chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 2AM mom called the doctor on call Dr. Mom stated patient developed a stutter while playing video games and was concerned. Per mom patient was alert and aware of time and place. Mom was advised to observe patient and see how he is doing in the morning. I called mom this morning at 11:45am. Per mom stuttering had stopped and patient was fine.
PREVNAR 13 given SQ in right arm. Area initially was bruised per right lateral arm. Injection painful. within approx 3 hours, site became red, firm, swollen of approx 4 cm area. Cool pack applied intermittently and Ibuprofen taken q 6 hours x 4days.
About 12 hours after receiving the vaccine I developed a temperature of ~101 that is not responding to NSAIDS. Muscles are achy. Joints are achy. Hips feel out of place. Difficult to walk. Comparable to actually having the flu, if not worse.
The day after the vaccine I felt very tired and I got so dizzy I thought I was going to pass out.  My arm was very swolen, red and discolored (patchy).
I have developed random urticaria; I break out in a rash in random places on a daily basis; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (I have developed random urticaria) and RASH (I break out in a rash in random places on a daily basis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced URTICARIA (I have developed random urticaria) and RASH (I break out in a rash in random places on a daily basis). At the time of the report, URTICARIA (I have developed random urticaria) and RASH (I break out in a rash in random places on a daily basis) outcome was unknown.            No concomitant and treatment medications were reported.
body chills; headache; soreness at the injection site; tiredness; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, NDC number and Expiry date was not provided), via an unspecified route of administration, administered in left arm on 26May2021 18:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.   On 26May2021, the patient experienced tiredness. On 27May2021, the patient experienced headache, soreness at the injection site and body chills experienced on 28May2021. It was reported that after received the first dose of vaccination, the patient stated that she continued to work, but started experiencing tiredness. Patient reported the next day she experienced a headache and soreness at the injection site. Patient reported today that she had experienced body chills and a headache. Patient stated the injection site did not bother her anymore and she felt as if she wanted to cover up with a blanket. Patient didn't felt that bad when she woke up, but as the day progressed, she started feeling body chills. She was using a cold towel. Patient reported that she signed up for be safe and she has not received any notifications. Patient hope these side effects will go away tomorrow. Patient was asking if these was normal side effects. Reporter seriousness for the events reported unspecified. The outcome was reported unknown for all the events. Covid Vaccine was a Pfizer product. Covid Vaccine manufacturer was unspecified. Investigation assessment was not provided.  Information on the lot/batch number has been requested. Follow up letter has been generated for further information.
About 5 minutes after receiving Tdap, MENACTRA and GARDASIL, the patient felt dizzy and weak. He looked pale. BP 97/57. HR 62/min. Anaphylactic reaction to vaccines. Epinephrine and oxygen was administered. BP went up to 108/62 20 minutes later. Recovered.
Chest pain with dyspnea upon exertion that began 3 days after the 2nd dose.  EKG, chest X-ray, blood work done.  Follow up with PCP.  High dose ibuprofen prescribed as well as colchicine for suspected pericarditis..
Pt. states she started to spit blood approximately 12 hours after Covid 19 vaccines.  It happened both times.  1st dose given on 2/25/21, reporting second dose from 3/25/21 because pt. sought ER care at .  She states the blood was coming from throat area, not vomiting.  She just spit out blood and blood clots.  Dr.  will send her to ENT to rule out lesion.
I received my first Pfizer Vaccination on 04/16/2021 and by then I had not noticed a growth on my left breast. Later, I received my second shot on 5/14/2021. From then on I had not realized that something was beginning to grow in my left breast, until it became noticeably large, palpable in the month of November and that is when, due to my surprise, I went to check myself, they did a mammogram, a breast ultrasound where they find nothing suspicious but that I have to return in 6 months. I get my biopsy and everything is normal. I put on the booster 12/27/2021 and a week later, I noticed that the growth has increased in size on my left breast, with the days I noticed that a reddened shadow has begun to appear. the breast area has hardened and in the third week I have begun to manifest a slight pain in the affected area.
On 7/6/17 approximately 7 hours after receiving the HBV vaccine, I began to experience mild malaise that by the following morning progressed to moderate-severe malaise, severe myalgias (particularly in my upper and lower back, pelvis, and thighs), headache, dizziness, and low-grade fever (Tmax 100F). The low-grade fever and other symptoms did not sufficiently respond to ibuprofen 600 mg, and I noted sufficient relief only after beginning to alternate acetaminophen 1000 mg and ibuprofen 800 mg (staggered on Q8H dosing). These symptoms persisted for approximately 2.5 days from the time of vaccination and at that point resolved entirely without any noticeable residuals effects.
After the second booster dose, her sister experienced boils under her tongue and within her mouth 7 days later.; boils under her tongue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: ORAL PAIN (non-serious), outcome "not recovered", described as "After the second booster dose, her sister experienced boils under her tongue and within her mouth 7 days later."; RANULA (non-serious), outcome "not recovered", described as "boils under her tongue". Therapeutic measures were taken as a result of oral pain, ranula.  Additional information: Event took place after use of product. Heart meds treat Hypertension. Patient's sister's doctor changed heart medications, but the boils persisted for at least 10 weeks, despite treatment with oral steroids.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
14.5 hours after receiving vaccine, I received my depo-provera birth control shot in my opposite arm, 1.5 hours later the side effect of chills started, sore arm, then 4 hours later a fever of 100.4, the fever broke 28.5 hours after my vaccine, additionally the same day as the chills and fever my period which had just finished, returned and was extremely heavy with bad cramps, my arm was sore for 3 days after starting on the second day after vaccination.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies Penicillin. Concomitant medication(s) included: ATORVASTATIN, start date: 10Jun2015, stop date: 08Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Anti viral details included product COVID 19 Treatment, treatment start date was 09Jun2022, treatment stop date was 10Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a licensed practical nurse, who reported that on 02-AUG-2013, two patients of unknown age and gender received a dose of GARDASIL (lot # reported as J004197, expiration date 27-NOV-2015) (dose and route were not reported) exposed to 31F for 84 hours over the past two months, since approximately June 2013. Concomitant medications were not reported. No adverse effects reported. This case is linked to 1308USA010552, 1309USA004737, 1309USA004746, and 1309USA004747 via same reported link. Additional information has been requested.
Initial unsolicited report received from consumer on 07 Mar 2017. This case involves a male patient (age not reported) who was vaccinated with first dose of FLUZONE ID (Batch number: UT5570BA, expiry date: 30 Jun 2017, dose, route of administration was not reported) via intradermal route in deltoid on 24 Oct 2016. The patient's medical history including illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown and concomitant medications were not reported. On 25 Oct 2016, one day following the vaccination, the patient experienced raised red hot area about the size of a small doughnut at the top of his deltoid with some pain at injection site. Reported that he went to his doctor to receive the Flu Vaccine and they have advised him they gave him Fluzone ID. It was reported that patient was worried that may be doctor gave him a different medicine or he received expired vaccine. On an unspecified date, post vaccination, the patient had numbness and tingling in his entire arm. It was reported that, patient plans to see his family doctor again on 21 Mar 2017 (patient hoped to get to the bottom of the issue). Patient required ER visit. Lab data was reported as none. Corrective treatment was not reported. On an unspecified date, the patient was recovered from the event inflammation localized and vaccination site reaction (reported as swelling and pain resolved). The patient was not recovered from the event numbness and tingling ("reported as still has it today"). List of documents held by sender: none.
many people who have received the vaccine had pain in the arm¨; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (many people who have received the vaccine had pain in the arm¨) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (many people who have received the vaccine had pain in the arm¨). At the time of the report, MYALGIA (many people who have received the vaccine had pain in the arm¨) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-106915, US-MODERNATX, INC.-MOD-2021-106499 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106915:case for patient US-MODERNATX, INC.-MOD-2021-106499:Case for patient nephew
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unspecified age. On an unknown dates the patients were vaccinated with oral ROTATEQ (dose, lot number and route not provided), which was improperly stored since 28-OCT-2014. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient got Shingrix vaccine on 9/19/2020. Right arm Patient returned to pharmacy to report reaction near the injection site. Site slightly larger than silver dollar, was red, warm, tender, & "hard or lumpy" under skin. Patient will monitor, and go to urgent care if necessary
24 hours after the vaccine she experienced flushed, bright red, warm, and itchy skin all over her head and neck.; 24 hours after the vaccine she experienced flushed, bright red, warm, and itchy skin all over her head and neck.; 24 hours after the vaccine she experienced flushed, bright red, warm, and itchy skin all over her head and neck.; 24 hours after the vaccine she experienced flushed, bright red, warm, and itchy skin all over her head and neck.; she may have trouble breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 09:00 as dose 3 (booster), single (Lot number: GK1657) at the age of 7 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 18Oct2022 as dose number unknown, single; MIRALAX; GAS RELIEF & PREVENTION. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FK5127), administration date: 01Dec2021, when the patient was 6-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE; Lot number: FL8094), administration date: 29Jan2022, when the patient was 6-year-old, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: FLUSHING (non-serious), ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 28Oct2022 at 09:15, outcome "recovered" (2022) and all described as "24 hours after the vaccine she experienced flushed, bright red, warm, and itchy skin all over her head and neck."; PRURITUS (non-serious) with onset 28Oct2022 at 09:15, outcome "not recovered", described as "24 hours after the vaccine she experienced flushed, bright red, warm, and itchy skin all over her head and neck."; DYSPNOEA (non-serious) with onset 28Oct2022 at 09:15, outcome "recovered" (2022), described as "she may have trouble breathing". Therapeutic measures were not taken as a result of flushing, erythema, feeling hot, pruritus, dyspnoea.  Additional information: The patient had no known allergies. It was reported that 24 hours after the vaccine the patient experienced flushed, bright red, warm, and itchy skin all over her head and neck. This happened at school and her teacher was extremely concerned she may have trouble breathing. The school nurse had her ice it and symptoms resolved. Itchy skin has remained. The adverse events did not resulted in hospital prolongation. Since the vaccination, the patient had not been tested for COVID-19. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.
A 16 year old patient received the Moderna vaccine as Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the Moderna vaccine as Booster) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, EW0182 and ER8736) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the Moderna vaccine as Booster). On 31-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the Moderna vaccine as Booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treat medications were given to patient.
PATIENT TOOK THIRD SHOT (BOOSTER) AND WITHIN 24 HOURS DEVELOPED SUBSTERNAL CHEST PAIN RADIATING TO THE LEFT FLANK AND BACK IT WAS INTERMITTENT FOR 5 DAYS, NONEXERTIONAL, AND COULD NOT BE RELIEVED.  GRADUALLY IT DISSIPPATED.  ECG SHOWED NSTWCS.   HAS PRIOR CAD LAD STENT, RCA STENT.  MEDICATIONS ADJUSTED AND NO OTHER ADDITIONAL TESTS ORDERED.
no adverse event; One dose was administered on 4/5/23 and was placed in the refrigerator storage on 3/31/23. / doses were administered after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One dose was administered on 4/5/23 and was placed in the refrigerator storage on 3/31/23. / doses were administered after the expiration 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. 047C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-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 05-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (One dose was administered on 4/5/23 and was placed in the refrigerator storage on 3/31/23. / doses were administered after the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (One dose was administered on 4/5/23 and was placed in the refrigerator storage on 3/31/23. / doses were administered after the expiration 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (One dose was administered on 4/5/23 and was placed in the refrigerator storage on 3/31/23. / doses were administered after the expiration date.).    No concomitant medication details was reported. The vial was initially stored in the refrigerator on 31-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720850 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720850:
-pt passed out in chair-5 minutes after shot -pt regained conscious after-mild shake and loud voice -pt explained later that he has done this at his last Dr visit -Transported to ER by paramedics
Vaccine recieved January 4th and 2nd shot recieved January 26th. Both pfieffer  On 2/27/2021 I became aphasic confused could not remember my name or say anything coherent. Husband called 911. MRI EKG CAT EEG done all negative. Speculating a TIA or seizure.
I have severe tinnitus.  It started a few weeks after the vaccine.  I have never had this before.
73 years old female with history of HTN, dyslipidemia, anxiety on xanax, brain tumor s/p surgery ,GERD who presented with mouth dryness s/p covid vaccination . pt denies any throat tightness, dizziness, SOB or tongue swelling PE:  vital signs stable. no tongue swelling.
fall; had a lot of things going on with his health; This case was reported by a consumer via call center representative and described the occurrence of fall in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fall and feeling unwell. On an unknown date, the outcome of the fall was unknown and the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the fall and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter's father resides in a nursing facility. The patient received Shingrix and had has had a lot of things going on with his health including a fall. The reporter was trying to determine when her father should get the 2nd dose of Shingrix. No further details were provided. The reporter did not consent to follow up.