chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen lymph nodes near neck; fatigue; Arm soreness; Arm stiffness; achiness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 11:00 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: LOESTRIN FE taken for polycystic ovaries, start date: 1996 (ongoing); METFORMIN taken for polycystic ovaries, start date: 1996 (ongoing); SPIRONOLACTONE taken for polycystic ovaries, start date: 1996 (ongoing); GLUCOSAMINE; LEXAPRO taken for depression, start date: 2009 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 13:30, Lot no: EL3247, Route: Intramuscular), administration date: 26Jan2021, when the patient was 41 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Time: 13:30, Lot no: EL3247, Route: Intramuscular), administration date: 16Feb2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 29Sep2021 20:00, outcome "recovering", described as "Arm stiffness"; PAIN IN EXTREMITY (non-serious) with onset 30Sep2021 11:00, outcome "recovered" (2021), described as "Arm soreness"; LYMPHADENOPATHY (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (2021), described as "swollen lymph nodes near neck"; FATIGUE (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (2021), described as "fatigue"; PAIN (non-serious) with onset 29Sep2021 20:00, outcome "recovering", described as "achiness". Therapeutic measures were not taken as a result of musculoskeletal stiffness, pain in extremity, lymphadenopathy, fatigue, pain.  Additional information: It was reported that, the patient had no known allergies. The patient did not receive any other vaccines prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 08-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000903:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The reporter reported that on 16-JUN-2014 the patient was administered a dose of RECOMBIVAX HB, (1 ml, lot#, strength, frequency and route unspecified) which was exposed to 70F for 72 hours. No adverse effects reported. Additional information is not expected.
Injection site arm very sore Woke 12 hours later breathing heavier than normal Fatigue  Muscle soreness
Diarrhea; Head was hurting; Light-headed/about to pass out; Body was aching; This is a spontaneous report from a contactable consumer (reporting herself). This 65-year-old female received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: EJ020) via an unspecified route of administration and administered in right arm on 12Mar2021 (age at the time of vaccination was 65-year-old) as single dose for COVID-19 immunization. The patient's medical history included diabetes, blood pressure high. The patient's concomitant medications include amlodipine, atorvastatin, famotidine, atorvastatin (LIPITOR [ATORVASTATIN]), metformin, omeprazole, ziprasidone, fluoxetine, metoprolol tartrate, vitamin d NOS and paracetamol (tylenol extra strength), all drugs were taken for an unspecified indication, start and stop date were not reported. On an unknown date, the patient went to work on this morning (on the day of reporting), the patient experienced diarrhea, body was aching, headache and had to come home. The patient has to take off work because having light-headed and about to pass out. The patient head was hurting. Therapeutic measures were taken as a result of event and the body was aching with Tylenol extra strength and that it did not help. Product details for Tylenol extra strength included LOT# and expiration was 2/19, the LOT number was GSJAJC and 2/19. Its 2/19, that was the date on it. There was no number. When probed for confirmation about 2/19 as expiration date, consumer stated, no, it did not say date on it, it just said 2/19 and regarding NDC number patient stated that whole lot of numbers wrote here at the bottom. That was a 12 number. The patient stated that can I get a letter that the patient talked to the representative. Consumer was provided with the reference number. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Worsening vasculitic ulcers to bilateral lower extremities. Multiple scattered new ulcers as well as worsening of established ulcer.
Moderna COVID-19 vaccine administered to a 17 year old but the minimum approved age is 18 years old
Took Paxlovid after getting Covid after 3 Moderna and one Pfizer vaccination; Took Paxlovid after getting Covid after 3 Moderna and one Pfizer vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lung cancer" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: ENHERTU [TRASTUZUMAB DERUXTEC-AN], start date: Dec2021.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Took Paxlovid after getting Covid after 3 Moderna and one Pfizer vaccination". The patient underwent the following laboratory tests and procedures: Blood creatinine: up to 2.6.; SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Took Paxlovid after getting Covid after 3 Moderna and one Pfizer vaccination. Creatinine level shot up to 2.6. No one warned me of this possible side effect nor did the medication say to take with lots of water or food. This has complicated my cancer treatments. A kidney biopsy was performed which showed both recent and longer term damage but my creatinine level had never previously been this high.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a certified medical assistant refers to a 64 year old patient of unknown gender. The patient's concurrent conditions included penicillin allergy and his concomitant medications included aspirin. None pertinent medical history was reported. On 13-APR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (subcutaneously; dose, lot # and expiration date were not reported). On an unknown date in April 2016, the patient developed redness, swelling and warmth at the vaccination site. On 14-APR-2016, the patient sought medical attention via returning to the office. The patient was advised for the treatment to use warm/cold compresses to the affected area and to take ibuprofen as needed. None lab diagnostics studies were performed. The outcome of the adverse events was unknown. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
simple local deltoid react w/red, sl rasied 5cm x 5cm lesion; no other assoc sx's;
delayed (11 days) redness/rash on right arm that has continued growing in size. Hot to the touch, slight pain and itching
dizziness/dizzy; I feel like I am on a boat, staggering, I can walk in a straight line so no one on the outside can tell; feel exhausted/fatigued; I feel like I am on a boat, staggering, I can walk in a straight line so no one on the outside can tell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 82 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; UNKNOWN MANUFACTURER, Lot number and expiration date not provided.), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; UNKNOWN MANUFACTURER, Lot number and expiration date not provided.), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); UNKNOWN MANUFACTURER, Lot number and expiration date not provided.), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 01May2022, outcome "not recovered", described as "dizziness/dizzy"; MALAISE (non-serious), GAIT DISTURBANCE (non-serious) all with onset 2022, outcome "unknown" and all described as "I feel like I am on a boat, staggering, I can walk in a straight line so no one on the outside can tell"; FATIGUE (non-serious) with onset 2022, outcome "not recovered", described as "feel exhausted/fatigued". The events "dizziness/dizzy", "i feel like i am on a boat, staggering, i can walk in a straight line so no one on the outside can tell" and "feel exhausted/fatigued" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, malaise, fatigue, gait disturbance.  Additional Information: It was reported that patient had two vaccines and two boosters, the most recent booster was on 13Apr2022 and got dizzy on 01May2022. Happened every single day all of the time. Worsened. "It is 24 hours..well not while I am sleeping. I feel like I am on a boat, staggering, I can walk in a straight line so no one on the outside can tell. I feel exhausted, I do not know what to do about it" (as reported). Patient was dizzy and fatigued for more than a year. She recently saw a doctor and she had heard that other people had experienced similar symptoms. She was wondering if there might be a connection between the vaccine and dizziness. If so, what could be done to cure it. Patient had many tests and tried many alternative and western therapies. Vaccine was administered to right arm just below the shoulder. No other products reported. Treatment reported was had VNG which was a medical test where hook up to different electrodes to see how inner ear was functioning. Had an MRI, CAT scan, physical therapy, osteopath, chiropractor and various practitioners.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of PROQUAD (Merck upgrade process) (lot number not reported). On an unspecified date the patient's mother called the physician stated that her child was "a little weary". It was mentioned that this happened when the vaccine was still recommended as a single dose therefore the second dose was not administered. On an unspecified date the patient had recovered. Additional information has been requested.
Got exposed to unvaccinated child 14Jan2022 then sx 17Jan2022 HA and cough mild illness - + test 19Jan2022 AG now recovered; Got exposed to unvaccinated child 14Jan2022 then sx 17Jan2022 HA and cough mild illness - + test 19Jan2022 AG now recovered; Got exposed to unvaccinated child 14Jan2022 then sx 17Jan2022 HA and cough mild illness - + test 19Jan2022 AG now recovered; Cough mild illness; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date 19Feb2021 (Lot number: EL3247) at the age of 33 years as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), EXPOSURE TO SARS-COV-2 (non-serious) all with onset 17Jan2022, outcome "recovered" (Jan2022) and all described as "Got exposed to unvaccinated child 14Jan2022 then sx 17Jan2022 HA and cough mild illness - + test 19Jan2022 AG now recovered"; ILLNESS (non-serious) with onset 17Jan2022, outcome "recovered" (Jan2022), described as "Cough mild illness". The events "got exposed to unvaccinated child 14jan2022 then sx 17jan2022 ha and cough mild illness - + test 19jan2022 ag now recovered", "got exposed to unvaccinated child 14jan2022 then sx 17jan2022 ha and cough mild illness - + test 19jan2022 ag now recovered", "got exposed to unvaccinated child 14jan2022 then sx 17jan2022 ha and cough mild illness - + test 19jan2022 ag now recovered" and "cough mild illness" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Jan2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, exposure to sars-cov-2, illness. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient was not hospitalized for the events. The device date was reported as 28Jan2022. The case was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and VACCINATION FAILURE , COVID-19, EXPOSURE TO SARS-COV-2,  ILLNESS  cannot be completely excluded.
This spontaneous report as received from a pharmacist refers to an approximately 60 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. Information about the patient's drug reactions/allergies was not reported. On 03-MAR-2015, the patient was vaccinated with ZOSTAVAX, single dose, subcutaneous, lot # K016320 and expiration date 24-DEC-2015 for prevention of shingles. The pharmacist reported that the patient had ZOSTAVAX reconstituted with sterile diluent (lot # K011199, expiration date 29-MA-2017). On an unknown date, in approximately March 2015, the patient experienced injection site reaction. The patient sought medical attention via visiting a physician. The outcome of injection site reaction was unknown. The relatedness between the event and ZOSTAVAX and sterile diluent was not reported. The pharmacist requested via company representative a lot check on ZOSTAVAX, lot# K016320 and sterile diluent, lot # K011199. This is one of several reports received from the same reporter. Additional information has been requested.
Facial swelling, shoulder swollen three times the size of other arm for 3 days. Shoulder was red, hot, stiff. We were advised by immediate care this was a severe allergic reaction and to give Benadryl every 4-6 hours.
Administered the / vaccine to a child that was under the age; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter administered the Kinrix vaccine to the patient that was under the age to receive the vaccine which led to inappropriate age at vaccine administration.  The reporter provided all information and stated, there were no reported adverse events with the patient at the time of reporting.  The reporter stated that she knew the patient was due for the DTaP and Polio vaccines. The reporter consented to follow up.
Ran fever for 3 days with temperatures  ranging to 104.4 degrees. Body aches and pains, headache, nausea, chills, no appetite, coughing, feeling weak, sweating, no energy and soreness in back of eyes. In bed for 4 days. Prior to vaccination  walked regularly, when I started walking again had ?rubber legs? for two weeks after started walking. Energy level still has not returned, still feel a little weak, lost interest in my hobbies, killed my taste for coffee, which I drank  since age 16.  Took Tylenol and tepid tub baths to get fever down.
12/18/20 10pm nausea with vomiting lasting one hour 9 pm headache, persistent and continues today at 12/1/20 at 8:30 am 8pm diarrhea lasting 2 hours
Information has been received from a pharmacist concerning a 15 month old white male with a milk allergy who on 09/26/01 was vaccinated with a first dose of MMR II IM in the leg (lot 639617/0739L). Concomitant therapy on an unknown date included diphtheria toxoid/pertussis/tetanus toxoid (manuf unk) and haemophilus B conjugate (manuf unk). There was no illness at the time of vaccination. On 10/04/01, the pt developed two "pea sized" knots on the back of each side of his head near the neck area. The pt had received medical attention for his experience. The pharmacist reported that the knots didn't get any larger and were still noticeable but smaller at 2 weeks. No additional info is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II lot number was H015829 with 24-AUG-2014. Medical assistant reported that five patient received doses of M-M-R II after the expiration date. The doses were administered on 28-AUG-2014, 17-SEP-2014, 22-SEP-2014, 23-SEP-2014. No adverse effects reported. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 15 month old male with no past medical history and no known drug allergies who on 3/25/03 in the AM was vaccinated in the left thigh with a fourth dose of Haemophilus B conjugate vaccine (lot # 644865/1101M). There was no illness at the time of vaccination. Concomitant therapy that day included a first dose of MMR (lot # 642700/0528M) administered in the right thigh and a fourth dose of Streptococcus pneumoniae vaccine (batch # 491565) administered in the right thigh. On 3/25/03 in the PM the patient developed a small knot in his left thigh and slight redness to the area, which was golf ball sized. No fever was noted. Unspecified medical attention was sought. The outcome was reported as recovered. There were no relevant diagnostic tests or lab data. No further information is expected.
Patient is a 73-year-old male with a past medical history of ESRD m/w/f, Crohn disease, neuropathy presents to the ED due to shortness of breath and altered mental status that started about a week ago.  Upon arrival to the ED patient was originally confused and confusion resolved by the time I saw the patient and was able to provide history.  Patient reports he recently tested positive of COVID-19 10/2/21 at  urgent care and that his sister who care for him periodically also tested positive for COVID-19.  Patient stats that he his vaccinated.  Patient reports headache, fever, chills, shortness of breath, confusion, weakness and body ache, vomiting, diarrhea.  Patient reports he ambulates with walker. Admitted to hospital 10/12/2021.Patient reports he ambulates with walking cane and he has had frequent fall,  over the past 6 months he has fell twice without hitting his head, last fall was 2 months ago.  Patient complains of back aching pain onset 2 months ago after fall, that radiates to the abdomen, intensity 7/10, no associated symptoms, alleviating factors include rest,  aggregative factors include movement.  Patient also has history of ESRD, and reports that his sister drove him to dialysis yesterday.  Patient reports he lives by himself in an apartment and his sister comes over to assist him periodically.  Patient denies chest pain, urine changes, loss of consciousness, dizziness, and any head trauma. ED course: Vital:  WNL except BP 105/69  Lab:  Creatinine 4.4, BUN 23.7, procalcitonin 8.64, lactic acid 2 UA wnl CXR:  Chronic markings with right bibasilar opacity possibly representing focal infiltrate. CT head or brain without contrast:  No acute findings BC pending cefepime, vancomycin. ESRD m/w/f Cataract crohn Anemia  Neuropathy GERD
Local reactions left deltoid WBC 17,800 1/28/04. Fever 101-103, WBC 13,000 1/30/04. CXR 1-29-04 normal. WBC 19,100 1/29/04. All Jan 04.