chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hiccup; This is a spontaneous report from a contactable physician (patient).   This 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EKS730), intramuscular at single dose in left deltoid on 21Dec2020 15:30 for covid-19 immunisation, dexamethasone sodium phosphate (Exp. date 31Dec2015), via an unspecified route of administration in Dec2020 at 8 mg, daily for an unspecified indication.  Medical history included atrial fibrillation from 2009. There were no concomitant medications.  The patient experienced hiccup on 27Dec2020 12:00 with outcome of not recovered. The action taken in response to the event for bnt162b2 was not applicable, for dexamethasone sodium phosphate was unknown. Therapeutic measures were taken as a result of hiccup. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   Pfizer is a marketing authorization holder of dexamethasone sodium phosphate in the country of incidence or the country where the product was purchased. This may be a duplicate report if another marketing authorization holder of dexamethasone sodium phosphate has submitted the same report to the regulatory authorities.
Red rash on both arms, back, right ankle-not itchy or painful but red and spreading since Wednesday
The patient complained of dizziness right after 15 minutes,  the patient waited another 15 minutes for a total of 30 minutes and the patient's symptoms subsided.
Patient started developing a large, red, sore arm at shot location the following day. Very painful to touch and very warm to touch. Counseled patient via phone to take tylenol if needed and to apply ice as needed. Started getting better by Monday 9/16/19.
Generalized pustular lesions with heaviest concentration on left shoulder and arm and anterior bilat thighs. Referred for dermatology eval. Treated with antihistamine for pruritis.
high fever 105, unk; not seen in clinic; mom called on 24FEB93, not hospitalized, given IV fluids, Ibuprofen suppositories, cooling measures; responded to cooling measures, antipyretics, recovered;
Heart palpitations; Dizziness; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations), DIZZINESS (Dizziness) and DYSPNOEA (Shortness of breath) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations), DIZZINESS (Dizziness) and DYSPNOEA (Shortness of breath). At the time of the report, PALPITATIONS (Heart palpitations), DIZZINESS (Dizziness) and DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. It was reported that the patient was in the emergency room with heart palpitations, dizziness, and shortness of breath after receiving the Moderna COVID-19 vaccination. Treatment information was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Moderate arm pain (on arm of injection) through the night (Starting approx. 12 hours post injection). Arm pain less severe compared to first Pfizer Injection (22 days prior). Arm pain lasted approx. 48 hours.  0800 (18 hours post injection) - Elevated temperature of 37.2 C 1000 (20 hours post injection) - Elevated temperature of 37.9 C, severe headache (worst I've ever felt), and general aching - both lasting approx. 6 hours (400mg Ibuprofen was taken at 1500 - approx. 25 hours post injection - and 1 hours prior to relief of headache, fever, and aches)
Pts father called stating that child had a rash on legs, arm and face. Pt came in to confirm a reaction to vaccination.
sweating but not bad; foggy brain; chills; fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERHIDROSIS (sweating but not bad), FEELING ABNORMAL (foggy brain), CHILLS (chills) and FATIGUE (fatigue) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating but not bad), FEELING ABNORMAL (foggy brain), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, HYPERHIDROSIS (sweating but not bad), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown and FEELING ABNORMAL (foggy brain) had resolved.            Concomitant medications were not reported.  Treatment information was not provided.
No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002936: US-009507513-2105USA002866: US-009507513-2105USA002933: US-009507513-2105USA002934: US-009507513-2105USA002942: US-009507513-2105USA002941: US-009507513-2105USA002940: US-009507513-2105USA002939: US-009507513-2105USA002938: US-009507513-2105USA002937: US-009507513-2105USA002943: US-009507513-2105USA002935:
pt was sleeping;started screaming;very white in color;went limp & listless-no response;wouldn't open eyes;mom thought quit breathing;this last 15min;went to ER pt then starting crying & was unconsolable;went to sleep very pale-drowsy;t99.7
Mom reports a red, swollen, tender to touch area on left arm the size of 50 cent peice.
17y/o patient received Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17y/o patient received Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17y/o patient received Moderna vaccine). On 13-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17y/o patient received Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.
Have red, big acne in my face and in my back and in my head; Have red, big acne in my face and in my back and in my head; Itchy, when I touch it, I feel pain; Itchy, when I touch it, I feel pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 24-year-old female patient received BNT162b2 (BNT162B2), on 03May2022 as dose 1 (bla tris), single (Lot number: FJ4989) at the age of 24 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ACNE (non-serious), ERYTHEMA (non-serious) all with onset 05May2022, outcome "unknown" and all described as "Have red, big acne in my face and in my back and in my head"; PRURITUS (non-serious), PAIN (non-serious) all with onset 05May2022, outcome "unknown" and all described as "Itchy, when I touch it, I feel pain". Sender's Comments: Linked Report(s) : US-PFIZER INC-202200673319 Same reporter/ drug, different patients (mom baby)
Child no longer babbled, no longer responded to sounds (his name being called), very limited eye contact and smiling after the vaccination. At the time of the vaccination, the pt had a cold on several occasions. Requested for him not to be vaccinated at that time but instead the doctors advised to go ahead. Called and informed the doctor's office about agitation, fever, crying and was advised to give acetaminophen. On annual report received 04/28/2003, reporter states, "(patient) no longer speaks, fixates on very limited activities and things. Behavior issues of self-injuring himself and others and great difficulty with change. He can do very little for himself. He still only tolerates being fed baby foods, is not potty trained, also some sounds are very upsetting and seem painful to him. He is only able to functin at school in a self contained class of 3 students and 3 adult instructors. He has tested positive for several heavy metal toxicities."
Patient was lethargic, but no noteworthy symptoms throughout the day. I put him to sleep in his crib, on his back, without any surrounding blankets, toys, or pillows. At approx. 8:30 pm, his owlet monitor alarm went off alerting us his oxygen levels were rapidly decreasing. When I went to his room to wake him, his body was shaking. No foaming at mouth to note. After checking breathing vitals, and for fever, I put him back to sleep and monitored him all night. The next morning, the alarm did go off again, alerting us of low oxygen levels. I placed a call to the pediatrician, and I made sure the call was recorded. I was told they "do not recommend Owlet monitors" and he was "probably shaking from a fever" and this was "normal". They had no further concerns and did not think he should be seen for any symptoms.
Slight headache and tired muscles. No fever. However slight constipation (difficulty passing stool) from next day after receiving vaccine. Continued for two days.
Patient is 17 years old.  Will reach out regarding 2nd dose if patient able to receive per CDC guidelines.
At about 6:00 pm started to feel very dizzy. States had to lay down and started to get "bad" headaches, states felt like she would pass out if she stood up. Called PMD next day. Felt better 10/10/2007, but still a little dizzy. By 10/11/07 symptoms resolved.
My neck (around left lymph node area) became very tender and I had general muscle aches.  By the next morning, my neck pain was worse (I would rate it 7/10 on a pain scale) and extremely tender to touch-  still on the left side.  My right neck was slightly tender but not nearly as bad.  I had trouble sleeping that night and the next due to the pain in my neck.  By 12/21/09 the pain has begun to subside-  it is resolving.
Woke up very dizzy. Became nauseated. Vomited. Ill all day!
had a fever afterthe 1st dose of the vaccine yesterday; This is a spontaneous report from a contactable consumer (patient), from Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient had a fever after the 1st dose of the vaccine yesterday. She wants to know if she is contagious. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Fatigue, fever chills, sweating, body aches. These symptoms started in the evening on the day I received the vaccine. I woke up in the middle of the night with the fever, body aches, chills, sweating. I slept most of the day on Tuesday. I got up and showered late afternoon Tuesday and went back to bed. This lasted until Wednesday, when I finally got dressed by 1:00 in the afternoon. I went out to run an errand for an hour and came home and went back to bed. On Thursday I could tell her was improving, but couldn't have gone to work yet. Friday I finally felt almost well again.
shaky, rash and nausea day of immunization time of 8pm. treatment: grandmother gave Benadryl for reactions at time of reaction
Developed focal seizures a little less than 2 days later.  Had not experienced any seizures since those initial seizures following surgery on 4/19/20.  This was first instance.  Nothing else in his life was new or different, and he had been on the 500 mg bid dose of levetiracetam for a couple of months, having gradually reduced from 1000 mg bid.
nauseous; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) and VOMITING (vomiting) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nauseous) and VOMITING (vomiting). At the time of the report, NAUSEA (nauseous) and VOMITING (vomiting) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Updated Onset date of mRNA-1273 first dose from 02-Feb-2021 to 14-Feb-2021.
pt recv vax 6DEC96 & w/in 24hr of vax pt devel a severe local rxn;pt was taken to ER & was treated w/histamine blockers & cortisone;pt recovered w/in 24hr;
03/27/2021 BREATHLESSNESS 3 DAYS AFTER SECOND DOSE OF MODERNA VACCINE ON 03/24/2021. 04/14/2021 HOSPITAL EMERGENCY ROOM CARE SOUGHT AFTER CONTINUED BREATHLESSNESS/dyspnea. 11/24/2021 BOOSTER DOSE OF MODERNA VACCINE 11/26/2021 SEVERE BREATHLESSNESS 2 DAYS AFTER BOOSTER. 12/07/2021 URGENT CARE FOR CONTINUED SEVERE BREATHLESSNESS/dyspnea. 12/23/2021 BLOODWORK AND SEVERAL ADDITIONAL ONES DONE AS FOLLOW UP LATER 12/27/2021 STRESS TEST ORDERED AND DONE 12/29/2021 URGENT CARE FOR CONTINUED SEVERE BREATHLESSNESS/dyspnea.
Dose given around 1225 4pm significant arm pain, neck pain, headache  5pm rash/hives 645pm sweating, flushed, nausea, itchy
PREVNAR 13 (Aug 23, 2016) (L) arm IM, red and tender area, bit painful no bleeding, no fever, no itchy, no rash elsewhere.
I became ill with flu like symptoms after the vaccine was given. I had a fever and body aches. I waited until 5 hours after or longer to take some ibuprofen. I was pretty much better after that second day. I recall having a bad cramp in my left calf muscle at night in December. I haven't been right since then. I was trying to walk one day, and the side of my leg started tightening up. A week ago, my hip started making a popping sound and now I can't walk normally. I can't see my doctor until January, so they said if it got worse to go to the emergency room. I went to see a chiropractor and he said to stay off it and ice it. I also had numbness in my left thigh. The doctors diagnosed me with Sciatica. They prescribed me with Naproxen 500mg, a steroid, and a muscle relaxer. The numbness went away on Monday morning, and I was able to make it to the chiropractor. The chiropractor gave me stretches to do that made it worse because my hip popped out again. It is worse than it has been before. My hip was sore to the touch. I have an upcoming appointment on January
Pt received booster on 11/30/21. Called hospital call center on 12/1/21 and spoke with RN about  c/o lump on his armpit and feels like its getting worse. pt reports rapid heartbeat. Pt was advised to go to ED for further evaluation.
Patient received dose from refrigerated vial of vaccine 16 hours after initial puncture to vial.   Vial punctured on 6/1/2021 2:20 pm;  dose drawn and given  6/2/2021 9:14am; Vaccine Exp date: 6/23/2021. No known adverse reaction to the patient.
Initial solicited report received on 08 March 2017 and follow up information received on 13 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 21 year-old male subject with no significant medical history. The subject's received one dose of Japanese Encephalitis as prophylactic vaccination on 25 March 2016. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 21 April 2016. On 05 May 2016, 14 days after vaccination the subject was diagnosed with I21.3 ST elevation (STEMI) myocardial infarction of unspecified site, on 03 May 2016, 12 days post vaccination the subject was diagnosed with I40.8 Other acute myocarditis/I40.9 Acute myocarditis, unspecified and 04 May 2016, 13 days after vaccination the subject was diagnosed with I50.40 Unspecified combined systolic (congestive) and diastolic (congestive) heart failure. The lab data included within 30 days post vaccination on 03 May 2016, the Troponin I was abnormal (highest value 16.50 ng/ml), ECG was normal, Echocardiogram was normal, MRI heart was abnormal on 13 May 2016, MRI (brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Relationship to investigational product according to investigator: not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a healthy 21-year-old male who developed ST segment elevation myocardial infarction, acute myocarditis unspecified and congestive heart failure with favorable temporal association post vaccination with ACAM2000. Subject had confounding factor as concomitant administrations of Japanese\ encephalitis vaccine. Myocardial infarction, Myocarditis and heart failure are listed adverse events that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
I had bad reaction to no more eggs because of swelling in my throat; vomiting 24 times in 8 hrs; Feeling sick for 6 months; bleeding intestine; Initial information received on 11-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves 27 years Adult unknown gender patient who experienced i had bad reaction to no more eggs because of swelling in my throat, vomiting 24 times in 8 hrs, feeling sick for 6 months and bleeding intestines after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for flu.  On an unknown date the patient developed i had bad reaction to no more eggs because of swelling in my throat (pharyngeal swelling), vomiting 24 times in 8 hrs (vomiting), feeling sick for 6 months (malaise) and bleeding intestines (Intestinal haemorrhage) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the events    Outcome was Unknown for all the events   Additional information was received on 15-Dec-2022: Case upgraded from non-case to valid case and age of patient and  event of pharyngeal swelling, vomiting, feeling sick and bleeding intestines was added and case updated accordingly.
Moderna COVID-19 Vaccine EUA...Pain in the left arm with tenderness and warm to touch. In addition joint pain in my left ankle, swelling.  Unable to put pressure when standing or walking.  Using a cane since I did have an injury in the ankle 10 years ago.  Also had a left hip replacement in 2016.
his heart went to 187; he is having a heart problem; Supraventricular tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "It was just a muscle under his armpit." (unspecified if ongoing), notes: Was having something in his armpit about 6 months prior to having the vaccine in Sep. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (medically significant), outcome "unknown", described as "his heart went to 187"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "he is having a heart problem"; SUPRAVENTRICULAR TACHYCARDIA (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Echocardiogram: Negative, notes: Had a scan, an MRI, an echo, and everything was negative; Heart rate: 187, notes: In Sep he was about to go to sleep and his heart went to 187; everything: Negative, notes: Had a scan, an MRI, an echo, and everything was negative; Magnetic resonance imaging: Negative, notes: Had a scan, an MRI, an echo, and everything was negative; Scan: Negative, notes: Had a scan, an MRI, an echo, and everything was negative.  Clinical Course: After receiving Pfizer COVID-19 Vaccine he was having a heart problem. He did not have any heart problem before until he took the Pfizer COVID-19 vaccine. Has supraventricular tachycardia now. Never had a past medical issue. Was having something in his armpit about 6 months prior to having the vaccine in Sep. Had a scan, an MRI, an echo, and everything was negative. It was just a muscle under his armpit. In Sep he was about to go to sleep and his heart went to 187. Was about to shock him. Has to wear a heart monitor for 2 weeks and takes it off today. His HCP said it was from the vaccine and a lot of people 30 and younger with no prior conditions are developing problems and most are supraventricular tachycardia. Never had a heart problem in his life.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.