chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching and redness on head, itching on arms and torso.; Itching and redness on head, itching on arms and torso.; This is a spontaneous report from a contactable Other HCP (patient).  A 50-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 09:00 at SINGLE DOSE at Left arm for COVID-19 vaccination. The patient was not pregnant. Medical history included hypertension.  Concomitant medication in two weeks included omeprazole (PRILOSEC [OMEPRAZOLE]), doxycycline and otc vitamins. The patient previously took oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET) and experienced drug allergies. On 12Jan2021 10:00, the patient experienced itching and redness on head, itching on arms and torso. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
After receiving his first Moderna vaccine dose the patient became light-headed, anxious and clammy. Patient was monitored and felt better after approximately five minutes. No treatment required.
Narrative:  COVID infection COVID vaccine series 03/29, Moderna , dose #1 04/26, Moderna , dose #2 08/27 COVID swab, result: detected 08/24 pt cc: cough, diarrhea, fatigue, fever, headache, loss of taste or smell, myalgias,  rhinorrhea, congestion, dyspnea, sore throat, exposure: co-workers 08/27 SARS- COV-2 Variant Sequencing result: pending
Tested positive for COVID-19; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.  No treatment medications were reported.  The patient did not have any allergies to medications, food, and other products.  The patient had not taken any other vaccines within 1 month prior to Moderna COVID-19 vaccination. The patient had a runny nose a week after getting the booster which led the patient to getting tested for COVID-19.  Company Comment: This spontaneous case concerns a 79-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive. Lack of drug effect was considered as an additional event. The events occurred approximately 10 months after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient tested positive for SARS-CoV-2. Treatment information was not provided. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-512683, MOD-2022-512669 (Patient Link).; Sender's Comments: This spontaneous case concerns a 79-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive. Lack of drug effect was considered as an additional event. The events occurred approximately 10 months after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient tested positive for SARS-CoV-2. Treatment information was not provided. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Initial unsolicited report received from a consumer (mother of patient) on 03-may-2017. This case involves a two months old (also reported as 9 weeks) female patient who was vaccinated with a dose of PENTACEL and HEPATITIS B VACCINE and PREVNAR and ROTAVIRUS VACCINE (batch number, expiry date, dose, dose in series, route and site of administration was not reported for all four vaccines) on 18-Apr-2017. The patient had a possible milk allergy. Patient has history of bloody diarrhea, was being breastfed, switched to a special formula and bloody diarrhea resolved. It was also reported that illness at time of vaccination was reported as none. Concomitant medications and any other vaccinations within 4 weeks of vaccinations noted above were not reported. On an unknown date, following the vaccination, the patient experienced bloody diarrhea. The patient's laboratory data and corrective treatment was not reported. On an unknown date, patient recovered from the event, which lasted for about a week. Upon internal review the case was considered as serious because of important medical event: bloody diarrhea. List of documents held by sender: none. Sender's Comments: Sanofi company comment dated 05-May-2017: Patient was vaccinated with PENTACEL, Hepatitis B, PREVNAR, Rotavirus vaccines. Following which patient experience bloody diarrhea unlisted as per PENTACEL. Patient's medical history such as allergies: possible milk allergy and concurrent administration of rotavirus vaccine can be alternative explanation. However need additional information of concurrent infection, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be excluded.
This study case was received from the investigator in a trial on 01 July 2011. A 23-year-old male subject, with no significant medical history, received an injection with ACAM2000, lot number not reported, on 04 February 2011. On 24 February 2011, the subject had an abnormal troponin I of 00.05, and an abnormal electrocardiogram (ECG). On 25 February 2011, the subject had an echocardiogram (results not provided). A magnetic resonance imaging (MRI) scan of the heart was performed (date not reported) but results were not available. On 25 February 2011, a diagnosis of unspecified disease of pericardium was made. On 02 March 2011, a diagnosis of acute pericarditis, unspecified was made. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
dizzy,nausea.  Pt received the J&J vaccine on Saturday. Pt had HA and body aches on Sunday. On Monday, pt has severe HA and ringing in his ears and has not gone away. 51 yo M w/ no known chronic medical conditions, J&J vaccine on Friday, presents w/ dizziness (room-spinning) that started this AM and has since resolved. Initially started when he sat up from bed after waking up; a/w moderate nausea (no vomiting). Pt went back to sleep, no sx when he woke up, but sx re-started when he stood up. Since then, dizziness has resolved. Pt has residual nausea, but currently no dizziness. He also reports constant ringing in his ears since this AM, w/ no associated muffled hearing, ear pain, ear discharge. Initially had fevers/
No adverse events reported. Patient received adult dose of Hep B (20 mcg/mL) and should have received 10 mcg/0.5 mL dose based on age.
Sat night night headache started, flu like and sunday and fatigue. Monday - all gone except headache. Tuesday - telehealth - doctor said that was normal. Wed - continued to have headache. Thursday it got extreme painful. Right side to the right eye. Went ER. PCP on tuesday - sought medical 4 times and still had headaches.
This spontaneous report was received from a physician, via a company representative, referring to a 13 year old male patient. Information about the patient's medical history and concurrent conditions was not provided. On 12-MAY-2016, the patient was vaccinated with his second dose of GARDASIL 9 lot # L016429, expiration date: 09-AUG-2016, intramuscular. On that same date, the patient developed hives all over his body. On 14-MAY-2016, the patient went to an urgent care unit, where he was given oxygen and a SOLU-MEDROL injection. The occurrence of hives continued and patient went to the emergency room again on 15-MAY-2016 to be treated with intravenous SOLU-MEDROL and intravenous steroid. The patient was prescribed prednisone for 12 days and BENADRYL for 2 weeks as an outpatient. The outcome of urticarial was unknown at the time of this report. Additional information has been requested.
Patient   age: 92 Admit: 1/15/2023 Covid + 1/15/2023 Death 1/31/2023, noted Covid + in D/C Summary with pseudomonas PNA and fall. Pt placed on comfort care Immunizations Moderna x3 local Medical Center,
Itchy, red, blotchy rash on chest, back, head; getting better as of 11/15/21
the noc of vax mom reports pt quit breathing turned blue & became flaccid;taken to hosp ER;on EMS arrival pt w/o problems 02 sat 75%, t103.2; to ER;no report available from ER;ER dx bronchitis poss pneumonia;
On 05/01/2019 to PCP office,person bringing me to office exclaimed that the injection site looked kind of low on the left arm. Upon exam she also agreed it looked a little low in location. Red raised bump appx. 3-1/3" in diameter, very warm, itchy. Swelling traveling behind injection site toward the back of the arm just above the elbow. Treated for possible skin infection w/ Cephalexin 250 mg. On 05/08/2019 Calls into and missing the office. Wondering if I should be seen at walk in care. Injection site still tight red,slight itch etc. Area on arm appears lighter but still bothersome. 05/17/2019-05/19/2019 Back and back shoulder pain only. Used ibuprofen for the aches. 05/26/2019-05/27/2019 front shoulder pain. 05/28/2019 Went to work and called PCP office. During the morning @ work on 05/28/2019 the shoulder pain I was having was unlike anything I'd ever had before. I was scared and called the doctors office because it was radiating toward my chest and starting to grip really bad. I was informed by Dr.'s nurse that I should then go to the E.R. which is what I did. Many hours later,tested, treated and released. Robaxin 4x daily. No cardiac results. On 06/05/2019 I went to PCP for the follow up on the E.R. visit. See, series of small checks. Neck x-ray ordered, MEG test and nerve conduction test ordered. Cyclobenzaprine and Prednisone prescribed. No relief when pills are even half gone. MEDS ARE NOT WORKING FOR THE PAIN< TINGLING AND NUMBNESS. The tingling seems to be in the 1st three fingers of the left hand. Arm, left shoulder pain and left sided chest pain are the most significant. 06/07/2019 Burning @ the bra line on back along with stabbing pain. 06/11/2019 tingling and numbness in arm and fingers is more constant now. Heavy area of pain just above and below the elbow area. 06/25/2019 fingers burning. Arm itchy at below elbow. Pointer finger, middle finger more extreme pain and wrist being felt now. Called PCP office to keep track of appt. for EMG. Scheduled for 07/03/2019. 07/03/2019 EMG and nerve conduction test w/ Dr. at 8:50 A.M. Any word I got from Dr. indicated pressure from around elbow area to wrist. He is sending report back to Dr. On 07/19/2019 I follow up with Dr. and see where we go from here. Today is 07/04/2019. I continue to have unexplained extreme arm and shoulder pain. The first three finger on my left hand have been constantly numb since about 06/11/2019. Now I scratch between the fingers daily because they now also itch. Up until now ,muscle relaxants have not worked and over the counter medications do not work. 07/19/2019 Primary care visit with Dr. He gave me a script for a wrist brace. He is treating this as carpal tunnel syndrome. I am to re-visit him in September sometime after having worn the brace.
On Sat, May 8th around 4:30 PM, while sitting and watching TV, I felt a numbing shock to the left side of my body (particularly left cheek, my entire left arm, and legs) and got up to check myself in the mirror. I got chills and my teeth began chattering, but my arm in particular felt like it was on fire. I thought I was having a stroke so I managed to drive myself to the ER where I was admitted. When the doctors performed the initial tests on me, my skin felt dull on my left side but my arm felt a burning-numbness to it. The doctors performed two MRIs, a CT scan, an Echo Cardiogram, Blood Tests, Blood Pressure readings, and a Covid-19 test and found no problems in my brain or heart, no Covid infection, and a healthy cardiovascular system. I was released May 10th with the diagnosis of a Transient Ischemic Attack (TIA) of unknown cause. When I woke up today on 5/11, the burning-numbing sensation returned to my arm again (even as I type this) but this time I know it is not a stroke. I have had no medical history, exercise regularly, have a healthy diet (vegetarian/vegan for more than seven years), the only thing I've done recently is had my first Moderna shot injected intramuscularly in my left arm, the same arm where this burning-numbness is taking place. I thought it is best proactive to report this event and if there is any correlation to the vaccine
After intranasal flu vaccine, had EGD 1 wk later, prolonged lethargy, increasing to 16 hrs/day, headache, mild deficits of memory, severe headache. Developed idiopathic intracranial hypertension. OP = 39.
Fatigue, mild low O2 (90-94). Unknown for how long. Only happened on exertion (walking, lifting heavy items, bending over to pack boxes). Wasn't noticed until Saturday the 23rd when patient tried to work and was SOB and fatigued upon walking, but was otherwise OK.  Wednesday, 10-20-21, patient tried to work (walk, lift, talk, stand) and was profusely sweating, SOB, shaky, and extreme fatigue. Severe fatigue continued until 10/23/21.
Under arm tenderness; Pain at injection (L); This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Under arm tenderness) and VACCINATION SITE PAIN (Pain at injection (L)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20R0A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection (L)). On 21-Jan-2021, the patient experienced TENDERNESS (Under arm tenderness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, bid and IBUPROFEN at a dose of UNK, bid. On 20-Jan-2021, VACCINATION SITE PAIN (Pain at injection (L)) had resolved. At the time of the report, TENDERNESS (Under arm tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the event included paracetamol and ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow Up received as email address for the reporter is updated.
feeling sickly.; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sickly.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced MALAISE (feeling sickly.). At the time of the report, MALAISE (feeling sickly.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient describes waking up at 2 am, sweaty with a fever.  Her head is spinning and she can't life her arm.  She states she feels the shot was given correctly, that it must've been something in the vaccine.
still have tenderness in the area of the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer.), for COVID-19 immunization; Covid-19 vaccine (kept thinking it would go away, but it was still the same, no change, as when first got the booster. DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization, reaction(s): "still have tenderness in the area of the shot"; Flu shot (flu shot. The 'pain' was similar to how patient's arm would feel a couple of days after the flu shot.), for Immunization, reaction(s): "The pain was similar to how patient's arm would feel a couple of days after the flu shot.". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "still have tenderness in the area of the shot".  Additional information: Patient received the Pfizer booster last Dec2021, but still have tenderness in the area of the shot. Patient can't seem to find any answers to questions about that and was hoping you could help. The pain was similar to how patient's arm would feel a couple of days after the flu shot. Patient kept thinking it would go away, but it was still the same, no change, as when patient first got the booster.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt called and reported that she was feeling feverish over the weekend and went to the urgent care. At the urgent care, they diagnosed her with Bell's Palsy. Pt called on 10/3/22 to let us know and to request that we submit a vaers report.
Patient lost consciousness and fell out of chair onto asphalt shortly after vaccination, suffering minor abrasions to his head, knee, and finger. Nurse had him lie supine, administered a cold pack, and dressed his abrasions with antibiotic ointment and bandages. Patient was given water and snacks once he felt well enough to consume them. His wife, who stated that the patient did not eat breakfast and that he has a history of vasovagal reactions, drove him home. 8/20/21 Called but no answer. No voice mail
The entire reaction was over in an hour started at 115pm 12/19/2020 I had pain in upper back and shoulder, within 5 mins it started hurting my left arm and traveled down to my wrist and then went into my left thigh and I had this sharp headache for 3 mins and then it all went away and I have not had any symptoms since. That day I went to the ER and they kept me for 2 hours for observation and I went back to my work, The only reason I sought care was because I was already in a hospital, I was taken by wheelchair, blood pressure was fine
His (R) upper arm swelled and turned red with dependent edema where he received the pneumococcal vaccine.
Tender around his nose area on one side; Swelling around nose and eyes; Swelling around nose and eyes; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 01Mar2021 (at the age of 59 years), as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took his first COVID-19 shot yesterday (01Mar2021) and had swelling around nose and eyes. The patient was reading the pamphlet and it said that it could be swelling. It was tender around his nose area this morning (02Mar2021). The patient wanted to know if it should be tender around his nose area on one side like that. The patient was just trying to be cautious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
PT BEING MONITORED FOR 30 MINUTES. AT 0930 PRIOR TO LEAVING. 0931: PT STATED THAT HER THROAT FELT SCRATCHY AND HER CHEST FELT FUNNY. PT AIRWAY ASSESSED. ERYTHEMA TO THROAT AND UVULA NOTED, NO EDEMA OR SWELLING NOTED AT THIS TIME. PT BROUGH BACK TO OBSERVATION FOR FURTHER ASSESSMENT, BY WRITER, PHYSICIAN AND EMT.  PT PLACED ON CARDIAC MONITOR- NORMAL SINUS RHYTHM. PT DENIES ANY CHEST PAIN, PALPITATIONS, PRESSURE, SOB, N/V/D NOTED. MD RECOMMENED PT GO TO ER FOR FURTHER EVALUATION PT REFUSED, BUT AGGREED TO STAY FOR TREATMENT OF IV BENADRYL AND IV DEXAMETHASONE. BOTH ADMINISTERED BT EMT AT 0958. PT TOLERATED WELL. PT CONTINUED TO BE MONITORED UNTIL S/S OF REACTION SUBSDED AT 10:20AM. PT STATES THAT THERE IS NO LONGER A SCRATCH FEELING IN THROAT AND HER CHEST FELT MUCH BETTER. VSS REMAIN STABLE. PT STILL REFUSES TO GO TO ER PRIOR TO LEAVING FACILIT. PT AMBULATED OFF SITE. ACCOMPANIED BY FAMILY.
VACCINE ERROR: This was the second dose in the series. Second dose was administered 16 days after the first dose. Initial dose was given 12/20/2020.
Information has been received from a registered nurse concerning a 75 year old female with no known allergies who on 9/14/2005 at 3:30 pm was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine 0.5ml IM lot 647661/0055R, in the right deltoid. Concomitant therapy that day included influenza virus split virion 3v vaccine inactivated lot U1772AA, in the left deltoid. Subsequently within 24 hours, the patient developed an adverse reaction on right arm. The patient experienced redness at injection site, mild swelling and achiness arthralgia. The patient was treated with acetaminophen Tylenol and Ibuprofen. The patient recovered on 9/17/2005. No product quality complaint involved. It was also reported that another patient had an adverse reaction following vaccination with Pneumococcal 23v polysaccharide vaccine (WAES0509USA03027). No further information is expected.
Fever, aches, headache, fatigue, weakness, soreness, redness, swelling where shot was given
I developed a dry cough about 7:30 PM, my tongue and gums felt painful. I went to bed at 10 PM and awoke at 1:30 am with headache, severely swollen tounge, severe facial swelling, eyes were completely blood shot. I was very concerned with possible anaphylaxis and contemplated going to the emergency room. I went back to bed at 4:30 am as my airway was patent and my wife frequently checked on me. I awoke at 8:30 am with headache, facial swelling and numbness but tongue was less swollen and not as painful. Eyes were not as bloodshot but I was very fatigued.
Information has been received from a physician concerning a 17 year old female who on 11-MAY-2007 was vaccinated with first dose of Gardasil. Concomitant therapy included meningococcal vaccine (unspecified). On 12-MAY-2007 the patient developed swelling of her lips. She did go to the emergency room, however she was not admitted to the hospital. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Received vaccine, waited 15 min. Walked to car.  side of face went numb, dry mouth. Patient walked back to vaccinate location.  Pulse 115, O2 Sat. 96.