chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I did have some headaches probably within that first week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 10:30 (Lot number: ER6199) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 09Apr2021 11:45, outcome "recovering", described as "I did have some headaches probably within that first week". Therapeutic measures were not taken as a result of headache.  Additional information: With the first dose I didn't receive the nausea side effect although I did have some headaches probably within that first week  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392242 same reporter/patient, different vaccine dose with partial same AE
Injection site was upper left bicep. Started with slight discomfort in left inner forearm as if bruised. Later, gradually became worse as a muscular ache that spread out in a larger area.  Eventually pain subsided by the afternoon of 02/23/2013 when small burst of body aches set in for about 2-3 hours and then stopped.
Found to be COVID-19 positive during hospital admission (patient fully vaccinated)   Admission Date: 8/23/2021          Discharge Date:  08/27/2021          Hospitalization - 8.23.21 - Active Hospital Problems   Diagnosis Date Noted POA ? Primary osteoarthritis of right knee 08/23/2021 No  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Primary osteoarthritis of right knee [M17.11]   HOSPITAL COURSE: Was admitted to the Hospital 08/23/2021.  She underwent a right total knee arthroplasty.  After short stay in PACU and she was transferred to the floor.  She is placed on appropriate antibiotics was DVT prophylaxis.  PT and OT rest evaluate see patient postop day 1. To begin weight-bearing as tolerated.  Patient postoperatively was very lethargic and had low blood pressure possibly secondary to her psychotropic drugs.  She did continue to improve and was finally discharged home on 08/27/2021.  She will continue weight-bearing as tolerated lower extremity.  She will follow up in the office in 2 weeks for re-x-ray and re-evaluation lower extremity.  She was called in or prescription for pain medication.  She will change her aspirin to 2 times a day of an 81 mg.  She will re-initiate her home medication as prior to surgery.  Visiting therapy and nurse have been set up to follow up outpatient.  It is of note that patient did have a positive COVID test with a subsequent negative follow-up test performed.  Prognosis for patient is guarded.
This spontaneous report was received from a medical assistant and refers to a 5 weeks old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 04-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M044397 with an expiration date in 20-JUN-2018), orally, for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown), that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001572: US-009507513-1712USA003377.
This is a spontaneous report received from contactable consumer or other non-HCP. A 15-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had oropharyngeal pain/sore throat and headache, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
I could not lift my arm the following day. Severe deep burning pain around armpit accompanied by some tingling in my hand as well as moderate to severe weakness of my arm (Left). Also pain at upper shoulder site where injection was given. Pain has subsided some but continues. I most ROM back but not all. Starting PT on August 3, 2015. Pain sometimes unbearable at night. and wakes me out of my sleep. Requires narcotic pain meds as OTC were not effective.
SLEEPINESS; STOMACH HURTS; This spontaneous report received from a parent concerned a 29 year old male. 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 admin not reported, batch number: 710127, and expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced sleepiness. On 26-JUN-2021, the subject experienced stomach hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleepiness, and stomach hurts. This report was non-serious.
Information has been received from a mother and a certified medical assistant concerning the development of a rash by a twin sister following vaccination. A 18 year old female who on 16-JUL-2008 was vaccinated with GARDASIL. Concomitant therapy included TRI-SPRINTEC Birth Control and CLARITINE. On approximately 06-AUG-2008, 3 to 4 weeks after vaccination, the patient experienced a rash. Patient's rash is currently resolved. Her rash was described as similar to her twin sister's (WAES 0809USA01996) Additional information has been requested. This is one of several reports received from the same source.
contracted Covid19 illness about 2 weeks after receiving his first dose of the Pfizer-Biontech Covid19 vaccine; contracted Covid19 illness about 2 weeks after receiving his first dose of the Pfizer-Biontech Covid19 vaccine; felt sick; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program . A 30-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient contracted Covid19 illness about 2 weeks (as reported) after receiving his first dose of the Pfizer-Biontech Covid19 vaccine.  He has since recovered, reporting that he feels "much better now" and wanted to know if he can still get his second dose on 14Apr2021 or he needs to wait 2 months. It was reported that, 2nd dose of the vaccine- dx with covid 2 weeks after the first dose, feeling much better now. He wanted to know he can get the second dose on 14Apr2021 as scheduled. Also, the second shot is considered just as effective, or he would need additional doses. He wanted to know if the second dose will still be effective or if he needs to re-start the series. The patient got his first dose of the vaccine last on 23Mar2021. He tested positive for Covid-19 two days (as reported) after the first dose. He mentioned that he felt sick but better now. He was due to have his second dose on 14Apr2021. He called in to ask if he should wait for 3 months before getting the second dose or can he take it on the 14th. Outcome of the event drug ineffective was unknown and other events was recovered.  Information about lot/batch number has been requested.
Information has been received from a registered nurse (R.N.) concerning a 9 year old male who on 14-FEB-2000 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (lot #631773/1033J).  On 16-AUG-2008 the patient developed a 50-500 lesions vesicular rash in the groin, chest and limbs.  Medical attention was sought via a telephone call.  No laboratory or diagnostics tests were performed.  At the time of this report, the patient recovered.  Follow up information was received from the R.N. who reported that the child was vaccinated subcutaneously with a first dose of VARIVAX (Merck) in his right arm on 14-FEB-2000.  The child's mother called and reported that the child's rash had not resolved, so the child went to see a dermatologist.  He was diagnosed with an "autoimmnune" type rash and not a case of varicella.  Additional information has been requested.
Information has been received from a nurse concerning a 17 year old female who 30-MAY-2007 was vaccinated with a dose of Gardasil. The patient was concomitantly vaccinated with a dose of Menactra. The patient reported to the nurse that the Gardasil injection was more painful than Menactra. Subsequently, the patient passed out in the waiting room after Gardasil. The patient sought unspecified medical attention. The patient recovered from the event on 30-MAY-2007. No further information is available.
No really bad side effects, however, my period started a week earlier than it was supposed to and then lasted twice as long. I wasn't sure if I should report it, and called my doctor first. I was told that any and all potential side effects should be reported.
Patient reported to pharmacy 3 days after receiving the flu shot complaining of pain and inability to move arm. Patient had not yet tried any kind of treatment.
This was a booster after Johnson and Johnson in April 2021.  I had arm soreness dizziness and weakness  earlier in the day on 10/23/21 And then swollen painful lymph node in  arm pit around 2 am on the 24th
Person passed out, was unable to hear, breathing was shallow, blood pressure 50/20, Pulse 44, oximeter 100%.  Epi pen was administered
This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. On 13-AUG-2012, the patient was vaccinated with dose 1 GARDASIL (lot#, expiration date and route not reported). On 26-OCT-2012, the patient was vaccinated with dose 2 GARDASIL (lot#, expiration date and route not reported). On 18-JAN-2013 the patient was vaccinated dose 3, with GARDASIL (lot#, expiration date and route not reported). Third dose of GARDASIL was too close in time to the first dose of GARDASIL per the reporter. Additional information has been requested.
Fever of 102, gave baby Tylenol (1 time at night, 1 time in morning), fever continued around 100 degrees until the following afternoon, baby was lethargic at times.  Fever broke that afternoon, baby had some sleep disruption that night.  The following evening baby had a sudden drop in temperature to 96.8, began crying inconsolably and broke into cold sweats.  Mother held her against her bare skin and covered baby with several dry blankets.  Baby passed out (fell asleep from exhaustion) while crying at 10pm.  Mother held and warmed baby all night. Cold sweats continued as baby slept.   In the morning baby's temperature was 98.1 and seemed better.
Patient began experiencing adverse effects October 2 (8 days after the immunization). He reported uncontrollable trembling, chills, cough, nausea, back pain, headaches.  On October 7th he came to the pharmacy with a raised circular rash solely at the injection site. His other symptoms have become less prevalent. He is still coughing and still has body aches in addition to the rash. Patient was referred to the local urgent care to undergo evaluation for his symptoms and rash.
Flu-like symptoms (headache, muscle aches, nausea, lethargy)
Vaccine Injury has caused serious problems / flipped my life upside down; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine Injury has caused serious problems / flipped my life upside down) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine Injury has caused serious problems / flipped my life upside down). At the time of the report, VACCINATION COMPLICATION (Vaccine Injury has caused serious problems / flipped my life upside down) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided. No treatment medications are provided.
COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: 7 drinks/week; "Hypertension" (unspecified if ongoing); "HLD" (unspecified if ongoing); "Graves disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer, ), for COVID-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 82 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; Alanine aminotransferase: 904 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: negative; Antinuclear antibody: positive; Aspartate aminotransferase: Return to baseline; Aspartate aminotransferase: 828 IU/l; Biopsy liver: Mixed lymphoplasmacellular infiltrates with mild, notes: to moderate interface hepatitis, focal bridging necrosis and focal multicinar necrosis. Consistent with AIH superimposed by DILI or DILI initiated AIH; Blood alkaline phosphatase: 85 IU/l; Blood bilirubin: 0.8 mg/dl; Blood immunoglobulin G: 2127; Blood immunoglobulin M: 66; Body mass index: 28.9; Imaging procedure: US normal; ASMA: positive; Liver function test: Incidental elevation; Serum ferritin: 604 ng/ml; Transient elastography: 3.5, notes: Unit: kPa; CAP 152, notes: kPa 3.5; Ultrasound liver: Normal.; Sender's Comments: Based on the available information in the case, an association between the reported events LIVER INJURY and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300089305 Same article/ drug/event and different patient;
8 hrs /p DPT/OPV given;infant developed 100 (AX) fever;swollen leg;screaming X 1 hr;had projectile vomiting episodes X 4. Mom call MD.No treatment given.
3 cm induration with erythema and pyrexia, and edema of the rest of the upper arm. The swelling has started to resolve (8 hrs. later) No signs of anaphalaxis.
after ~30 minutes became dizzy and hot and had rash on chest extending up neck to lower face. 25mg Benadryl and 4mg of dexamethasone administered. at 10:35 symptoms progression stopped. at approximately 10:45 (15 minutes after reaction, symptoms were resolving)
I tested positive for COVID-19 on 1/5/23. I had a lot of pressure in my head, itchy eyes, runny nose, body aches, fatigue, and cough. I contacted my doctor and was prescribed 5 days' worth of Paxlovid. I felt better after taking Paxlovid right away. I tested myself on days 5 and tested negative.
Patient stated she has a rash the day after receiving flu vaccination.  She stated the rash is on the arms, back, and from the waist up.
Tested Positive for Covid 19 on 19May2022 after receiving 4 Doses of the Pfizer Covid 19 Vaccine; Tested Positive for Covid 19 on 19May2022 after receiving 4 Doses of the Pfizer Covid 19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6203), on 03Sep2021 as dose 2, single (Lot number: EW0173), on 01Feb2022 as dose 3 (booster), single (Lot number: FJ6369) and on 18Mar2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Immune Compromised Multiple Sclerosis" (ongoing), notes: Comments: Immune Compromised Multiple Sclerosis. Concomitant medication(s) included: OCREVUS taken for multiple sclerosis.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "not recovered" and all described as "Tested Positive for Covid 19 on 19May2022 after receiving 4 Doses of the Pfizer Covid 19 Vaccine". The event "tested positive for covid 19 on 19may2022 after receiving 4 doses of the pfizer covid 19 vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive, notes: she initially tested positive for Covid 19 on 19May2022; (24May2022) Negative, notes: Unit: Not Provided; (28May2022) Positive, notes: Unit: Not Provided; (01Jun2022) Positive, notes: on day 14, she is still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Vitamin D and Evosheld.  Clinical course: Reporter on the line to report an Adverse Event with Paxlovid for rebound effect and stated that she tested Positive for Covid on day 1 and she started Paxlovid that same day. Reporter stated on Day 6, she tested negative for Covid and then on day 10, she tested positive again and on day 14, she was still testing positive. Confirmed reporter details and above information with the caller. Reporter stated she initially tested positive for Covid 19 on 19May2022 and she started Paxlovid that day. Reporter stated she tested negative for Covid on 24May2022. Reporter stated on 28May2022, she started feeling sick again and tested positive for Covid and she was still testing positive. Reporter stated that when she very first tested positive was lighter and now it was a lot darker and she feels worse.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant refers to a 37 years old female patient. The patient was vaccinated with dose the first dose of 0 .5 ml live (Merck) VARIVAX on 21-SEP-2012. The patient was vaccinated with dose the second dose of 0 .5 ml live (Merck) VARIVAX on 21-OCT-2012. The patient was vaccinated with dose the third dose of 0 .5 ml live (Merck) VARIVAX (Lot reported as H0114272, Exp. date:25-JUL-2014) on 14-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 19-JAN-2013 the patient had negative varicella antibody titers. No treatment information was reported. The outcome of the event was unknown. The relatedness for the event was unknown for live (Merck) VARIVAX. Additional information is not expected.
Mild symptoms such as muscle soreness; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician (patient himself) reported that a 31-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# EJ1685), via intramuscular on 17Dec2020 20:00 in right arm at single dose for routine vaccination. There were no medical history and concomitant medications. Vaccination facility type was hospital, not a military facility. No additional vaccines were administered on same date of the Pfizer suspect.  Prior Vaccinations (within 4 weeks) was none. Event following prior vaccinations was none. Relevant test was not tested. Patient was calling about COVID vaccine. He got the vaccine last Thursday and experienced mild symptoms such as muscle soreness around 6 am on Friday, 18Dec2020. On Sunday, his family became symptomatic and got tested for COVID and tested positive. He wanted to know if the COVID vaccine could produce false positive and if he can get the second dose. Caller did provide medical information's number and patient would need to be transferred over. There was no prescriber. It was given as routine from the hospital that he worked at. ER (emergency room) or physician's office required was none. Outcome of event was recovering.
Case number PHEH2014US003773, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 16 year old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with one dose of FLUCELVAX 2013/2014 (batch number: unknown) at a dose of 0.5 ml intramuscularly on 01 DEC 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug use in unapproved population".
It has bruiser; Soreness; Bump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (It has bruiser), PAIN (Soreness) and VACCINATION SITE PAPULE (Bump at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007M20A) for COVID-19 vaccination.     Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (Soreness) and VACCINATION SITE PAPULE (Bump at injection site). On 03-Mar-2021, the patient experienced VACCINATION SITE BRUISING (It has bruiser). At the time of the report, VACCINATION SITE BRUISING (It has bruiser) had not resolved and PAIN (Soreness) and VACCINATION SITE PAPULE (Bump at injection site) had resolved.            No treatment information was provided.
Moderate back pain for a few days, culminating in severe immobilizing back pain requiring treatment with hydrocodone.
This child received a second Tdap-a little over 1 month after her first one on 8-30-07 as there was no record of it on her immunization record and parent did not inform PHN that she had had one earlier when PHN was reviewing VIS form for Tdap and explaining about the vaccine. Per Tel. call on 10-10-07 she continues to have a sore arm (started in 1st 24 hours) and a silver dollar sized area of redness around injection site. No fever, warmth, swelling. No missed school.