chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shaking; anxiety; arm pain that went worse after the second dose; joint pain; Headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Shaking), ANXIETY (anxiety), PAIN IN EXTREMITY (arm pain that went worse after the second dose), ARTHRALGIA (joint pain) and HEADACHE (Headaches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination.     Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) and INDOMETHACIN [INDOMETACIN] for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced TREMOR (Shaking), ANXIETY (anxiety), PAIN IN EXTREMITY (arm pain that went worse after the second dose), ARTHRALGIA (joint pain) and HEADACHE (Headaches). At the time of the report, TREMOR (Shaking) was resolving and ANXIETY (anxiety), PAIN IN EXTREMITY (arm pain that went worse after the second dose), ARTHRALGIA (joint pain) and HEADACHE (Headaches) outcome was unknown.            Treatment information was not provided.  On an unknown date, post-vaccination, the patient was seen by a neurologist for the shaking. Per the reporter, the neurologist stated they were unsure if the patient had a movement disorder but the tremors will slowly go away.   This case was linked to MOD-2021-022325 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07 Jun 2021. Updated reporter information, concomitant medications and events.
1455: Pt c/o of dizziness, diaphoresis with hx: of anxiety, NKA. Laid pt down to floor and elevated legs on chair. 1500 called EMS. 1st vitals: 102/60 02 99 HR 84.  1500 NP assess pt, she stated her face was pale. NP instructed her to deep breath and increase oral fluids. Pt states she was dizziness. Sat patient up 2nd vital 85/56 O2 97 HR92. 3 vital patient sitting on chair 101/66, O2 90, HR 92.  NP assessed patient. Patient denies dizziness was able to stand and walk to car.
body aches; sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B1A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (body aches), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, PAIN (body aches), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown. Not Provided          Concomitant information use was not reported.  Treatment information was not provided.
General malaise began within 24 hours of administration.  C/O: Headache, low grade fever, body aches, swollen glands under arm closest to site, large area of erythema, warmth, swelling on Right upper arm.
sick; flu like symptoms; fever; chills; tiredness; soreness; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ILLNESS (sick), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (tiredness), MYALGIA (soreness) and NAUSEA (nauseas). At the time of the report, ILLNESS (sick), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (tiredness), MYALGIA (soreness) and NAUSEA (nauseas) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Non-Significant Follow up-Snapshot Document attached, Reporter contact details updated
Subsequently, the pt experienced swelling and redness at site of injection down to arm and elbow. Additionally, it was noted that 3 other pt experienced similar reactions.
12/12 developed L shoulder/arm pain. 10/10 especially at night. Sx x 2 1/2 wks. ER visit - negative ECG, negative arm/shoulder x ray. EMG diagnostic of PARSONAGE TURNER Syndrome.
Patient report nausea and vomiting following injection. 2 days later, developed a rash on the injection site.  Recommend take OTC Benadryl or Claritin for swelling  on injection site.
1639: Patient received Pfizer 1st dose after initially receiving J&J the first ime 1656: patient reported itchiness in the throat and facial flushing  1657: IM EPI .30mg given  1658: IM 50mg Benadryl given  1705: Patient was wheeled out to ED and states "I feel so much better my chest is less tight"
The vaccine was administered 3 days after the beyond use date. The dose was administered on 10/5/2021 when the beyond use date was 10/2/2021.  The expiration date of the vial was 10/31/21. The expiration date was used instead of the beyond use date.
This employee advised she received FLUARIX on 12/31/2015 as part of hiring requirement as a mental health worker. She advised for years she had never received the flu vaccine as she had impetigo (?) as a child (age 5-6 years) and was told never to eat shellfish, nuts or eggs. She advised she doesn't eat eggs and did not like them any ways. She can eat items cooked with eggs such as breads, pastries, potato salad (picks out eggs if sees them). On 12/31/2015 she advised within 12 hours of the vaccine she began to experience a runny nose and watery eyes. Then she noticed "hives" to bilateral lower arms (forearms) and bilateral lower legs (shins) only. She denied hives to face, back, chest or abdomen. She described the hives as red raised single bumps that itched and she covered with calamine lotion x 4 days before they resolved. She was also anxious but was able to calm herself down prior to seeing HCP at clinic. (these records unavailable to this HCP at this time). She denied any recent travel, new foods, detergents, deodorants, clothing, nylons, lotions, hiking, razors, creams, or exposure to any items. She stated HCP attributed reaction to flu vaccine received day before.
Narrative: COVID infection following COVID vaccine series 02/10, Pfizer, dose #1 03/03, Pfizer, dose #2 12/31 COVID swab, result: detected 12/21 pt cc: fevers, chills, bodyaches, mild cough, back pain. exposure: unknown 12/31 CXR impression: No acute cardiopulmonary disease. 12/31 SPINE CERVICAL impression: Severe cervical spondylosis is present worst at C5-6 and C6-7. Negative for scoliosis. The C1-C2 relationship is maintained. No acute fracture or dislocation is seen, however if there is a history of trauma, a CT of the cervical spine is recommended is distended care. 12/31 SARS-COV2 TOTAL AB: 1929 12/31 SARS-COV IGG 0.01 12/31 TROPONIN I: 0.190 12/31 DDIMER; 0.43 12/31 TROPONIN I: 0.177 12/31 Pt admit to Medicine cc: Upper back pain dx: Upper Back/Neck Pain- symptoms present since becoming sick with COVID019, likely MSK etiology in setting of coughing LOS 3 days
excruciating pain in lower right back for 24 hours. Still minor aches 4 weeks later  After second dose, flu like aches everywhere for 24 hours, especially in my back.
AcuteTubularNecrosis Narrative: Was hospitalized on 1/13/21 and discharged on 1/15/21. Given IV fluids.
Arm soreness. Muscle aches.  Fatigue. Cognitive fog  Backache.  Lasting 5 days. Cognitive fog and backache still there after 8 days, improving but not totally gone.  Muscle aches still present but improving.
awoke less than 48 hours later with symptoms of severe head cold/sinusitis; completely lost senses of smell and taste; extreme fatigue.  As of today, sinusitis better, but not gone.  Sense of smell and taste still completely absent.
arm pain; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (arm pain) and MYALGIA (Body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (arm pain) and MYALGIA (Body ache). At the time of the report, PAIN (arm pain) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported Treatment medications was not provided
Patient was brought to the hospital for evaluation for signs of congestive heart failure. He was managed in the hospital for a few days and was sent back to Hospital. However, he was brought back to the hospital where he came from since he was not stable.
Got vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history report provided by the reporter.  The patient's past medical history included Pregnancy (Live, full-term birth) on 15-Sep-2016. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Jan-2021 and the estimated date of delivery was 16-Oct-2021. On 04-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 04-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Uterine cramping led to preterm birth/loss. No prior history of preterm labor or incompetent cervix.  Cervix was long and closed at 18-week checkup. Got vaccinated at 20 weeks. Increased discharge and cervical dilation week following vaccination with preterm delivery exactly 2 weeks post vaccination (Moderna on 30 April) on 14 May at 22 weeks gestation. Baby did not survive.  Following delivery, I had a brain bleed and postpartum preeclampsia.
(NOTE:Baseline BP 04/01/19 Doctors on Duty 120/80 pulse 60). 5-15-21 Felt amped. 5-17 Couldn't catch breath when stood up, palpitations. 5-18 heart felt under pressure, ached. During easy run, heart rate 178, sharp pain up left side of chest. 5-19  went to Doctors on Duty BP 160/82 pulse 63. EKG normal range elevated V2 and V3. 06-01-21 Physical  Dr. BP 169/75 pulse 62.BP monitored Omron 3 cuff beg.6-01-21. As high as 173/100. Pulse quickly climbs to 172 during 2 mile easy runs. Dr. Ordered 5mg amlodipine daily. Beg. 6-20-21. BP up/down 141/94 pulse 70 to 110/84 pulse 86 since. Palpitations, high heart rate when active and slight chest pain still present.
This is a spontaneous report from a contactable consumer who reported for herself, a 65-year-old female patient who received PREVNAR 13 (lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nauseous, pain in arm, limitation of arm movement, frozen shoulder, fever 102.2, fatigued and swelling. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Incredible stiffness; Lower extremity joint pain in the hips, knees, calves,and feet.; Joint pain that lingers; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Incredible stiffness), PAIN IN EXTREMITY (Lower extremity joint pain in the hips, knees, calves,and feet.) and ARTHRALGIA (Joint pain that lingers) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A, 032M20A and 016M20A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), ESCITALOPRAM and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Incredible stiffness), PAIN IN EXTREMITY (Lower extremity joint pain in the hips, knees, calves,and feet.) and ARTHRALGIA (Joint pain that lingers). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Incredible stiffness), PAIN IN EXTREMITY (Lower extremity joint pain in the hips, knees, calves,and feet.) and ARTHRALGIA (Joint pain that lingers) had resolved.            Reported that the events started a week after vaccination and lasted for months.   This case was linked to MOD-2022-544380, MOD-2022-544329, MOD-2022-544382 (Patient Link).
MISSED LAST DOSE; This spontaneous case report (PVX2019-1983) was received from a consumer on 01-Aug-2019. It describes a female consumer who "missed last dose" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer missed her last dose that was due on 31-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "missed last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed last dose" was considered as not applicable.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    Concomitant product use was not provided by the reporter. More or less 170 - monovalent and 20 bivalent doses had been administered which were beyond the 30 day beyond use date. Vaccine administered on 23-Feb-2022 with lot number 042J21A after 30 days BUD date which was 17-Feb-2022 Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
On 12/6/00, pt developed a fever of 103F and his left arm was swollen and solid. He had chills as well. Pt was given 2 Advil every 4 hours and had ice placed on his left arm. Pt was also encouraged to drink plenty of fluids.
Lymph node on injection arm (left) was swollen and tender for approximately three days after injection. No other lymph nodes seemed to be affected.
- Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC meds. Sometimes too high for thermometer to read.  - Swelling at injection site (and halfway to elbow), soreness. By Monday this was down to about a golf ball, and it resolved in a week.  - Fatigue, slept all weekend and was tired but functioning the following week.  - Severe joint pain and muscle aches Saturday and Sunday. I took OTC pain relievers. Went to bed.  - Blindingly bad migraine Friday night, worse Saturday, and resolving some on Sunday, somewhat responsive to Naratryptin.
Arms were so sore; This case was reported by a consumer and described the occurrence of pain in arm in a adult female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 1 day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported that the patient rolled over the morning after receiving vaccine, the patient's arm was sore. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252430:same reporter US-GLAXOSMITHKLINE-US2020AMR252429:same reporter US-GLAXOSMITHKLINE-US2020AMR252428:same reporter
Patient received vaccine by mistake even though their age did not meet the minimum age requirement for Moderna Covid19 vaccination of 18 years old. No adverse effects were reported upon notifying patient's mother
Fever of 100.6, painful body aches, chills, mild headache for 24 hours Felt fatigue and sore muscles for the following 24 hours
Fever, extreme persistent throbbing pain in shoulder and arm where the injuction was administered, chills and flulike sypmtoms, soaking night sweats, and severe headache (2 days in duration).  The throbbing in the arm was so severe that sleep was not possible, this resolved in 18 hours, the arm remained moderately sore for an additional 2 days.  General body weakness has persisted.
First 24 hours had cold feet, cold hands sleepy hands and chills ..very fatigued, Within the next 6-hours developed fever---slight fever of 101 that was taken care of with Tylenol.  Muscle- aches and slight redness at area of injection.  After 48 Hours felt  a lot better.  No fever--nothing!
Full body hives, swollen bottom lip. Treated with benadryl, pepcid and prednisone.
chills, fever, anxiety, slurred speech, shaky, weak, sensitive to light;T100.3, BP 116/60, P114 reg;
patient received Adacel vaccination into the posterior upper left arm, subcutaneously; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 38 years old female patient who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6272AA (Expiration date not obtained) via subcutaneous route in the left arm on 06-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines administered.   It was a case of actual medication error due to Inappropriate route of vaccination.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  Documents held by sender: none.
arm was itching; body pain; change in taste sensation; arm was hot; lump at the injection site; very tired; nausea; fever; chills; muscle ache; head hurt; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm was itching), PAIN (body pain), TASTE DISORDER (change in taste sensation), VACCINATION SITE WARMTH (arm was hot) and VACCINATION SITE MASS (lump at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Allergy to chemicals (allergic to unknown dye used during CAT scans) and Pre-diabetic. Concomitant products included METFORMIN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (chills), MYALGIA (muscle ache), HEADACHE (head hurt) and PYREXIA (fever). On 03-Mar-2021, the patient experienced PRURITUS (arm was itching), PAIN (body pain), TASTE DISORDER (change in taste sensation), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE MASS (lump at the injection site), FATIGUE (very tired) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, PRURITUS (arm was itching), PAIN (body pain), TASTE DISORDER (change in taste sensation), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE MASS (lump at the injection site), CHILLS (chills), MYALGIA (muscle ache), HEADACHE (head hurt), FATIGUE (very tired), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 99.5 (High) 99.5 F. On 03-Mar-2021, Body temperature: 101.5 (High) 101.5 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she takes occasionally a sinus pill.