chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back was achy; Tired/Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back was achy) and FATIGUE (Tired/Fatigued) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02/A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced BACK PAIN (Back was achy) and FATIGUE (Tired/Fatigued). On 13-Mar-2021, BACK PAIN (Back was achy) and FATIGUE (Tired/Fatigued) had resolved.            No relevant concomitant medications were reported.  Treatment information include exercise.   This case was linked to MOD-2021-372106, MOD-2021-372416 (Patient Link).
the initial dose of Twinrix and received the 2nd dose 1 month later and now wants to complete the series with a dose of Engerix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received In April 2022) and Twinrix (2nd dose received  in May 2022).   On an unknown date, the patient did not received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Additional Information: GSK receipt date: 09-NOV-2022 Reporters comment:  The patient received the initial dose of twinrix and received the 2nd dose 1 month later and now wants to completed the series with a dose of Engerix. Health care professional  did not have the exact dates of dose 1 and 2 dose, and belived it was April/May. The dose of Engerix  was not yet administered at the time of this report The reporter consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive 3rd dose of twinrix, which led to incomplete course of vaccination.
5/14 11:50 pm  chills, dry heaves, body aches , extreme headache.  Took 2 Exedrin Migraine tablets.  Chills, and aches lasted approximately 4 hours. 5/15 4am still had a headache and body aches and was very tired but the pain kept me from sleeping 5/15 5am I took 2 acetominofen tablets, drank some apple juice, tried eating toast but felt nausea, fell asleep for a couple hours but woke still with a headache and body aches. 5/15 9am  conditions continued and I took 2 ibuprofen tablets.  I was able to sleep for about 4 hours. 5/15 2pm chills are gone, body aches were not severe but present, headache still bad. 5/15 slept through the night for the most part - very exhausted. 5/16 at 6am was able to eat and my body was not in pain.  Had no energy all day and my thoughts were slow to think through.  This condition lasted all day. 5/17 6am woke still with a headache - went away about 2:30 pm
Painful swollen lymph node in left armpit. Tenderness in left pectoral. Onset was approximately 5 days after vaccination.
The patient was administered improperly stored V ARlV AX; This spontaneous report has been received from a registered nurse  concerning a 4 years-old male patient. The patient's concomitant therapies included sterile diluent( MERCK STERILE DILUENT). The patient's concurrent conditions, historical drugs and medical history were not reported.    On 13-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) formulation not reported but defaulted to subcutaneous injection, Lot # T002848 has been verified to be a valid lot number, expiration date 23-JAN-2022 for prophylaxis (dosage regimen was not provided).  It was reported that multiple excursions took place. One temperature excursion, was reported to had been in between -14°C to -10°C, more specifically at -12.1°C for 3 hours. A different temperature excursion, was reported to had been in between -9°C to 8°C, more specifically at -7.5°C for 8 hours and 30 minutes.  The sterile diluent used to reconstitute the Varicella virus vaccine live (oka/merck)(VARIVAX) was stored properly.  There was digital data logger involved and  no previous temperature excursion was reported.
The morning after shot, I had a bad headache; slight nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included tadalafil (CIALIS) once a week for unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 after the shot at 12:00, the patient experienced headache and slight nausea for hours or so. Both faded, but the headache never went away completely. It was low-grade (1 on the 10 point pain scale) except if the patient coughed, sneezed, or otherwise suddenly moved his head, then it was maybe a 3 on the 10 point pain scale. The patient was expecting it to go away, but it had been almost two months, and there's been no change since the second day after his second shot. Before the patient virtually never got headaches, maybe once a year or so. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event headache and slight nausea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Several spots on stomach, baring resemblance to chicken pox.  Saw Dr. who confirmed chicken pox/ Shingles type spots.  He prescribed Valacyclovir which I filled immediately and took first pill at 4:00 pm on 08/24/2012.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No Treatment medication was provided.
Patient complained about stomach cramps 6 hours after she received the flumist dose.  Stomach cramps continued throughout the evening and she developed a temperature of 105 degrees F.  Friday morning, Nov. 9th, her pediatrician instructed them to go to the Emergency Room.  The patient was seen and diagnosis with gastritis from the flumist.  She was placed on a liquid diet.  She still has mild stomach cramps to this day.
sharp pain in arm, chest pain, allergic rxn to horse serum, pain all over, difficulty breathing, can't lift arm;
8/18/2022-Presnts to ED, fell at home and hit her head. EMS-82% on 4L, improved to 88% on 12L NRB. Stroke response, CT R upper lobe infiltrate. T-102.2,  RR-50's, HR-118 BP 101/56 -IV bolus and levophed. ABg:7.45/24/16 Covid + test. Ordered Vacno, cefepime and Flagyl. On chronic steroid for colitis, add hydrocortisone covid inflammatory pneuomonitis, no baricitnib active sepsis likely UTI.  Acute hyponatremia contributing to encephalopathy. Admit acute metabolic/toxic encephalopathy s/t to sepsis Covid pna. Transfer to ICU.  8/19/2022- Off levophed. WBC-20.2  Temp down to 100.8. Has high RR-42 and on HFNC. WBC 34. CT chest-RLL plueral effusion. 8/22/2022- Continue cefpime, flagyl and vanco. Currently on 2l NC. no o2 baseline 8/23/2022-Resolving acute resp failure. Continue antibiotics, vanco d/c. VSS.  8/27/2022- Moderate gallbladder dilation, 2 large cholelithiasis seen on CT. asymptomatic. Pt family refused Hida scan.  8/28/2022- DNR/DNI. Continue cefepime and Flagyl . 2L nc, o2 stable,  8/29/2022- Palliative and family met, few more days of aggressive treatment  8/30/2022- Adult failure to thrive, severe dysphagia-NPO. Acute delirum with dementia . Continue IV hydration. NO NG or G tube per family. Continue cefepime and flagyl. Pt is letharigc.  9/1/2022- oropharygeal dysphagia, Resp failure/acute delirium with dementia. Lethargic. Afebrile, VSS WBC-7.7 9/2/2022-Moderate right -sided compressive atelectasis. Failure to thrive. On 2L NC. Family made pt palliative and d/c to facility.  (Pt later died 9/4/2022).
Patient received vaccine in (R) thigh on 8/16/16. Mother noted swelling of Right thigh on 8/17/16 in the morning, thigh was warm to the touch as well. Patient reported pain in leg. Patient seen in clinic on 8/18/16. One tsp of BENADRYL was given. (R) thigh 28.8cm circumference. Patient had follow up appointment scheduled for  8/19/16 but did not show up. Called patient's mother and she gave a verbal update. Patient was doing better, leg is not as swollen but still warm. Mother thinks BENADRYL helped. Advised mother to give another dose of BENADRYL. No fever and no new symptoms. Follow up appointment scheduled for 8/23/16 in clinic. Follow up call 8/22/16. Patient is doing well, swelling is gone and no more warmth in leg. He is acting normal and no complaints of leg pain. Appointment 8/23/16 - Right thigh was remeasured at 26.3 cm. No redness, swelling or warmth to area. No fever and patient acting normal.
she had great difficulty, her body felt weird, she felt completely out of mind, it was terrible; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she had great difficulty, her body felt weird, she felt completely out of mind, it was terrible) in an 85-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient has some allergies and issues with blood pressure. Medications: 1 pill of Levothyroxine, Metoprolol and 1 pill for her eyes.  The patient's past medical history included Blood pressure fluctuation (issues with blood pressure). Previously administered products included for Drug use for unknown indication: Levothyroxine and Metoprolol; for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Levothyroxine, Metoprolol, Pfizer and Pfizer. Concurrent medical conditions included Allergy (Patient had some allergies.).    On 28-Sep-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 50 microgram. On 28-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced IMMUNISATION REACTION (she had great difficulty, her body felt weird, she felt completely out of mind, it was terrible). On 29-Sep-2023, IMMUNISATION REACTION (she had great difficulty, her body felt weird, she felt completely out of mind, it was terrible) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. She had one pill for her eyes as past medication. No treatment medication reported.
Chills; Joint pain; Muscle pain; Nausea; Headache; Tired all the time; got really sick the day after she got the shot; whole body was hurting; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206; Expiration Date: Jun2021) via an unspecified route of administration, administered in Arm on 07Mar2021 10:00 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation at school. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced nausea, headache on 08Mar2021, joint pain, muscle pain on 09Mar2021, chills on 11Mar2021, tired all the time, got really sick the day after she got the shot, whole body was hurting on Mar2021. Reported as, the patient got really sick the day after she got the shot and it was being a week and a half now. Patient started with nausea, then it went to joint pain, then muscle pain, then chills, then a really bad headache, then really tired all the time. Patient whole body was hurting. Patient has recovered from the joint pain and muscle pain. The chills, headache, and nausea all come and go. Patient was given nausea medicine. Adverse event resulted in Physician office: Primary Care Provider. Therapeutic measures were taken as a result of nausea (nausea). Outcome of the event joint pain, muscle pain was recovered on Mar2021, recovering for nausea, headache, chills, not recovered for got really sick the day after she got the shot, and unknown for tired all the time, whole body was hurting.  No follow-up attempts are possible. No further information is expected.
Pt. noticed rash on L arm, initially blistery, pruritic, stinging. Two other areas on L arm have developed. Characteristic pattern of shingles, lesions appear to stay in L dermatome, possible C6. Lesions are crusted over and don't require treatment: over 10 days from onset. Follow up in 2 weeks.
Chest tightness within 5 minutes of dose injection. No pain. Dissipated within 15 minutes of dose injection.
Fast, shallow heart beat, aching in joints, slight fever. The follow up received on 1/13/04 states 11/9 onset about midnight, rapid heart about 2 hrs, aching joints 8 to 10 hrs.
Pt received vaccine on 2/11/21.  She reported onset of redness (approx. 5-6" diameter) and itching at the site on 2/17/21.  She was seen by a dermatologist on 2/19/21 and was diagnosed with cellulitis and started on a five day course of cephalexin.  Pt reports redness and itching is resolving and that no further follow up is necessary.
After getting the vaccine my vision changed, everything looked clear and sparkly, and my arm is swollen and still hurts. And my left leg hurts really bad, and my upper chest hurts and I have a major headache and my eyes are burning. It feels like a train is running back and forth on my chest. I also had a very high fever and was stuck under the covers and I had to wear a lot of clothes just to stay warm.  And I lost my appetite. a couple of hours later I got really hot all over my body and it goes back and forth.
I started with chills, muscle aches, fever of 100.9F, a heavy cough, and mild nasal congestion. I decided to take an at-home COVID-19 on 12/08/2022 which came back negative. So I waited and retested on 12/10/2022 which came back positive almost immediately. I texted my doctor who prescribed me PAXLOVID. I started the prescription the same day and took 2 doses. The next morning, I had a terrible taste in my mouth and discontinued taking PAXLOVID on my own from the taste discomfort. I stopped taking atorvastatin during PAXLOVID and half-doses of amlodipine at the time. But for treatment, I started alternately taking ibuprofen and acetaminophen for treatment. I've been doing much better with still slight nasal congestion & light cough.
Sore throat, chills, headache, body aches, cough, sneezing, runny nose, fatigue, mental fogginess, and soreness at the injection site.
felt very sick; small rashes; sore arm; nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable female patient of an unspecified age reported to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 14Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced felt very sick, small rashes, sore arm, nausea. it was reported that patient wanted to know how long the reaction lasts and what medication she can take. She also mentioned that her husband took the first dose but did not have any reactions. The outcomes of all reported events was unknown.
Developed COVID after Moderna series; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed COVID after Moderna series) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Illness (Health issue hat makes patient eligible for the booster dose.).   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 November 2021, the patient experienced COVID-19 (Developed COVID after Moderna series). At the time of the report, COVID-19 (Developed COVID after Moderna series) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, COVID-19: positive (Positive) POSITIVE.         No concomitant medication information provided.  No treatment medication information provided.  The patient had a breakthrough case in the beginning of November i.e. 6 months  after the vaccine series. The reporter stated that his son had health issues that make him eligible for the booster dose  Company comment: This case concerns a 27-year-old male patient, with medical history of illness, who experienced the non-serious, unexpected AESI event of Covid-19, 6 months after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient's medical history of illness may have increased his risk of getting infected with Covid-19.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 27-year-old male patient, with medical history of illness, who experienced the non-serious, unexpected AESI event of Covid-19, 6 months after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient's medical history of illness may have increased his risk of getting infected with Covid-19.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
breakthrough symptomatic COVID infection; breakthrough symptomatic COVID infection; sore throat; fever; cough; general body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 15 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 05Jun2021 (Lot number: EW0187) at the age of 14 years as dose 2, single and intramuscular, administered in arm left, administration date 15May2021 (Lot number: EW0185) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 22Dec2021, outcome "recovered" and all described as "breakthrough symptomatic COVID infection"; OROPHARYNGEAL PAIN (non-serious) with onset 22Dec2021, outcome "recovered", described as "sore throat"; PYREXIA (non-serious) with onset 22Dec2021, outcome "recovered", described as "fever"; COUGH (non-serious) with onset 22Dec2021, outcome "recovered", described as "cough"; PAIN (non-serious) with onset 22Dec2021, outcome "recovered", described as "general body aches". The events "breakthrough symptomatic covid infection", "breakthrough symptomatic covid infection", "sore throat", "fever", "cough" and "general body aches" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive, notes: PCR. Nasal Swab; (24Dec2021) positive, notes: Rapid. Nasal Swab. Therapeutic measures were taken as a result of covid-19, vaccination failure, oropharyngeal pain, pyrexia, cough, pain. No known allergies and none Other medical history. Patient was tested post vaccination. No covid prior vaccination. Patient received treatment for event as Mucinex D; Advil. Adverse event breakthrough symptomatic COVID infection; fever, cough, general body aches, sore throat.  No follow-up attempts are possible. No further information is expected.
I experienced COVID after my vaccine. I experienced fever, cough, tightness in my chest. They ended up giving me steroids and a nebulizer treatment. This all lasted about four days and felt tired for a bit longer.  I am not experiencing any symptoms today.  I felt completely fine after two weeks.
1 hours after receiving vaccine, pt felt dizzy and nauseated. 30 minutes later, he began feeling "hot". He laid down for 2 hours and recovered.
Per the patient "36 hours after the shot, I woke up itching at my ankles/lower legs (I had assumed at the time it was just dry skin) but also in the waist area on both sides which seemed very peculiar.   I have a pinkish rash at my waist that looks like the area indicated on the shingles CDC statement for where  shingles appears on a body.   Also the itching on my legs has a bumpy rash, but it is not red.  None of it looks dramatic like I would think "hives" would be and I am not experiencing any of the serious symptoms of an allergic reaction.