chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the vaccine at 17 years of age; A spontaneous report  was received from a consumer, concerning a 17 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced receiving the vaccine at 17 years of age.  The patient's medical history included no relevant adverse event. No relevant concomitant medications were reported.   On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient received Moderna COVID-19 Vaccine and he was 17-year-old.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome of the event was resolved on 29 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Moderna COVID-19 Vaccine EUA Starting one week after first dose my injection site got itchy and red, hardening and then heating up.  The arm swelled above elbow and injection site becoming red.  Still red and slightly itchy 3 days later
This spontaneous report was received from a registered nurse (age not reported) via a company representative referring on herself who on an unknown date (reproted as "several years ago) was vaccinated with a dose of ZOSTAVASX (dose and duration not reported). On an unknown date ("several years ago") the patient experienced sever pain at the injection site after administration of ZOSTAVAX. The day after administration of ZOSTAVAX, the patient developed rash on her arms. The rash subsequently resolved. Relationship between several pain in the injection site, rash and ZOSTAVAX was not reported. Additional information is not expected.
Pt received vaccines on 6/3/11. 5 hours later fever and febrile seizure. Pt hospitalized.
A small hive on my back that grow into multiple hives on my back.  It lasted for two or three weeks. I went to see the doctor and he gave me a steroid and cream for the hives.
This spontaneous report was received from a nurse refers to a 3 patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of ROTATEQ which was administered orally (dose and lot# were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. On approximately January 2013 (also reported as over a year) the patient was vaccinated with 2 doses of GARDASIL (lot number and expiry date was unknown) possibly off schedule. No concomitant medications were reported. It was reported that the patient had visited the doctor for a third dose on 14-JAN-2014. No adverse events were reported. No product quality issue was reported. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and MYALGIA (upper body pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-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 HEADACHE (headaches) and MYALGIA (upper body pain). At the time of the report, HEADACHE (headaches) and MYALGIA (upper body pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. This case was linked to MOD-2021-039887 (E2B Linked Report).; Sender's Comments:  MOD-2021-039887:Same reporter
She got her 4th vaccine, started with shaking chills and nausea, and terrible fatigue.  She slept for 21 hours.  Then she couldn't eat anything, but was able to take in fluids.  She got up and moved around a little yesterday and then had to go back to bed.  She has no chills or fever, but is still very nauseated and she can barely walk from one end of the house to the other.  She just checked her BP and was concerned and it is OK.  She feels like she has been hit by a truck.  She is a very high energy person and works out every day and can barely walk today.  Her arm is still sore and not able to sleep on it.   The first vaccine she was terribly ill and got dehydrated and had to go to the hospital for IV's.  The 2nd vaccine she got very dehydrated again and had to get IV's for that and thrown into A-fib that did not resolve for quite a while.  She did go back into sinus rhythm on her own but it took weeks.   She has had a history of A-fib but has been controlled for a long time.    Her doctor was aware of the other reactions, and wanted her to get the other booster.
101.9 fever, body aches, fatigue, dizziness, migraines, vomiting, shaking
This spontaneous report as received from a nurse via company representative refers to a 2 patients (no demographics or the treating physician were provided for either patient). On an unknown date the patients were vaccinated with ZOSTAVAX. On an unknown date the patients experienced mild case of shingles. The outcome of mild case of shingles was unknown. Relatedness  between event and vaccination with ZOSTAVAX was not reported. Additional information is not expected, reporter declined to be contacted.
Beyond use date was on 07-Jun-2023 and Jynneos was given on 13-Jun-2023; Case reference number US-BN-2023-001049 is a spontaneous case report initially received from other health professional via Communications (reference number: USBAV23-0787) on 21-Jun-2023 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (batch number not provided), at unknown dose, route and site of administration for indication reported as smallpox/monkeypox prophylaxis.  On 13-Jun-2023, an unknown amount of time after the first Jynneos dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number not provided) that was past the beyond use date (BUD) which was on 07-Jun-2023, at unknown dose, route or site of administration (explicitly coded as 'expired vaccine used').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received on 22-Jun-2023 included local case ID number.; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos for smallpox/monkeypox prophylaxis, via unspecified route of administration. It was found that the vaccine was past the beyond use date, which is considered expired product administered. No associated adverse events were reported. Expired product administered is considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. Expired product administered is assessed as not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos for smallpox/monkeypox prophylaxis, via unspecified route of administration. It was found that the vaccine was past the beyond use date, which is considered expired product administered. No associated adverse events were reported. Expired product administered is considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. Expired product administered is assessed as not related to Jynneos, but to human error. The case is non-serious.
Vaccine stored in the practice longer than the manufacturer's recommended time (6 hours past first puncture of vial) Vaccine was potentially  stored for 28 days in the practice. Patient suffered no adverse effects, no illness
Ten minutes after receiving vaccine, felt a wave of dizziness/fogginess.  Rush of palpitations afterwards that lasted 1-2 minutes.  Walked over to ED with staff for observation.
4/6/2021 vaccination 4/7/2021 body aches and chills 4/8/2021 That morning, I woke up because I had R side of my face, in my teeth; Trigeminal Neuralgia. Lasted for several hours. I found some codeine in medicine cabinet to help with pain and I could go back to sleep. It was achy on that side my face, throbbing for 48 hours. It tapered off by that Saturday 4/10/2021 4/16/2021 I started having tingling in my face again. Largely numb on R side of my face and low ache. Lasted till presently and still presenting but not as persistent; 2 weeks. Constant ache but not sharp as it had been at the beginning. The numbness went from my ear to my nose  4/23/2021. I went to urgent care. They confirmed it was Trigeminal Neuralgia. Dr. ordered blood test and referral to see a neurologist.  *Appt with NEW PCP 05/14/2021 telehealth **still waiting on appt with neurologist
expired pentacel was administered to patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (nurse) and physician via global medical information (GMI) (Reference number- 00674667) and transmitted to Sanofi on 08-Jul-2021.  This case involves a 19-month-old female patient who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not reported.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13),MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) and HEPATITIS A VACCINE.  On 07-Jul-2021, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB [Pentacel] VACCINE (total, lot UJ336AAA and Expiry date- 05-Jul-2021) via an unknown route at the right vastus lateralus site for prophylactic vaccination (expired product administered) (latency: on the same day).  It was a case of actual medication error due to expired vaccine used.  At the time of report, reporter was asked for any adverse event to watch for and what should they do.   At the time of report, no adverse event was reported.  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 the 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.
On 1/18/21, developed a large right axilla lymph node approx.3 cm x 2 cm which was painful, radiated up neck & developed  headache. Lymph node after one week was 1 cm x 2 cm, less painful, still tender,  Self treated with Tylenol & Motrin.  On 2/9/21 symptoms resolved mostly, slightly tender to touch. Scheduled for # 2 Moderna vaccine on 2/10/21.
Rash & hives Narrative: Pt reported rash & hives 3 days after given 1st covid vaccination. Pt did not use any meds for treatment.
Called us 5/26 to report her RT arm was red, hot, hard with a bulls eye about the size of a 50 cent piece and this was 9 days after getting the shot. No other problems. She said it started a day or so after got shot as a smaller red tender area and grew. Rec. apply cold to area and come into Public Health 5/28. Reported past 2 days she'd had a fever, temp normal on 5/28. Red indurated area on upper arm 80 x 50mm only tender to touch; full ROM.
Patient received both flu and pneumonia shots in the left arm. She states that later that day it was swollen and very painful with muscle strain. She states that her upper arm is painful to the touch and that her lower forearm has a tingling sensation that radiates to her fingers. She has been using oral and topical NSAIDS but that doesn't help. She states that the feeling she has was similar to when she had a blood clot, so she went to the doctor for an ultrasound and results were negative. The doctor thinks it might be cellulitis, so they prescribed her some antibiotics to help with her reaction but the patient doesn't feel like it's working.
Information has been received from a physician concerning a child who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Subsequently, the patient developed swelling at the injection site.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
No additional AE reported.; Caller stated the VARIVAX expired on 20-AUG-2021, but was administered today, 31-AUG-2021; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 31-AUG-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 milliliters (ml) as prophylaxis (lot number S025913 which has been verified to be valid, expiration date reported and validated as 20-AUG-2021) (route of administration and anatomical site of injection were not reported) (expired product administered). In addition, the reporter mentioned that the administered dose of the vaccine did not go through any temperature excursions. No additional adverse events were reported in the patient.
Patient inadvertently received COVID-19 Moderna mRNA vaccine as first dose at age 16. Our clinic followed up with patient and mother to notify of administration, and mother reported no serious adverse reactions to vaccine. She stated he went to school the following day without any concerns or complaints.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 16:45 as dose 2, single (Lot number: EW/017218) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No follow-up attempts are possible. No further information is expected.
Sunday: Big headache, unable to sleep soundly, nausea.  Monday: fever (102.1, no Tylenol yet), and eventual vomiting and diarrhea on the next day, morning and afternoon.  Symptoms had mostly subsided by midnight on Monday.
unable to receive second dose, lack of availability; unable to receive second dose, Covid pandemic; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date, intramuscularly about 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue and social problem. On an unknown date, the outcome of the product supply issue and social problem were unknown.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not applicable for this report. The reporter was not able to provide information regarding the lot number and expiration date. She was unable to receive the second dose due to lack of availability, which led to product supply issue. And then later was not able to get the second dose due to the Covid pandemic, which led to social problem. The reporter did not consent to follow-up. This case was linked with US2021210630, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021210630:Same reporter
The patient received the vaccines 9/24/20. Later, on 10/9/20 she was hospitalized and diagnosed with Guillain-Barre Syndrome.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2012 (reported as approximately 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose and route of administration were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT) for prophylaxis. There was no medication with vaccine given. On approximately 08-AUG-2017 (reported as approximately 6 weeks ago), the patient experienced shingles on his face and close to his eyes. The patient saw pharmacist. The patient was pretty uncomfortable because of the event. He began taking acyclovir 800 mg five times daily on an unspecified date in 2017 for a treatment of the shingles. The patient's shingles were getting worse even with the treatment with acyclovir. The outcome of the event was reported as not recovered. It was unknown if the patient was taking acyclovir at the time of the report. The relatedness between vaccination with ZOSTAVAX and the event was not reported.
Hives on chest, back, arms and top of the eyes. On 3 day prednisone and amoxicillin.
Vaccine stored outside of manufacturer guidelines, product stability is unknown. Potential expired product used for immunization.
Very early menses - I am currently being treated for very long cycles but after receiving the Moderna vaccine I am now bleeding and am on day 11 of my cycle. My normal cycle for over a year has been greater than 45 days.
LIGHT HEADED; DARK BLACK COLOR STOOL; FELT LIKE SICK; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-NOV-2021, the patient experienced dark black color stool. On 06-NOV-2021, the patient experienced light headed. On 06-NOV-2021, the patient experienced felt like sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light headed, and the outcome of dark black color stool and felt like sick was not reported. This report was non-serious.
Pt received 1st dose of vaccine on 11/15/2005 and reported no problems with vaccine. pt received 2nd dose of vaccine on 11/22/2005. when pt came back to clinic on 12/6/2005 to receive 3rd dose, she told the RN that she had severe headache, nausea, muscle aches, fever and fast heart rate after getting her 2nd dose. Under doctors order, the third dose was not given and a titer was drawn. pt was instructed to call her primary care provider for further instructions.
Immediately tired  Chills Shaking  Sweating  Fever 101 Lymph swelling  Sight injection swelling
Developed multiple vesicular rash on entire body from head to toe, redness of ears 2 weeks post vaccine staring on January 18, 2021. Vesicular rashes are itchy and becomes dark and patchy with small discharge. Seen by urgent care and was prescribed Deltasone PO and Triamcinolone 0.1% topical cream
Arm began to develop a big red itchy patch around injection site. Patch has grown over the past 24 hours over an inch. I do have pictures from start to now if necessary.
I COULDN"T WRITE DOWN WHAT WE WENT THROUGH .  DOCTORS SAID THE VACCINE STIMULATE A CELL THAT MIGHT NEVER BE SEEN IF HE DID NOT HAVE VACCINE.   HE WAS A VETERINARIAN UNTIL AFTER THE SECOND SHOT  HEALTHY WALKING 2 MILES 3 TO 4 TIMES DAILY ETC ETC   DID THE VACCINE SO WE COULD GO ON VACATION....ENTERED HOSPITAL AND WITH ALL THE DOCTORS SAYING  HE WILL BE ALRIGHT  IN A FEW DAYS   OUR VACATION TURNED OUT TO BE A 15,000DOLLAR FUNERAL  THEN DIED
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-APR-2015 or 01-MAY-2015, the patient was vaccinated with either improperly stored (Merck) VARIVAX (strength, dosage, frequency and route unspecified) (Lot reported as K015375 with expiration date 18-SEP-2016, Lot reported as K018990 with expiration date 15-OCT-2016, Lot reported as K011317 with expiation date 13-AUG-2016 and Lot reported as K016153 with expiration date 24-SEP-2016) or improperly stored MMR II (strength, dosage, frequency and route unspecified) (Lot reported as K021930 with expiration date 10-NOV-2016, Lot reported as K021487 with expiration date 03-NOV-2016 and Lot reported as L001329 with expiration date: 13-JAN-2017) (incorrect product storage). It was unspecified exactly which lot # of vaccine the patient was given. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness; Vertigo; Severe abdominal pain; Shortness of breath; Skin had pallor; Urine was dark; Stool was lighter; lethargy; Generalized body aches; Generalized weakness; localized pain in injection arm; extreme fatigue/fatigue; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizziness), VERTIGO (Vertigo), ABDOMINAL PAIN (Severe abdominal pain), DYSPNOEA (Shortness of breath) and PALLOR (Skin had pallor) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholecystitis (surgically removed about one month after the vaccine was given.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), VERTIGO (Vertigo), ABDOMINAL PAIN (Severe abdominal pain), DYSPNOEA (Shortness of breath), PALLOR (Skin had pallor), CHROMATURIA (Urine was dark), FAECES PALE (Stool was lighter), LETHARGY (lethargy), PAIN (Generalized body aches), ASTHENIA (Generalized weakness), INJECTION SITE PAIN (localized pain in injection arm) and FATIGUE (extreme fatigue/fatigue). At the time of the report, DIZZINESS (Dizziness), VERTIGO (Vertigo), ABDOMINAL PAIN (Severe abdominal pain), DYSPNOEA (Shortness of breath), PALLOR (Skin had pallor), CHROMATURIA (Urine was dark), FAECES PALE (Stool was lighter), LETHARGY (lethargy), PAIN (Generalized body aches), ASTHENIA (Generalized weakness), INJECTION SITE PAIN (localized pain in injection arm) and FATIGUE (extreme fatigue/fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: high (High) bloodwork showed that  liver enzymes were high.     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 medication information was provided.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received on 09-Aug-2021 and new event added.