chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included sterile diluent lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 4 year old male patient. The patient administered the vaccine on 20-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
HISTORY OF PRESENT OF ILLNESS: pt with rash after having been given Pneumovax on 1/8/14. She stated it was swollen and itchy yesterday but some better today. never had Pneumovax in past. Pt states area cleaned before shot given. Treatment predniSONE TAB  5MG  TAKE FOUR (4) TABLETS BY MOUTH DAILY FOR 1 DAY THEN TAKE TWO (2) TABLETS BY MOUTH DAILY FOR 1 DAY THEN TAKE ONE (1) TABLET BY MOUTH DAILY FOR 1 DAY TO CONTROL INFLAMMATION. *TAKE WITH FOOD*  Quantity: 7 Days: 6  Refills: 0 *Chronic Med: NO Dispense as Written: NO Indication: Rash and other nonspecific skin eruption.  Outside Med ACETAMINOPHEN TAB  325MG  TAKE TWO (2) TABLETS BY MOUTH Q6H PRN Jan 10, 2014  Outside medication recommended by provider for pain. Outside Med diphenhydrAMINE CAP, ORAL  25MG  TAKE ONE (1) CAPSULE BY MOUTH FOUR TIMES A DAY Jan 10, 2014  Outside medication recommended by provider for itching.
1:55pm, Shortness of Breath, O2 desaturated to 89%. Code called.   Epinephrine 1.5mg x 2 (1:58pm, and 2:15pm). HR 110s-200s.  0xygen 1 Liter via Ambu bag with infant mask.  O2 100% HR 125.  EMT arrived 2:20pm. taken to  hospital ED.
Woke up this morning to tingles/ pins and needles in my ankle. It has moved to the top of my foot and is going up my shin on my right foot.
This case was reported by a physician via call center representative and described the occurrence of erythema in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 13th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, swelling arm, chills, headache and nausea. On an unknown date, the outcome of the erythema, swelling arm, chills, headache and nausea were unknown. It was unknown if the reporter considered the erythema, swelling arm, chills, headache and nausea to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional was the patient and physician. Safety could follow up with the healthcare professional. The patient stated that she experienced adverse events with SHINGRIX. There was consented to follow up.
I had vaccine and still got it / Suspected vaccination failure; cancer; immunosuppressed; still got it; 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 had vaccine and still got it / Suspected vaccination failure) (serious criteria GSK medically significant), cancer (Verbatim: cancer) (serious criteria GSK medically significant), immunosuppression (Verbatim: immunosuppressed) (serious criteria GSK medically significant) and shingles (Verbatim: still got it).The outcome of the vaccination failure was unknown and the outcome of the cancer, immunosuppression and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, cancer, immunosuppression and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, cancer, immunosuppression and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient had Shingles vaccine and still got shingles but he/she was immunosuppressed and also got cancer when he/she got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
This spontaneous report as received from a CMA (certified medical assistant) regards an unknown number of patients (no demographic details were provided). The medical history of the patients was unknown. The reporter stated that an unknown number of patients may have received VAQTA, RECOMBIVAX HB, VARIVAX (Merck), LIQUID PEDVAXHIB and GARDASIL that was improperly stored. This report concerns VARIVAX (Merck). No details were provided regarding the administration dates, dosing regimen or lot number. No adverse event was reported. This report is linked to the cases with MARRS ID 1305USA003372, 1305USA007106, 1306USA007108 and 1306USA007109 which concern VAQTA, RECOMBIVAX HB, LIQUID PEDVAXHIB and GARDASIL, respectively. Additional information 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. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 16-NOV-2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about November 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
a 70 y.o. female with past medical history of rheumatoid arthritis on chronic immunosuppressive therapy, hypertension hyperlipidemia, and diabetes who presents to the Emergency Department with chief complaint of as mentioned above.   The patient explains for about the last 10 days she has had progressive weakness.  Is getting progressively worse.  It is associated with some dizziness.  Early on she thought she had some blurred and double vision but this is resolved.  Patient says she has had a mild dry cough/tickle in her throat but denies any severe coughing or phlegm production.  She denies nausea or vomiting and says her appetite has been okay.  Due to her poor balance she has had to hold onto furniture to walk and has become increasingly weak.  She normally ambulates unassisted and is fully functional.  She denies fevers chills nausea vomiting or other constitutional symptoms.  She denies focal neurological deficits.  Her emergency evaluation revealed her to be hypoxic with a room air sat of 85%.  X-ray showed some vague infiltrate on the right side of her lung.  Subsequently her COVID-19 PCR has come back positive.  She did undergo an MRI of her brain showing no evidence of stroke.  He also appeared to be volume depleted with elevated BUN to creatinine ratio.  Due to her progressive symptoms she and COVID-19 pneumonia is developing she was admitted to hospital for further evaluation and treatment.  Of note the patient says she had her first COVID-19 vaccine approximately 5 days before her symptom onset.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 69-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.    This case was linked to MOD-2021-307201 (Patient Link).
I had a fever of 104 for 4 days and the arm with the Shingrix was very very swollen like a foot ball, heavy and i was unable to move it. terrible body aches and chills along with the fever
Small raised red hives on face, started near eyes. Did not spread to anywhere else on body. 5 mL Children's Diphenhydramine given.
very big rash on our back; fever; Numbness on the left side the numbness comes and goes its not consistent/left arm where I feeling the numbness; hives; palpitation; rapid heartbeat; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer (patient) reported for herself.  A 50-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, after the vaccination patient experienced all this fever and all that from the beginning of the first dose but now what he just breaks into hives, the patient experienced very big rash on back and then on his left side of face. Patient was asking a question can it be normal a little bit like his cheek area underneath his eye can it be become normal its normal a little numb just a little bit. rash has started about a week ago. some weeks a day. The patient wants to be treated because the numbness on the left side comes and goes it's not consistent, but he is feeling a little bit of it especially later underneath of his eye and cheeks. consumer has rash and numbness on the face, consumer stated, "Right on my left side of my face and that she gave me shot on the left side and I can feel it today, underneath my eyes and cheeks and I have the rash, but she does" Patient also have palpitations, rapid heartbeat. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Pregnant and received Moderna COVID-19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID-19 vaccine) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (prior use, 1-2 servings a week). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 22-Jan-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Jul-2020 and the estimated date of delivery was 28-Apr-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID-19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID-19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Ultrasound scan: normal (normal) anatomical was normal at 20 weeks.         Treatment medication was not reported.  This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
20 minutes post vaccine to approximately 1 hour post vaccine: hot flushing from chest up to face. Flushing felt like nose and cheeks were numb.  12 hours post vaccine: left upper arm (injection site) with not only muscle soreness but arm was difficult to lift.  27 hours post vaccine: sudden onset of diarrhea (only 1 episode)
1 hr after vaccination left arm became very swollen and painful. Area grew down to elbow with redness and pain throughout. Patient back on 10/27/12 at 16:45 to report.
20 min after receiving vaccine reports hives on neck, swelling of tongue and slight difficulty swallowing.  No breathing issues.
Patient received her 2nd Moderna vaccine on 3/6/21; two weeks later on 3/20/21, patient woke up and felt nauseous for 1 hour that went away; no vomiting.  On 6/21/21 at 1:30 pm, patient was standing at the kitchen counter when she started feeling "loose and weird in the head" as it is difficult to describe. This was then accompanied with "uncoordinated" movement in her lower legs. She walked over to the back porch, held on to the door while standing and called "help me" to her husband. Husband came over to help her sit and symptoms improved within 15 minutes. She states that is when her seizure happened and she was able to hold on to the door and did not fall - patient described this event as "violent." She felt continued to feel dizzy and got a headache but was able to track her husband's finger with her eyes which caused additional dizziness. She immediately went to the ER where she was diagnosed with dizziness and headache at the ER on 6/21/21.
Flu like muscle soreness; fever up to 101.3; chills; Dose Number #1, Date of start of drug 23Dec2020/ Dose Number #2, Date of start of drug 19Jan2021; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), via an unspecified route of administration in the left arm on 19Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and escitalopram oxalate (LEXAPRO). The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported) in the left arm on 23Dec2020 14:00 at single dose for COVID-19 immunisation. On 20Jan2021 05:15, the patient experienced flu like muscle soreness, fever up to 101.3, and chills. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.
Vomiting within 10-15 mins. Developed hives over entire body. Mid lip swelling & eye swelling intense itching was given 2 tsp ORAPRED 2 1/2 tsp BENADRYL & monitored for 1 1/2 hrs.
pt called from another pharm 30 mins p/inject; stated that had a rash @ site;
Initial and follow-up information has been received from a licensed practical nurse concerning a 62 year old male with no allergies who on 15-NOV-2006 was vaccinated IM in the deltoid with a second dose, 0.5 mL, of Pneumovax 23 (lot # 654982/0675F).  On 15-NOV-2006, the patient's arm swelled from the injection site in his deltoid to his elbow.  Follow up information from the nurse indicated that on 16-NOV-2006, the patient developed redness and swelling at the injection site.  The patient had no fever or respiratory symptoms.  The patient did not have any intervention for the reaction and has recovered.  The nurse reported that the patient recovered (date not reported).  It was also noted that the patient had his first injection with Pneumovax 23 five years ago and had no reaction.  A product quality complaint was not involved.  Additional information has been requested.
Information has been received from a registered nurse concerning a 10 year old white male with no known medical history who on 23-JUL-1997 was vaccinated SC in the left thigh with a first dose of Varivax (lot # 622969/0423E). On 19-JAN-2007 it was reported that the patient "now" has chickenpox with greater than 50 lesions and was being treated with acyclovir. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information from the registered nurse indicated that on 19-JAN-2007 the patient developed classic varicella lesions on his face and trunk, erythematous papules with clear vesicles. A lesion was noted on the roof of his mouth and one on the outer left ear canal. The patient was prescribed acyclovir and mupirocin (BACTROBAN) for the lesion on the ear. The patient was diagnosed within 24 hours of the outbreak and new lesions appeared for up to 4 days. Subsequently the patient recovered. The reporter considered the chickenpox and acyclovir treatment an other important medical event. No further information is expected.
COULD NOT WALK FAR WITHOUT FEELING TIRED; HAD BEEN TIRED; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced could not walk far without feeling tired. On MAR-2021, the subject experienced had been tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not walk far without feeling tired, and had been tired on MAR-2021. This report was non-serious. This case, involving the same patient.
Started fussy. Fussy & sleepy all day. Threw up at 6:15 pm.
PATIENT FAINTED, THEN EYES OPENED BUT WAS NONRESPONSIVE, LEGS WERE STRETCHED OUT FEET TURN INWARD, ARM WAS STIFF INITIALLY FLUSHED RED IN COLOR THEN SUDDENLY PALE.
Large swelling of lumphatic system. Lymph nodes are visibility swollen all along arm and immensely painful when moving arm.
Site injection pain; Body Aches; tiredness;headache; minor fever (2 degrees above normal but below 100)
Caller and his wife received the 1st dose of the Moderna vaccine on 23July2021 and got Covid-19; Was scheduled to receive the 2nd dose on 20-Aug-2021; the doctor said they should wait 90 days after the symptoms are gone; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller and his wife received the 1st dose of the Moderna vaccine on 23July2021 and got Covid-19) and OFF LABEL USE (Was scheduled to receive the 2nd dose on 20-Aug-2021; the doctor said they should wait 90 days after the symptoms are gone) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-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 COVID-19 (Caller and his wife received the 1st dose of the Moderna vaccine on 23July2021 and got Covid-19) and OFF LABEL USE (Was scheduled to receive the 2nd dose on 20-Aug-2021; the doctor said they should wait 90 days after the symptoms are gone). At the time of the report, COVID-19 (Caller and his wife received the 1st dose of the Moderna vaccine on 23July2021 and got Covid-19) outcome was unknown and OFF LABEL USE (Was scheduled to receive the 2nd dose on 20-Aug-2021; the doctor said they should wait 90 days after the symptoms are gone) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient stated that he and his wife scheduled to receive the 2nd dose on 20 Aug 2021, but their doctor said they should wait 90 days after their symptoms are gone.  No concomitant product use was provided by the reporter.   No treatment medications were reported.   This case was linked to MOD-2021-294322 (Patient Link).
This spontaneous report as received from physician assistant refers to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that improperly stored doses of GARDASIL (dose and route unspecified) was administered to unspecified number of patients on unknown dates. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This is one of several reports received from the same reporter. Additional information has been requested.