chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started to have fever 8 days after vaccine and then whole body , maculopapular rash 9 days after vaccine. fever has now resolved but rash still present. rash not appearing to be vesicular or with any crusts. no one else in household with similar symptoms.
6 hours after vaccine, I became weak and tired. I fell asleep. Woke up 12 hours post vaccine with fever of 102.4 (lasted about 6 hours) accompanied by aches, chills, viral rash on neck and trunk and arms. Headache noted at 4 hours post vaccine and lasted 6 days. Heavy menstrual bleeding and cramping despite being on continuous birth control pills in May. Cramping not relieved by 600-800mg ibuprofen and 1000mg Tylenol every 4-6 hours. Usually my period is completely suppressed with the birth control but now and having break through cycles lasting 10-14 days. Viral rash noted again 7/10 during the 14-day menstrual cycle.
Large inflamed wheal at site of administration measuring approximately 3-4 inches in length.  Knot under skin slightly smaller.
On November 29, 2022 I felt like I was having an asthma attack and I used my inhaler. The next day I felt like my throat was congested and I had a cough. I felt feverish and achy. Thursday, December 1, 2022, in the morning I tested positive for COVID-19. On the same day I saw the physician's assistant and received PAXLOVID. Within about 3 days I felt better.
On 5/1/03: I developed fever, severe headache non-responsive to ASA, lethargy and rash on neck and thirst. Symptoms increased, went to local hospital, had CT brain and LP - DX viral encephalitis. Rash increased 5/11 and 5/12 - symptoms resolved by 5/9/03. Temp 101 (when I took it on 5/10/03)
11/22/22 presents to ED for "fever, headache, nausea, sore throat, nasal congestion, urinary frequency". PMHx of "Crohn's disease, psoriatic arthritis"
9/4/22 I went out and had some drinks. 9/5/2022 I felt like a had a hangover. I felt fatigue and tiredness with a fever  99.2 to 99.4 fever. I took TYLENOL and the next day, I went back to work because I was feeling feeling better. Then I started having symptoms at around 130 to 2PM. Elevated temperature, fatigue and chills. I went to the urgent care at 430PM. The doctor confirmed that I was positive and no need for the antiviral. I was to rest and if you have a breathing issue to contact healthcare.
I passed out about 24 hours after the vaccine and fell on the kitchen floor. I passed out a second time about 5- 10 min later when my husband was helping me sit up.
a little numbness in pinky finger; pinky finger is colder than the rest of her fingers; day of vaccination her arm was sore/tender; knot; site of vaccination was itchy (for about half day); site of vaccination had some reddens; site of vaccination was swollen; site of vaccination was warm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (a little numbness in pinky finger), PERIPHERAL COLDNESS (pinky finger is colder than the rest of her fingers), PAIN IN EXTREMITY (day of vaccination her arm was sore/tender), VACCINATION SITE WARMTH (site of vaccination was warm) and VACCINATION SITE INDURATION (knot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VIT D3), ASCORBIC ACID (VIT C), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced VACCINATION SITE WARMTH (site of vaccination was warm), VACCINATION SITE ERYTHEMA (site of vaccination had some reddens) and VACCINATION SITE SWELLING (site of vaccination was swollen). On 08-Jul-2021, the patient experienced HYPOAESTHESIA (a little numbness in pinky finger), PERIPHERAL COLDNESS (pinky finger is colder than the rest of her fingers), PAIN IN EXTREMITY (day of vaccination her arm was sore/tender), VACCINATION SITE INDURATION (knot) and VACCINATION SITE PRURITUS (site of vaccination was itchy (for about half day)). On 09-Jul-2021, PERIPHERAL COLDNESS (pinky finger is colder than the rest of her fingers), PAIN IN EXTREMITY (day of vaccination her arm was sore/tender), VACCINATION SITE WARMTH (site of vaccination was warm), VACCINATION SITE PRURITUS (site of vaccination was itchy (for about half day)), VACCINATION SITE ERYTHEMA (site of vaccination had some reddens) and VACCINATION SITE SWELLING (site of vaccination was swollen) had resolved. At the time of the report, HYPOAESTHESIA (a little numbness in pinky finger) outcome was unknown and VACCINATION SITE INDURATION (knot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included blood pressure medication, Thyroid medication.  Treatment information was not provided.  Second dose is on 31-Jul-2021.
muscle ache at injection site and fatigued and tired at the end of the 1st day and throughout the 2nd day. 3rd day i was fine
severely impaired anti-body response to both 13-valent pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPV23); severely impaired anti-body response to both 13-valent pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPV23)/ poor response to pneumococcal vaccinations;   This literature marketed report had been received from the authors of a published article, titled as stated above, and referring to a female patient of unknown age. The patient's medical history included that she was hospitalized in the neonatal intensive care unit (NICU) for the first 4 months of life; intrauterine growth retardation (IUGR); compound heterozygous RNU4ATAC variants were identified, both specifically associated with MOPDI/III [1]: n.50G more than C and n.51G more than A; EGD and colonoscopy were performed at the age of 2 years for emesis and dyschezia; referal for immune evaluation after gastrointestinal biopsies revealed a paucity of plasma cells and lymphoid aggregates without well-formed germinal centers; infection history at that time included probable sepsis at age 3 months and 2 courses of antibiotics for upper respiratory infection; and at the age of 2.5 years demonstrated hypogammaglobulinemia, decreased numbers of CD19 + B cells and CD8 + T cells, and protective diphtheria and tetanus titers. The patient's concurrent conditions included spondyloepimetaphyseal dysplasia with extreme short stature, microcephaly, lissencephaly, agenesis of corpus callosum, arachnoid cyst, atrial septal defect, congestive heart failure, renal dysplasia, hypertension, feeding dysfunction, global developmental delay, and cortical visual impairment Immunizations were up to date, given on a catch-up schedule. Her concomitant medications were not reported.  On an unknown date, the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (reported as pneumococcal polysaccharide vaccine [PPV23]) and pneumococcal vaccine conj 13v (crm197) (reported as 13-valent pneumococcal conjugate vaccine [PCV13]), both administered for prophylaxis (doses, vaccination schemes, frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported).  On an unknown date, the patient experienced severely impaired antibody response to both 13-valent pneumococcal conjugate vaccine (PCV13) and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), therefore an immunoglobulin replacement therapy was initiated due to markedly low IgG and poor response to pneumococcal vaccinations (antibody test negative, vaccination failure). The outcome of these events was not reported.  The causal relationship between antibody test negative and vaccination failure regarding pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccination was determined as related.  This is one of two reports regarding the same article.  A copy of the published article is attached as further documentation of the patient's experience.
patient had pfizer as first dose and moderna as second dose. no symptoms, signs, or reactions noted as per staff giving vaccine as well as monitoring after vaccine.
MICRO INFARCTION/SLIGHT DROOP ON RIGHT SIDE OF LIP/RIGHT EYE CLOSING ALONE; BOTH LEG PAIN BEHIND HER KNEES; EXTREMELY TIRED; This spontaneous report received from a consumer concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, total 1 dose, administered on 06-APR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. The patient was not pregnant at the time of reporting. On 07-APR-2021, the patient was extremely tired. On 08-APR-2021, she experienced leg pain on both legs behind her knees. On 10-APR-2021, both the event both leg pain behind her knees and extremely tired. On 12-APR-2021, her right eye started to close on its own, along with a slight drop on her right side of her lips. The doctor, he recommended her to take aspirin and ordered lab work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from both leg pain behind her knees, and extremely tired on 10-APR-2021, and had not recovered from micro infarction/slight droop on right side of lip/right eye closing alone. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210427668-Covid-19 vaccine ad26.cov2.s- MICRO INFARCTION/SLIGHT DROOP ON RIGHT SIDE OF LIP/RIGHT EYE CLOSING ALONE. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Information has been received from a physician concerning a 76 year old female with no known drug allergies, osteoarthritis, osteoporosis and back pain who on 15-MAR-2007 was vaccinated with a single dose of Zostavax (Lot # 656608/0032U). On 19-MAY-2007 patient experienced chest pains and developed lesions on her left thigh and physician considered it as shingles. The patient also had post herpetic neuralgia. The patient was treated with Valtrex 1 g TID/7 days, Kenalog 40 mg IM, Darvocet-N 100 one 8-4-6 hr PRN, Neurontin up to 900 mg/d, Vicodin and Ambien PRN. At the time of report the patient was recovering. A product quality complaint was not involved. The patient's experiences were considered to be disabling. Additional information has been requested.
Patient 101 years old, nursing home resident, received vaccine 1/11, on 1/13 found on floor without obvious trauma, unresponsive.  Brought to ED and was bradycardic, hypotensive, hypothermic and refractory to aggressive medical management.  No obvious cause of death found on exam or labs, cxr.  Unknown if event could be related to vaccine or not.  Medical Examiner accepted case although initially unknown that patient had recently received vaccine. ME updated with that information today as soon as discovered.
Sx ~ 10 days post MMR vaccine: Rash possibly began on torso - spread throughout body, mostly upper body (face, arms, torso front and back) Fever, high of 102F, 4-5 days Fatigue + weakness
Rash on the body that broke out on 2/23/13. Erythematous blanching macules all over body.
Rash & pruritis @ site of inject occurring w/in 24 hrs post inject; rash intensified spread to arms & legs; Seen by MD on 14NOV91 placed on antihistamines w/improvement;
Patient received Varicella (Varifax) vaccine on 5/9/22  given. We do not have information with regards to the lot # of this vaccine.  The state registry also does not have this information. On 6/9/22, Dr. saw this patient in the clinic to assist in the treatment of varicella.  Patient was seen at clinic on 5/30/22 for vesicular rash 4 weeks status-post varicella vaccine.  Wound positive for Varicella by PCR.  Treated with Valtrex at Zoster doses (has 2 more days of pills as of 6/9/22). Patient has underlying HTN, Hashimoto's, PCOS and DM2 on metformin. No drug allergies. CXR negative.   No other immune problems.  Had impetigo as a child and an Chikungunya infection, no other infection. Rash is drying out. No fevers. Feeling better, a few pustules left on legs. No other rashes in household.  Patient was instructed to finish the antibiotic and was informed that spots  with liquid remain infectious, no one without chickenpox immunity should touch these. Patient is come back for fever, increasing skin redness or shortness of breath or cough.  Patient did go to the ED on 6/2/22 for evaluation of the skin rash.
This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in the right arm, administration date 24Feb2021 12:00 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing); "blood pressure high" (unspecified if ongoing); "possibility she had had COVID" (unspecified if ongoing), notes: she was not diagnosed. The patient's concomitant medications were not reported. Vaccination history included: flu shot (left arm hurt for months, she could still feel where the person stuck her at), administration date: 2021, for immunisation, reaction: "left arm hurt".The following information was reported: LYMPHADENOPATHY (non-serious) with onset 25Feb2021, outcome "recovering", described as "lmph node under her arm was swollen"; AXILLARY PAIN (non-serious), PAIN (non-serious) all with onset 25Feb2021, outcome "unknown" and all described as "pain up under her arm and side"; FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 25Feb2021, outcome "unknown" and all described as "tired, didn't have a lot of energy". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The events did not result to emergency room or physician office visit. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional concerning an 18 year old female who on 19-MAR-2008 was IM vaccinated in the right deltoid with Gardasil (lot number 659964/1978U). On 24-MAR-2008 the patient experienced redness, a hive like rash and swelling from shoulder to elbow. The patient phoned the physician to report the adverse reaction on 24-Mar-2008. The patient was not seen and no treatment was recommended. There were no other symptoms reported. Additional information has been requested.
Mild headache and fatigue started approx 1 day after shot. Have had mild to moderate headache and fatigue since then and continuing now.
First dose I had a long standing rash, SOB and allergic reaction needing treatment. Second dose the rash went away, and all my lymphnodes have swollen and all over my body, I have persistant fatique, brain fog, DOE, and occasional chest pain and tightness.   I have had no relief. Being referred to local Infectious Disease.
Patient experienced swelling, redness, and pain at and around the site of injection (from shoulders to elbows). Swelling has improved after 2 days with ibuprofen and diphenhydramine.
brother died behind his vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "brother died behind his vaccination". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: It was reported that, reporter's brother died behind his vaccination , she wanted to speak to a manager or with the CEO . It was mentioned that they knew that the vaccine can cause heart inflammation but they still proceeded with the vaccination. No medical questions addressed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: brother died behind his vaccination
4/14 PM, Pt c/o of arm hurting after school, 2 inch area of redness, swelling and heat at injection site.  No fever.  Advised to apply ice and use Tylenol or ibuprofen for discomfort. 4/15 6 am Pt vomiting and complaining of stomach ache.  Temp 100.7, area of redness at injection site is now 2.5 inches, arm warm and painful to the touch.  Advised appointment. 4/15, approximately 9am, appt. with Dr., arm painful, 4.5-5cm area of erythema and swelling at injection site.  Keflex 250mg bid x5 days for cellulitis.  Instructed to contact if continued fever or increase in pain. 4/15, PM  Redness has spread, fever 102.8 1 hour after 400mg ibuprofen administered.  Arm hot and painful, referred to ER. 4/16 appt with Dr. in allergy.  Rx alternating Tylenol and ibuprofen and icing the area as much as possible.  Prednisone 20mg x 3 days prescribed. Rx go to ER if symptoms/fever worsen over weekend, f/u appt. made for 4/20 with Dr.
Pt called and stated she received her vaccine on 05/18/2021, started having arm and neck pain, nausea, lightheadedness, stomach cramping, on 05/19/2021 in the afternoon. She sat up to get some saltine crackers to help her feel better, and she started to get dizzy. She then remembers trying to hold herself up, and then the next thing she recalls is laying on her back on her kitchen floor. It was then she felt dizzy again and then sat herself up enough so she could vomit 3 times. She also reported having profuse sweating and dry heaves. Her husband found her about 30 minutes later when he returned home from picking up lunch for them. She refused to go in the hospital to get checked out until she called her PCP on 05/21/2021 because she still was not feeling well. They recommended that she go into the ER. She had a CT scan, UA, troponin levels checked, and other blood work. Was treated with IV lactated ringers in the ER, and given meclizine for the dizziness. UA showed positive E. coli, indicative of a UTI. Pt chose to be discharged home instead of staying overnight because she stated she would get plenty of rest at home. Spoke with pt 05/25/2021 after she had called to let us know what happened. Pt has scheduled additional CT scan on 06/08/2021 and follow-up with a neurologist 06/10/2021.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patients pertinent medical history, drug reactions/allergies were not provided.  On 30-SEP-2014, the patient was vaccinated with an expired dose of PNEUMOVAX23, Lot # J004332, expiration date on 26-SEP-2014. No adverse effects reported. Additional information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 204B21A and expiry: Unknown) dose was not reported, dose number in series was 1, 01 total administered in left arm on 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JAN-2022, the patient had headaches, fever, head congestion and runny nose (suspected covid-19 infection) till 09-JAN-2022. Antigen rapid test was positive on 02-JAN-2022 confirming infection for Covid-19 (suspected clinical vaccination failure) and was advised to remain at home for 10 days (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 09-JAN-2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority.; Sender's Comments: V0. 20220122115-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Swelling, soreness, or redness where I got the shot. Mild fever. Fussiness or irritability. Loss of appetite. Sore muscles.
RECEIVED SHOT AROUND 1430 IN THE AFTERNOON OF 10/20/2008....STARTING INCHING AROUND 2030-2100 THAT NIGHT...WHEN I REMOVED MY CLOTHES, I NOTICE HIVES ON LEGS , ARMS & STOMACH..
Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     The patient's past medical history included Liver disorder.    On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
the tingling that she is feeling to her side of the face; lethargy; chills; pain to injection site; and a lump under injection armpit; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: not provided), via an unspecified route of administration on 02Jun2021 as a single dose for Covid-19 immunisation. Patient had previously received first dose of BNT162B2 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced side effects which included lethargy, chills, pain to injection site, a lump under injection armpit. Patient stated her concern is the tingling that she is feeling to her side of the face. Is this something that I need to worry about? It was reported that a review of the Prescribing Information for Pfizer-Biontech Vaccine did not find information regarding tingling to the side of your face. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. Because your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider is in the best position to advise you about the appropriate action to take. The outcome events was reported as unknown.  Information about lot/batch number has been requested.