chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of papular rash in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of pain in extremity (refer case US2018GSK135722). On 19th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th July 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, pain in arm and erythema of extremities. On 20th July 2018, the patient experienced papular rash and itchy rash. On an unknown date, the outcome of the papular rash and itchy rash were not recovered/not resolved and the outcome of the swelling arm, pain in arm and erythema of extremities were unknown. It was unknown if the reporter considered the papular rash, itchy rash, swelling arm, pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient received the first dose of SHINGRIX on the day before reporting and she experienced redness, swelling and soreness in the arm in which she received the vaccine. The patient states that this afternoon she noticed an itchy, bumpy, rash that was on the upper part of her left shoulder, on her upper back and on the right shoulder blade. The physician information was added. This case has been linked with US2018GSK135722, reported for the same patient.
Unsteady on her feet; Loss of appetite; Stomach upset; sleeping a lot; Very tired; Headache; Nauseous; Severe pains throughout the body; Pain across shoulder to neck; Very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), GAIT DISTURBANCE (Unsteady on her feet), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset) and SOMNOLENCE (sleeping a lot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included NITROGLYCERIN for an unknown indication.   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 12-Mar-2021, the patient experienced ARTHRALGIA (Pain across shoulder to neck). On 13-Mar-2021, the patient experienced MYALGIA (Severe pains throughout the body). In March 2021, the patient experienced ILLNESS (Very sick). On 16-Mar-2021, the patient experienced NAUSEA (Nauseous). On 17-Mar-2021, the patient experienced GAIT DISTURBANCE (Unsteady on her feet), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset), SOMNOLENCE (sleeping a lot), FATIGUE (Very tired) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, ILLNESS (Very sick) had not resolved and GAIT DISTURBANCE (Unsteady on her feet), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset), SOMNOLENCE (sleeping a lot), FATIGUE (Very tired), MYALGIA (Severe pains throughout the body), NAUSEA (Nauseous), ARTHRALGIA (Pain across shoulder to neck) and HEADACHE (Headache) outcome was unknown.
Pt had 12 mon vaccines 1/8/2013. Rash, started on abdomen 1/13 and pt was seen 1/14 in the office with red, maculopapular rash that was on trunk and face, no increased T no hives no itching. No other sx. F/U appt 1/18 pt now with red blanchable circular lesions on face, abd, back & legs. Bil hands purple and swollen, ankles swollen. Abd. soft & nondistended. No increased T . F/U will be as needed. Dx HSP.
CHIEF COMPLAINT:   BIBA from home with c/o pain with urination x 2 days, hx dementia, pt poor historian but denies any other complaints, awake and alert, oriented to person and place   HISTORY OF PRESENT ILLNESS:     Patient is a 99-year-old female coming from home with abdominal pain and back pain over the past 2 days, has been weak since this morning when she woke up, normally is able to make her bed and dress herself, she was unable to do those things this morning.  Denies chest pain or shortness of breath.  Denies fever chills.  Denies any known Covid contacts.
I was diagnosed with breast cancer and am currently in chemo therapy (currently on four types of chemo and will switch to two beginning 06/2021). My PCP discovered the lump and ordered an ultrasound along with a biopsy on my left breast. Upon receiving the results (cancerous mass), I was referred to an oncologist who referred me to a surgeon that did the port placement inserted for all my blood and infusions including lab work every three weeks along with echocardiograms. I was placed on Taxotere, carboplatin, Herceptin, and Pejeta, the surgery date has not been set and is scheduled for my next appointment in October where I will decide which surgery to have on my left breast (3rd or 4th week in October is when the surgery will take place).
Sore throat, chest congestion and high fever. Patient went to urgent care. Prescribed antibiotic azithromycin and bought over the counter cold medications.
Shortness of breath, tight chest, burning sensation in the eyes, significant fatigue, and joint pain in all fingers, hands, knees, toes and neck.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299809, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299814, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 65 years old male patient (height: 75, weight: 225) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. 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.
Localized reaction to (L) arm extending from shoulder to 2" above elbow. Firm, indurated, erythematous skin with quarter sized area vesicles at site of injection.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age. Their pertinent medical history and concurrent conditions were not provided. On an unknown dates, the multiple unspecified patients were vaccinated with doses of M-M-R II lot # L027591, expiration date:23-JUL-2017 (routes, anatomical location and doses number were not reported) that were improperly stored. No adverse effects were reported. It was reported that the temperature of the refrigerator had reached a -3.7 Celsius and not previously reported 0 Celsius with the time frame of 548 hours and 48 minutes and data logger was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient started to feel very ill (fever, body aches, nauseous) on 03/12/2017.  On 03/14/2017 her arm that she received the vaccine in started to swell up and also started producing a rash.  Didn't see any sign of cellulitis.  Patient came into the pharmacy on 03/15/2017 with prescriptions for the swelling/rash in arm.
3 doses were administered from a vial that was involved in a temperature excursion.; 3 doses were administered from a vial that was involved in a temperature excursion.; Product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses were administered from a vial that was involved in a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (3 doses were administered from a vial that was involved in a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in an 83-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses were administered from a vial that was involved in a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (3 doses were administered from a vial that was involved in a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses were administered from a vial that was involved in a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (3 doses were administered from a vial that was involved in a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses were administered from a vial that was involved in a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (3 doses were administered from a vial that was involved in a temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    No Concomitant medications were provided. No treatment medications were provided.  This case contains information for patient 1 out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-695788, US-MODERNATX, INC.-MOD-2023-695789.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695788: US-MODERNATX, INC.-MOD-2023-695789:
pt recvd vax 7SEP85 & 31OCT95 & exp a lack of response, w/a titer of 0.43;no further details were provided;
We took my mom to ED on Nov 19 because she was lethargic and had mental status changes and had steadily declined over the last 3 days. she had recently been treated for a UTI on 11/7 at hospital with cipro for 7 or 10 days of cipro 500 bid. The first 2 things she was checked for was UTI and covid and both were negetive. Then she was checked for a brain bleed, which was also negetive. They continued to order futher testing and order narcan because she is on chronic pain pump for chronic pain. For whatever reason, her troponin level was checked and found to be elveted (50). They did ask if she was diabetic and I said no, that we checked her sugars every mornig and her most recent A1c have been between 5 and 6. She had a recent thorough visit with a cardiologist on sept 30 and was told her heart was healthy, although a stress test and heart cath were not done. She had a NSTEMI on 11/19 had a stent placed on 11/20 and had a STEMI on 11/24 and v tach and had another stent placed that day. She is current in hospice care.
School nurse and father notes faint rash on trunk after injection. No other problems. Child active and happy. Observed for 45 min. Sent home returned to school following day. Raised rash faint on trunk no other symptoms.
fever to 106 according to mom by thermo-scan (ear);in hosp temp was 100.9 in ER
9/19 dizzy, rapid pulse, lightheaded. 9/20 - 2:00 am diarrhea, lethargy. 9/20 10am phoned personal physician. 9/20 currently 7pm -diarrhea continued, vomiting any food intake. Trying to maintain hydration. Weak and lethargic.
Extreme swelling of right thigh, a bit of swelling on left thigh. Bright red on the whole swelling for two days on both thighs, right thigh currently still swollen. Warm Compress given.
Patient had a lump at the injection site after the vaccine that was the size of a quarter and then went down to the size of a dime after about 30 minutes.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment; Positive, notes: positive PCR test 1.5 days after recurrence of symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.
redness at the site of injection. the redness area is 2" X 1". It is also a pink area srounding that which is 4" X 2.5". the area is warm. But no fever at this point.
He died.  He got the shot then several hours later he was found DEAD in his sleep. We are still awaiting coroners reports.
Syringe leaked vaccine down the arm of the patient. Much of the vaccine was perceived to be lost. Offered patient another vaccine in the other arm, but she declined/refused. The syringe was either faulty or the hub/needle attachment wasn't on tightly
Acute nausea, vomiting and diarrhea starting 15 minutes after injection. Elevated WBC 24,00.
Redness, swollen size of goose egg (3-4 in) in next day 7/20/12 and still continue today 7/23/12 per patient's husband. I called patient today, the swollen is going down & no redness. She is fine now.
ATRIAL FIB WENT TO HOSPITAL & HAD TX TO SLOW HEART RATE.
Intense bone pain, headache, body pain, neck pain, fever 100.8, joint swollen hands, legs, nausea, taking extra strong tylenol and rizatriptan.
Big welt and itchy as hell right around the injection site; Big welt and itchy right around the injection site; Felt like drinking all night; Woke up middle of night room spinning and lightheaded; Shaking uncontrollably; Hives; Itchy; Rash; Fever; Chills; Nausea; Headache; Aches and Pains; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like drinking all night), DIZZINESS (Woke up middle of night room spinning and lightheaded), TREMOR (Shaking uncontrollably), URTICARIA (Hives) and PRURITUS (Itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Factor V Leiden thrombophilia and Neutropenia. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Factor V Leiden thrombophilia.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 06-Mar-2021, the patient experienced TREMOR (Shaking uncontrollably), URTICARIA (Hives), PRURITUS (Itchy), RASH (Rash), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Aches and Pains). On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Felt like drinking all night) and DIZZINESS (Woke up middle of night room spinning and lightheaded). On 15-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Big welt and itchy right around the injection site) and VACCINATION SITE PRURITUS (Big welt and itchy as hell right around the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 07-Mar-2021, URTICARIA (Hives), PRURITUS (Itchy) and RASH (Rash) had resolved. On 08-Mar-2021, TREMOR (Shaking uncontrollably), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Aches and Pains) had resolved. At the time of the report, FEELING ABNORMAL (Felt like drinking all night), VACCINATION SITE URTICARIA (Big welt and itchy right around the injection site), VACCINATION SITE PRURITUS (Big welt and itchy right around the injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown and DIZZINESS (Woke up middle of night room spinning and lightheaded) had resolved.            No events after dose 2 were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Added Reporter address, Patient demographics ( race, height, ethnic group, weight, medical history). Added second dose of the drug and updated the Action Taken from unknown to not applicable. Added the events and updated the outcome of the event (Dizziness) from unknown to recovered.
PATIENT DID NTO EAT BEFORE THE VACCINATION AND WE GAVE HER A SNACK. SHE FAINTED AND THEN THREW UP. SHE WAS HYPOTENSIVE AND BARDYCARDIC. SHE REBOUNDED QUICKLY AND CLOTHES WERE CHANGED. pT OBSERVED FOR 10 MINUTE AND SENT HOME WITH MOM.
Can't lift arm/ put arm backward; can't hook a bra/ can't zip pants/ can't move arm above head with the injection arm; can't lay on arm; Tendonitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOBILITY DECREASED (Can't lift arm/ put arm backward), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't hook a bra/ can't zip pants/ can't move arm above head with the injection arm), PAIN IN EXTREMITY (can't lay on arm) and TENDONITIS (Tendonitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-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 experienced MOBILITY DECREASED (Can't lift arm/ put arm backward), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't hook a bra/ can't zip pants/ can't move arm above head with the injection arm), PAIN IN EXTREMITY (can't lay on arm) and TENDONITIS (Tendonitis). At the time of the report, MOBILITY DECREASED (Can't lift arm/ put arm backward), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't hook a bra/ can't zip pants/ can't move arm above head with the injection arm), PAIN IN EXTREMITY (can't lay on arm) and TENDONITIS (Tendonitis) had not resolved.            No concomitant medications were provided. The patient was given the diagnosis of Tendonitis by the HCP.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient states she has had shooting arm pain since the injection which was on 1/4/22. She believes she has SIRVA (Shoulder Injury Related to Vaccine Administration)
Patient was first of three family members receiving a flu shot. Patient was fine after administration and watched sibling and father get immunization. At this point he fainted, falling into the drywall and atop a small metal garbage can.  Patient came too within seconds of falling. Rested for a moment. Had no complaints of pain, no bruising or cuts. No longer dizzy either. Father felt no harm done and they chose to leave. A follow-up call next morning by pharmacy manager was done at 8:10am. Father said child is doing well and having no problems. I explained what a vasovagal response is, and that if alerted to this history we can do a better job of protecting him in case he faints. Father reports child getting "white as a ghost" many times before, but never going down. The father was very thankful for the call and the concern exhibited by all.
states 11 days p/vax administered devel a knot in back of head which subsided 4 or 5 days later; on the day p/knot appeared, devel pain in wrists, hands & knees-no swelling;
She stated that after the second shot she had enlarged lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (She stated that after the second shot she had enlarged lymph node) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (She stated that after the second shot she had enlarged lymph node). At the time of the report, LYMPHADENOPATHY (She stated that after the second shot she had enlarged lymph node) had not resolved.            No concomitant medications were provided.  No treatment medications were provided.    This case was linked to MOD-2021-435489 (Patient Link).
Received injection at approx. 10:30am. Waited at vaccination site for approx. 30 minutes with no reaction. At approx. 11:10am (40 minutes after injection) I started to feel tightness in my chest and developed moderate wheezing. I immediately took two puffs of my albuterol sulfate HFA inhaler. The wheezing stopped after I used the inhaler. I did not need to use my epi injector but it was definitely anaphylaxis based on prior experience. I did not report this to the vaccination site as I had already left. It is now 12:45pm and I feel fine.
Patient notes got influenza and pneumonia vaccine on 11/20/14, both in left arm. 6-8 hours after began with severe fevers, chills, and shaking. Notes (L) arm became very red, swollen, severely painful, could not move, was vomiting. Given cephalexin for cellulitis.
Small pinpoint raised areas on face/neck/abdomen/back.. Our MD assessed sites. Instructed mom to give OTC Tylenol as needed/Benadryl before bed. This nurse instructed to use OTC hydrocortisone cream to raised areas. MD informed any respiratory issues 911.
After receiving the vaccine I had soreness in my arm and fatigue for a day. Then I had tested positive for covid in April 2022. I had cold like symptoms. I was prescribed Paxlovid. My covid symptoms lasted for about a week.
Extreme pain occurred in left thigh on 4/25/2021, went to ER. Was diagnosed with spontaneous bleed in gluteus muscle.  Sent home from hospital 4/28/2021. Pain reoccurred 5/5/2021 and was again admitted to the hospital. Doctors unable to determine exact site of bleed. Stopped blood thinners to allow bleeding to stop and leg to heal. Inserted IVC filter on 5/9/2021. Had to go to to a rehab facility from 5/11 to 5/19. Saw doctor on 6/21 who ordered an MRI to be sure of no blood clots. Found out on 6/23 that there were blood clots in the lungs and was sent to the ER. Admitted to the hospital again. Had to stay until they could take out the IVC filter which was done on 6/28/2021 and she went home on 6/29/2021.