chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On unknown dates, unknown number of patients have been administered PEDVAXHIB (lot number, dose, frequency and route unspecified) which was improperly stored. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PEDVAXHIB was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Info has been received from an RN concerning an approximately 16 month old healthy female with no allergies, who on 10/22/93 was vaccinated with a dose of MMRII. On approximately 10/26/93 "within a few days", the pt developed a head to toe rash, which lasted for about 4 days. At that time, it was described as a fine raised red rash. Unspecified medical attention was sought. On approximately 10/30/93, the pt recovered. No product quality complaint was involved. Additional info has been requested. It was also reported that the pt's twin sister was vaccinated with a dose of MMRII and experienced an adverse event.
pt recvd vax & 24hrs later pt exp 3.5 x 2 cm red,swollen,& tender area @ inj site of lt arm,lt arm flushing,muscle twitching in the lt arm,vomiting,& flu-like sx;pt had an office visit to MD 2 days p/vax 15FEB95;tx DPH & APAP;
11:00AM 11 year old female - given MENACTRA shot, immediately after, child felt weak and unable to see, she was sweating and pale, crying hard, unable to see anything, duration equal to 10-15 mins - observation - about to call 911. 7-13-10 3:00PM - Follow up call - telephone. Mom stated child is doing well, back to normal self, no complaints, no other problem, ate lunch.
cold and hot; headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (cold and hot), HEADACHE (headache) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021 at 4:00 AM, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (cold and hot), HEADACHE (headache) and CHILLS (Chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (cold and hot), HEADACHE (headache) and CHILLS (Chills) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.
Patient developed chest pain in the afternoon of 9/4.  EMT's were called.  Mom is an RN and reports HR of 170.  EMT's recorded HR in 130's.  ?SVT on the rhythm strip.  She was transported to the ER and was found to be OK at that time.  EKG was normal.
I had my first Moderna shot on March 18 with no immediate reactions except for a sore left arm. But two weeks later I developed a rash around my navel which rapidly spread across my torso, chest and breasts, and back as well as itching (and some bumps) on the back of knees and itching/redness on  my forearms. My doctor first suggested over the counter Zyrtec and Benadryl, which I took for 3 days with no result. On day 6 of the rash he prescribed Prednisone. I started it immediately. Today is day 7. I think the rash is calmer but I still need to take the medication to see if it has effect.
The patient came to the pharmacy on 4/2/19 she said that she has an adverse reaction due a vaccine that she received in our pharmacy. On 3/27/19 two vaccines FLUARIX on right arm and PNEUMOVAX on left arm. On 3/29/19 she said that her left arm was swelling and hot but nothing further. On 3/30/19 the back of her ear was swelling then on Sunday 3/31/2019 the forehead was swelling and on Monday April 1, 2019 the area under the eyes start swelling she visit her primary physician on 4/2/19. Her primary physician sent a prescription of Methylprednisolone Dose pack.  Dr. (her primary physician) said that the patient apparently has an allergic reaction that her arm do not appear to has infection just a normal reaction at the site of the injection but her eyes are swelling he prescribe corticosteroids to relief the inflammation.
This spontaneous report as received from a physician reporting on himself a 72 year old male patient with diabetes and CIPRO allergy who on 04-FEB-2013, was vaccinated with PNEUMOVAX23, intramuscular (dose and lot # not provided). Concomitant medications included unspecified medication. The primary physician stated that on 05-FEB-2013, he (the physician) developed an injection site reaction following vaccination with PNEUMOVAX23, the injection site reaction was described as a swollen, painful and tender to the touch. The physician also reported flu like symptoms with general malaise (unspecified time frame development). The physician reported that his shoulder joint was swollen and painful on the side that the PNEUMOVAX23, was administered and that he could not move his arm. The outcome of adverse events was reported as not recovered/not resolved. The relatedness for adverse events was unknown for PNEUMOVAX23. Could not move arm at shoulder was considered to be an significant disability or incapacity event by reporter. Additional information has been requested. This is one of several reports from the same source.
I started experiencing adverse events almost immediately following the vaccine (1st & 2nd dose of Moderna). It started with extreme fatigue, debilitating bone pains and night sweats. After months of tests, they discovered the vaccine gave me a pituitary brain tumor.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 07/17/2022 from a home test. I have asthma and I am prone to bronchitis. I had extreme fatigue, chills, achy all over and a bad cough. I contacted my doctor and was prescribed Paxlovid but had to stop after four days due to diarrhea.  After I stopped taking Paxlovid I had a rebound case of COVID-19. Same symptoms as listed above.
Information has been received from a pharmacist concerning a female patient whose husband was vaccinated with a dose of Zostavax. Subsequently, the wife may have developed shingles. A product quality complaint was not involved. Additional information has been requested.
Client developed a large red bump on back or right arm where varicella vaccine had been given, and also small raised bumps 3 on the left arm, one on forehead, 1 in groin, 1 on nose. On Jan 17 client developed more raised pimples and the left arm at the injection site became painful and more swollen.  Parent took to Urgent Care, client diagnosed with Chickenpox and cellulitis of the left arm.  Placed on Keflex 500mg TID.  Client did not have fever or any other problems.
MS; Received the Pfizer bivalent booster on the 28Oct2022 and re-boosted with Pfizer bivalent booster on 03Nov222; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 bivalent booster (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), administration date: 28Oct2022, for COVID-19 immunization; Covid-19 vaccine (Primary immunization series completed; Manufacturer unknown), for COVID-19 immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant) with onset 03Nov2022, outcome "unknown", described as "MS"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Nov2022, outcome "unknown", described as "Received the Pfizer bivalent booster on the 28Oct2022 and re-boosted with Pfizer bivalent booster on 03Nov222". Patient received the bivalent booster on the 28th and then another company came and re-boosted the patient. The patient had 2 boosters within a few days. Nurse asked if there was anything to monitor for. The patient has MS. The Nurse was unsure with the color of the cap as the card only says "Pfizer bivalent on 28Oct and the other one just says Pfizer on the 03".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event multiple sclerosis  and the suspect product BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
a little soreness with the initial shot part; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EN53190) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: WIXELA INHUB taken for chronic obstructive pulmonary disease. The following information was reported: PAIN (non-serious), outcome "unknown", described as "a little soreness with the initial shot part".  Additional information: The reporter stated she takes a cholesterol pill and as of recently she had to start a high blood pressure medication, it's not that high but they want to make sure.
pressure on center of chest...fever....muscle aches....sweating....lack of appetite....fatigue.....sleep problems  lasted 4 nights and days
On 12/2/12, after a 2 week upper respiratory illness, the patient developed numbness and weakness of the lower extremities. He was seen in a local ER and felt to be dehydrated. No specific Rx was given. The mother felt he might have Guillain-Barre syndrome and called me on 12/3/12. I advised going to the ER. He was hospitalized with the diagnosis of Guillain-Barre Syndrome.
Anaphylaxis (loss of vision and sensation in hands) 14 days after vaccine dosage.
pt recvd vax; abdo pain, swelling & itching at site p/ dose 1 & 2; pre tx w/ dph dose 3;
Bad reaction; Not feeling well; Got a fever that is consistently around 102; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Bad reaction), MALAISE (Not feeling well) and PYREXIA (Got a fever that is consistently around 102) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Bad reaction), MALAISE (Not feeling well) and PYREXIA (Got a fever that is consistently around 102). At the time of the report, FEELING ABNORMAL (Bad reaction), MALAISE (Not feeling well) and PYREXIA (Got a fever that is consistently around 102) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
fever 103.7 w/in 4 hrs of vax; constant fever for 2 days; lt arm red & swollen to the elbow; no react to prev DTPs;
PATIENT GIVEN HEP A/B TWINRIX INTRANASAL VICE FLU-MIST. THERE WAS NO ADVERSE REACTION TO THE VACCINE. PATIENT FOLLOWED UP THE NEXT DAY WITHOUT ANY COMPLICATIONS.  STAFF MEMBER WAS TAKEN OFF GIVING IMMUNIZATIONS AND WILL BE ATTENDING THE NEXT CLASS FOR IMMUNIZATION ADMINISTRATION.
VIIS ID: 11344242 Moderna COVID-19 Vaccine Vaccine Lot Number:  018B21A first dose. Reaction at injection site, mild. denies SOB, chest pain. Administered 25mg diphenhydramine oral @ 11:25hrs. 11:40 consult with healthcare provider. Lungs clear, denies: itch throat, throat swell, swallow and speech. 27 weeks pregnant with 3rd child. Allergy: sulfa. vaccine given at 11:07; reaction 11:15. EMS called 11:17; 11:22 P 82; 11:30 100/59 P 85.
On December 16,2021 had I experienced facial numbness and paralysis. It started with tongue moved to entire side of my face. I went to ER had a CT scan diagnosed with Bells Palsy was prescribed a steroid.
HAD TO STOP ON THE WAY HOME VOMITING CHOKING. CONTINUE HOME LOW GRADE FEVER WEAKNESS AND PAIN WAIST DOWN. CLIENT CALLED 8:30 OR SO 12/17/2009 ENCOURAGE CLIENT TO SEE md IF SYMPTOMS CONTINUES
Shortness of breath, palpitations,  chest pain, chest discomfort. Pericarditis
Severe headache for hours, Tylenol did not help Dizziness Body shaking Tingling sensations in legs Feeling sick Muscle cramps, was painful to move
33 weeks gestation presents to the emergency department referred from urgent care and her OB/GYN for evaluation of left-sided facial tingling and left-sided facial droop. Bells palsy secondary to left ear infection vs COVID vaccine. Recommended to follow up with neurologist
Information has been received from a pharmacist intern concerning a 24 hours old male who on 14-MAY-2009, was vaccinated with PNEUMOVAX (dose, route and lot unspecified). The pharmacist intern mentioned that a patient received a dose of the vaccine instead of PREVNAR. It was unspecified if the patient sought medical attention. No adverse effects reported. Additional information is not expected.
I'm not completely sure if it is related, but no one could figure out why this happened. I am 37 weeks 2 days pregnant as of today, and yesterday I was treated in labor and delivery  for spotting. When my urine was examined I had no bacteria, but I had a large amount of blood in it. So no infection but gross hematuria (51-100 hpf)
Rash on buttocks and along T2-T3 nerve root per patient report. Has occurred more than once since booster shot.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 61 years old male patient who was vaccinated with a 0.5 ml once a dose of FLUZONE HIGH DOSE (Batch number: UJ006AA and expiry date: 14-Apr-2019) via intramuscular route instead of TDAP and also received a dose of 0.5 ml dose of FLUARIX not produced by Sanofi Pasteur (lot number: 794A3 and expiry date: 30-Jun-2019) via intramuscular route. Site: IM Right and Left Arm (received FLUZONE HIGH DOSE and FLUARIX but it is undertermined which arm each vaccine was given in) on 24-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because a 61 year old patient received the following vaccine; extra dose administered because received two doses on the same day and wrong vaccine administered because not received TDAP. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
pt recvd vax 1104 AM 5NOV92 @ 10AM pc form pt's mom pt has fine pinpoint red rash on trunk, itchy; relates also had mild temp; rash lasted 24 hrs; took pt to MD; t103;
This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 31Mar2021 09:00 (at the age of 35-year-old) (Batch/Lot Number: ER8730) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included hypertension. Concomitant medication included ascorbic acid, beta carotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN). The patient previously took bactrim and experienced allergies. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN 6206), administered in left arm on 10Mar2021 at 08:45 AM (at the age of 35-year-old) as 1ST DOSE, SINGLE for COVID-19 immunization. On 27Apr2021 at 08:00 AM, the patient experienced bilateral embolisms (blood clots in lungs) and also had blood clot in left leg. Symptoms before diagnosis included dry cough, coughing up blood, chills, fever, body aches, and body pains. The events caused hospitalization. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included COVID-19 test via nasal swab post vaccination which was negative on 29Apr2021 and on 07May2021. Therapeutic measures were taken as a result of bilateral pulmonary embolisms and had blood clot in left leg, chills, and body aches/body pains which included Lovenox injection (blood thinner) and Tylenol for pain. The patient was recovering from all events.
CAN BARELY WALK; WEAKNESS; FELT LIKE THROWING UP; HEADACHE; BACK STARTED TO HURT (TERRIBLE PAIN IN LOWER BACK); SORE ARM; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 175 pounds, and height was 66 inches. The patient's concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included patient had no known allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced back started to hurt (terrible pain in lower back). On 03-JUN-2021, the subject experienced weakness. On 03-JUN-2021, the subject experienced felt like throwing up. On 03-JUN-2021, the subject experienced headache. On 04-JUN-2021, the subject experienced can barely walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and headache, had not recovered from felt like throwing up, weakness, and back started to hurt (terrible pain in lower back), and the outcome of can barely walk was not reported. This report was non-serious.
Fever > 104 degrees. Nausea/vomiting and stomach cramps. Stiff neck and headache. (Patient will see PCP 7/8/15).
Patient called on 10/13 stating her arm was swollen/hard/red and she could not raise her arm the day prior. She described it as "severe swelling, like a balloon-type pressure" in her upper arm and the swelling moved down to underneath her arm to under her elbow. She reported no fever. She went to a clinic to get checked out and was prescribed an antibiotic, Clindamycin three times daily for 7 days. She did not start the antibiotic therapy. I followed up with her on 10/15 and she stated her arm was still swollen but improving. Patient was instructed to follow up with clinic if she has any further adverse events.
Pain,redness,and swelling in right upper arm above the injection site.Tingling  and numbness radiating up right side of neck and tingling and numbness in the right side of face.
***********************************COVID  BREAKTHROUGH CASE ********************* On Monday May 9,2022 I had a tickle in my chest I felt like I was getting a cold. Then on the 10, I had a deep nasty cough so I took another test and it was negative. I took a PCR test at the pharmacy (positive) saw my Doctor on the 11th and he gave me Paxlovid.
Started with itching at injection site, approximately 5 cm swelling around injection site, then with in 90 minutes of injection had sneezing and wheezing.
Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe
No adverse event; Patient received the Moderna vaccine monovalent on 30-Oct-2021 and second on 30-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Moderna vaccine monovalent on 30-Oct-2021 and second on 30-Mar-2022) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Moderna vaccine monovalent on 30-Oct-2021 and second on 30-Mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Moderna vaccine monovalent on 30-Oct-2021 and second on 30-Mar-2022) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Moderna vaccine monovalent on 30-Oct-2021 and second on 30-Mar-2022).    No concomitant medication was reported.  Patient was over 65 years old. Patient got bivalent on 19-Sep-2022 and were at higher risk. No treatment information was reported.  This case contains information for patient 2 of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-720117 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720117:Patient 1
pt recvd vax & w/in 30mins p/vax exp abd pain & was hospitalized;tx Maalox, APAP, advil, & IV fluids; sx persist