chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After you get a shingles vaccine shot, does the site get itchy?; This case was reported by a consumer and described the occurrence of injection site itching in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient wanted to know did the shingles vaccine site get itchy after shot.
Narrative:  57 yo F with h/o chronic bilateral prominent varicosities of legs, obesity, abnormal mammograms, migraines, and tobacco use died on 06/13/2021 at an out patient, unknown location. Pt had received covid vaccinations on 03/26/2021 and 04/23/2021. Death unrelated to vaccinations.
she developed Covid; she developed Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2022, outcome "unknown" and all described as "she developed Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
CHILLY; ACHY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 2021, the subject experienced chilly. On 2021, the subject experienced achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chilly and achy was not reported. This report was non-serious.
Inappropriate schedule of vaccine administered; No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037E21A, 019B21A and 027A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:(Master case)
Patient had a transplant after getting both doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSPLANT (Patient had a transplant after getting both doses) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRANSPLANT (Patient had a transplant after getting both doses). At the time of the report, TRANSPLANT (Patient had a transplant after getting both doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered TRANSPLANT (Patient had a transplant after getting both doses) to be not related.    The patient recently underwent a transplant and the doctor was recommending that the patient get a 3rd dose because the antirejection medication might have rejected the vaccine. The pharmacist confirmed that the transplant was not related to any possible side effects the patient might have had after getting the Moderna COVID-19 vaccine.
Body ache like if I had COVID; Pain in the arm; Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache like if I had COVID), PAIN IN EXTREMITY (Pain in the arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included EMPAGLIFLOZIN (JARDIANCE), METFORMINE [METFORMIN] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (Body ache like if I had COVID), PAIN IN EXTREMITY (Pain in the arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On 27-Jan-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PAIN (Body ache like if I had COVID), PAIN IN EXTREMITY (Pain in the arm) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Event treatment included Tylenol (acetaminophen).
Immediate pain at injection site.  Woke up at 3 AM with 103.1 fever, body aches, chills and lethargy.
pt says he started feeling bad like he had the flu so went to bed early.  He had body aches, joint pains and chills.  Next day he still had these symptoms and loss of appetite.  His symptoms lasted about 48 hours.  Pt says he no more symptoms today.
Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Spinal stenosis. Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for Spinal stenosis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt). At the time of the report, VACCINATION SITE PAIN (Arm hurt) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-296540, MOD-2021-022507 (Patient Link).
8 days later, I experienced swelling at the injection site and I broke out in hives. The hives were mostly on my arms, but some were on my neck, face and stomach.
DIARRHEA; EXTREME FATIGUE; MUSCLE ACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 31-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced diarrhea. On 15-MAY-2021, the subject experienced extreme fatigue. On 15-MAY-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, extreme fatigue, and muscle ache. This report was non-serious.
Flublok Quadrivalent was given to a patient under 18 years of age, no AE; Initial information received on 26-Sep-2019 and Additional information was received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional via sales representative.  This case involves patient (less than 18 year of age) who was vaccinated with vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a Dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of the report, no adverse event was reported.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none
Injection site itching; Injection site redness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site swelling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    There was no reported medical history.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site swelling) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter did not have the lot number information, because the packaging was discarded.  No concomitant medication reported. No treatment medication reported.
Sore throat; Mouth sores; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 09:00 (Lot number: EP6955) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Batch/lot number: EP6955, Anatomical Location: Arm Left , Dose Number:1, administration time: 04:00 PM), administration date: 17Mar2021, for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 09Apr2021 09:00, outcome "recovering", described as "Sore throat"; STOMATITIS (non-serious) with onset 09Apr2021 09:00, outcome "recovering", described as "Mouth sores". The events "sore throat" and "mouth sores" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oropharyngeal pain, stomatitis.  Additional Information: Facility where the most recent COVID-19 vaccine was administered:Workplace clinic. Patient did not received any other vaccines within 4 weeks prior to COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Valtrex, Dexamethasone, Flonase was the treatment received for the events.Prior to vaccination the patient was not dignosed with COVID-19. Since the vaccination the patient has been tested for COVID-19.Test Name: Nasal Swab Date: 13Apr2021 Result: Negative.       No follow-up attempts are possible. No further information is expected.
Patient received a dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours previously; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours previously) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen COVID-19 vaccine in March 2021 and Pfizer COVID-19 vaccine in October 2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours previously). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours previously) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Medical history was not provided by the reporter.  Patient was not on any concomitant medications.  Reporter stated that, a patient received the first booster dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours previously on 06-Apr-2022. The patient had not reported any adverse reactions at this time. No treatment information was provided.
Patient had a reaction to the vaccine that developed approximately 3 days after receiving it. Redness and warmth developed on the outside and back of her right arm. This reaction did no occur at the injection site.
Patient complained of pain that was more severe than expected that evening after injection and stated that the pain lasted for 3-5 days. Patient also had extensive bruising on that arm. She states that it is much better. I have contacted her primary care doctor.
Infant was at the health department for 2 month immunizations.  Vaccines were taken from the state refrigerator and scanned in to system prior to administration.  Pediarix, Hib, Prevnar, and Rotateq.  Vaccines were ordered and scanned prior to administration with no flags noted.  Vaccines were administered per protocol.  During completion of the administration section of system, it was noted that the Rotateq was expired.  RN supervisor notified.  Follow up with the infant's mother after the event.  Mother reported that child had no adverse effects and was doing well.  Per recommendation of Immunization program- Rotateq is to be repeated in 1 month.
fever to 101 F on 6/17/2021  at 8am which persisted.  Chest pain started 6/18/2021 at 3am and has been constant.  sharp chest pain lower chest midline, worse with laying, better with sitting or walking. Shortness of breath with laying also.  Also has palpitations, light headedness, dizziness, nausea, feels clammy.  Chest pain worse on 6/19/2021 at 1:30 am and came to the ED for further evaluation and treatment.  Just got admitted and full evaluation in progress.
Developed arm soreness, headaches and some chills over the few days after vaccine, which then resolved.  Approximately 2 weeks after vaccination, noticed that goiter had returned and developed difficulty sleeping and constipation.  Goiter lasted for approximately 8 days and then began to improve on its own.  Consulted with my endocrinologist, who felt that it might be a transient thyroiditis due to having had the immunization
Flu Vaccine - Fluarix Quadrivalent  given at 14:37. Pt showed no signs or symptoms of allergic reaction immediately after administration. Pt reports having had the flu vaccine in the past. Pt listed as first time dose in center.  At 15:42 pt c/o "feeling hot", SOB, facial flushing and shaking noted. This RN initiated allergic reaction protocol. Benadryl 50 mg IV given at 15:44 followed by Solumderol 125 mg IV over 5 minutes. 4L oxygen started, EMS called. BS 99. BP remained stable ranging 130's to 140's. Post medication administration Pt reports shaking subsiding and easier to breathe. Facial flushing noted to be lighter. Pt care transferred to EMS. Pt going to hospital. MD notified. Flu Vaccine - Fluarix Quadrivalent  added to allergy list.
Moderna 3/12/22, 4/9/22. Positive on 8/24/22
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by  COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
cried nonstop form 1230PM-515PM; strong persist cry sometimes piercing per mother;pt not crying when arrived @ 5:30;site of injection w/o redness or edema, will touch base with mom in am via phone.
Serum sickness reaction occurred within 24-48 hours, post vax. Had a fever up to 39.4F, vomiting, swelling of hands, feet and knees with erythema of overlying; skin  (maculo-papular) rash on dorsum of feet. Treated with Solu-Medrol IM, Prelone and Atarax.
Patient presented with multiple red papules on the arm, legs, neck and back.  At the present lesions are not pruritic.
Red, hardened, swollen, sore area around the injection site. The treatment is to just apply warm compresses and take some BENADRYL if needed. PNP believes it is just a localized reaction and that it will go away on its own.
ON TUESDAY, JULY 20, 2004, THE CLIENT'S MOTHER, NOTICED SMALL, RED AND SKIN COLORED, RAISED BUMPS AROUND EACH INJECTION SITE.  THERE WERE A TOTAL OF 4 INJECTION SITES.  SHE STATED THAT THE BUMPS WERE GREATEST IN QUANTITY ON THE LEFT LEG.  VACCINES THAT WERE ADMINISTERED IN THE LEFT LEG WERE COMVAX AND PREVNAR.  SHE STATED THAT SHE GAVE INFANT TYLENOL ALL DAY ON FRIDAY, JULY 16, 2004, WHICH WAS THE DATE THE VACCINES WERE ADMINISTERED.  SHE STATES THAT SHE DID NOT NOTICE ANY OTHER SYMPTOMS.  SHE CONTACTED HER DOCTOR ON TUESDAY, JULY 20, 2004 TO DESCRIBE THE SYMPTOMS, AND HER DOCTOR INFORMED HER THAT THE CONDITION DID NOT REQUIRE MEDICAL TREATMENT AND TO NOTIFY THE COUNTY HEALTH DEPARTMENT OF THE REACTION.
Diarrhea; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history was not reported by the reporter.  Concurrent medical conditions included HER2 positive breast cancer (Stage 1, right breast cancer). Concomitant products included TRASTUZUMAB (HERCEPTIN) and LETROZOLE (FEMARA) for an unknown indication.    On 22-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information on treatment medications was reported
Strong abdominal pain from day after 2nd dose of vaccine intermittent through May 27. Went to the doctor on May 24, ultrasound May 25 diagnosed with hemorrhagic cysts. Health care providers not sure if directly related to vaccine, could have been part of an immune response or not. Resolved after May 27 and have not recurred since then. Did begin right after vaccine and have had this happen unrelated to any vaccine one time previously 8 years ago.
Approximately 5 minutes post vax, pt fainted and tonic-clonic movements of his right UE were noted. No apnea, no cyanosis. Pt regained consciousness approximately a minute after event with stable BP and pulse.