the left deltoid.  On an unspecified date, the patient experienced syncopal episode.  There were no labs or diagnostic tests performed.  The patient recovered from syncopal episode on 08-JAN-2010.  No further information is available.
Day after vaccine had flu symptoms-vomiting, diarreah, fever 104, aches, chills unable to hold anything down for 16 hours.   The worst flu I have experienced in years.  I called the nurse line the day I was so sick as my fever kept going up, I just wanted to know how high it should get before I really had to get medical help.  It broke late that night.I have a rash that developed 3-4 day later.  I didn't even correlate to the vaccine.  I was thinking it was posion oak.  But tomorrow it will be two weeks and I still have the rash.  I was speaking to someone else and they two developed a rash a week after their shot and that was back in January and they are no going to a dermatologist as it has been driving the crazy for the last 3 mo.  My rash hasn't developed liked I expected with poison oak. No blisters but it is raised, red and so itchy.  It is located on my neck mostly.  Just thought it was important to report.and maybe you can shed some light as to what to do.  Maybe it is not related.  I have an appt. with my doctor at over the phone tomorrow.  Thank you
Starting day 7 noticed a hard bump along with pain, itching and redness surrounding the injection site.
Tinnitus and partial loss of hearing.; Tinnitus and partial loss of hearing.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206, Expiry date was not reported), via an unspecified route of administration, administered in left arm on 06Mar2021 11:15 (at the age of at 61-year-old), as single dose, for covid-19 immunization at other facility. The patient's medical history was not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), oxybutynin, and rosuvastatin calcium (CRESTOR). On 11Mar2021 at 14:00, the patient experienced tinnitus and partial loss of hearing. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with steroid injection and oral steroids. The outcome of the events tinnitus and partial loss of hearing was not resolved.  No follow-up attempts possible. No further information expected. Information on batch/lot number already obtained.