chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore at injection site; mild achiness; fatigue; dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 48-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 18:15 (Lot number: FH8030) at the age of 48 years as dose 3 (booster dose), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product Covid 19, prev dose brand Pfizer, prev dose brand unknown False, prev dose lot number unknown EN6203, prev dose lot unknown reason False, prev dose administration date 01Mar2021, prev dose number 2, prev dose vaccine location Right arm), administration date: 01Mar2021, when the patient was 47 years old, for Covid-19 immunization; Bnt162b2 (Prev dose product Covid 19, prev dose brand Pfizer, prev dose brand unknown False, prev dose lot number unknown EN9581, prev dose lot unknown reason False, prev dose administration date 08Feb2021, prev dose number 1, prev dose vaccine location Right arm), administration date: 08Feb2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 18:15, outcome "unknown", described as "dose number=3"; VACCINATION SITE PAIN (non-serious) with onset 23Nov2021 13:00, outcome "recovered", described as "Sore at injection site"; PAIN (non-serious) with onset 23Nov2021 13:00, outcome "recovered", described as "mild achiness"; FATIGUE (non-serious) with onset 23Nov2021 13:00, outcome "recovered", described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, pain, fatigue.  Additional information: Patient didn't received other vaccines with 4 weeks prior to vaccination. Patient didn't had covid-19 prior to vaccination. Patient was not tested with Covid-19 to post vaccination.  Follow-up attempts are completed. No further information is expected.
Large reddened area expanding/covering most of left arm. Measured 90mm wide and 170mm long on upper outer left arm on 1/4/21. Outer edges were darker then inner area. Entire area had a purple hue. On Day 2(1/5/21) the size of the area had gone down, though the outer edges had gotten darker and the inside of the rash appeared as though it may bruise. By Day 3(1/6/21), the rash had disappeared completely.
Pt started with some scratchiness to her throat then she was administered Zyrtec 10mg PO. She proceeded to state she was starting to feel some swelling. Pt was administered 50mg IM benadryl and 1 epi-pen. Pt was transported to hospital after symptoms continued to persist with nausea vomiting and lightheadness with syncopal episodes.
29JAN94 mild fever; 30JAN94 moderate fever, cranky; 31JAN93 skin red w/small dots over body up trunk; t103.2; APAP for fever;
the injection site was raised after injection; Initial information was received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2023SA315554(CLUSTER) and 2023SA315006(CLUSTER).  This case involves an unknown age and gender patient who experienced the injection site was raised after receiving influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (Injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on the batch number will not be available.  On an unknown date the patient had the injection site was raised after injection (vaccination site swelling) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
COVID 19 Treatment; COVID 19 Treatment; dose 1-3 Pfizer / BioNTech, dose 4-5 Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 27Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16May2022 as dose 4 (booster), single (Lot number: 057M21A), in left arm and on 18Nov2022 as dose 5 (booster), single (Lot number: olot122A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "prediabetic" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "allergies with penicillin" (unspecified if ongoing); "allergies with sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16May2022, outcome "unknown", described as "dose 1-3 Pfizer / BioNTech, dose 4-5 Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sometime following the vax, the pt developed a lump at the injection site. It was reported that the pt recovered from this experience.
Patient was not due for 3rd dose yet. Previous doses were 4/23/2021 and 5/21/2021
within 24-36 hours after giving IPV and PNC patient became irritable (crying for almost 3 hours), felt hot, vomited, had loose stools, and right thigh area where vaccine given was swollen and questionably tender.  Mom called us on 4/21/05 about above and child brought in immediately for exam. At the 4/19/05 checkup patient did have an upper respiratory infection and Left som and just finished high dose amoxil.  At 4/21/05 visit patient still had an upper respiratory infection and early right acute otitis media and was afebrile, the right thigh was mildly to moderately erythmatous at shot sites, was nontender, patient was treated with omnicef.
I started getting on sick the day before, but I thought it was just an upper respiratory thing - had a lot of coughing. I thought it might turn into Bronchial asthma because it was coughing and drainage. I went to   Urgent Care on Monday, and she tested me for COVID-19. She gave me medication - an antibiotic to stop the thing in the lungs. I started having body aches and just tired, tired, tired - very tired. My sister said that I could get monoclonal antibodies infusion. So, I did that on Wednesday of that week (four days after). And I started getting better. By the end of the two weeks of being home, I was ready to go back to work. I did have a negative test to go back to work.
Got tingling in finger, back and neck. Neuropathy in the toes got worse. Pain in her back. Her Dr doesn't think the vaccine caused this but is still running blood tests.
This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of VARIVAX (dosage, frequency and route of administration were not reported), lot#: N025933 (expiration date: 19-SEP-2019), lot#: N020686 (expiration date: 27-JUL-2019,) lot # N014630 (expiration date: 11-AUG-2019 "also reported on 11-MAY-2019", for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported.
Very sudden feeling of dizziness, nausea, and weakness all at once, followed quickly by a numb feeling in both legs (barely able to stand) and feeling faint (seeing white spots and close to blacking out).  Profuse sweating and clammy skin accompanied this.  As these specific symptoms slowly subsided after about 15 minutes, a severe headache and extreme exhaustion set in.  After about 6-7 hours, I finally felt normal again.
No additional AE.; Patient was administered M-M-R II by intramuscular route; This spontaneous report was received from a pharmacist and refers to a 70 years old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-APR-2021 at "noon", the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), by intramuscular route for prophylaxis (dose, lot# and expiration date were not reported). No additional adverse event was reported. No product quality complaint (PQC) was involved.
Pt recvd MMR/DT/Matoux test & on 29JUL91 pt fainted; pt returned to nl p/a few minutes; @ the time of the report, pt had recovered;
There were no adverse events noted. Client was given an MMR vaccine by accident when she should have received a Varicella vaccine instead. Client came back and got the correct vaccine.
case of an immunization resulting in a large local reaction after vaccination; pain, swelling, and erythema at the injection site; pain, swelling, and erythema at the injection site; pain, swelling, and erythema at the injection site; Physical examination revealed tenderness to palpation, erythema, and edema extending from the right deltoid to mid-humerus; Physical examination revealed tenderness to palpation, erythema, and edema extending from the right deltoid to mid-humerus; extensive edema of the brachialis muscle and subcutaneous tissue causing complete stenosis of the basilic vein with less pronounced edema involving the surrounding muscles;   Information has been received from the authors in a published literature article entitled as stated above.  This case concerns to a 26-year-old female with a history of refractory idiopathic thrombocytopenic purpura status post splenectomy presented to an immunization clinic for Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) immunization nine weeks after receiving the 13-valent pneumococcal vaccine (PCV13). Three hours after immunization in her right deltoid, the patient experienced pain, swelling, and erythema at the injection site. Her symptoms increased in severity leading her to seek care in the emergency department. Physical examination revealed tenderness to palpation, erythema, and edema extending from the right deltoid to mid-humerus. Laboratory evaluation showed a leukocyte count of 17.8 X10^9/L, hemoglobin of 11.7 g/dL, and a latelet count of 92 X10^9/L, C-reactive protein was 0.50 mg/dL, and erythrocyte sedimentation rate was within normal limits. Contrasted axial CT imaging of the right humerus demonstrated extensive edema of the brachialis muscle and subcutaneous tissue, causing complete stenosis of the basilic vein with less pronounced edema involving the surrounding muscles. These adverse events led to hospitalization of the patient on an unspecified date. Orthopedic surgery was consulted for a diagnosis of possible necrotizing fasciitis. The patient was treated with multiple intravenous antibiotics and underwent fasciotomy with excisional biopsies of the deltoid fascia and muscle. Findings included healthy-appearing tissue without evidence of necrotizing fasciitis. Negative gram-stain preceded deep wound cultures that failed to isolate any organisms. The patient fully recovered with resolution of edema two days after surgery.  The authors presented a case of an immunization resulting in a large local reaction that concerned multiple providers for necrotizing fasciitis, but ultimately revealing healthy subcutaneous tissue, so the clinicians should remember that localized infection following immunization could be rare, while large local reactions could be common, so as to avoid unnecessary medical treatments surgical interventions.  A copy of the published article is attached as further documentation of the patient's experience.
Patient has not yet received the second dose in the Moderna vaccine series (> 42 days); Patient administered expired Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (Patient has not yet received the second dose in the Moderna vaccine series (> 42 days)) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not yet received the second dose in the Moderna vaccine series (> 42 days)). On 24-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not yet received the second dose in the Moderna vaccine series (> 42 days)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were unknown.  No treatment details were reported.
Myalgia, Fever, Chills Narrative: Took OTC ibuprofen
tested positive for Covid-19 after receiving 1st dose; COVID-19 PCR test: positive on 31Dec2020, Covid-19 rapid test: positive on 31Dec2020; smell was gone/no sense of smell; no sense of taste; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) via unspecified route of administration in the left arm on 26Dec2020 at single dose for Covid-19 immunization. Medical history included cholesterol, blood pressure (controlled blood pressure), hypothyroidism. Concomitant medications included TELMISARTAN (MICARDIS) for blood pressure and ATORVASTATIN (LIPITOR) for cholesterol; both on unspecified date. The patient was asking if she was able to get the 2nd dose of vaccine, since she was tested positive for Covid-19 (31Dec2020) after receiving 1st dose. The patient was asking information about missing 2nd dose and when can she get it and wanted to know if it was still okay to get the second dose. The patient asked if she needed to have a test negative for covid-19 prior to receiving 2nd dose. The patient experienced no sense of taste and actually realized it on 29Dec2020 that her food was not tasting good. The patient didn't notice her smell was gone until she was cooking the chicken curry, she even tested it out by spraying some perfume, she has no sense of smell on 30Dec2020. The patient informed that both her taste and smell returned 02Jan2021 but was not recovered completely. The patient underwent lab tests and procedures which included A1C: 6.4 on 12Dec2020, COVID-19 PCR test: positive on 31Dec2020, Covid-19 rapid test: positive on 31Dec2020. The patient informed that she had no positive test before the Covid-19 vaccine, she took Covid-19 antibody test in Apr2020 and it was negative. The outcome of the events tested positive for Covid-19 after receiving 1st dose was unknown, no sense of taste and smell was gone/no sense of smell was recovered with sequel on 02Jan2021.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID represents the pre-existing infection prior to vaccine use.
Diagnosed with Guillain Barre Syndrome at Hospital on November 2, 2009.  Immunoglobulin IV started Nov. 3, 2009.  Developed paralysis throughout his body and placed on ventilator.  Transfered to Continuing Care Hospital and on February 2, 2010 unable to wean him from the ventilator, to Respiratory Care Center.  Transfered back to hospital and then to Nursing Home.  March 9, 2010 admitted to hospital for infection.
heterozygous for Factor V Leiden; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), 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: "DVT" (unspecified if ongoing), notes: DVT. The patient's concomitant medications were not reported.  The following information was reported: FACTOR V LEIDEN MUTATION (non-serious), outcome "unknown", described as "heterozygous for Factor V Leiden".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Female received yellow fever, Hep B (peds) and HPV approx 09:45. Monitored x 30 minutes before leaving immunization clinic. Approx 12:20-12:22 member back in clinic c/o lips swelling; audible wheezes when attempting to breathe; hives noted on face and neck area. At 12:22 Epi 0.3mg given x1 at 12:45 BENADRYL 50mg IM given vitals at 12:22 137/83; P-78 - R-20 Temp 97.6. Transferred to cardiac room for continuous monitoring by Dr.
Diarrhea; Expired vaccine given; This spontaneous, initially received from other health professional on 12-Oct-2018, concern a 39-year-old, adult, female patient.   On 10-Oct-2018, the patient was administered expired Afluria Quadrivalent (Influenza Vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 01344611A (reported as 0134461A) and expiry date: 30-Jun-2018) for influenza prophylaxis (explicitly coded as expired vaccine used).    On 12-Oct-2018, 2 days after vaccination, the patient experienced diarrhoea. The patient did not receive any treatment medications.  The reporter confirmed that the event of diarrhea lasted only for few days.   The reporter assessed this case as non-serious.  The reporter confirmed that the event of diarrhea was not related to the vaccine because it was prevalant around the office (reported as evet had been going around the office).   This case: 201804450 was crosslinked to the case: 201804449 due to same reporter.  Follow-up received from the reporter on 29-Oct-2018: The onset date of the event diarrhea was updated from Oct-2018 to 12-Oct-2018. The outcome of the event diarrhea was updated from not reported to recovered. The stop date was updated as Oct-2018. The reporter causality of the event diarrhea was updated from 'not reported' to 'not related'. The narrative and case comment were amended accordingly.; Reporter's Comments: A 39-year-old female patient experienced diarrhoea, 2 days after receiving expired Afluria Quadrivalent (explicitly coded as expired vaccine used). The company assessed the causality of the event expired vaccine used as not related to the suspect vaccine, considering the accidental nature of the event. The company assessed the causality of the event diarrhoea as not related to the suspect vaccine as the event was prevalant around the office during the specified period.
Rise in blood sugar levels; rise in hemoglobin A1c; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Rise in blood sugar levels) and GLYCOSYLATED HAEMOGLOBIN INCREASED (rise in hemoglobin A1c) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Rise in blood sugar levels) and GLYCOSYLATED HAEMOGLOBIN INCREASED (rise in hemoglobin A1c). At the time of the report, BLOOD GLUCOSE INCREASED (Rise in blood sugar levels) and GLYCOSYLATED HAEMOGLOBIN INCREASED (rise in hemoglobin A1c) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information is provided by the reporter. No treatment information provided. Spouse had a readjustment in insulin pump settings was described by the caller. According to reporter's endocrinologist same symptoms than reporter's spouse were experienced by 30 other diabetic patients after receiving Moderna vaccine.
Burning, crushing feeling in chest. 911 was called. I was rushed to the E.R.  It was ruled a Heart Attack. I was given a Heart Cath procedure. Hospitalized for 3 days.
DTP given 445PM, t103.8 abd pain & refusal to walk @ 8PM; Up all night; 21MAY t101 @ 8AM; generalized body stiffness; sleeping @ present, seems weak;
red, warm, and painful  to the touch on site where the vaccine was given.  Treatment given Amoxil 500mg 3 times a day, for 7d.
Mom and daughter came by the clinic complaining of moderate amount of rashes on pt; both arms only. Checked on other parts of body; none. Noted red rashes with moderate amount and mom states with slight temp. 99F to 100F. Child was active. No other problems noted.
1)Pain, swelling, and redness at the injection site. Starting within 24 post-injection. 2)Left-arm muscle pain and limited mobility (opposite arm of the injection site). Increasing in severity. Starting apx. 30 hours post-injection. 3) Mild lethargy starting apx. 36 hours post-injection.
Pleurisy, sharp chest pains leading to an ER visit where pleurisy was diagnosed
She also experience fever 100.8; had anyone experience heart rate on higher side of normal; soreness at site; fatigue; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced fever, heart rate increased, injection site pain and fatigue. On an unknown date, the outcome of the fever, heart rate increased, injection site pain and fatigue were unknown.   It was unknown if the reporter considered the fever, heart rate increased, injection site pain and fatigue to be related to Menveo.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced heart rate on higher side of normal.  The patient also had fever 100.8 degree F,soreness at injection site and fatigue. No other information was reported.
trout closing , chills , high fever, bells palsy , ringinging in right ear , very sensitive to noise, smell and taste off, dizziness, nauseousness
patient was give a Pfizer dose number 3 (booster ), but he is only 15 years old
Headache, Myalgia, Fever, Anxiety, restless legs, fatigue Narrative:
100.7 fever, headache, body aches. Then the L arm started itching and hives, redness, welts. The whole arm and shoulder are swollen and twice the size of other arm. Hives beginning to appear on other parts of my body.