chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart rate shot up last night and had shooting pains every once in a while; Heart rate shot up last night and had shooting pains every once in a while; Blisters on her stomach and shoulder; Dots on her torso; Discomfort; This spontaneous report was received from an 84 year old female patient regarding herself. The patient's medical history was not reported. Drug allergy included codeine. Concurrent conditions included breast cancer and heart problems. Concomitant therapies included ibuprofen(MOTRIN), acetaminophen(TYLENOL), metoprolol and pravastatin. On an unspecified date in April 2011, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, frequency, lot# and expiry date were not provided) in the arm for prophylaxis before she started radiation treatments for breast cancer on an unspecified date in April 2011. She had back discomfort on 05-OCT-2019 and dots on her torso (rash macular) on 06-OCT-2019. She noticed a blister on her stomach and shoulders on 07-OCT-2019 and she had an office visit with her physician on the same day, patient sought medical attention. She reported her heart rate shot up last night on 08-OCT-2019 and she had shooting pains every once in a while and then the pain stops. The patient was treated with valacyclovir hydrochloride (manufacturer unknown) (lot# ST.DEA:BC0389711, expiration date 07-OCT-2020) two tablets every 12 hours. She took two valacyclovir hydrochloride (manufacturer unknown) tablets at 8PM last night 08-OCT-2019, which were like the size of footballs. Her heart rate jumped up to 178, then back down, then back up to 169, then down to 79. It kept going back and forth. The last time she checked before bed, it went down to 77 then back up to 122. She took two more tablets at 7 AM on 09-OCT-2019, and so far it seems OK. Her heart rate had never gone over 124 before this. Outcome of the events were reported as not recovered/not resolved. Causality assessment was not provided. Product quality complaint was not involved in the case.
4Feb91 pt had T 101 in evening.5Feb T was 102 in pm,7Feb91 T 98.9 prior to imm.11/2 hrs post vax,pt developed T 105-perioral cyanosis,no convuls.Episode of shaking but responsive to mom(lasted 10 min)Admit-hosp that pm.8Feb hyperemic throat
High fever 14 days later  Rash all over body  Swollen lymph nodes
Patient reports a normal resting heart rate in the 70s, immediately after inject felt her heart racing and had tachycardia to the 140s; Patient reports a normal resting heart rate in the 70s, immediately after inject felt her heart racing and had tachycardia to the 140s; This is a spontaneous report from a non-contactable physician.   A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Left Arm on 15Apr2021 16:00 (Batch/Lot Number: EW0150) as SINGLE DOSE (at the age of 21 years) for covid-19 immunisation.  Medical history included seasonal allergy from an unknown date, hypersensitivity of environmental allergies from an unknown date and food allergy from peanuts from an unknown date. Concomitant medications included loratadine (LORATADINE) taken for an unspecified indication; pseudoephedrine (PSEUDOEPHEDRINE) taken for an unspecified indication; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for an unspecified indication and montelukast (MONTELUKAST) taken for an unspecified indication.  The patient was not pregnant when she received the vaccine. The patient did not have any other vaccine in four weeks.  The patient reports a normal resting heart rate in the 70s, immediately after injection felt her heart racing and had tachycardia to the 140s (palpitations) on 15Apr2021 16:00 with outcome of recovering.   The patient underwent lab tests and procedures which included heart rate: 70s on unspecified date and palpitations: 140s on 15Apr2021.  The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.   Therapeutic measures were taken as a result of patient heart racing and had tachycardia to the 140s. The events persisted for 5 hours and improved only after IV (0.9% normal saline) fluid bolus.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Heart racing and Tachycardia cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Tingling; Numbness,; Pins and needles in hands, arms, and legs. Also had random needle-like stabbing over different parts of my body.; This is a spontaneous report from a contactable consumer, the patient. A 63-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 12Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took ciprofloxacin lactate (CIPRO) and sulfamethoxazole; trimethoprim (BACTRIM) for unknown indications on an unknown date and experienced drug allergy. On an unknown date in Mar2021, 5 hours after vaccination, the patient experienced tingling, numbness, pins and needles in hands, arms and legs. The patient also had random needle like stabbing over different parts of her body. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with hydroxyzine hydrochloride (ATARAX). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling, numbness, pins and needles in hands, arms and legs and random needle like stabbing over different parts of body was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
health care provider told the patient to wait 90 days before getting the second dose; Lower back pain; feeling warm; Soreness in right arm; Body aches; Fever (feeling warm); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (health care provider told the patient to wait 90 days before getting the second dose), BACK PAIN (Lower back pain), FEELING HOT (feeling warm), PAIN IN EXTREMITY (Soreness in right arm) and MYALGIA (Body aches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FISH OIL, GINKGO BILOBA LEAF (GINKGO 100) and TADALAFIL for an unknown indication.   On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced BACK PAIN (Lower back pain), FEELING HOT (feeling warm), PAIN IN EXTREMITY (Soreness in right arm), MYALGIA (Body aches) and PYREXIA (Fever (feeling warm)). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (health care provider told the patient to wait 90 days before getting the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (health care provider told the patient to wait 90 days before getting the second dose) had resolved and BACK PAIN (Lower back pain), FEELING HOT (feeling warm), PAIN IN EXTREMITY (Soreness in right arm), MYALGIA (Body aches) and PYREXIA (Fever (feeling warm)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: other (Positive) The patient tested positive for COVID-19 after 5 days of 1st dose.         No treatment information was provided   This case was linked to MOD-2021-261623 (Patient Link).
I had the Shingrix vaccine on the morning on Sept 6 and that night before going to bed had a lot of difficulty urinating.       The urination difficulties continued for about three weeks and then cleared up.      Could not be determined if the urination difficulties had anything to do with the Shingrix vaccine.
had a 16 year old who accidentally got the moderna covid vaccine; A spontaneous was received from a health care provider (HCP)  concerning a 16-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273)accidentally.  The patient's medical history was not provided. Products known to have been used by the patient, were not provided.  On an unknown date, the patient accidentally received mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    Treatment information was not provided. Consent has been given to contact the HCP.  HCP was inquiring as to whether or not the second dose of mRNA-1273 should be given.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, a 16-year-old accidentally receiving the vaccine, was considered resolved.; Reporter's Comments: This case concerns a 16-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age.
Patient slouched to the side after vaccination was administered, arms tensed up, and he began shaking in his seat.  He sat back up and opened his eyes after about 10 seconds and was unaware anything had occurred.  He claimed he "thought he fell asleep."  Paramedics were called and the patient was evaluated but not transported to a hospital.
pt became very pale & 30 sec p/recvd HIB vax; mo started screaming; blew in pts face & pt took deep breath & appeared OK; mom states pt almost died p/recvd DTP; mom later took pt to ER pt was fine;
Pt appears to suffer from a localized reaction that appears to be cellulitis nine days post injection. Per the patient she started having symptoms a few days post injection but did not have the pain, induration and warmth that she had when she made her appointment here at the clinic.
Low-grade fever; Sore arm; Extreme fatigue; Sinus problems; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 21Mar2021 at 11:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes type 2 and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. On 21Mar2021 at 15:00, the patient experienced low-grade fever, sore arm, extreme fatigue and sinus problems. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low-grade fever, sore arm, extreme fatigue and sinus problems was resolved on an unspecified date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Mother called to say her son was complaining of numbness from his elbow to his hand on the left side where the immunization was given.  No other complaint.
Covid Booster shot (3rd shot of Pfizer) was administered on 12-Jan-2022. I started noticing a lump on the left throat after vaccination I  had extreme reactions to the booster shot including fever, chills and an episode of fainting. From then on, i started having fever every day (reaching high temperatures in the evening). I had trouble sleeping and sensitivity to cold. The throat lump started aching on the right side. I consulted my primary care physician on 30-Jan-2022 Throat culture came back positive, and the doctor put me on Penicillin 500 mg 3 times a day for 10 days I was also taking Tylenol especially in the evenings when the fever became high After 10 days, the fever subsided An ultrasound scan of the thyroid revealed that the right side is larger than the left side. No nodules were found. I was maintaining a weight of 140 LBs for several months, but since Jan-2022 until now, I have dropped to 120 Lbs My doctor has recommended consulting a Endocrinologist for further treatment My doctor has also recommended taking Propranolol 20 mg tablets 3 times a day
Swollen lymph node under my left arm after 3rd dose.; Lasted about 3 days and was noticeably sore but did not interfere with activity.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 08Apr2021, when the patient was 38-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left), administration date: 14Mar2021, when the patient was 38-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 10Nov2021, outcome "recovered" (13Nov2021), described as "Lasted about 3 days and was noticeably sore but did not interfere with activity."; LYMPHADENOPATHY (non-serious) with onset 10Nov2021, outcome "recovered" (13Nov2021), described as "Swollen lymph node under my left arm after 3rd dose.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, pain.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Headache, Sedation, Myalgia, Arthralgia, Diarrhea, Redness,swelling, itching, rash @ injection site Narrative:
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were unknown. Concomitant therapy included sterile diluent (MRK INJ). On 12-APR-2018 the patient was vaccinated with improperly stored dose in PROQUAD immunization series (dose, units and frequency unknown) (lot # M043306 and expiration date 24-APR-2018). The sterile diluent (MRK INJ) used to reconstitute PROQUAD was properly stored. The temperature excursion was at 9F (degree Fahrenheit), for time frame of 288 hours cumulatively, multiple excursions. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complaint was reported.
This spontaneous report as received from a other health professional refers to a 11 year old patient.    On 15-APR-2019 the patient was vaccinated with GARDASIL 9 lot # R025155 dose 2, 1 dosage form for prophylaxis. On 15-APR-2019, 1 year 21 days after onset of therapy the patient experienced inappropriate schedule of product administration. On an unknown date the patient experienced no adverse event.
patient was in the hospital due to an unrelated reason, but after the 1st dose of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE EVENT (patient was in the hospital due to an unrelated reason, but after the 1st dose of Moderna) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (patient was in the hospital due to an unrelated reason, but after the 1st dose of Moderna) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (patient was in the hospital due to an unrelated reason, but after the 1st dose of Moderna) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered ADVERSE EVENT (patient was in the hospital due to an unrelated reason, but after the 1st dose of Moderna) to be not related.    No concomitant medication details were provided. No treatment medication details were provided.   Patient was waiting to be discharged to a nursing home but no nursing home was willing to take her, if she does not receive her 2nd dose of the Moderna COVID-19 vaccine prior to discharge from the hospital. Patient had already received her 1st dose of Moderna and HCP was looking to see if the patient can receive her 2nd dose prior to the recommended period of 28 days.   HCP had some guidance from early 2021 and wants to know if the guidance remains the same or was there new, updated information for flexibility in vaccine scheduling.  Company Comment This spontaneous case concerns an unknown-years-old female patient, with  no medical history reported who experienced the unexpected seriousness criterion hospitalization event of adverse event unknown days after 1st. dose of  mRNA-1273 vaccine.  At the time of the report, the event outcome was unknown.   The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: Company Comment This spontaneous case concerns an unknown-years-old female patient, with  no medical history reported who experienced the unexpected seriousness criterion hospitalization event of adverse event unknown days after 1st. dose of  mRNA-1273 vaccine.  At the time of the report, the event outcome was unknown.   The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Weight gain and fluid retention. Normal TSH levels in the past and at yearly exam patient had a TSH of 12.30 on 10/6/2021. Subsequently patient was started on thyroid supplementation for hypothyroidism.
54 yo female who received 2 pfizer vaccine this day. Patient sat in observation area without complaint. Patient was walking to vehicle and began to vomit. Patient came back into observation area c/o vomiting and dizziness. Patient has history of uncontrolled diabetes. Patient said she felt her sugar was low. Patient was observed another 20 minutes with condition unchanged. Patient's vitals were taken.BP: 166/78, HR: 74, RR:16. 9-1-1 was called and transfer of care was taken over. Patient was transported to Hospital.
2 inch diameter red spot around injection site. Spot is warm and firm to touch.  Patient reports that it is painful.
Pt presented to clinic 2 days after injection. Site red, swollen and hot. Pt was diagnosed with cellulitis and given KEFLEX 500mg QID x ten days.
pt recvd vax; 10cm wheal at inject site; fever of 99.6;
pain muscles & joints, t100.1, localized warmth & firmness @ inj site;
injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (injection arm soreness) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (injection arm soreness). On 27-Jan-2021, PAIN IN EXTREMITY (injection arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided by reporter.  Treatment information was unknown.   This case was linked to MOD-2021-095499 (Patient Link).
exposure to daycare worker w/shingles 10 days prior to onset @ 3-4 red papular lesions on trunk that became vesicular;pt otherwise afeb, no pruritus & parent sought eval p/3rd day;exam c/w varicella type vesicles one scabbed 2 fluid filled;
ADMINISTERED TWO DOSES OF VACCINE (FIRST DOSE ON MAR-2021 AND SECOND TWO DOSE ON 04-SEP-2021); OFF LABEL USE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021, and dose was not reported, administered on 04-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-SEP-2021, the patient experienced administered two doses of vaccine (first dose on mar-2021 and second two dose on 04-sep-2021). On 04-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and administered two doses of vaccine (first dose on mar-2021 and second two dose on 04-sep-2021) was not reported. This report was non-serious.
Left arm - upper arm - warm erythema on 5/18/11. Meds told to give CLARITIN 10mg am, ZYRTEC 10mg pm.
01/13/2021 metal taste in mouth for about 12 hours after injection (started about an hour after injection)  01/13/2021  Headache for about 12 hours after injection  (started about an hour after injection)  01/14/2021 - 01/19/2021 soreness / tightness in left arm (hurt to move arm and tender to the touch)  01/18/2021 -01/23/2021 hard knot / lump  at injection site, (quarter size to golf ball size) tender / achy and warm  to the touch 01/23/2021- 01/25/2021 knot dissipated but now formed a round light red / brownish itchy rash about a quarter in size and warm to the touch and achy in the left arm.  01/25/2021 - present: " bullseye rash"  developed;  rash is itchy, warm to the touch, red in color and about hand palm in size at injection site.  left arm continues to be achy.
05/27/05- onset of raised, red  bumps all over body. Itcht. HA, sore throat, fever 101.2 F . Sibling with chicken pox 2 weeks prior to pt eruptions appeared. Lesions on eyelids and conjunctival margins. lUngs clear.