chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching; Fever; extreme headaches; Chills; very sore at site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itching), PYREXIA (Fever), HEADACHE (extreme headaches), CHILLS (Chills) and VACCINATION SITE PAIN (very sore at site of injection) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031047) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), PYREXIA (Fever), HEADACHE (extreme headaches), CHILLS (Chills) and VACCINATION SITE PAIN (very sore at site of injection). At the time of the report, PRURITUS (Itching), PYREXIA (Fever), HEADACHE (extreme headaches), CHILLS (Chills) and VACCINATION SITE PAIN (very sore at site of injection) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 3rd patient out of 5 patients as described by the reporter.  Concomitant and treatment medications were not reported.  The reporter said that the reporter had five other employees that were given the shot on the same morning of vaccination and all those had adverse side effects. Three of the employees had to call out sick next days with several symptoms ranging from fever, extreme headaches which still haven't subsided, chills, itching, very sore at site of injection.   This case was linked to US-MODERNATX, INC.-MOD-2023-748333, US-MODERNATX, INC.-MOD-2023-748403, US-MODERNATX, INC.-MOD-2023-748404, US-MODERNATX, INC.-MOD-2023-748342, US-MODERNATX, INC.-MOD-2023-748215 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2023: Live follow-up received that contains significant information: Batch number and event details were updated. On 03-Nov-2023: Live follow-up received that contains non-significant information: Reporter information and narrative were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748333:Patient 1 out of 3 US-MODERNATX, INC.-MOD-2023-748404:same reporter Patient 5 US-MODERNATX, INC.-MOD-2023-748403:same reporter Patient 4 US-MODERNATX, INC.-MOD-2023-748342:same reporter Patient 2 US-MODERNATX, INC.-MOD-2023-748215:Reporters case
about 5 minutes post injection, patient appeared dazed and unresponsive, but maintained conciseness, pulse, and breathing during event.  Patient regained baseline shortly after. EMS arrived on scene and medically cleared patient to leave without further medical attention. Patient did not inform us of history of similar reaction to vaccination and blood draws in the past until after the reaction occurred.
Severe Fatigue, fever, Headache, Mental confusion, Sleeplessness, Swollen Lymph Nodes, High Sedimentation rate
Information has been received from a physician for VARIVAX (Merck), a Pregnancy Registry product, concerning a 17 year old female patient, who on 13-APR-2012 was vaccinated with a "booster" dose of VARIVAX (Merck) (dose route and lot number not reported). Other suspect therapy included third dose of GARDASIL, administered on the same day. It was reported that the patient was due to begin her menstrual cycle on approximately 16-APR-2012. The patient notified the physician on 23-APR-2012 that she took a home pregnancy test which was positive. No adverse effect was reported. The date of the patient's last menstrual period was approximately 16-MAR-2012 and estimated delivery date is due on 21-DEC-2012. Follow up stated no additional information could be provided since the reporting physician retired the previous year. The pregnancy outcome has been updated to lost to follow up. Additional information is not expected.
I started to have asthma and allergies around one year old, and I believe it was caused by one of the vaccinations I received prior to that.
Qualifier:  I don't know if this qualifies as an adverse event or not. I got the vaccine at 4:00 pm on 1/12/21.  When I woke up on 1/13/21, I was very sick.  I felt like I had a severe, very bad, horrible flu.  I didn't get out of bed until 5pm that evening.  No fever.  No body or joint aches.  Just extreme, overwhelming fatigue and feeling flu-y.  This phase lasted about 24 hours.  (my right am also hurt, but that was minor) I have a severe case of Sjogrens, a systemic autoimmune disorder.  My most debilitating Sjogrens symptom is overwhelming fatigue.  If I weren't retired, I would be qualified as disabled.  Handicapped tag, etc.   Since the vaccination, my Sjogrens has "flared."  I feel terrible, exhausted, can't do anything. I have cancelled everything.  All I can do is sleep, and feed the cat.  I am directly connecting this Sjogrens flare to the vaccine.  When I'm in a flare this bad, I usually take a course of prednisone.  I have not done this because I don't want to modulate my immune system while it is building covid antibodies.    I can't wait for the 2nd vaccine on 2/2/21!
This spontaneous report was received from a nurse practitioner referring to a 6 month old child patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 21-MAY-2018, the patient was vaccinated with the first dose of ROTATEQ (lot # reported as N026174 with expiration date reported as 16-MAR-2019), per oral for prophylaxis. No adverse effects were reported. Lot number N026174 is an invalid lot number for ROTATEQ.
tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left upper arm on 18Dec2020 15:30 at a single dose for COVID-19 immunisation.  Medical history included high blood pressure and had electrocardiogram (EKG) unknown result a week before vaccination in Dec2020.  Concomitant medication included acetylsalicylic acid (ASPIRIN), lisinopril, and guaifenesin (MUCINEX).  It was reported that patient tested positive for COVID on 31Dec2020. She has not gotten her second dose but it was scheduled for 08Jan2021 for which will still be in quarantine then and requested guidance on when/if she should get the second dose. Patient explained her parents have COVID and that the rapid test for the COVID test was how she found out she had COVID. The patient has not recovered from the events.
with the second dose, swollen and cracked lips; dry mouth; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262), dose 2 via an unspecified route of administration in left arm on 10Feb2021 13:15 (at 74-years age) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. With the 1st dose, patient's lips were swollen and cracked and with the second dose, swollen and cracked lips, dry mouth on 12Feb2021. No treatment received for reported adverse event. Patient not tested for COVID-19 after the vaccination. The event outcome was reported as not resolved.
Soreness in arm; Fatigue; Nausea; Pain/pins and needles sensation in lower left hand and arm, which spread to the right arm and then both lower legs. Has persisted in all four limbs.; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 30Apr2021 at 11:45 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, environmental allergies, autism spectrum disorder, esophagitis, atypical migraines, acne, sulfonamide allergy, shellfish allergy and whey protein allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone propionate (FLOVENT) inhaler, cetirizine hydrochloride (ZYRTEC) and ibuprofen (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. Within four weeks prior to the vaccination, on 08Apr2021 the patient received allergy injection (MANUFACTURER UNKNOWN) in upper left arm and upper right arm for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 at 17:00 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. On 30Apr2021 at 17:00, the patient experienced soreness in arm followed by fatigue, nausea. This got improved, but it was followed by pain/pins and needles sensation in lower left hand and arm, and then spread to the right arm and then both lower legs, it had persisted in all four limbs. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with physical therapy referral (unspecified). The clinical outcome of the events soreness in arm followed by fatigue and nausea were resolving and the clinical outcome of the event pain/pins and needles sensation was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Nurse in the ER administered by error intravenously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix (intravenous). On an unknown date, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: Additional Information: GSK Receipt Date: 24-May-2022 Reporter's Comments: Pharmacist called to report that a nurse in the emergency room administered by error Boostrix intravenously.  No other information available at the time of reporting. The reporter consented to follow-up by email. Additional Supportive Information: The patient received Boostrix intravenously, which led to intramuscular formulation administered by other route.
8/10/10 immunizations given. 8/11/10 was seen for induration (L) thigh with redness, hot to touch, draining clear fluid. Culture neg. Placed on antibiotics. Dx - cellulitis. Culture negative - final result.
Patient's mother called to report rash on lower left arm that started shortly after vaccination. Rash did not occur after first dose of GARDASIL. Rash is raised, itchy bumps about 1/8" in diameter. Do not look fluid filled. No other accompanying symptoms. Patient does not remember when the rash began.
Line of Soreness from arm to neck to below the ear; Huge painful Swelling just below the ear/ swollen lymph nodes which were likely a late reaction of the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Line of Soreness from arm to neck to below the ear) and LYMPHADENOPATHY (Huge painful Swelling just below the ear/ swollen lymph nodes which were likely a late reaction of the vaccine) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FUROSEMIDE, AMLODIPINE, AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE]), APIXABAN (ELIQUIS), TIOTROPIUM BROMIDE (SPIRIVA), LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX), POTASSIUM CHLORIDE, EZETIMIBE (ZETIA) and SIMVASTATIN for an unknown indication.   On 04-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) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (Line of Soreness from arm to neck to below the ear) and LYMPHADENOPATHY (Huge painful Swelling just below the ear/ swollen lymph nodes which were likely a late reaction of the vaccine). The patient was treated with AMOXICILLIN in March 2021 for Swollen lymph nodes, at a dose of 1 dosage form. At the time of the report, PAIN (Line of Soreness from arm to neck to below the ear) and LYMPHADENOPATHY (Huge painful Swelling just below the ear/ swollen lymph nodes which were likely a late reaction of the vaccine) outcome was unknown.            Other concomitant products include Respimat.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25-JUN-2021 contains non significant information. Patient's contact details were updated.
On 7/28/00, post vax, pt had a temperature of 104F (A) seen in ER and dx'd with bilateral OM. Pt fussy with decreased PO intake. Thrush. No rash or cough. Symptoms are still present.
received a booster dose of Moderna vial after vial had been punctured 20 times already; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT USE ISSUE (received a booster dose of Moderna vial after vial had been punctured 20 times already) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021 at 4:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced PRODUCT USE ISSUE (received a booster dose of Moderna vial after vial had been punctured 20 times already). On 10-Nov-2021, PRODUCT USE ISSUE (received a booster dose of Moderna vial after vial had been punctured 20 times already) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  Patient received a Moderna Booster on 11/10/21 from a vial where 20 punctures had already occurred. The right vaccine was given to the right patient at the right time with the right dose.   This case was linked to MOD-2021-392366 (Patient Link).
On day 6  injection site became red, swollen, itchy, and sore.  As on today still remains really red, swollen and sore.
08/06/21 CLIENT FATIGUED FOR 2 DAYS, HAS FELT FEVERISH EVERYDAY SINCE VACCINATION.  EXPERIENCING COLD NUMBING FINGERTIPS IN BOTH HANDS.  8/13, WOKE UP AND BOTH HANDS VERY ITCHY RED AND SWOLLEN.  CLIENT IS ALSO EXPERIENCING MIGRAINE HEADACHE THAT IS DIFFERENT THAN HER TMJ HEADACHES.  CLIENT WAS REFERRED TO HER PRIMARY HEALTH CARE PROVIDER FOR FOLLOW UP AND INSTRUCTED TO UPDATE WRITER.
This case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a 17-year-old female patient who received BEXSERO. On 7th July 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 7th July 2017, 2 hrs after receiving BEXSERO, the patient experienced fatigue, fever and migraine. In July 2017, the patient experienced tingling and tremor. In July 2017, the outcome of the fatigue, fever, migraine, tingling and tremor were recovered/resolved. It was unknown if the reporter considered the fatigue, fever, migraine, tingling and tremor to be related to BEXSERO. Additional details were reported as follows: The patient's age at vaccination was 17 years and 7 months old. Six hours after vaccination, the patient experienced migraine and had fever of 100 degree F. Fifteen hours post vaccination, the patient was shaky, her fingers felt tingly and had fever of 102 degree F. The reporter did not know if the vaccine was administered at the main office or at the satellite office.
really bad reaction to the 2nd shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (really bad reaction to the 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 experienced ADVERSE REACTION (really bad reaction to the 2nd shot). At the time of the report, ADVERSE REACTION (really bad reaction to the 2nd shot) outcome was unknown.            No concomitant medications and treatment medications reported.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    Patient received the vaccine at a Pharmacy.  No concomitant medication reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up document received on 24-Jan-2023 no new significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Pt. states that after receiving the 2nd dose of Moderna 04/12/2021, started experiencing symptoms 04/13/2021 of shoulders shaking uncontrollably (Possible Fever associated) lasting 15-20 minutes. No noted Primary visit/communications.
A pharmacist reported that his 67 year old wife received an injection of flu shield on 11/14/2001. That same day, she developed an injection site reaction characterized by tenderness, bruising, and redness.
Vomiting every 20 to 45 minutes from 8:30 am to 2:00 pm. Resolved after 2:00 pm.
Dtap Lot # C5643AA  MMRV T013542  IPV R1F972M    5/6 days after receiving the three vaccines patient developed really swollen eyes (eyes were almost shut). This lasted a couple weeks then two weeks later he had really bad swollen penis.  At that same time he had a lacy rash all over his body and that started on his scalp and moved down his body from his stomach area down to his thighs and his backside, legs and his feet.  The rash was itchy and it lasted a few months long.  It was lastly on his feet and they would be extremely itchy for him for weeks.
Employee was seen in the drive through testing center with a positive test after being fully vaccinated.  Symptoms include: congestion, runny nose and headache
Information has been received from a registered nurse referring to a 12 months old female patient. Information about concurrent condition, concomitant medication and medical history was not reported. On 17-AUG-2016, the patient was vaccinated with a dose of ROTATEQ (lot number and expiration date were not provided) orally for prophylaxis (inappropriate age at vaccine administration). No adverse effects were reported. No product quality complaint (PQC) was involved in this case.
p/vax pt exp serious flu sx & erythema @ the inj site;pt was seen in ER;sx resolved on day 6 or 7;
(L) deltoid area w/discoloration - yellow/greenish bruising noted as well as swelling on posterior of upper arm since vaccine on 10/16. Patient stated felt painful w/palpation and if he leaves his arm up/elevated for any length of time, arm becomes painful. Pt on clopidogrel, warfarin, and ASA.
Pt received MMR, varicella, MCV and finally HPV. When HPV was administered pt became pale, sweaty and light headed immediately. Pt was reclined w/ feet up and recovered within minutes. Pt kept in clinic 30 minutes then left w/ father.
Cried & screamed from 4PM to 10PM; temp not taken MD @ ER checked pt gave suppositories for fever & Pedialyte; Was okay p/slept that noc;
This spontaneous report was received from a vaccine coordinator and refers to an unknown number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with an unknown number of improperly stored doses of LIQUID PEDVAXHIB)(dose, frequency and route of administration were not reported) lot# M001814 and expiration date: 15-OCT-2018. No adverse effects were reported. The LIQUID PEDVAXHIB was stored in 48 Fahrenheit degrees (F) for 1 hour 20 minutes and in 47 F for 23 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA011251:
Approximately 2 hrs after receiving a pneumonia injection in my left shoulder, my arm below the site, (bicep area) began turning red and with considerable pain. The next morning my whole bicep area had swollen to 1 1/2 to 2 inches its normal size, that afternoon I went to the ER.
15JAN93 fine raised rash began to devel on the inferior surface of both arms-rash itchy; benadryl recommended; no relief; rash on epigastrium & legs;16JAN Bellergal was discontinued; 16JAN93 itching & discomfort were increasing; Rx:Seldane.