chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed an irregular heartbeat; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE IRREGULAR (I developed an irregular heartbeat) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE IRREGULAR (I developed an irregular heartbeat). At the time of the report, HEART RATE IRREGULAR (I developed an irregular heartbeat) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported. With both moderna shots the patient  developed an irregular heartbeat and is afraid to get the booster This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected event of heart rate irregular. The event occurred on an unknown date after the second dose of mRNA-1273. The rechallenge was positive for first occurrence of event (described in linked case) since it was reported that the patient developed an irregular heartbeat with both moderna shots. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-390452 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected event of heart rate irregular. The event occurred on an unknown date after the second dose of mRNA-1273. The rechallenge was positive for first occurrence of event (described in linked case) since it was reported that the patient developed an irregular heartbeat with both moderna shots. The benefit-risk relationship of mRNA-1273 is not affected by this report.
PATIENT CALLED THE PHARMACY MONDAY AFTERNOON 2 DAYS LATER WITH SLIGHT RASH ON INSIDE OF UPPER ARM VACCINATION ARM AND ALSO ON THE LEFT ARMS ALSO. SINCE IT APPEARED TO POSSIBILY BE SYSTEMIC /I RECCOMENDED THE PATIENT CONTACT HIS DR /PATIENT DID CONTACT DR AND HE FELT WOULD BE OK. IN INSTRUCED PATIENT TO START BENADRYL ANYWAY ALONG WITH ICE PACKS. /CONTACTED PATIENT BACK THAT NIGHT BEFORE CLOSE/ PATIENT AGREED TO CONTACT PHARMACY IF ANY FUTHER PROBLEMS DEVELOPED/WE TRIED TO CONTACT PAT/3 TIMES THE NEXT DAY/PATIENT DID NOT RETURN OUR CALL/
Edema "blood beet red" arm from armpit to approximately 3" below elbow - edema whole arm area to within 2-3''' of wrist. Soreness and fever - whole  arm to within 2-3" of wrist. Soreness and fever- whole arm and knot at injection site. Benadryl 25mg at bedtime and ice packs during day. Began reaction afternoon after injection. Had similar but less. Reaction last Fall when she had same injection. MD - told he she needed another one.
This spontaneous report was received from a registered nurse and referred to an unspecified number of patients of unknown age and sex. On an unknown date, the unspecified number of patients may have received improperly stored VARIVAX (Merck) (lot #, expiration date, strength, dose and frequency were not reported) injection. No adverse effects were reported. This is one of four reports received from the same source. Additional information has been requested.
Adverse reaction caused by varicella virus live vaccine Mild to moderate rash hives immediately and 12-24h vomiting and pallor 12-24h
Ringing in ears have been high-pitched, continual and unbearable. I've never had this condition in my life. Swollen lymph glands, sore throat, body aches and flu-like symptoms have subsided.
15 hours after injection I experienced onset of ACUTE muscle and joint pain, nausea, EXTREMELY achy, and chills. Lasted for about 30 hours.
Patient reports having had Johnson and Johnson covid vaccine on May 8 2021 and then 4 weeks afterward having blood clot in his right leg (calf) that kept him in the hospital for 3 days until released on blood thinners. Patient reports still having valve issues in his right foot as a result.
patient did not receive the full dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number N3755, expiry date 26th June 2023) for prophylaxis.   On 7th April 2022, the patient received Shingrix (intramuscular) .5 ml. On 7th April 2022, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 07-Apr-2022 Reporter's Comments: The reporter stated that while administering the Shingrix vaccine there was an issue with the syringe and the patient did not receive the full dose of Shingrix. The reorter did not have patient's Healthcare professionals information. The reporter did not consent to follow-up. Additional Supportive Information: The patient did not receive the full dose of Shingrix, which led to accidental underdose.
ADMINISTERED PUNCTURED VIAL STORED AT ROOM TEMPERATURE FOR 2.5 HOURS (OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS); VACCINE STORED AT ROOM TEMPERATURE FOR 2.5 HOUR (OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS); This spontaneous report received from a pharmacist concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced administered punctured vial stored at room temperature for 2.5 hours (outside of the recommended storage conditions). On 14-NOV-2021, the patient experienced vaccine stored at room temperature for 2.5 hour (outside of the recommended storage conditions). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered punctured vial stored at room temperature for 2.5 hours (outside of the recommended storage conditions) and vaccine stored at room temperature for 2.5 hour (outside of the recommended storage conditions) was not reported. This report was non-serious.
Patient's family members said that patient is experiencing shoulder pain. She cannot raise her arm at all without pain. Pain is a 10 on the pain scale. There is no redness/swelling at the injection site and pain is under her arm (armpit area rather than injection area). She has taken Excedrin (at 5pm) and put ice on the arm. Pain started approximately 3 hrs after injection. I instructed family to seek medical attention if pain gets worse, or does not get better. There is no numbness or tingling. She can move her elbow, hand and fingers.
Pneumonia; Shingles; Sick/Ill post-vaccines; UTD; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (051529).  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), outcome "unknown", described as "Pneumonia"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles"; ILLNESS (non-serious), outcome "unknown", described as "Sick/Ill post-vaccines"; URINARY TRACT DISORDER (non-serious), outcome "unknown", described as "UTD". Clinical Course Reports missing doses when she becomes ill post-vaccines. Happens with every vaccine she had ever gotten. She was UTD with COVID vaccines,pneumonia, and shingles, but does not get the flu shot because she gets sick.Suspect Product(s): XELJANZ TAB 5MG Start Date: 03Jan2019  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.  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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Patient states he has been coughing up phlegm about 8 to 10 times daily after getting vaccine.
On July 13th I had a very sore throat.  I had a strep test and it came back negative.  Throughout the night, my mouth and throat became itchy and red.  My uvula swelled it was gagging me.  I went to the doctor in the morning and received a steroid shot and mouthwash to reduce the pain and swelling.  After about 48 hours I began to feel better.   I'm not sure this was caused by the COVID-19 vaccination, but I had never had this type of reaction before.
achy; joints were hurting; had a headache; chills; lymph nodes stayed swollen for a few months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Jan2021 (Lot number: EK9231) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date Sep2021. The following information was reported: PAIN (non-serious) with onset 14Jan2021, outcome "recovered" (2021), described as "achy"; ARTHRALGIA (non-serious) with onset 14Jan2021, outcome "recovered" (2021), described as "joints were hurting"; HEADACHE (non-serious) with onset 14Jan2021, outcome "recovered" (2021), described as "had a headache"; CHILLS (non-serious) with onset 14Jan2021, outcome "recovered" (2021), described as "chills"; LYMPHADENOPATHY (non-serious) with onset 14Jan2021, outcome "recovered" (2021), described as "lymph nodes stayed swollen for a few months".  Additional information:  Anatomical Location of Administration of Pfizer vaccine considered as suspect: right arm  Emergency Room was No. Physician Office as no, but had called doctor. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none within 4 weeks, had flu vaccine in Sep2021. AE(s) following prior vaccinations was none.  No follow-up attempts are possible. No further information is expected.
Developed muscle aches, low grade temperature, still with same aches and pains when last seen.  A detailed summary is noted in doctor's consult note attached.
Patient was given two doses of Fluzone HD with no reported adverse event; Initial information received on 29-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via consumer.  This case involved an unknown age gender patient for whom it was stated that patient was given two doses of fluzone high dose (HD) (product dispensing error) with no reported adverse event, while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at dose of 2 dosage form (lot number and expiry date) via unknown route in unknown administration site.  On 29-Oct-2021, it was reported "patient was given two doses of fluzone high dose (HD)" (product dispensing error) with no reported adverse event (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory data was not reported.  Action taken with QUADRIVALENT INFLUENZA VACCINE was not applicable.  It was not reported, if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  The reporter did not report causality of events with suspects.
Outer left ankle had a red sore (quarter-size location), where the top layer of skin had been removed. Patient noticed after getting out of the shower, the evening after vaccination, when putting on oil.
Upper torso rash, facial edema, fever, vomiting, malaise, body aches.
Pt received influenzae vaccination at drug store. 1 day after developed headache followed by paraesthesias of hands and feet. Then progressive weakness of legs and arms. Information from 60 day follow-up report states: I did not treat him after diagnosis. Per follow up: patient was evaluated on 10/19/05 and diagnosed with Guillain Barre syndrome. The reported receiving an influenza vaccination approx 1 week before the visit. Symptoms of headache and stiff neck began the day following the vaccination followed by paresthesis of all 4 extremities and progressive weakness. Pt was admitted to hospital, under the care of different neurologists. I do not have further information at this time.   1/25/06 Hospital medical records received for 10/19-10/27/2005. FINAL DX: Guillain-Barre syndrome; type 2 diabetes mellitus; hypertension Records reveal patient experienced HA, neck stiffness, numbness of feet, increased warmth of hands, eye pain & generalized weakness x approx 1 wk.  Had developed myalgias & achiness almost immediately s/p flu shot that progressed to numbness & tingling of fingers/toes,loss of taste, LBP,  & balance difficulty.  Neuro, Nephro, Pulmo consult done, admitted to ICU, tx w/IVIG, improved.  D/C to inpatient rehab
17-year-old female patient received the first dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old female patient received the first dose of Moderna COVID-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old female patient received the first dose of Moderna COVID-19 vaccine). On 12-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old female patient received the first dose of Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs and treatment medications were reported.   This case was linked to MOD21-081893, US-MODERNATX, INC.-MOD-2021-090693 (E2B Linked Report).; Sender's Comments:  MOD21-081893:crosslinked US-MODERNATX, INC.-MOD-2021-090693:crosslinked
Patient developed erythema and mild tenderness at injection site on left thigh.  Mother advised to apply warm compresses.  If worsening increases call office and antibiotic will be prescribed.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a certified medical assistant (C.M.A.) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 10-JUN-2021, the patient was vaccinated with one of following incorrectly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (strength, dose and route were not reported) for prophylaxis: lot # T003384 has been verified to be a valid lot number, expiration date reported as 27-JAN-2022, but upon internal validation established as 28-JAN-2022; lot # T007231 has been verified to be a valid lot number, expiration date reported as 26-FEB-2022, but upon internal validation established as 27-FEB-2022; lot # S023656 has been verified to be a valid lot number, expiration date reported as 29-JUL-2021, but upon internal validation established as 30-JUL-2021; lot # S039313 has been verified to be a valid lot number, expiration date reported as 03-DEC-2021, but upon internal validation established as 04-DEC-2021 (incorrect product storage). The vaccine underwent a temperature excursion as it was stored at 47.2 Fahrenheit (F) (above 46 F) for 52 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
ACUTE DVT, UNSPECIFIED VEIN 10/14/2022 ATRIAL FIBRILLATION, PERSISTENT HYPOTENSION 10/7/2022 ATRIAL FIBRILLATION, PERSISTENT ACUTE DVT, UNSPECIFIED VEIN 10/14/2022 ACNE VULGARIS HYPOTENSION 10/7/2022 ACNE VULGARIS ACUTE DVT, UNSPECIFIED VEIN 10/14/2022 INTRAABDOMINAL ABSCESS HYPOTENSION 10/7/2022 INTRAABDOMINAL ABSCESS ACUTE DVT, UNSPECIFIED VEIN 10/14/2022 BACTERIAL PLEURAL EFFUSION HYPOTENSION 10/7/2022 BACTERIAL PLEURAL EFFUSION ACUTE DVT, UNSPECIFIED VEIN 10/14/2022 BILAT PLEURAL EFFUSION HYPOTENSION 10/7/2022 BILAT PLEURAL EFFUSION
pain lt neck, shoulder, lt breast & back;swelling,neg redness, neg warmth, neg fever/chills;pain on  range of movement lt shoulder;
Local erythema and swelling at site and extension down arm 14cm x 6cm itching locally.
pt recv vax;to er because of sz;14apr96 1 hr sz activity;
about 14 hrs p/vax pt had t104.2 & hallucinating; cont to give APAP & temp declined; pt acting nl next morning;
Developed itchy red papules 24 hrs after vaccination on abdomen, back, lower leg. Consistant with allergic reaction, not generalized vaccine.
This spontaneous report as received from a Nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients might have received M-M-R II, reconstituted with expired doses of sterile diluent (lot number H006212, expiration 30-JUN-2014). No adverse effects were reported. This is one of three reports from the same source. Additional information has been requested.
Developed mouth ulcers and linear patterned ulcer like mild swelling on front interior mouth soft tissue.; Developed mouth ulcers and linear patterned ulcer like mild swelling on front interior mouth soft tissue.; Developed mouth ulcers and linear patterned ulcer like mild swelling on front interior mouth soft tissue.; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6202), via an unspecified route of administration in right arm on 25Feb2021 (at the age of 70-years-old) as single dose for covid-19 immunisation. The vaccine facility was in a hospital. The first dose of bnt162b2 (lot: EL9265) was given on 04Feb2021 at 14:30 in right arm (at the age of 70-years-old) as single dose for Covid-19 Immunisation. The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included alfuzosin. There were no other vaccine in four weeks. The patient had no Covid prior vaccination and was not Covid tested post vaccination. The patient developed mouth ulcers and linear patterned ulcer like mild swelling on front interior mouth soft tissue on 01Mar2021 at 09:00. There was no treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Emergency room. Inpatient 2 days. Another hospital 7 days. Miller Fisher syndrome. Treatment = IVIG.
Went to ER evening of 12/13/14. Massive swelling, inflammation. Diagnosed with Cellulitus. Given oral antibiotics in ER. Sent home with prescriptions for pain, nausea and antibiotics which did not work. By 12/14/2014, rash and swelling continued to spread. On morning of 12/15/2014, rushed to ER with chest discomfort, shortness of breath. Admitted and transported by medical transport ambulance and admitted to hospital. From 12/15/2014 until discharge on 12/17, administered continuous IV antibiotics. At discharge last afternoon 12/17/14 was given prescriptions for Keflex and Bactrim. As of 12/22/2014 infection and swelling reduced 95%. Small knot still is at injection site.
Ran a fever of 102F-103F on 11/28/02, which rose to 105.2F on 11/29/02 at approx. 16:00. Child had been medicated with Motrin on 11/29/02 around 09:00. Then medicated him about 16:00 with both acetaminophen and Motrin, which dropped his temperature to 101F-102F. No prior history of fevers this high (105F).
Intensely painful menstrual cramps for two consecutive days, noticeably worse than the norm.
94 y.o. female with history of CAD, HTN, HLD, HFpEF, a fib on Eliquis, AS s/p TAVR, and OSA who presents with shortness of breath and signs of volume overload. Also tests positive for COVID-19. Did get  diuresed with improvement of symptoms. Intermittently desaturating, started on steroids. Does not qualify for Remdesivir due to renal function.
Patient described confusion and fogginess the night after receiving flu and Spikevax Moderna vaccines. Said she was forgetting words when talking to her husband. No other changes in medical history.
Sore arm at injection site, tired, injection site redness and nausea. Third day I felt fine, back to normal.
injection site pain, swollen, muscle pain, warmth.  Swelling/pain/sensitive throughout body, chest pains, fever over 104, hives/rash throughout body, nausea/vomitting, cellulitis, headache, chills, fatique, decreased appetite, dizziness, cough, throat tightnes, dry mouth, eye itching/red/swollen. 7/11/07-records received for DOS 6/7 and 6/9/07-DC DX: Allergic reaction to Pneumovax vaccination. Secondary DX: Headache, hypothyroidism. HX of Palpitations. C/O fever and rash on left arm. Fever to 104. Rash at injection site gradually spread. Muscle tightening makes arm movement difficult.
BUD date excursion. BUD was 4-7-23 and vaccine was administered 4-22-23.
Janssen COVID-19 Vaccine EUA  High fever (104), shaking chills, bone and joint pain, headache