chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 15JUL98 & several hr post vax pt exp extreme, generalized itching, hives & blotches on face;16JUL98 pt felt uncomfortable & exp chest pressure & some diff breathing;semi-faint;lung capacity abn;
soreness in her arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm) and FATIGUE (tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (soreness in her arm) and FATIGUE (tired) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-089523 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received: No significant information was found.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089523:Cross linked with Dose 2
Patient presents with local site reaction including upper arm redness, swelling, and hot to the touch.
Pt was given high dose flu vaccine instead for regular dose. Pt. did not need any additional treatment.
Approximately 5 hours after injection, I had cold chills and muscle aches. The next day, I was lethargic with some muscle aches. Approximately 48 hours after injection, I'm having moderate joint pain.
Phone report of low grade fever, cold like symptoms, and warmth and redness at injection site on 9/12/13 for shor received on 9/10/13, no treatment, symptoms reported by phone with no exam or vitals as patient denied clinic visit.
Subsequent to receiving varicella virus vaccine live, the pt developed a "full blown case of chickenpox". The pts sister had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
Lethargic Back ache Muscle weakness Fever 100.6-101.6
pt recv vax 9DEC97 130PM;11DEC97 in AM had sx of nasal congestion,h/a, productive cough was seen in ER x 2;tx expectorant sx lasted approx 1wk;
Brief burning at time of injection. Soreness at injection site developed over next hour, muscle pain in arm over next several hours; both subsided within 48 hours. Severe shivering fit and muscle cramps/tightness on evening of injection day (11/08/2019). Headache, nausea, fatigue, muscle aches throughout next day. (11/09/2019) Continuing, but reduced fatigue and malaise the following day (11/10/2019) Interfered with/prevented normal activities for ~48 hours
FLUZONE administered 11/15/10 (L) arm 11/16/10 mom called office to state "pts (L) arm numb, looks pale & blue seen in office 11/17/10 to watch.
10 days after the first vaccination I developed Shingles on my back.  Confirmed by doctor via videocall on 04/01/2021.  I had Chicken Pox as a child but never before had Shingles..  At that time I had not taken Shingrex, the Shingles vaccine.  Subsequently I have had the first shot of Shingrex.  I was most fortunate in that I must have had the mildest case of Shingles ever, as I never felt any itching or pain.  It's not clear whether the Moderna vaccine was the causal agent of Shingles.
Restless Sleep on the first night; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 17:15(at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 17Mar2021 at 22:00, the patient experienced restless sleep on the first night. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event restless sleep was recovered on an unknown  date in Mar2021.   No follow-up attempts are needed. No further information is expected.
high blood pressure; weakness; unable to stand; rapid heartbeat; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number EN9581) via an unspecified route of administration, administered in Arm Right on 18Feb2021 10:00(Age at vaccination was 80 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, bronchitis chronic, asthma, covid-19 on 19Oct2020. The patient previously took percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced drug hypersensitivity. No other vaccine in was received in four weeks. Concomitant medication(s) included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); ibuprofen (IBUPROFEN); esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) all taken at 12.5 mg for unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. The patient had identical side effects after initial dose of vaccine.  On 19Feb2021 08:00 patient experienced high blood pressure, weakness, unable to stand, rapid heartbeat. Went to emergency room by ambulance on 19Feb, patient still experiencing weakness in legs and arms. No treatment was received for adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included blood pressure measurement: high on unspecified date, heart rate: rapid on unspecified date, sars-cov-2 test: unknown result on Oct2020. The report was non-serious. The outcome of events was recovered with Sequel.  Follow-up attempts completed. No further information expected.
Pt had red patch with petechial appear to R cubital area in 1 hr after vaccine given (vaccine of deltoid area). Pt had similar reaction last summer to THYROGEN injection. I believe pt had fixed drug reaction.
Patient states that she developed muscle weakness of bilateral upper and lower extremities which lasted for 48 hours after receiving vaccine, and which resolved spontaneously without treatment. She did not seek care for these symptoms.
Chills , Fatigue , Severe Head Ache , Body Aches , congestion , fever
Had chills all night. Severe headache and body aches started around 10pm (vaccination was around 11am). I felt great for a few hours immediately following vaccination but developed severe light-headedness that evening. Passed out the following morning (01/01/2021) and my daughter called 911/ paramedics. I declined going to the hospital but I still feel horribly dizzy and ache.
61 y/o male with PMH significant for HTN, HPL, DM, CAD, GAD, PTSD, panic disorder, and depression, reports numbness and tingling in right arm and leg at a visit approximately 1 month after H1N1 injection. He did not mention this complaint at other visits immediately after the injection. He says that a few hours after injection, he developed numbness of the entire right arm and all fingers, which progressed to the point where he could not do buttons with the right hand. This lasted about a month, and now has completely resolved. Nerve conductions were performed. Right median sensory, right median motor and right ulnar motor responses were normal.
tested positive for Covid19; tested positive for Covid19; sick; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on an unspecified date in late Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for Covid19 a couple of weeks later, has been sick for about 2 1/2 weeks. Patient would like to know that when he can get second dose. The patient underwent lab tests and procedures which included Covid-19 (sars-cov-2 test): positive on an unspecified date in Aug2021. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug Ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from a nurse refers to a 14 year old patient of an unknown gender. On 13-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot# K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
FERRITIN DROPPED TO ALMOST BARE MINIMUM; TROUBLE WITH STAMINA; This spontaneous report received from a parent concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced ferritin dropped to almost bare minimum, and trouble with stamina. Laboratory data (dates unspecified) included: Ferritin (NR: not provided) dropped to almost bare minimum. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the trouble with stamina and ferritin dropped to almost bare minimum was not reported. This report was non-serious. This case, from the same reporter is linked to 20211044338.
Diarrhea; Fatigue; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Headaches). At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment include (Pepto-Bismol) and yogurt in order to mitigate the diarrhea. No concomitant medication reported
Patient experienced common side effects of vaccine but described it as very exaggerated. She felt extremely fatigued and had a "hangover" feeling. This lasted overnight. Although these side effects are common, the patient still wanted to file a report.
Symptoms of generalized ascending paresthesias with right hand weakness since May 18,  2021,  first right foot then left, then ascending to the trunk and upper extremities. As of June 21 left with residual right hand weakness and paresthesias.  second Covid Pfizer vaccine given May 19, 2021
Patient had a reaction within 2 hours after returning home from the vaccination.  Patient had to go to Hospital ER 24 hours later.  Angioedema Was put on IV with steroids' and antibiotics to bring down the angioderma
Employee received 2nd dose of Hep A/B TwinRix on 5/11/09.She had no problems with 1st dose on 1/12/09. Within an hour of receiving the shot, her arm at injection site started to hurt with pain and tingling going into the neck and up to face.  This lasted off and on for about 1 hr, then dissipated.  Thirty hours later she became febrile with aching all over.  Temp. went to 102.5 and remains over 101 today with flu like symptoms continuing. Follow-up Information 14-May-2009: The client went to the doctor on 5/13. She had the rapid flu test which was negative. The doctor stated he was not sure what it was but if the fever continued for another couple days, she was to contact the doctor and they would send the specimen to the state for testing. She has a temp this morning of 101.8 and feels very ill. She is not coughing but does have a sore throat.
Passed Out, has concerns; This serious case was reported by a physician via sales rep and described the occurrence of passed out in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced passed out (Verbatim: Passed Out, has concerns) (serious criteria GSK medically significant). The outcome of the passed out was unknown.   It was unknown if the reporter considered the passed out to be related to Shingrix.     It was unknown if the company considered the passed out to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-APR-2023 Customer relationship management request sent in by sales representative on behalf of health care professional reported two patients within 1 month that passed out post Shingrix vaccination shot and had concerns.  The vaccine administration facility was the same as primary reporter. No additional details were provided.  Unknown if follow up was permissible. This case has been linked to the case US2023AMR062251 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR062251:Same reporter
c/o "out sick next day. Vomited, chills, nausea, hot/cold, lot of pain at injection site" after vaccination.
Arm severely tender to the touch, joint pain, muscle pain, chills, fever 103.6, dizziness, neck pain, burning in back. Brought to doctor on  (10/29/2015) the doctor doesn't know what it is. It has been 4 days now (10/30/2015) he is still with fever and body pain, bruised, raised and hotter than body at injection site on left arm, it is still on going.
Student developed pain, tenderness, redness, swelling 1.5 inches in diameter (flat) and warm to touch at injection site, approx. 1 hr. post injection. Pt iced area.
Patient recently diagnosed cirrhosis felt secondary to NAFLD, DM2, AAA s/p repair 2015, HTN, and nephrolithiasis. Recent complicated admission to Hospital 10/29-11/3 for decompensated cirrhosis, AKI with creatinine 2.3 and asymptomatic SBP. Readmitted 11/9-11/11/2021 with recurrent AKI, this time treated with lithotripsy, basket extraction and right ureteral stent placement. ED to hospital admission within 6 weeks of receiving the COVID vaccine.
Patient states that the following day he noticed redness, numbness, and tightness in the arm but it has been improving. Patient still experiences some tightness and an "unusual" feeling.
Pt. rec'd Hep B vaccine instead of Hep A No treatment required. Pt. contacted to return to correct Hep A vaccine.
Developed a rash that spreads all over body on 12-29-021. Rash described as blistery looking that itched intensely. Was treatment at hospital on 12/30 with steroids. taken to another hospital twice in January and treated. Taken to the hospital around January 16, 02 and was diagnosed per blood work with severe reaction to the MMR received in Dec, 01. Now on cortisone creams, Has residual white patches all over arms and legs. Rash has resolved. May have skin grafts in the future.
Patient came out in the hallway and sat by the garbage can. I told him to go sit in the room with it. Nurse went in and said he was pale with blue lips. She laid him down, put his arm above his head. He was on his right side. After a minute or so his color started returning and nausea went away.
Patient signed up for vaccine online for a Moderna booster. At point of registration, when asked for vaccine card and identification, patient only presented Janssen vaccine card which reflects administration date of 04/01/2021. Patient proceeded to vaccine table, answered required questions and was administered vaccine.  No signs or symptoms of distress noted. Patient wife also registered and signed up for same booster and at vaccination table she presented two vaccine cards reflecting Janssen and Pfizer (2doses). We informed her that she was not in need of a booster as she has fulfilled her CDC requirement and had already received 3 doses. She states that her husband just got vaccinated with Moderna booster (4th dose) at which point we caught the med error. Patient remained stable and no signs of distress, alert and oriented x4. Informed patient of med error and advised him to contact his Provider if he has concerns and ED precautions if he develops worsening or life threatening symptoms.
LARGE RED SWELLING AND PAIN AT INJECTION SITE 10 DAYS AFTER ADMINISTRATION, VERY WARM TO TOUCH, 3 DAYS AFTER INITIAL SWELLING, A RED RING APPEARED AROUND THE SITE AND LASTED FOR ANOTHER 4 DAYS.
Sore muscles joints head feels to be in a twist, awful stiff. Change in behaviour, wheezing hard breathing, very weak, unsteady to walk or stand. I forgot I bad hellva time in 1976. I was so darn bad young. Dr said I got tennis elbow.
administered from a vial that was at room temperature for more than 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered from a vial that was at room temperature for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered from a vial that was at room temperature for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered from a vial that was at room temperature for more than 12 hours) 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.   Concomitant medications were not reported.
patient developed flushing face ears neck and upper chest redness and hot sensation about 15 minutes after the first Moderna shot.  no wheezing  no shortness of breath  no itching.   she drove from the drive through vaccination site to the Clinic.  Photos taken.   the flushing was resolving by 90 minutes after the vaccination.    she did have some throat tightness.  no stridor  no swelling of the conjunctiva tongue or lips.
This spontaneous report as received from a 73 year old female consumer with blood pressure abnormal and cholesterol abnormal refers to herself. The patient had no drug allergies. On 17-SEP-2014 the patient was vaccinated with ZOSTAVAX (strength, dose, and lot # not reported), one single shot, subcutaneous injection. Concomitant therapies include "unspecified blood pressure and cholesterol medication". On 17-SEP-2014, the patient experienced redness and itching at the injection site. No treatment was given. No lab was performed. The patient did not sought medical attention. The outcome of redness and itching at the injection site was reported as not recovered/not resolved. Additional information is not expected because no reporter's contact information provided.
Patient describes rash on injection site that still exists 16 days after receiving injection. Rash descipates
Chills 17 feb 7pm-18feb 11pm The rest occurred during the day 18feb21 Fever 9am-11pm highest 101 Headache 9am-11pm Fatigue 9am-11pm only out of bed for bathroom  Achy muscles and joints 9am-11pm Worsened tinnitus 9am-11pm Missed meals.
chills; eyes were burning; tightness between eyes; headache; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (tightness between eyes), EYE IRRITATION (eyes were burning), CHILLS (chills) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Sinus infection on 31-Dec-2020. Concurrent medical conditions included Headache (Had headache before receiving the vaccination.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced OCULAR DISCOMFORT (tightness between eyes) and HEADACHE (headache). On 11-Feb-2021, the patient experienced EYE IRRITATION (eyes were burning). On 12-Feb-2021, the patient experienced CHILLS (chills). At the time of the report, OCULAR DISCOMFORT (tightness between eyes), EYE IRRITATION (eyes were burning) and CHILLS (chills) outcome was unknown and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Treatment activities for event was done with Antibiotics.
Expired Flulaval administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 7K95C, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: The case was reported by nurse. Nurse reported that patient inadvertently administered an expired Flulaval expiry date 30th June 2022 on 14th October 2022. Reporter did not consent to follow. Additional supportive information: As patient administered expired dose which led to expired vaccine used.