chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had my booster shot on last Friday; I had my booster shot on last Friday; my arm is swollen; I have a big red ring around it; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received booster dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 01Oct2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on an unknown date as DOSE 2, SINGLE and also received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on an unknown date as DOSE 1, SINGLE both for covid-19 immunisation. The patient had booster shot on last Friday and on an unknown date in Oct2021 had some minor, minor things but they went away and the patient's arm was swollen and it looked like the patient have a big red ring around it. The patient asked if they should be concern about that. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Arm pain, shoulder pain, armpit pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Arm pain, shoulder pain, armpit pain) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seizure, Acid reflux (oesophageal) and Cholesterol. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), LEVETIRACETAM for Seizure, ZOLPIDEM TARTRATE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced PAIN (Arm pain, shoulder pain, armpit pain) and CHILLS (Chills). On 21-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN (Arm pain, shoulder pain, armpit pain) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-059497 (Patient Link).
Moderna COVID-19 Vaccine EUA first dose given at 6pm.  Mild pain at injection site within a few hours.  3am (9 hours after injection) I went to the bathroom, and while standing got dizzy and lightheaded tried to sit down.  Collapsed while trying to sit down and hit head on bathroom floor.  Cut right eyebrow on floor.  Tried to get back to bed and was in and out of consciousness for 30-60 seconds per spouse.  Vasovagal response symptoms.  Cold sweats.  I was very thirsty and drank a tall glass of water.  5 minutes later I stood up and went back to bed feeling fine.  I slept the rest of the night and felt fine the next day, and for the rest of the weekend with no other symptoms.
pt recv 29OCT97 P 13NOV97 pt devel a varicella like rash;pt was covered w/lesions;
About 9pm on July 15, 2021, my daughter started to feel a tingling sensation on her face. Between 9:30pm-10:30pm she gradually begin to have mild to severe numbness in her face, legs, chest and arms and her heart was beating rapidly. She told us she feels that she?s going to die. We took her to the emergency room where heart rate rose as high as 175bpm and the numbness got worse
I initially developed seborrheic dermatitis several months ago. A few weeks after I developed a tremor in my left arm. I was seen by a neurologist because it was suspected diagnosis of Parkinson's in January 2022. SPECT scan confirmed possible Parkinson's disease. I was started on Sinemet 3 times a day and subsequently on the 28th of February I was switched to Carbidopa / Levodopa immediate release at first, but now on continuous release. which I'm taking now. I also noticed some initial balance issues at onset. Symptoms have improved, but not recovered.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 03-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml in the left upper arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
Headache; Upset stomach; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) and ABDOMINAL DISCOMFORT (Upset stomach) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20A) for COVID-19 vaccination.     Concomitant products included MORPHINE, DULOXETINE, CYCLOBENZAPRINE and OMEPRAZOLE for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (Headache) and ABDOMINAL DISCOMFORT (Upset stomach). On 11-Mar-2021, HEADACHE (Headache) and ABDOMINAL DISCOMFORT (Upset stomach) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports that he had a headache and upset stomach in the morning. He thought it was related to taking his pills before he ate. Patient reported he felt better after he ate breakfast.   No treatment information was reported.
one dose of Menveo when was 2 months old; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose received in January 2010, at the age of 2 months old, batch number A410A818A).   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of menveo,which led to incomplete course of vaccination. The reporter was not sure that it was a Menveo vaccine and the lot number was not clear. no expiration date The reporter conented to follow up. This case was linked with case US2020213887 and US2019073149, reporte by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020213887:same reporter US-GLAXOSMITHKLINE-US2019073149:same reporter
severe chills for 1 hour then fever followed by a headache   Chills were so bad that I couldn't control my body. I could not stop shaking , I could barely walk,  and elevated heart rate
Initial unsolicited report received from non-healthcare professional on 20 May 2015. A female patient (age not reported) had occupational exposure while administering product PENTACEL (batch number C4879AB, expiry date not reported) on 20 May 2015. The patient's medical history and concomitant medications were not reported. On 20 May 2015, when removing ACTHIB component vial of PENTACEL from the box the patient received a small, finger laceration due to broken vial. Laceration was treated with first aid measures and no stitches were required. Laboratory investigations and corrective treatment were not reported. The event outcome was unknown. Documents held by sender: none. Addendum: 23/June/2015. Upon second medical examination of case at time of internal review the following has been modified in this case. Significant correction was done to correct the event coding and drug/Vaccine PTC box checked.
Information has been received from a physician concerning a 22 year old female patient who three years ago, in 2007, was vaccinated with 3 doses of GARDASIL. In March 2010, the patient developed HPV and that included type 18. A laboratory diagnostic study was performed to confirm the HPV type. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Had chicken pox in 1959. First pox appeared rt. lower eye lid at point where eye lashes grow (center of lid) after those blisters healed, no eye lashes ever grew back. Day after I received shingles,
Vaccine given 8/8/2012, 11/21/2012. 1st shot - had a fever and sore throat - negative for strep. Noticed lump on side of neck below ear in the same spot approx 2-4 weeks following vaccine. Plans to see doctor to assess the lump.
This case was reported by a consumer via call center representative and described the occurrence of herpes ophthalmic in a 78-year-old female patient who received SHINGRIX for prophylaxis. On 25th April 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a year after receiving SHINGRIX, the patient experienced herpes ophthalmic (serious criteria GSK medically significant) and blurred vision. The patient was treated with VALTREX, ZIRGAN and prednisone. On an unknown date, the outcome of the herpes ophthalmic was recovering/resolving and the outcome of the blurred vision was recovered/resolved. It was unknown if the reporter considered the herpes ophthalmic and blurred vision to be related to SHINGRIX. Additional details were provided as follow: This case was not reported to anyone previously. The patient received SHINGRIX on left arm. In late May, the patient developed ocular herpes and blurred vision. In June, the patient went to the healthcare professional (HCP) and was diagnosed with ocular herpes and blurred vision. The HCP put her on VALTREX, ZIRGAN and Prednisone. The patient had been advised to contact their physician and Product Information (PI) was offered. The patient had denied permission to contact their physician. No further information was available.
Flushing/sweating, light-headed. Vitals wnl. Anxious about shot.
9 hours after the vaccine I had a sudden onset of flu-like symptoms. I had a fairly severe pounding headache, muscle aches, and felt very hot and cold. I was warmer than normal but did not have a full fever. I was extremely fatigued. Most of these symptoms subsided in about 24 hours with acetaminophen. I am still having occasional (every other day) mild headaches and shortness of breath, heaviness in the chest, and a couch that have persisted 5 days so far.
Headache; Chills; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th December 2019, the patient received the 1st dose of Shingrix. On 2nd January 2020, 3 days after receiving Shingrix, the patient experienced headache, chills and upset stomach. On an unknown date, the outcome of the headache, chills and upset stomach were unknown.   It was unknown if the reporter considered the headache, chills and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient experienced headache chills and an upset stomach in the night of 2nd January 2020. The patient asked, did it usually take this long to have a side effect.
PT COMPLAINS OF "PROBABLE" ANXIETY ATTACK. SYMPTOM CONSISTANT SLIGHTLY ELEVATED RES. NO OTHER OBVIOUSE SYMPTOMS. PT MOST COMFORTABLE IN TRIPOD POSITION. BP 148/82 HR 75 O2SAT 99 SKIN WARM AND DRY AT 1420 PT PLACED UNDER OBSERVATION. PT STATED SYMPTOMS CONSISTENT WITH MILD ANXIETY ATTACK PREVIOUSLY EXPERIENCED. ONSET PRIOR TO VACCINATION. 1435 BP 120/82 HR 77 RESP 12 O2SAT 99 SKIN WARM AND DRY CAP REFIL LESS THAN 2 SEC. RESPIRATORY BREATH SOUNDS CLEAR BILATERALLY. FOLLOW UP TREATMENT OF REASSURANCE.
sore throat, fever, cough - gave tylenol and cough syrup, by 5:00 pm she was running a high fever and the tylenol would break it and the fever kept coming back until 10/10/09 about 11:00 AM fever finally broke.
Approximately a week after shot  got 104 temp Went to emergency room. Have and had muscle aches, lethargy, an inability to concentrate. Got severe diarrhea and this  is still and issue although not as severe(was incontinent during first few months)
I developed Tinnitus approximately one week after getting the second dose of Pfizer. At first it would come and go but now it's been a consistent high pitched ringing in both ears for the past 10 days that gets worse at night. It causes a headache and it feels like an extreme pressure inside my head and my ears. It also causes anxiety because of the trouble sleeping due to the noise.
Patient is experiencing shoulder pain months after the shot was administered. pt states he didn't think anything of it, but now still has dull pain. believes the shot may have been administered too high
Numb sensation came over entire body; face, arm and leg remained feelingpartially numb for the next 24 hours.; Right side of my face had a numb sensation; Felt like loosing the sensation.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 21Apr2021 at 11:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included human leukocyte antigen (HLA-B27) positive (creates inflammation issues), iritis (outer iris eye inflammation), bell's palsy (the patient never had a stroke but have had bell's palsy in 2009 which took 3 months to recover) and stress. 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 COVID vaccine. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (MICROGESTIN FE 1/20), bupropion (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); all were from unknown date and for unspecified indication. The patient previously took CECLOR on an unknown date for unspecified indication and experienced drug allergy. On 21Apr2021 at 11:45, fifteen minutes after the vaccine, the patient experienced right arm (injection side) and right side of face numb sensation, could feel the temperature of fingers and pinches on arm and face but felt like she was losing the sensation. It almost felt like the patient were to have a stroke. The feeling she had on face was exactly how bell's palsy felt initially, but then again, she was able to move all her muscles and feel. Twenty minutes after the vaccine, the numb sensation came over entire body. This lasted about 1 minute and then resided however, the right side of face, arm and leg remained feeling partially numb for the next 24 hours. Due to this scary reaction, the patient stated that she would not be taking the second vaccine, until more information is released on its connection to nerve inflammation, bell's palsy and the proteins the vaccine uses. 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 the result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right arm (injection side) and right side of face numb sensation, could feel the temperature of fingers and pinches on arm and face but felt like she was losing the sensation, face, arm and leg remained feeling partially numb , the numb sensation came over entire body were recovered on 22Apr2021.  No follow-up attempts are needed. No further information is expected.
chills 1 day after vaccine administration; found dead by family 1/18/2021 Narrative:  Per patient family report, patient said the next day after vaccination that he didn't feel well because of chills. Patient was found dead at home by his family on January 18th. He was a 74yo man with castrate resistant prostate cancer and liver and bone metastases with rising PSA, status post intravenous chemotherapy 1/7/21
Was shaky; Didn't feel good overall; Fever; Chills; Very tired; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of TREMOR (Was shaky), MALAISE (Didn't feel good overall), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Very tired) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy, OMEPRAZOLE for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced TREMOR (Was shaky) (seriousness criterion medically significant), MALAISE (Didn't feel good overall) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), FATIGUE (Very tired) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, TREMOR (Was shaky), MALAISE (Didn't feel good overall), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Very tired) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: This case concerns a 50-year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of tremor, malaise, pyrexia, chills, fatigue, headache. The events occurred on the same day after the second dose of mRNA-1273. The rechallenge is not applicable since the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-403240, MOD-2021-403241 (Patient Link).; Sender's Comments: This case concerns a 50-year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of tremor, malaise, pyrexia, chills, fatigue, headache. The events occurred on the same day after the second dose of mRNA-1273. The rechallenge is not applicable since the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, 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 12-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    No concomitant medication was provided by reporter.  Nurse supervisor reports that they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date. Lot number AS7168B, beyond use date 08Jan2023. Administration dates are as follows: 09Jan2023 (2 patients) 10Jan2023 (2 patients) 11Jan3023 (4 patients) 12Jan2023 (4 patients) 13Jan2023 (3 patients). All of the patients were 12years and above, but HCP did not have the information if some of them were below 17 years old.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:case
Major swelling of shot area. Anaphylactic shock. Extreme breathing issues. Loss of balance.
Patient reports ongoing pain in her arm since the time the vaccine was given. Pain is intermittent and presents as a brief stabbing pain, or general soreness in the arm
Patient went to primary care provider's office with c/o chest pain or discomfort and pain in her arm at site of administration. Patient received prescription for pain and was released. No other adverse effects reported, patient's symptoms abated next day.
Cerebral venous sinus thrombosis (CVST) of the left transverse sinus.  (Normal platelets)
Swelling on both underarms, left side was more swollen and sore Achy, weak, tired for about 36 hours
This spontaneous report as received from a nurse refers to a female patient of unknown age. The nurse reported GARDASIL which expired on 11APR2015 was inadvertently administered to a patient on 28APR2015. No adverse effects reported. No additional information was provided. Additional information is not expected.