chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt passed away with an hour to hour and 1/2 of receiving vaccine.  per nursing home staff they did not expect pt to make it many more days.  pt was unresponsive in room when shot was given.  per nursing home staff pt was 14 + days post covid
arm pain for 48 hours; early menstrual cycle (came 4 days early); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Mar2021 14:30 (Lot number: ER8730) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies to Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "arm pain for 48 hours"; POLYMENORRHOEA (non-serious) with onset 2021, outcome "recovering", described as "early menstrual cycle (came 4 days early)". Therapeutic measures were not taken as a result of pain in extremity, polymenorrhoea.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
My left arm became hot and throbbed, a condition that lasted about a week, and disrupted my sleep each night. Even after the pain lessened, I woke about every two hours every night for more than 6 weeks. Within a couple of weeks after receiving the vaccine, I suddenly began experiencing severe and frequent hot flashes, which went on for 2-3 weeks, then stopped completely. In late April, I also began experiencing shooting pains down my left arm, which may or may not be related to the vaccine.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 3 year old male patient with no pertinent medical history and no drugs reactions or allegies who on 28-MAR-2008 was vaccinated with a dose of VARIVAX (Merck) (lot #658525/1255U; expiration date: 07-AUG-2009). There was no concomitant medication. The nurse reported that on 17-SEP-2010 the patient developed possibly shingles on his leg down to his foot and on the right side of his back. "The lesions were in small clusters but the patient had no pain or itchy". No laboratory diagnostics studies were performed. At the time of the report, the patient was recovering from possibly shingles. The patient sought unspecified medical attention. Additional information has been requested.
Patient called and said she got the Fluzone HD on 10/9/19 and she has been really sick for a few days with really bad headaches, fever, and not feeling good. The patient did not go to urgent care or ER and called her doctor and her doctor said that was normal and she had a case of the flu. Apologized to the patient about what happened and the patient said she is feeling a lot better now and she just wanted let us know patient came in yesterday 10/17/19
Following second dose administered on 2/28/21, approximately 1 month later, experienced shingles - like/herpes  out breaks on both wrists (itching, blisters). Condition persisted for perhaps one week, scabbed and resolved with no recurrence. Although I am a long term herpes sufferer on a daily maintenance dose of valacyclovir, this was not the type of outbreak i have experienced in the past. Normal outbreaks (not recent) have been on lower back and genitals. I heard in a tv report of similar outbreaks attributed to the vaccine.
Mom reports entire L thigh red/swollen/tender on 10/15/02. Seen 10/16/02 for large local rxn 8x5" erryth and swell anterior L thigh min tenderness no limp no fever.
Headache,  Severe  Vomiting,  Sore Arm, Weekness, Stuffy Nose, Hard to Breath, Chills, and Body Aches
Client was sitting in the observation after receiving Pfizer booster. He stated he felt weak, stared sweating and unaware that he passed out. Client was adjustable and able to communicate with staff, accepted hydration and snacks. Vitals WNL 100/60,  68, 16, 97.6, 99% O2 sat on room air. Client over down for approximately 15 min before  On all Provider notified.    Client sitting up in chair. States he feels better. 118/70, 73, 99% on RA
Pt reported that the day after he got the vaccine he experienced " sick in the stomach, tremors, weakness, sweating" for 1-2 hours then on days two when he called the pharmacy he said he was fully recovered.  Rph recommended him to call doctor if those were symptoms of other issues besides the vaccine.
This serious medically-confirmed report (initial receipt: 19-Apr-2013) concerns a 29-year-old female pregnant patient. She had 1 previous pregnancy with full-term delivery and no birth defect. Her last menstrual period was 08-Dec-2012 and estimated delivery date was 14-Sep-2013. As of 18-Mar-2013, the patient was 13 weeks pregnant. On 17-Nov-2012 the patient received a flu vaccine (brand name, manufacturer and batch number were not reported) and dTap intramuscularly. On 10-Dec-2012 she received VARIVAX (batch number: 670988/0972AA) injection. On 06-Jan-2013 she also received Z-PAK and 2 other Abx (antibiotics) (category B). On 15-Mar-2013, the patient had an ultrasound scan (screening after vaccination) that showed ABN (abnormal) Rt (right) hand. On 19-Apr-2013 a detailed anatomy eval (evaluation) done via ultrasound revealed absent of radius (ABN Rt hand). The physician reported fetus right hand was not formed and had a malformed right forearm. The physician also reported there was a bleeding from the placenta. There was no maternal adverse event reported.
3 year old child have a reaction to the Prevnar 20; 3 year old child have a reaction to the Prevnar 20; increased swelling, pain, and tenderness in the arm; increased swelling, pain, and tenderness in the arm; increased swelling, pain, and tenderness in the arm; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 3-year-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2022 as dose number unknown single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 2022, outcome "unknown" and all described as "3 year old child have a reaction to the Prevnar 20"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), TENDERNESS (non-serious) all with onset 2022, outcome "unknown" and all described as "increased swelling, pain, and tenderness in the arm". Additional information: The doctor stated back in March he had a Pfizer Rep came to his office and told him that the Prevnar 20 was replacing the Prevnar 13 so he has only been ordering and giving the Prevnar 13. He placed his first order for Prevnar 20 in March and has only had that vaccine since he received the 20. And he has done that based on the recommendations of the Rep that came to the office and advised him to use the Prevnar 20. Now he stated he had a 03-year-old child have a reaction to the Prevnar 20 and the parent was upset because the Prevnar 20 should be used in individuals 18 years and older. Child had increased swelling, pain, and tenderness in the arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After booster dose of Moderna, 10 days later, itchy hands and feet (spontaneous hives that come and go) on the soles of my feet and palms.)  Toes are a bluish color on occasion
Patient presented to the emergency room with complaints of fever, chills, and myalgias mostly in his neck and low back. Patient was also complaining of a headache. He reported a 102.0 temperature at home, checked it again after taking Ibuprofen and reported it to be 101.3. Patient presented to ER where temperature was 99.9. Patient was given oral Tylenol and other IV pain medication for body aches pain rating 8/10. CMP and CBC were obtained. Results currently pending. Patient will most likely be sent home following ER treatment. Patient denies any anaphylactic symptoms of angioedema or airway swelling.
Hospitalized due to an infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Hospitalized due to an infection) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (Hospitalized due to an infection) (seriousness criterion hospitalization). At the time of the report, INFECTION (Hospitalized due to an infection) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient clarified that who was hospitalized due to an infection was her husband. When agent asked for information about AE form, caller stated she was running out of time and could not answer to the queries (limited AE). Treatment information was not provided.; Sender's Comments: This is a spontaneous case concerning reported by a consumer regarding a male patient of unknown age with no reported medical history, who experienced the unexpected serious (hospitalization) event of infection. Due to very limited information, it is unclear latency and /or relationship with the administration of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Topical reaction lasting 4 days. Fever, burning sensation, pain in the injection area and on the body.  The area turned red.
First I had chills and quite violent shaking. I then got a fever and felt muscle aches, joint pain and my skin hurt.  I also had a headache on and off.  Sleep was almost impossible due to being uncomfortable, and I had thoughts racing through my head.  I also had lack of appetite, but not nausea.
Information has been received from a licensed visiting nurse concerning a 7 year old white male with no allergies or medical history who on 07/07/1998 was vaccinated subcutaneously in the right arm with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  On 08/24/2004, the patient was diagnosed with chickenpox.  The patient had about 10 to 15 lesions at that time.  Follow up information was received from the licensed visiting nurse who indicated that on 08/24/2004 the patient had macular lesions on the trunk and was diagnosed with varicella.  No diagnostic laboratory tests were performed.  The patient recovered on 08/30/2004.  Neither the patient nor his sibling had any adverse events following prior vaccination.  No further information is expected.  The nurse also reported that the patient's sister developed chickenpox after therapy with varicella virus vaccine live.
80 yo male received J&J COVID-19 vaccination on 2/5/21.  Pt with history of bladder cancer (s/p TURBT 11/04/2020), COPD (quit smoking 1 month ago) on 2 L nocturnal O2, HTN, CAD, MI s/p CABG x3v, apical cardiac aneurysm s/p repair, recent hematuria requiring cessation of chronic warfarin therapy who presented on 2/14 as a direct admission for evaluation of NSTEMI and new LLE DVT. He was initially placed on heparin and was stopped due to anemia and hematuria. DVT at outside hospital, repeat dopplers negative at our institution. Acute R femoral DVT likely due to patient being taken off chronic anticoagulation with warfarin. Discussed case with heme and not needed for IVC filter......and even though cardiology would like him on long-term AC given high risk for LV thrombus, bleed risk outweigh benefit at this point. He was diagnosed with new HFrEF and NSTEMI. He will stay on hydralazine, imdur, lasix every other day, baby asa, and statin.
Seriousness criteria: other - medically significant.  Initial non-serious report received from a consumer on 08 November 2007.  A male patient (age and date of birth not reported) had received a dose of flu vaccine (trade name, lot number, route/site of administration not reported) on an unspecified date in 2006 and developed a tingling sensation in the crown of his head, sometimes accompanied by headaches and dizziness (onset dates not reported).  The reporter indicated that this sensation lasted for well over eight months, with no further diagnosis from many doctors.  No additional information was provided at the time of this report.  Follow-up information received on 04 December 2007 from the patient.  Following review of the reported events, this case was upgraded to serious.  An approximately 61-year-old male patient had received an injection of influenza vaccine, manufacturer not reported, lot number not reported, on an unspecified date in 2006.  The symptoms that the patient experienced lasted eight to nine months and had also included a numbness sensation in the crown of his head.  The patient was examined by a neurologist, and an unspecified CAT scan was negative.  The patient recovered from the event.  Contact information was provided for the patient's personal physician.  The reporter of this case is the same as for cases 2007-03792 and 2007-03793 and involve the same patient who experienced events following influenza vaccination in 2005 and 2007.
Swelling and redness around the eyes and lives.  Treatment benadril 50 mg po stat.
Left arm red circle rounding; looks like broken vessels; Left arm itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Left arm red circle rounding; looks like broken vessels) and VACCINATION SITE PRURITUS (Left arm itching) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Antidepressant therapy, VITAMINS NOS for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Left arm red circle rounding; looks like broken vessels) and VACCINATION SITE PRURITUS (Left arm itching). At the time of the report, VACCINATION SITE ERYTHEMA (Left arm red circle rounding; looks like broken vessels) and VACCINATION SITE PRURITUS (Left arm itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included pressure medication (not specified). No treatment medications were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
55 patients received a dose of a vial after 12 hours of initial puncture; Vial punctured 6/1/21. Vial stored in refrigerator once punctured, in freezer prior to puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial punctured 6/1/21. Vial stored in refrigerator once punctured, in freezer prior to puncture) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Vial punctured 6/1/21. Vial stored in refrigerator once punctured, in freezer prior to puncture). On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial punctured 6/1/21. Vial stored in refrigerator once punctured, in freezer prior to puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  The vials were being used past the recommended 12 hour post puncture time.   This case was linked to MOD-2021-418964 (Patient Link).
Patient c/o swelling/redness of left arm started a few days after receiving influenza and PCV13 vaccines. Treated with topical steroid/ZYRTEC and BENADRYL
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 08:30, as a single dose for COVID-19 immunisation. Medical history included mild hypertension. The patient did not have any known allergies. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and alprazolam (MANUFACTURER UNKNOWN), both started on an unknown date for unspecified indication. The patient previously took two doses of shingles vaccinations in 2018. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021, 1.5 weeks after vaccination, the patient experienced shingles. Therapeutic measures were taken as a result of shingles which included treatment with antiviral medication. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event shingles was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
admitted to hospital; 74-year-old female with a past history of hypertension has been feeling exhausted feeling tired recently as a pressure in the chest and some chest pain.  She is presented to the ER and was found to have complete heart block placed on a monitor rate is in the 30s; patient found to be also coronavirus positive.  Patient placed in isolation
Fever/Chills that evening; pain in injection site and muscle aches started the next day (both lasted 5 days); Nausea and vomiting started on 10/19 and lasted 24 hours; went to physician for previously scheduled yearly physical on 10/20; patient took ibuprofen for pain.
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-MAR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10 SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius)for a total of 144 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Almost out of breath after doing simple things; More fatigued than normal; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA EXERTIONAL (Almost out of breath after doing simple things) and FATIGUE (More fatigued than normal) 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 14-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA EXERTIONAL (Almost out of breath after doing simple things) and FATIGUE (More fatigued than normal). At the time of the report, DYSPNOEA EXERTIONAL (Almost out of breath after doing simple things) and FATIGUE (More fatigued than normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Headache, muscle aches, diarrhea the following day and one week later.  Soreness and discoloration at injection site the following day to date.
No additional adverse event.; the patient was inadvertently administered a dose of VARIVAX, that had been improperly stored; This spontaneous report was received from a nurse, referring to a 5-year-old female patient. The patients' pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 20-JUL-2020, the patient was inadvertently administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T002844, which has been verified to be valid, expiration date reported and validated as 23-JAN-2022) as prophylaxis. A properly stored sterile diluent (MERCK STERILE DILUENT) was used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX). The vaccine experienced temperature of 70 degrees Fahrenheit (F)for a time frame of 48 hours, as record by a data logger. There was no previous temperature excursion. No additional adverse events were reported.
Headache, body aches, nausea and diarrhea few hours after the vaccine
fever; Could not sleep that night; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 4th May 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms and sleeplessness. On 6th May 2020, the patient experienced fever. On an unknown date, the outcome of the influenza-like symptoms and sleeplessness were recovered/resolved and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, sleeplessness and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and later that evening she developed flu like symptoms and could not sleep that night. Flu like symptoms lasted for approximately 24 hours.  The patient stated that at the time of reporting she has a fever. The reporter did not consent to follow up. The patient stated that she did not have an health care professional.
Tightness in arm/lymph node. Lymphatic draining caused cording in my left arm for several weeks. Had an ultrasound to make sure it wasn't a clot.
NOTED TODAY THAT PATIENT RECEIVED BOTH DOSES OF MODERNA OUTSIDE OF THE LICENSED AGE GROUP. PATIENT IS 17 AND MODERNA IS ONLY LICENSED FOR 18 AND ABOVE.  PATIENT REPORTED HE HAD NO ADVERSE EFFECTS FROM THE FIRST DOSE.
Flu-like symptoms occurred approximately 24 hours after the injection!  Immediately, the injection site was sore, but after 24 hours I experienced body aches, headache, fever, light-headedness, and a lack of balance.  These symptoms persisted for approximately 48 hours.  Therefore, I was unable to go to work on Monday due to my symptoms.  I treated symptoms myself with rest, fluids, Ibuprofen, and Tylenol.