chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I also received a second shot of Moderna, LOT 007C21A, at the Pharmacy on April 24, 2021. Same route and location.  Around the beginning of June 2021, I began to experience signifi cant fatigue, including tiredness and heavy limbs. These symptoms peaked in late June and I decided to see my physician, who ordered blood work to investigate potential causes. These tests did not show any explanation for my symptoms. Dr. offered additional testing, but I declined it as I had begun to improve. However, this fatigue continues on a lesser and more intermittent basis than I was experiencing earlier this year. I want to stress that I am not expressing either an expert or lay opinion that my symptoms are caused by the two doses of vaccine I received. I don't know whether they are or aren't. They are correlated. I participated, reported these symptoms, and received a follow-up call encouraging me to provide you with this data, so I am.
pt presented to ED on 2/20/22 w abdominal pain, nausea, vomiting. Hx chronic constipation. CT showed some groundglass opacities in r lung, so pcr was done for covid and was positive.
Patient reports fatigue, low grade fever and GI issues every day from 10/3/23 to 10/6/23. Patient states she feels better on 10/7/23.
Woke up on the morning of 6/24/2022 with sharp chest pain, head pain rated a 10/10, and uncontrollable shaking with fever. This pain was constant and continued throughout the day.  Unable to eat because of extreme pain upon eating and high production of stomach acid.  On 6/25/2022, contacted Pharmacy, PCP, and nurse at medical school, was diagnosed with functional dyspepsia. Unable to eat for four days and feeling of extreme chest pain. Lost 6 lb body weight. On 6/27/2022, visited Urgent Care and was given an EKG and directed to take 20mg famotidine. Chest pain and disgestive pain persist, and patient has been in contact with PCP about this.
Inoculated woman spoke words that made no sense, backed her car through the closed garage door, did not respond to stroke questions, was taken to hospital by ambulance, had an MRI, and was diagnosed with a blood clot in her brain.  The blood clot was removed; speech therapy was required.
TREATMENT: PREDNISOLONE AND CLINDAMYCIN SUSPENSIONS.  SITE WHERE INJ. WAS GIVEN WAS RED, PAINFUL AND WARM.
Interchange of vaccine products; Revaccination with different COVID-19 vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine).    Concomitant medications were not reported.  The 17 month pediatric patient whose first dose was Pfizer Covid-19 vaccine, second dose was Moderna. They were here for their booster dose. Treatment medications were not reported.
Information has been received from a nurse practitioner concerning a female who was vaccinated with Gardasil, (No lot # was provided). Subsequently the patient experienced immediately after being vaccinated, numbness, and tingling in the arm on both her first and second dose. The patient sought unspecified medical attention. Subsequently, it was reported that the "patient was fine when she got home". It was reported that the patient was fine now. Additional information has been requested. It has been determined that WAES # 0705USA00161 is a duplicate of WAES # 0705USA01053. Therefore, WAES #0705USA00161 is being deleted from our files and the reports consolidated into WAES # 0705USA01053.
Patient received Moderna Vaccine series on 02/04/2021 (004M20A) and 03/04/2021 (013A21A). Patient was later incarcerated and then received a dose of Pfizer on 08/05/2021 (EW0165). Booster dose (3rd dose) of a different brand is not recommended and therefore being reported. No adverse reactions have been reported with the patient.
right  way I could not breathe.  I was at speedway and the Dr. let me walk around for about 20 minutes, and I was able to leave. At home I had to keep walking-two days later I had extreme swelling in my knees, especially behind,, they puffed up, as if you cut a tennis ball  in half and placed it behind each knee, especially the right. My knees have gone down some, but they are still swollen. I had shortness of breath for two weeks. I had and have extreme fatigue, and my eyes are extremely red and irritated, more so that before the vaccine. Also initially I had really bad memory problems, I did not even know the name of my dr. when I read a message from her, I did not know who she was, that was disturbing.  I had an Igg antibody test which has come back at .12, not sufficeint for antibodies, and I am wondering what to do about the second shot, which I fear could send me over the edge.  I need advice.
I had severe chills and sweats, and then I had a seizure late at night, Saturday, February 19th, 2022.
Shaking; This case was reported by a other health professional via call center representative and described the occurrence of tremor in a 35-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 12th August 2019, the patient received Boostrix and Menveo. On 12th August 2019, 5 min after receiving Boostrix and Menveo, the patient experienced tremor. On 12th August 2019, the outcome of the tremor was recovered/resolved.   It was unknown if the reporter considered the tremor to be related to Boostrix and Menveo.  Additional case details were reported as follows: The healthcare professional stated that a patient was vaccinated with both Menveo and Boostrix vaccine and within 5 minutes of vaccination, they had a shaking reaction which had been resolved. The reporter consented to follow up.
feeling very fatigued all the time; out of breath easily; she has shrunk; She screamed when she got her Covid shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 73 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Knee replacement" (unspecified if ongoing), notes: She had knee replacement years ago; "Covid" (unspecified if ongoing), notes: She got Covid before getting the Covid vaccine, She had Covid about a year and a half ago; "thyroid" (unspecified if ongoing), notes: pill for her thyroid; "UTI" (unspecified if ongoing), notes: UTI's were before the Covid vaccine. Concomitant medication(s) included: EXTRA C; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE ;Lot number: Unknown), for Covid-19 immunization, reaction(s): "screamed when she got her Covid shot"; Flu (It was for flu and the one that makes you burn and itchy body), for immunization, reaction(s): "burn and itchy body", "burn and itchy body". The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "feeling very fatigued all the time"; DYSPNOEA (non-serious), outcome "not recovered", described as "out of breath easily"; BODY HEIGHT DECREASED (non-serious), outcome "unknown", described as "she has shrunk"; SCREAMING (non-serious), outcome "unknown", described as "She screamed when she got her Covid shot". The event "feeling very fatigued all the time" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Two days of severe body aches, chills, mild fever. Five additional days of severe leg cramps, loss of strength, headaches, disorientation, extreme fatigue.
Dizziness began 7 days after first dose and as of 5 weeks later still has not stopped. Lightheaded every day, sometimes heavy dizzy spells. Almost fainted once. The lightheadedness sometimes clears after a short walk outside, but then returns the next day. I was completely fine and extremely active physically up until receiving the first dose. In addition to the dizziness, my energy has been effected. It took an extreme downturn 5 days after the first dose. I have not regained my normal health or routine since receiving the first dose.
pain behind ear; burning of her chest (like a sunburn); colder skin; tearful; anxiety; more depressed than usual; Pain in lower abdomen periodically; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (pain behind ear), CHEST PAIN (burning of her chest (like a sunburn)), PERIPHERAL COLDNESS (colder skin), TEARFULNESS (tearful) and ANXIETY (anxiety) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EAR PAIN (pain behind ear), CHEST PAIN (burning of her chest (like a sunburn)), PERIPHERAL COLDNESS (colder skin), TEARFULNESS (tearful), ANXIETY (anxiety), DEPRESSION (more depressed than usual) and ABDOMINAL PAIN LOWER (Pain in lower abdomen periodically). At the time of the report, EAR PAIN (pain behind ear), CHEST PAIN (burning of her chest (like a sunburn)), PERIPHERAL COLDNESS (colder skin), TEARFULNESS (tearful), ANXIETY (anxiety), DEPRESSION (more depressed than usual) and ABDOMINAL PAIN LOWER (Pain in lower abdomen periodically) outcome was unknown.            No concomitant medication were provided.  No treatment medication were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.   This case was linked to MOD-2021-058166 (Patient Link).
About 20 minutes after I received the vaccine, I developed severe heartburn that lasted 8+ hours.  (I didn't eat or drink anything half hour before or after being vaccinated.)  I also got cankers in my mouth the same day I was vaccinated and continued to get more for about a week.  (Less than 10 total cankers.)  I was extremely fatigued and slept a lot for about 48 hours after, too.
Bruising reaction; Muscular issue in my left arm; Muscular pain; Drs suggested there may be a protein in them that I may be allergict to; This spontaneous case was received on 16-Aug-2021 via Med Communications (reference number: SEQW21-01609) from other non-health professional (consumer) and concerned a female patient of an unreported age.   The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included unspecified vaccine (not a flu vaccine) after which the patient experienced muscular pain and bruising reaction that lasted far longer than the 'typical' timelines listed as side effects.  On an unknown date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration, dose, anatomical location and indication: not reported). The batch number was not reported. This was the first flu vaccine the patient had ever gotten.  On an unknown date, unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced severe muscular pain/bruising reaction, that also lasted far longer than the 'typical' timelines listed as side effects. Doctors suggested there may be a protein in them that patient may be allergic to. The patient also experienced a muscular issue in her left arm.   The outcome of the events was unknown.   The reporter did not provide causality assessment.  Company comment: A female patient experienced allergic reaction with severe muscular pain and bruising reaction Flucelvax Quadrivalent. The patient also experienced a muscular issue in her left arm. Information regarding the related diagnostic findings have not been provided. Due to limited information regarding the temporal relationship, causality is unassessable.; Sender's Comments: A female patient experienced allergic reaction with severe muscular pain and bruising reaction Flucelvax Quadrivalent. The patient also experienced a muscular issue in her left arm. Information regarding the related diagnostic findings have not been provided. Due to limited information regarding the temporal relationship, causality is unassessable.
Four hours following vaccination, pt developed inconsolable screaming for 3 1/2 hours.
After receiving vaccine, developed joint pain, increased heart rate, nausea, vomiting, headache and lethargy.
Redness (2" x 1 1/2 ") and warm to touch (2 3/4" x 2 1/2") - at 9 AM 10/3/13. Localized reaction.
felt draggy (malaise all day 1NOV93; severe h/a w/vomiting devel; h/a lasted 3 days; had fever (did not take) one evening; coughing; lasted 5 days altogether; called MD;
This spontaneous report received from a consumer via pharmacist via Varicella Zoster Virus Identification program (VZVIP) referred to a male patient of unknown age. The patient's medical history, concurrent conditions were not reported. The pharmacist reported that on 14-NOV-2016, the patient received a dose of ZOSTAVAX (dose, route, lot number and expiry date not reported) and an unspecified flu vaccine (concomitant medication) both given in an unspecified arm. Within a week of receiving ZOSTAVAX, the patient developed itchiness on the back of his neck and rash on his legs. At the time of this report, the events were not recovered. Causality assessment was not reported.  Additional information has been requested.
Information has been received from a registered nurse referring to an unspecified amount of patients of unknown age and gender. On an unknown date, an unspecified amount of doses of PROQUAD (lot number, dose and frequency were unknown) that underwent a temperature excursion were administered to an unspecified amount of patients. No adverse effect reported. This is one of several cases received from the same source. Additional information has been requested.
Possible Breakthrough Case Covid + on 12/03/2021  Per H & P, patient was first Covid +on 10/25/2021, but was not hospitalized at that time Patient received Moderna Booster on 10/28/2021 at Pharmacy Store
Pt experienced bumps by injection site that spread to chest. After review signs of anaphylaxis & medical history, recommended BENADRYL 2 at 6 hour x 24 hours, then 1 Q 6 pm.
Intermittent heart palpitations  - for three or four days; no pattern to it. This time they gave me a heart monitor and they monitored for three weeks and they found they were benign. There was no treatment.
Right arm pain and swelling, Right arm with TPP, surrounding superficial erythema without warmth, no abscess formation. Pt. was advised to use cool compresses 4-6 times a day, Tylenol 500mg every 6 hours as needed for pain. RTC is pain worsens, fever or chills or increase in swelling.
This child had scattered papules on her face and trunk approximately 10 lesions in total, starting to come to a head. Temperature 100.
This spontaneous report was received from a registered nurse and refers to a male patient, he was 10 months old at the time of report. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 06-DEC-2016, a mother of the patient was vaccinated with a dose of GARDASIL 9 injection (dose number, rout of administration, lot number and expiration date were not provided) for vaccination, while she was five months pregnant and the patient was exposed via transplacental route to the vaccine. He was born on an unknown date. On an unknown date, the patient experienced growth retardation (reported as "he was not growing like he should") It was also reported, that the mother of the patient would be seeing a genetics. The outcome of growth retardation was unknown. The causality assessment was not provided. Upon internal review, the event of growth retardation was considered to be medically significant. This case is linked with the MARRS # 1803USA005894 case due to parent-child link.; Sender's Comments:  US-009507513-1803USA005894: Original Case : 1803USA005894.
Fever, chills, and nausea followed for approx. 48 hours after onset of symptoms.
About 9pm same day as shot, all of my finger tips on the right hand became sore and the hand felt like it was going to seize up.  The next day I was very tired and couldn't stay woke slept all day.  Woke up with a headache, which remained all day.  Later that night or the next morning I realized I have a knot on the base of my next where the chest and neck meet on the right side.  It was and still is sore.  I think it is a lymph node? because it kind of moves...
Bell's Palsy; diarrhoea; fever between 98-99 degree Fahrenheit; several headache; nausea; A spontaneous report was received from a consumer concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bell's palsy, diarrhea, fever between 98-99-degree Fahrenheit, several headache and nausea.  The patient's medical history included: Covid-19 (start date 08-JAN-2021).  No relevant concomitant medications were reported.  On 8-FEB-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch:012M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 09-FEB-2021, the patient's symptoms had started. The patient mentioned a fever between 98°F - 99°F,  headache, nausea, and diarrhea. Then on 15-FEB-2021, she had a (facial) paralysis, the left side of the mouth bent to the side and the eye fell. On 20-FEB-2021, the patient had visited the doctor's office and she was diagnosed with Bell's palsy. The patient was treated with, prednisone , valacyclovir, injection (unspecified) like a Cortisone. At the time of this report everything was coming back to normal, but it was not at 100%. The adverse event of ball's palsy was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event of bell's palsy, diarrhea, fever between 98-99-degree Fahrenheit, several headache and nausea was resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
patient was administered with the expired Flublok, with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professionals via Media Information (under reference number 00814705).  This case was linked to 2021SA346022 , 2021SA345306 and 2021SA345043 (same reporter).  This case involves a 48 years old female patient who was administered with the expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given to patient.  On 03-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Total, lot QFAA2017 and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Stated that they gave 15 patients expired Flublok vaccine, and wants to know what to do.There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."   At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1027am C/o itching all over arms, upper torso & head. BENADRYL 25mg po reported latex allergy to nurse. 1050am C/o tongue feels thick & like it is pushing out of her mouth. 10:53am SOLU-MEDROL 125mg IM. 1245p Pt. feeling better. Left with family member.
Blistering rash on shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th January 2019 from batch 9KT7T and expiration date 13th March 2021).   On 28th March 2019, the patient received the 2nd dose of Shingrix. On 22nd July 2019, 116 days after receiving Shingrix, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was unknown.   It was unknown if the reporter considered the blistery rash to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on an unknown arm and experienced a blistering rash on the shoulder. At the time of report, the reporter did not know which arm was injected with the Shingrix.
.D: 03/18/16 : 08:22pm .T: vaccine reaction Last Visit:  03/14/16 .ENC: JS: 1: 03/20/16: 08:22 PM: Office Visit: N: Y Assessment: .DX: Adverse reaction to Tdap - tetanus, diphtheria and acellular pertussis vaccine : ICD10 = T50.A15A / SNOMED = 429521000124101 Plan: VAERS Patient Education: prior to and follwing vaccines, you should take benadryl for about 48 hrs, preemptively, and tylenol. Follow-up: prn Subjective: Patient is a 43 year old female who got a Tdap on Monday, and developed fever of 102.5 on Tuesday and Wednesday, along with squeezing chest pressure off and on throughout the day for about 3 days, never lasting as long as a minute, as well as a huge local reaction with red swelling entire length of left lateral upper arm. She states she typically gets fever 102 with annual flu vaccines and takes Advil or Tylenol for this. She took a few days off work.  Did not call or tx with Benadryl, just an antipyretic. Objective: lateral left arm warm red swollen about 10 cm, now.