chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot in the area of the injection; itchy; red; arm was a little sore for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore for 2-3 days), VACCINATION SITE WARMTH (hot in the area of the injection), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Patient  stated that she had cancer in the lymph nodes in both armpits years ago.).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (arm was a little sore for 2-3 days). On 02-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot in the area of the injection). At the time of the report, PAIN IN EXTREMITY (arm was a little sore for 2-3 days) had resolved and VACCINATION SITE WARMTH (hot in the area of the injection), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
c/o lightheadedness and light headache. Cold pack applied to nape of neck, head down, felt better and returned to work Narrative: c/o lightheadedness and mild headache. resolved and returned to work
Pt devel GBS 5 days p/receiving flu vax; additional info has been requested;
mom reports pt ran fever on 16JUL94; did not reduce w/meds; sz occurred & pt taken to ER febrile sz dx
neck and back hurt; she felt like a train wreck; husband said she felt warm; in so much pain it was hard to sleep; ached all over; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck and back hurt), FEELING ABNORMAL (she felt like a train wreck), FEELING HOT (husband said she felt warm), INSOMNIA (in so much pain it was hard to sleep) and MYALGIA (ached all over) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 immunisation.     Concomitant products included LOSARTAN and CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced NECK PAIN (neck and back hurt), FEELING ABNORMAL (she felt like a train wreck), FEELING HOT (husband said she felt warm), INSOMNIA (in so much pain it was hard to sleep) and MYALGIA (ached all over). At the time of the report, NECK PAIN (neck and back hurt), FEELING ABNORMAL (she felt like a train wreck), FEELING HOT (husband said she felt warm), INSOMNIA (in so much pain it was hard to sleep) and MYALGIA (ached all over) was resolving.            No treatment medication details were provided.
Hospitalization: ADMITTED 8/25/2022; DISCHARGED 9/1/2022. Presentation to the ED: generalized weakness and fatigue, initial encounter afebrile and hemodynamically stable, basic labs with urinalysis suggestive of UTI. COVID-19 + date: 8/25/2022. Treatment: did not initiate remdesivir or dexamethasone.  Discharge to: Skilled Nursing Facility
I went to the ER because I was having trouble breathing. They did EKG, slight abdominal. They did bloodwork, normal results. I had a follow-up with my primary care doctor. She did an Echocardiogram, normal result. I was referred to cardiologist. He adjusted my medicine a little bit. Now, I  have been diagnosed with high blood pressure. I am on 3 heart and blood pressure medicine.
nurse injected an empty syringe into her husband's arm; her husband's arm is extremely burning; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program .  A male patient received bnt162b2 (BNT162B2), administration date 06May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number:1), for Covid-19 immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset 06May2021, outcome "unknown", described as "nurse injected an empty syringe into her husband's arm"; BURNING SENSATION (non-serious) with onset 06May2021, outcome "unknown", described as "her husband's arm is extremely burning"; MALAISE (non-serious) with onset 06May2021, outcome "unknown", described as "not feeling well".  Additional information: The nurse injected an empty syringe (air) into patient's arm, the nurse apologized and then proceed with the second dose and then coming home his arm was extremely burning as the particular and not feeling well. His wife wanted to know what to do the next. Product details (LOT#, Expiration Date, NDC# and UPC#) were reported as unknown. Limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient was in 15 minute observation when nurses witnessed patient seizing.  patient was on floor, pulse and respiration was monitored.  pulse diminished ; oxygen was administrated,  CPR started    AED applied  patient shocked and transported to ER
Hospitalization: 9/13/2022 - 9/15/2022 Presentation to the ED: seizure-like activity in setting of testing positive for COVID-19 associated with generalized weakness, nausea and vomiting. COVID-19 + date: 9/13/22 Treatment: NO THERAPY GIVEN.  Discharge to: Skilled Nursing Facility (SNF) with insurance Certification in Anticipation of Skilled Care.
Administered HEP-A RAT-IM.  Upon withdrawal of syringe, noted bleeding.  Applied direct pressure until bleeding stopped which was less than one (1) minute.  Instructed mother to expect bruising at site and to apply ice for 10 min on then 10 min off for one (1) hour.  Called out to mother within 48 hours to f/u on patient.  No answer.  Left detailed message requesting a call back from parent - no response.  Parent brought patient and other children to clinic on 3/12/2008 and was seen by Nurse Practioner.  Parent stated there was bruising at the site but the patient was "ok".  Parent placed a call to the clinic on 3/20/2008 c/o "hard area" at injection site.
tongue started feeling numb about 3-5 minutes after vx the slowly started spreading to my throat and lips started to feel a little swollen nurse on site gave me the emp pen and a shot of benadryl and called the ambulance. I started feeling better right after the emp pen injection
Information has been received from a Registered Pharmacist concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# unknown). The pharmacist reported that the patient mentioned on a pharmacy medical history questionnaire that she had an unspecified allergic reaction to PNEUMOVAX 23. At the time of the report, the patient had recovered. It was unknown if the patient sought medical attention. No further information is available.
Experienced occasional nausea from Humira; Got covid vaccine and experienced body pain similar to flu; Got covid vaccine and experienced body pain similar to flu; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Got covid vaccine and experienced body pain similar to flu), MYALGIA (Got covid vaccine and experienced body pain similar to flu) and NAUSEA (Experienced occasional nausea from Humira) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF Pen. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Got covid vaccine and experienced body pain similar to flu), MYALGIA (Got covid vaccine and experienced body pain similar to flu) and NAUSEA (Experienced occasional nausea from Humira). At the time of the report, INFLUENZA LIKE ILLNESS (Got covid vaccine and experienced body pain similar to flu) and MYALGIA (Got covid vaccine and experienced body pain similar to flu) had resolved and NAUSEA (Experienced occasional nausea from Humira) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of occasional nausea from Humira with Humira(adalimumab) was a reasonable possibility. the reporter's causality for the events of got covid vaccine and experienced body pain similar to flu unknown onset with Humira(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received, event outcome and narrative description updated.
pt devel varicella @ 38month w/varivax dose 1;Annual follow-up received on 11/27/00 provides no additional data.
pt w/dec activity, t104F p/vax given- 12 hrs did start to have cold sxs; rhinitis, cough p/vax given;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2022 as dose 3 (booster), single (Lot number: FJ8757) at the age of 32 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive; (Jul2022) Negative, notes: Finished the antivirals and tested negative for COVID; (Jul2022) Negative, notes: Tested negative Tuesday to make sure; (28Jul2022) positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that took the antivirals after testing positive for COVID. Finished the antivirals and tested negative for COVID that Monday (about 2 days after finishing). Tested negative Tuesday to make sure. Thursday 28July started having a runny nose. Woke up 29th feeling terrible, tested for COVID again and tested positive. Rebound into COVID not even a week after finishing the treatment and testing negative.  No follow-up attempts are possible. No further information is expected.
Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021 at 2:08 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021 at 2:08 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021 at 2:08 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not have any adverse events and did not require any medical attention.  No Concomitant medication was reported. No Treatment information was reported.   This case was linked to MOD-2021-366266, MOD-2021-366280 (Patient Link).
I feel tiredness; headache; injection site pain; nauseas; feeling unwell; This is a spontaneous report from contactable Healthcare Professional. A non-pregnant 39-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered in Hospital via an unspecified route in left arm on 12Mar2021 08:00, at 39 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient didn't receive any other vaccine in the previous 4 weeks. The patient was not diagnosed with COVID-19 prior vaccination and didn't test positive for COVID-19 post vaccination. On 12Mar2021 08:00 the patient felt tiredness and experienced headache, injection site pain, nauseas and feeling unwell. No treatment was administered for the events. At the time of the report the outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a licensed practical nurse and refers to eight patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # L033343, expiry date 13-SEP-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of RECOMBIVAX HB underwent temperature excursion at 1.2 Celsius degrees for 54 minutes. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
After first dose on 07-MAR-2021 I felt injection site pain, redness and swelling. It was mild and lasted a few days. After the 2 nd dose on 28-MAR-2021 about 3 hours later I developed a headache.  About 12 hours after the vaccine I developed a headache, muscle aches, joint pain, fatigue and a fever of 100.1.  The headache body aches and fatigue were severe, joint pain moderate and fever low grade. I was unable to work a full day and did end up staying in bed for most of the day.
Vaccine given ID in R forearm. Leakage occurred. Vaccine re-administered 2 inches from 1st. No leakage. Dose administered successfully.
11012hr p/vax awoke in middle of noc w/difficult breathing;became panicked;sat up for 1hr-no sx;went to bed, difficult breathing lying down;sat up to sleep;awoke-no sx since;did not call MD;
This spontaneous report as received from a medical assistant refers to a 10 years old Child, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported). Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
3 inch area of redness (dark red spot in the middle surrounded by light pink area), swelling, itching, warmth to touch.
Symptom onset 7/19/2021 with cough, runny nose, muscle aches, sore throat, nasal congestion, fever, headache & fatigue.  Called nurse triage line and COVID-19 test ordered which resulted as positive.
Nausea; Mild vomiting; Diarrhea; Moderate abdominal pain; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and gluten. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), pseudoephedrine hydrochloride (SUDAFED), ethinylestradiol/ levonorgestrel (CAMRESE LO) and multi-vitamin (MANUFACTURER UKNOWN); all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in left arm on 31Mar2021 at 10:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 23:30, the patient experienced nausea, mild vomiting, diarrhea, moderate abdominal pain and sweating-no fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, mild vomiting, diarrhea, moderate abdominal pain and sweating were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
I received the COVID19 Pfizer-BioNTech first doze on 3/28/2021 (11:30AM).  On 4/5/2021 and 4/7/2021, the pregnant hcg tests were positive.  The due date is 12/12/2021.  On 4/16/2021, I did the first ultrasound and I was told the fetus was 5 days smaller than expected.  On 4/30/2021, after doing the second ultrasound, my Doctor told me that I had a miscarriage.  I will need to see my Doctor on 5/6/2021 and may need to do a surgery.
No further AEs reported; Patient received a post-expiry dose of VARIVAX; This spontaneous report was received from a Medical Assistance referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.      On 19-APR-2021, the patient was vaccinated with an one post-expire dose (expired product administered) of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot number S012040 had been verified to be a valid number; expiration date 17-APR-2021; strength, route of administration, and anatomical location were not reported). No further adverse event reported.
Sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 80 years as dose 1, single and administered in arm left, administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Food allergies", start date: 2012 (unspecified if ongoing), notes: She has minor food allergies diagnosed 10 years ago. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Feb2021, outcome "unknown", described as "Sore left arm".  Additional information: Patient has minor food allergies diagnosed 10 years ago and follows a special diet. No prior Vaccinations within 4 weeks of Covid-19 vaccination. No Relevant Family Medical History. Reporter stated that she had no problem at all with first two doses, other than little soreness in left arm. No vaccinations were taken by her since she was a kid. It is assumed by her that everyone does have arm soreness. Patient stated she had her stay for 15 minutes and arm soreness started right away on the same day. Patient had sore arms with the first two, it was no biggie and it was in the left arm. She said it kind of matters that she did everything together with husband and she had no significant things. She did have a strange event. No Relevant Tests. Patient had no Emergency Room or Physician Office visit. Patient stated she just felt Pfizer should know there are people that are experiencing side effects. It is not mentioned and it may have changed their mind about it.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Headache, Myalgia, fatigue, site pain "swollen glands" Narrative:  Headache, Muscle/ Body Aches, extreme Fatigue, Swollen glands and pain/soreness at injection site. I had to call out of work today due to these symptom, as I am unable to work with a throbbing headache and my body feeling weak.
progressive rash development/slightly below the injection site/ near her armpit/ the rash was red and itchy; progressive rash development/slightly below the injection site/ near her armpit/ the rash was red and itchy; she had 2 quarter size areas (injection site and slightly below the injection site) and a third area near her armpit which was a bit smaller than the other two; Information has been received from a nurse referring to a 66 years old female patient. The patient's current condition included breast cancer, ischemic heart disease, malignant melanoma of skin and seasonal allergies. The patient was allergic to penicillin and hydrocodone. The patient's concomitant therapies included anastrozole(ARIMIDEX) and unknown nasal medication for allergies. The patient's historical vaccine included pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13).     On 28-OCT-2019, the patient was vaccinated with her first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot#S025133, expiration date 01-SEP-2020, intramuscular in the left deltoid) for prophylaxis (reported as age related vaccines). Throughout the day of 30-OCT-2019, the patient reported progressive rash development. By the time the patient spoke with the office, she had 2 quarter size areas (injection site and slightly below the injection site) and a third area near her armpit which was a bit smaller than the other two. The rash was red and itchy. The patient denied fever, breathing problems and arthralgia. The physician prescribed use of diphenhydramine hydrochloride (BENADRYL) on 30-OCT-2019 and cold packs with a follow up if there was no resolution. No lab diagnostics or studies was performed. The outcome of all the events was reported as not recovered. The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication, medical history and drug reactions/allergies was not provided. On an unknown date the patient was concomitantly vaccinated with VARIVAX (strength, dose, route, lot # and expiration date were not reported) and PROQUAD (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (overdose). No adverse symptoms were reported. No product quality complaints (PQC) was involved.
Pt recvd 1st dose of Hep B vax 01FEB91 & later exp lightheadedness,dizziness,nausea & tachycardia.
After 8 days pt developed gout in left big toe and hands hurting. She states she does have arthritis but felt noticable worse. Went to dr. on day 8 left arm swelled to a 5x3" red hot area. Lab work showed  normal uric acid and sed rate but inflammatory markers elevated.