chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After he had the vaccine he vomited a lot for a couple of days, then he started to have fever recurring until present time. Last fall he was sick less than his younger brother and was not having fever, he did have flu and RSV but no fever to my recollection but after his vaccine everything changed his immune seemed to kick into overdrive from every little germ like his immune system kickeed into overdrive.  So he is having recurring fevers without the rest of the family getting sick, we have had strep and flu this season but the fevers he has or more than those occasions.  His Doctor says it may be an immune response since the vaccine.  After he had the vaccine he now reacts to Gluten or is having a food sensitivity and has gonre a gluten free diet but it has not taken away the fevers but it has helped him with his energy levels.  In summary before the vaccine it was very normal and now his immune system seems ob=verly sensitive.  My theory is that the dose or last vacine was to high for him.
Approximately 2-3 weeks after 2nd shot, I had what might have been a 'silent migrane', dancing, dazzling  3-D prisms at bottom of both eyes, followed by pain on top left side of head from top of skull to the front.  This happened 2 more times over the next month or so. The 4th time, it was just the prisms.  I have also noticed more discomfort on the  left side of my head...not quite a headache, but not exactly right.  Since then I have noticed a decrease in short term memory:  putting something down and not remembering where it is; thinking of something that needs to be done and then forgetting it shortly thereafter; not being able to remember a wanted word;  typing a wrong word.  Since I have never had any sort of migraine in my life, I think these events are connected to the Moderna shot I received.
Vial was initially stored in the fridge on 11-Oct-2022 and administered to the patient on 30-Nov-2022, after 30-days use by date; No adverse event; Vial was initially stored in the fridge on 11-Oct-2022 and administered to the patient on 30-Nov-2022, after 30-days use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the fridge on 11-Oct-2022 and administered to the patient on 30-Nov-2022, after 30-days use by date), PRODUCT STORAGE ERROR (Vial was initially stored in the fridge on 11-Oct-2022 and administered to the patient on 30-Nov-2022, after 30-days 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. 061f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-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 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the fridge on 11-Oct-2022 and administered to the patient on 30-Nov-2022, after 30-days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the fridge on 11-Oct-2022 and administered to the patient on 30-Nov-2022, after 30-days use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the fridge on 11-Oct-2022 and administered to the patient on 30-Nov-2022, after 30-days use by date), PRODUCT STORAGE ERROR (Vial was initially stored in the fridge on 11-Oct-2022 and administered to the patient on 30-Nov-2022, after 30-days use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the fridge on 11-Oct-2022 and administered to the patient on 30-Nov-2022, after 30-days use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in the fridge on 11-Oct-2022 and administered to the patient on 30-Nov-2022, after 30-days use by date).    No concomitant medications were reported.  It was the individual vial with size of 2.5 mL and vial did not underwent the temperature excursion.  No treatment medications were reported.  This case is for the 8th patient of 8 adult patients described by the reported.   This case was linked to MODERNATX, INC.-MOD-2022-680810, MODERNATX, INC.-MOD-2022-680811, MODERNATX, INC.-MOD-2022-680808 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2022-680810:Samer Reporter MODERNATX, INC.-MOD-2022-680808:Samer Reporter MODERNATX, INC.-MOD-2022-680811:Samer Reporter.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not reported. On an unknown date in August 2015, the patients were vaccinated with improperly stored doses of (Merck) PROQUAD Lot# reported as "L008353", expiration date 11-SEP-2016 (administration routes was not reported). No concomitant therapies were reported. No adverse effects were reported. According to the reporting nurse, the doses were exposed to a temperature excursion from 12-AUG-2015 12:30 pm to 14-AUG-2015 5 pm for a total of 53 hours at 13.1 C. This is one of several reports from the same reporter. Additional information has been requested.
Pt vaccinated with DTP/OPV cried constantly for about 30 min had temp of 99. Given nasal gtts at ER & told to continue antibiotics for resp infection.
2 hours after receiving shot started with a dry cough, full sinuses within an hour or so of cough, had chills, fever 101 +, and unbelievable aches.
Swelling, redness, severe pain at site of injection; severe fatigue and not feeling well.
Fever, body aches, swollen injection site, red injection site, sore injection site, sore muscles in back, neck and arm pit on left side
ACHINESS AND HEADACHE- A LITTLE OVER 24 HRS STARTING THE NIGHT VACCINE WAS RECEIVED. RASH ON NEC, CHEST, UPPER BACK AND STOMACH STARTING 2ND DAY AFTER VACCINE. LASTED A LITTLE LESS THAN 24 HRS. TOOK TYLENOL AND MOTRIN
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: pt reports soreness and redness and swelling at injection site; inquiring if normal; characterzied as mild
Headache, fever, chills, nausea, coughing, sore throat.
pt recvd 1 dose of Engerix-B @ 3PM & exp a grand mal seizure from 6-7PM; the event resolved;
UNKNOWN   ED to Hosp-Admission Discharged  7/5/2021 - 7/10/2021 (5 days)  Hospital  DO Last attending ? Treatment team MVC (motor vehicle collision), initial encounter
This spontaneous report as received from a registered nurse (other health professional) refers to three patient of unknown age. Pertinent medical history and concomitant medications were not reported. On 27-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M017983, expiry date 30-MAY-2018, for prophylaxis which were improperly stored (incorrect product storage) temperature/ time: 35.6 F for 24 hours and call was not because of data logger. Previous temperature excursion was 59.4F for 1 hour and AE was administered. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to M-M-R II. No adverse effects were reported. No further information provided. This is one of two reports from same reporter. MARRS # 1701USA003719 Additional information is not expected as the reporter did not give us consent to contact physician.
Patient had Varicella vaccination about 3:30 pm. His mother drove him to football practice. About 5:00 PM he took a very hard hit. 15-30 minutes later he started to experience tongue swelling, tingling and numbness of the tongue and one side of his face. One eyelid twitching and closing. Air evacted to hospital. Later transferred to another hospital. Still hospitalized, can't swallow, has had aspiration pneumonia.  9/22/09 Hospital records received DOS 8/20/09 to 9/4/09. Assessment: Lateral medullary infarct/Wallenberg Syndrome. Patient admitted after football injury, hit on left side of face. Later developed numbness on left side of face and tongue. Problems with swallowing and ataxia. Aspiration pneumonia, dysphonic voice. Scissoring and steppage gait. Deficits of ADLs. NG tube feeding. Impairment of cognition.  ICD-9 Codes: 959.01, 434.91, 507.0, 781.2, 787.20, 754.70, 351.0, E886.0 E849.4, V57.89, 438.11, 438.84
28JAN93 5 minutes p/vax pt became pale & fell to floor, eyes were rolled back & there was some slow movements of the upper extremity which only lasted a few seconds; paramedics were called & pt was released home to mom w/instructions;
Initial report received on 11 March 2010 from a health care professional. A 16 year old male patient, with no allergies and no medical history, received a first dose of MENACTRA (lot number unknown) on 04 March 2010. The vaccine was not administered at the reporter's facility. Upon waking on 10 March 2010, the patient experienced back pain from his neck to his tailbone and he had a little dizziness. On 11 March 2010, the back pain continued and was more intense on movement. The patient had no headache and no weakness. He had not taken any medication for the pain. At the time of the report, the patient's recovery status was unknown. Follow-up information was received on 22 April 2010 from a healthcare professional. The MENACTRA lot number was U3012M and the site of injection was the right deltoid. The treatment medication was ibuprofen 600 mg, once every 8 hours as needed. He was expected to return to the clinic 21 April 2010. At the time of this report the patient had not recovered.
Urinary tract infection, hypotension, ureteral stone, Severe sepsis without septic shock. Several ED visits and hospital admissions within 6 weeks of receiving COVID vaccine.
At injection site, took shot on Friday, by Saturday morning, was achy all over, entire arm where injection took place felt as though someone had hit me with a board, very sore could hardly use the arm, today Monday the 20th I still have a hard 3 inch in diameter spot, red, very itchy.
SHOT WAS GIVEN ABOUT 1 INCH ABOVE ELBOW. ARM WAS SWOLLEN, RED AND SORE. ON 10/29/18, CLIENT STARTED NOT FEELING WELL (WEAK, STOMACH PAIN, ETC.). BY 11/1/18, HE WAS SO WEAK HE COULDN'T GET WOULD OF BED, EVEN TO GO TO THE BATHROOM. HE WAS INCOHERENT. 911 WAS CALLED. HE WAS ADMITTED TO HOSPITAL, WHERE HE STAYED FOR 3 DAYS.
Patient received  both the Flu and Pneumonia Vaccine.  Shortly after she  became unresponsive in her chair.  Her son and I moved her to the ground.  After a few seconds she became responsive.  We had her lay for a few minutes and then helped her up to the chair.  I sat with her to ensure  she was ok.  She then told me that she passes out often and felt it coming  on but didn't say anything because she felt silly.  I called the patient later and she said she was doing great.
Mom stated child became ill and she took him to their PA on Wed December 3. He had bronchitis. PA did not feel there was any relationship of his illness to vaccines. He had seen PA on Nov 25, the day before immunizations were given and he was fine then.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 01/20/2021 and 02/17/2021. They tested positive for COVID-19 via antigen test on 10/27/2021 at the mental health facility at which they were a resident. They were admitted to hospital 10/27/2021 for hypoxia, even with oxygen supplementation. Their overall condition continued to decline. They remained hospitalized until their death on 11/01/2021.
pt recv vax 24APR97 & 1hr later pt devel urticarial, irregular rash described as red blotches on abd, arms & inj site;pt was exam by MD;papules were noted around the site of the tuberculin skin test;pt rash faded;t102;
Numbness and tingling down my left arm to my middle and ring finger; Numbness and tingling down my left arm to my middle and ring finger; Occasional thoracic spasms; chills; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELD26U, expiry date: unknown), via an unspecified route of administration in the left arm, on 05Feb2021 09:00, at single dose, for COVID-19 immunization, at a physician's office. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3303, expiry date: unknown) received at 57 years of age, via an unspecified route of administration in the left arm, on 15Jan2021 10:45, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 06Feb2021 at 10:00, the patient experienced "numbness and tingling down my left arm to my middle and ring finger and occasional thoracic spasms and chills". It was unknown if treatment was provided. The outcome of the events was unknown. The reporter assessed the events as non-serious.
Stomach pain for several hours then diarrhea.  Then vomiting.  Fainted on the bathroom floor and was found by my husband.  More diarrhea and vomiting.  Now just a headache.  Lost 7 pounds in one night due to diarrhea and vomiting.
17JUL92 pt recvd 1st dose of Engerix-B vax & 2 wks later devel nausea, vomiting, inc liver test, elevated white blood count & fatty liver; pt was hospitalized for an unk length of time & recovered;
This spontaneous report as received from a registered nurse refers to an infant patient of unknown age and sex. On an unknown date the patient was vaccinated orally with the first dose of live, oral, ROTATEQ. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient was due to receive Dose 2 of live, oral, ROTATEQ on an unspecified date but "got sick" (unspecified illness) shortly before the appointment so the patient did not receive Dose 2. This occurred sometime in the past (unspecified date) and the patient never returned for Dose 2. The nurse reported that at the present time the patient was older than 32 weeks of age. So far the patient had received only one dose total of live, oral, ROTATEQ and would not be receiving any further doses. Dose 1 of live, oral, ROTATEQ was administered correctly according to the prescribing information. The outcome of "got sick" was unknown. Additional information has been requested.
Product temperature excursion; Patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 54-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Resident was observed closely s/p COVID-19 vaccination on 1/12/2021 for 30 minutes per plan of care. No c/o of pain or discomfort. No adverse reaction noted. Overnight shift continued to monitor with no alteration to baseline. No c/o breakthrough pain reported, slept well. Received by AM RN on 1/13/2021 alert and verbally responsive at baseline. Multiple staff assisted with needs including colostomy care, meals, ADLs etc with no change reported by resident or observed by staff. During routine med rounds at appx 11:45am, RN on duty observed pt was non responsive verbally or to tactile stimuli. Assessed immediately with no rise and fall of chest, no pulse, no resp.
6 hours after injection, mild headache, painful injection site and fatigue.  18 hours after vaccination, fever of 99.8, sore muscles, very painful injection site, extremely fatigued.
This spontaneous report as received from a nurse practitioner refers to a 15 months old patient of unknown gender. On 12-NOV-2012, the patient was vaccinated with dose 1 M-M-R II (dose, route and lot # not reported). Secondary suspect therapy included on 12-NOV-2012, dose 1 PROQUAD (Merck) (dose, route and lot # not reported). No concomitant medications were reported. The nurse stated that there was no adverse symptoms. Additional information has been requested.
Left leg swollen to double the size. Hard all the way up and down both sides of thigh. Red and warm to touch.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
double sided Bells Palsy; Gullian Barre Syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), 7 days after the suspect product(s) administration, outcome "recovering", described as "double sided Bells Palsy"; GUILLAIN-BARRE SYNDROME (medically significant), 7 days after the suspect product(s) administration, outcome "recovering", described as "Gullian Barre Syndrome". The patient underwent the following laboratory tests and procedures: Lumbar puncture: double sided Bells Palsy and Gullian Barre Syndrome. Therapeutic measures were taken as a result of bell's palsy, guillain-barre syndrome. 2 and half years later the patient was still recovering and going to the cancer center every other week to receive IVIG treatment. This is going to be for the rest of patient's life.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was given Moderna and not Pfizer. Patient did not meet qualification to receive Moderna as she is 16 years.
mild bleeding at injection site and mild swelling at site. happened right after vaccination and patient was fine soon after when he left the pharmacy and he had no concerns
Mother called in today and reports that when pt woke up this AM she, mother, found that pt had a red area the size of a baseball on her lt upper arm. Also states that she had a hard area the size of a silver dollar in the center of the red area. Denies that it was there last night. Also denies any fever. Denies any other illnesses.
He had hardly any side effects for the 1st 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses). At the time of the report, IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant product use was reported.  No treatment information was reported.   This case was linked to MOD-2022-562710, MOD-2022-563454 (Patient Link).
Vaccine administration error - Janssen Covid-19 vaccine administered to patient under the age of 18. No adverse reaction noted within 30 minutes of observation time following vaccine administration.
Patient has had COVID 3 times; Patient has had COVID 3 times; Long Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "transplant recipient" (unspecified if ongoing), notes: was a transplant recipient 17 years ago. There were no concomitant medications. The following information was reported: POST-ACUTE COVID-19 SYNDROME (medically significant) with onset 2019, outcome "not recovered", described as "Long Covid"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2019, outcome "not recovered" and all described as "Patient has had COVID 3 times". The patient underwent the following laboratory tests and procedures: test: Unknown results; Protein total: continued to be high, notes: protein levels have continued to be high.  Clinical course: Caller was positive with COVID in 2019, she brought it home from a student and then patient got it. She doesn't know where patient got COVID the next two times. Also clarified that she thinks one of patient's vaccines were by Pfizer. Clarified patient took the Johnson and Johnson COVID-19 Vaccine. Patient tried to do another one as a follow-up booster, but had such an adverse effect she didn't proceed with further vaccination. Patient has had COVID 3 times and she's been vaccinated. Patient is now experiencing long COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.