chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 14 year old female with no medical history and drug allergies who on 29-SEP-2010 was vaccinated 0.5 ml IM with the first dose of GARDASIL (lot # 663559/1178Y, expiration date unknown). There was no concomitant therapy. The patient experienced swelling on an unspecified date. The patient did not contact the office when the swelling occurred, the medical assistant was made aware of this reaction today, 08-DEC-2010 when the patient received the second dose of GARDASIL. The patient received the second dose of GARDASIL (lot # 1017Z, expiration date 12-APR-2013) 0.5 ml IM right arm and had an immediate reaction of redness and swelling. The patient while still in office experienced dizziness along with numbness and tingling that went down into her right hand. The patient was treated with BENADRYL and warm compress. She did not recover at the time of report. No lab diagnostic studies performed. In follow-up, the medical assistant indicated that the 14 year old female who on 08-DEC-2010, 9:15AM was vaccinated IM into left deltoid with the second dose of GARDASIL (lot # 663559/1178Y). Concomitant therapy included the first dose of FLUZONE (lot # U3580AA) vaccinated IM into left deltoid on 08-DEC-2010, 9:15AM. On 08-DEC-2010, 9:15AM the patient experienced immediate swelling with injection site and redness. The patient complained of dizziness and headache, as well as numbness and tingling in her left hand. She was monitored for an hour and a half. Symptoms improved and the patient had recovered. No further information is expected.
awakened with swollen lymph nodes lt. axilla extending to lt. breast.  reported a large lump in her armpit. States had a mild headache relieved by Tylenol.  States had some chills intermittent for 24 hrs, no fever. Swollen lymph nodes resolved within 48 hrs. no  treatment needed.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 48 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 19Apr2021 as dose 2, single (Lot number: EW0153), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Pre-diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Certain adhesives (bandages) cause a topical reaction" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with PAXLOVID from 04Oct2023 to 09Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329602 same  patient/reporter, different drug/AE;
Patient arm/shoulder was swollen so patient went to ER that night. Patient was prescribed Benadryl, pain killers, and steroid and was sent home.
p/vax pt exp vomiting, incontinent, limp, talking nonsense, stated "my brain hurts", fever; responded well to APAP & tepid bath;
I am breastfeeding-Milk supply significantly decreased (<50% of typical) day of vaccine. Milk supply still decreased 5 days later,
12MAY92 mom state pt had rash below inject site-macular rash 1" area lt arm non-tender; no temp or systemic rash; advised observation-return;
I noticed there is a big red circle around the site of injection that wasn?t there at the time of shot. The red spot (about 1.5-2 inches) is itchy and slightly raised.
Shortly after my shot I developed a phantom smell of smoke, while it is not an unpleasant smoke smell, it smells like firewood burning in a fireplace.  It is concerning because I can't tell if I am smelling a real smoke smell or a phantom smell should a fire occur.  It goes away but comes back.  I notice the smell more when I am getting ready to go to sleep or when I am not actively doing anything .  At first I thought it was someone in my neighborhood burning firewood all the time, but as time went on I asked my wife is she smelled it and she said she smells no smoke.  So I just monitored my self, but as of today I am still experiencing the phantom smells since March 2021..
Shots around 2 pm. Intermittently inconsolable for 10 hours. Red, screaming, shreaking, kicking arms and legs. "Would not breast feed well." Totally not acting himself.: TYLENOL did not help. (Started at 5 pm).
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Generalized anxiety disorder and Allergy (Allergy of unspecified drug.).   On 24-Nov-2021 at 6:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.            No Concomitant medication reported.  It was unknown if the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment.   It had been reported that Took Paxlovid starting 20-May-2022 for full 5 day course. Symptoms resolved (except on-and off fatigue), then bad symptoms came back 14 days after initial symptoms appeared on the 19 -may-2022 , on 01-Jun-2022. Relapse of disease.  The patient had no drug allergy.  Company comment: This spontaneous case concerns a 41-year-old female patient with no relevant medical history, who experienced the unexpected non-serious of Covid-19, 6 months after receiving the second dose of mRNA-1273 vaccine. She was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. The outcome of Covid-19 was reported as not resolved. Details of symptoms, clinical course, investigation reports were not provided. Details of first dose were not provided. The current pandemic situation of Covid-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old female patient with no relevant medical history, who experienced the unexpected non-serious of Covid-19, 6 months after receiving the second dose of mRNA-1273 vaccine. She was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. The outcome of Covid-19 was reported as not resolved. Details of symptoms, clinical course, investigation reports were not provided. Details of first dose were not provided. The current pandemic situation of Covid-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient with 2 Pfizer vaccinations, last dose 02/04/21, who admitted with hypoxia and positive COVID test who subsequently had failure to thrive.  Respiratory status improved, however, had complex care giver needs upon discharge with pending guardianship issues and had prolonged hospital stay.
I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/17/2022 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Pt complained after her flu shot, she has pain on her arm. She thought it would go away so she didn't report to us until 2 wks later. Because she said she still has a lot of pain and can't raise her arm. I recommended her to go see MD.
Breakthrough case admission after 2 vaccines Pfizer 11/24/21 lot# FH8028;  Pfizer 12/17/21 lot# FE3594
Numbness, pain in limbs loss of vision & balance. Treated with IVIG for Guillain-Barre syndrome.
This spontaneous report was received from a physician via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date not reported) subcutaneously. On an unknown date the patient experienced developed shingles after receiving ZOSTAVAX. The outcome of the event was unknown at the time of this report. Treatment information and lab diagnostic studies were unspecified by the reporter. Patient sought medical attention by visiting the doctor. Causality was not reported. Additional information has been requested.
Hib component of vaccine omitted.  Diluent of Dtap and IPV given.  Called parent of patient to return for administration of Hib. CDC    recommended VAERS report made.
Information has been received from a female physician who "a few years ago" was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently the patient underwent "lab work" which revealed no titer count. As of 07-JUL-2006, the patient had not recovered. Additional information has been requested.
STARTING ON THE THIRD WEEK: SEVERE PERPETUAL LEFT-SIDE HEADACHE WITH LEFT BRAIN MODERATE CONTRACTION. NOT SURE AT FIRST BECAUSE OF SLEEPLESSNESS PROBLEM. OVER THE COUNTER COMBO TYLENOL IBUPROFEN ASPIRIN, THEN ADVIL, NOTHING WORKS AS BEFORE AFTER SEVERAL ATTEMPS OVER SEVERAL DAYS. THEN OUT OF THE BLUE WHILE SITTING TWISTING MY BACK TO CHANGE POSTURE, SUDDEN SHARP PAIN AROUND THE WAIST ON THE BACK NEEDING HELP TO WALK UP TO LIE DOWN WHICH USUALLY WILL RECOVER SOON, BUT NOT THIS TIME. TRIED THAI ASAIN BALM[CREAM] RUBBING ON THE BACK WAIST PAIN AREA AND USUALLY THE BALM'S MEDICINAL HERBS SMELL WILL FILL THE AIR AROUND THE BODY, BREATHING IN THE BALM AROMA USUALLY HELP FASTEN THE RECOVERY, SOMEHOW ALL ACHE/PAIN JUST STOP. SOMEHOW PERHAPS COINCIDENTLY ALL ACHE/PAIN JUST STOP FOR SEVERAL HOURS, SO DID NOT THINK IT WAS FROM THE VACCINE. AT THE END OF THE THIRD WEEK HEADACHE CAME BACK THOUGH NOT SEVERE WITH MILD BRAIN CONTRACTION THIS TIME UNTIL NOW THE FOURTH WEEK APRIL 19, 2021 AND SEEM PERPETUAL AS NO PAIN MEDICINE CAN CURE IT, JUST REDUCE THE PAIN A BIT. THAT IS WHEN I THINK IT IS FROM THE SIDE-EFFECT OF THE VACCINE, HENCE THIS REPORT. THE SECOND SHOT WILL BE THIS SATURDAY APRIL 24,2021; SHOULD I DO THE 2ND VACCINATION?  TASTE, SMELL NORMAL THROUGHOUT WITH MILD FEVER, NO ACCURATE THERMOMETER AT HOME, STILL SLEEPLESSNESS EVEN INCREASE DUE TO THE HEADACHE WITH FEW MINUTES SLEEP DURATION IN BETWEEN HERE AND THERE THROUGH DAY AND NIGHT. BY THE END OF THIS WRITING HEADACHE REDUCED MUCH MORE AND DO HOUSE CHORES FINE.
Pt fainted twice in our office after the shot. He did routine resuscitation per protocol. Recovered in 3 min BP went down to 60/20.
Janssen COVID-19 Vaccine EUA.  Just reporting that I experienced side effects of fever, full body ache, and headache.  The side effects lasted 18 hours.
knees & elbows became stiff & sore shortly p/receiving 1st MMR; few days later knees popping & were stiff, also knees began swelling; presently exp sore elbows & dull aches to sharp pains when weight bearing on knees;
fever chills chest pain 2 days later chest pain and swelling upper lip W vesicles c/w herpes simplex
Large warm welt at injection site, tightness, swelling of left arm. Swollen tongue. Lasted 2 days. Did not take any medication for symptoms.
Body chills from 8-11 pm on the evening of vaccination.  Took Tylenol to alleviate symptoms.
Shingles shot gave discomfort for a few days after; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (dad had shingles, he was in so much pain) and pain (Family History) (dad had shingles, he was in so much pain).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was recovered/resolved.   The reporter considered the discomfort to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-APR-2022 Reporter's comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced discomfort for a few days after.  The patient felt happy to be protected, though. Additional Supportive Information: The follow-up could not be possible as no contact details were available. This case has been linked with case US2022AMR064705, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR064705:Same Reporter
During the night of the injection of 1/26/21, could tell that her leg was sore, in her buttock area, could not lay on it for very long, tried to.  Noticed that her leg was sore to walk today 1/29/20, the area is swollen.  Not bad but she can tell that it is swollen.  Has not taken anything for it.  Not having serious problems, but it is in the left buttock area, sore when she sits on it, hard to walk.
Welt, water blisters on arm at injection site, 1 week, post vax. Also had small bumps like insect bites, on arm that feels tight at times.
Received flu vaccine, a few hours later developed dry itchy eyes - lasting 48 hours.  No treatment needed
Severe nosebleeds started.; extremely high blood pressure 180/110; This is a spontaneous report from a contactable consumer. A 62-years-old female patient received second dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 15:00 PM as dose 2, single for covid-19 immunisation. Medical history included high cholesterol and recently resolved prolactin tumor on pituitary from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took hydrochlorothiazide and experienced drug allergy. The patient previously received first dose of bnt162b2 (Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 17Mar2021 15:00 PM as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. On 17Apr2021 20:30 PM patient experienced Severe nosebleeds started. Got the first one Saturday evening, 3 days after 2nd dose. Then 3 more severe bleeds Monday the 19th, 5 days after second does. Required nasal packing. Only one prior incident, 7 or 8 years ago, not a bleed of this magnitude. I also have extremely high blood pressure 180/110 and just started meds. BP was creeping up but not to this amount prior to vaccine. The patient received treatment with nasal packing, now on BP meds. AE resulted in emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab test include Blood pressure: 180/110 unknown unit on 17Apr2021. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
moderate chills; fatigue; headache; injection site soreness; arm muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset Oct2022, outcome "unknown", described as "arm muscle pain"; FATIGUE (non-serious) with onset Oct2022, outcome "unknown"; HEADACHE (non-serious) with onset Oct2022, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "injection site soreness"; CHILLS (non-serious) with onset Oct2022, outcome "unknown", described as "moderate chills".  Additional information: Description of event: Received bivalent Covid booster on 12Oct. Within 12 hours experienced moderate chills, fatigue, and headache as well as injection site soreness and arm muscle pain. No fever. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache and fever, lightheaded sx's day after getting vaccinated.  12/06/2007 MR received for DOS 10/27-31/2007 and 11/2-5/2007 with D/C DX (10/31/07):  Viral illness, possible viral meningitis.  UTI due to E. coli.  R maxillary sinusitis.  Retention cyst or polyp of the L maxillary sinus.  Bilateral ethmoid sinus disease.  Elevated fasting glucose.  D/C Dx (115/07):  severe spinal headache improved s/p blood patch.  Muscle tension H/A.  Negative MRI spine.  R maxillary sinusitis with opacification.  Pt presented to ER with severe H/A unrelieved by pain meds.  Pt had experienced aches and chills since the day prior to admission. Pt developed a fever and severe dizziness. Was admitted for possible meningitis. Tx with pain meds, abx, Meclizine with some improvement. Pt was readmitted 11/27/07 for severe positional H/A with nausea and vomiting. A blood patch was performed with gradual improvement.
08/25/2004, here for routine health maintenance-this 08/27/04 AM, mother noticed swelling.
Pt received her immunizations at around 10:30 - 11:00 AM on 08/27/2001. About 7.5 hours later she developed fever and was given Tylenol by mother. About 11.5 hours alter she developed staring episode, unresponsive to her parents which happened again 30 minutes later.
Stated "feel funny, think I'm having a reaction to my flu shot tongue feels funny". She was lowered to floor seizure activity present O2 applied transferred to Emergency.
Breakthrough case admission after two vaccines ; Pfizer 1/19/21 Lot# El3249;  Pfizer 2/9/21 Lot# EM9810
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On 10-JUN-2014, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # 0387AE exp date 31-MAY-2014, 1 ml, intramuscular. Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PYREXIA (Fever). On 28-Mar-2021, PYREXIA (Fever) had resolved. Not Provided    mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-090520 (Patient Link).
4cm x 3cm reaction at immunization site. Also fever 103 orally noted.
This spontaneous report was received from Novartis an was assigned manufacturer report number PUS2013US116373 refers to a currently 50 years old female patient. On 11-FEB-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (route, dose and lot # not reported). On an unknown date, the patient had a reaction after vaccination with PNEUMOVAX23. The outcome of reaction was unknown. This was originally reported by a nurse. Additional information has been requested.
Bleeding; Easily bruising; Muscle twitching; cramps; Head pressure; Abdominal cramping; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on Mar2021 05:00 PM, at the age of 65-years-old, (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported.  Historical vaccine includes BNT162B2, DOSE 1, SINGLE received on 04Mar2021 05:00 PM. Prior to vaccination, the patient has not been diagnosed with COVID-19. On Apr2021, the patient experienced bleeding, easily bruising, muscle twitching, cramps, head pressure, and abdominal cramping. All symptoms persistent for months.  The events include emergency room/department or urgent care and physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 22Jul2021.  The outcome of the events was not recovered. No treatment was received for the events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (fingers felt funny), muscle twitching (twitching in face) and vaccination site pain (arm pain wrist to elbow) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 12, 2021, patient experienced feeling abnormal (fingers felt funny), muscle twitching (twitching in face) and vaccination site pain (arm pain wrist to elbow). At the time of the report, feeling abnormal (fingers felt funny) resolved; muscle twitching (twitching in face) and vaccination site pain (arm pain wrist to elbow) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. After 5 to 10 minutes after the injection, her arm started aching from the elbow to her wrist. Then her two middle fingers started feeling funny and that lasted two days. The evening of Aug 12, 2021 she started having a twitch in her face. No concomitant medication or treatment information provided.
Pt given Pneumovax 0.5cc per started procedure R shoulder. That night developed T 100.7 then swelling and redness at site. Rx A6, 48 h later better.
Information has been received from a medical assistant referring to 5 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (dose, strength and route were unknown, lot # reported as L028276, expiry date: 28-JUL-2017 and lot#: L021216, expiry date: 10-JUN-2017). No adverse effects were reported. This case is one of several cases from the same source. Additional information has been requested.
Patient presented to ED on 8/26/2021 with difficulty breathing, the onset was 8/24/2021.  Also complains of fever, chills, and cough.  Chest Xray in ED showed pulmonary fibrosis and viral PNA.  He was started on IVF, IV abx and covid 19 treatment protocols, he was placed on Bipap.  The patient was DNR.  He was admitted to step down unit and continued on Bipap.  He was given tocilizumab and started on baricitinib, and IV steroids.  The patient showed little improvement and started to get worse.  Family placed patient on comfort measures and wanted to discontinue the bipap.  The patient expired on 8/29/2021.