chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Continued headache one week later. Has not gone away since 2nd vaccine.; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 13:30 as SINGLE DOSE for covid-19 immunization. Medical history included dust allergy, asthma, anaemia vitamin b12 deficiency. Concomitant medications included levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR). The patient previously took bnt162b2 for covid-19 immunization, had past drug therapy with aspirin [acetylsalicylic acid] and experienced drug hypersensitivity. It was reported that, on 15Feb2021 at 17:00, patient experienced continued headache one week later and has not gone away since 2nd vaccine. As a therapeutic measure, Tylenol Advil were provided to patient. The outcome of the event not recovered.
Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 13-NOV-2018, the patient was vaccinated with a expired VAQTA (dose, strength were unknown; lot# N026997 and expiration date 10-NOV-2018) intramuscularly for prophylaxis (expired product administered). No adverse effect reported.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 27-FEB-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006953, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Itching throat and tounge was given liquid Benadryl by head nurse in charge of COVID site  vaccinations were being given and had to wait extra time. Symptoms resolved.
Patients states within 12 hours of vaccine administration she had urinary incontinence and butterfly rash developing into full facial rash and ear flushing.  Incontinence resolved after 10 hours and facial flushing continues to improve 2 days later.  Other more common symptoms included myalgias and fatigue.  NO oral swelling/symptoms or difficulty swallowing
Acute encephalopathy; ALTE. Discharge Summary received on 2/1/2005 states final diagnosis as respiratory failure, R/O sepsis.
MD reported a pregnant 14yo adm MR on 29MAR91 had emergency c-sect due to fetal distress & inc BP WAES90120184; pt born  w/pilonidal sinus, mildly deformed lt ear lobe, lt index finger w/only half nail bed, mild micrognathia & nevus flammes
Patient completed Covid 19 vaccine series 01/14/2021, tested positive for covid 19
i miss my 2nd dose of covid vaccine; 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 PRODUCT DOSE OMISSION ISSUE (i miss my 2nd dose of covid vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (i miss my 2nd dose of covid vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (i miss my 2nd dose of covid vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Less than 1 month after vaccine, I went back to pediatrician because i noticed little red dots all over my legs that didnt go away after a week. Doctor informed me the dots were petechiae, and sent me for immediate blood work. Platelet count was 12 (10*3/uL).  I have had ITP since receiving the vaccine, and about a year after the vaccine was diagnosed with LUPUS (SLE), with the ITP being from the SLE. I have tried just about every SLE treatment with no improvement (plaquenil, imuran, methotrexate, cellcept, medrol, prednisone, benlysta, saphnelo)
I had complete flu like symptoms: intense body aches, headache, chills, and general weakness. I stayed in bed for 2 days. I have had a dull pain in my upper abdomen, on the right side, under my ribcage, since then.
A report has been received from a Study Investigator concerning a 17 year old, female subject, Height: 68.0 inches; Weight: 137.0 pounds, enrolled in study MA-VA-MEDI3250-1115; A post marketing Safety Study of Q/LAIV in subjects 2 through 49 years of age. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on 10-Oct-2013 for influenza. The date of last menstrual period was 20-Sep-2013. The first test was done with urine on an unknown date which was positive. The second test was done on 26-Nov-2013 with ultrasound and was found positive. The patient experienced pregnancy which was started on unknown date. The estimated conception date was 04-Oct-2013. The estimated date of delivery was 27-Jun-2014. The outcome of the pregnancy was reported to be a healthy baby. The baby was male, weighed 3.735 kg, height 52.1 cm. The number of weeks at outcome of pregnancy was 40. There were no complications during delivery or pregnancy and the delivery was normal (vaginal type). The report was considered to be non-serious. The study investigator considered that there was no causal relationship between pregnancy and study therapy.
rash on body and chest / his second shot the same thing happened only worse; rash on body and chest / his second shot the same thing happened only worse; This is a spontaneous report from a contactable physician. A 7-decade-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose arm for COVID-19 IMMUNIZATION and experienced a rash on body and chest 36 hours after receiving first shot and it eventually cleared up. Relevant medical history and concomitant medication were not provided. On an unknown date, when patient got his second shot, the patient experienced experienced a rash on body and chest, described as, the same thing happened only worse, so he sought care from the provider. The outcome of the event rash on body and chest was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
"Covid arm" began 1 week after first Vax. Arm near and around injection site was red, hot to the touch, swollen, painful, and itchy.
Developed left calf pain which was diagnosed ad DVT by doppler on 3/29. Treated with xarelto.
PATIENT FELT NAUSEAOUS  AND THREW UP ABOUT 5 MIN AFTER RECEIVING SHOT.  SHE ALSO FELT LIGHT HEADED AND I HAD HER PUT HER HEAD DOWN WHICH MADE HER FEEL BETTER.  BLOOD PRESSURE NORMAL.  NOT SWEATING OR HOT.  AFTER ABOUT 20 MINUTES SHE WAS FEELING BETTER AND LEFT THE STORE ON HER OWN.  SHE DID NOT HAVE ANYTHING TO EAT THAT MORNING.
Mom called she noticed rash on cheek on Friday 4/30/07 after being in sun at amusement park. On 4/28/07 rash still on cheek, on 4/29/07 student returned to amusement park entire body covered with bumps-his body look like measles, fever 101 deg. patient was seen by doctor 4/30/07. Fever subsided. Placed on Claritin P.O. MD confirmed reaction.
PCV13 administered to patient after the CDC began recommending the PCV20. CDC guidelines not followed-- no adverse reaction from patient.
Parents & child came over the clinic after 2 days of vaccinating stated child both thighs are sore and child was fussy. Noted both thighs are swollen with redness and hot to touch. No temp reported high. Told parents will have moderate soreness welling and redness and normal after having shots. No treatment done.
Severe headache and coughing significantly (increased coughing) resulting vomiting on occasion. Extreme lethargy and a slight fever. Duration: lasted about six days. And the course of treatment recommended by the doctor: rest and lots of fluids and a fever reducer. Wednesday,  July 14th, Urgent Care - when I sought care, I had them do a COVID test - rapid and PCR and both turned out to be negative.
Extreme migraine; Muscle aches; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 19Apr2021 at 13:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 19Apr2021 at 20:00, the patient experienced extreme migraine and muscle aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not 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 extreme migraine and muscle aches was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Leaked on the patient's arm; Leaked onto the patient's arm; Medication leaked out of the prefilled syringe at the location between syringe hub/luer lock and syringe needle; The patient did not receive a full dose of GARDASIL 9; This spontaneous report was received from a nurse, concerning a 30 year old female patient. There was no information about the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On 11-SEP-2020, the medical assistant was administering the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S010729 with expiration date of 01-DEC-2021, intramuscular for prophylaxis (dose, frequency and anatomical location were not provided) to the patient, and the medication leaked out of the pre filled syringe at the location between syringe hub/Luer lock and syringe needle, and leaked onto the patient's arm. There was no exposure to the medical assistant that was administering the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The patient did not receive a full dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Product would not be obtained because it was biohazard.    The syringe needle was attached to the syringe tip before the leaking occurred and was able to be attached securely to the syringe. The defect was noticed while the plunger was being pushed forward and while giving the injection. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Child had 1st fainting episode after receiving the HPV vaccine. Was given smelling salt (ammonia inhalant).  Recovered quickly, sat up after 10 minutes, then had 2nd fainting spell. Heart rate 100, given oxygen via nasal cannula, 2 liter flow rate for 15 minutes. Allowed to lay down for 15 min, then sit for 15 min.  Room was hot, per mom, patient did not not eat prior to immunization.  911 called initially, but mom refused.  Pt was able to walk out of clinic on his own after 30 minutes of observation.
This spontaneous report as received from a 25 year old non-pregnant female patient with unspecified drug reactions or allergies refers to herself. On 10-OCT-2014 the patient was vaccinated with 0.5 ml dose of GARDASIL, (in the arm, intramuscular, lot #, expiration date not reported). There were unspecified concomitant medications. Right after the vaccination, on 10-OCT-2014 the patient experienced swelling, redness and itching. On 21-OCT-2014 (reported also as: two weeks later) the patient noticed a small bump on her arm at the site of the injection. The patient reported that the bump was "pea-sized" and noticeable. She also reported that it could be felt underneath the skin when it was touched. There were no laboratory test performed. There were no treatment given for the events. Product quality complaint (PQC) was not involved. The outcome of the events was unknown. The patient did not seek medical attention. The relatedness between the therapy with GARDASIL and events was not reported. Additional information has been requested.
Muscle aches, severe local reactions, nausea, malaise, cellulitis, severe arm pain, headache, weakness lasting a week.  Treatment: 500 mg Keflex 4 times per day, 7 days; hot compresses on arm, visit to ER.
Information has been received from a physician concerning a 62 year old female who sometime during the week of 12-APR-2010 was vaccinated with a dose PNEUMOVAX 23, 0.5 mL. Physician reported that sometime during the week of 12-APR-2010 and after receiving only one dose of PNEUMOVAX 23 the patient had a swollen arm and it was hot to the touch. The physician reported that the patient came back in the office later that she received PNEUMOVAX 23 and was given a cold pack and BENADRYL. At the time of reporting the patient had recovered.  Additional information has been requested.
died after having the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died after having the vaccine) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 17-Jul-2021 The patient died on 17-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported.  Reporter was not the only one with this issues, (liver discomfort) that he had family members, and people in his social networks that had the same issue after the second dose of the Moderna COVID-19 vaccine.   No treatment medications was reported.  Company Comment: This spontaneous case concerns a 62-year-old, male patient with no medical history reported, who experienced the unexpected, serious (fatal and medically significant) event of death. The event occurred approximately 6 months after receiving an unspecified dose of the mRNA-1273 vaccine. The reporter stated that his father died after having the vaccine. No further details were provided. It was reported that the patient expired on 17Jul2021 and the cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-551786 (Patient Link).; Sender's Comments: This spontaneous case concerns a 62-year-old, male patient with no medical history reported, who experienced the unexpected, serious (fatal and medically significant) event of death. The event occurred approximately 6 months after receiving an unspecified dose of the mRNA-1273 vaccine. The reporter stated that his father died after having the vaccine. No further details were provided. It was reported that the patient expired on 17Jul2021 and the cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Chills; Fever; Fever blister on the top lip and a cluster of 4 blisters on the bottom lip; Pimple on the lip; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORAL HERPES (Fever blister on the top lip and a cluster of 4 blisters on the bottom lip), ACNE (Pimple on the lip), CHILLS (Chills) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included METFORMIN, SOLIFENACIN SUCCINATE (VESICARE), OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced ACNE (Pimple on the lip). On 08-Mar-2021, the patient experienced ORAL HERPES (Fever blister on the top lip and a cluster of 4 blisters on the bottom lip). On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with DOCOSANOL (ABREVA) for Blister, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Fever blister on the top lip and a cluster of 4 blisters on the bottom lip), ACNE (Pimple on the lip), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt called hospital call center to report side effects. Pt stated pt got covid vaccine Pfizer 7/29/2021 and pt got pain(pain score 8/10) on left arm injection site for 2 weeks in consistence. Noted no swelling or redness on injection site. Proceed covid vaccine side effects questions. Noted pt has no emergency s/sx at this time. Noted pt is taking Tylenol for pain. Pt is educated covid vaccine side effects. Pt requested to make appt with MD for consultations.
tiredness; chills; rash on his arm at the injection site; feels a little bit of warm when I touch it; rash on his arm at the injection site; feels a little bit of warm when I touch it; This is a spontaneous report from a contactable consumer (patient's wife). An 85-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263) via an unspecified route of administration in the left arm, on 11Feb2021 (at the age of 85 years-old) at single dose for COVID-19 immunization. Medical history includes emphysema and COPD (Chronic Obstructive Pulmonary Disorder) and Rheumatoid arthritis. The patient previously received the first dose of BNT162b2 ("it says Pfizer, can't make it out good but looks like Lot Number EL0142"; at the age of 85-years) on 21Jan2021 for COVID-19 immunization. Concomitant medications included methotrexate, weekly for rheumatoid arthritis and folic acid once daily for an unspecified indication. Concomitant medications include unspecified inhalers for emphysema and COPD. After receiving the vaccine, he experienced tiredness and chills (Feb2021). More than a week later he experienced a rash at the injection site which feels a little bit warm to the touch it (Feb2021). The rash is 2.5 inches wide, 3 inches long. His wife put a cold pack on it and it helped, the rash is not hurting or itching. The patient's wife stated it was odd that his rash appeared a week later right in the injection site in his left arm, she attributed it to the fact that he sleeps on this side. The outcome of the events fatigue, chills, injection site rash and injection site warmth was unknown.
This spontaneous report as received from a licensed practical nurse refers to a an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unspecified dates (reported as after temperature excursion on 21-SEP-2015), the patients were vaccinated orally with improperly stored doses of oral ROTATEQ lot # K019370, expiry date 16-JUL-2017; lot # K013410, expiry date 27-FEB-2016; lot # L013197, expiry date 26-JAN-2017 (dose was not reported). Administered dose of vaccine experienced the temperature excursion of 48.7 Fahrenheit degrees for 55 hours. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Lot # L013197 has been verified to be a valid lot number of oral ROTATEQ. Additional information has been requested.
Expressed thanks to Moderna that her breathing has been easier; she just had some allergies growing up; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) and HYPERSENSITIVITY (she just had some allergies growing up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) and HYPERSENSITIVITY (she just had some allergies growing up). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) had resolved and HYPERSENSITIVITY (she just had some allergies growing up) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-404870, MOD-2021-404866 (Patient Link).
Pt states  she got the Moderna COVID Vaccine on 01/05/2021 and felt fine till 01/14/2021 when Left arm at site of injection started itching, states it is now red / raised and warm to touch. States she has also experienced vertigo since 01/14/2021 at about 8:45 pm. States she has had a headache for a few days. Pt presented to Health Dept for eval. Left arm did have a oval shaped area that was red and had what appeared to be red stratch marks. the area is 50mm X40mm. Advised she can treat with over the counter remedies as directed & / or follow up with provider of choice. Advised pt will make note & file VAERS Report. Pt verbalizes understanding.