chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 2 hours after the injection I experienced breathing issues that lasted through the evening and into the nest day.  The morning after the injection I awoke with an itchy rash covering my entire legs - I took a Zyrtec which eliminated the itch.  I was also running a temperature of 101.
PATIENT REPORTS THAT EMERGENCY DEPARTMENT DIAGNOSED HER WITH ATRIAL FIBRILLATION. SHE WAS OBSERVED AT THE HOSPITAL AND DOES NOT RECALL THE MEDICATIONS SHE WAS GIVEN. SHE REPORTS FEELING WELL TODAY
Patient c/o arm pain since given the flu vaccine. Patient states her pain travels from her shoulder down to her wrist. Patient describes it as a nagging pain. Patient states she also experience behavior changes last 24 hours. Patient was accompanying by her daughter.
I had sciatic-type pain in my left lower limb, starting at hip and radiating down to my ankle, starting the morning of Feb 19th, along with moderate lumbar pain and SOB. Symptoms increased to increased lower back pain, left leg numbness, and increased shortness of breath. I went to the ER on 2/20/21 and was diagnosed with a left common iliac vein DVT and with multiple PEs, I was given lovenox injections and kept overnight, discharged the next morning. I was prescribed Xarelto for 3 months. A stent was placed in 5/29/21.
Information has been received from a registered nurse referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 21-MAY-2016, the patient was vaccinated with one dose of improperly stored VARIVAX (lot# reported as L043620, expiration date 02-NOV-2017, therapy type: data digital logger; route was not reported; temperature: -12.6 Celsius degree, time frame: 56 minutes). No adverse effects were reported. There was no previous temperature excursion. Additional information has been requested.
Flushed - like a surge of adrenaline. This happened twice. First time it occurred, it lasted a few minutes. The second time it was more intense , I got dressed in case it didn?t go away I was prepared to go to the ER. that lasted several minutes as well.  I also felt anxious (separate occasion). I am currently experiencing  continual tinnitus. It started yesterday 9/5/2021.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as needed.No concomitant medication was provided. No treatment medication was provided. Rx number includes 802094.
coughing; fatigued / tired; Not felt good/ Not been myself; My body has not been normal like my specimen not good and it was dark; I am very irregular with going to bathroom so I have not felt good; Might have ulcer because it burns when I eat anything; Might have ulcer because it burns when I eat anything; I have aches, body aches; Slept like all the way around the clock; This is a spontaneous report from a contactable consumer (the patient).  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot E13246), via an unspecified route of administration on 05Jan2021 (at the age of 83-years old) as a SINGLE DOSE for Covid-19 immunization.  Medical history included hypertension, reported as pretty regular, from an unknown date and unknown if ongoing. Family medical history included bleeding ulcer from her mother. Concomitant medications included benazepril and felodipine for hypertension. The patient experienced my body has not been normal like my specimen not good and it was dark; i am very irregular with going to bathroom so i have not felt good; might have ulcer because it burns when i eat anything; I have aches, body aches; slept like all the way around the clock all in Jan2021; I was coughing and felt fatigued / tired on 15Jan2021; and not felt good/ not been myself in Jan2021. The patient underwent lab tests and procedures which included body temperature which was checked 3 times with no fever on an unknown date.  Therapeutic measures were taken as a result of slept like all the way around the clock which included ibuprofen (ADVIL). The outcome of the events bowel movement irregularity, burning sensation, ulcer, pain, hypersomnia, cough, fatigue and malaise was unknown.
This spontaneous report as received from a Registered Nurse refers to patients of unknown age and gender. The reporter stated that improperly stored doses of PROQUAD (lot number reported as M035143, exp. date 30-JAN-2018, Lot: M033210 Exp:09-JAN-2018, Lot:M031566 Exp: 24-DEC-2017, Lot: M017335 Exp:05-OCT-2017 and Lot: M023932 Exp:09-NOV-2017) were administered to an unspecified number of patients in December 2016, following the initial excursion that was reported on 01-DEC-2016 and not following the most recent excursion that was reported on 07-DEC-2016. No adverse effects reported. A data logger was involved. Temperature was 13.8 Fahrenheit (F) for 13 hours, the previous excursion was of 9 F for 15 hours. This is one several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004071.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing). Concomitant medication(s) included: CLONOPIN, start date: 09Sep2020; PROPRANOLOL, start date: 03Apr2022; EMGALITY [GALCANEZUMAB], start date: 01Oct2020; UBRELVY, start date: 01Oct2020 were also other medication in 2weeks product. Past drug history included: Codeine, reaction(s): "Known allergies: codeine". Vaccination history included: Flu shot, reaction(s): "Known allergies: Flu shot". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling of the (L) thigh around vaccine site. Splotchy rash over the area.
like something was working in my body; felt somewhat feverish/it wasn't measurable; lower than authorized dose of Moderna bivalent administered to patient/.25 dose for bivalent; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (like something was working in my body), PYREXIA (felt somewhat feverish/it wasn't measurable) and ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent administered to patient/.25 dose for bivalent) in a 68-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Blood cholesterol abnormal. Concomitant products included PRAVASTATIN for Blood cholesterol abnormal.   On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 08-Sep-2022, the patient experienced FEELING ABNORMAL (like something was working in my body), PYREXIA (felt somewhat feverish/it wasn't measurable) and ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent administered to patient/.25 dose for bivalent). On 09-Sep-2022, FEELING ABNORMAL (like something was working in my body) and PYREXIA (felt somewhat feverish/it wasn't measurable) had resolved. At the time of the report, ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent administered to patient/.25 dose for bivalent) outcome was unknown.        The action taken with mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       It was reported that, the patient received the bivalent vaccine 0.25 mL dosage instead of 0.5 mL. A couple days after receiving the bivalent vaccine, the vaccine provider called the patient and told about the error and wanted the patient to come in to get an additional 0.25 mL dosage of the bivalent vaccine. Patient also had received his flu shot along with his Moderna bivalent vaccine on the same day. Later, the patient felt somewhat feverish for 24 hours but was not sure if it was caused due to the flu shot or the bivalent vaccine. Patient reported that, it was not a measurable temperature rise and did not feel sick, but felt like something was working in body.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2022: Significant follow up received contains additional event information. On 12-Sep-2022: Follow-up document received includes no new information.
This spontaneous report was received from a pharmacist reporting to a 74 years old female patient. The patient's medical history and concurrent conditions were not reported. On 17-AUG-2016, the patient was vaccinated with ZOSTAVAX injection, 19400 PFU (plaque-forming units)by subcutaneous route number: M015926, expiration date :28-JUN-2017. (Dose was not provided). There were no concomitant medications reported. On approximately AUG-2016, reported as 3-4 days after receiving ZOSTAVAX, the pharmacist reported that the patient developed red "patchy dots" that are itchy "throughout the patient's body(Rash pruritic), The reporter stated that no laboratory tests were performed to the patient, additionally no treatment was given for the event and no product quality complain was involved. The patient was seen on 23-AUG-2016 in the pharmacy. The outcome of the Rash pruritic was unknown. The relationship between the event and the vaccine ZOSTAVAX was unknown. Additional information is not expected as the reporter did not consent for new follow up attempts.
A serious report of congenital anomaly has been received from a study investigator concerning a four-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population for 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 07-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for congenital anomaly on 09-Nov-2008. The length of stay was five days. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was moderate. The sponsor also assessed the causality for the event as not related to FLUMIST.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursions of 24 hours. The lowest recorded temperature was 34 F. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". On 25-JUL-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of M003659 and expiration date on 20-SEP-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Employee developed shingles rash on left scapula four days after receiving the vaccine . Valtrex started. Rash resolved in one day.
On 05.11.2021 I went in for an ultrasound due to spotting.  I should have been 13 weeks pregnant.  The fetus was measuring 9 weeks 4 days which means the fetus died on 4.22.2021.  4.7.21 - received vaccine shot 4.8.21-4.9.21 - fever (used tylonel), nausea, vomiting I had significant nausea and vomiting the week of 4.11.21 - particularly the end of the week. 4.15.21  - ultrasound (baby measuring 8 weeks, 4 day;  HR -176) I continued to vomit, though I was able to hold more food down. 4.22.21 the fetus would have been 9.4 days which is when the fetus stopped developing 5.11.21 - Ultrasound discovering missed miscarriage  Doctor recommended reporting due to the timing with the vaccine.
Initial unsolicited report received from a pharmacist on 02 November 2015. This case involves a (age unknown) female patient who was vaccinated with a intramuscular [dose series not reported] dose of FLUZONE HD (batch number UI448AA, expiry date and site of administration were not reported) on 22 October 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination patient complaining of vertigo. Laboratory investigation and corrective treatment were not reported. The outcome of event was not recovered. List of documents held by sender: none.
Severe rigors,  fever,  malaise, extreme generalized weakness,  lip and tongue swelling,  generalized skin rash with itching,  shortness of breath,  dizziness,  presyncope, tachycardia.
Pt states around 6:00 pm, he noticed swelling/ soreness/ fever in left arm distal vaccination site, states raise in temp to 103 degrees with N+Vx6, plus blood noted left ear. Pt stated he spoke with doctor by phone (primary physician). Took 2 Tylenol PO for pain/fever which helped. All day Sunday dizzy with headache and low grade temperature all symptoms 3 day in duration.
Joint ache Congestion Low grade fever (99.7) Starting approximately 730am and lasting approximately 12 hours.
Pt with hx of severe allergic reactions was administered pfizer Covid-19 immunisation, Lot #FD8448, mfr exp 10/31/2021, member reported getting clearance from outside of KP allergist prior to scheduling appointment. Patient kept in holding room under RN super vision. 30 minutes post injection, member reported tighetening of throat and middle of chest. Vital signs stable, 02 sat 100%, patient able to speak in complete sentences, lung sounds clear bilaterally and patient did not appear to be in distress. Pt reported these symptoms have been start of severe allergic reaction in the past. DOD Dr. notified, benadryl 25mg IV ordered and administered. Patient reported symptoms stopped worsening after benedryl, DOD assessed pt after benadryl injection, and ordered solumedrol 125mg IV. Pt observed another 20 minutes after injection, reported symptoms greatly improved. Pt discharged home, advised by Dr. to take otc antihistamine and prescribed prednisone short pack. Patient advised to call Advice Line if symptoms returned or 911 if severe.
Has developed ITP. Symptoms include bruising, petechiae, bleeding that is hard to control. Future treatment includes corticosteroids/IV/Ig/possible spleen removal.
This spontaneous report has been received from a healthcare student referring to a currently 24 years old female patient. The patient's pertinent medical history, concurrent conditions and drug reaction/allergies were unspecified by the reporter. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (strength, dose, frequency lot number, expiration date and indication were not provided). Concomitant therapies were not provided. On an unknown date, approximately seven days after vaccination the patient developed swelling at the injection site. The patient sought medical attention as she contacted a pharmacist. The patient did not require any prescription drug for the experience and she was not hospitalized, the reporter stated that the events were not considered to be life threatening, overdose, disabling or medically significant. On an unspecified date the patient recovered from her injection site swelling. The causal relationship between the injection site swelling and GARDASIL was not reported. PQC was not involved. Additional information has been requested.
shoulder achiness  within a few hours, in less than 24 hours had entire body ache and chills lasting 24 hours
The patient told us he had a history of fainting. Last time he got vaccine for HPV he passed out. Upon inject Moderna patient became shakey and head dropped for a few minutes. His companion was able to wake him. He had something to drink and we provided a cool compress for his forehead. Patient remained seated for 30 minutes for observation.
Day of Injection and day after no Problem, 2nd Day after, I have Diarrhea for the next 5 days.
headache; migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the parent.  A 10-year-old female patient received BNT162b2 (BNT162B2), as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 12Apr2023, outcome "unknown"; MIGRAINE (non-serious) with onset 12Apr2023, outcome "unknown". Additional information: she got her second shot of Pfizer covid vaccine on Monday.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 04-JAN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # M000442 exp date 31-MAR-2018) (dose and route not reported). The temperature of excursion was below 32 F (-12F) for 24 hours. There was no previous temperature excursion. Data logger issue was reported. No adverse experiences were reported. This is one of several reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007386:
pt received booster at 10am and by 4-5 pm that day she started having ear pain, headache, muscle pain and sore throat making it difficult to eat/swallow. The muscle pain and headache went away but she still has ear pain and sore throat.
Developed Shingles around left eye. (Severe pain for 1 month, followed by less pain, followed by extreme itching which continues to this day.)
such a bad reaction that the daughter has to drop out colleage; This spontaneous report was received from an unspecified reporter who saw online that a mother came up to company representative and reported regarding a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and drug reaction/allergies were not unknown by the reporter. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiry date, dose number, anatomical location and route of administration were unspecified) for prophylaxis. On an unknown date, the patient experienced such a bad reaction that she had to drop out of college. The outcome and causality of the event were not reported. Product quality complaint was not involved.  Upon internal review, the event bad reaction was considered to be serious due to disability.
Immediate rash less than an hour after shots-no treatment given from doctor, joint swelling in fingers and right knee less than a week after shots- told to use ibuprofen, limping started, swelling never went down,  given referral to rheumatologist 3 months after injections
Prior to the vaccination I had a history of abnormal ECGs in the last 30 or more years.  They showed at different times, athletic heart, low level RBB. abnormal changes, possible enlarged left atrium. The eckocardiograms where always normal.  I got the 2nd vaccine on 03/12/21. On 03/29/21 my ECG showed a LBBB type 1. The echocardiogram was normal again. I started to experience symptoms during April and May. Early june I fainted. went to ER the next day. ECG showed AV block level 1 and a few minutes later complete AV Heart block. I had a pacemaker implanted on 06/03/21
In March I noticed hair loss around my face. What really got me was I noticed my widows peak was gone which I have always hated. I thought maybe this was from getting my hair done maybe chemicals had burned me or something like that. However I noticed it in my eyebrows as well and then I noticed that skin just past my new hair loss was smooth and white. That made me call my dermatologist who could not get me in until November.  I was diagnosed with a rare form of alopecia that is autoimmune- Frontal follicular alopecia. I am now on a steroid cream that I apply twice a day and this hair loss is not reversible
pt recvd vax & devel inject site react of erythema 6cm x 1.5 cm & induration 4cm x 1.5cm; required ER/MD visit;
Urticarial lesion at injection site- few lesions on abdomen, back, and left lower leg. Also fine erythematous papules of face, back, trunk, and extremities. Urticarial lesions resolved with BENADRYL 2 ml po x 1. The infant was observed for 30 minutes and otherwise remained stable and well appearing.
pt recv vax; screaming for 8 hr; red lines running up arm which felt hot to touch;
The patient had a reaction to Pneumonia shot and had a golf ball sized red swell; The patient had a reaction to Pneumonia shot and had a golf ball sized red swell; This initial spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, lot #, expiration date, route of administration and anatomical location not provided) as prophylaxis. After the use of the product, the reported advised that the patient had an unspecified reaction to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) as she had a golf ball sized red swell (injection site swelling, injection site erythema). At the reporting time, the outcome of injection site swelling, and injection site erythema was unknown.    The reporter considered injection site swelling and injection site erythema to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Patient received Moderna 0.5mL (Full dose) on 08/23/21 as indicated in this report and was not IC.