chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), FEELING ABNORMAL (Felt horrible), AXILLARY MASS (painful lump in the armpit), NECK MASS (lump on the collar bone) and BACK PAIN (back pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness), FEELING ABNORMAL (Felt horrible), AXILLARY MASS (painful lump in the armpit), NECK MASS (lump on the collar bone), BACK PAIN (back pain), ASTHENIA (no energy for two weeks) and VACCINATION SITE LYMPHADENOPATHY (swelling under the arm). On an unknown date, the patient experienced MOBILITY DECREASED (Her arm still doesn't have full mobility due to soreness) and AXILLARY PAIN (painful lump in the armpit). At the time of the report, PAIN IN EXTREMITY (Arm Soreness), FEELING ABNORMAL (Felt horrible), AXILLARY MASS (painful lump in the armpit), NECK MASS (lump on the collar bone), BACK PAIN (back pain), ASTHENIA (no energy for two weeks), MOBILITY DECREASED (Her arm still doesn't have full mobility due to soreness), VACCINATION SITE LYMPHADENOPATHY (swelling under the arm) and AXILLARY PAIN (painful lump in the armpit) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
penis got hard when Pfizer gave the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPONTANEOUS PENILE ERECTION (non-serious), outcome "unknown", described as "penis got hard when Pfizer gave the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Felt sick that night. Body aches Arm pain. Over 1 week later, still arm red swollen & hot with 2 ? diameter of hot around it.
This case was reported by a pharmacist via sales rep and described the occurrence of atrial fibrillation in a 90-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUZONE HD for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 1st dose of FLUZONE HD. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation was recovered/resolved. It was unknown if the reporter considered the atrial fibrillation to be related to SHINGRIX. Additional details were reported as follows: The patient was approximately 90 years old and received SHINGRIX in unknown arm. Before the reporting date, past weekend the reporter had a patient that experienced atrial fibrillation. The patient had received FLUZONE HD in an unknown arm. According to the reporter, the patient was then thrown into atrial fibrillation. They were able to correct this and the patient was now stable.
- within 5 min, felt slightly dizzy - within 1 hour, nausea - within two hours, moderate neck pain; weakness; paleness - within 3 hours, dizziness - enough to have to lay down; increase in neck pain - 6 on a scale of 1-10; slowed speech and thinking; mild tightness in chest and difficulty breathing; mild swelling in throat and ears - within 4 hours - felt as if full on flu - called facility & was advised to go to Hospital - Medical Center determined difficulty breathing was not severe enough and was discharged
On 1/13/21 throat suddenly seized, had to work hard to expell or inhale air Turned slightly got dizzy then almost passed out but held on to handle of cart and then it passed and was able to  breathe freely whole episode took about 20 seconds  on the following night (1//14/21) about the same time was overwhelmed with nausea and strong  abdominal cramps . Thought I was coming down with the stomach flu. Reaction disappeared after about an hour.
Patient stated on 10/3/13 (date vaccine provided) that has asthma attack and difficulty breathing, but today (10/4) when I called to follow up, she said yesterday she had fever, swollen mouth, and hives, but feel fine today.
Left leg is swollen and 3 by 3 cm reddened in diameter. Warm to touch.
For the first 2 days, I only had a sore arm.  Starting on day 3 after the vaccination, I started having joint pain, chills, loss of appetite and headache.  This continued for 3 straight days, but only at night.  It went away for a few days, but returned and has continued, 2 weeks past my vaccination date.  Symptoms remain predominantly at night and are bad joint pain, especially in hips in legs; chills and inability to get warm; headaches.
Shortness of breath; High blood pressure; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), HYPERTENSION (High blood pressure) and CHEST PAIN (Chest pain) in a 42-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) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Sep-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Single-Dose Prefilled Syringe. On 19-Sep-2022, the patient experienced DYSPNOEA (Shortness of breath), HYPERTENSION (High blood pressure) and CHEST PAIN (Chest pain). At the time of the report, DYSPNOEA (Shortness of breath), HYPERTENSION (High blood pressure) and CHEST PAIN (Chest pain) had resolved.     No concomitant medications were reported.  It was reported that, the reporter did not have the lot number information, because the packaging was discarded.  No treatment medications were reported.  The reporter's causality for the events of chest paint, high blood pressure and shortness of breath with adalimumab was not provided.   Reporter did not allow further contact
headaches, fever, chills, achy muscles, soreness, nausea, and pain on the entire arm injected with the vaccine. All of those started on April 12th (2days after i got the shot) and have gotten worse since then. I feel ill.
intially sore; itchy; large swollen area on the her left arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN (intially sore), PRURITUS (itchy) and PERIPHERAL SWELLING (large swollen area on the her left arm) in an 82-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057965) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: pfizer (Dose 1, Lot-ELN263) on 26-Jan-2021, Pfizer (Dose 2, Lot-EN6201) on 11-Feb-2021, Pfizer (Dose 3, Lot-FC3180) on 30-Aug-2021, Pfizer (Dose 4, Lot-FKN891) on 17-Feb-2022, Pfizer (Dose 5, Lot-BJ5342) on 21-Sep-2022, Pfizer (Dose 6 and Lot-GJ6743) on 29-Mar-2023. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer, Pfizer, Pfizer and pfizer. Concurrent medical conditions included Celiac disease.    On 22-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (intially sore), PRURITUS (itchy) and PERIPHERAL SWELLING (large swollen area on the her left arm). The patient was treated with CORTISONE in September 2023 at an unspecified dose and frequency. At the time of the report, PAIN (intially sore), PRURITUS (itchy) and PERIPHERAL SWELLING (large swollen area on the her left arm) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Within less than 24 hours of vaccination there was a large swollen area on her left arm. It got progressively worse measuring about 5 by 4 inches.
Immediately post vax, redness and swelling noted. Physician treated with ice pack and observed for 30 minutes. No further reaction noted.
Developed idiopathic intercranial hypertension 4-5 months after second vaccine. Symptoms included headaches, loss of vision, neck pain, joint pain, nausea , vomiting
They are very itchy; It's red raised like welts; UTI; Big red spots everywhere on her body; There are also blisters all over her body including her chest, her back, and her arm; Rash sore to touch; it was not normal; Rash started on arm, but now it's all over the body/rash/sore to the touch; It was very hard; Arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (They are very itchy), URTICARIA (It's red raised like welts), URINARY TRACT INFECTION (UTI), RASH MACULAR (Big red spots everywhere on her body) and BLISTER (There are also blisters all over her body including her chest, her back, and her arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029 _ 20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immune disorder (NOS) ((primary immune deficiency) or very low immunity.) and Drug allergy (her leg jerks).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE INDURATION (It was very hard) and VACCINATION SITE SWELLING (Arm was swollen). On 29-Jan-2021, the patient experienced VACCINATION COMPLICATION (it was not normal) and RASH (Rash started on arm, but now it's all over the body/rash/sore to the touch). On an unknown date, the patient experienced RASH PRURITIC (They are very itchy), URTICARIA (It's red raised like welts), URINARY TRACT INFECTION (UTI), RASH MACULAR (Big red spots everywhere on her body), BLISTER (There are also blisters all over her body including her chest, her back, and her arm) and RASH (Rash sore to touch). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of twice daily and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (They are very itchy), URTICARIA (It's red raised like welts), URINARY TRACT INFECTION (UTI), RASH MACULAR (Big red spots everywhere on her body), BLISTER (There are also blisters all over her body including her chest, her back, and her arm), RASH (Rash started on arm, but now it's all over the body/rash/sore to the touch), INJECTION SITE INDURATION (It was very hard), RASH (Rash sore to touch) and VACCINATION SITE SWELLING (Arm was swollen) outcome was unknown and VACCINATION COMPLICATION (it was not normal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. Patient received second dose of vaccine on 20 Mar 2021 and had flu like symptoms after the vaccine.   This case was linked to MOD-2021-254059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: significant Follow-up received on 12-JUL-2021.contains updated Email id and event.Medical history updated from initial source document.
LEFT DELTOID WITH LOCALIZED RAISED RED AREA, WARM, APPX 7MM X 8MM, PT DENIES PAIN. ADVISED COLD/WARM COMPRESSES TO INJECTION SITE AND/OR BENADRYL.
1/29/21/after vaccination reported "numbness and tingling around her mouth and lips area and described it as feeling swollen.  Pulse 80, breathing unlabored and red cheeks." reported neck pain in the back left  which was  similar reaction after 1st dose. She also reports having congestive heart failure. Observation for 20mins  no swelling noted on mouth, tongue or lips. reported tingling has subsided. She was instructed to call doctor if symptom worsened and to return to ER. She stated that she text her heart doctor . Pt left with mother.
Today I have severe pain in my right shoulder have have a lump under my skin to the right of my spinal cord and I had a bloody nose
Additional information received provided the hospital discharge summary that included additional source information, additional events and details of hospitalization, including dates of admission and discharge, treatment, laboratory data, and patient outcome and discharge status. Upon receipt of the additional information, this report has been upgraded to a serious unexpected cased report. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a physician regarding a 5 year old female patient who received a dose of Prevnar on an unspecified date and developed necrotizing group A streptococcus pneumonia, dehydration, hypoxia and empyema. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. concomitant medications were not reported. On an unspecified date, the patient received a dose of Prevenar. On 31-Oct-2005, the patient was hospitalized for right lower lobe pneumonia with effusion, hypoxia (hypoxia) and dehydration (dehydration). A chest computerized tomogram done on admission showed consolidation with a large effusion. Rocephin and vancomycin were initiated. A pulmonary and pediatric consult suggested a decortication be performed. On 01-Nov-2005, video assisted thorascopic surgery with a central line placement was performed. The patient received oxygen and chest physical therapy and an unspecified medication for epigastric pain. An additional consult with infectious disease agreed with plans for an incision and drainage with video assisted thorascopic surgery and central venous placement following cultures. The patient was followed closely for her empyema (empyema) and seemed to be improving on therapy consisting of oxygen, chest tube drainage, chest physical therapy, vancomycin. Rocephin and close monitoring. Morphine and Tylenol were administered for pain. She continued to recover from her decortication, although continued to have fevers. A repeat chest computerized tomogram was obtained. On 05-Nov-2005, she began having necrotic-appearing chest tube drainage and was again taken to the operating room where it was found her right middle lobe appeared to be necrotic. This was sent for pathology, which showed a necrotizing group A streptococcus pneumonia (pneumonia necrotizing) (beta hemolytic streptococcal infection) and a right middle lobe lobectomy was performed. Post-operative treatment included oxygen, chest tube placement, "chest hygiene" and chest physical therapy. Follow-up chest x-rays showed an improving right effusion and no pneumothorax. Vancomycin was discontinued on 11-Nov-2005. The reporter observed the patient was doing well clinically and continued to improve. On 12-Nov-2005, she was discharged to home on Rocephin. Follow-up care was scheduled with the patient's primary care provider.
Sore on left side from neck, arm, under arm, and chest. Day 2  Felt achy all over and low energy.
Patient admitted as inpatient on 5/30/22 due to a brain mass. Patient was tested for COVID-19 and was positive on 5/31/22 (asymptomatic) upon admission.
tinnitus; worsening of loud ringing in ears; extremely loud; can barely fall asleep; bothersome; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus), TINNITUS (worsening of loud ringing in ears), TINNITUS (extremely loud), INSOMNIA (can barely fall asleep) and FEELING ABNORMAL (bothersome) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, EZETIMIBE, LEVOTHYROXINE and PROPRANOLOL HYDROCHLORIDE (PROPANOLOL BOEHRINGER) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus), TINNITUS (worsening of loud ringing in ears), TINNITUS (extremely loud), INSOMNIA (can barely fall asleep) and FEELING ABNORMAL (bothersome). At the time of the report, TINNITUS (tinnitus), TINNITUS (worsening of loud ringing in ears), TINNITUS (extremely loud), INSOMNIA (can barely fall asleep) and FEELING ABNORMAL (bothersome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
EPILEPSY, UNSPECIFIED ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 6/28/2022,  8/12/2022,  2/28/2023 --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pimples all over the body/Jingles; Psoriasis; Extreme pain; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Pimples all over the body/Jingles), PSORIASIS (Psoriasis) and PAIN (Extreme pain) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, 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 experienced ACNE (Pimples all over the body/Jingles), PSORIASIS (Psoriasis) and PAIN (Extreme pain). At the time of the report, ACNE (Pimples all over the body/Jingles), PSORIASIS (Psoriasis) and PAIN (Extreme pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Body hurts; Nose bleed upon blowing; Coughing up blood; Body pain that hurts worse; Migraine; Dizziness; Fever of 101.8 degrees fahrenheit; Bad headache; Arm started to hurt pretty bad, 10 minutes after shot; Pain traveled to neck and head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started to hurt pretty bad, 10 minutes after shot), NECK PAIN (Pain traveled to neck and head), PAIN (Body hurts), EPISTAXIS (Nose bleed upon blowing) and HAEMOPTYSIS (Coughing up blood) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sulfonamide allergy. Concurrent medical conditions included Bee sting hypersensitivity.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm started to hurt pretty bad, 10 minutes after shot), NECK PAIN (Pain traveled to neck and head), PAIN (Body pain that hurts worse), MIGRAINE (Migraine), DIZZINESS (Dizziness), PYREXIA (Fever of 101.8 degrees fahrenheit) and HEADACHE (Bad headache). On 31-Mar-2021, the patient experienced PAIN (Body hurts), EPISTAXIS (Nose bleed upon blowing) and HAEMOPTYSIS (Coughing up blood). At the time of the report, PAIN IN EXTREMITY (Arm started to hurt pretty bad, 10 minutes after shot), NECK PAIN (Pain traveled to neck and head), PAIN (Body hurts), EPISTAXIS (Nose bleed upon blowing), HAEMOPTYSIS (Coughing up blood), PAIN (Body pain that hurts worse), MIGRAINE (Migraine), DIZZINESS (Dizziness), PYREXIA (Fever of 101.8 degrees fahrenheit) and HEADACHE (Bad headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment products-Ibuprofen and Excedrin
Patient received the 2nd dose of the COVID19 Pfizer vaccine on 1/20/21.  Patient reports a high risk community exposure to 2 COVID positive household members starting 5/5/21. Patient reports COVID like symptoms starting 5/7/21 and tested with  a COVID PCR NP swab on 5/10/21, testing COVID positive.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient had began feeling anxiety during check in , reported fear of needles, after injection she became pale, sweating, and lost consciousness in a seated position, there was no fall associated with this event. She was not responding to her husband or pharmacist, pharmacist checked pulse and breathing, both were fine, prompted student to call 911.  After a few minutes she regained consiousness and therefore no response from ems.After observation of 30 minutes was fine and left with her husband.
achy after covid vaccine; sore arm after covid vaccine; hives at injeciton site the day after the injection; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy after covid vaccine), VACCINATION SITE PAIN (sore arm after covid vaccine), INJECTION SITE URTICARIA (hives at injeciton site the day after the injection) and HEADACHE (headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Ulcerative colitis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (achy after covid vaccine), VACCINATION SITE PAIN (sore arm after covid vaccine), INJECTION SITE URTICARIA (hives at injeciton site the day after the injection) and HEADACHE (headache). At the time of the report, PAIN (achy after covid vaccine), VACCINATION SITE PAIN (sore arm after covid vaccine), INJECTION SITE URTICARIA (hives at injeciton site the day after the injection) and HEADACHE (headache) had resolved.            Concomitant medication was not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported.  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.