chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Possible uveitis flare up; Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Possible uveitis flare up) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Panuveitis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE) and Panuveitis (NON-INFECTIOUS INTERMEDIATE POSTERIOR AND PANUVEITIS).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced UVEITIS (Possible uveitis flare up) (seriousness criterion medically significant) and INFLAMMATION (Inflammation). At the time of the report, UVEITIS (Possible uveitis flare up) outcome was unknown and INFLAMMATION (Inflammation) had not resolved.        mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication provided. No treatment information mentioned.  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  Company Comment:  This is a spontaneous case, reported by a consumer, concerning an elderly female patient with relevant medical condition of Non-infectious intermediate, posterior and panuveitis, who experienced the unexpected serious (medically significant) event of Uveitis, reported as possible uveitis flare up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event Uveitis was unknown. The medical condition of Non-infectious intermediate, posterior, and panuveitis remains as a confounder for possible uveitis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an elderly female patient with relevant medical condition of Non-infectious intermediate, posterior and panuveitis, who experienced the unexpected serious (medically significant) event of Uveitis, reported as possible uveitis flare up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event Uveitis was unknown. The medical condition of Non-infectious intermediate, posterior, and panuveitis remains as a confounder for possible uveitis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report.
worst fatigue; feels having a cold; nasal congestion; pain in the injection site; mild headache; tiredness; mild nausea; A spontaneous report was received from a Consumer concerning a 73-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site pain , headache, fatigue, nausea, nasopharyngitis, nasal congestion.  The patient's medical history was not provided. Concomitant medications reported were Simvastatin for cholesterone, Buspirone for anxiety, Trazodone for anxiety, Zyrtec for allergy, Venlafaxine for depression, Preservision for macular degreneration, Calcium for Osteoporosis, Vitamin D for Osteoporosis for drug use for unknown indication.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the events nausea, nasopharyngitis, nasal congestion.  On 30 Jan 2021, the patient experienced the events  headache, fatigue.  Treatment details included Tylenol yesterday  Action taken with mRNA-1273 in response to the events was not reported.  On 28 Jan 2021 the outcome of events injection site pain  was resolved.On 31 Jan 2021 the outcome of events  headache was resolved.On 28 Jan 2021 the outcome of events fatigue was resolved.On 28 Jan 2021 the outcome of events  nausea was resolved.On 29 Jan 2021 the outcome of events feels having a cold was resolved.On 29 Jan 2021 the outcome of events nasal congestion was resolved.On 30 Jan 2021 the outcome of events  headache was resolved.On 30 Jan 2021 the outcome of events  fatigue was resolved.
developed small blisters and red patches on her chest and her neck; developed small blisters and red patches on her chest and her neck; has about 6 inch rash on the right; her neck feel slightly stiff; there is like a rash on the right side of her neck and last night I noticed there was tiny little blisters like filled with the fluid; some of it itches a little some of it just uncomfortable; Pfizer Coronavirus booster shot on September 26; Pfizer Coronavirus booster shot on September 26; This is a spontaneous report received from a contactable Consumer or other non-health professional. This consumer reported for a female patient (reporter's mother). A 88-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), booster dose on 26Sep2021 (at the age of 88 years old) (Batch/Lot Number: EW0217, Expiry date: Unknown) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Relevant medical history includes AFib on an unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included Eliquis, Metoprolol taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (COMIRNATY, Solution for injection) on an unspecified date as dose1 and dose2 for COVID-19 immunization (at the age of 88 years old). On an 01Oct2021, patient experienced small blisters and red patches on her chest and her neck, 6-inch rash on the right, rash on the right side of her neck, tiny little blisters like filled with the fluid, Neck feel slightly stiff, red patch on her chest, quite uncomfortable, some of it itches a little, some of it just uncomfortable, Itchy rash. The patient received treatment for the events small blisters and red patches on her chest and her neck, 6-inch rash on the right, rash on the right side of her neck, tiny little blisters like filled with the fluid, Neck feel slightly stiff, red patch on her chest, quite uncomfortable, some of it itches a little, some of it just uncomfortable, Itchy rash with 1% hydrocortisone cream. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Two weeks post vax the pt developed 11 pustular vesicular erythematous skin lesions on the stomach and extremities. It was reported that the pt was afebrile. An ER or physician visit was required. Subsequently the pt recovered.
On day of vaccines, I of course had pain in both shoulders but the pain in my right was much worse. Could not sleep on either shoulder at night. When I went to bed I felt clammy and had the chills. I didn't take my temp but did take some Tylenol. Day two around 4pm I started to get aches in my legs and the chills, took my temperature and it was at 101, took Tylenol, around 7pm chills came back, I was at my daughters basketball game so not much I could do, started to shiver like mad and had shooting pains in my legs, aches in my legs and lower back. Got home and fever was at 104.2. Took pain meds (ibuprofen brought it down to 102.6 so a couple hours later I took Tylenol. Pain was pretty much gone in left arm. The pain in right arm still severe. Could not move arm up without significant pain, although it didn't appear to be swollen. Went to bed feeling ok but was very clammy all night. Next day woke up to 100 fever and it stayed between 100-101 all morning and afternoon with pain meds (ibuprofen and Tylenol) around 4pm fever started spiking again by 7 was at 104 again. Did the same thing as I did the night before. Next day same fever all day as the day before but tried to take the meds at different times and fever only went to 102.6 ( but still miserable)  Pain in right arm still super painful and not able to use. This evening I also developed a big red rash on my forearm that was warm to touch and painful. The next day woke up with 100 fever, took Tylenol and around 12 noon started to feel good enough to venture out although pain in right arm still there. It is now 6pm on this same day and I'm feeling ok but unsure if fever will return tonight.
Felt like couldnt catch breath , skipping feeling in chest went to doctor he placed me on holter monitor.  Interpretation: Underlying rhythm is sinus rhythm/sinus tachycardia, heart rate ranges between 58 beats per minute to 149 beats per minute, average heart rate 96 beats per minute. Episodes of sinus tachycardia are seen. QRS duration is within normal limits. Rare, Isolated PVCs. No significant arrhythmias or heart blocks were noted. Patient's reported symptoms of chest pain, skipped heartbeats, numbness in the hands, shortness of breath correlated with sinus rhythm or sinus tachycardia.  Conclusions: 1. Predominant underlying rhythm is sinus rhythm with episodes of sinus tachycardia; average heart rate high normal at 96 beats per minute. 2. No other significant arrhythmias or heart blocks were noted. 3. Patient's reported symptoms of chest pain, skipped heartbeats, numbness in the hands, shortness of breath correlated with sinus rhythm and sinus tachycardia.
Information has been received from a health professional concerning a female consumer who in March 2007, was vaccinated with Gardasil. In March 2007, the patient experienced petechiae rash all over her body within 24 hours after receiving the first dose of Gardasil. No medical attention was required. This is one of two reports received from the same source. Additional information has been requested.
Started itching around the injection site; Hot to the touch; Injection site area became a little swollen/more swelling around the injection site; injection site area beacme red; A spontaneous report was received from a consumer concerning a 32-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced injection site area became a little swollen and red, itching, more swelling and hot to touch.  The patient's medical history was not provided. The concomitant medication included included vitamins.  On 30 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020 after administration of vaccine patient experienced, injection site became a little swollen and red, but went away.   On 06 Jan 2021, it started itching and more swelling (size of a biscuit) at the injection site. That night, it was not as red but swollen and hot to touch.  Treatment included diphenhydramine and fexofenadine.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of injection site area became a little swollen, itching, more swelling and hot to touch, were considered unknown and recovered for redness.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Spontaneous report received on 22MAR2013 and 25MAR2013. An immunization nurse reported that a 24 year old female patient experienced headache, dizziness, nausea and vomiting. On 19MAR2013 15:23 pm, the female received dose 3 of BioThrax (FAV439) intramuscularly in the left deltoid. On 20MAR2013, she developed a headache with some dizziness. On 21MAR2015 she experienced nausea with vomiting; the headache with dizziness continued. She treated with symptoms with TYLENOL and GATORADE. On 22MAR2013, symptoms continued and she was seen in the emergency room where she was treated with ZOFRAN and intravenous fluids. Laboratory testing revealed an elevated white blood cell count. She was discharged several hours later, and subsequently the nausea resolved, however, the headache and dizziness continued. On 25MAR2013, all events were considered resolved. Of note, the patient had a recent history of left ankle fracture with surgical repair and continued pain. At the time of immunization, she was non-weight bearing with crutches, and on treatment with ULTRAM and ARTHROTEC for pain and inflammation.
I had excruciating pain to try to move my arm - felt like muscle was tearing. I kept my arm (like it was in a sling) for three days. I couldn't move it to do anything. I got no sleep that night. The next day - all the flu symptoms: headache, chills, body aches - never had a measurable fever but I felt like I did. I missed three days of work. I went to the doctor on Thursday - I kept messaging them and nothing they had suggested was working - even with ibuprofen - so I went to doctor 21st - and they gave me an extra strength Aleve. I took one - it - Tinnitus - ringing in my ear so I didn't take it again. It was still sore for about a solid week after the weekend. When that resolved - but it was a couple of weeks later - I had another bout of arm soreness - it wasn't as intense as the first time but it came back - it lasted about four days. And then about a month after the vaccine, I had noticed a ton of mucous in the back of my throat - felt like I was choking on it. That lasted for a few days - it was a crazy amount of mucous running down the back of my throat - draining down the back of my throat.
Sore arm; fever; chills; sweats; Sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 15 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweats"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat". This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
a little swollen little knot under her arm and it's sore; a little swollen little knot under her arm and it's sore; she had swelling where she got the shot; itching; under arm is swollen its like a little knot in there and its sore/swollen lymph nodes under the arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced a little swollen little knot under her arm and it's sore, she had swelling where she got the shot and it just kept getting bigger and bigger and it was itching, and swollen arms and swollen lymph nodes under the arm on an unspecified date. She asked regarding to put ice or heat on it. She also already consulted her doctor and was advised to take Tylenol. Outcome of all the events were unknown.Information about lot/batch number cannot be obtained.
Fever, dry cough, diarrhea, nausea, vomiting, no appetite,  eyes hurt, joint pain. Took Tylenol PM so far for 3 nights. No appetite so have not eaten. If I eat, I have nausea and vomiting.  This has been constant for approximately 70  hours now. Fever at second night was 102.8. Fever at third night was 101.9.  Might have been higher as nights progressed, was too sick/weak to care about taking temp again.  Fever today, the third day, has been off and on but temperature earlier today was 100.5.
SLEEPLESS; TIRED; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Lot # 1805020, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included metformin, and metoclopramide. On 14-MAR-2021, the subject experienced sleepless. On 14-MAR-2021, the subject experienced tired. On 14-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site, and had not recovered from tired, and sleepless. This report was non-serious.
Vaccine given at 9:05 am - by late afternoon felt sluggish, chilled, headache, achy  During the night, I went to the bathroom several times.  Each time I felt very "sick," aches and pain all over, headache, weak, hard to walk, fever of 100 (usually run 97.4.)  Last trip to the bathroom, felt very weak and tried to get back to my bed.  I blacked out, fallingl in the floor.  I have no idea what part of my body hit the floor first, but my entire right cheek and under my chin, right shoulder,  right hand all bruised and very sore.  Both knees hurt from the fall.  Still experiencing facial bruising/soreness, chin area, right shoulder, right hand and knees.
1 1/2 hrs after receiving vaccine Pt. developed chills, shakes, vomiting, then could not move. Ambulance was called pt was taken to hospital was given morphine and spent the night pt had a battery of tests. CT scan, xray, felt better in 24 hours.
Erratic blood pressure. Decreased heart rate. Weakness. Fatigue, increase in PVC?s. I am an athlete and was simply unable to workout due to response. I did workout the two days after the vaccine and perhaps I shouldn?t have done that. The following week I was exhausted and ended up I?m emergency room with dropping pulse rate and erratic blood pressure, swelling in my face and ankles.
Patient presents from rehab center with Covid Like Symptoms Pt reports testing positive for COVID 1/22.Noted to be having acute on chronic hypoxic respiratory failure, Multifactorial-COPD, CHF, recent covid infection and admitted for further evaluation and treatment, COVID-19 Test Result:  Negative Patient diuresed well improved medications optimized and was discharged to nursing home.
Patient is Stable at present--states  weakness- fatigue- sinus headache; loss of energy and sweats since dose #1 of Pfizer; Has not rec'd dose #2; Rec'd Covid vaccine from a pharmacy; Patient presenting to this Clinic for F/U
Doses administered after manufacturer date of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after manufacturer date of expiry) in an 83-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Date the vial was initially stored in the refrigerator was on 08 Mar 2022 (5 doses) was administered on 29 Mar 2022 gave 1 dose and 31 Mar 2022 gave 4 doses.Date the vial was initially stored in the refrigerator was on 30 Mar 2022 (2 doses) and administered on 05 Apr 2022. The vial did not undergo any temperature excursions. It was reported that the patient had no side effects. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow-up information received and added dates of vaccine administration.
Patient was given the flu vaccine around 830am and then went home. Close to 12pm , mom returned to clinic stating patient's face was swollen. Patient was checked in and examined by a doctor, given Benadryl, monitored and then release home.
Patient received vaccine on 02-Apr-2022, which had expired on 01- Apr-2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-Apr-2022, which had expired on 01- Apr-2022.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported. On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-Apr-2022, which had expired on 01- Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-Apr-2022, which had expired on 01- Apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received vaccine on 02-Apr-2022, which had expired on 01- Apr-2022.  The vial did not undergo any temperature excursions.  It was reported that the pharmacist thought that the vaccine would expired on Jun-2022, however it got  expired in 01-Apr-2022.  No treatment information was reported.
This spontaneous report was received from a registered nurse via a company representative and refers to a female patient of an unknown age (reported as the nurse's mother's neighbor's daughter). There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies.  On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly (IM) (strength, dose, frequency, anatomical location, lot number, and expiration date were not provided) for the prevention of human papillomavirus (HPV) and other diseases. On an unknown date, the patient experienced seizures. It was reported that the patient sought medical attention through a visit that she made to a neurologist. At the time of reporting, it was unknown whether the patient recovered or not from the event of seizures. The neurologist considered the event of seizures to be related to the therapy with GARDASIL 9. The primary reporter did not assess the relationship between the event and suspect therapy. No product quality complaint was involved. Upon internal review, the event of seizures was considered to be medically significant. Additional information has been requested.