chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 hours afer reciept of Anthrax #5, patient experienced worsening of pre-existing tremors in all four extremities.  Patient states trembling began after Jan 2007, after Anthrax #3.  Patient has never reported this issue until today.
left leg has been worse than regular neuropathy; swelling; red area on her left arm above the injection site; Fatigue that is worse than usual; bad headache that are worse than usual; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (left leg has been worse than regular neuropathy), SWELLING (swelling), VACCINATION SITE ERYTHEMA (red area on her left arm above the injection site), FATIGUE (Fatigue that is worse than usual) and HEADACHE (bad headache that are worse than usual) in a 72-year-old female 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.  The patient's past medical history included Neuropathy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) from 27-Apr-2021 to an unknown date, CLONAZEPAM, BUSPIRONE, AMLODIPINE, CYANOCOBALAMIN (B 12), ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]), VITAMIN D3, VITAMIN C [ASCORBIC ACID], MAGNESIUM and GARLIC [ALLIUM SATIVUM] for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (left leg has been worse than regular neuropathy), SWELLING (swelling), VACCINATION SITE ERYTHEMA (red area on her left arm above the injection site), FATIGUE (Fatigue that is worse than usual), HEADACHE (bad headache that are worse than usual) and MYALGIA (muscle pain). At the time of the report, NEUROPATHY PERIPHERAL (left leg has been worse than regular neuropathy), SWELLING (swelling), VACCINATION SITE ERYTHEMA (red area on her left arm above the injection site), FATIGUE (Fatigue that is worse than usual), HEADACHE (bad headache that are worse than usual) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Medical history includes compromised immune system. No treatment provided by the reporter. Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up added on 01 May 2021 had no new information.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JULY-2017) (dose, frequency and route not provided). No adverse effect was reported. The minimum of temperature was 0.8 degree C and the time frame was unspecified. There was no previous temperature excursion. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Pfizer Lot #FJ6369 with temp excursion. Reported to Pfizer company and ok'd for use. Instructed by their staff to report each dose given in this system.
A normal little soreness on her arm; She developed a some kind of hive on her leg it is itchy and uncomfortable; She developed a some kind of hive on her leg it is itchy and uncomfortable; She developed a some kind of hive on her leg it is itchy and uncomfortable; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. Medical history included allergy like seasonal. Concomitant medication included loratadine taken for seasonal allergy, start and stop dates were not reported. The patient experienced a normal little soreness on her arm. The patient applied some ice on her arm and she was fine. The patient developed some kind of hive on her leg and it was itchy and uncomfortable on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Since my Pfizer booster, I have been having huge blood clots with my periods, as well as, a lot more pain.
Within 20 minutes of HEP B vaccination, pain increased at injection site, radiated to neck, "mild swelling" of tongue. Denies airway obstruction, denies dyspnea. Denies visual disturbances. Pulse regular, afebrile. Ambulates steadily. Symptoms of pain and tongue swelling subsided within 25-30 minutes after reporting.
Delayed reaction; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Delayed reaction) in a 37-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (Delayed reaction). At the time of the report, SKIN REACTION (Delayed reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.    This case was linked to MOD-2021-012462 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jan-2021 and was forwarded to Moderna on 25-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Delayed reaction) in a 37-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (Delayed reaction). At the time of the report, SKIN REACTION (Delayed reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.    This case was linked to MOD-2021-012462 (Patient Link).
3-25-21 TC FROM PT - STATES AFTER COVID SHOT #1 SHE HAD A FEVER AND BECAME CONFUSED ON THE NEXT DAY. STATES SHE FELL IN HER BATHROOM AND LAYED FOR HOURS ON THE FLOOR BEFORE HER FAMILY FOUND HER. SHE WAS TAKEN TO ER AND KEPT FOR 3 DAYS (MRI & XRAYS WERE OK). SHE THEN SPENT 4 DAYS @ LTCF. AFTER COVID SHOT #2 SHE BECAME CONFUSED AGAIN/COULDN'T REMEMBER ANYTHING AND HAD TO STAAY WITH HER FAMILY X 1 WEEK. SHE STATES SHE IS BETTER NOW AND HAS MADE A FULL RECOVERY.
Passed away; UTI; Abnormal bleeding; A spontaneous report was received  from a healthcare professional concerning a patient who received the Moderna COVID-19 Vaccine (mRNA-1273) and experienced abnormal bleeding, UTI, and passed away.   The patient's medical history included a long term history of anticoagulation therapy. Concomitant product use included anticoagulation therapy.  On 31Jan2021 prior to the onset of the events the patient recieved their first dose of mRNA-1273 (Lot number:not reported) intramuscularly for prophylaxis of COVID-19 infection.  On 07Feb2021, the patient complained of abnormal bleeding. Patient was seen at clinic on 10Feb2021 and was diagnosed with a UTI and given antibiotics. An INR was also completed that day due to patient having a long term history of anticoagulation therapy. Results of that showed the INR to be 12. Prior to vaccination, patient's INR was normal and no changes to medications and diet were made after vaccination and prior to complaint starting.   On 12Feb2021 the patient passed away.  Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 12Feb2021. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns an 82 year old male patient, with history of long term anticoagulation therapy (unknown indication), who experienced a fatal event of death and abnormal hemorrhage, 13 days after receiving second dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sore arm; Chills; A spontaneous report was received from a consumer concerning a 75-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm and chills.  The patient's medical history was not provided. Concomitant medications reported were cholesterol medication and Hypertension medication for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 3 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events sore arm and chills. Consumer reported that she and her husband took second vaccine on same day but, her husband experienced the symptoms. Patient gave consent to be contacted by safety team.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable   The outcome of events, sore arm and chills were unknown.
Almost constant nausea. I've had surgery to correct my A Fib (which occasionally flares up. Rarely though.) Since then it's been CONSTANT! Not sure why this is.
Patient had generalize rash on arms and abdomen 1-2 days after vaccination that gradually resolved over a few days.
This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (opened a vial last Friday, October 7 and the vial was not discarded at the end of the day. So today, the vial was still in the fridge and was accidentally given to a patient), PRODUCT STORAGE ERROR (opened a vial last Friday, October 7 and the vial was not discarded at the end of the day. So today, the vial was still in the fridge and was accidentally given to a patient) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (opened a vial last Friday, October 7 and the vial was not discarded at the end of the day. So today, the vial was still in the fridge and was accidentally given to a patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (opened a vial last Friday, October 7 and the vial was not discarded at the end of the day. So today, the vial was still in the fridge and was accidentally given to a patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (opened a vial last Friday, October 7 and the vial was not discarded at the end of the day. So today, the vial was still in the fridge and was accidentally given to a patient), PRODUCT STORAGE ERROR (opened a vial last Friday, October 7 and the vial was not discarded at the end of the day. So today, the vial was still in the fridge and was accidentally given to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     No concomitant medication information was provided. It was reported that a vial was opened on last Friday, 07-Oct-2022 and the vial was not discarded at the end of the day. So the vial was still in the fridge and was accidentally given to a patient. No treatment information was provided.
Pain/ whenever she wears clothes it bothers her skin; Full body rash/ rash was all over body, in arm her arms and in her arm pit; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Pain/ whenever she wears clothes it bothers her skin) and RASH (Full body rash/ rash was all over body, in arm her arms and in her arm pit) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included TRIAMCINOLONE and PREDNISONE for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain/ whenever she wears clothes it bothers her skin) and RASH (Full body rash/ rash was all over body, in arm her arms and in her arm pit). At the time of the report, PAIN (Pain/ whenever she wears clothes it bothers her skin) and RASH (Full body rash/ rash was all over body, in arm her arms and in her arm pit) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reportedly, after about 17-18 days of receiving first dose, the patient had a reaction all over her body. She thought that was may be from her laundry detergent. The rash was all over body, in her arms and in her arm pit. Whenever she was wearing clothes it was bothering her skin. No treatment information was provided.   This case was linked to MOD-2021-048012 (Patient Link).
Pancreatitis; Blood sugar spiked very high; This is a spontaneous case, initially received from consumer via agency (reference number: SEQ19-06147) on 04-Nov-2019, concerning a 68-year-old, male patient.   The patient's medical history was not reported.  The patient's concomitant medications included Keprom (ketoprofen) and levetiracetam, both for an unknown indication.  On an unspecified date in 2018, the patient was administered INN Flu Vaccine [influenza vaccine, dose, route of administration, batch number, expiration date and anatomical location: not reported] for unknown indication.   On an unspecified date in 2018, after vaccination, the patient's blood sugar spiked very high and he developed pancreatitis.  On an unspecified date in 2018, the patient was recovered from the events of pancreatitis and 'blood sugar increased'.  The reporter assessed the case as serious but did not provide causality assessment.  The case was linked with 201905879 (due to same patient).  Company comment: The patient experienced pancreatitis and blood glucose increased after vaccination with INN flu vaccine. Chronology is plausible. No medical history and diagnostic findings were provided. Causality was also confounded by therapy with concomitant medications, Keprom (ketoprofen) and levetiracetam. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced pancreatitis and blood glucose increased after vaccination with INN flu vaccine. Chronology is plausible. No medical history and diagnostic findings were provided. Causality was also confounded by therapy with concomitant medications, Keprom (ketoprofen) and levetiracetam. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
48 hours of exhaustion, severe body aches 8 hours of 102°F Fever Left Arm Pain-6 days
Routine Blood Test 8 days after 2nd vaccination/dose detected spike in Kidney BUN and Liver ALT.
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 18-MAR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Pt. had apparent vasovagal episode after vaccine. Observed, went home seeming ok, then had repeated episodes of syncope and near-syncope for weeks: Evaluation included neurology, mildly abnormal EEG, and cardiology including Holter monitor/sleep study.
Aches; Arm soreness; Muscle pain; Chills; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), AXILLARY PAIN (Arm soreness), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included ATENOLOL, CALCIUM, VITAMIN D NOS and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for an unknown indication.  On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Feb-2021, the patient experienced PAIN (Aches), AXILLARY PAIN (Arm soreness), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea).   At the time of the report, PAIN (Aches), AXILLARY PAIN (Arm soreness), MYALGIA (Muscle pain) and NAUSEA (Nausea) had resolved and CHILLS (Chills) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 100 f (High) 100 F and 100.1 f (High) 100.1 F.   No treatment information was provided.
PATIENT HAD ADVERSE REACTION TO PNEUMOVAX 23 AND FLUZONE HD VACCINE; FOUND UNRESPONSIVE IN ROOM APPROXIMATELY 11 HOURS LATER; EMS NOTIFIED AND PATIENT TRANSFERRED TO HOSPITAL FOR WEAKNESS DUE TO VACCINE ADMINISTRATION.
Pt previously had Covid in November. He received the vaccine on 1/14. On 1/15 he woke up with chills, fever, and a headache. Tylenol resolved the fever but he still had a headache. All symptoms resolved by 1/16 AM.
Initial report was received 30 October 2008 from a consumer, who is the patient.  A female patient stated that approximately two weeks ago, she received a flu vaccine manufactured by sanofi pasteur (lot number not reported) and subsequently experienced a severe allergic reaction.  The patient stated her physicians requested she obtain a list of the ingredients for the current years flu vaccine (2008), as well as ingredients for the 2007 and 2006 flu vaccines.  No additional information was provided at the time of the report.  Documents held by sender: None.
Patient states that 1 day post vaccine she started having intense stomach cramping and loose bowel movements which have continued thru today mostly in the evenings or waking her up at night. Today is day 3 of symptoms.
first dose in 2020, second August 9 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose in 2020).   On 9th August 2022, the patient received the 2nd dose of Shingrix. On 9th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was recovered/resolved.   Additional Information: GSK receipt date: 29-Aug-2022 Reporter's comment: The registered pharmacist called on behalf of the patient. The patient did not receive the second dose until 9th August 2022. No demographic details were reported. Did not consent to follow-up. Additional supportive information: The patient received second dose of Shingrix later than the recommended interval, which led lengthening of vaccine schedule.
Itchy at site of injection on 9/29/12. Noticed 2" x 2" round, red, swollen, warm to touch area on arm at site. Took BENADRYL 50mg PO that night gone after 24 hours.
Information has been received from a physician concerning a female patient who on unspecified  dates were vaccinated with two doses of GARDASIL (LOT#s not reported). After the patient receiving the dose 1 her acne flared up and then later subsided. After she receiving her dose 2 her acne flared up again. The patient was seen by physician and the physician has prescribed ACCUTANE. At this time of reporting, the recurrent acne flared up's outcome was unknown. The physician did not want this reported. No further information is available.
A non-serious spontaneous report of a child inadvertently receiving two doses of FLUMIST one month apart was received from a physician concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient required one dose of FLUMIST but inadvertently received two doses of FLUMIST one month apart. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
9 hours later I had fatigue, body aches, headache and nausea. Lasting less than 24 hours. Then about 5 days through 14 days after the shot I had chest pain when lying in bed early in the morning made worse by breathing. That chest pain occurred 3 mornings during that time period.
Severe joint pain (shoulders, elbows, hips, knees, ankles); chills; overall body aches. Lasted a little more than 24 hours, although the severity lessened on the 2nd day. Did not take any medicine to treat symptoms. Resolved by day 3. Enlarged, painful lymph node (right arm pit); lasted 5 days. Dull headache; lasted 3 days.
Began with severe fatigue and transitioned into severe shaking, body chills, aches that stayed for a prolonged period. In the course of trying to bring warmth to the body, I showered and ended up having severe vomiting. The body aches, fatigue, and overall sickness stayed with me for over 48 hours. Two days post vaccination, my left arm was swollen with severe redness. I am still struggling with fatigue and body aches (4 days later) but have regained mobility and strength.
numbness & tingling in feet 10NOV96;progressed into fingers 11NOV96 & 12NOV96;diff walking 13NOV96;inc diff walking  w/weakness that was also noted in the arms 18NOV96;