chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several hours after receiving SHINGRIX, the patient experienced fever (serious criteria other: as per reporter) and chills (serious criteria other: as per reporter). The patient was treated with TYLENOL. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by healthcare professional (HCP) on live television for himself in the morning of the reporting date. The age at vaccination was not reported. When the patient got SHINGRIX, he stated it was such potent vaccine that night he had a little bit of a fever and chills. The patient felt it. The patient had TYLENOL and he felt better. It was unsure if these adverse events were reported previously.
Pt described feeling lousy, muscle aches, and temp of 102.3 10 days post vaccination.  On day 11, presented to immunization clinic with temp of 100.6.  Around site and approximately 4 inches medially was red, swollen, and hot to the touch.  Pt had episode of lightheadness and almost fainted when having smallpox dressing changed.  Was taken to the Urgent Care clinic where they cultured the site and put her on Keflex 500 mg tid x 10 days because of a concern of cellulitis.  Pt missed 24 hrs of work as a result of illness/fever.
Just like 1st vaccine dose, After approximately 15 minutes lips, tongue, gums, roof of mouth, eyes swelling.  Was given Benadryl and stayed for 1 1/2 hours while monitored by nurses.  Went home, rested and felt poorly the rest of the day.   The new issue was then on Sunday, the lymph gland on my left clavicle swelled up. I thought it was a blood clot so I went to the ER. Had I been told this may happen I would not have gone to the ER.   The swelling has not gone down but gotten worse, has expanded to both arm pits, arms, groin areas, upper chest and breasts. Overall feeling of malaise and tiredness. Occasional heavy chest and headaches.   Spoke with PCP yesterday. He asked if I was given anything for my symptoms ( swelling and pain ) I said no. He is hoping this will resolve itself with time.   Have used heating pad and Tylenol and have rested for three full days.
Pt's cause of death was due to COIVD -19 illness. No one believes that the vaccine was part of the death. The patient was fully vaccinated with 2 doses of Pfizer vaccine.
I feel hot after 15-30 minutes of the injection. I turn red and flush. I feel tingling to my legs and arms. And numbness to the left side of my face. I felt like my heart was beating  fast. The administrator gave me bendryl. I felt better, but I felt weak. I was able to go home 2 hours after the administration.
Experienced nausea for 3+ days, red streaking from vaccination site to just below the elbow, a lesion appeared in the area where the streaking stopped 6 to 8 weeks later.  Later diagnosed as granuloma anulare.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 20-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
On 1/27/21 noticed severe itching in upper back, scratched places formed scabs.  Went to dermatologist on 1/29/21 and was told it was shingles.  They performed a biopsy to confirm the diagnosis.  Positive for shingles.  Took the second Moderna vaccine on 2/22/21 and developed a raised, red rash on left upper arm.  It subsided after about a week.
p/vax pt devel anaphylactic rxn described as throat constriction;taken to hosp tx w/epi, steroids & DPH;pt sx abated;rxn considered important medical event;36hr later pt throat constriction reoccurred accompanied w/local rxn;pt hosp;60 day follow-up received on 10/25/00 provided no additional data.
RED CIRCLE AROUND INJECTION SITE, WARM TO TOUCH & RAISED, TINGLING IN FINGERS, GENERALIZED FATIQUE AND NOT FEELING WELL
Pt came by the pharmacy on Sept 18, 2019, to report that her left arm bruised. She received Fluzone HD on left arm and Shingrix 1st dose on right arm. She reported her left arm swell with bruising for more than a week. Her bruise size was 2 inches in diameter when she came to the pharmacy on sept 18, 2019.
ended up with a rash on my upper chest up into my neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (ended up with a rash on my upper chest up into my neck) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced RASH (ended up with a rash on my upper chest up into my neck). On 30-Mar-2021, RASH (ended up with a rash on my upper chest up into my neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
she did cut her thumb on the broken part of the plunger; 2 syringes of GARD ASIL 9 where the round portion of the plunger broke which occurred once when a nurse was giving the injection and once when the nurse was about to give an injection; This spontaneous report as received from a registered nurse refers to a nurse female patient of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  On 15-FEB-2021, the patient had 2 syringes of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringes where the round portion of the plunger broke, which occurred once when she was giving the injection and once when the she was about to give an injection  for prophylaxis (lot # T008152, dose:0.5 milliliter, intramuscularly, expiration date reported as 01-JUN-2022, but upon internal validation established as 21-JUN-2022).    The nurse, who was giving the injections did cut her thumb on the broken part of the plunger. The registered nurse described the portion of the plunger breaking as a snap, with once small piece breaking off. No additional adverse events. No further information provided. It was reported that she was unable to obtain broken syringes/plunger as they had been placed in the sharps disposal. It was reported that the patientt did not received treatment for the events. It was mentioned that the patient did no seek medical attention. It was stated that the plunger rod (only) did not fell out of syringe barrel during use or loose and the circular part of plunger broke during use. the broken area was of one piece broken off.  The nurse mentioned that the one syringe broke after removal from tray and rather easily per costumer.  It was reported that when nurse went to give vaccine bottom of where plunger is (circular area) broke off. This occurred with 2 syringes, with one resulting in nurses thumb getting cut. The broken area was of one piece broken off.  The outcome of skin laceration was reported as recovered, on an unspecified date in 2021. The causal relationship between the skin laceration  and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. 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.; devicelotnumber: T008152; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
3 hours, post vax, felt tired, stomach and tongue burned. Mother brought him to the clinic on 3/12/01 and to ER at hospital. ER to him to "take it easy". Pepto-Bismol helping with stomach. New tooth brush may have bothered tongue; recovering. Doctor told mom "a viral infection too soon for vaccine reaction".
Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm, on 21Sep2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm and on 10Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Borderline Diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Diabetes mellitus: Borderline, notes: Borderline Diabetes; SARS-CoV-2 test: Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with paxlovid on 28 Jun for 5 days.The patient had no known allergies. The patient had not received any other medications within 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5cm x 3cm erythematous, swollen sore area developed within 24 hours of vaccination
Vaccine given 5/5/10. Runny nose, cough started 5/12. Fevers 103-104 started 5/17-5/22. Mild red eyes. Rash, maculopapular started on leg and ascended up 5/17-5/22. Irritability.
I was alerted that on June 26, 2022 that I had been exposed to COVID-19, I took a home COVID-19 test and it was negative. The next day I had a sore throat but my test was negative. On June 30, 2022 I had a positive COVID-19 test, called my doctor, had a telehealth visit, she prescribed Paxlovid. I started taking it that night, I noticed my symptoms, were mostly a small headache, congestion, nausea and diarrhea. None of this lasted long. My nose is still a little stuffy today (day 13) but otherwise I feel good.
"Moderna COVID-19 Vaccine EUA" C/o itching with tingling in hands. Seen by provider. Denies CP, SOB, Chills, Sweats, No dizziness, nausea, vomiting. No rash, Hives, or welts. Pruritis. 1 injection of Benadryl 50mg/ml given. Check again on patient and provider will f/u again tomorrow.
Diarrhea; body aches; chills; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown) via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunisation. Medical history included covid-19 (if covid prior vaccination Yes). The patient's concomitant medications were not reported. The patient experienced diarrhea, body aches and chills on 29Jan2021. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021.  No follow-up attempts needed. No further information expected.
First 24 hrs included sore throat, itchy runny eyes, and headache.  Day 2 added low energy, achy.  Day 3 and 4 added fever, cough and congestion.  Improvement started on Days 5 and 6.
Narrative:  On Nov 2, 2021 78yo patient presented to Primary care to establish care with facility for possible hearing aid as receives his medical care & medications from outside facility providers. Pt had received covid vaccines on on 2/12/21, 3/5/21, & 9/29/21 at store. Pt died of unknown causes & unknown location on 12/15/2021. Not able to assess if covid vaccines are related to this death. Pt medical history included DM & COPD.
Pt received DTaP in left deltoid. Today 01/18/2002 presents with large area (approx 8cm) redness and edema with blistering in some areas. No treatment other than Tylenol at this point.
On 11/17/00, the pt developed a rash, high temperature and swelling of the hands, knees and lips. The pt was seen in the ER on 11/19/00.
Body aches; Headache; Chills; Fatigue; This is a spontaneous report from a non-contactable consumer. A 46-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in left arm, on an unknown date in Mar2021 at 11:00 at the age of 46 years as a single dose for COVID-19 immunisation. Past medical history was not provided. Past drug history included allergic to sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included allegra (MANUFACTURER UNKNOWN) for an unknown indication, dymista (MANUFACTURER UNKNOWN) for an unknown indication and prozac (MANUFACTURER UNKNOWN) for an unknown indication these medications were used within 2 weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in left arm on an unknown date in Feb2021 as a single dose for COVID-19 Immunisation. The facility where the most recent COVID-19 vaccine was administered was at a workplace clinic. On an unknown date in Mar2021 (9 hours after 2nd injection), the patient experienced body aches, headache, chills and body aches during sleep time. Fatigue with worse body aches next day and night and into next day. The patient received advil and alleviated some discomfort as a therapeutic measure. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events body aches, headache, chills and fatigue was recovered on an unknown date. Information about lot/batch number cannot be obtained. No further information is expected.
Patient still complains of arm soreness after receiving the flu vaccination on 11/2/07.
Member states pain heat and hard lump at injection site. Rash developed on left arm and remained for two weeks plus left arm pain.
Red swollen area warm to touch at injection site. 60 MM x 75 MM redspot.
-04/07/2021 @9pm-Fatigue -04/08/2021 @12:30am- Headache (like a migraine), chills and body aches
Pt presented 48 hrs post vaccination with erythema extending in a 3" diameter around injection site. Pt monitoring.
6/13 61y.o. male with PMH for HTN,  HLD, IDDM, PAD s/p left iliac stent 6/2020, known severe AS and CAD s/p prior distal LAD stent 2015, proximal DES RCA 3/2020. He initially presented to the Clinic this morning for pre operative testing in preparation for CABG/AVR tomorrow 6/14/22 with Dr.. He c/o chest pain on arrival and was taken to the EC for evaluation.
Pt (PREGNANT) recv vax on 1/25/99; post vax on same day pt stated she was 6 - 8 wk pregnant
Raised red area approximately 4 inches in diameter with a pink circular eurthmia approximately another 2 inches surrounding the outer portion of the immediate raised area. Benadryl was administered but to no affect. Over the past 4 days the size of the red raised area has reduced
Per parent child c/o right arm pain. Parent states right arm red and swollen x 2 days. Vacc 10/13/06. Right arm still with swelling, color light pink. Arm warm to touch. Parent states arm with 1-2 cm blister at right deltoid injection site.
Breakthrough - PT Deceased cant confirm VAX  1st dose - 4/23/2021 - moderna - 038B21A 2nd dose - 5/21/2021 - moderna - 023C21A
pt recv vax; devel rash on face, chest,legs; at 5pm T of 102.3 R;seen by MD;APAP not given prior to vax but started when T noted;
Mom called and went to ER. Fever 102-103 degrees, joint pain and hand burning- feeling. Pt with fever, joint pain had meningococcal and HPV vaccine today. No cough or URI sxs. (+) headache, joint pain. No rash.
Information has been received from a nurse practitioner concerning a 12 month old female who on 02-SEP-2009 was vaccinated SQ with 0.3 ml first dose of MMR II (lot number: 663857/0355Y). Suspect therapy included VARIVAX (Merck) SQ on 02-SEP-2009 (lot number: 664933/0866Y). The nurse practitioner reported that while giving a child the first dose of MMR II the syringe became faulty and only 0.3 ml was administered. This was an office syringe. The patient also received VARIVAX (Merck) in the same thigh. An area on the thigh was slightly red after administration but was unknown if it was from of MMR II or VARIVAX (Merck). The patient sought unspecified medical attention. At the time of the report the outcome of the patient was recovering. Follow-up information has been received from the nurse practitioner concerning the infant with no known drug allergies and no past medical history who was vaccinated on 02-SEP-2009 with a SQ first dose of MMR II (663857/0355Y) at 10:00 AM in the left thigh. There was no illness at the time of vaccination. The nurse practitioner reported that they were unable to administer more than 0.3 ml of MMR II due to a faulty syringe. They did not give the balance of MMR II with the new syringe as the patient's thigh appeared red where the partial dose had been given. No further information is available.
There was accompanied pain in the knee and ankles; There was accompanied pain in the knee and ankles; I had varicose veins in my right leg that after the vaccination became very badly swollen and then one appeared in my left leg.; This is a spontaneous report from a contactable consumer or other non hcp.   A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EL9261; Expiration Date: unknown), dose 1 via an intramuscular in Arm Left on 27JAN2021 11:45 as single dose and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EN6200; Expiration Date: unknown), dose 2 via intramuscular in Arm Left on 28Feb2021 11:40 as single dose for COVID-19 immunization. Medical history included blood pressure increased from an unknown date and Kidney Stone from 28Nov2017 to 4Feb2018. Patient surgical procedure includes Catheter operation 1Dec2017, Removal 1 , 15Jan2018 and Removal 2, 14Feb2018 The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced varicose veins in right leg that after the vaccination became very badly swollen and then one appeared in left leg, accompanied pain in the knee and ankles. The outcome of the events was not recovered.   No follow up attempts are possible. No further information is expected.
about 7 to 10 days after Moderna shot, started to notice some petechia spots around both feet and working up legs. 10 days after spots started to developed on both forearms. Went to clinic and they did lab work-up to include PT/INR. CBC, BMP etc. all labs normal. Spots continued to grow with some starting to look like large healing bruising, nut never went away. Received second moderna shot on 2/2/21 and about 5 to 7 days after shot noticed an increase in blotchy spots to both legs and arms. I then had a visit with Dr. who ordered steroid cream, which had no effect on areas and was given referral to a dermatologist.   Spots then started to run from wrist on both arms up to biceps and from feet on both legs up to mid-thigh. I then start to have spots start on abdomen and in groin area. With some spots looking to irregular ringworm type marks. Dermatologist appointment was cancelled due to weather.
rt arm swollen egg size & reddened;c/o pain when bump arm is using it;only noticed today 30APR96;
I had all the symptoms I had when I was coming down with the disease.  Cough, fatigue, headache, neck & shoulder aches, no appetite,  blah feeling lasting 3 days
mom states pt recvd vax approx 10AM 24FEB93; about 8PM that day pt began to cry-temp 102 & lt leg had some swelling & felt warm to touch; mom took pt to MD 25FEB93;
5 in x 5 in area of erythema (blanchable) and warmth around injection site (right ant. thigh).
slight fever 99.7 (normal 97.4) , allover body aches 4/10
Moderna Lot Number 045J21A was inadvertently used one day beyond the expiration date of May 2, 2022.  Per FDA (Food and Drug Administration) guidance, the company was contacted on May 3, 2022 about the vaccine storage error.  The company conducted research on the same lot number and simulated the same conditions noted by the agency.  The company found that the vaccine met the required activity to produce the needed immune response.  This is company Case Number CEA-2351.  Although the company noted this vaccine was sufficient to produce the needed immune response, patient was encouraged to speak with their provider to determine the next steps appropriate for them.  Patient has experienced no known adverse events.
2 days after flu shot, had febrile seizure. Short duration, less than 2 min. Stopped seizing and back to normal level of consciousness by the time EMS arrived. Did not go to hospital or ER. Sibling has had febrile seizure.