chrisvoncsefalvay/vaers-outcomes huggingface dataset:
continued pressure on the head the brain area side and the front, hissing sound in the ears, uncontrollable muscles twitching, weakness throughout the body, mental mood changes
Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter. Treatment medication was not reported.  Patient reports that maximum or minimum temp reached as applicable(specify temp is in C or F)-minimum:-4.2 degrees F; Maximum : 5.7 degreed F and Excursion duration- 6 minutes. There was another excursion that happened in September. HCP stated it was at 5 point something for a couple of minutes.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient details(initials,age,gender) and vaccine information (dose number, date of vaccination)
4OCT96 pt recv vax 5OCT96 arm sore & swollen;arm sore for 2wk;
Information has been received from a physician concerning an 18 year old female patient who in September 2006 was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently in September 2006 the patient developed 102 degree temperature and chills. Medical attention was sought. The patient was recovering. Additional information has been requested.
24 hours later the patient felt "yucky"; Sore left arm for 3 days after the first Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (24 hours later the patient felt "yucky") and VACCINATION SITE PAIN (Sore left arm for 3 days after the first Moderna Covid-19 vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Bronchitis. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), FINASTERIDE, ROSUVASTATIN CALCIUM (CRESTOR), NIFEDIPINE, RABEPRAZOLE SODIUM (ACIPHEX), HYOSCYAMINE SULFATE (LEVSINEX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 11-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 VACCINATION SITE PAIN (Sore left arm for 3 days after the first Moderna Covid-19 vaccine). On 12-Jan-2021, the patient experienced FEELING ABNORMAL (24 hours later the patient felt "yucky"). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 13-Jan-2021, VACCINATION SITE PAIN (Sore left arm for 3 days after the first Moderna Covid-19 vaccine) had resolved. At the time of the report, FEELING ABNORMAL (24 hours later the patient felt "yucky") outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received the second dose on 08-Feb-2021 and third full dose on 13-Oct-2021.
Pt covid POSITIVE Narrative: Pt received his dose #1 of covid vaccine on 1/26/21 and dose#2 of covid vaccine on 3/1/21. Pt was admitted to hospital on 3/15/21 with covid POSITIVE pneumonia. Pt started on remdisivir & dexamethasone therapy. Pt remains in ICU care. Of note, pt had prior recent hospital admission 2/24/21-3/3/2021 for HF exacerbation. Pt received the covid vaccine dose#2 during this admission on 3/1/21.
Hospitalization: 3/4/2023 - 3/9/2023 (5 days) Presentation to the ED: bilateral lower extremity weakness  COVID + date: 3/4/2023 Treatment: empiric antibiotic therapy with ceftriaxone and doxycycline Discharge to: hospice. 001A21A 2/26/2021 047A21A 3/26/2021 045J21A 12/17/2021
Daughter,  reported to me by phone on 10/19/2021 that patient received her 3rd dose of COVID-19 vaccine on 10/18/2021 and that patient had fallen that evening.  She was also complaining of arm soreness, with redness and warmth to the area of the injection site.  Daughter stated that this is similar symptoms to her second dose.
Patient contacted the pharmacy to report a tingling sensation in her left arm which she later described as a poking in her hand/ fingers.
Swollen upper arm (below injection site) developed around 9 pm, Tuesday, May 18, 2021 and has not resolved. Large, pinkish, red patch developed around 5 am on Thursday, May 20, 2021 and has not resolved. I rested and took ibuprofen, with no results. Vaccine administrator stuck the needle at an angle, which likely caused much of the prolonged swelling.
24 hours after vaccination she developed erythematous, indurated, warm patch 8x2 cm on left deltoid 2x2 cm patch right deltoid.
Rebound COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Drug name not reported).    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 11-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound COVID) was resolving.            No concomitant medication was reported.  The patient previously received a COVID-19 Vaccine. It was reported that he patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Device Date : 29-May-2022.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 that occurred 4 months and 2 days after receiving the mRNA-1273 vaccine as 3rd dose. Patient took Paxlovid for 5 days as treatment regimen. Twelve days after completion of Paxlovid, patient reported rebound COVID. No laboratory tests were reported. Clinical course was not reported. At the time of reporting, the outcome of event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgment.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 that occurred 4 months and 2 days after receiving the mRNA-1273 vaccine as 3rd dose. Patient took Paxlovid for 5 days as treatment regimen. Twelve days after completion of Paxlovid, patient reported rebound COVID. No laboratory tests were reported. Clinical course was not reported. At the time of reporting, the outcome of event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgment.
At about 8:00 a.m. on Saturday, April 17, 2021, the morning after my 2nd Moderna COVID19 vaccination, I woke up with shaking chills, a bad headache, and body aches. By the afternoon of 4/17/21, I had a fever of 100 F, and I was so weak, I could not walk to the bathroom, without feeling like passing out. My husband had to help me with walking to the bathroom. My blood pressure on 4/17/21, became very low, at 4:00 p.m., my husband took my blood pressure, and it was 106/52, my Temp was 100F.  I was able to drink water, and electrolyte fluids while I was experiencing all this. My left arm where I had the vaccine was painful, but tolerable.  I was also very nauseous, however, I did not throw up. This continued for two days.  It was very concerning that I was so weak that I could not make it to the bathroom by myself. I called and spoke with a nurse on call at Medical Group, , about these symptoms.  I also spoke with a nurse at  Medical Group on Monday, April 18, 2021.
Initial report received on 9/29/06 from a health care professional. An 18 year old pt, with an unk past medical history, had received a left deltoid dose of Menomune, lot number UE493AA on 2/20/06. The route of administration was not reported. On 9/23/06, 214 days post immunization, the pt developed petechiae on his hands and feet, and had a fever of 103 deg F. Treatment received was not reported. Three days later, he was admitted to the hospital with myalgia, stiff neck and continued petechiae on his hands and feet. The pt had a positive CSF for Neisseria, and results of group strain were expected in a week. At the time of this report, the pt was stabilizing and was moved from the ICU ped unit. The pt has not recovered from these adverse events.
I woke up at 5:45 am on February 9, 2021 with bright red, raised bumps on the back of my right shoulder extending down the back of my right upper arm. I also had a few spots on my right cheek under my eye, and on my left elbow. They were very itchy and warm to the touch. I took benadryl and it started to clear up. Around 12:00, the spots reappeared and started spreading across my right upper arm. I went to the doctor at 4:45pm on February 9th. He confirmed they appeared to be hives and recommended continuation of benadryl. Over the course of 4 days (February 9th through the 12th) the hives spread across my body (both arms, back, stomach, neck, face, both legs, left foot). They ranged in size from the size of a Q-tip end to banana size hives. They would almost completely clear up when I would take benadryl and reappear as the benadryl wore off.  I woke up again on February 20th with about 20 small hives on my neck. They cleared up in about an hour without medication.
This case was reported by a healthcare professional (occupational health nurse) and described the occurrence of flu like symptoms in a 38-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 23 March 2012 at 12:00 the subject received a dose of BOOSTRIX at 0.5 ml in the left arm. On 23 March 2012, 6 to 8 hours after vaccination with BOOSTRIX, the subject experienced flu like symptoms, body pain,  nausea and low grade fever. The subject was treated with TYLENOL. The events were reported to be resolved as of 25 March 2012; however, the subject reported still having malaise, tiredness and a sleepy feeling the day prior to reporting. Outcome of these events was not reported. It was noted that the subject returned to work. The healthcare professional considered the events of flu like symptoms, body pain, nausea and low grade fever were probably related to vaccination with BOOSTRIX. Attribution of malaise, tiredness and sleepy feeling to BOOSTRIX administration was not known.
2 1/2hr p/vax pt awakened screaming-screaming w/o stopping cont x 3hr;temp @ time of vax 99.4R;temp during screaming episode 102.3 R;mom gave APAP q 4hr, temp back to nl & screaming ceased p/3hr;
No additional AE reported; an expired dose of GARDASIL 9 was administered to a patient on 6 DEC 2021; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 06-DEC-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # S010729, expiration date 01-DEC-2021, 0.5 milliliter) for prophylaxis (expired product administered). The expired vaccine did not experience a temperature excursion. No adverse event was reported.
Client called (approx 12 noon)  to report she had severe itching started in her nose, then to scalp, head, neck and chest. Had a bumpy raised rash on her chest.  Client did call her doctor and they did tell her to take 50 mg benadryl and to take every 4 to 6 hours.   RN called back around 4:25 PM.  Client reports is better now after taking benadryl.
Patient seen day after Tdap, appeared pale, temperature 99.2, blood pressure normal and not orthostatic.  Injection site not swollen or red.  Neurologic exam normal except for somewhat ataxic gait.  Respiratory rate normal, pulse normal.  Headache/skin sensations.  Thursday, July 27th vaccine given around 2:30, 3:00 took 400 mg ADVIL per suggestion of the nurse, no reaction yet. 11:00 or so-went to bed but couldn't sleep, started to develop aches, muscles soreness, skin sensitivity, then chills (around 1:30 am).  1:30-got up to check list of possible reactions.  All of mine were listed as "mild" and I had none of the more serious ones, but I would not have called mine "Mild".  The chills were bad despite the heat and lack of air conditioning.  Didn't sleep at all that night. (Seems like I would have taken something for fever at that point, but I didn't make a note of it, and now I can't remember).  Friday the 28th 8:00 took 600 mg of Advil and slept until 9:30. 9:30-got up and felt better, but then "relapsed" about an hour later and worsened throughout the day.  Still had a low-grade fever and all of the reactions listed above.  Started to develop a mild headache.  Noon-took 2 aspirins for fever (didn't help). 4:00-returned to Health Services.  Once home, I took your dietary advice, I hadn't eaten since the day before.  Fever was 99.4 I think (do you have a note of that?). 10:00-took BENADRYL (25mg) to sleep and also used a topical muscle icer (Bio-Freezer) to ease my back pain (this is chronic pain, worsened but not caused by the vaccine).  Slept well.  Took another BENADRYL when I woke up (maybe around 5:00 am).  Saturday the 29th up early, still achy, easily fatigues and feverish 9slight), but the sensitive skin felt better.  Ate lightly and drank fluids, but didn't really feel better that day.  Headache worsened a little.  It was low and in the back of my head and the pain "surged" when I turned my head from side to side.  Late afternoon, I took 2 ADVIL tablets, and that cleared the headache up finally.  Felt terrible through the evening until around 10:00 or so.  Between 9:00 and 11:00 pm all reactions vanished rather suddenly, it seems.  I didn't notice until I stood up to let the cat in that I felt almost normal.  I haven't had no more reactions.
I26.99 ACUTE PULMONARY EMBOLISM 5/17/2022 CKD STAGE 3B (GFR 30-44) I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/11/2022 CKD STAGE 3B (GFR 30-44) I82.413 ACUTE DVT OF BILAT FEMORAL VEINS 5/17/2022 CKD STAGE 3B (GFR 30-44) I26.99 ACUTE PULMONARY EMBOLISM 5/17/2022 CANCER METASTATIC TO INTRAABDOMINAL LN I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/11/2022 CANCER METASTATIC TO INTRAABDOMINAL LN I82.413 ACUTE DVT OF BILAT FEMORAL VEINS 5/17/2022 CANCER METASTATIC TO INTRAABDOMINAL LN I26.99 ACUTE PULMONARY EMBOLISM 5/17/2022 BLADDER MASS I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/11/2022 BLADDER MASS I82.413 ACUTE DVT OF BILAT FEMORAL VEINS 5/17/2022 BLADDER MASS I26.99 ACUTE PULMONARY EMBOLISM 5/17/2022 ELEVATED TROPONIN I I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/11/2022 ELEVATED TROPONIN I I82.413 ACUTE DVT OF BILAT FEMORAL VEINS 5/17/2022 ELEVATED TROPONIN I I26.99 ACUTE PULMONARY EMBOLISM 5/17/2022 TRANSITIONAL CELL CARCINOMA, POSTERIOR WALL OF BLADDER I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/11/2022 TRANSITIONAL CELL CARCINOMA, POSTERIOR WALL OF BLADDER I82.413 ACUTE DVT OF BILAT FEMORAL VEINS 5/17/2022 TRANSITIONAL CELL CARCINOMA, POSTERIOR WALL OF BLADDER I26.99 ACUTE PULMONARY EMBOLISM 5/17/2022 BLADDER CANCER, UNSPECIFIED SITE I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/11/2022 BLADDER CANCER, UNSPECIFIED SITE I82.413 ACUTE DVT OF BILAT FEMORAL VEINS 5/17/2022 BLADDER CANCER, UNSPECIFIED SITE
feel terrible; low grade fever; felt like he had a sinus infection; was very tired; sleepping/napping; napping; never went back for shot #2 and now is past the six month window; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles outbreak November 2017 to January  2018 caused by extreme stress) and fever blister.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced malaise, fever, sinus infection, tiredness, somnolence, sleep disorder and incomplete course of vaccination. On an unknown date, the outcome of the malaise, somnolence, sleep disorder and incomplete course of vaccination were unknown and the outcome of the fever, sinus infection and tiredness were recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix. The reporter considered the fever, sinus infection, tiredness, somnolence and sleep disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient.  The patient received Shingrix in pharmacy in spring 2019 intramuscularly in the left deltoid. The reporter did not had the exact date of the shot in front of him and did not had paperwork given to him by the pharmacy thus did not have the lot number or expiration date. The reporter never went back for shot 2 and was past the six month window, which led to incomplete course of vaccination. The patient feel terrible for a weekend and asked to elaborate on this and said that this was over a year ago so cannot remember exactly but from what did not remember was very tired and so he was sleeping, napping and felt like he had a sinus infection and had a low grade fever. These events resolved. The reporter did not consent to follow up and did not want to provide MD contact information. The reporter provided a personal email address and did not had a personal fax number and did not want to give his exact date of birth but did state was currently age 64 and was born in 1956.
Woke from deep sleep 3 a.m. 09-18-21 w intense abdominal pain that was constant. Called emergency services and sent to the local hospital.  Treated in ER then admitted.  Dscharged home 09-22-21. Dshch diagnosis Acute ischemic colitis (poss, anemia, acute respiratory failure. Called Dr. to follow with weekly lab draws as had not established care in local HCF yet.  He called with critical low sodium on 09-30-21 and was told to go directly to ER.  Had friend take me to another hospital (didn't like experience in the first hosp).  They did tests, labs, and admitted me for critical low sodium/electrolyte/E-coli infection/anticoagulation treatment. Discharged 10-04-21.
Raised lump, erythema, hot to touch, febrile, unable to sleep.
Received both seasonal flu and H1N1 on 11/16/09. Developed hives > 24 hrs later.
This spontaneous report was received from a medical assistant, concerning a child (>12 months) patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored VARIVAX injection, lot #N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: US-009507513-1801USA002808: US-009507513-1806USA010177: US-009507513-1806USA010179: US-009507513-1806USA010180: US-009507513-1806USA010181: US-009507513-1806USA010176: US-009507513-1806USA010175: US-009507513-1806USA010174: US-009507513-1806USA010173: US-009507513-1806USA010178.
pt says that he started getting a blood clot and his left hand wrist.  He had this for 2 days.  It disappeared and then the next day he discovered he had another blood clot on his right hand palm.  He says it is a bump and he can see the blood clot under the skin.  Pt will contact his PCP.
The patient came in to get a PNEUMOVAX 23 vaccine it was administered 7/19 and the patient came back that night and said her arm was swollen and red. The pharmacist said to contact md in the morning. The patient made an appt with the md on 7/20 and she was prescribed cephalexin for the infection on 7/20.
HAD VAGUL RESPONE AND BP DROPPED AND BECAME SWEATY AND CLAMMY
Seen in village clinic and vaccinated - then taken to grandma's where baby slept. Mom and baby went home and infant slept again - when he woke in the evening had total body hives - afebrile. Treated with Benadryl at clinic with good resolution of most hives by morning. No new foods or exposures.
Unable to lift right arm even to brush teeth 3 days post vaccine, extreme pain in shoulder joint, extreme weakness and ROM deficits.  Called my primary doctor on 2/8/2021 and was informed this is not an adverse effect of the covid  vaccine, but is due to improper location of the vaccine. The diagnoses was  frozen shoulder caused by injecting too high on my arm.. Began to have numbness on 2/11/2021 went to primary care and was told it was related to frozen shoulder and gave me an order for PT if no improvement in a week. Reported all this to supervisor on 2/8/2021 and an incident report was filed with HR.  Pain  and shoulder restrictions lasted 1 month after vaccine was administered.
Got vaccine and is Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Got vaccine and is Pregnant) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (DICLEGIS) for Nausea, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in July 2020 and the estimated date of delivery was 19-May-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Got vaccine and is Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 22-Jan-2021, EXPOSURE DURING PREGNANCY (Got vaccine and is Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, Prenatal screening test: normal (normal) normal. In January 2021, Blood glucose: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Patient developed "flu" like symptoms shortly after receiving the vaccine. She experienced body discomfort, mild fever, chills, pain, redness, numbness and tingling that lasted 2-3 hours. She also developed a rash. She described it as little red bumps all over but later went away.
developed multiple brown lesions - flat, not itchy on left arm started this morning.  largest 4cm x 1 cm. scattered on inside of her wrist mostly round or oval.