chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever or chills ( 3 weeks off and on, chills - I did not get feverish) Cough (fits of coughing, still) Shortness of breath or difficulty breathing (still have this) Fatigue (still) Muscle or body aches (still) Headache (still) New loss of taste or smell I got smell back, though it is different. I have trouble tasting savory foods. I hardly eat. Sore throat (off and on) Congestion or runny nose (yes, still) Nausea or vomiting (nausea, yes, vomiting, no.) Diarrhea (horrible, weeks and weeks) Trouble breathing (yes, still) Persistent pain or pressure in the chest (on and off) New confusion (yes, and short term memory loss) Inability to wake or stay awake (for a solid month) water in lungs, (felt like) joint pain (severe, still have it, although it has diminished) eyesight worsened
I had the black stool, there was blood; Stomach upset; muscle ache; Fatigue; Nausea; A spontaneous report was received from a Reporter like Consumer concerning a 67 Year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle ache, had the black stool there was blood/ Haematochezia, nausea, stomach upset, fatigue were reported.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch:024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021 , The patient experienced the events muscle ache, had the black stool, there was blood , nausea, stomach upset, fatigue were reported. Event i had the black stool, there was blood was considered medically significant.  Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event haematochezia was unknown and for other event it was resolved on 13 Feb 2021.; 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.
Patient came in for Covid Booster on 4/27/2023 and received Comirnaty (mono-valent) injection rather than Bi-Valent injection that was due. Patient had previously received Moderna products for original series and boosters in past with no issues. Patient did report feeling more fatigued for 1 to 2 weeks after administration of Comirnaty. No other issues reported. Patient will be re-vaccinated with Moderna Bi-Valent product per vaccine schedule.
big tumor on the side of his neck; He says last night his neck was tight because it stretches so much; This is a spontaneous report from a contactable consumer.   A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 12Mar2021 (Batch/Lot Number: EN6208) at single dose (at the age of 91 years old) for COVID-19 immunisation. Medical history included emphysema from smoking, which was diagnosed about 11-12 years ago. He says he doesn't know if he has got it, his doctor had took some test that come back then he said you have emphysema. He says that it never bothers him, and he doesn't take oxygen at all. He says he take 8 medicines that he has been taking since he had a heart attack in 1996, they are not new medications. He says he had heart surgery then too.  The patient's concomitant medications were unspecified. The patient previously took BNT162B2 on 16Feb2021, dose, 1 (lot number: EN6200) for COVID-19 immunisation; the patient also had flu shot (INFLUENZA VACCINE) for immunisation. On Mar2021, the patient said he has got a big tumor on the side of his neck from it, and he wondered if there is anyone there that can tell him something to put on his neck to make it softer or go down, he has had it 4 weeks since that Friday. He said it was after the second shot that the tumor started, about the second day after it.  He said last night his neck was tight because it stretches so much. He says he has done no treatment. The events were reported as medically significant. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
22 y/o F contacts Vaccine Call Center on 06JAN13. CC was re NVP, but patient mentions that she was seen in the ER on 23DEC12 (day #2 s/p receipt primary SPV) for new onset of chest pain "heart racing, tightness chest/SOB." She was told that her blood work and EKG were normal. (SEE BELOW: CK was mildly elevated, no serial enzymes drawn, no PCM f/u after ER visit no repeat EKG). Patient agreed to be contacted by a NP to obtain a more detailed h/o of her chest pain / SOB to r/o possible SPV associated myopericarditis, although the onset of patient's chest tightness and slight SOB on day #2 s/p SPV is clearly atypical / early. Sx of myopericarditis generally begin during the window of the peak cytokine activity of the vaccine, which occurs between days 6-12 s/p receipt of SPV. Patient did not attempt working out again till after the Christmas/New Year Holiday. On 03JAN13 (day #13 s/p SPV) she attempted working out, but her heart began racing and she felt tightness in her chest on deep breathing, which was ongoing when NP spoke with patient on 07JAN13. At that time, her exercise tolerance was "still pretty bad" & she was not able to work out without her heart racing & tightness in her chest on deep breathing. She did not have a f/u with her PCM & she has not returned to the ER for recurrent or worsening sx. ON-CALL No contacts patient on 07JAN12 to obtain further history of patient's onset of chest pain, slight SOB and ER visit on 23DEC12. Patient confirms that she received primary SPV AVA #1 & TYPHIM Vi vaccines on 21DEC12, in preparation for work in FEB 2013. Patient denies prior viral or GI infection or any sx of anaphylaxis during first 3 hours after receipt of vaccines. States she was at church around 5PM on 22DEC12 and she felt tightness in the center of her chest, near her sternum, like someone was pushing on her chest and she couldn't breathe deeply, her heart began to race and she felt hot- episode lasted x 2 min. The next morning (23DEC12) she began to work out and tried to run. Within 2 minutes her HR had increased to > 170 bpm & she had to stop. She states that she is an endurance runner and has never experienced these symptoms before. She tried doing some lunges, but her chest was still hurting. No radiation of pain to her neck, jaw or left arm. CP not positional, but she was not supine. She read the smallpox vaccine pamphlet she had been given and called the Vaccine Call Center, as noted above. When the tightness in her chest and slight SOB recurred again around 14:30PM, she decided to go to ER and get it checked out (SEE ER Note, 23DEC12, 14:59). EKG obtained (23DEC12, 15:54) with "no ischemic changes"; ER VS (1600) BP 137/72, HR 78, RR 16, T 97.1 F and (1700) 133/76, HR 78, RR16, T 96.1 F. (SEE LABS BELOW- CK 147 U/L (30-135) / no serial enzymes drawn). No echocardiogram obtained. ER Dx: Immunization Reaction (not Myocarditis). Patient was home over holiday and did not attempt working out again till 03JAN13 (day #13 s/p SPV). Her heart rate increased very rapidly & she felt tightness in the center of her chest, which was worse with deep breathing.
Breakthrough case admission after 2 vaccines Moderna 3/24/21 Lot# 017B21A;  Moderna 4/21/21 Lot# 043B21A
6/30/15 Adult Hep A dose given in error. 7/3/15 wellness check revealed temp of 101.4. Given TYLENOL & PEDIALYTE. F/U appt scheduled. 7/4/15 Afebrile but URI s/s noted - not attributed to vaccine. 7/5/15 Asymptomatic.
Information has been received from a mother of triplets who reported that two of her triplets have received the second dose of Varivax (Oka/Merck) and have experienced low grade and persistent fevers that spike at night. The following is regarding one of the triplets, a 7 year old female, who on 26-JAN-2007 was vaccinated with Varivax (Oka/Merck) in her arm (unknown which arm or specific route). There was no concomitant medication or medical history. On 01-FEB-2007, six days after receiving Varivax (Oka/Merck), the patient experienced low grade fever and persistent fevers that spike at night. The highest the fever had been was 103 degrees F. The fevers have been ongoing for 22 days. The child has been on (cefdinir) OMNICEF since 18-FEB-20007, but is still experiencing fevers. On 22-FEB-2007, the patient underwent laboratory evaluation which included a CBC and Lyme disease test (results not provided). The patient's sister also experienced an adverse event (WAES # 0702USA04021). Additional information has been requested.
- Local erythema, swelling, warmth, pain at injection site. - (R) axillary lymphadenopathy (large).
This spontaneous report was received from Pfizer and was assigned manufacturer report number 2016305571 for PREVNAR 13. This was originally reported by a registered nurse, and refers to a 66 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-JUN-2016, the patient was vaccinated with PNEUMOVAX 23 (dose, dose number, route, anatomical location lot # and expiration date were unspecified) and PREVNAR 13, (dose, dose number, route, anatomical location lot # and expiration date were unspecified). Additional information has been requested.
This spontaneous report was received from a physician via a company representative, concerning a 70 year-old female patient. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date in February 2016 (reported as "about 1 year ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported) to prevent shingles. On an unknown date, after getting ZOSTAVAX, the patient experienced "chronic outbreaks of shingles". The outcome of the adverse event was unknown. The causality between the event and ZOSTAVAX was unknown. No product quality complaint was involved (PQC). Additional information has been requested.
Pt. complained of feeling anxious shortness of breath, heart pounding, face and chest tingling.  Rapid response called and provider assessed.  Pt. given cold water.  Pt. began to calm down.  Provider encouraged patient to take her anti-anxiety medication.
1yr 1 month p/initial series completed employee found to be not immune to HBV according to neg; Anti HBs testing; Given 5 doses 19MAY89, 30JUN89, 7NOV89, 14DEC90m 22MAR91 fr 1893P, 1893P, 1802R, 0302S, 1238S;
Red rash around the neckline area and around the face. The neckline area was warm to the touch. Slight irritation felt in the neckline area.  Patient's face and neckline remain red color as of 11/18/2016 @ 1350 (1:50 pm).  Patient contacted Dr and telephone on 11/18/2016 to report adverse event. When the patient called again later on that same 11/18/2016, patient was informed by the Patient Services Representative of Clinic that Medical Assistant to Dr. received patient's email, and would be informing Dr.who according to the Patient Services Representative would be following up with patient.
Pt experienced recurrent bouts of poly arthralgias in both hands, shoulders, hips and elbows. Symptoms started after pt received Anthrax shot. Symptoms lasted for 2-5 days and are minimally responsive to NSAIDS.
1st dose given saturday 11/27/22 at Pharmacy within 2-3 days he experienced symptoms including dizziness, belching, tightness in his chest with exertion, tiredness, myalgia/arthralgia, HA which seems to be ongoing since then.  He found if he takes  otc mucinex 12hr  600mg twice daily it relives dizziness nearly by 75% or more, started this approx 6 wks ago for relief for constant hoarseness in this throat.  He reports the hoarseness is pretty much gone.   2nd dose given Wednesday 12/22/22 at Pharmacy, Friday he noticed his both hands were shaking very badly when he went to his kitchen to get a glass of water. Pt denies fam hx tremor. The intensity of tremor and frequency has lessened. Initially every time he awoke from sleep he also felt a whole body vibrating sensation which is less frequent or rarely now, he also notes a electric shock across the ball or heel or toe when laying or sitting 1 -2 x per week, initially it was daily.
Around 3pm, Started with itchy ears and at nape of neck, moved to chest and groin area. First hives popped up at bra line. When I arrived at urgent care approximately at 6pm hives started showing themselves on stomach, arms, legs, and buttocks.
FEELING FAINT,NAUSEA,DIZZY,SWEATING, AND A LARGE LUMP IN MY RIGHT LYMPH NODE
Patient reported shingles DX in April 2012; consult w/ her employer's occupational health clinic on 5/14/12 & ZOSTAVAX vaccine ordered for patient; received ZOSTAVAX vaccine on 5/18/12; Developed chicken pox rash on 5/29/12. Rash appears on face, trunk, arms & legs.
Received second dose of Moderna. Developed a headache one hour after receiving vaccine (08/17/2021) and has a headache daily since then. Taking naps every afternoon (2-6 hours). Injection site is still red (~28 days later), developed lumps and bumps on injection site arm that have varied in size since 08/17/2021. Larger muscles fatigue quickly, trouble bringing in groceries. Notices SOB and palpitations upon exertion.
The client stated the day after the second dose he developed swelling, redness, and small bumps around the vaccination site. The client stated the site was painful and hot. The client denied any other symptoms of anaphylaxis. The client also reported onset of mild flu-like symptoms that lasted one day. The client's mother stated she gave him Benadryl which provided no significant relief of the rash. The client's mother stated that the client also took Advil for the flu-like symptoms which provided some relief. The client didn't follow up with his PCP.  The client denies any chronic medical conditions, current medications, or known allergies.
Fatigue, body aches occurred 1 day after receiving the injection. Symptoms lasted only for that one day. Rest and fluids were the only treatment.
patient developed a cold sore in her mouth; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect from a non-contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed a cold sore in her mouth that she knows she gets them from time to time either once or twice a year. The cold sore developed 6 days after receiving the Covid vaccine on 23Dec2020. She asked if she can take Acyclovir while having received the Covid vaccine. She found answer after speaking to pharmacist. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Local erythema, induration, pain @ inject site; Onset same day of inject, still present 7 days later;
Irritable, high fever (104) and listless 4 days post vax. Lasted 24+ hrs. Other evaluation for infectious etiology was negative.
Miscarriage/IUFD at approximately 17 weeks pregnant.; . The mother was 10 weeks pregnant at the onset of the event; This is a spontaneous report received from a contactable consumer (patient). This is a maternal report. A 31-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0153 at the age of 31-year-old), dose 2 via an unspecified route of administration, administered in arm left on 16Apr2021 12:30 as single, dose 1 via an unspecified route of administration, administered in arm left on 25Mar2021 12:30 (batch/lot number: EP6955) as single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included sertraline, loratadine taken for an unspecified indication and prenantal. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced miscarriage/IUFD at approximately 17 weeks pregnant on any unknown date Jun2021. The mother reported she became pregnant while taking BNT162B2. The mother was 10 weeks pregnant at the onset of the event. The mother was due to deliver on 07Nov2021. The patient received treatment was dilation and evacuation for the event. The event resulted in doctor or other healthcare professional office/clinic visit. The fetal outcome was intrauterine death. The outcome of the event miscarriage/IUFD at approximately 17 weeks pregnant was resolving. The outcome for the other event was unknown.  Follow-up attempts are completed. No further information was expected.
At 7:30 p.m., I began shivering and had nausea.  At 9:30 p.m., I began having aches all over my body and had a fever of 100.8.  The fever persisted all night long.  In the morning, all of the symptoms had subsided, but at 11:30 a.m. on the 28th, the nausea returned for a few hours.
Immediately following injection, swellig at injectionsite occurred. Area was approx. 1 inch in diameter and raised. No treatment given. Pt was watched for 25-30.
pain in my muscles; pain in my joints; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in my muscles) and ARTHRALGIA (pain in my joints) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-May-2022, the patient experienced MYALGIA (pain in my muscles) and ARTHRALGIA (pain in my joints). At the time of the report, MYALGIA (pain in my muscles) and ARTHRALGIA (pain in my joints) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
DTAP may have inadvertently been administered intravenously. Needle inserted, drew back, no blood, injected part of dose, went in too easily, drew back again, flash, aborted administration.
Patient came back from cardiology appointment (at 2pm) unresponsive. It was reported that she had vomited while at the appointment. She was confused when she could be aroused, stating that she does not have a name.
i HAD RADIATION ON MY SKIN IT WAS HEALING AND AFTER I TOOK THE SHOT IT BECAME INFLAMED. tHE DOCTOR TOLD ME TO TURN IT IN
?Covid arm.? Redness and swelling began at injection site.  Some itching. The rash is still present., swelling has gone done and rash is fading but definitely still there.
Mom called 03/08/2006 reporting that child went to private doctor because left leg vaccine site was red and swollen.  Was told by doctor to just keep an eye on the size.  No treatment given.
fatigue; achiness; headache; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On an unknown date, 3 hrs after receiving Shingrix, the patient experienced fatigue (Verbatim: fatigue), pain (Verbatim: achiness), headache (Verbatim: headache) and fever (Verbatim: fever). The outcome of the fatigue, pain, headache and fever were resolved (duration 2 days).   It was unknown if the reporter considered the fatigue, pain, headache and fever to be related to Shingrix.     It was unknown if the company considered the fatigue, pain, headache and fever to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR061467   Additional Information: GSK receipt date:25-APR-2023 The reporter reported that he received the first Shingrix vaccine and about three hours after he received the first Shingrix vaccine, he experienced fatigue, achiness, headache and fever.  His symptoms resolved two days later. The reporter does not give permission to contact HCP. For tolerance to the 2nd dose refer case US2023AMR061467.; Sender's Comments:  US-GSK-US2023AMR061467:Same reporter
24 hours after administration of DTap, IPV and MMR patient developed maculo-papular rash over entire body. Positive itching. Sore throat. Fever (Tmax 103.9). Given Benadryl and Tylenol as recommended by pharmacist.
17x14 cm area of erythema and induration that is warm to touch and itchy.
Dizziness Numbness in legs and feet Vomit  diarrhea  Extreme chest pain Warm legs to touch  Cannot drive anymore
Low grade fever of 100 degrees; Injection site very painful, red and swollen; Site is now 4 days past injection and site is still very swollen and red.
Patient was admitted to the hospital on 03/27/2021. He was symptomatic and died at the hospital on 04/06/2021.
Second day afyer vaccination flu like body aches.  Third day fine.  Fourth day awoke with extreme dizziness body aches, confined to bed all day. Fifth day dizziness and some body aches  have improved able to stay up.
On 3/29/2023, Two and a half hours of what presented as ocular migraine/visual prisms in both eyes. Vision reduction in both eyes but most of right eye vision was gone.  Dizziness, numb but not tingling in whole face,  Weakness in left arm and left leg, both legs heavy to walk. I couldn?t reach and grab a pill that was handed to me.  On 3/30/2023, the ocular vision issue reoccurred and last for an hour .. so far.  No heart rate changes, no breathing issues, no swollen airway, etc.
45 minutes to an hour after administration, while riding home in the car, the patient complained of a headache, became weak, and by history, lost consciousness. He recovered some what when he arrived home; remained weak, required assistance in walking, went to bed, slept for several hours. Normal upon awakening and has had no further problems.
Itching, rash=legs, stomach, arms, swelling calfs, redness. Pain. I had no temperature. I used over the counter "NATUREPLEX" hydrocortisone 1% lotion for itch, helped, but as of 05/18/2015 still itching calfs of legs. Feel bad, unable to function normal.
16AUG96 pt exp itching on outer aspect of lt arm @ site of MMR vax;17AUG96 itching cont devel a swollen, red area which measured 3inches by 3 inches & included inj site about 1/2' below the margin;no self;cellulitis;mottled w/red & yellow
Rheumatoid arthritis; Got very sick; Arthritis got worse; her body was starting to swell; she was not being able to walk; She has pain every day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "arthritis" (ongoing), notes: She has had arthritis for a long time. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis"; ILLNESS (non-serious), outcome "unknown", described as "Got very sick"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis got worse"; SWELLING (non-serious), outcome "unknown", described as "her body was starting to swell"; GAIT INABILITY (non-serious), outcome "unknown", described as "she was not being able to walk"; PAIN (non-serious), outcome "unknown", described as "She has pain every day". She didn't know if this is a side effect from 2nd shot or not. She felt like it may have been a side effect. She had pain every day, swelling every day, can't walk, and it was hard.   The lot number for bnt162b2 was not provided and will be requested during follow up.