chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flare up of rheumatoid arthritis in shoulders; right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (flare up of rheumatoid arthritis in shoulders) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (flare up of rheumatoid arthritis in shoulders) (seriousness criterion medically significant) and PAIN IN EXTREMITY (right arm soreness). At the time of the report, RHEUMATOID ARTHRITIS (flare up of rheumatoid arthritis in shoulders) had not resolved and PAIN IN EXTREMITY (right arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported.  No treatment information was provided.  Very limited information regarding these events has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected.
An excessive joint pain, that increased about 25 percent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Mar2021 (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: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "An excessive joint pain, that increased about 25 percent".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mild injection site soreness; mild light headed; tiredness; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly on 22Dec2020 at left arm, at single dose for covid-19 immunization. Medical history included hypothyroid, migraine and known allergies: Penicillin. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced mild injection site soreness, mild light headed, tiredness on 22Dec2020. No treatment received for all events. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Slightly elevated temperature for approximately 24 hours after the vaccination.  Chills occured for approximately 24 hours after the vaccination.  Body aches, headache to toes, occurred for 32 hours after the vaccination.
DIARRHEA; ABDOMINAL PAIN; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to anesthesia.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced headache. On 23-MAY-2021, the subject experienced diarrhea. On 23-MAY-2021, the subject experienced abdominal pain. On 23-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: loperamide hydrochloride, and electrolytes nos/glucose. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from abdominal pain, headache, diarrhea, and nausea. This report was non-serious.
In the evening I started having major fatigue. Then I started having postnasal drip and a low-grade fever. I took a home COVID-19 test and that was positive. They put me on Paxlovid which at first, I did well with but I had a reaction to it, but I think I took two doses too closes together and that gave me diarrhea that night. Otherwise, I was doing really well in about a week, and it did help with my COVID-19 symptoms I would say I was ninety percent better. Then would say it was about one hundred percent better.
Hospitalized for 17 days because of kidney problems; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Hospitalized for 17 days because of kidney problems) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: METFORMIN, FORXIGA and INSULIN. Concurrent medical conditions included Diabetes. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced RENAL DISORDER (Hospitalized for 17 days because of kidney problems) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 19-May-2021 to 04-Jun-2021 due to RENAL DISORDER. On 04-Jun-2021, RENAL DISORDER (Hospitalized for 17 days because of kidney problems) had resolved.            Patient has to do dialysis three times a week.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
patient said next morning her arm was fine and could move it but near her collarbone and neck area very swollen and painful on left side
After I received the vaccine, I had severe pain in my feet and later  lost sensation in both feet. I went to my PCP who who prescribed Gabapentin with plan to follow up in a few days. At follow up, my PCP witnessed loss of sensation, severe pain, and poor balance.  My PCP then advised me to go to hospital. I was then admitted to hospital for further care. I was admitted 2/19/21.
25 minutes Post injection: Left eye issues. Itchy, swollen behind the eye and feeling like something was in it or irritating it. It kept driving me to check if something was in it. I put in renu eye drops and did not think any more of it. 40 minutes post injection: both feet red and swollen left foot about half of the top, the whole right foot looked like a giant hive or welted area across the whole top of foot. The injection site began being quite sore, and it also looked welted and felt hot to the touch. I kept checking my left rib cage and my left thumb as I was sure there was going to be hives, because I could not stop rubbing or scratching them as they itched so badly. I continued itching and feeling weird tingly sensations and either rubbed or scratched these areas to no avail. Even my head itched terribly by the second day. 45 minutes post injection: Tightness and scratchiness in throat appeared and my throat was sore, my voice began going out and my voice got hoarse. There was about a two inch area of my throat in which I felt I needed to keep trying to clear something that was stuck. (This made no sense to me as I was able to drink water without any issues.) I had a slight cough every time I stopped drinking, so I continually drank water while I was not trying to sleep. My chest was tight, but because I have asthma I took albuterol and thought nothing of it. (This really did not help, but I did not get worse either.) About an hour after the shot, I constantly felt on the verge of shaking, much like when you have a fever, but I did not think to check my temperature until the following morning when I was extremely tired, felt like I had a sinus headache and possibly did have a fever. My temperature was 99.4 degrees farenheight. At this point, I felt very flu-ish and achy. My armpit area hurt a lot and I chewed two aspirin. I experienced wheeziness, chest tightness, and hoarseness the second and third day as well. I had the morning congestion and stuffiness as well as the need to keep clearing my voice still as of this morning but to much less degree as the initial onset. The skin itchiness is still ongoing, but to a much lesser degree than previously had.
I received the Pfizer Bivalent booster on 9/12/2022. On 12/8/2022, I woke up with some chest congestion, nasal congestion, and a sore throat. I took a home antigen test and got a negative result. None of the symptoms resolved by 12/9/2022, so I took another antigen test, which came back positive this time. I went to an urgent care on 12/10/2022 to be evaluated and to get a PAXLOVID prescription, which they wrote for me. I began taking the PAXLOVID that very day. On 12/14/2022, I took another antigen test and got a negative result. I then took another test on 12/15/2022 and got another negative result. When I developed the aforementioned symptoms, they progressively got worse until 12/11/2022. On 12/10/2022 and 12/11/2022, I had labored breathing and a very productive cough. When I woke up on 12/12/2022, though, I felt noticeably better. Even though I felt better, though, I continued to take the entire course of PAXLOVID. I concluded my isolation on 12/15/2022. At the time of this writing, I feel fine, generally speaking. I still have some nasal congestion, which could be caused by an allergy rather than COVID-19, as I have a history of allergies.
Starting around 1:00 in the morning, the night of receiving the vaccine, I started with the aches, joint pain, chills, and low-grade fever.  I forced myself to go to work.  I am a Registered Nurse.  The joint pain and aches increased throughout the day along with altered periods of chills and hot flashes.  Around 6 PM on the 29th is started feeling worse.   I felt like I was tachycardic.  I had my wife take my blood pressure.  My normal vitals are Pulse-50, BP 110/60.  When I took my vitals at 6:00 pm my pulse was 91 and my BP was 85/53.  Clearly an allergic reaction.  I had no difficulty breathing.  Finally, around 1:00 am on 1/30, my fever broke and my heart rate and BP returned to normal ranges.  My first vaccination was unremarkable with only a sore arm for three day.
During my wellness check up I had an ECG and Chest x-ray and it was discovered that I had Pneumonia and an enlarged heart. I had wheezing and coughing due to Pneumonia. I also have had elevated BP of 160/90. I have an upcoming Cardiologist appointment in March to address my enlarged heart.
Adverse reaction to pneumococcal vaccine, injection 1 day previous.  Patient complains of severe pain 8/10 and dysesthesia on her left arm almost immediately after getting her PPSV yesterday at our clinic. Pain limits patient's ability to move her arm and she was not able to sleep last night.  Location is left upper arm, lateral aspect, at deltoid muscle.  There is no evidence of erythema, edema, or mass, but tenderness on touch. Pain is described as shooting.  Patient prescribed anti-inflammatory and nerve pain medication and requested to return in a week.  Note that patient we provided with VIS in advance of the injection and had reported no prior reactions to vaccines.
During a mass vaccination clinic, client was administered one dose of Janssen COVID19 vaccine IM.  Pt was under age 18 at time of vaccination, Janssen  and our standing orders for Janssen vaccine state patients must be 18 or older to receive this vaccine.
Onset of generalized rash with purpura & petechiae, over extremities, trunk. Mucous membranes spared. No arthralgias.
No adverse event, pt got 1st dose of Moderna at then 3 months later came to our pharmacy for the pfizer series.
focal seizure Having muliple focal sezures  around 2 weeks after 2nd vaccine no treatment yet
Large red, itchy rash on the arm around the injection site. Onset 6-7 days after first dose of the Moderna COVID-19 vaccine was administered. Currently has been 36 hrs since the rash began. Rash is hot and itchy.
Subject in pneumococcal vaccine trial, with severe COPD, was diagnosed with stage 3A carcinomia of the right lung that as of June 2009 has spread to his brain. Vaccination took place 6/25/2007. According to the physician the relationship is 'None'. We would be happy to forward on the Study's SAE Reporting Form upon request.
REDNESS AT INJECTION SITE. MORE THAN THE USUAL AMOUNT OF REDNESS. 2 INCH ACROSS, RAISED AND RED.
Beginning at 6:00 pt c/o soreness.  On the next am noted redness, paiful to touch, warmth and edema rt arm. Applied ice packs and OTC Benadryl given.  Pt seen via PCP on 7-14-09 at 12:00 MD assessment - 5 cm X 8 cm red indurated area rt deltoid - ice and Benadryl 25mg TID ordered with well hydration ordered.  S/S improved later that pm.
Immunization: COVID-19 (Janssen/J&J) - vaccine was administered - reported by patient  ACUTE RESPIRATORY FAILURE 12/30/2021 LEG EDEMA ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/30/2021 LEG EDEMA
I suffered 2 (L) legt DVT and massive pulmonary embolism 1 week after my second Covid booster.
Patient developed extensive bruising and a petechial rash 3 days after receiving the H1N1 vaccine.  11/18 and 11/20 Medical records and discharge summary recieved for DOS 11/09 - 11/11 Idiopathic thrombocytopenia purpura S/P vaccine petechail rash LEs, bruising UE/LE. Platelets decreased. IVIG therapy. Improved. D/C to home.
Patient came to clinic visit on 4/14/2021 c/o headache, sharp chest discomfort, fingers tingling sensation, dark orange urine, pain scale 8/10 self medicating with ibuprofen. with minimal improvement. Patient referred to ER for further evaluation 4/16/2021 states developed - L sided facial droopiness, drooling, numbness, continued headache. Went to hospital for further evaluation. Was admitted until 4/19/2021. Stated diagnosed mild TIA, aneyrism; low B12 level, elevated cholesterol, pending neurology consult 4/26/2021.
Nausea and vomiting starting 10/18/03, pt to PCP started on antiemetic. Still having nausea and vomiting, poor food/fluid intake.
The night of the shot I was unable to sleep while in excruciating pain all over by body. I had a fever for 6 hours. I was to week to move for hours and when I finaly could get up and move around I was unable to even open my contact case to take them out because I was to week. The pain continued until noon when it lessened some with tons of advil I was able to move around slowly but pain persisted throughout the day and into the next 2 days. I finaly woke up pain free 4 days after getting the vaccine.
Severe dizziness for about an hour with Temperature 100.4 while alternating Tylenol and Motrin that started about  27.5  hours after receiving vaccine.  Temperature decreased to 99.4-99.7 and lasted for 2 days after. Pain in both hips, skin hurt to touch on back, headache, slight runny nose, malaise, and back pain lasted all day the second day after vaccine.
Acute upper gastrointestinal bleeding. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
PT INDICATED SORE/STIFF ARM, WITH PAIN/STIFF IN NECK AREA AND HEADACHE, WITH TINGLING IN ARM AND FINGERS.
Above elbow inward of left arm swell and red very itchy fever 100.4 took children's allergy relief. BENADRYL 10ml lasted 1 week of pain and feeling ill. Right arm influenza Flu vaccine: inactivated or recombinant flu vaccine swell above right elbow red itch fever 100.4 lasted 1 week compress on both arms 9/25/17 12noon.
About 3 days after vaccine, pt got intermittent facial neuralgia pain at distribution of trigeminal nerve, ophthalmic branch (left). No other symptoms.
Within 10 minutes of receiving the injection, as I was scheduling my second dose and then while I was waiting, my left should (upper left side of my back) started aching. I do not normally have any kind of a response to any vaccine, so I didn't immediately connect this pain with my COVID-19 vaccine, however, it continued to get progressively worse and ultimately became my entire arm, shoulder, neck and head.  I had a lot of difficulty sleeping for the next two nights and I noticed yesterday morning (Sunday, 3/21/21) that my left clavicle was completely obscured by significant swelling (I assume lymphnodes). Golf ball-sized swelling.  Today (Monday, 3/22/21) the swelling continues to be significant and I think maybe covering more area.  Not as pronounced of a lump, but more of a squashed, larger lump, if that makes sense?
Pharmacy failed to have him stay for the 15 min minimum  required after receiving the vaccine. He got home and the first thing he said was I have to go to bed and that is highly unusual  for him.  He has never had a reaction to a vaccine except statins. He fell out of bed twice, he was slopping dripping wet and the verge of  being delirious. He said I can't roll over and I don't feel good and couldn't move while he was on the floor. And he had taken his Parkinson medication. He told the paramedics that he slid down. He was pale, soaking wet from sweat, very low grade fever. They gave him half of an Aleve and took to the hospital. He was there since Saturday 10/29/2022 and kicked out Wednesday 11/2/2022.
Patient says shook all over for 45 min night of sept 16 2016 also very painful when touching hips arms hair. sat in chair all night could not slepp didn't feel like eating. felt like he had the flu. 9/16 am reports getting better on its own.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 16:15 as dose 5 (booster), single (Lot number: Gh9694), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID; Positive, notes: I was essentially had COVID twice. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Reported as, Rebound COVID The patient was essentially had COVID twice and missed ten days of work and two weeks of any productivity. With hindsight, think she would have probably done better had she not taken paxlovid. She wanted to report it so that they would have more accurate information to share with future patients. The patient received anti viral treatment with Paxlovid for COVID 19 form 02Mar2023 till 07Mar2023. No other medication in 2 weeks. No known allergies.
Headache  New loss of taste or smell  Sore throat  Congestion or running nose
PT received vaccine yesterday and this morning she was extremely dizzy and reported almost falling and passing out. I told pt she should call her PCP but she does not have one so I referred her to ER.
6 x 8 cm tender red area l/tricep.  Pt describes elevated temp to 103 at home responded to ibuprofen.  Ice to injection site. Vague Shortness of Breath sx's but transient resolved.
Arm turned red, began uncontrollable shakes, all over body. Lasted 2 hours. Restless night. Shortness of breath.
This spontaneous report has been received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not reported. From 30-DEC-2016 to 02-FEB-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M033216, expiration date 09-JAN-2018 (strength, route of administration, dose, and frequency were not provided) for prophylaxis. The reporter stated that the temperature range of the vaccine was more than -10 Celsius degrees but less than 8 Celsius degrees and the timeframe was 768 hours. Also, they stated that previous temperature excursion was not involved, and this information was no registered in a digital data logger. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000473:
No adverse event; Monovalent doses administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis. No Medical History information was reported. On 02-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient). Concomitant medication was not reported. Patient ID was reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Reportedly, in this report the patient was eligible for COVID-19 vaccine. Breakdown of doses were reported as 51 doses from batch numberAS7140C and 60 doses from Batch number AS7148B. Treatment medication was not reported.
Pt devel fever 102, 1 day p/APAP t99.6; rash on arms, legs, face 2 days blotches;
Weakness, nausea, vomiting, unable to hold food down, hoarse voice, productive cough
This spontaneous report was received from a medical assistant and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L034370, expiration date 08-SEP-2017 (dose and route of administration were not reported). There was no adverse effects reported. The administered doses of VARIVAX (Merck) experienced a temperature of maximum 6 degrees Celsius for 260 hours and 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.