chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This study case was received from the investigator in a trial on 19 September 2012. A 21-year-old male subject (date of birth not reported) with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 30 January 2012 an elevated Troponin, central laboratory level of 0.32 ng/ml (also with as reported date of 31 January 2012). The subject had a rapid Troponin I level on 30 January 2012 that was within normal limits (negative). The subject had no chest pain and no shortness of breath. Vitals included: BP 114/67, HR 53 regular, RR 16, T 98.6 oral, HT 74 in (stated), WT 210 lbs (states), BMI 29.29. An ECG on 07 March 2012 was normal. The subject had no concomitant medications., The subject did not use tobacco and alcohol use was yes. No further information was available at the time of the report. The subject's outcome was recovered 07 March 2012. According to the investigator, the event of elevated Troponin was considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
At the injection site she has a huge red area; Super hot to the touch at injection site; Between my neck bone and shoulder bone I have like a ball inside that literally moves in my skin, I; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (At the injection site she has a huge red area), VACCINATION SITE WARMTH (Super hot to the touch at injection site) and AXILLARY MASS (Between my neck bone and shoulder bone I have like a ball inside that literally moves in my skin, I) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (At the injection site she has a huge red area), VACCINATION SITE WARMTH (Super hot to the touch at injection site) and AXILLARY MASS (Between my neck bone and shoulder bone I have like a ball inside that literally moves in my skin, I). At the time of the report, VACCINATION SITE ERYTHEMA (At the injection site she has a huge red area), VACCINATION SITE WARMTH (Super hot to the touch at injection site) and AXILLARY MASS (Between my neck bone and shoulder bone I have like a ball inside that literally moves in my skin, I) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant was provided. Patient treatment information was not provided.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 06Apr2023 to 11Apr2023. The patient had no known allergy.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received 2nd Covid vaccine on 1-22-21. The next day had muscle aches, fatigue(1-23). On 1-24-21 woke up with 2 black eyes and a blood nose. This was about 8-8:30am. Blood nose lasted between one hour and one and a half hours. She packed her nose and by 10am it was not bleeding through and she left in place until 1pm. No more bleeding from nose after that time. All symptoms resolved by the end of the day 1-25-21.  No more bleeding, denies bruising or any symptoms after that date.
On--going fever 100.8F within 24 hours after injection; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the right arm on 02Jul2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Other Medical history and was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 12Jun2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03Jul2021, the patient underwent test for body temperature and the result was 100.8 degrees Fahrenheit. On 03Jul2021 at 04:00, the patient experienced on-going fever of 100.8 F (degrees Fahrenheit) within 24 hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event on-going fever was not recovered at the time of this report.
I was just having reaction because it was like anxiety reaction; Heart reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "I was just having reaction because it was like anxiety reaction"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer (patient). The consumer reported 2 reports, this is the second of two reports. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took first dose of BNT162B2 on 28Jan2021 for COVID-19 immunization and she experienced these side effects to be untoward in that none of clinical /anecdotal reports. Patient reviewed before or after injection suggested that recipients could experience this range of effects after first dose included: Low grade headache(24hours), Arm site pain(48hour), Feeling of Un-wellness (48 hour), Muscle ache/joint pain(48 hours), Fatigue/Tiredness (strong for first 72 hours; moderate for up to 3 weeks), Anxiety/palpitation(3 weeks). All the same side effects occurred after the second dose but largely subsided after 48hours: with the addition of temporary rash near the injection site week after the second dose. The patient experienced low grade headache, arm site pain/limited range of motion, joint pain, feeling of unwellness, muscle aches, fatigue/tiredness, anxiety, palpitation, temporary rash near the injection site all on an unspecified date. The outcome of events was recovering.   No follow-up attempts possible. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021194876 Same reporter, same patient, same product, different dose and similar events.
Information was received on 14-APR-2017 via a licensed practical nurse regarding a 5 month old baby. Medical history, concurrent conditions and concomitant medications were not reported. On 14-APR-2017 the nurse inadvertently administered a dose of PNEUMOVAX 23 (lot # M026317, expiration date 11-JAN-2018), (dose not provided) instead of an intended dose of PREVNAR 13. The nurse reported this occurred because she looked at the patient's chart and saw the patient was due for "PCV", which she knew meant PREVNAR 13; however, she inadvertently selected and administered PNEUMOVAX 23 in error. No adverse effects were reported. No additional information was provided. The nurse did not rate the causal relationship. Additional information has been requested.
Covid + on 10/09/2021. Hospitalized. Per ED Note: History of Present Illness     64-year-old male with a past medical history of COPD on 4 L nasal cannula, hypertension, diabetes and obesity presents to the emergency department for feeling tired.  Patient states symptoms began this morning.  Patient did get a vaccine for COVID-19.  Patient states he is just feeling very weak.  He denies fever, chills, cough, nausea, vomiting, shortness breath, chest pain, abdominal pain and urinary symptoms.
Fever, chills, nocturnal enuresis within 12 hours of flumist
DTaP IM left thigh about 9:30 AM on 6/25/03. Severe pain left thigh 6/27/03 evening. Fever and headache 6/27/03. Lower leg pain. Rash and swelling shot site 6/27/03.
received expired doses of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  On 28-Mar-2022, patient received the booster dose (lot no: 059h21a, Expiration Date: 27-Mar-2022) of Moderna vaccine.  It was reported that 8 Vials were initially stored in the refrigerator on 25-Mar-2022. Doses were administered after manufacturer date of expiry.  The Vial did not undergo any temperature excursions.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-534443 (Patient Link).
Approximately 4 hours after receiving the first dose of covid vaccine, patient reported muscle pain in his thighs and a low grade fever was noted 100.8F. Patient was brought down to infirmary for close observation and treatment of symptoms.
t104 x 1.5 days; rash occurred w/temp dec; 2DEC91 seen by MD for pruritic rash & cough;
experienced warm feeling in the chest; Big bumps on left arm and red; Arm soreness; Itch; left arm broke out with rash; Redness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (experienced warm feeling in the chest), RASH MACULAR (Big bumps on left arm and red), PAIN IN EXTREMITY (Arm soreness), PRURITUS (Itch) and RASH (left arm broke out with rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced FEELING HOT (experienced warm feeling in the chest), RASH MACULAR (Big bumps on left arm and red), PAIN IN EXTREMITY (Arm soreness), PRURITUS (Itch), RASH (left arm broke out with rash) and ERYTHEMA (Redness on the arm). On 25-Jan-2021, FEELING HOT (experienced warm feeling in the chest), RASH MACULAR (Big bumps on left arm and red), PRURITUS (Itch), RASH (left arm broke out with rash) and ERYTHEMA (Redness on the arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Benadryl
Pfizer BioNTech COVID-19 Vaccine EUA: Allergic Reaction Received first dose of Pfizer vaccine on 10/23/2021. Patient presented to the ED following an episode of dizziness and subjective fatigue after receiving the COVID vaccine. The office gave the patient a single dose of epinephrine and no other medications. The patient was not observed to have a decrease in BP, tachycardia, or decreased SpO2. The patient has not verbally responded while in transport. The patient was was observed for >3 hours with improvement in her subjective symptoms and stable clinical findings. Patient was provided with detailed return precautions and was agreeable to discharge.
I had the normal muscle aches and pain at the injection site after my first dose. After my initial dose I also experienced a late period for the first time since being pregnant 10 years ago. I use a period tracker and always get regular periods. After my first injection I was 5 days late and had a heavier than normal period with cramping. After my second dose which was in August, I only experienced pain at the site of the injection and another delayed period. This time it was a week late, with cramping occuring a few days before and during my period and heavy bleeding for two out of the seven days which lead to bleeding through pads. I suspected it was related to the covid vaccine as I have not struggled with late periods, or heavy periods before. Last time I've had severe cramping like I have experienced since getting my covid vaccine was over 10 years ago. I am waiting to see if my period goes back to normal in the next couple of months.
30 minutes after admin of IM, I developed tingling around the mouth and had a panic attack which I thought may be related to anxiety. However, I got the second shot and tingling around my mouth and tongue continued with some heighted anxiety but no panic attack. Two weeks after the last shot the tingling has continued on and off feeling like neuropathy of the tongue and mouth. It typically last thirty minutes or so and then subsides. This has happened 3 x since getting the second shot 3 weeks ago.
Information has been received from a physician via a field representative referring to a 3 month old female patient with seasonal allergy. On 14-AUG-2015 the patient was vaccinated with her first dose of GARDASIL 9 (0.5 ml/injection; lot# reported as 1007560 with unknown expiration date), intramuscularly (inappropriate schedule of drug administration). Information regarding concomitant medication was not reported. On 21-AUG-2015, the patient experienced cellulitis at the injection site. The patient sought medical attention by calling her doctor. Unspecified treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event cellulitis at the injection site was reported as recovered on an unknown date of August 2015. Additional information has been requested.
Six hours after administration, child developed fever 101, became listless, unresponsive and bluish. Was taken to ER and recovered completely within 10-15 minutes. Was admitted because of the fever. Discharge Summary received on 12/15/2004 states final diagnosis was ALTE and hypotensive response to vaccine. Additional symptoms include gasping and tremor.
My menstrual cycle will not stop.  I am cramping everyday, clotting daily.  My cycle came on 7/25/21 was suppose to go off on 7/28/21.  Still on as of today 8/8/21.  Usually light flow but today heavier.
12/7/99, Pt passed out at school after standing up. Eyes rolled back and hit head on floor. 911 called, unconscious for 15 secs, no jerking witnessed.
Feeling sick; fever; chills; Body aches; back pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK9231), intramuscular (left arm), on 12Jan2021 15:00 at single dose, for covid-19 immunization. Medical history included had Covid prior vaccination, high blood pressure, high cholesterol, and myocarditis. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EJ1685), intramuscular (site: left arm), on 22Dec2020 15:00 for covid-19 immunization at 58-years-old. The patient experienced feeling sick, fever, chills, body aches and back pain - all on 13Jan2021 06:00AM. No treatment was received for these adverse events. The patient had no other vaccine in four weeks, and had not been Covid-tested post vaccination. The outcome of the events was unknown.
When she woke up on the morning of the 19th, I noticed right away that her leg looked a little swollen and when I pulled her pajamas off she had a bright red circle roughly 4 inches in diameter and it was sore to the touch she said. By the end of the day it had spread another inch. I took her into the doctor's office and a nurse snuck us into a room to look at her leg and they thought that she must have just tensed her muscle when the vaccine was given and said it should go away by end of the day and suggested giving her motrin. By the next day the redness was still spreading. By now it was the entire width of her leg and wrapping around that was all red. I gave her motrin again and had her put ice on it throughout the day. When she woke up on the 21st the center started to look bruised, then the outside was still red, so the redness is slowly fading and turning into a bruise.
Approximately 10 minutes after receiving the vaccine she started experiencing numbness and inability to move all 4 extremities. No difficulty breathing or swallowing. Benedryl 25 mg was administered with no relief. EMS was called, she was transported to the ED and admitted to the hospital for evaluation. She was given Ativan 0.5 mg IV with some mild improvement in symptoms. She has had gradual improvement in her symptoms, now able to move her arms normally. She has persistent weakness and discomfort in both lower extremities and is unable to ambulate without assistance.
Myalgia, Diarrhea, fatigue Narrative: Pt experienced the following ADRs with the 1st dose of covid vaccine: Diarrhea, fatigue, myalgia, Pt was relieved with Pepto Bismal, Imodium, ibuprofen- dose not give (pt self medicated)
Injection site was constantly pulsing; Dizzy; Felt that her body was fighting a battle, or something very serious; Still feels pain at the injection site; Feeling tired; She thought that she was going to die; The back of her throat was ticklish; This spontaneous case received on 13-Nov-2020 from pharmacist via The Agency (reference number: SEQW20-05113) and concerned a 71-year-old female patient.  The patient's medical history was not reported. The patient was not taking any concomitant medications, not even Aspirin (as reported).  On 07-Mar-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration and anatomical location: not reported) for flu prophylaxis. The batch number was not reported, 2019-2020 season.  On 21-Mar-2020, exactly two weeks after receiving Fluad Quadrivalent, the patient said that the injection site was constantly pulsing, but it was not painful.  On an unknown date in 2020, unknown time after receiving Fluad Quadrivalent, the patient was feeling tired, dizzy and the back of her throat was ticklish. She felt that her body was fighting a battle, or something very serious. She thought that she was going to die. The patient also said that she still feels pain at the injection site. The patient also reported that it was sever reaction.  At the time of initial reporting on 13-Nov-2020, the patient had not recovered from the event 'vaccination site pain'.  The outcome of all other events was not reported.  The reporter did not provide a causality assessment.  The event of 'near death experience' was considered to be medically significant by a Physician within The Company's Risk Management Department.  Company comment: The patient experienced  vaccination site discomfort two weeks after administration of Fluad Quadrivalent while other reported events: near death experience, throat irritation, dizziness, feeling abnormal (reported as 'felt that her body was fighting a battle, or something very serious'), vaccination site pain and fatigue occurred on an unknown date. The patient was not taking any concomitant medications, not even Aspirin (as reported) while medical history was not reported. Causality is assessed as possibly related for vaccination site reactions (discomfort and pain) and unassessable for all other events. (unclarified chronology); Sender's Comments: The patient experienced  vaccination site discomfort two weeks after administration of Fluad Quadrivalent while other reported events: near death experience, throat irritation, dizziness, feeling abnormal (reported as 'felt that her body was fighting a battle, or something very serious'), vaccination site pain and fatigue occurred on an unknown date. The patient was not taking any concomitant medications, not even Aspirin (as reported) while medical history was not reported. Causality is assessed as possibly related for vaccination site reactions (discomfort and pain) and unassessable for all other events. (unclarified chronology)
1130 pm chills, fever, kidney pain took ibuprofen went back to bed 12/30 same symptoms, alternated tylenol and ibuprofen 12/31 still not well added dayquill 1/1 kidney pain ongoing 1/3 saw a provider for ongoing kidney pain and being very tired, had to return to work 1/4 labs came back normal however I am still tired
Pt received KINRIX, Varicella, MMR vaccines 1545, pt tolerated well, cried, mom pt and brother left. Mom left office made it to elevator pt vomited, became lethargic, hives. Mom returned with pt. Dr. evaluated, EPIPEN Jr given immediately 1550 due to increased work of breathing, wheezing and lethargy. O2 93% on room air. Given blow by O2, saturation 99-100%. Pt alert at this time. Transport team for Hospital notified and in route. Return of wheezing and lethargy 1608, EPIPEN Jr repeated by Dr. Pt alert and transported to hospital.