chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client arrive on 4/22/21 for her second covid-19 vaccination. Nurse discovered that client was only 15 years old, and that the first vaccine was given too young. Nurse explained to both client and mother, that the first vaccine should not have been given until 16 years old, and that we cannot give dose 2, until the client turns 16. No adverse reaction reported from client of mother following dose #1.
supposed to receive the 2nd dose of Shingrix received two doses of the same vaccine on the same visit; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number Y227N, expiry date 25-OCT-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 09-AUG-2023, the patient received the 3rd dose of Shingrix. On 09-AUG-2023, an unknown time after receiving Shingrix and SHINGRIX, the patient experienced overdose (Verbatim: supposed to receive the 2nd dose of Shingrix received two doses of the same vaccine on the same visit). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date:09-AUG-2023 The reporter informed that earlier that day, a patient that was supposed to receive the 2nd dose of Shingrix received two doses of the same vaccine on the same visit, which led to overdose. The reporter consented to follow up.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 55 years old male patient who was vaccinated with 0.5 ml dose of FLUZONE HIGH DOSE (batch number lot UJ023AA and expiration date 25-APR-2019 via intramuscular route in the left deltoid on 25-Sep-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to vaccine administered to patient of inappropriate age and overdose. It was reported that, patient visited to physician at 25-Sep-2018. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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 sender: none.
Chills, progressively worst, started around 7:00pm on April 19th until about 6:00am April 20th. Fever (up to 101.60) started at 10:00 on April 19th until about 1:00pm April 20th. Headache, started overnight sometime around 1:00am on April 20th, until 11:00pm on April 20th.  Body Ache ( stiff neck, back-pain) from around 1:00am on April 20th, until 11:00pm on April 20th.
Hives/itching Scratchy Throat Pruritus Angioedema of lips Urticaria
This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a patient who received FLULAVAL Tetra (batch number 5LR3F, expiry date 30th June 2018) and (batch n umber N7GN5, expiry date 30th April 2018). On an unknown date, the patient received FLULAVAL Tetra (subcutaneous). On an unknown date, the dose was an unknown dose. On an unknown date, less that a year after receiving FLULAVAL Tetra, the patient experienced injection site bruising and inappropriate route of vaccination. On an unknown date, the outcome of the injection site bruising and inappropriate route of vaccination were unknown. Additional information was provided as follows: The age at vaccination was not reported. The health care professional reported that about 4 to 5 patients received doses of FLULAVAL QIV in the subcutaneous region of the arm instead of the deltoid which caused bruising approximately 2 inches in diameter. This led to incorrect route of vaccination. The health care professional was unsure which lot numbers were administered to the patients, so he provided both of the lot number which would have been administered. No further information was provided regarding the event.
Bleeding; Pain in hip; Flu; pain; arthritis waking up; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis, Fibromyalgia and Osteoarthritis.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 13-Apr-2021, the patient experienced INFLUENZA (Flu). In April 2021, the patient experienced ARTHRITIS (arthritis waking up) and PAIN (pain). On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant) and ARTHRALGIA (Pain in hip). At the time of the report, HAEMORRHAGE (Bleeding), ARTHRITIS (arthritis waking up), INFLUENZA (Flu) and PAIN (pain) outcome was unknown and ARTHRALGIA (Pain in hip) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Arthrogram: abnormal (abnormal) found blood in it. On an unknown date, Arthroscopy: unknown (Inconclusive) unknown and unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab tests also included Left and right hip arthroscopy but the results were unknown. She got arthrogram of her hip done and there was blood in it and she got injected with an unspecified steroid gel. The patient also underwent a total knee replacement. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt recv vax 03JUN97 on 07OCT97 pt developed a fever and a red swollen arm. The following day pt presented to a physician's office and was treated with acetaminophen (Tylenol). Subsequently, the patient recovered.
First the MCV4 was given, next the MenB (Bexsero) was given. Soon after the Bexsero vaccine was given and needle withdrawn, patient turned pale, he slumped over, his body started shaking with seizure-like activity and his eyes rolled up. This lasted 15 seconds.  He came back to normal mental status soon after. BP = 116/80, PR: 68/min, pulse ox 98%. Fingerstick glucose 117 . EKG normal. He was interacting appropriately , well oriented and walked out of clinic without assistance.
Left arm 2cm x 3 cm, warm, reddened, indurated area.  RXN noted 8/1/08.  Resolved 8/4/08.
soreness and tightness starting at arm and expanding all over body. Continuing for several days after shot. Back and neck pain, along with shoulders and armpits.
Started having throat tightness and chest tightness, having difficulty breathing. Lasting about 15-20 minutes
I was positive for COVID-19 on 27SEP2022, I had severe headache, diarrhea, fatigue and congestion. I was also coughing. I contacted my doctor and they gave me a Z-PAK and a steroid shot, I was positive for 15 days and I felt bad for 12 of the 15 days.
Extreme swelling of Axillary area of right arm.  Ibuprofen, Pepcid and Loratidine - Swelling went from Softball size to golfball size with first 2 days of medication therapy.  Swelling continues to reduce with additional doses.
Pain to R arm, no swelling, redness, or warmth on assessment. ROM impaired due to pain.
she may not have gotten a full dose of the Flulaval because the nurse shot a good bit of it into the air before she injected it into her; nurse did not shake the Flulaval prior to administering it to her, she rolled it in her hands to warm it up; This case was reported by a consumer via call center representative and described the occurrence of underdose in a 61-year-old female patient who received Flu Seasonal QIV(FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced underdose and wrong technique in product usage process. On an unknown date, the outcome of the underdose and wrong technique in product usage process were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's comment: The reporter reported that the nurse did not shake the Flulaval prior to administering it to the patient in right arm.  When asked the nurse said she rolled it in her hands to warm it up. The reporter also reported she might not had gotten a full dose of the Flulaval because the nurse had a shot a good bit of it into the air before she injected it into the patient. The reporter would like safety to contact her to see if she needed to be revaccinated, or if she was okay to do nothing. The reporter did not give permission to contact health-care professional.   The reporter did not consent to follow-up. Additional Supportive Information: The nurse did not shake the Flulaval prior and a good bit of it into the air before she injected it into the patient, which led to underdose and wrong technique in product usage process.
Chills, headache, malaise, fever 100.3, prostration. Started about nine hours after shingles vaccine was administered.  Still have headache 24 hours later and had fever of 100.3 all day.  BP also elevated.
Patient developed an extensive rash. She was seen by Dr. 6/21 and thought to have a contact dermatitis. The rash worsened and patient was seen by an allergist who stated patient had an allergic reaction to one of the vaccines. This is in follow-up to report(s) previously submitted on 9/14/2008. Information has been received from a licensed piratical nurse concerning a 16 year old female with no pertinent medical history and sulfa allergy, CECLOR and seafood allergy who on 18-JUN-2008 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (LOT# 660391/0063X). On the same day, the patient was also vaccinated with a dose of ADACEL, MENACTRA, and HAVRIX. There was no concomitant medication. On 19-JUN-2008 the patient developed blisters that varied in size from a pin point to an eraser. The blisters first appeared under one arm (which arm was unspecified) and then spread over her entire body. Her face was swollen and covered with blisters. The patient was examined by her physician on 21-JUN-2008 and an allergist on 23-JUN-2008. The allergist prescribed prednisone. The patient was recovering. Follow up information was received from the physician who reported that the patient was a female student with no pre-existing allergies, birth defects, or medical conditions who on 18-JUN-08 was vaccinated with a first dose of GARDASIL and a first dose MENACTRA (lot #U2621AA) in her right deltoid. On the same day, the patient was also vaccinated with a first dose of ADACEL (lot #C2938AA) and a first dose of HAVRIX (lot # AHAVB238AA) in her left deltoid. There was no illness at the time of vaccination. On 28-JUN-2008 the patient developed an extensive rash. On 21-JUN-2008 the patient was seen by a physician and was thought to have a contact dermatitis. The rash worsened, the patient was seen by an allergist. The allergist stated that the patient had an allergy reaction to one of the vaccines. At the time of this report, the outcome was unknown. Additional information has been requested.
Patient passed away unrelated to covid vaccine Narrative: The patient had new onset of CHF,A.fib and hx f COPD. Patient was admitted to hospital on 1/21 and Patient discharge against medical advise on 1/22. Patient aware of risk including early death and increased morbidity but patient still wanted to leave. Patient received the first dose of Pfizer vaccine on 1/19 and no adverse reaction was reported. Patient presented to ER for shortness of breath and chest pain and was admitted on 1/29. Patient passed away on 1/31. No indication that death was related to COVID 19 vaccination.
Hives on back of left hand approximately 1.5 hours after dosage. Took an over the counter anti-histamine and rash subsided within an hour. Rash never came back. However 2-3 days after the shot I have a non-spreading rash around my knees. Not hives, but raises red bumps aligned with hair follicles. Rash is itchy randomly through the day.
GENERAL SORENESS; ARM HEAVY; FEELS WEAKER; BODY CHILLS; GENERAL MALAISE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced general soreness, arm heavy, feels weaker, body chills, and general malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm heavy, feels weaker, body chills, general soreness and general malaise was not reported. This report was non-serious.
Onset of symptoms: approximately 4-5 hours after vaccination Signs & symptoms: body aches; muscle aches; severe skin tenderness all over body, but especially on back, upper thighs, and abdomen; hard, swollen upper left arm with raised, red reaction as large as fist in size. Headache is moderate, felt all over, but especially back of head and back of neck
PATIENT HAD NO ADVERSE EVENTS, BUT RECEIVED THE INCORRECT PFIZER PRODUCT. PATIENT RECEIVED LOWER DOSE FOR PEDIATRIC (5-11YO) INSTEAD OF ADULT DOSE
This case was reported by a consumer via other and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 7 days after receiving SHINGRIX, the patient experienced shingles, pain and flu symptoms. The patient was treated with antivirals for systemic use (Anti-Viral Medication). On an unknown date, the outcome of the shingles, pain and flu symptoms were unknown. It was unknown if the reporter considered the shingles, pain and flu symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had a dose of SHINGRIX shot two weeks before the reporting date. A week and half later the patient had come down with a full blown case of shingles all over right side of head and upper forehead.  The patient was in pain, flu symptoms, etc. The patient was put by dermatologist on an anti viral. The patient reported that he was not a happy camper.
I ovulated and got my monthly menses one week early. My menses was otherwise normal, with normal flow and duration.
Arm that the injection was in ached. Spread to full body aches. Headache. I got queasy. I was freezing. I did not take my temperature, but assume I had a fever. I took ibuprofen and slept a lot. The symptoms would get slightly better and I would be hot. Then I'd be extra achey and freezing all over again. This repeated several times. I received my shot approximately 48 hours ago. I still feel queasy, slightly achey, have a headache, and have tenderness in the arm where I received my injection.
Mother called and reported: swelling and redness of right arm from the shoulder to the elbow with some itching. Made an appointment to see her doctor and child was put on antibiotics. Redness remained but swelling was down after 5 days. Child still scratched at area occasionally.
swelling; red of arm; arm was hot; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 73-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included egg allergy.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and extremities hot feeling of. Flu vaccine was discontinued. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities and extremities hot feeling of were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and extremities hot feeling of to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported but the patient was 73 years old, at the time of reporting. Around 1991, the patient received a flu vaccine, name unspecified and her arm became as big as a football and it was red and hot.  The physician advised the patient not to receive a flu vaccine again.  The patient never received a flu vaccine again.  The reporter did not consent to follow up.
Information has been received from a health professional concerning approximately 15 patients who on an unspecified date were vaccinated IM with GARDASIL (dose and lot#s not reported). It was reported that post vaccination on an unspecified date the patients developed itching and redness at the injection site. Additional information has been requested.
No adverse event; administration error; The vaccine was given 9 days past BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (administration error), EXPIRED PRODUCT ADMINISTERED (The vaccine was given 9 days past BUD) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 02-Jul-2022, the patient experienced PRODUCT ADMINISTRATION ERROR (administration error) and EXPIRED PRODUCT ADMINISTERED (The vaccine was given 9 days past BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (administration error) had resolved and EXPIRED PRODUCT ADMINISTERED (The vaccine was given 9 days past BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTRATION ERROR (administration error) and EXPIRED PRODUCT ADMINISTERED (The vaccine was given 9 days past BUD).    No concomitant drug information was provided.  Beyond use date of the product was reported as  23-Jun-2022. It was unknown if the patient was ever diagnosed with or tested COVID-19 positive. It was also unknown if there was any acute illness at the time of vaccination or any chronic or long standing health conditions of the patient.  Reporter further reported that as per Moderna, the product was still active and patient need not to be re-vaccinated.  No treatment drug information was provided.   This case was linked to MOD-2022-599989 (Patient Link).
Dizzy, fell to ground minutes after receiving vaccines. Pale, lips turned white, tired for 1-2 hours.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-NOV-2015 10:49, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 7.5 and 2.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient reported on 3/21/22 that she has been experiencing muscle ache, headache, fever, and swollen lymph node under the left arm since her 2nd Moderna vaccination on 3/18/22.  She denies any shortness of breath, swelling of the lips or tongue, or difficulty breathing.  Pharmacist informed patient that these symptoms are normal but to address concern with her doctor if condition worsens.
Seen 8/30/18 for Shingles of Left Arm. Started on Acyclovir due to severity and seen again on 8/31/18 for pain. Has clustered vesicles all down forearm and onto hand consistent with Zoster.  Sister also noted to have Varicella type lesion on trunk for last 5 days.
Vaccination site rash; Vaccination site pruritus; larger than a large egg-sized rash at the injection site, which itched and was warm and slowly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE WARMTH (larger than a large egg-sized rash at the injection site, which itched and was warm and slowly) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 046A21A) for COVID-19 vaccination.     Concomitant products included LABETALOL, LOSARTAN, RIVAROXABAN (XARELTO), SIMVASTATIN, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), FUROSEMIDE and OMEPRAZOLE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE WARMTH (larger than a large egg-sized rash at the injection site, which itched and was warm and slowly). At the time of the report, VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE WARMTH (larger than a large egg-sized rash at the injection site, which itched and was warm and slowly) had not resolved. Not Provided          No Treatment Medication was available. multivitamin is included as con concomitant  Action taken with mRNA-1273 in response to events were not applicable.   This case was linked to MOD-2021-061554 (E2B Linked Report).; Sender's Comments:  MOD-2021-061554:second dose
12/25/2020 felt funny. 12/26/2020 developed fever of 102, chills and body ache.
Arm soreness, redness and swelling in arm below injection site. Low grade Fever,  body aches, tiredness.
pt recv vax;lab eval revealed "metpath test" to be .04;MD reported this as a "vaccine failure";