chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore joints; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore joints), HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Vestibular migraine. Concomitant products included IBUPROFEN for Vestibular migraine.    On 11-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced ARTHRALGIA (sore joints), HEADACHE (headache) and PYREXIA (fever). At the time of the report, ARTHRALGIA (sore joints), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that she took 2 Ibuprofens 3 hours before receiving the vaccine because she had vestibular migraine. She forgot about not taking medications before receiving the vaccine. She took the medications to keep her migraines from getting worse.  Reporter clarified that her migraines had nothing to do with the vaccines and she had been experiencing migraines before receiving any Moderna vaccine.  She had sore joints, headache, and fever after receiving the vaccine.  No treatment information was provided.   Reporter did not allow further contact
Expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. It was reported that number of doses/vials was 4 doses/1 vial. On 5-MAR-2022 vial was initially stored in the refrigerator. Vial did not undergone any temperature excursions.   This case was linked to MOD-2022-532744, MOD-2022-532746 (Patient Link).
Woke up with very sore shoulder, on the same arm that I received the vaccination in. I have a very limited range of motion, and pain when arm is not at side. Pain was worse when I woke up today (10/7/2013), and has stayed constant.
No adverse event; patient received the monovalent booster instead of bivalent booster; received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 02-SEP-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the monovalent booster instead of bivalent booster), PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 02-SEP-2022) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the monovalent booster instead of bivalent booster) and PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 02-SEP-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the monovalent booster instead of bivalent booster), PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 02-SEP-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the monovalent booster instead of bivalent booster) and PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 02-SEP-2022).    No relevant concomitant medications were reported.   The patient was traveling who was requiring booster. The patient was traveling before the bivalent booster became available.  The patient have not reported any adverse reactions.  It was reported that no expired dose was given to the patient on 02-SEP-2022.  No treatment information was provided.
WEIGHT LOSS; DIARRHEA; FATIGUED; HEADACHE; BODY ACHES; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug sensitivity when treated with amoxicillin/clavulanic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 13-OCT-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 13-OCT-2021, the patient experienced body aches. On 13-OCT-2021, the patient experienced diarrhea. On 13-OCT-2021, the patient experienced fatigued. On 13-OCT-2021, the patient experienced headache. On 20-OCT-2021, the patient experienced weight loss. On 29-OCT-2021, Laboratory data included: Blood test (NR: not provided) clean, and Stool analysis (NR: not provided) negative, very watery. Treatment medications (dates unspecified) included: loperamide hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and headache on 15-OCT-2021, had not recovered from diarrhea, and the outcome of fatigued and weight loss was not reported. This report was non-serious.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received a healthcare professional regarding a 24 month old female patient who experienced warmness, redness and swelling at the injection site, At 24 months of age the patient received a dose on 3/16/2005. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 3/16/2005. Dose regimen was 1 dose. Patient was not taking concomitant therapy. The patient experienced redness (injection site erythema), swelling (injection site swelling) and warmness (injection site warmth) at the injection site (right thigh) in Mar 2005. The patient recovered 2005. No additional information was available at the time of this report. The reporter also stated that another patient also received this same lot number and developed the same reaction (see case HQWYE632101APR05).
The patient developed a sudden onset of bilateral hamstring pain within seven days following the shingles vaccine administration 4/28/15. Left shoulder pain followed over the next two weeks with limited mobility in the left arm. During this time, the patient continued to develop weakness in the lower extremities with difficulty in gait function. The patient was unable to dress or shower without assistance due to pain and weakness. Myalgia and joint pain continued throughout the month of May and June. The patient saw an orthopedic physician on 5/11/15 for gait weakness and left shoulder joint pain. The patient received a steroid joint injection into the left shoulder. A return follow-up visit on 5/27/15 indicated lab work studies and physical therapy implementation. The physician diagnosis was noted to be "adhesive capsulitis left shoulder; myofascial pain, and hamstring tightness both lower extremities". On 6/4/15, the patient was seen at the Clinic and more lab studies were ordered. Other return visits for medical assessment followed 6/11/15, 6/17/15, and 7/14/15. On 7/14/15 a different orthopedic physician injected steroid injections into both shoulders for frozen shoulders and joint pain. The patient was prescribed Meloxicam on a daily basis. On 7/29/15, the patient was seen by a rheumatologist.  A confirmed diagnosis for rheumatoid arthritis was discussed with the patient. The patient was healthy prior to this event and was highly recognized as a referee in high school football for over thirty years. The rheumatologist said the patient would be unable to referee football this season. The rheumatologist said there was possible association of this condition/disease with the shingles vaccine in discussion with the patient. The patient was prescribed RA medication (Sulfasalazine) to be taken on a daily basis. Also, Methylpred pak was prescribed as needed for flare-up with joint pain and swelling. Prior to the 7/29/15 appointment, the patient had swelling and finger joint pain to the left and right hands. Each hand would swell approximately 2.5 times the size of the opposite hand. The events were separate and continued for at least ten days in each hand. These events happened during the months of June and July. Please note the patient reported no fever (> 100.4 degree F) anytime following vaccine administration.
Beginning less than 12 hrs after initial dose experienced fatigue, intense headaches, arthralgia lasting throughout weekend, fever of 100.1, chills, shortness of breath, injection site soreness/swelling.
Patient completed Pfizer COVID vaccine series by different vendor on 3/7/2021 and 3/28/2021.  Patient then received 3rd dose of Pfizer by us as documented on this report on 8/15/2021.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. The patient developed chicken pox 4 to 6 hours after vaccination. The outcome was unknown. There was no product quality complaint. This is one of several reports from the same source.
Spoke with client today. Reported severe ache and sometimes pain at injection site. States radiates down arm at times denies swelling or redness onset 2 days after injection.
8-9 hours later, walking down dorm hall "passed out" bumping front of head. C/o nausea and low backache afterwards. 10/21/03 to clinic, told her possible small concussion and possible kidney stone (per mother). No treatment. Urine test reports pending (2:45 PM).
A pharmacist reported the occurrence of an exacerbation of heart failure in a 44 year old male who was vaccinated with Twinrix for prophylaxis. The subject's medical history included heart failre and chronically elevated liver enzyme concentrations due to heart failure. The subject was on a waiting list for a heart transplant. The subject's concurrent medications included Lasix, calcium, amiodarone hydrochloride, Prevacid, lisinopril, Lipitor, Ecotrin, vitamin C, Coumadin, digoxin and spironolactone. On 5/20/03, the subject received his first injection of Twinrix. On 5/21/03, he developed an injection site reaction characterized by "severe" pain and swelling, which limited his ability to move the arm. The subject presented to the ER in the evening of 5/21/03, for treatment of the injection site reaction. The ER physician noted that the subject was "obviously edematous." Upon questioning, the subject reported that he had not urinated for 24 hrs. A diagnosis of worsening heart failure was made, and the subject was hospitalized. Lab analyses revealed increased creatinine concentration. During hospitalization, the subject reported night sweats, which were attributed to heart failure. The worsening heart failure was treated with IV dobutamine. The injection site reaction was treated with an injection of methylprednisolone, followed by oral prednisone. The pharmacist reported that there was some question as to whether the swelling at the Twinrix injection site represented a hematoma. On admission to the hospital, the subject's international normalized ratio was 1.7. The injection site swelling and pain responded "quickly" to corticosteroid therapy, so his physicians did not want to attempt to ascertain if a hematoma was present. On 5/23/03, the subject developed hives on his knees. As of 5/23/03, the exacerbation of heart failure and the injection site reaction had improved. The outcome of the hives was unknown. The reporter considered the exacerbation of heart failure to be unrelated to Twinrix administration. He considered the injection site reaction to be related to Twinrix administration. He considered the hives to be possibly related to Twinrix administration.
Modern Arm...extreme raised rash and swelling. Brushing and muscle soreness at injection site.  Symptoms continue after 16 days and subsides and rein-flames continuously..
s/p vaccination with 2nd Covid Vaccine dose, developed low grade viral type illness with fevers up to 102 with myalgias, fatigue. Began to recover, teh awoke in the morning of 1/16/20 wtih crushing, substernal chest pain. Presented to the emergency department. Was admitted to he hospital  -  diagnosed with myopericarditis. Stayed in the hospital one night, and discharged the next day.
In morning soreness and swelling in right arm by the afternoon (5 pm) had chills lasted for 12 hours, started again afternoon of 10/5 by 1 pm.  Had chills until 10/6.  Had a 4-inch round node by injection site.
on 3JAN95 3 hr unconsolable crying 4 to 6 hr p/shots; eval @ MR 4JAN95; advised no more DTP/DTAP
Immediate redness, swelling, itching, feeling woozy. Took 2tsp Benadryl. By evening painful & swollen armpit & lymph nodes. Very painful shoulder joint - could not raise my arm. Took more Benadryl & applied ice pack. 72 hours later still red painful & swollen- will see doctor.
11:58am- tingling in right chest and neck , felt a high 8:00pm- back pain and neck pain/ shoulder blades stiffness and muscle ache /soreness at right arm place of injection  8:30: sleepy 2:40am - Instense stiffness pain in the neck  and shoulder blades with aching pain.  4:00am : Insomnia  Pain lesson next day by 50 percent. Still experiencing soreness throughout today 1/19/2021  Took 3 Tylenol every 6 hours
Nausea, dizziness, fever, headache, night sweats for four days only threw up the first day too dizzy to drive fever would starts in the afternoon and was never higher than 101.4 temperature was normal 97.9 in the mornings
NARRATIVE: Per secure message from patient. Got the shot at 9:00 am, noticed reactions starting by 11:00 am until 29th at about 9:00am. Had confusion, disorientation, weakness, changes in vision, headaches, nausea, vomiting, cramps and diarrhea during this time. Also felt hot, cold and fever. I'm wore about but recovering fine. I don't want a booster after this episode.
Diarrhea; Fever; Chills; Weakness; Dizziness; This is a spontaneous report from a contactable other healthcare professional, (patient). A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in May2021 (at the age of 31-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications included aciclovir (ACYCLOVIR), biotin (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C) pills and colagen (MANUFACTURER UNKNOWN); from an unknown date for unknown indication. 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 vaccine within four weeks prior to the COVID vaccine. On an unknown date in May2021, the patient experienced diarrhea since the day of the vaccine (4 days), fever the next day of the vaccine, chills, weakness and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of fever and included treatment with naproxen (MANUFACTURER UNKNOWN). The clinical outcomes of the events diarrhea, fever, chills, weakness and dizziness were resolved on an unknown date in May2021.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Covid positive after vaccine; Covid positive after vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: SUSPECTED COVID-19 (non-serious), DRUG INEFFECTIVE (non-serious), outcome "unknown" and all described as "Covid positive after vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 55 year old female patient. On 01-AUG-2014 the patient was vaccinated with a single dose of ZOSTAVAX, subcutaneous (dosage and lot# not reported). On 02-AUG-2014, the patient developed a red, itchy welt at the injection site. The patient called the pharmacy on 04-AUG-2014 to report the reaction was getting worse. No treatment was given, none of lab test was performed. The outcome of event was not recovered/not resolved. Additional information is not expected.
Chills; Fever; Fatigue; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body ache) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body ache). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) had resolved and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was unknown.  No treatment information provided.
ARM HURTS FROM COVID BOOSTER; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (ARM HURTS FROM COVID BOOSTER) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (ARM HURTS FROM COVID BOOSTER). At the time of the report, VACCINATION SITE PAIN (ARM HURTS FROM COVID BOOSTER) was resolving.            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.  No concomitant medication information was  provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information was provided   This case was linked to MOD-2021-624331 (Patient Link).
No additional AE; patient was given VARIVAX product that had been reconstituted with sodium chloride solution instead of sterile diluent.; This spontaneous report has been received from a pharmacist referring to a patient of unknown age or gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 23-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot# U039722, expiration date 15-DEC-2023, strength, dose, route and anatomical location were not reported) for prophylaxis, which was reconstituted with sodium chloride solution (strength, dose, frequency, lot#, expiration date, route and indication were not reported) instead of sterile diluent (product preparation error). No additional AE details available. No additional AE reported.
Sx started 1:30PM began sweating, lightheadedness, tremors of extremities, queasy, 170/88, P100, Temp 97.3.
On 10-21-19 patient reported prolonged soreness in left arm with some restriction in range of motion. Vaccine administered 9-20-19.
Information has been received from a health professional for GARDASIL, a Pregnancy Registry product, concerning a female baby. On 15-SEP-2006 the baby's 17 year old mother with no known allergies was vaccinated IM with the first dose of GARDASIL (lot# 653735/0688F) in the right deltoid. On 11-OCT-2006, the baby's mother had a positive urine pregnancy test. It was reported that the mother had previously had a negative serum pregnancy test on 17-JUL-2006. The mother's last menstrual period (LMP) was 15-AUG-2006. Subsequently the baby experienced fetal tachycardia. On 04-JUN-2007 the baby was delivered with no congenital anomalies by cesarean section. The baby was healthy and normal. Estimated gestational age at delivery was 38 weeks, 1 day. The reason for the cesarean section was "unrelieved pain". The mother and baby were both discharged on 11-JUN-2007. The reason for the extended hospitalization was unknown. The mother's experience has been captured in WAES 0612USA01320. The event of fetal tachycardia was previously reported in WAES 0612USA01320. Attempts to obtain additional information regarding the infant have been unsuccessful. No further information is available.
pt woke 3/12/12 with  blood sugar on low side; low grade fever, chills, achy, tired, headache and nausea without vomiting.
I have not had a period due to taking birth control for almost 2 years. I got the first shot on July 12th and started my period on July 28th. This period was heavy, passed quarter sized clots, painful cramps and lasted 7 days. I stopped bleeding for 5 days then started bleeding again with the same pain, flow, and clots. This lasted 6 days. I stopped bleeding for 5 days and then started bleeding again  for 6 days.  I have stopped bleeding now for a week.