chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of syncope in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced syncope, pain and dizziness. On an unknown date, the outcome of the syncope, pain and dizziness were unknown. It was unknown if the reporter considered the syncope, pain and dizziness to be related to BEXSERO. Additional details were provided as follows: The sales representative heard from the physician that she had at least two patients with the same side effects with BEXSERO. The representative did not have further details. This case has been linked with UG2017023509, reported by the same reporter.
arm soreness; reddish rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and VACCINATION SITE RASH (reddish rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and VACCINATION SITE RASH (reddish rash). On 01-Apr-2021, VACCINATION SITE RASH (reddish rash) had resolved. On 03-Apr-2021, PAIN IN EXTREMITY (arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information provided.
eyes are puffy and bloodshot was present; left side of his body was numb and tingly; fatigue/tired; left side of his body was numb and tingly; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (eyes are puffy and bloodshot was present), PARAESTHESIA (left side of his body was numb and tingly), FATIGUE (fatigue/tired) and HYPOAESTHESIA (left side of his body was numb and tingly) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PERIORBITAL SWELLING (eyes are puffy and bloodshot was present), PARAESTHESIA (left side of his body was numb and tingly), FATIGUE (fatigue/tired) and HYPOAESTHESIA (left side of his body was numb and tingly). At the time of the report, PERIORBITAL SWELLING (eyes are puffy and bloodshot was present), PARAESTHESIA (left side of his body was numb and tingly), FATIGUE (fatigue/tired) and HYPOAESTHESIA (left side of his body was numb and tingly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product were not provided/unknown. Treatment medication included Benadryl and Tylenol.
Narrative:  Please note that patient is a hospice patient. Death occurred 10 days post vaccination. Providers do not believe that there was a correlation. Facility requires that we reports all death even if we suspect no correlation between death and vaccine.  Symptoms: & death
This is a spontaneous report from a contactable nurse. A 68-year-old female patient received the first dose of PREVNAR 13 (Lot Number: R49358, Expiration date: 01Apr2018), intramuscular on 26Jun2017 at 10:47, at 0.5 mg, single as pneumonia booster. Medical history included ongoing high blood pressure, ongoing hyperlipidaemia, ongoing diabetes type II, and ongoing diverticulosis. The patient had no relevant family medical history. Concomitant medications included ongoing vitamin D, ongoing metformin, ongoing DIOVAN, and ongoing FLONASE. The nurse called from the facility regarding the patient who received PREVNAR 13 on 26Jun2017 and had a reaction to it. Explained that she had a splotchy red rash from her shoulder to her elbow the next day, on 27Jun2017. She also stated that it was there when she got up that next morning after she received the vaccination. It's just splotchy, not like the whole arm was covered. It was her left arm; the injection arm. The patient did not go to the Emergency Room but went to the physician's office because it wasn't going away. No relevant tests were done. Outcome of the event was not recovered and was reported as worsened. Two doctors who looked at it thought it was a reaction to the PREVNAR 13. Both physicians felt like it was related to the vaccination.
Patient LOC decreased resulting in her hitting another vehicle with her vehicle. Pt Conscious and responsive  119/81, 68, 98% O2.  VS Remained WNL at 09:54 and 10:05.
Pt noted prolonged tension type headache 2 and 13 days after flu vaccine.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). Other case identifier: NVSC2021US231939_NS). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient's C-reactive protein level increased (outcome unknown). Relevant laboratory tests and procedures available in the appropriate section. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No medical history or drug reactions/allergies were reported. On 28-SEP-2012, the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route not provided) and on 30-AUG-2013, the patient received second dose of GARDASIL (lot#, dose and route not provided). The patient did not get the third dose. No adverse effect was reported. Additional information has been requested.
Patient reported developing joint pain to his knees, hips, elbows and wrists 24 hours after he had his flu vaccine. Pain level was 10/10. Patient took a morphine and had relief. Pain level was at 5/10 (10/16/08)
On the day after 1st vaccination- diarrhea x 2 with blood on toilet paper after wiping(unusual event)  Have had Colonoscopy about 1 1/2 yrs. ago.
complains of swollen lumps (not red) in his forearm, elbow area, and one in his pectoral area of the same arm he was immunized in following his 2nd Moderna vaccine yesterday.  says that if he touches the lumps they hurt, otherwise they do not bother him.  will continue to monitor the bumps.
From initial information received on 9/21/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 30 year old female patient received an INFLUENZA VACCINE, lot number and manufacturer were not reported, administered in the arm on approximately 12/18/03. On approximately 12/24/03, the patient developed severe congestion, shortness of breath, difficulty breathing, constipation and chronic fatigue that lasted for months and still continues, but is less severe. The patient had emergency room visits, but was never admitted (dates unknown). She has had IV oxidation treatments. The difficulty breathing, constipation and chronic fatigue continued to persist. The patient reports severe allergies to foods, including eggs, wheat and corn. She has a follow up visit scheduled with a pulmonologist and plans to follow up with another alternative medicine doctor. The patient reported that she is not sure if she received Fluzone or Fluvirin in December 2003. The patient has not recovered from these events. (OMIC) From additional information received on 13OCT2004 from a health care professional, it was reported that the patient experienced symptoms of a "chest cold" on 26DEC2003. She was seen multiple times in the ER and urgent care facilities and underwent a thorough evaluation including an electrocardiogram and a chest x ray , which showed bibasilar atelectasis and infiltrates. Blood work included D. dimer and arterial blood gasses, however, no results were provided. A CT scan of the chest on 15MAR2004 was normal. She has a pulmonary consult and it was felt that she had a respiratory infection, as well as a history of asthma. I was not reported whether the patient recovered from these events.  From additional information received on 8NOV2004 from a health care facility, the patient's consent for influenza vaccine administration was provided. According to the consent, the pt does not have allergies to eggs, chicken , chicken feathers, chicken dander, mercury or thimerosal. In addition, the patient does not have sever latex sensitivity or an acute illness with fever. She did not have a fever within the 24 hours prior to vaccination. Reportedly, she received a dose of Influenza Vaccine, expiration date 30JUN2004 , in the right deltoid. Patient's pulmonologist's contact information was provided. The patient was last seen by the pulmonologist on 1MAR2004. At that time, she was felt to have bronchial asthma, cough and allergic rhino sinusitis. She underwent a chest x ray and a CT scan. Per pulmonologist, the chest xray demonstrated congestion, but was "better than the lat one" and the CT scan was "okay". Cspine x ray obtained on an unspecified date demonstrated soft tissue swelling. PA chest xray, obtained on 4MAR2004, demonstrated atelectasis. Patient's concomitant medicatioons at the time of vaccination included Albuterol, Aerobid, Biaxin, Zithromax and other unspecified antibiotics. The patient did not receive an influenza vaccine last year. No further information is anticipated. The case is considered closed.
Information has been received from a health care professional concerning 3 pts who were vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a local reaction. The pt sought sought unspecified medical treatment. Additional information has been requested.
NAUSEA; ACHY; TIRED; FEVER; WEAKNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 and batch number was not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced weakness. Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 08-APR-2021, the subject experienced achy. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 99.7 F, 100.2 F. Treatment medications included: paracetamol. On 09-APR-2021 04:30, Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever and the outcome of achy, tired, weakness and nausea was not reported. This report was non-serious.
After first shot, only side effect was a very sore arm, could hardly raise it for a few days.  Did not affect life. Same after second shot until 5 weeks later.   Woke to being VERY dizzy!  This did, and has continued to,  affect my life.  I am walking with a cane, using a grabber, can't bend over to anything below table height.  I didn't drive for 2 weeks, now afraid to leave town. on my own.  Since I am prone to these episodes, I wasn't too concerned, because they do pass, BUT I am still having the issue, daily. I understand that so many unknowns are with the Covid-19 vaccination.  My hope is that this DOES pass and I don't have to live with it the rest of my life!  Thank you for taking my symptoms.
Patient broke out in hives/rash within minutes of administration. No respiratory distress or edema noted by physician, no other complaints of symptoms made by patient.
right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; This is a spontaneous report from a contactable consumer or other non HCP. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and received dose 2 via an unspecified route of administration on an unspecified date BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) as dose 2, single both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that after receiving the first dose of the vaccine on an unspecified date she had right ear itching and burning and then the skin started to crack. These side effects lasted about 5 days. About a week after receiving the second dose she reports her other ear was burning, red, felt hot and started cracking again. She reported to DSU that this same side effect happened to her son's wife's father and grandfather, both received the Pfizer COVID-19 vaccine per reporter, and she would like to know if this side effect was something new or if this was something normal. Sister had the same side effect as well. The caller stated that 4 different people from 4 different states have all experienced the exact same side effect after receiving the Pfizer COVID-19 vaccine. The outcome of all events was unknown.  Follow-up attempts are needed, Information on the lot/batch number has been requested.
Knots under my under arm; Warm to touch; swelling up; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Knots under my under arm), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (swelling up) and HEADACHE (Headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (Knots under my under arm), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (swelling up) and HEADACHE (Headache). At the time of the report, SKIN MASS (Knots under my under arm), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (swelling up) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.  Patient stated that he got his shot a week ago.
cough that never gone away; sore throat that never gone away; glassy eyes; she has felt ill ever since; she can barely walk; fever of 103°F for 24 hours/fever of 101°F for 2 days/low fluctuations in her temperature at least 3 times a week; fatigue; nausea; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough that never gone away), OROPHARYNGEAL PAIN (sore throat that never gone away), GLASSY EYES (glassy eyes), MALAISE (she has felt ill ever since) and GAIT DISTURBANCE (she can barely walk) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, Lot number- EN5318, Route of administration- Intramuscular) on 28-Jan-2021, Pfizer (Dose 2, Lot number-  IL9266) on 19-Feb-2021 and FLU [INFLUENZA VACCINE] (7 years ago had similar reaction.). Past adverse reactions to the above products included Adverse reaction with FLU [INFLUENZA VACCINE]; and Sickness with PFIZER BIONTECH COVID-19 VACCINE and Pfizer.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced COUGH (cough that never gone away), OROPHARYNGEAL PAIN (sore throat that never gone away), GLASSY EYES (glassy eyes), MALAISE (she has felt ill ever since), GAIT DISTURBANCE (she can barely walk), PYREXIA (fever of 103°F for 24 hours/fever of 101°F for 2 days/low fluctuations in her temperature at least 3 times a week), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, COUGH (cough that never gone away), OROPHARYNGEAL PAIN (sore throat that never gone away), GLASSY EYES (glassy eyes), MALAISE (she has felt ill ever since), GAIT DISTURBANCE (she can barely walk), PYREXIA (fever of 103°F for 24 hours/fever of 101°F for 2 days/low fluctuations in her temperature at least 3 times a week), FATIGUE (fatigue) and NAUSEA (nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 103 degree F for 24 hours and 101 degree F for 2 days. In October 2021, Body temperature fluctuation: Low fluctuation 3 times a week.         Concomitant products were not reported.  Patient neither diagnosed nor tested positive for COVID-19 test. Patient did not have a history of acute and chronic illness at the time of vaccination. No other vaccines was taken within 1 month prior to Moderna COVID-19 vaccine. The event did not cause the patient to seek medical care. It was reported that approximately 112 hours after receiving first booster patient experienced fever. All the symptoms come and go, still ongoing.  No treatment had been taken.
Severe  headache, body aches, extreme fatigue, fever, nausea, vomiting. Redness and swelling at the injection site.
devel chickenpox rash 4MAY98;no fever, no URI sx, no itching, no secondary infect;dx as mild case;comfort measure as tx;
After receiving the Moderna second vaccine on 1/26/2021 I had generalized urticaria on 1/29/2021 lasting for 2 days, resolved with antihistamine Benadryl 25mg. Had the stomach flu on 12/11/2021. After receiving the Moderna booster on 12/2/2021, I had full body urticaria and shortness of breath that resulted in a trip to the Emergency Room on 12/14/2021. Was given Epinephrine, prednisone 60mg taper, benadryl 75mg, and famotidine 20mg. Later substituted hydroxyzine 25mg for benadryl with no resolution of symptoms, so returned to benadryl 50mg. Have completed a second round of prednisone 20mg taper with no resolution. Next step will be to try Dupixent, starting the week of February 14, 2022.
I just starting feeling stuffy and we did travel internationally and it got worse I did loose hearing in my ear this occurred mid March. The day after returning I went to Urgent care and was diagnosed with a sinus infection and I still have hearing loss in my right ear.
First and second day severe  injection site pain. Third day heart ache. On the forth and fifth day severe diarrhea, vomiting, fainting, headache, body ache, joint pain, exhaustion.  After that only body and joint ache and fatigue.
The day after receiving H1N1 mist, client started coughing and the cough has persisted. At times the cough is dry and progresses to crackles and wheezing. Has been treated with ATB, inhaler, albuterol, liq. steroids. Has had T & A. Has been several office visits and urgent care.
Headache; Ringing in the ears; Sore arm; Difficulty sleeping; A spontaneous report was received from a consumer, who was also a 31-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced ringing ears, sore arm, had difficulty sleeping and woke up with headache.  The patient's medical history was not provided by the reporter.  No concomitant medications were reported.  On 04 JAN 2021, the patient received their first two planned doses of mRNA-1273 (batch number: 037K20A) intramuscularly on her right arm for prophylaxis of COVID-19 infection.  On 04 JAN 2021, the patient received her first dose of vaccine and at 22:00 patient experienced ringing ears, sore arm, had difficulty sleeping and on 05 JAN 2021, woke up with headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, ringing ears, sore arm, had difficulty sleeping and woke up with headache were not reported.  The reporter did not provide causality for the events; Reporter'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.
This case was reported by a other health professional via call center representative and described the occurrence of woozy in a 63-year-old female patient who received SHINGRIX (batch number E3Z7E, expiry date 18th May 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 hrs after receiving SHINGRIX, the patient experienced woozy, nausea, headache, chills and tiredness. On an unknown date, the outcome of the woozy, nausea, headache, chills and tiredness were recovered/resolved. It was unknown if the reporter considered the woozy, nausea, headache, chills and tiredness to be related to SHINGRIX. Additional details were provided as follows: The medical assistant reported that the patient was tired, nauseous, woozy, chills and slept with 4 layers of blankets on. The patient denied for fever. The patient then started with headache in the middle of the night after receiving 1st SHINGRIX vaccine. Symptoms subsided within 24 hours. Outbound calls were attempted, however it was unable to reach the healthcare professional, therefore voice message was left.
little bit of pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2021 10:00 (Lot number: EN6198) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "fibromyalgia" (unspecified if ongoing), notes: for 30 years; "feeling feverish without a fever in the past" (unspecified if ongoing); "blood pressure" (ongoing); "Tachycardia" (ongoing). Concomitant medication(s) included: VERAPAMIL taken for blood pressure abnormal (ongoing); METOPROLOL XL SANDOZ taken for tachycardia (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Feb2021, outcome "recovered" (25Feb2021), described as "little bit of pain at the injection site".  Additional information: There were no additional vaccines administered on the day of Pfizer suspect vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was also reported to be taking VERAPAMIL for 30 years and METOPROLOL XL for 15 years.  No follow-up attempts are possible. No further information is expected.