chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored VAQTA lot#M021124 with expiry date: 02-FEB-2018, lot#M015290 with expiry date: 20-SEP-2017, lot#M018644 with expiry date: 20-SEP-2017, lot#M033611 with expiry date:02-MAR-2018, lot#M047658 with expiry date: 28-OCT-2017, lot#M022924 with expiry date: 24-JAN-2018, lot#M038572 with expiry date: 11-MAR-2018 and lot#M030598 with expiry date: 13-OCT-2017 (dosing details, anatomical location, route were unknown) for prophylaxis. It was reported that all lots of VAQTA vaccines were exposed to a temperature range of 47F to 77F. The duration of exposure was 33 minutes for lot# M021124, lot# M015290, lot# M018644; 37 minutes for lot# M033611, lot# M047658; 70 minutes for lot# M022924, lot# M038572 and 66 minutes for lot#M030598. The duration of exposure was 33 minutes for lot# L024993, lot# L043214, lot#L036301; 37 minutes for lot# M041212; 66 minutes for lot# M016193 and 70 minutes for lot#M018810, lot#M032650. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA012447: US-009507513-1708USA012445: US-009507513-1708USA012444: US-009507513-1708USA012446: US-009507513-1708USA012448.
Racing heart, mild fever, body aches - 12-24 hours after shot Nausea - 12-36 hours after shot Hives outbreak - 36 hours after shot
I had the Moderna vaccines for my first 3 doses and I have had noticeable nausea but it went away. After I switched to Pfizer that's when the nausea really set in and I have been experiencing it now for five weeks. I also have experienced swollen lymph nodes under both of my arms. I have taken Advil or Ibuprofen and that seem to help with the pain from the lymph nodes. The lymph nodes did resolve after a week. I experienced extreme bloating that has been consistent for the past month. On 05/10/2022 also ended up having a sore throat that only affected the left side of my throat. I saw my doctor and he said he saw a scratch in my throat but didn't find anything stuck. He was unsure as to the cause. I did have fish and I'm unsure if it was a fishbone or not, but it did resolve after about a day and half. The sore throat was gone for about five days, but it has now returned and it is not only on one side of my throat, but my whole upper throat. The lymph nodes in my throat are now swollen. I am experiencing slight congestion as well. I was exposed to a lot of unmasked people while travelling. I will test for COVID-19.
104 degree Temp., shaking uncontrollably; shivering. Chest Pain - Infection of unknown origin. Sepsis. Mild heart attack.
For 2 days, my left shoulder was mildly painful and very sensitive to touch. On the 3rd day, the pain was negligible. On the 4th day, I was standing at the reception desk and began to feel light headed. I am susceptible to low blood sugar and asked the receptionist for some hard candy. I used the candy and a glass of orange juice, and it took 30 minutes for me to feel well enough to complete the reservation change. I went to my room and felt completely drained of energy. I saw no improvement until the 7th day. I was able to drive home from the conference that I had paid to attend and which I missed entirely because I lacked the stamina to attend and fight the crowds.
All symptoms were known potential side effects and not serious including: 1) chills at 8 hours after the injection lasting for about 4 hours 2) fatigue beginning at same time as chills and lasting about 36 hours
Oct 30  Scab bled, a little and some deltoid pain. Nov 11 bled from bumped scab more than before. Increased pain in deltoid into brachial area. Still pains 11/12  redden area around injection site and a little raised. Took photo using cell phone.
Initial information received on 03-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 15 years old male patient who experienced rash on both arms and legs, while he received vaccines Diphtheria, Tetanus And Acellular Pertussis Vaccine and Menactra. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On an unknown date, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine lot number, exp date and dosing details not reported via unknown route in the arm nos and a dose of suspect Diphtheria, Tetanus And Acellular Pertussis Vaccine produced by unknown manufacturer lot number not reported via unknown route in the arm nos. On an unknown date, in the same evening, following vaccination, the patient developed a non-serious rash on both arms and legs. No lab data was reported. Final diagnosis was rash on both arms and legs. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for rash on both arms and legs.
Out of work for 2 days; Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (Out of work for 2 days), DIZZINESS (Dizziness) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-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. On 27-Feb-2021, the patient experienced IMPAIRED WORK ABILITY (Out of work for 2 days), DIZZINESS (Dizziness) and HEADACHE (Headache). At the time of the report, IMPAIRED WORK ABILITY (Out of work for 2 days), DIZZINESS (Dizziness) and HEADACHE (Headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment medications were not provided.
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 4 month old female pt who experienced diarrhea. At 4 months of age, the pt received the second dose on an unspecified date. The pt previously experienced diarrhea while taking Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection). See related case: HQWYE769302MAR05. Indication for Prevnar was immunization. Product was administered on an unspecified. Dose regimen was 1 dose. Concomitant medications were not reported. The pt experienced diarrhea. No additional information was available at the time of this report.
This case was reported by a healthcare professional and described the occurrence of myalgia in a 29-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 12 June 2008 at 11:30, the subject inadvertently received a dose of INFANRIX (.5 units unspecified, unknown, left arm), instead of an intended 1st dose of TDAP vaccine. Five hours after vaccination with INFANIX, at 16:30, the subject experienced myalgia, fatigue, joint pain, and sleepiness. The subject returned to the physician's office the next day due to the symptoms being unresolved. The physician referred the subject to a neurologist as a precaution. The reporting healthcare professional indicated that the events were systemic and considered the events to be clinically significant (or requiring intervention). At the time of reporting, the events were unresolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX.
PT RECIEVED FLUMIST ON 20 DEC 08 @ 1400. EXPIRIENCED HIVES APROX 6 HOURS AFTER VACCINATION. WHICH CONTINUE DAILY TO THIS DATE.
Vaccination adverse reaction; Fatigability generalized; Fever; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), IMMUNISATION REACTION (Vaccination adverse reaction), FATIGUE (Fatigability generalized) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 12-Jun-2017, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN (Pain), FATIGUE (Fatigability generalized) and PYREXIA (Fever). On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, PAIN (Pain), FATIGUE (Fatigability generalized) and PYREXIA (Fever) was resolving and IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  Primary reporter did not have the lot number information, because the packaging was discarded.   The reporter's causality for the event(s) of FEVER, PAIN, GENERALIZED TIREDNESS and REACTION TO COVID-19 VACCINE with HUMIRA 40MG/0.8ML(ADALIMUMAB) was no reasonable possibility.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
2-3 days after Pfizer Covid 19 vaccine I suddenly got tinnitus and it has not gone away, though the volume has decreased significantly.  I saw ENT, etc., no remedy other than rest.  Did not think about reporting it until a friend sent me an article today.
Large inflamed red area within few hours of vaccine. Pain/sore, hot. Headache (normal target). Lymph area under arm/pit painful to touch or move arm. Symptoms remained for 7 days. Ice pack/Advil taken.
Patient fainted, started having seizures, EMTs were called but patient refused recommendation to go to hospital for evaluation
3x3 redness, painful to touch on right deltoid area and down.  3x3 redness to lower right arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown if the patient took other medications in 2weeks. The patient took Anti-viral medication Paxlovid from 21Aug2022 to 25Aug2022 via oral route for the treatment of COVID-19. It was reported that from 21Aug2022, there was metallic taste in mouth when patient was taking meds. Initially felt sicker with meds than before taken. Later started feeling better and by end of regimen, was feeling great on 25Aug2022 without any treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My first symptoms were labored breathing and coughing. I felt like I had a weight on my chest. During the night I had a  fever of 102, chills, all over joint pain, nerve pain and muscle pain. Mild to moderate nausea. The following my symptoms were overall muscle weakness and fatigue.
pt recv vax 7OCT96 & on 12OCT96 pt devel severe swelling radiating from the inj site & exp pain that moved from fingers to the mid chest;
Patient came in in 8/29/21 and got her 1st dose of Moderna  Covid vaccine. she returned to the pharmacy on 10/11/21 for her 2nd dose and upon reviewing her questionnaire, I questioned her about the blood transfusion she indicated that she recieved in the past 4 weeks.  I then called the CDC to advise me on what to do regarding the 2nd dose but CDC referred me to MODERNA.  I called MODERNA and after relating the issue with the female representative, she asked to speak with the patient and in my presence, the patient gave further details relating to her experience She stated that a week after her 1st  moderna shot, she started cramping and her hand had swelled up. She said she went to the ER and it was determined that her baby's heartbeat had stopped. She eventually suffered a miscarriage and had D&C. She stated that that caused her to lose a lot of blood and she eventually got a blood transfusion. The representative advised me to hold off on giving the 2nd dose and she also gave me a case #: MOD 21-151604.
tested positive for Covid-19 during screening; tested positive for Covid-19 during screening; This is a literature report.  A 30-year-old female patient received BNT162b2 (BNT162B2), 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: "multiple sclerosis (MS)" (unspecified if ongoing).  The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), all with latency 4 months after the suspect product(s) administration, outcome "recovered" and all described as "tested positive for Covid-19 during screening". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 23 day(s)). The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: revealed persistent low levels of IgG and IgM and, notes: negative covid specific antibodies; Blood immunoglobulin M: revealed persistent low levels of IgG and IgM and, notes: IgM and negative covid specific antibodies; Oxygen saturation: 90 %, notes: on room air; SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: She was started on dexamethasone and nasal cannula oxygen. Her oxygen requirements increased significantly within 72 hours of admission and she was placed on high flow nasal cannula. Despite supportive care, her hypoxic respiratory failure persisted for 2 weeks. After extensive multidisciplinary discussion, Remdesivir with compassionate use of monoclonal antibodies was given. The patient received one infusion of 4000 mg of Casirivimab and Indevimab. She improved within six days of administration and was discharged home without any oxygen supplementation on hospital day 23.; Sender's Comments: Based on the available information in the case, the causal association between the event COVID-19, Drug ineffective and the suspect drug BNT162B2 cannot be excluded.
Vaccine seemed to be administered too high-closer to AC space rather than the bulky portion of the deltoid. Symptoms: acute onset of left shoulder pain, stiffness, decreased range of motion.
Patient received first dose of Moderna COVID 19 Vaccine on 1/27/21.  Pt returned for 2nd dose on 3/2/21 and syringe jammed after patient received 0.3ml of 0.5ml dose.  (this was reported in a separate VAERS submission)  Pharmacist on site recommended no repeat dose as per CDC recommendations as patient had received the majority of the dose.  However, patient's daughter was insistent that patient receive additional dose.  Case discussed with Chief of Infectious Disease who gave the ok for an additional dose of vaccine to be given.  Pt came back to  vaccine clinic on 3/4/21 and received an additional 0.5ml dose of Moderna COVID 19 vaccine.   Increased  risk of adverse effects was explained to patient and daughter who gave verbal consent.  As far as we are aware, no adverse reactions occurred.  Reporting this event since it is outside of CDC recommendations.
Information has been received from a physician concerning a 18 year old male patient who on 18-NOV-1992 and 01-JUL-1997 was vaccinated with the first and the second dose of MMR II. On 11-NOV-2009 the patient experienced mumps. The patient had no fever. The parotitis was on the both sides. The parotitis count was 6. The date diagnosed was 17-NOV-2009. It was unknown if the patient had sought medical attention. The lab diagnostic tests performed: On 17-NOV-2009 IgM was negative, IgG was 2.94 and serum amylase was 478. At the time of report the patient's status was unknown. Follow-up information has been received from a physician indicated that the 16 year old male patient was on 28-NOV-2009 experienced mumps. The date diagnosed was 30-NOV-2009. The parotitis was on the right side. The date of first blood work was 30-NOV-2009. Additional information has been requested.
'COVID Arm' - Red area at injection site that has 'hives' on the perimeter and is warm to the touch.  Itchy at times.  Sore and swollen on first day of symptoms.
Patient had redness and swelling at injection site for 2 days, beginning on the evening of vaccination date - also had slight fever and chills. No treatment.
He received Pfizer COVID vaccines on 3/2/2021, 3/23/2021, and 10/18/2021. On 5/254/22, he presented to local ER with chief complain of generalized weakness. Upon arrival, his temp was 101.4, and found to be COVID PCR positive. He was admitted to a local hospital on 5/25/22. He was given steroids, but he did not develop other symptoms. He was discharged to the inpatient rehabilitation unit on 5/31/22.
I woke up and felt fibromyalgia pain that lasted about a week. I had pain all over my body. I woke up one morning and it was gone as quickly as it came on. I called my doctor and she said if it got worse to call her back. This happened again after my second shot also that still goes on at random from time to time.
RA flare up on my left side of my body; I"m still in a lot of pain; I've had tingling in my hand and pain in my left breast; I've had tingling in my hand and pain in my left breast; sharp shooting pain in my arm that continued for an hour. Then my arm was very stiff and sore.; sharp shooting pain in my arm that continued for an hour. Then my arm was very stiff and sore.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 05May2021 at 14:30 (at the age of 44-years-old) at 1st dose, single dose for COVID-19 immunization. Medical history included rheumatoid arthritis (RA), injuries, surgery, Celiac (dairy and gluten made her very sick), Hashimoto's, and ACL repair on left knee. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (T3), and naltrexone. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as unknown. Since the vaccination, the patient has not been tested for COVID-19. Minutes after injection on 05May2021, the patient experienced a sharp shooting pain her arm that continued for an hour, then her arm was very stiff and sore. She then had an RA flare up on the left side of her body where she had several injuries and surgery on 06May2021. It's been over two weeks and she was still in a lot of pain, additionally, she had tingling in her hand and pain in her left breast, all of which started in 06May2021. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Site: Pain at Injection Site-Medium, Additional Details: pain (possible nerve pain) on the radial and ulnar nerve on the left arm.
I woke up and my bottom lip- right side was painful, red, and swollen. I have filler in my lip I received Nov. 30 2020. It feels like the filler is inflamed and hard.
fatigue, am pain, eyes hurt, brain expands, dizziness, motion sickness, naseau
SCRATCHY THROAT , BLURRY VISION, LIGHTHEADEDNESS. SOLUMEDROL, BENADRLY, PEPCID. 1 LITER OF FLUIDS.
LEFT ARM RASH STARTED AT AROUND 6PM DAY OF VACCINATION AND SPREAD TO LEFT WAIST/BACK AND BOTH LEGS AND ARMS.  PATIENT TAKING 25-50MG BENADRYL TABS EVERY 6 HOURS AS NEEDED AND WILL FOLLOW UP WITH MD ON MON OR SEEK MEDICAL TREATMENT IF CONDITION WORSENS.
Flu symptoms; Chills; Fatigue; Usual side effects; This spontaneous case was received on 05-Oct-2020 with additional document (being processed together) received on 07-Oct-2020 from other non-health professional (consumer) via agency and concerned a female patient. At the time of this report the patient was 70-year-old.  The patient's medical history and concomitant medications details were not reported.  On unknown dates, for many years (as reported) the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.  On unknown dates, unknown amount of time after vaccination, the patient developed mild flu symptoms, chills, fatigue and suffer from usual side effects.   The outcome of the events was not reported.  The reporter did not provide causality assessment.  This case is linked with the case 202004938 (same patient).  Company comment: A female patient was administered influenza virus vaccine polyvalent. On unknown dates, unknown amount of time after vaccination, the patient developed influenza, chills, fatigue and adverse event (reported as usual side effects). The patient's medical history and concomitant medications details were not reported. Due to insufficient information regarding temporal relationship and patient's medical history, causality is unassessable for all events.; Sender's Comments: A female patient was administered influenza virus vaccine polyvalent. On unknown dates, unknown amount of time after vaccination, the patient developed influenza, chills, fatigue and adverse event (reported as usual side effects). The patient's medical history and concomitant medications details were not reported. Due to insufficient information regarding temporal relationship and patient's medical history, causality is unassessable for all events.
Synovitis of thigh - legs shaky and giving out "L leg appears minimally tender". She is able to internally and externally rotate the hip as well as to extend and flex it although w/extension of hip and knee at same time - some discomfort present.
Information has been received from a Nurse Practitioner referring to 8 unspecified patients of unknown age and gender. Information about the patients' concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. On unknown dates, the patients were each vaccinated with a dose of improperly stored VAQTA (dose and route were unknown, lot # M033611 with expiration date 02-MAR-2018). No adverse effect was reported. The vaccines had been exposed under temperature 48.9 Fahrenheit for 1 hour and there was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.