chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the shot, now 3 weeks with it/suspected vaccination failure; I'm 3 weeks with it; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 03-JAN-2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient had the Shingles shot and he/she was 3 weeks with it. Additional supportive information: 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 would not possible as no contact details were available.
Information has been received from a physician concerning an 83 year old immunocompromised male with Waldenstrom's macroglobulinaemia who was exposed to his wife who on 07-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On 14-MAY-2008 the patient developed herpes zoster (HZ) on his trunk and extremities, along with severe illnesses including one was not diagnosed as pneumonia bilateral infiltration.  At the time of this report, the outcome was unknown.  A specimen was taken for polymerase chain reaction (PCR) analysis.  The PCR result for the specimen was positive for varicella zoster virus (VZV) (wild-type).  Follow-up information was received from a physician which reported the patient with Waldenstrom's macroglobulinaemia, dementia and Chronic kidney disease (CKD) who on 14-MAY-2008 to 15-MAY-2008 began to develop papular lesions on trunk and lower extremity.  The patient had lower left chest discomfort around this time.  On 17-MAY-2008, the patient was seen in emergency department (ED) and discharged.  On 21-MAY-2008, the patient was admitted to hospital with confusion and short of breath (SOB).  The patient had a disseminated vesicular eruption with lesions at different stage of development.  The patient was hypoxic (ABG 7.42/20/66 on 3L) and had bilateral lower lobe infiltrates.  He also had elevated hepatic transaminases- alanine aminotransferase (ALT) 127 and aspartate aminotransferase (AST) 185.  He was started on IV acyclovir and ZOSYN and vancomycin.  He had a low IgG (around 350) and received IVIG on HD # 3.  He had the base of a lesion unroofed for culture and no virus was isolated.  A skin biopsy was performed and culture was negative as well as VZV antigen by fluorescent antibody.  He had completed a 7 days course of IV acyclovir.  All skin lesions crusted over by the end of therapy.  The patient had improvement in his respiratory status and was discharged to a rehab facility on day 12.  This is one of several reports received from the same source.  Additional information has been requested.  All available medical record will be provided upon requested.
Patient received his doses of the Maderna Vaccine on:  3/20/2021 and 4/23/2021.   Two days later he started complaining of chest pain and pressure midsternal which improved by sitting forward and worse by lying down.   His EKG showed diffuse ST elevations c/w possible pericarditis.  He has no prior cardiac hx.  His troponins were extremely elevated.  Cardiology consulted and his assessment is that pt has combined myocarditis and pericarditis.  Likely immune-mediated response post vaccine and also there are reports of young men in other countries with post vaccine pericarditis.
Pt was vomiting and had a low oxygen level.  Facility sent him to the emergency room in an ambulance.
Large area of redness and swelling with warmth to left leg at DTaP injection site which began Wednesday evening and progressed through out the next day; rash visible on other leg is mild,"spotty"; no pain to te right leg; fever to 100.0; recommended ice application for swelling; antibiotics for infection in the legs.
expired two days prior; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired two days prior) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired two days prior). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired two days prior) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.
hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) 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 ALOPECIA (hair loss). At the time of the report, ALOPECIA (hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) 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 ALOPECIA (hair loss). At the time of the report, ALOPECIA (hair loss) outcome was unknown.          No concomitant medication was reported. Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   Reporter did not allow further contact   Reporter did not allow further contact
Fever, shortness of breath, cough.  Dx with pneumonia.  Pt did not come in until 7 days after vaccines admin.
Local reaction with redness and swelling followed by varicella like rash x 3 days on chest (not seen by health provider).
This spontaneous report was received from a nurse refers to a multiple unspecified patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored PNEUMOVAX 23 lot # was not provided). No adverse effect was reported. Temperature 48.79 Fahrenheit, time frame was 13 hours for 30 minutes. Previous temperature excursion was 46.5 Fahrenheit for 10 hours 48 minutes. There was no data logger. This is one of the several reports received from the same reporter. Additional information has been requested.
malaise; severe swelling in entire arm; soreness; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced swelling arm, pain in arm and malaise. On an unknown date, the outcome of the swelling arm and pain in arm were recovered/resolved and the outcome of the malaise was unknown.   It was unknown if the reporter considered the swelling arm, pain in arm and malaise to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient personal experience with shingrix was a pretty severe swelling in my entire arm and soreness for about 12 days.   The patient also had some malaise. The patient reported that if they had a patient who exhibits a response like the patient experienced what was their  recommendation give 2nd dose or not. For tolerance to 2nd dose refer linked case US2019AMR146574.
Approx. 12 hrs after vaccine I suffered chills which lasted several hours but no fever. Following day was weak and stiff and developed fever about 9 PM day after vaccine. After a good night's sleep I returned to normal and remain well.
Patient was given Peds Moderna dosing (6-11yr) 0.5ml She then came back to get the rest of dose to qualify as adult booster dose of 0.5ml
Left shoulder has periodic pain and stinging as if someone with a heavy hand is giving me an injection now. The pain wakes me up at night. Sometimes in the day I feel the pain level at about a 6.
pt recv vax in 1999 & subsequently exp about 10-20 generalized pox
Patient began experiencing severe chills, high temperature (103 degrees) and vomiting approximately 4 hours after vaccination. She went to ER, was found to be dehydrated, admitted for fluids (IV) and monitoring she stayed for 3 days - today 9/28/12 patient states she is fully recovered.
Face, Teeth, and lips went numb 15-30 min, felt numb flashes a few days after vaccine.
Erythematous bared blisters pearly in some, scabs on others on face and torso, itchy.  Has had varivax on  09/21/1998.
Vomiting three times, crying, exhaustion. Treatment is rest and hydration and watching carefully.
Vaccination was given too high. Patient reported pain and immobility of left arm one day after receiving vaccination by a floater pharmacist.
Smallpox self inoculator. Sites to chin, neck, left knee and right thigh. All sites are apparently one week or older (pus filled pockets except for several that patient removed shaving, healed scars at those sites) Patient recieved smallpox vaccine this facillity on 25 August 2014 with major reaction documented on 2 September 2014.
At 2:30 PM RN administered 0.1 ml of first dose of Jynneos vaccine Lot # FDP00015 exp date 12/10/2022 via intradermal route to left forearm to Male patient, age 27. Prior to vaccination, patient advised RN that he has a needle phobia (Trypaophobia)  and sometimes gets nauseous following procedures involving needles. RN offered education of intradermal procedure. Patient appreciated education and said he was ready for the vaccine. RN administered the vaccine and asked how the patient was feeling good following the procedure. Patient said he was fine but the RN noted a loss of color in the patient's face and new sweat beading on his forehead. RN told patient to stay seated and offered water, which the patient accepted. Patient then said he was starting to feel nauseous so the RN provided a receptacle for the patient. The patient leant over the receptacle and regurtitated the water he has just sipped. He regurgitated 3 times. RN comforted the patient and slowly transistioned him to a reclining chair. After 3 minutes, the patient was feeling relieved and the RN offered a small snack. The patiet accepted the crackers and started eating a few slowly. He started feeling much better and the RN monitored him for an additional 15 minutes. RN noted a significant improvement in the patient's color and demeanor and was satisfied that the patient was able to safely and comfortably leave the vaccination sight.
Bumps appeared on back, chest, right ear, and right eye 09/17/2019
Very high diastolic blood pressure and severe pressure in head, dizziness, and lightheadedness
diluent only administered; diluent only administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXZ723Z, expiry date 01-SEP-2023) for prophylaxis.   On 21-FEB-2023, the patient received Menveo. On 21-FEB-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: diluent only administered) and inappropriate dose of vaccine administered (Verbatim: diluent only administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-Jul-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal mail. The patient received only diluent component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Felt tired, ached all over, upset stomach without vomiting, frontal headache left arm injection site tenderness radiated to left neck and shoulder blade - dizzy at times, per 10-11-10 report. Used ice to forehead, over the counter pain meds. On 10-13-10 she called our office - stated she went to see her doctor - but he had not given any instructions to relieve fatigue, arm soreness that persists. I suggested use of Preservative free flu shot next year.
Sick long time; Initial information received on 10-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves Adult and unknown gender patient who was sick long time while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency,administration site, route, lot number and expiry date was unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "sick long time" (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"only ever 1 flu shot...sick long time."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Sick long time).  At time of reporting, the outcome was Unknown for the event sick long time.
Systemic: Neurological Disorder (diagnosed by MD)-Severe, Additional Details: pt says he has bell's palsy as a result of the vaccine
Patient began to feel short of breath on May 7th. May 10th seen by doctor and diagnosed with new onset atrial fibrillation.
Face became hot and flushed; The right side of face had a slight rash; Face and forearms were tingly; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in the right arm on 22Mar2021 at 17:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 19:00, approximately 1.5 hours after receiving the vaccine, the patient's face became hot and flushed and the right side of the face had a slight rash, face and forearms were tingly, similar to the feeling of novocaine wearing off. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events hot flushes facial, rash face and tingling was recovered on an unknown date in Mar2021.   Information on the lot/batch number has been requested.
Suspected UTI (urinary tract infection) after receiving the Moderna COVID-19 Vaccine; Pain at "the lower stomach , probably where is the bladder" after receiving the Moderna COVID-; Arm turned bright red; Arm was swollen; Arm was kind of itchy; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Suspected UTI (urinary tract infection) after receiving the Moderna COVID-19 Vaccine), ABDOMINAL PAIN LOWER (Pain at "the lower stomach , probably where is the bladder" after receiving the Moderna COVID-), VACCINATION SITE ERYTHEMA (Arm turned bright red), VACCINATION SITE PRURITUS (Arm was kind of itchy) and VACCINATION SITE SWELLING (Arm was swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE and ANASTROZOLE for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Arm was kind of itchy). On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm turned bright red) and VACCINATION SITE SWELLING (Arm was swollen). On an unknown date, the patient experienced URINARY TRACT INFECTION (Suspected UTI (urinary tract infection) after receiving the Moderna COVID-19 Vaccine) and ABDOMINAL PAIN LOWER (Pain at "the lower stomach , probably where is the bladder" after receiving the Moderna COVID-). At the time of the report, URINARY TRACT INFECTION (Suspected UTI (urinary tract infection) after receiving the Moderna COVID-19 Vaccine), ABDOMINAL PAIN LOWER (Pain at "the lower stomach , probably where is the bladder" after receiving the Moderna COVID-), VACCINATION SITE ERYTHEMA (Arm turned bright red), VACCINATION SITE PRURITUS (Arm was kind of itchy) and VACCINATION SITE SWELLING (Arm was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Email ID added, date of birth updated, concomitant medications added and newevents added
FELT SOMETHING DRIPPING DOWN HER ARM; NEEDLE GO IN A LITTLE BURN; This spontaneous report received from a patient concerned a female of unspecified age. 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 admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced felt something dripping down her arm. On 20-MAR-2021, the subject experienced needle go in a little burn. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt something dripping down her arm and needle go in a little burn was not reported. This report was non-serious.
This spontaneous report as received from a nurse practitioner refers to a 77 years old female patient of. The patient's pertinent medical history included type II diabetes, hypertension and history of breast cancer (remission). The patient had no drug reactions/Allergies. On 27-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported) at a local pharmacy. Concomitant therapies included aspirin (81mg), QUESTRAN, vitamin d (unspecified), hydrochlorothiazide, triamterene and verapamil. On 01-MAR-2014 the patient was presented to the Hospital with difficulty breathing - and diagnosed as having an allergic reaction to ZOSTAVAX. The patient was admitted, intubated and remained in the intensive care unit of the hospital for several days, total hospital time was "several" weeks. The nurse practitioner reported that patient was then transferred to an unspecified nursing facility for rehabilitation in which she was discharged on 24-APR-2014 and required physical therapy in the home. The nursing home diagnosis was anaphylaxis, chicken pox pneumonia, hypoxia, ischemic brain injury (TIA's) -which was ruled by CT Scan. The nurse practitioner reported that she saw patient in the office on 05-MAY-2014 and the patient presented with a weak, low voice; progressive problems swallowing, right eye drooping, use of a walker to walk. The nurse practitioner reported that she ordered a CT Scan looking for additional stroke symptoms, but the scan showed negative. Nurse practitioner then sent the patient to a gastrointestinal specialist who diagnosed patient with esophageal dysphagia, disturbance of speech and gastric reflux - which was diagnosed via an upper endoscopy. The nurse practitioner reported that on 13-MAY-2014, patient presented to her office and could not speak (patient was writing notes on paper). She stated that she no longer could speak, the dysphagia had gotten worse and continued to get progressively worse. Nurse practitioner reported that on 20-MAY-2014, she received a phone call from the patient's family member who stated the patient could not swallow, could not speak, could not close her mouth and could not open her eyes without holding them open with her fingers. The nurse practitioner sent patient to the emergency room at Medical Center, in which the patient has remained since. Patient has had a feeding tube inserted since the admission and has been diagnosed with Myasthenia gravis. At time of the report, outcome of these events was reported as not recovered. The reporter considered these events to be medically significant and life threatening. Additional information has been requested.
No adverse effects; a patient was administered an improperly stored ROTATEQ.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 22-AUG-2019, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot# S010702 with expiration date 16-JAN-2021; dose, frequency, route of administration were not reported) for prophylaxis (Product storage error). The temperature and time frame were unknown (late shipment). Information of previous temperature excursion was not provided. No adverse effects were reported. The call was not because of Data logger.
Severe chills and fever beginning approximately 8 hours after injection and lasting for 8 hours.  The  next day extreme fatigue.  Day after that moderate fatigue.  Third day  still fatigued.  Mild headache all three days. Soreness at injection site.  Diminished appetite.