chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. A 3-year-old male patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration on 18Apr2012. The patient medical history was not reported. The patient's concomitant medications were not reported. On 18Apr2012, the patient was not able to lift his arm after vaccination. Relevant laboratory tests were unknown. Therapeutic measures taken as a result of the event were unknown. The outcome was reported as not recovered at the time of the report.
Within a few minutes of receiving the Moderna Booster shot, I started to get very dizzy. I knew I was about to faint, having experienced that a few times in my life. I had had no adverse reactions to the first 2 Moderna vaccines, so this was shocking.  I was sitting and put my head down between my legs.  The pharmacist brought me water but that did not help. My vision blurred badly and I tried breathing deeper after lowering my mask. I tried to stand up and then based upon what the pharmacist told me, I dropped to the floor passing out and he caught me.  About 10-15 minutes later laying on the floor, I recovered and was no longer dizzy. They called an ambulance to take me to the hospital.
soreness in the arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) and FATIGUE (fatigue) in a 64-year-old male patient 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 PAIN IN EXTREMITY (soreness in the arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (soreness in the arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.                   No treatment medication was reported.   This case was linked to MOD-2021-293377, MOD-2021-293637.
Two weeks after the vaccine he got up and had a nickel sized blister on his arm between the shoulder and elbow, below the injection site.  He pressed on it and it burst open and water came out of it.  The skin then dried up and came off, and left a dime sized sore place under that blister and is still there on Monday 2/8/21 and has not gone away.  It has not scabbed up.  He did not take anything for it.
Arm pain; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 16:00 (Lot number: EW0153) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D3; ZINC. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm pain"; FATIGUE (non-serious), outcome "recovered", described as "Fatigue".  Additional information: The patient did not have COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Crohn's disease aggravated; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) formulation: Solution for injection in pre-filled pen. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease aggravated) (seriousness criterion medically significant) and ILLNESS (Sickness). At the time of the report, CROHN'S DISEASE (Crohn's disease aggravated) and ILLNESS (Sickness) outcome was unknown.            Formulation of Humira was reported as solution for injection in pre-filled pen.  It was reported that Humira not working, crohn's disease flare up and sick wit Humira. It was unknown if patient was enrolled in a covid-19 vaccine trail. Primary reporter did not have the lot number information, because the packaging was discarded.  No concomitant medication was reported.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning a 66-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease (Crohn's disease aggravated), on unknown date after receiving a dose of mRNA-1273 vaccine. The patient reported that Adalimumab is not working and reported Crohn's disease flare up and being sick. Dates of vaccination of the 3 doses of mRNA-1273, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of Crohn's disease remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 66-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease (Crohn's disease aggravated), on unknown date after receiving a dose of mRNA-1273 vaccine. The patient reported that Adalimumab is not working and reported Crohn's disease flare up and being sick. Dates of vaccination of the 3 doses of mRNA-1273, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of Crohn's disease remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
not feel better until 16 hours after the vaccination; Fever for four hours; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (not feel better until 16 hours after the vaccination) and PYREXIA (Fever for four hours) 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 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 FEELING ABNORMAL (not feel better until 16 hours after the vaccination) and PYREXIA (Fever for four hours). At the time of the report, FEELING ABNORMAL (not feel better until 16 hours after the vaccination) and PYREXIA (Fever for four hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information were not provided.
Temp 6/29/03-7/2/03 101-102. Pain right axilla 6/27/03. Joint pain knees, elbows 6/17. Shortness of breath 6/30/03. General weakness and fatigue 6/30-7/2/03. Recovered 7/3/03.
Low grade fever (99.6) , Headaches , pain in joints throughout body , moderate paint at injection site on right arm , swelling and redness at injection site on right arm , nausea , fatigue .
I had arm soreness that I needed to take  Tylenol and I was exhausted no energy I had a hard time walking around the hospital I almost fell asleep on my desk. I fell asleep that night and felt fine the next day!  Advanced maternal age because I'm 40 so I'm high risk, Low on Vitamin D3 early in my pregnancy, beginning of Dec I was lightly anemic, due date Feb 9th
patient tested positive for Covid-19; patient tested positive for Covid-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 09Feb2021 (Lot number: EL3247) at the age of 30 years as dose 2, single and administered in left arm, administration date Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "recovered with sequelae" (Jan2022) and all described as "patient tested positive for Covid-19". The event "patient tested positive for covid-19" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Received MMR to left thigh 6/17/03, 24 hours later developed hard, tender, indurated area to left thigh. Treated with topical steroid, began resolving. No fever, no other rash.
On 7/6/17, Acute onset of fussiness and bright red blood streaked stools (x 5) 1 day following oral rotavirus vaccination, very fussy and inconsolable, fever tmax 101F. Patient seen at Pediatrics by PA-C for above symptoms, + hemoccult stool in office, sent to Hospital Emergency Department, Abdominal US done to r/o intussusception- negative. GI pathogen panel done - + Rotavirus, otherwise negative.
Initial report received 30 October 2009 from a health care professional. A 50-year-old female patient with a history of orthostatic syndrome, had received an intramuscular injection (site not reported) of FLUZONE SV 2009-2010, lot number U3199AA on 06 October 2009 and immediately following vaccination, she experienced dizziness, faintness, nausea and trembling hands. The patient was taken to the hospital where she was admitted, and subsequently discharged (dates not reported). At unspecified amount of time later, the patient was re admitted and was tested for GBS (Guillain Barre Syndrome) (dates not reported). Test results were unknown at the time of the report. The patient had no concurrent illness and no known allergies. It was unknown if she had been taking any concomitant medications. The patient had received influenza vaccines in the past, however it was unknown if she had experienced any adverse events following prior vaccinations. No further information was known at the time of the report. Documents held by sender: None.
I had Confirmed case of Covid-19 7/3/2020.  I received the 1st dose of the Maderna vaccine 1/7/21,   I had a slight headache in the afternoon of 1/7/2021.   On the morning of 1/8/21, 6am I awoke with chills, fever of 104.2 and severe left arm pain.  I took Tylenol 1000mg and fever came down to 102.4,  When I awoke again, my temp was 106.1.   I took 800mg of Ibuprofen and 1000mg of Tylenol.  My fever continued all day and again in at bedtime of 102.8.   I did not exceed the Tylenol dose if 24 hour and I only took Ibuprofen that one time.    On Sunday I stated having fever blisters and my entire mouth is sloughing off because of the fever.
Throat swelling at least three times a day, rash, restricted breathing, food allergies I have never had before, food intolerance, anxiety attacks, shaking, tremors, hands, tongue, feet and vagina swelling, feeling of warmth all over, toothpaste intolerance, sulfate intolerance.
Severe left side knee and shoulder pain; Could barely walk; could not lift left arm above 90 degrees; The arm pain was not your typical injection site pain from a flu shot; This is a spontaneous report from contactable healthcare professional, the patient.  A 56-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), intramuscular in the left arm on 25Dec2020 at 09:00 as a single dose for COVID-19 immunization.  Medical history included asthma, hypertension, arthritis, and sulfa allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included colecalciferol (VITAMIN D) and losartan (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Dec2020 at 21:00, the patient experienced severe left side knee and shoulder pain, could barely walk, and could not lift left arm above 90 degrees. The patient stated that the arm pain was not your typical injection site pain from a flu shot. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any treatment for the events. The clinical outcomes of severe left side knee and shoulder pain, could barely walk, could not lift left arm above 90 degrees, and arm pain was not your typical injection site pain of flu shot, were recovering. The events were all reported as non-serious. However, it was also reported that the duration of hospitalization was 1 (not further specified).
10/4/11 Received the flu shot and afterward started to have pain in left side of neck & chest pain.
10/20/13 - Reported having onset of sx after receiving the Tetanus injection. Started with w/onset of sx at approximately 18:35 w/nausea, then blurred vision, & lightheaded lasting approximately 2 minutes, per donor and all sx resolved per donor after vomiting. MSA arrived while donor was vomiting in the trash can with moderate amount of thick brownish colored food that had the appearance of beans. Donor's skin was dry, pink, alert/oriented and was brought to the medical office for vitals. Immunization site w/o any any noted reaction.
Information has been received from a pharmacist concerning a 78 yr old hospitalized female who was vaccinated SC with a 575mcg dose of PNEUMOVAX 23 (lot 651539/1100P). Subsequently, the pt developed a whole body rash. Unspecified medical attention was sought. Subsequently, the pt was discharged from the hospital and noted to be improved. No product quality complaint was involved. The pt's hospitalization was possibly prolonged due to the adverse events. No further information is available.
Patient states that when she got home she started to experience post nasal drip and then a sore throat.  Then she stated that she has labored breathing, but after about an hour the breathing normalized and the issue resolved on its own.
No additional adverse events; 10/20/2021 one dose of an improperly stored V AQT A vaccine was administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 20-OCT-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # U013969 was confirmed to be valid, expiration date 06-FEB-2023 (exact dose, route of administration, anatomical location were not reported) for prophylaxis. The temperature excursion was 51 degrees Fahrenheit for 4 hours and 15 minutes. There were no previous excursions reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA006206: US-009507513-2110USA005970:
Adult dose given to pediatric patient, no harm to patient, on site infectious disease doctors were notified and consulted, parent of patient notified or error and the recommendations of the infectious disease doctors.
Initially swelling and pain at injection site, progressing to fever, chills and myalgia with severe back spasms. Protracted recovery with NSAIDs and rest.
Vomiting, fever, rash bilateral arms, torso, some facial rash, chest pain.
Shingles of the face and eye within three weeks after my vaccination. I then got COVID before I could get my second shot. Was told to delay it until after my shingles cleared up. Never got second shot due to complications of first. I have been healthy my entire life and this vaccine was the catalyst to now experiencing daily pain on my face/scalp, relentless headaches and permanent damage to my eye.
Redness and swelling of right thigh. Pt was seen at local ER 8/25/06 with history of spiking fever. Pt was given Cephalexin for dx of cellulitis. When seen at office Monday 8/28, nl exam.
Severe headaches for 8 days and severe lethargy for 8 days. Only treatment was ibuprofen and rest. After 8 days, returned to normal.
Fever, chills, muscle soreness, body aches, overall yuckiness  for ~36 hours
she has a low grade fever; a swollen left node on the neck; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported for self that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. patient got her 1st dose last Dec2020 and is scheduled for the 2nd dose today. She mentioned she has a low grade fever and a swollen left node on the neck. She wants to know if that will contraindicate on taking the vaccine. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Myalgia, NauseaVomiting, Nausea, vomiting, chills, body aches, fatigue Narrative:
Pt developed Temperature 102, "shook from head to toe". Pt felt was either from flu shot or related to previous heart condition. ER doctor felt pt had a virus and put on antibiotics. Pt recovered.
This spontaneous report was received from an office manager via a company representative and refers to a 26 year old female patient. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 11-JAN-2017, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not not reported). On 13-MAR-2017, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not not reported). On 15-MAY-2017, the patient was vaccinated with the third dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not not reported) (reported as early dose). No adverse effects were reported. Additional information has been requested.
hives occurred the same night i received my flu shot, took benadryl to stop hives and contacted primary care doctor that gave me the flu shot, doctor told me to for two weeks to take 10mg of zyrtec daily and 200mg of tagamet twice daily. Hives became less severe, but still continued to show up. Hives can be anywhere on elbows, wrists, forearm, hips, spine, eyes, lips, back of knee/leg, ankles. Went back to primary care doctor and had blood drawn but results were normal and hives continued daily. Went to get a second opinion from another primary care doctor in December 2019, she prescribed prednisone for 5 days and that stopped the hives completely for a couple weeks.  Then at the beginning of 2020 hives began to show up in the same places. Went to an allergist in January 2020 who told me to take Allegra, Xyzal, Benadryl or a combination of those to stop the hives when they occur. Hives continue occur 5-6 times a week in the same spots.
After receiving seasonal flu vaccination, went back to work area. Approximently 3 hours later, came back to clinic area and complained of feeling dizzy and having a tight lump in chest, described of throat choking. No wheezing noted. Client observed. 3:20 PM-BP 102/64. 3:35 PM-BP 110/78. Nurse Practioner called. She advised the Registered Nurse at clinic location to administer eppy. Breathing difficulty continued. Eppy pen of 0.3mg given in Left Anterior thigh. 911 called. Breathing and tightness in throat improved almost immediately. Paramedics arrived and client was transported to area hopsital.
Parathesis  Numbness ear as scalp  Headache Unbalanced  Pain in toe  Sensitivity to one side of my body
02/14/22 presents to ED for "intractable nausea/vomiting". PMHx of "esophageal stricture, EtOH cirrhosis s/p OLT 10/16/21 on immunosuppression, HTN, and COVID (approx 1 month ago)"
Area of hair loss was reported. First course of treatment was to send with clavamox 125mg tabs to give twice daily for 10 days, as well as Miconazole Cream and Dermalone Cream to be applied alternatavely three times daily. The animal was later sent with Pentoxyphylline 14mg capsules given by mouth twice daily for 30 days. Area of hair loss has not improved.
Subsequent to receiving one dose of Lymerix, the pt was achy for 3-4 days. This event resolved. Subsequent to receiving the second dose of Lymerix, the pt was achy for 48 hours. This adverse event resolved. Subsequent  to receiving the third dose of Lymerix, the pt experienced edema and ache in his upper left arm. This adverse event resolved. No treatment was given. As of 10/16/2000, the outcome of the events is resolved.
Erythema and pruritis for at least 11 days; continues as this report is being completed, through has improved
High fever 103 with in 24 hours of receiving vaccine and continued for 3 days. When pt received shots he was on antibiotics for otitis media.
"if I lift my arm, I have pain in that area/has radiating pain from injection site, up and down; sore arm ever since then; little bit swollen; she thought it was a muscle thing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN ("if I lift my arm, I have pain in that area/has radiating pain from injection site, up and down), VACCINATION SITE PAIN (sore arm ever since then), VACCINATION SITE SWELLING (little bit swollen) and MYALGIA (she thought it was a muscle thing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included OMEPRAZOLE, IRON and BUPROPION for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PAIN ("if I lift my arm, I have pain in that area/has radiating pain from injection site, up and down), VACCINATION SITE PAIN (sore arm ever since then), VACCINATION SITE SWELLING (little bit swollen) and MYALGIA (she thought it was a muscle thing). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN ("if I lift my arm, I have pain in that area/has radiating pain from injection site, up and down), VACCINATION SITE PAIN (sore arm ever since then), VACCINATION SITE SWELLING (little bit swollen) and MYALGIA (she thought it was a muscle thing) outcome was unknown.            This case was linked to MOD-2021-065224 (Patient Link).
Client with history of allergic reaction experiences facial flushing, some red splotches appeared on skin, reported head pounding and heart racing. Client handed off to EMS and transported to ER.