chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Type 2 diabetes number went from 135 to 200 plus for 3 days return to 135 area readings; head had preciption problems; Sore arm for 1 day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 (Lot number: ER8733) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (ongoing); "Cholesterol" (unspecified if ongoing); "High Blood" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus (ongoing); SIMVASTATIN taken for blood cholesterol (ongoing); LISINOPRIL taken for hypertension (ongoing); TAMSULOSIN (ongoing). Vaccination history included: Bnt162b2 (1st dose, Anatomical site of injection: Right arm, Batch/Lot number: Pfizer EN6203), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "Sore arm for 5 days". The following information was reported: Diabetes mellitus inadequate control (medically significant) with onset 25Mar2021, outcome "unknown", described as "Type 2 diabetes number went from 135 to 200 plus for 3 days return to 135 area readings"; DIZZINESS (non-serious) with onset 25Mar2021, outcome "recovered" (2021), described as "head had preciption problems"; PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "Sore arm for 1 day". The patient underwent the following laboratory tests and procedures: investigation: (25Mar2021) 200 plus, notes: Type 2 diabetes numbers went from 135 to 200 plus for 3 days return to 135 area readings; (2021) 135 area readings, notes: Type 2 diabetes numbers went from 135 to 200 plus for 3 days return to 135 area readings. Clinical course:Patient age at vaccination: 76/77 years.Concomitant drugs: Drug name: Metformin,Reason for use: Type 2 diabetes,Route: Mouth Checkbox if ongoing: Ongoing.Concomitant drugs: Drug name: Simvastatin,Reason for use: Cholesterol,Route: Mouth,Checkbox if ongoing: Ongoing.Drug name: Lisinopril,Reason for use: High Blood,Route: Mouth,Checkbox if ongoing: Ongoing.Drug name: Tamsulosin,Reason for use: Prostate,Route: Mouth,Checkbox if ongoing: Ongoing.Patient's medical history: None.Relevant tests: None.Specific Relevant test: None.Comments/narrative: No serious complications 03Mar2021 Sore arm for 5 days.25Mar2021 1) Sore arm for 1 day.2) Type 2 diabetes numbers went from 135 to 200 plus for 3 days returned to 135 area readings.3) My head had preciption problems while driving for 1 months. Could have been medication and Diet? On18Oct2021 Had a temperature raise from 97.7 to 98.5 for 1 day and chills for 12 hours.  No follow-up attempts are possible. No further information is expected. Follow-Up (08Dec2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101725122 Same reporter/ patient, different AE/ drug dose
Swelling similar to an allergic reaction to a spider bite or bee sting, raised, red, hot, bumpy, extremely painful. Even a light shirt or sweatshirt was extremely uncomfortable. Bouts of itchiness
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 24th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 25th July 2018, the patient experienced injection site warmth, injection site swelling, injection site erythema and general body pain. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site swelling, injection site erythema and general body pain were unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site swelling, injection site erythema and general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The patient experienced injection site pain the day they received SHINGRIX. A patient's injection site became swollen, red, and hot one day after receiving SHINGRIX. The patient also developed whole body pain. The symptoms were "moderate to severe."
4 years post-menopausal, started heavy menstrual bleeding for a10 days.   Hormone responses like pms/acne/tender breasts and cramps still occurring monthly but no more menstrual bleeding.
Employee Candidate came to Employee Health and said she has swelling in right lower jaw.  States she doesn't have any pain.  Came in to Employee Health to report because the only thing different she knew of was getting the MMR on 3/29/22.
TIA; a rush of numbness came over my whole left arm. My arm; My arm was numb, heavy and weak; My arm was numb, heavy and weak; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208, expiration date not reported), via an unspecified route of administration on 17Mar2021 (at the age of 52-years-old), 8:00am at single dose in the left arm for COVID-19 immunisation. Medical history included hypothyroidism and ADHD (attention deficit hyperactivity disorder). The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) 88mg and lisdexamfetamine mesylate (VYVANSE) 40mg both taken from unknown dates and unknown indication. The patient previously took clarithromycin (MACROBID) and experienced allergies. Historical vaccine included first dose BNT162B2 (brand: Pfizer) received on 24Feb2021 6:00pm (lot number: EN6202) at the age of 52-years-old in the left arm. It was reported that on Thursday, 08Apr2021 at approximately 7:00pm, the patient was standing in her kitchen when all of a sudden, a rush of numbness came over her whole left arm. The patient's arm was numb, heavy, and weak. She knew that this feeling was not normal, so she had her husband take her to the hospital, their local hospital. They arrived at approximately 7:30pm where the patient was took in right away. At that time, the feeling had returned to the patient's arm. The patient was taken back for a CAT scan on her head after which the doctor came to tell her that they would be keeping her overnight for observation since they think she had TIA (transient ischaemic attack). The patient was monitored overnight and at 6am the next day on 09Apr2021, she had an ultrasound on her carotid artery and later in the morning, at around 10am, the patient had an echo cardiogram. The patient was released at approximately 12pm on Friday, 09Apr2021. The events experienced resulted in "Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization from 08Apr2021 to 09Apr2021". The patient has no COVID prior vaccination and had not tested for COVID post vaccination. Outcome of all the events was recovering.
Urticaria pruritus and edema, erythema, itching. Acetaminophen 2 tab once, ceftriaxone 1 gm once, methylprednisolone 80 mg once.
shakes; chills; muscle aches; no energy whatsoever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), CHILLS (chills), MYALGIA (muscle aches) and ASTHENIA (no energy whatsoever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced TREMOR (shakes), CHILLS (chills), MYALGIA (muscle aches) and ASTHENIA (no energy whatsoever). On 08-Feb-2021, TREMOR (shakes), CHILLS (chills), MYALGIA (muscle aches) and ASTHENIA (no energy whatsoever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Chills; shakes; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on left arm on 18Dec2020 at 11:45 (dose number: 1) as a single dose for COVID-19 immunization. The patient medical history included anxiety. Concomitant medication were not reported. The patient was not pregnant at the time of vaccination and the facility where the most recent COVID-19 vaccine was administered was a hospital. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took clindamycin and had allergies. On 19Dec2020 01:30, the patient experienced chills, shakes, headache and nausea for 2 hours, 13 hours after administration (as reported). The patient did not receive any treatment for the events. The events were assessed as non-serious. The reported outcome of the events was recovering.  Information on lot/batch number has been requested.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age. On an unspecified date the patients were vaccinated with MMR II which was exposed to 67F for 25 hours. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patients had sought medical attention. No adverse reaction reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source.
This spontaneous report was received from a registered nurse referring to infants patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with M-M-R II, via subcutaneous (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The registered nurse reported that it was the practice at her office to administer M-M-R II to infants in the thigh (vaccine administered at inappropriate site). The package insert stated: preferably into the outer aspect of the upper arm. No adverse effects reported.
Initial report received from a healthcare professional on 06 September 2013. A 31-year-old female patient had received an intramuscular first dose of ADACEL (lot number: C4432AB) in the right deltoid on 04 September 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 03 February 2013 and the estimated date of delivery was reported as 10 November 2013. The patient's health during pregnancy, risk factors (e.g. : alcohol, tobacco or recreational drugs), concomitant medications and treatment for infertility were not reported. Laboratory investigations were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by sender: none.
pt recv vax 28MAR95 & evening of 28MAR soreness-burning; 29MAR95 inc soreness, stiffness, redness & swelling & firmness; 30MAR95 inc redness, pain, swelling dec lightheaded, t99.8, nausea; referred to MD;has tingling & numbness;h/a,v;
Fever of 101. High resting heart rate. This happened with the second shot too, and fever lasted 3 days. High heart rate lasted 1.5 days
Took prednisone and the reaction went away.; WARNING: THE STUDY CONFIGURATION IS MISSING THE STUDY PHASE. PLEASE UPDATE THE STUDY PHASE AND RE-GENERATE THE NARRATIVE AGAIN.  Based on the current case data, this case has been classified as invalid. This     The subject received mRNA-1273 (Moderna COVID-19 Vaccine). The report describes a case of THERAPEUTIC RESPONSE UNEXPECTED (Took prednisone and the reaction went away.).     No Medical History information was reported.  On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Took prednisone and the reaction went away.). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Took prednisone and the reaction went away.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant drugs were used by patient.
Pt. came for flu vaccine. Acknowledged has no known contraindications to the flu vaccine. VIS provided and wishes to proceed with the flu vaccine. After 5 minutes, pt c/o dizziness, heart palpitations, chest tightness, trouble swallowing, and a little SOB. Notified Dr. her primary MD. MD ordered Dipenhydramine 25mg IM, Aspirin 81mg 2 tabs PO recorded, EKG, BP check. Instructed to call 911. 911 arrived. Pt was alert and responsive and was taken by the Paramedics.
Patient received Moderna Vaccine and she is 16 years of age.  No adverse event from Vaccination.
Labored breathing, body aches and pain, congestion in chest, runny nose, coughing.
This spontaneous report has been received from a pharmacist via a company representative referring to a 20 year old male patient. Information about concomitant medication, pertinent medical history and drug reactions/allergies was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9, 0.5 mL dose,  second dose, for prophylaxis (anatomical location, route of administration, lot # and expiration date were not reported). On an unknown date (reported as 6 weeks later), the patient was diagnosed with leukemia. It was unknown if the patient received treatment for the event. The outcome of the event was reported as not recovered. No causality assessment was provided. Upon internal review, leukemia was considered to be medically significant.
This spontaneous report as received from a registered nurse via a company representative refers to a 13-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL lot# L038917 (exact dose, route and site of administration and expiration date were not reported) for prophylaxis. Reporter reported GARDASIL with lot # L038917 which was not valid for GARDASIL. However, lot #L038917 was valid for GARDASIL 9. On an unknown date, the patient was vaccinated with a second dose of GARDASIL lot# L040164, expiration date: 20-FEB-2018 (exact dose, route and site of administration were not reported) for prophylaxis. Reporter reported GARDASIL with lot # L040164 which was not valid for GARDASIL. However, lot #L040164 was valid for GARDASIL 9. On an unknown date, the patient was vaccinated with a third dose of GARDASIL lot# M011840 (exact dose, route and site of administration and expiration date were not reported) for prophylaxis.  On 13-JUN-2018 (reported as after receiving GARDASIL, the patient "received stretch marks and varicose veins". The patient sought unspecified medical attention. There was no treatment given for the events. The outcome of stretch marks and varicose veins was reported as not recovered. The outcome of product lot number issue was unknown. The relatedness between GARDASIL and the events was not provided.
worsen arthritis; 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 ARTHRITIS (worsen arthritis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ARTHRITIS (worsen arthritis). At the time of the report, ARTHRITIS (worsen arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's arthritis was worsen after the vaccine.  No concomitant medications were reported. No treatment medications were reported.
Hives, shortness of breath, flushing/sweating. BP 161/109 (heart rate 84); repeat BP 164/111 (pulse 74).
Swollen lymph nodes in head, neck and shoulder creating pain in same areas. As of 8/4/2020 symptoms persist (12 weeks).
Lymphadenitis, superficial phlebitis (R) axilla and erythema (R) ant chest, began 4d after vaccine. 1st OV 9/23/19 - Rx with Keflex 500mg bid x 10d & warm compresses Last OV 10/15/19 - some residual small cords in Rt. Axilla - still some axillary pain
no side effects except a sore arm and I feel great; This is a spontaneous report from a contactable consumer. This 68-years-old elderly consumer (patient) of unknown gender received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown), via an unspecified route of administration on unknown date at single dose for an COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated she experienced "no side effects except a sore arm and I feel great" on unknown date. The outcome of event "no side effects except a sore arm and I feel great" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
PATIENT CALLED AT 5 P.M.  AND REPORTED TO ME THAT SHE HAD REDNESS AND TENDERNESS AT INJECTION SITE. I RECOMMENDED SHE TAKE 2 BENADRYL 25MG CAPSULES AND GO TO NEAREST EMERGENCY FACILITY FOR TREATMENT.
pt started to cough hrs p/vax was administered; pt seem completely well but suddenly went into coughing spasms, producing rapid coughs & becoming very red in face & even blue lips; MD felt pt had cold;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 21-MAY-2013 the patient was vaccinated with a dose of M-M-R II lot number H014648, expiring 03-AUG-2014 (dose and route not provided) and a dose of VARIVAX (Merck) lot number H0168784, expiring 15-OCT-2014 is an invalid lot number for VARIVAX (Merck) (dose and route not provided), which were exposed to unknown temperatures for unknown time frame. No adverse effect was reported. Additional information has been requested.
This spontaneous prospective pregnancy report was received from a physician refers to a 25 year old female patient. Medical history and concurrent conditions were not reported. The physician informed that on 26-DEC-2014 the patient was vaccinated with the first dose GARDASIL lot # K006960, 0.5 ml, intramuscular, when the patient was pregnant "approximately 18 weeks gestation". No adverse effects reported, the patient sought medical attention with her physician, there was not treatment given for the event. The Last menstrual period (LMP) was approximately 22-AUG-2014, and the estimated date of delivery (EDD) was 29-MAY-2015. The pregnancy outcome was outcome pending. The fetal outcome was unknown. Additional information has been requested.
improperly stored doses of ROT ATEQ and PED VAX; No adverse event reported; This spontaneous report was received from Other Health Professional referring to an unknown age and gender patient.  The patient's medical history, concurrent and concomitant therapies were not reported.  On 15-FEB-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1742464, expiration date: 20-SEP-2022 (strength, route of administration, and indication were not provided); and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, lot #U024089, expiration date: 27-OCT-2023 (strength, route of administration, and indication were not provided).  It was reported that the vaccines were expose to a temperature above 47 Fahrenheit degrees (F), 47.5 F for 20 minutes, 46.7 F for 10 minutes and 47.1 for 20 minutes. No previous temperature excursions or adverse events were reported. At the time of reporting, the outcome of the event improperly stored doses of ROT ATEQ and PED VAX (Product Storage Error) was unknown.
seen by MD 25JUN97 w/ 1 1/2mm raised area on rt deltoid;bleeds on impact-advised to use Ibuprofen x 7-10 days & apply hydrocort cream of persist RTC 23JUL97;
Sudden rash appeared on 4/16/21 in few spots (right arm- not the injection arm) , upper back and lower back. Total of five spots. It is itchy and red. I have applied fluocinonide 0.05 percent cream. It was prescribed to me me for another rash happened 2-3 years back for other reasons.
none Covid-19 Vaccine expired 11/22/2022 given 12/07/2022
Tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-046523 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information received and had non-significant information.
Case number PHEH2014US012463 is an initial spontaneous report received from a health care professional on 18 Jun 2014. This report refers to a 19 year old male patient. His past medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: not reported) on 18 Apr 2014. He was accidentally vaccinated with MENVEO (batch number: A12131) again on 18 Jun 2014. No adverse events were reported following this medication error.
Initial misuse report received from a healthcare professional on 25 February 2013. ACTHIB was reconstituted with sterile water instead of ACTHIB diluent and dose was administered. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
I had running nose, headache, congestive with a cough, and sore throat.  It felt like a bad cold.  These lasted about 3 for 4 days.  On Dec 30th, I was tested positive for Covid-19.
Lethargic; Body aches; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LETHARGY (non-serious), outcome "unknown", described as "Lethargic"; PAIN (non-serious), outcome "unknown", described as "Body aches"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.