chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Achiness; Chills; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Achiness), CHILLS (Chills) and FATIGUE (Feeling tired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Achiness), CHILLS (Chills) and FATIGUE (Feeling tired). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Achiness), CHILLS (Chills) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received for the first dose. No concomitant medication was received.   This case was linked to MOD-2021-254040 (Patient Link).
Severe immune thrombocytopenia with platelet count zero. Required ten day hospitalization, platelet transfusions, IVIG and pulse dose steroids. Required long term oral steroids and 10 weeks out of work.
with the first Covid shot he got was sick and throwing up; with the first Covid shot he got was sick and throwing up; tired; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 53-yearsold male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0173), via unknown route of administration in left arm on 04May2021 as 1st dose, single dose for COVID-19 immunization. Medical history included amyotrophic lateral sclerosis from an unknown date and unknown if ongoing, patient has something like ALS or Lou Gehrigs disease, but has not been diagnosed. The patient's concomitant medications were not reported. The patient had no medical history. The patient states that with the first Covid shot he got was sick and throwing up for four days. He was worried about getting second shot because he heard it was stronger. He now feels sick, kind of, not throwing up. He did not file report after the first Covid shot. Confirmed details of being sick as: threw up a lot first day, slept for 17 hours straight, and stayed in bed a total three to four days. He doesnt remember the date on that first Covid shot. He didnt go to the doctor or anything. Two to three hours after he got the first shot the throwing up got to be violent. After that, he was just sick and tired for three to four days. Confirmed he was throwing up for one day only and that he fully recovered on that same day he got the Covid shot. Initially stated he doesnt remember the date he got the vaccine. He guesses it was three weeks before. Dont they say to wait three weeks to get second shot He recovered completely after 4th day and was back to normal self. Commented he has a sickness like does not feel well. No lab tests were done. The clinical outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Fever, cold sweat, swollen tongue and face, numbness, trouble breathing. Light headed and dizzy. Had my teeth and jaw hurting, eyes were swollen, puffy and red.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine administered to patients post temperature excursion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003M21A) for COVID-19 prophylaxis. No Medical History information was reported. On 10-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine administered to patients post temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine administered to patients post temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Vaccine was stored at the refrigerated storage condition. Minimum temperature was 26 degree F and average temperature was 28 degree F was reached. Excursion duration was 15 minutes at minimum temperature and total duration was 5 hours. All the vaccine which was stored was used up. No changes was noticed in vaccine state change. Pertinent details included vials were administered to patients with no previous temperature excursions. It was unknown if patient was diagnosed or tested positive for COVID-19. It was unknown if patient was having chronic or long standing health condition. It was reported events did not cause patient to seek medical care. It was reported that the patient did not report any adverse effects. It was reported that the patient had received the vaccine after it had undergone freezing in refrigerator the day before for about a five hour period. No treatment information were reported.
It's only pain in my arm. Quite severe in the beginning. Right now it is easing. Just thought it would be good for you to know for statistics.
arm was sore, today is better, but still sore; This is a spontaneous report from a non-contactable consumer or other non hcp(patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced arm was sore, today is better, but still sore on an unspecified date in Feb2021. The reporter inquired can she rub alcohol or apply something in it. The outcome of the event was reported as resolving.  No follow-up attempts are possible. Information on the lot/batch number cannot obtained. No further information is expected.
Red rash on left bicep, noticed approximately 4 hours after injection, very sore arm around the same time which persisted for 2 days
This case was reported by a healthcare professional and described the occurrence of muscle aches (post treatment) in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included knee surgery. Concurrent medications included diabetes medication. In October 2009 the subject received unspecified dose of FLUARIX (unknown). In October 2009, 3 weeks after vaccination with FLUARIX, the subject experienced muscle aches (post treatment) and body pain. At the time of reporting the outcome of the muscle aches (post treatment) and body pain were unspecified. The pharmacy intern reported that the subject came into the pharmacy to inquire about a recent flu vaccine. The pharmacy intern reported that she did not know the subject's initials or any personal information, and was unaware where or who administered the vaccine.
At the time of the first injection (4/27/21), I was prescribed antibiotics (5/3/21) for a sinus infection from seasonal allergies and the infection seemed to go away.  But, just a few days after my second injection (5/25/21), I had severe sinus pain and tiredness, so I thought the sinus infection came back.  My doctor prescribed Methylprednisolone (6/10/21) which didn't help.  Then she gave me Amoxicillin - CLAV again (6/22/21) and that didn't help.  I kept feeling more and more tired.  It made me feel like I had mononucleosis again.  I went back the doctor's office but saw a different doctor and was given Doxycycline (7/26/21).
This spontaneous report as received from a pharmacist refers to a 56 year old female patient with unspecified cancer. ON 10-AUG-2014 the patient was vaccinated with ZOSTAVAX (lot # J013453, Expiry: 24-JAN-2015, 0.65 ml, subcutaneous). Pertinent medical history and concomitant medications were unspecified by the reporter. On 11-AUG-2014, 2 days after onset of therapy the patient experienced red bump on the back of an unspecified arm. The reporter also states that the patient had an unspecified cancer in the past and was in remission when she received the ZOSTAVAX. On 12-AUG-2014, the patient visited pharmacy and spoke to the pharmacist. IT was reported that no treatment was given for the event. No lab tests were performed. The outcome of the events was reported as not recovered/not resolved. The causality was unknown. No further information was provided. Additional information has been requested.
extreme muscle weakness, weakness in legs; fever; severe muscle aches throughout the body; headache; Initial information received on 24-Apr-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case is linked to case 2020SA109892 (same reporter).  This case involves male patient (age unknown) who experienced extreme muscle weakness, weakness in legs (muscular weakness), fever (pyrexia), severe muscle aches throughout the body (myalgia) and headache, while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 13-Sep-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On 13-Sep-2019 (same night), the patient developed a non-serious extreme muscle weakness, weakness in legs (muscular weakness), fever (pyrexia), severe muscle aches throughout the body (myalgia) and headache following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No laboratory data reported.  Final diagnosis was headache, pyrexia, muscular weakness and myalgia.   An unknown corrective treatment was received the patient except tyenolol.  Case details: patient stated that the headache, muscles aches, and muscle weakness come and go over about a 2-day interval; he will get better, then 2 days later the symptoms come back again, and this has been going on since September 2019. Patient stated that the one symptom he has not experienced since that first night, 13 Sep 2019, is fever. Patient stated that he was previously very healthy, and he has worked in a cardiology laboratory for many years.  The patient recovered from fever after one and a half day while was recovering other reported events..  There will be no information on the batch number for this case.
Extremely sore throat, headache, cold symptoms. Monoclonal antibody sotrovimab on 2/5/2022.
This is a serious study case from a physician in the USA who reports WHEEZING. The reporter determined the events to be possibly related to FluMist vaccination. A physician reports a patient experienced wheezing, considered medically important (OMIC), after receiving FluMist as a participant on a study. On 10/26/04, a 7 year old male received FluMist vaccination. On 10/27/04, the patient developed a mild sore throat in the evening. On the morning of 10/28/04, the patient continued to have a sore throat in addition to a temperature of 101 degrees F and mild nausea. All of the symptoms resolved by noon on the same day, 10/28/04. He remained asymptomatic until the afternoon of 10/30/04 when he developed wheezing and mild shortness of breath. At that time, he had no fever and no other respiratory illness symptoms. His parents took him to the emergency department later that day. He was treated in the ED with a nebulizer treatment to which he responded well. He was sent home with a prescription for albuterol inhaler. The parents of the patient have been giving him albuterol four times daily. The patient has a cough but no other symptoms. The mother anticipates the patient will be able to discontinue albuterol within the next two days and will follow up with their family doctor as needed. The patient's clinical outcome is unknown.
Seriousness criteria: other-Medically Significant. From initial information received on 07 January 2008 from a literature report: it was reported that "a 27-month-old female was evaluated because of a history of recurrent sterile abscess formation at the sites of routine childhood vaccinations. She had an uneventful course after her first series of vaccinations at age 2 months, which included Daptacel, IPOL, Comvax (manufacturer Merck) and Prevnar (manufacturer Wyeth). One month after the patient's second set of vaccinations at age 4 months, she developed a draining abscess on her left thigh at the site of Daptacel and IPOL administration. Her right thigh, where she received Comvax and Prevnar, was unaffected. The lesion healed after an incision and drainage and a course of oral antibiotics. At age 6 months, the patient received Daptacel and Prevnar in her right thigh. One month later, she developed an abscess in that extremity. The lesion was incised. Wound culture and Gram's stain were negative, and she was given an empirid couse of antibiotics. At age 18 months, she received the MMR II vaccine (manufacturer Merck), with no complications. At age two years, she received Comvax in her left arm, and one month later developed an abscess at the site. The lesion healed after an incision and drainage, but without antibiotics. Wound culture was negative, and a tissue biopsy was obtained from the base of the abscess. The patient had no history of other skin lesions or frequent infections. Her mother reported that umbilical cord separation was not delayed. Quantitative immunoglobulins and IgG subclasses were normal at age 8 months. The white blood cell count at that time was 10,300, with 20% neutrophils and 72% lymphocytes. Flow cytometry for CD11b/CD18, performed to exclude leukocyte adhesion defect type 1, was normal. It was felt that the patient's hypersensivitity to a common ingredient in Daptacel, IPOL, Comvax, or Prevnar vaccines was the cause of the recurrent lesions. Aluminium, formaldehyde, 2-phenoxythanol, and thimerosal were considered as possible causes of the reactions. Notably the MMR II vaccine, which contains gelatin and neomycin, was not associated with abscess formation in this patient. Patch testing was performed for aluminium (2% aluminum chloride solution), for undiluted DAPTACEL, and for a normal saline control by applying 0.1 mL of each solution to 1-cm gauze patches, applied to the upper arm and occluded with Tegaderm. The patches were examined at 12 hours. The control patch was negative, and minimal erythema was noted at the DAPTACEL site. A moderate reaction, characterized by erythema, multiple papules, and scattered vesicles, was seen at the aluminium chloride site. Patch testing on a negative control subject was negative for all three solutions. We diagnosed aluminium hypersensitivity in our patient, and recommended that she not receive any more aluminium-containing vaccines." The patient recovered from these abscesses.
Achy; Weak; Flu like symptoms; Temperature was 99.1 Farenheit; This spontaneous case was received on 28-Sep-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-02423) and concerned a 79-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included acyclovir occasionally and hormones, both used for unreported indication.  On 24-Sep-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: intramuscular, anatomical location: deltoid) for flu prophylaxis. The batch number reported was 279809, expiry date: 30-Jun-2021.   On 25-Sep-2020, one day after receiving Fluad Quadrivalent, the patient started having flu like symptoms. The patient was feeling achy, weak but her temperature was 99.1 degrees Fahrenheit.  At the time of initial reporting on 28-Sep-2020, the patient did not recover from the events.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: Pain, asthenia, fever and influenza-like illness were associated with the suspect product - Fluad Quadrivalent. One day after receiving the product all events emerged making chronology suggestive. The patient's medical history was not reported while concomitant medications included acyclovir occasionally and hormones, both used for unreported indication. Although influenza like illness developed within same day, it represents a body's normal immune response to the inactivated virus in the vaccine and therefore causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. Causal role for pain, asthenia, fever was also assessed as unlikely related to medicinal product. (''unlikely related'' defaults to ''relate'' in the safety database for reporting purposes); Sender's Comments: Pain, asthenia, fever and influenza-like illness were associated with the suspect product - Fluad Quadrivalent. One day after receiving the product all events emerged making chronology suggestive. The patient's medical history was not reported while concomitant medications included acyclovir occasionally and hormones, both used for unreported indication. Although influenza like illness developed within same day, it represents a body's normal immune response to the inactivated virus in the vaccine and therefore causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. Causal role for pain, asthenia, fever was also assessed as unlikely related to medicinal product. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)
Immediately following shot had lots of pain.  Has lots of redness, swelling, warm to touch.  Following day redness has spread to majority of his right thigh.
This spontaneous report as received from a registered nurse refers to another registered nurse of unknown age. On 19-FEB-2013 the registered nurse splashed M-M-R II (lot# unspecified) into her own eye, while retracting the needle on the syringe after M-M-R II was administered to a patient. The reporter stated the nurse's eye was itchy and red. The nurse mentioned the patient did not receive less than a full dose of M-M-R II. The outcome of the events was not reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 15 year old female patient. On an unknown date the patient was vaccinated with an extra dose of GARDASIL. Dosage, route of administration and lot number were not provided. 4th dose of GARDASIL was administered 3 months after the third dose was given on an unspecified date. No further information was available. Additional information has been requested.
- Swelling of the throat. - Trouble breathing. -Confused.      Emergency Room: 4/17/2021 6:52:00 PM   Hospital -   Attending Physician:    Medications Given in the ED:   4/17   8:21 pm    EPINEPHrine  0.3 mg IM  4/17   8:22 pm    methylPREDNISolone  125 mg IV Push  4/17   8:22 pm    famotidine  20 mg IV Push  After receiving this emergency care I felt I could breathe again but had many palpitations.   New prescriptions provided at the time of service    New Prescriptions:  BENADRYL 25 MG ORAL CAPSULE  1 CAP  BY MOUTH  2 TIMES A DAY;  AS NEEDED FOR         FOR ITCHING  FOR 3 DAYS; Dispense: 6 CAP(S); Refills: 0; Prescription    FAMOTIDINE 20 MG ORAL TABLET  1 TAB  BY MOUTH  2 TIMES A DAY  FOR 3 DAYS;         Dispense: 6 TAB(S); Refills: 0; Prescription Electronically Submitted to   PREDNISONE 50 MG ORAL TABLET  1 TAB  BY MOUTH  ONCE A DAY  FOR 3 DAYS;         Dispense: 3 TAB(S); Refills: 0; Prescription Electronically Submitted to  The treatment gave me palpitations and exhausted me. It took me 4 weeks to recover my full mobility but it is still difficult to move, lift weights or perform at work and in daily life as before the vaccine. I feel a lot of fatigue after this experience.
I noticed I was itchy and had hives/swelling near my right eye, right shoulder, and right thigh.
Severe post-COVID 19 vaccine polyarthritis  Within 10 hours of receiving the first mRNA Pfizer vaccine, I experienced joint pain and crepitus in the cervical spine, right shoulder, left hip, bilateral knees, and left foot.  The pain lasted 3-4 days.  4-5/10 pain  Within 10 hours of receiving the second mRNA Pfizer vaccine, I experienced joint in the same joints, but the pain lasted 3 to 4 months.  By July 2020, I experienced recurrence of the symptoms every 2 weeks.  The pain was 4-5/10.  My rheumatologist said the phenomenon of experiencing a flare up of my symptoms months after the vaccine was called "immunologic echo."  Because I experienced these symptoms 10 hours after receiving the mRNA vaccine, he said it was probably a vaccine reaction.  He also said it could be but less likely reactive arthritis.  He said I could never take another mRNA vaccine again.  Because I am a health care worker, mandatory COVID 19 booster shot was needed.  So I had a Janssen booster, dsDNA.  Within 10 hours, I experienced intense pain in all the joints described above and in addition a new symptom of joint pain, crepitus, and decreased motion of my left hand joints.  This pain was intense 8/10, and required pain medications daily for 3 months (alternative motrin, tylenol, and occasional benadryl).  I could not walk, drive, type, sleep well, and do usual activities.  I had to take medical disability leave and needed physical therapy.   My joint pain significantly improved within 6 months and depression symptoms within 10 months.  My rheumatologist said he has confidence that I will make full recovery.    My autoimmune work up and laboratory blood work were normal,  only the ANA and anti-cardiolipin antibodies were positive.
Initial unsolicited report received from office staff on 25-Jul-2018. This case was linked to 2018SA206650 and 2018SA206651 (same reporter). This case involves a four-month old patient (gender not reported) who was vaccinated with 0.5 ml expired second dose of PENTACEL (Batch number: C5402AA, expiration date: 24 Jun 2018, was not reported) via intramuscular route in left leg on 25 Jul 2018. The patients medical history was not reported. Concomitant medications included PREVNAR 13 and ROTATEQ for Immunisation. It was an actual medication error due to expired vaccine used. It was reported that, the patient did not have any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
On 2/24/21 woke up around 10 AM due to the need to urinate. He was rigid (straight as a board) and unable to sit up in bed and barely able to move. After about 30 minutes he was able to sit up, stand and walk with a walker and assistance. generally has difficulty walking, but the concern was the rigidity and inability to bend for such a long period of time. After that he seems to be the same as he was prior to the vaccine.  Also, on 2/22/21 shortly after getting his vaccine he had a tremor in his hand (not sure which one) which stopped shortly after getting the vaccine.
Pain in shoulder and arm.  Limited motion with shoulder. Pain radiates down the arm. Pain when using the arm.