chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bad reaction; injection arm felt weak/legs were wobbly; dizzy; dry mouth; trouble breathing; felt nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (bad reaction), MUSCULAR WEAKNESS (injection arm felt weak/legs were wobbly), DIZZINESS (dizzy), DRY MOUTH (dry mouth) and DYSPNOEA (trouble breathing) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026Z20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included METFORMIN for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ADVERSE REACTION (bad reaction), MUSCULAR WEAKNESS (injection arm felt weak/legs were wobbly), DIZZINESS (dizzy), DRY MOUTH (dry mouth), DYSPNOEA (trouble breathing) and NAUSEA (felt nauseated). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Feb-2021, ADVERSE REACTION (bad reaction), MUSCULAR WEAKNESS (injection arm felt weak/legs were wobbly), DIZZINESS (dizzy), DRY MOUTH (dry mouth), DYSPNOEA (trouble breathing) and NAUSEA (felt nauseated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication include vitamins, medication for blood pressure and cholesterol She mentioned that she's not planning to take the second dose of the vaccine.
Patient had systolic and diastolic heart failure on 02/20/2021 possibly related to COVID-19 Vaccination given 12/30/21 & 2nd Dose on 01/20/21 (heart inflammation?); Grade III left ventricular diastolic dysfunction was observed during hospital stay; cause unknown; EF of Lt. Ventricle has increased form 21% on 02/22/21 to 33% on 04/29/21 per two echocardiograms on each date. Pt. was given meds for Heart Failure, BP and Hyperlipemia; Pt. had a Cardiac Cath of Rt. & Left Heart on 02/23/21; no signs of coronary disease. Pt. is receiving ongoing outpatient chronic care treatment for issue.
Pain injection site, 5 hrs later, fever up to 101 degrees F, still has fever day 2 taking TYLENOL for fever, vomiting x1 last night.
Serious flu like symptoms for two days followed by serious chest tightness and pain with high heart on day three and continues now five days later.    I had a far worse reaction to this Moderna booster then my original first two Moderna shots in January anc February 2021.  Something is clearly different with this booster.  I will not get another Moderna booster ever.  The subsequent side effects are just too extreme.    We need a different annual booster that is more like a flu vaccine where at the worst we feel a slight set of flu symptoms.  I literally have just gone through 4 days of severe flu symptoms combined with chest pains and shortness of breath.
Patient's son called stating that his mother got her vaccine yesterday (4/6/2021) and a few hours later she started having chills, feelig feverish and sob.
Information has been received from a health professional concerning a 4 month old pt who was vaccinated once with a 2ml oral dose of Rotavirus vaccine. The pt had no adverse reaction. It was reported that the pt came back at 6 months of age and was vaccainted with a second dose of Rotavirus vaccine. No product quality complaint was involved. No other information was provided. Additional information has been requested.
2nd dose:  Stinging a few minutes after shot, I felt really woozy, and then started shaking all over having a hard time processing and talking.  Went home the next day (Wed)  fever, chills, headache, 24 hours better, returned to work on Thursday, day (2).  Day (3), Friday, I  noticed a red rash at the site of the injection earlier in the day, but no symptoms, just a little tender.  Friday evening I noticed a little SOB,  a little burning sensation under my skin on both forearms, and a couple times felt a little dizzy, but I didn't think much about it.  Day (4) Saturday morning, I went to spin class, I felt a little off, halfway through spin class I noticed I was struggling with some breathing, thought it was because I was wearing mask, but pushed through.  Ran a couple of errands afterwards and then noticed the SOB was continuing, my skin started burning again under forearms and now my legs with tingling into my feet.  At this point I decided I probably needed to go home.  On my way home my chest started to hurt in the very center of my chest, and slowly felt like some pressure, with squeezing sensation.  Then starting at the center of my chest I could almost feel what felt like a numbness creepy from my chest to my throat.  I went to the ER.  My legs felt really wobbly and had a difficult time walking, and was feeling dizzy.  They ran a variety of blood work and tests.  They noted my D-dimers were elevated and (4) lymph nodes enlarged.  They ran an additional series of test and released me at 10pm with follow-up to cardiologist.   I am still experiencing SOB, not as bad, and the burning sensations under my skin.
Rash started 2 days after vaccination, came to see us 5 days after vaccination (4/2/07).  Sent to derm clinic, with this note from derm: Bilat arms and lower extremities/buttocks wtih papules coalescing into plaques, most prominent on bilat knees.  Petechiae bilat medial knees;  scattered papules on chest and dorsal hands.  She was started on Prednisone 50 mg. po daily, seen in f/u by derm 4/9/07 with improvement noted, Prednisone changed to decreasing doses.
Very Sore Arm 08/11/21 Nausea on 08/12/21 Nausea, Diarrhea and Loss of Appetite 08/13 - 08/18
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left 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's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
During/after injection patient had syncopal/ seizure like activity. Lasted approx 35-45 seconds before patient came to. Patient was alert and oriented immediatly after episode however remained Nauseated and dizzy diaphortic. Patient was given a bottle of water, cold compress and rested. After 15-20 min patient was back to normal and back in stable condition left office with mother.
Patient developed nausea, vomiting, and abdominal pain within 8 hours of first dose of COVID-19 vaccination on 3/5/2021. Patient continued to have symptoms overnight, but is reporting mild improvement in symptoms on 3/6/2021 in the morning.
On 11/1 pt reports that during the night he noticed a rash and this morning he has rash on trunk. Says no other symptoms. Has not taken any additional medication. He had flu shots for several years without problem. Complete recovery by 11/2/02.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.
Retested positive for Covid on 25Apr2022 after experiencing sinus symptoms; Retested positive for Covid on 25Apr2022 after experiencing sinus symptoms; sinus symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6203), in right arm, on 22Mar2021 as dose 2, single (Lot number: ER8727), in right arm and on 01Nov2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 65 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 25Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 25Apr2022, outcome "recovering" and all described as "Retested positive for Covid on 25Apr2022 after experiencing sinus symptoms"; SINUS DISORDER (medically significant) with onset 25Apr2022, outcome "recovering", described as "sinus symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Had a rebound effect of Covid symptoms 9-10 days after finishing the Paxlovid and texting negative; (25Apr2022) positive, notes: Retested positive for Covid on 25Apr2022 after experiencing sinus symptoms. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of sinus disorder.  Clinical course: Serious: No Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.
1/21/2010 , 2100 Left arm swollen, red, warm to touch-per nurses notes. 1/22/10 RN reports area is firm, red, warm to touch. Primaxin 500mg N every 6 hours for treatment (possible Cellulitis).
AUTOIMMUNE DISEASE; GOT SICK; This spontaneous report received via social media from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown Expiry: unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, patient got sick. Patient had 10 follow up doctor appointments, weekly physical therapy and injections (unspecified). The patient reported that she was being treated for an autoimmune disorder and had been a trainwreck for months post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the auto immune disease and got sick was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210925713-COVID-19 VACCINE AD26.COV2.S-Autoimmune disease. This event(s) is considered unassessable. The event(s) has a unclear/unknown temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Doctor ordered vaccine for patient prior to discharge. Vaccine RN went to bedside to provide education with EUA form and VAERS. Pt verbalized understanding, questions answered, sitting up in chair. Administered vaccine per protocol in R deltoid per patient preference at 1429 . Observed pt for 15 min. Patient reported feeling well, and documentation completed. RN left the room at 1448 and then went on to administer another vaccine on the same unit, and previous bedside nurse pulled Vaccine RN aside, and said that the patient became hypotensive at 1450. Per Bedside RN BP was 81/42, HR 84. RN assisted patient back to bed and placed in trendelenberg. Doctor notified. 1457- BP 146/55, HR 75, SaO2 93%. MD ordered 250cc bolus of NS. 1550- BP 138/57, HR 79, SaO2 92% on 2L NC. Patient reported feeling better.  Pt was cleared for discharge, and sent home.
Localize arm pain; My whole arm is kind of aching and my armpit on that side; My heart is racing a little fast; I just kind of thought like it is different than it looks; Its just a little strange; feel like a little jittery; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date: 31Mar2021), via an unspecified route of administration on 17Dec2020 at single dose for Covid-19 immunisation. There was no medical history nor concomitant medications. The patient had COVID-19 vaccination on 17Dec2020. She did have some like localize arm pain and then it resolved. It is like a week later her whole arm was kind of aching and her armpit on that side. It was just that side effect with this, her arm and the other thing, its just like she was starting to feel like little a bit like my heart was racing a little fast, like I just feel like a little jittery. The arm pain was like two days before and it started and she just kind of thought like it was different than it looks. The patient just noticing that like feeling like little bit her heart was racing, its just a little strange. All event was in Dec2020 with outcome of unknown. The patient did not received any treatment, it was mild but she just notice it.
The arm/area where vaccine was given was very painful, not able to move arm, very achy, lethargic, feverish warm to the touch.
250PM 1NOV96 pt recv vax & returned +- 20min later flushed, sore throat, hoarse voice, anxious, epi given;BP 120/62, P88;
CHRONIC LYMPHOCYTIC LEUKEMIA; This spontaneous report received from a patient via a company representative concerned a 62 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 and patient was in bed for 18 days and concurrent conditions included fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 15-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in MAR-2021, The patient developed pain in joints or bones. On 17-MAR-2021, two days later, the patient felt very tired and extreme fatigue. On 24-MAY-2021, the patient had additional bloodwork and CT Scan and has been diagnosed with Chronic Lymphocytic Leukemia (CLL) On 24-MAY-2021, laboratory data included: Blood neutrophils (NR: 42.2 - 75.2) 25.3 %, Blood neutrophils (NR: 1.4 - 6.5) 3.5 10*3/uL, Blood test (NR: not provided) Elevated WBC, CT scan (NR: not provided) Enlarged lymph nodes., Haemoglobin (NR: 11.0 - 18.0) 12.5 g/dL, Hematocrit (NR: 35.0 - 60.0) 40.3 %, Lymphocytes (NR: 20.5 - 51.1) 70.7 %, Lymphocytes (NR: 1.2 - 3.4) 9.7 10*3/uL, MCH (NR: 37.0 - 31.0) 28.0 pg, MCHC (NR: 33.0 - 37.0) 30.9 g/dL, MCV (NR: 80.0 - 99.9) 90.4 fL, Mean platelet volume (NR: 708 - 11.0) 7.0 fL, Monocytes (NR: 1.7 - 9.3) 4.0 %, Monocytes (NR: 0.1 - 0.6) 0.5 10*3/uL, Plasminogen activator inhibitor (NR: 150.0 - 450.) 261 10*3/uL, Prophylaxis (NR: 4.00 - 6.00) 4.46 10*6/uL, Red cell distribution width (NR: 16.6 - 13.7) 13.8 %, and WBC (NR: 4.5 - 10.5) 13.7 10*3/uL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue/ very tired, and the outcome of joint pain, chronic lymphocytic leukemia and bone pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210614079-covid-19 vaccine ad26.cov2.s-Chronic Lymphocytic Leukemia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This literature marketed report has been received from the authors of a published article concerning a 16 year old male patient. The patient's concurrent condition included sleep apnoea. On an unknown date, the patient was vaccinated with a second dose of HPV (manufacturer unknown) or HPV 9 (manufacturer unknown) (dose, route, lot# and expiration date were not reported). Concomitant therapy was not reported. The patient presented to the sleep clinic for evaluation of hypersomnia. This was sudden in onset and started on an unknown date after he received the second dose of the HPV (manufacturer unknown) or HPV 9 (manufacturer unknown). He had an excessive day time sleepiness with an Epworth score of 24. He had multiple sleep attacks during the day, naps were slightly refreshing and he was sleeping more than 15 hours in a 24-hour period. He had no hallucinations or rapid eye movements (REM) behavior disorders. He did have one episode of sleep paralysis. He also developed abnormal right-sided limb movements followed by weakness. These were also associated with facial drooping on the same side. These episodes were triggered by emotions such as excitement or anger and lasted about 10-15 seconds and at times occurred in clusters. He underwent a brain nuclear magnetic resonance imaging (MRI) and electroencephalogram (EEG), which were both negative for any pathology. These episodes could represent an atypical presentation of cataplexy. He underwent an in-lab sleep study followed by an Multiple Sleep Latency Test (MSLT). The sleep study ruled out sleep apnea as a cause of hypersomnia. The MSLT was consistent with a diagnosis of narcolepsy with a mean sleep latency of 0.6 seconds and five out of five naps with sleep -onset REM periods. The outcome of narcolepsy was unknown. The authors considered narcolepsy to be related to the HPV vaccination. Upon internal review, the event of narcolepsy was considered to be medically significant. Additional information has been requested.
Swelling to right thigh 48 hours after administration. Area of swelling 4 inches x 6 inches - red/purple raised - blanches, no induration, not warm to ER Wed 3-9-16.
left upper arm displaying local reaction measuring 6 1/4 inches long by 9 inches wide-red, warm
This spontaneous report was received via a company representative (a patient's friend), from a 58-year-old female patient, who was reporting on herself. The patient's concomitant medications and drug reactions or allergies were unknown. The patient's concurrent conditions included getting sick "at the drop of a dime". On 27-APR-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (exact dose, route of administration, lot # and expiry date were not reported). On the same day, within a couple of hours, she experienced injection site soreness. On the following day, the patient still had the injection site soreness and also developed a low grade fever, malaise, chills and nausea. The patient did not seek medical attention and had no lab diagnostics studies performed. It was unknown whether she received a treatment for the event. The outcome of the events was recovering. The causality between PNEUMOVAX23 and the events was not provided. Additional information has been requested.
Extreme fatigue, loss of appetite, upset stomach/nausea, trouble sleeping, noticeable vision getting worse (already wear glasses: last check up was March 2018) Headaches/light headedness persisting over the last few weeks. Sometimes I can feel my heart pounding. General feeling of unwell and not normal.   The extreme fatigue has subsided, but I was unable to work from 04/23-05/02.   Temp had remained normal throughout and never reached above 99.6. Took a rapid test on 04/23/2021 at Urgent Care, and a lab test from pharmacy for COVID on 05/23/2021; both came back negative.
I had 3 stages of reactions to the first dose. 1. Same day of the vaccine, I had a mild soreness in my arm which was normal for a vaccine shot. Nothing out of the ordinary. 2. Second day, I felt tired, similar to what I would feel if I am getting  the flu. I felt as if I had a elevated body temperature, but the forehead thermometer was normal. 3. Third day, I felt better overall, only had the soreness in the arm left. 4. Day 12, I noticed 3 patches of a rash on and around the injection site. I only noticed them because I felt my arm warmer than usual. The texture of the rash is a bit different than my regular skin, mildly reddish in color, 1 patch is 2 inches in diameter, the others are smaller. I called in to vaccination team and the nurse took my statement and directed me to report it here.
Severe muscle pain all over body. Later settled in arms & legs. Right arm (injection site) very painful event after rx of steroids. Started and continues shortly after injection. Pain like a tooth ache. Difficulty getting out of bed and in & out of a car. Various lab work by two doctors-cannot determine cause of pain. Started in the neck & shoulders on left side a few days after injection.
I was having issues with my sinuses after my third dose.  I tested negative for COVID-19 and was diagnosed with a sinus infection.  I got an antibiotic but had to go through two rounds of the antibiotic before I recovered.  In addition, I began having trouble with my feet in late January 2022 that have progressively gotten worse.  My instep on top will occasionally spasm and cause pain.  The bottoms, my heels and my toes will hurt.
Pain in joints, muscles, knees, back and shoulders; Pain in joints, muscles, knees, back and shoulders; Pain in joints, muscles, knees, back and shoulders; This is a spontaneous report from a contactable other-HCP dentist (patient). An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP7534 and expiration date were not reported) via unknown route in left arm on 17Mar2021 13:30 at SINGLE DOSE for covid-19 immunization. The report is not related to a study or programme. Medical history included high blood pressure unspecified time and was ongoing and hypothyroidism from unspecified time to unspecified time. Patient reported that he does have severe arthritis and that it could be that. There was no relevant family medical history. Concomitantly patient had been taking levothyroxine sodium (LEVOXYL) at a dose of 175mcg tablet once a day in morning for hypothyroid since about 15 years, lisinopril at a dose of 30mg tablet for high blood pressure since about 2-3 years, buspirone as antidepressant at a dose of 15mg tablet twice a day since about 2 years, escitalopram oxalate (LEXAPRO) at a dose of 20mg tablet once a day as antidepressant since about 3 years and trazadone at an unknown dose of for sleep since about an year. Reportedly, all the concomitant medications were ongoing at the time of report. Patient stated that he takes a cataract medicine does not know the name of it, states that it is a large pill and is brown colored. There was no investigation assessment and relevant tests. On Mar2021 (2 days after the injection), patient had pain in joints, muscles, knees, back and shoulders. Patient took Tylenol as treatment for event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no history of previous vaccinations. There were no other vaccinations administered on same day. Vaccination facility type was pharmacy, it was not administered in military facility. Patient reported that he had vaccination on 17Mar2021 and today is 30Mar2021 and he was still having pain. The event did not require any visit to physician or emergency room. Patient wanted to know why this is happening and if this can happen. Patient was scheduled for second dose on 07Apr2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.