chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar levels spiked, are extremely high and the insulin is not helping) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Cholesterol. Concomitant products included INSULIN and METFORMIN for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar levels spiked, are extremely high and the insulin is not helping). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar levels spiked, are extremely high and the insulin is not helping) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment medication included Insulin.
pt recvd vax; 30dec94 checked by MD for rash & t 102 ax x 3 days;instructed to file VAERS per MD; 3jan95 mom reports pt "OK" now;
Breakthrough case admission after 3 vaccines Moderna 3/16/21 lot# 045A21A;  Moderna 4/13/21 lot# 016B21A; Moderna 11/19/21 lot# 039F21A
4/16  after leaving the vaccine facility just got dizzy and slight chest pain while driving as soon as I got home I took the medication   4/17  just slight chest pain and coughing all day   4/18  felt no pain           4/19  10:00 am the chest pain hit me hard I couldn't stand up but I manage to get a ride to the hostipal.  Apparently I lost consciousness before I entering the hostipal.   The rest of the week I spend coughing up blood and not breathing well. 04/19 - 4/25 spend I.C.U.  at  Hostipal
Information has been received from a registered nurse and the patient's mother concerning a 14 year old female patient with no allergies and no pertinent medical history who on 23-MAR-2007 was vaccinated with the first dose of GARDASIL (date also reported as 22-MAR-2007 by the patient's mother), on 23-MAY-2007 the patient received the second dose of GARDASIL the patient's mother reported that in approximately may 2007, the patient experienced severe hair loss. On 24-SEP-2007, the patient was vaccinated with the third dose of GARDASIL. Concomitant therapy included vitamins (unspecified). In July 2008, the patient came into the doctor's office and stated that her hair started to fall out and she had had dramatic weight loss (onset date not reported). The nurse reported that the patient was going to have various test done. As of 30-DEC-2008, the patient had not recovered. Additional information has been requested.  2/9/09 PCP records received. 2/6/08 WCC with Impression:  Well Teenager.  (Some records illegible) Seen 3/27/08 for bradycardia.   OV 4/24/08 with c/o sore throat and H/A.  Throat hyperemic on PE.  Imp: Pharyngitis.  OV 7/7/08 with c/o losing hair x 1 month, facial hair x 1 month, irregular periods with R sided pain, R foot lump, lump on coccyx, and significant weight loss (169 in 2/08 to 146). Sent for labs. Returned 12/31/08 for f/u of hair loss. No dx noted.
chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and NAUSEA (nausea) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and NAUSEA (nausea). At the time of the report, CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up was received on 25-MAY-2021,Email was updated
Late schedule of vaccine; Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late schedule of vaccine), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Shingles (at the age of 17, 55 yrs ago).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late schedule of vaccine). On 05-Apr-2021, HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late schedule of vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication information was not provided by the reporter.  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-036376 (Patient Link).
Severe headache, fatigue. pain in arm on the side of injection site, pain in shoulder up to the neck.
A week after receiving the first injection of Moderna vaccine, my arm began to itch and develop a red rash on the upper arm. My armpit also began to swell and was sore, indicating swollen lymph nodes.  The symptoms lasted about 3 days, then subsided.
This spontaneous report as received from a Register Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-OCT-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous, lot number reported as J007855, expiration date 28-SEP-2014 (dose was not reported). Secondary and concomitant therapies were not reported. Nurse reported that a unspecified patient received an expired dose of ZOSTAVAX vaccine on 06-OCT-2014. No adverse events were reported. Additional information has been requested.
A report was received from a health care professional on 11/01/02, concerning a male vaccinee older than 60 years who experienced chills, soreness and erythema of the arm one day after receiving 0.5ml Fluvirin intramuscularly on 10/30/02. On 10/30/02, the vaccinee experienced chills approximately 4 hour post vaccination. The following morning, the vaccinee experienced soreness and erythema from the injection site to the elbow and encircling the arm. The vaccinee had not recovered at the time of reporting and is currently taking prophylactic antibiotics. the vaccinee received Fluvirin last year without any adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/18/02: A 71 year old vaccinee experienced fever and a red area was hot to touch after receiving Fluvirin on 10/30/02. It was reported that symptoms lasted a week and then resolved.
No additional AEs reported; On 17MAY2022, the patient was administered a second dose of VARIVAX, along with a dose of PROQUAD; This spontaneous report was received from a nurse concerning a 35 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.     On 19-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).  On 17-MAY-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter for prophylaxis (lot number U025205 was determined to be valid for varicella virus vaccine live (oka/merck), expiration date reported and established as 13-AUG-2023) (strength, route of administration and anatomical location were not provided) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot number U029325 was determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and established as 19-MAR-2023) (strength, route of administration and anatomical location were not provided) (overdose).   No adverse event reported.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 27-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pain in calf, swelling in lower leg (left leg), weakness/numbing in that leg- led to blood clot diagnosis.
Patient in lobby for covid flu observation Father present Called by staff to child Patient observed altered consciousness Diaphoretic Near syncope episode Vitals:   06/08/21 1450 06/08/21 1452 06/08/21 1503 06/08/21 1509 BP: (!) 80/27 96/41 109/54 107/54 BP Patient Position: SITTING LYING LYING SITTING BP Location: RA-RIGHT ARM RA-RIGHT ARM RA-RIGHT ARM RA-RIGHT ARM Cuff Size: Standard Adult Standard Adult Standard Adult Standard Adult Pulse: (!) 44 (!) 40 (!) 48 (!) 49 Resp:   32     SpO2:   99% 100% 100%   Assisted child to wheelchair, 2 person assist Initial blood pressure while sitting And then layed patient on gurney Legs elevated Past Medical History reviewed, Rechecked vitals   Continuously monitored patient  Patient at 1503 alert, no longer diaphoretic Denies nausea or shortness of breath Heart rate remains brady cardia reivew of previous vitals 1/12/20 105/65Hr 60   Lung sounds clear no wheezing Per father he has not needed his inhaler for asthma recently   He does play basketball and baseball   Call to urgent care to discuss patient status Verbal order for 911 related to bradycardia   911 called at 1521 Father agreed to plan of action for son to be assessed by physician    Paramedics on scene, verbal report provided  114/54 hr 47 upon arrival
Patient states that she had an inflammation, itching, and pain from elbow up to her neck. Felt her skin was extremely stretched out. Also complained aboout difficulty breathing. Went to the hospital and states she felt she was going to die.
-one week after injection (jan 22), began experiencing hives all over my body. injection site was particularly swollen and itchy (but not painful). itchy throat, ears. almost one week since the hives began, and they are still there. injection site still itchy and swollen. hives especially prevalent on legs.
Information has been received from healthcare worker (pharmacy technician) who reported that a dose of PROQUAD (Merck) lot number reported as H015644 exp. date 23-FEB-2014 (dose and route not reported) that was improperly stored at 36-46 degrees F in the refrigerator for possibly 816 hours on 01-NOV-2012 was administered on 28-NOV-2012. The patient's identifiers were not available at the time of the call (age, gender not provided). No adverse effect reported. This is one of several reports from the same source (MAARS # 1212USA011255, 1212USA011256, 1212USA001732). Additional information has been requested.
? Shortness of breath ? Feelings of having a fast-beating, fluttering, or pounding heart
Little soreness; This is a follow-up spontaneous report from a Pfizer-sponsored program. A 78-year-old contactable male consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced little soreness on the site where it has been injected. Patient took treatment as opioid (pain medication). Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Information has been received on 10/09/2002 from a medical supplier on behalf of 2 physicians concerning a female patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the patient developed "severe redness in an area 2-3 inches around the injection site," and flu-like symptoms.  The patient sought unspecified medical attention.  It was reported that two other females had a similar reaction (WAES # 0210USA01012, 0306USA02723).  Additional information has been requested.
died 2 weeks later; was diagnosed w COVID; was diagnosed w COVID; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died 2 weeks later"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "was diagnosed w COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: diagnosed w COVID, notes: was diagnosed w COVID. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The clinical course was reported as follows: elderly woman 80 years-old who was fully vaccinated with Pfizer's vaccine otherwise healthy traveled this summer to visit family. Upon return home was diagnosed with COVID and died 2 weeks later. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: died 2 weeks later
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 17-MAY-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry fate 08-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Had soreness in my left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Had soreness in my left injection site arm.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 VACCINATION SITE PAIN (Had soreness in my left injection site arm.). At the time of the report, VACCINATION SITE PAIN (Had soreness in my left injection site arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-375113 (Patient Link).
he was unable to receive his second vaccine as scheduled; This spontaneous case was reported by a health care professional and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (he was unable to receive his second vaccine as scheduled) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (he was unable to receive his second vaccine as scheduled). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (he was unable to receive his second vaccine as scheduled) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2020, SARS-CoV-2 test: positive (Positive) COVID Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment included Dsansone was noted.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Lab data added were added.
Case number PHEH2015US003148 is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 11 year old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 03 Feb 2015. It was reported that the vaccine which was given to the patient was frozen with excursions at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, at 0.8 Celsius for 36 minutes on 24 Jan 2015 and at 0.6 Celsius for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error.
Massive Headache for 4 days 103 degree temp for 3 days large injection site reaction
Right arm was sore for about 3 days; This is a spontaneous report from a contactable consumer reporting for a patient. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant at the time of vaccination. The facility type vaccine was hospital. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced right arm was sore for about 3 days on an unspecified date with outcome of recovered. Patient didn't receive treatment for the adverse events. The event was reported as non-serious.  Information on the lot/batch number has been requested.
Dizziness, Headache, NauseaVomiting, Injection site soreness,Fatigue Narrative:
Patient had 2 grand mal seizures 4.5 days following his MENINGOCOCCAL vaccine.  Stomach ache night before.  Started vomiting @ 2:30.  Vomited 3-4 times.  First seizure @ 10:30 AM duration of 30 sec.  Two hours later second seizure in E.R.  Lasted 45 seconds.  No prior seizure history or adverse reactions to vaccinations.  Anti seizure Med. 11/25/09 ER records received for date 7/25/09 to 7/26/09. DX: gran mal seizures, GERD, elevated creatinine, recent meningococcal vaccine. Pt. presented to ER via EMS. Had witnessed seizure, postictal on arrival to ER. Witnesses of pt seizure states pt had contractile seizure, some shaking, pt not aware, foaming from mouth. At ER pt had vomiting and diarrhea.  Assessment: tachycardia RR, headache, weakness, sleepy. Pt was (+)HA, N&V, prior to seizure 12/3/09 Medical records received for DOS 11/7. Final DX: seizure w/sub therapeutic Dilantin level. H/O seizure disorder. C/O seizure x2.  H1N1 vax on 10/30/09.  Dilantin level sub therapeutic.
Pt was given Gardasil #1 at 8:58 AM, was fine immediately after but fainted around 9:06. Pt immediately recovered and was evaluated by physician.
Within 20 minutes after receiving the first dose of Pfizer vaccine until today, I feel itchiness on my face, my ears, my neck, my whole body and my eyes.; Within 20 minutes after receiving the first dose of Pfizer vaccine until today, I feel itchiness on my face, my ears, my neck, my whole body and my eyes.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Feb2022 15:45 (Lot number: FJ6369) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing); "If COVID prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. The following information was reported: EYE PRURITUS (non-serious), PRURITUS (non-serious) all with onset 03Feb2022 16:00, outcome "not recovered" and all described as "Within 20 minutes after receiving the first dose of Pfizer vaccine until today, I feel itchiness on my face, my ears, my neck, my whole body and my eyes.". Therapeutic measures were not taken as a result of eye pruritus, pruritus.  Additional information: No other vaccine received by the patient in four weeks. Patient has not been tested Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
pt recv vax 11MAY98 & reports local rxn of lt arm @ inj site w/ 1/2" ecchymosis resolved p/1wk on 13MAY98;pt reports edema of lt leg from knee & foot;tingling & dec of touch;edema;
Information has been received from a health professional concerning a 15 month old female (also reported as male) with a cough and runny nose who on 1/30/04, at 13:45, was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot # 646535/0575N). Concomitant medications included a fourth dose IM in the right thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (lot 495033) and guaifenesin. On 5/6/04 the patient presented to the office with a chicken pox rash. There were about 15 lesions confined mostly to the abdomen, legs, and feet. Medical attention was sought, but no treatment was required. No product quality complaint was involved. No other information is available. Follow up information indicated that the patient was seen in the office on 5/6/04 with a cough, runny nose, and rash which started with small bumps on 5/5/04. At the office, the patient had one red papule on the abdomen, about 10 red papules on the feet and legs, and 1 on the labial margin. It appeared to be itchy. Symptomatic treatment and isolation was advised and the parent was told to follow up as needed. No labs or diagnostic tests were done and recovery status is unknown. Additional information is not expected.
Within one week of vaccination the client had a sore swollen arm and also developed hives along both labias and swollen, tender inguinal lymph glands.
3RD DOSE PFIZER COVID VACCINE GIVEN 9/29/21, #FF2587; 4TH DOSE PFIZER COVID VACCINE GIVEN 4/13/22, #FK9895; 8/1 - 8/5/22 pt hospitalized with C.Diff positive, positive COVID test, hypokalemia due to chronic diarrhea; 8/25/22 pt returns to hospital with hypokalemia, acute metabolic encephalopathy; AKI; electrolyte derangements; bloody stool; received 3 U pRBCs and 3 U platelets during hospitalization; broad spectrum empiric ABX; O2 supplementation; pt's condition worsened; thrombus in both legs; pt declined and passed away in the hospital
Rash (red, raised, small) started 4 hours after administration. On abdomen & legs, buttocks. Took BENADRYL that night. Rash on legs & buttocks resolved next AM but several on left elbow & still on abdomen 11/21/12 spread to her back & very itchy.