chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was not able to ovulate; shortness of breath; chest pains; LH levels for the following three cycles are much lower than they were prior to vaccination; i was infertile; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jul2021 (Lot number: FA7484) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ARMOUR THYROID; UNITHROID; CONCERTA; MAGNESIUM; ZINC; VITAMIN D [COLECALCIFEROL]; SELENIUM; VITRON-C. The following information was reported: OVULATION DISORDER (non-serious) with onset 26Jul2021, outcome "recovered with sequelae" (2021), described as "was not able to ovulate"; INFERTILITY (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "i was infertile"; DYSPNOEA (non-serious) with onset 26Jul2021, outcome "recovered with sequelae" (2021), described as "shortness of breath"; CHEST PAIN (non-serious) with onset 26Jul2021, outcome "recovered with sequelae" (2021), described as "chest pains"; BLOOD LUTEINISING HORMONE DECREASED (non-serious) with onset 26Jul2021, outcome "recovered with sequelae" (2021), described as "LH levels for the following three cycles are much lower than they were prior to vaccination". The events "was not able to ovulate", "i was infertile", "shortness of breath", "chest pains" and "lh levels for the following three cycles are much lower than they were prior to vaccination" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ovulation disorder, infertility, dyspnoea, chest pain, blood luteinising hormone decreased.  Additional information: Patient was not able to ovulate (she have been tracking her ovulation for 6 months daily and LH levels). Her LH levels during ovulation would not go above A .7 which means she was infertile (this has never happened prior to this). Patient's LH levels for the following three cycles are much lower than they were prior to vaccination (again, all have been tracked). She also started to experience shortness of breath, ches pains etc. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination: armour thyroid, unithroid, concerta, magnesium, zinc, vitamin D, selenium, iron (VITRON-C). Patient was not diagnosed with COVID, prior to vaccination. Patient has not been tested for COVID, since the vaccination. Patient received second dose on 17Aug2021 (lot number: FC3181) in left arm for covid-19 immunisation.  No follow-up attempts are possible. No further information is expected.
No adverse event; Past lot that had also been expired that was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event) in an 88-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients).    Patient age was reported as 88 year 5 months. No concomitant medication was provided.    It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
Headache and exhaustion; Headache and exhaustion; This is a spontaneous report from a contactable consumer (patient)  This 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 13:30 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation.Age at vaccination:  The patient received the first dose of the same vaccine on 23Feb2021 on left arm Lot # EL3247. Medical history included , raw apricots allergy .The patient's concomitant medications were not reported.  The patient experienced headache and exhaustion on 17Mar2021 with outcome of recovering .Additional information : Prior to vaccination, the patient was not diagnosed with COVID-19Since the vaccination, the patient has not  been tested for COVID-19.
Severe L arm pain and tenderness, with inability to move arm or shoulder, following PNEUMOVAX 23 vaccine not abating when assessed at 5 days following vaccination. She reports some initial hives, but rash has resolved in the first 24 hours.
Patient was at clinic to receive his 2nd dose of the Moderna CoVID-19 Vaccine.  Approx 13 minutes after receiving the dose, patient became weak, dizzy, and extremely diaphoretic.  Rapid response was called.  Patient was wheeled into exam room.  BG checked immediately and was 110.  Initial vitals showed HR 39 with BP 83/48.  Patient was transferred to exam table w/o incident.  He did not complain of CP or SOB.  Denies any throat swelling or itching.  He felt very weak and tired.  He continued to be extremely diaphoretic.  An 18G IV was introduced to the left forearm without incident.  He was connected to 1 L bag of 0.9% Normal Saline which was hung to bolus, running well without pressure.  EKG obtained and showed sinus bradycardia with a rate of 43.  Possible ST changes in V1 and V2, but not diagnostic of ST elevations or depressions.  There is IVCD noted.  Patient has hx of AFib - not in Afib currently.  Reports on Eliquis instead of Coumadin.  EMS was contacted.    Physical exam performed revealed a bradycardic HR which was regular. No murmurs.  Lungs are clear.  Patient is extremely diaphoretic and pale.  He is alert and oriented x 3.  He is not in respiratory distress and shows no signs of oral swelling. No hives noted on his skin.  Vitals were rechecked at 3 mins and showed SaO2 at 95% and then 92%.  NC O2 applied at 2 L/min continuous and there was improvement to 95%.  He still denies any respiratory distress and was not manifesting any signs of respiratory distress.  Still denied any chest pain.  NS continued to infuse at bolus dose and BP recheck improved to 108/65 - patient was lying supine.  HR remained between 40-42.  At this time, the patient reported improved symptoms and he was not sweating as profusely as previously.  At this time EMS arrived.  Atropine was not administered in the clinic, but was prepared in expectation as a possible next step.  As patient's symptoms improved, but his vital signs remained altered, he was agreeable to transport to the hospital by EMS.  He was placed on stretcher and care was relinquished to EMS team.  Patient transported out of clinic in guarded condition.
What are the side effects from this vaccine ? / YES; 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 VACCINATION COMPLICATION (What are the side effects from this vaccine ? / YES) 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 VACCINATION COMPLICATION (What are the side effects from this vaccine ? / YES). At the time of the report, VACCINATION COMPLICATION (What are the side effects from this vaccine ? / YES) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMITANT AND TREATMENT DRUGS WERE USED
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2, Solution for injection), on 06Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROZAC, start date: 01Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had received anti viral COVID 19 treatment on 20May2022, for treatment of COVID-19. Reporter stated, I am taking generic prozac. The patient had received other medication in 2 weeks with prozac generic start on 01Feb2022. On 21May2022 06:00 PM, the patient experienced adverse event red itchy rash behind each of my knees', outcome "unknown". Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
withouth being able to get up; all the symptoms: body pain, back pain, diarrhea; all the symptoms: body pain, back pain, diarrhea; all the symptoms: body pain, back pain, diarrhea; Weakness; Lot of fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (all the symptoms: body pain, back pain, diarrhea), BACK PAIN (all the symptoms: body pain, back pain, diarrhea), DIARRHOEA (all the symptoms: body pain, back pain, diarrhea), ASTHENIA (Weakness) and PYREXIA (Lot of fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced ASTHENIA (Weakness) and PYREXIA (Lot of fever). On 11-Apr-2021, the patient experienced PAIN (all the symptoms: body pain, back pain, diarrhea), BACK PAIN (all the symptoms: body pain, back pain, diarrhea) and DIARRHOEA (all the symptoms: body pain, back pain, diarrhea). On an unknown date, the patient experienced FATIGUE (withouth being able to get up). At the time of the report, PAIN (all the symptoms: body pain, back pain, diarrhea), BACK PAIN (all the symptoms: body pain, back pain, diarrhea), DIARRHOEA (all the symptoms: body pain, back pain, diarrhea), ASTHENIA (Weakness), PYREXIA (Lot of fever) and FATIGUE (withouth being able to get up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: follow-up received on 13-APR-2021, contain no significant information.
Off label; Booster third dose; Aches; Fever; Swollen Lymph nodes; Fatigue; This is a spontaneous report from a contactable healthcare professional. An adult female patient of an unspecified age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Oct2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient receive any other vaccines within four weeks prior to the vaccination or not. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 08Oct2021, the patient experienced aches, fever, swollen lymph nodes and fatigue. It was unknown whether any therapeutic measures were 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 aches, fever, swollen lymph nodes and fatigue was resolved on an unknown date of Oct2021 at the time of this report.   The lot/batch number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a pharmacist regarding 1 patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX lot # L028286, expiration date 28-OCT-2016. No adverse event was reported. The outcome of the event was unknown. Yes there was a Previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 38-year-old male patient who received TWINRIX adult (batch number 3NK9A, expiry date 28th May 2017). Concomitant products included TWINRIX adult, Typhoid vaccine, Yellow Fever vaccine, DT+TD vaccine and multivitamin. On 11th May 2016 07:55, the patient received the 2nd dose of TWINRIX adult (intramuscular) 1 ml. On 11th May 2016 11:55, 4 hrs after receiving TWINRIX adult, the patient experienced itchy rash and pruritus. TWINRIX adult was interrupted. On an unknown date, the outcome of the itchy rash and pruritus were recovered/resolved. The reporter considered the itchy rash and pruritus to be almost certainly related to TWINRIX adult. Additional details were provided as follows: The reporter's office was not informed until the time of reporting, when the patient came in for his 3rd dose. On 13th April 2016, the patient received 1st dose of TWINRIX adult on the left deltoid, Typhoid vaccine and TD on the right deltoid manufactured by Sanofi Pasteur. The patient might have also received yellow fever vaccine from the health department during this time period. The patient received 2nd dose of TWINRIX adult on the left deltoid and experienced an itchy rash on his chest. The symptoms resolved within 48 hours.
"panic attack" as patient described prior to vaccine. Patient jumped with Vaccine  injection. Took deep breathe, became diaphoretic. gasping respirations. Patient then began to cough, breathe rapidly, returned to normal rate depth and quality. Patient advised prior to the injection that these events would occur as described. Episode lasted 5 minutes.   At 10:25 hr 88 rr 30 bp 171/91 10:35 hr 73 rr18 bp155/82 10:50 hr 70 rr12 bp 141/84 Monitored by paramedic for 30 minutes
pt recv vax 28OCT97 & was hosp 1APR98 & dx w/pneumonia;the causative organism was not known by the reporter;
Information has been received from a nurse practitioner referring to a 9 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. On 04-MAY-2016 at 15:00, the patient was vaccinated with M-M-R II lot # L026553 dose 2, subcutaneously in the left arm. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
After injection, patient complained of feeling "light headed" and like he "might pass out". Patient stated he had not eaten all day. Crackers, water, and an ice pack given to patient. Patient recovered and was released.
Pt vaccinated w/Meruvax II developed aching of hands & ankles, a fine red rash over upper body, injected eyes and swollen eyelids, fever, headache & malaise.
memory issues; got more mixed up/ got confused; Is repeating herself more; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). An 80-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), (ongoing) (Lot number: FK3383, Expiration Date: 31Oct2023) at 11 mg daily, oral for arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), administration date: Mar2021, when the patient was 79 years old, for COVID-19 immunization. The following information was reported: SPEECH DISORDER (non-serious) with onset Oct2021, outcome "not recovered", described as "Is repeating herself more"; CONFUSIONAL STATE (non-serious) with onset Oct2021, outcome "not recovered", described as "got more mixed up/ got confused"; MEMORY IMPAIRMENT (non-serious) with onset Oct2021, outcome "not recovered", described as "memory issues". The events "memory issues" and "got more mixed up/ got confused" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The action taken for tofacitinib citrate was dosage not changed. Therapeutic measures were taken as a result of memory impairment. Therapeutic measures were not taken as a result of confusional state, speech disorder.  Additional information: the reporter did not know if it is related to her age or medication or the COVID shots, did not know what is causing her memory issues. If someone calls she cannot remember who it was. The reporter went with the patient to her doctors appointments because she does not remember what was said.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patients left deltoid was swollen and red about 3 times normal size with pain pt was treated with a in office injection of dexamethasone sodium phosphate 1mg and told to take benadryl at home
This spontaneous prospective pregnancy report as received from a registered nurse for GARDASIL a Pregnancy Registry product, refers to a 27 year old female patient who on 28-DEC-2010, was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) IM and on 17-APR-2013, was vaccinated with the second 0.5 ml dose of GARDASIL (Lot # reported as SH010649, expiration date 20-FEB-2015) IM. The nurse reported that the patient was pregnant for an unspecified amount of time, "7 to 8 weeks pregnant", when she received her second dose of GARDASIL. The patient's LMP was on approximately 13-MAR-2013 and er EDD would be on approximately 18-DEC-2013. No adverse effect was reported. Additional information has been requested.
Pfizer dose #1 2/17/21 (lot #EN6204) and dose #2 3/11/21 (lot EN6200) Patient presented on 3/12/21 with dyspnea, fever, and cough one day after receiving dose #2 of Pfizer COVID-19 vaccine at outside facility. Administered ibuprofen, acetaminphen, and IV fluids. SARS-CoV-2 RNA negative. Patient discharged to home stable.
Contracted chickenpox as documented by pediatrician. Under physician's care from 1/25/04-2/1/04. Illness began 1/23/04.
Early 7/2, nausea, loss of appetite. Evening 7/2, vomiting. Night of 7/2, insomnia, vivid dreams. Early 7/3 AM diarrhea, loss of appetite.
Information has been received from a registered nurse concerning a 15 month old male patient who was born a healthy infant with apgar of 9 and 9, with no history of problems with previous vaccinations, no history of allergies and with a history of outpatient pediatric visits for periodic childhood illnesses of colds, diarrhea, otitis media and viral sinusitis. On 12/22/03 the patient was vaccinated with a dose of MMR (lot # 646339/0585N). On 1/11/04 the patient developed a petechiae rash. On 1/12/04 the patient presented to the physician's office. A complete blood count was drawn and the patient had a platelet count of 15. Further information reported that laboratory evaluation done in the physician's office on 1/12/04 revealed the platelet count was 15,000. A repeat platelet count was also done on the same date and sent to an outside laboratory and the result was 7.000. The patient was noted as having idiopathic thrombocytopenic purpura. The patient was being treated with oral steroids, oral prednisone 7ml, twice a day for seven days. The patient was also scheduled for a gamma globulin infusion. Further information received reported that on 1/13/04 the patient was given a 10 gm IV Gamma Globulin infusion and was started on prednisolone sodium phosphate two times a day, total daily dose of 45 mg per day, for 7 days. The patient was seen again in the office on 1/14/04 and laboratory evaluation revealed that the platelet count was 110,000. The child continued on the prednisolone sodium phosphate. On 1/19/04 the child was seen again in the office and laboratory evaluation revealed the platelet count was 587,000. It was noted at this visit that the child was happy, active and that the petechiae was resolving. The patient was prescribed prednisolone sodium phosphate in tapering doses for the next 7 days. Upon internal review, idiopathic thrombocytopenic purpura was determined to be an other important medical event (OMIC). Additional information has been requested.
Pt had an episode of syncope, pt's mother supported the pt's head, ammonia tablet was used to rouse pt and pt was assisted to the floor. Vitals were monitored, legs elevated, cold compress provided to the pt and placed on her neck. Pt rested and awoke 2-3 minutes later.
No adverse event; Monovalent vaccine for ages 12 years plus was administered on 16-Mar-2023 after expiry date on 11-Mar-2023.; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine for ages 12 years plus was administered on 16-Mar-2023 after expiry date on 11-Mar-2023.) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     It was reported that patient had no allergy or diseases. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 16-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 16-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine for ages 12 years plus was administered on 16-Mar-2023 after expiry date on 11-Mar-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine for ages 12 years plus was administered on 16-Mar-2023 after expiry date on 11-Mar-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine for ages 12 years plus was administered on 16-Mar-2023 after expiry date on 11-Mar-2023.).    No concomitant information was reported. No treatment information was provided.