chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11 adult patients received the expired Bivalent booster beyond 30 days; No adverse event; 11 adult patients received the expired Bivalent booster beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days), PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days), PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days) and PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days).    This case contains information for the 9th out of 11 adult patients described by the reporter. No concomitant information was reported. 11 adult patients received the expired Bivalent booster beyond 30 days in the refrigerator. At this time reporter does not have the patient information handy and reporter was not sure if any of those patients received any other vaccines at the same time. Vaccine vials were a case of 10pcs and 7 vials from the case were used to administer vaccines from 13JAN2023 thru 22JAN2023. Reporter advised that 11 doses of vaccines were used from the 7 vials. Reporter advised that label on case of vials advised that vials should have been used before 12JAN2023 Reporter advised that NONE of the patients that have received the 11 doses have reported any adverse reactions. it was intact cartons, 2.5 ml, The vial was initially stored in the refrigerator 13DEC2022 and administration of vaccine from 13JAN2023 thru 22JAN2023. Vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704253 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704253:Master case  1st adult patient
This spontaneous report as received from a nurse practitioner refers to a 14 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. ON 26-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K006191 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
My mom died 3 months after 2nd moderna vaccine every day became weaker and weaker finally needed 02 to survive...She was medically a heathy 90 yo before the shots Cleared after all tests
LOCALIZED SWELLING AND REDNESS.  PATIENT IS TO TAKE BENADRYL, IBUPROFEN AND ICE AREA
A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 11-Dec-2011. On 12-Dec-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Gave booster 2 weeks after initial vaccination on 1/7/2022,  both Janssen.
Mother reports:  patient started feeling sick the morning after the shot. She started out with a mild headache, neck, and back pain. She originally attributed it to being tired. By 9:00 pm on 4-11-07 she was running a high fever, hurting everywhere, had back pain, and a severe headache. She left work early because she was so ill. She did not sleep well that night. Her fever was high enough that you could feel the heat rising from her from a foot away. She was delirious, saying strange things throughout the night. I gave her tylenol and kept cold rags on her head. During her high fever time she had chills and severe headache. The shot sight was approximately four inches in diameter. Patient was unable to walk without assistance because she was dizzy and lightheaded. She was in bed with someone watching her for two days. She was still very week on the third day and slept most of the time. The shot was given on 4-10-07. She missed school Thursday (4-12) and Friday (4-13). She returned today 4-16-07. She still has a headache and neck pain. She is taking tylenol every four hours so that she can function. Patient has asthma and is allergic to septra and ceclor. She also had seizures from the pertussis in DPT shots and was never able to finish the series. She is still tired and has no color in her face but continues to do what she has to because she needs to be at school due to graduation being only 24 days away. If she had been the only one to get sick we would have said she must have had something else but we know of three other students to have reactions, that is why we were concerned.
About 4 hours after getting my flu shot, my arm movement was restricted.  It has continually gotten worse over the last two days.  I cannot lift my arm higher than 45 degrees
I injected today what I though was the patient's Moderna booster dose.    From our records, he received  his first & second dose on 3/26/21 AND 4/23/21 from our pharmacy.    However,  upon entering today's vaccine,    patient was shown to receive  the Pfizer series from.   Pharmacy RPh confirmed the vaccinations.     So,  in sum, patient received 5 doses of COVID-19 vaccine  in 1 year.   Patient doesn't report a prescriber to call on his consent form.
p/vax pt began vomiting throughout day; hosp;tx c/IV fluid; vomiting persisted & became very pale;passed bloody stool;surgery; Dx intussusception;pt recovered & disch p/3-4 days;
Information has been received from a physician concerning a 22 year old female with no pertinent medical history who on 05-JAN-2007 was vaccinated with a 0.5 ml dose of Gardasil. Concomitant therapy included penicillin, prednisone and hormonal contraceptives (unspecified). On approximately 15-FEB-2007 the patient experienced strep throat. On 21-FEB-2007 the patient sought medical treatment for rash/purpura and nose bleeds. On 28-FEB-2007 the patient had a sinus biopsy and was diagnosed with leukocytoclastic vasculitis. It was determined that the patient had been exposed to parvovirus. The patient was referred to an infectious disease physician who was "ruling out" the parvovirus. At the time of the report, the results of the parvovirus are unknown. After seeing several specialist, the patient was diagnosed with Henoch-Schonlein purpura. At the time of the report, the patient had not recovered.  Upon internal review, Henoch-Schonlein purpura was considered to be an other important medical event. Additional information has been requested. 6/21/07-records received for DOS 2/27-5/17/07-office visits. Presented on 2/27/07 with complaint of generalized maculopapular rash. Ecchymosis around ankles pruritic. Some resolving areas on thighs and trunk and shoulders. Started superiorly and moved inferiorly. Likely viral exanthem. Seen on 3/8/07-rash continues, assessment:leukocytoclastic vasculitis confirmed with biopsy. Seen on 3/29/07-continues to have intermittent episodes of joing swelling and stiffness, no rash at present. CT scan sinuses negative. Recent infectious history included cold in late December, on a cruise in January and developed a sore throat. HPV vaccine early January. Patient had a pet hedgehog and a python. Visit on 5/17/07-vasculitis substanitally improved.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 41-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive.  Additional comment: The reporter accompanied by her husband, her son and a friend have all been vaccinated and boosted with Pfizer Covid vaccine. While vacationed together on a cruise ship the week from 05Apr2022 to 12Apr2022, they were notified on 12Apr2022 having been tested positive for Covid. They were therefore removed from the shipped and self quarantined in a hotel. Since being quarantined they have all developed mild to moderate Covid symptoms. Symptoms developed by patient:  mild headache and runny nose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX in the arm. Concentration and route of administration were not reported. Concomitant medications were not reported. On approximately 12-OCT-2013, 2-3 days ago, the patient developed a "big, red, inflamed swelling on the back of his arm at the injection site". The patient sought for medical attention. The outcome of the adverse event was unknown. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE ERYTHEMA (Injection site red spot), HEADACHE (Headache) and PYREXIA (Mild fever) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, pre-filled pen. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE ERYTHEMA (Injection site red spot), HEADACHE (Headache), PYREXIA (Mild fever) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE ERYTHEMA (Injection site red spot), HEADACHE (Headache), PYREXIA (Mild fever) and VACCINATION SITE SWELLING (Injection site swollen) had resolved. Concomitant medication list was not provided. Treatment information was not provided. The reporter's causality with respect to Humira for the events, injection site redness, fever, headache, injection site warmth, injection site itching and injection site swelling were not related. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Patient received Pneumovax to left upper arem later developed redness swelling, warmth and soreness at injection site.
Information has been received from a registered nurse concerning a 13 year old female with a penicillin allergy and drug hypersensitivity to Zithromax. On 14 Nov 2006, the patient was vaccinated with Gardasil (yeast) ( Lot # 653978/0955F). There were no concomitant medications reported. On 15 Nov 2006, the patient was noted to be very emotional, nauseated, felt dazed and "high". The patient sought unspecified medical attention. No treatment was required. On 16 Nov 2006, the patient had recovered from the events. Additional information has been requested.
Terrible taste in mouth for 2 days. I couldn't get relief with gum or food. It went away on its own. It caused a flare of my Sjögren's. I had sores in my mouth, joint/muscle pain and extreme fatigue. Still getting back to normal now. I had no problems at all with the first 2 shots. Not even arm pain at the injection site; only the booster.
Large, red whelp 5 cm long and 3 cm wide, warm to touch and itchy, on the back side of right upper arm SQ.
Pt was mistakenly given pfizer bivalent for his first Covid-19 injection.  No adverse effect.  Pt's mom was called the following day and 5 days later to check on the patient.  Pt had no adverse reactions.
pt recv vax 23OCT95 & became jaundiced & lab eval revealed a serum bilirubin of 13-15 which was elevated;@ the time of report,pt sx remained despite the MD discontinuing the use of breast milk;
This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL. On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an Unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752835A and A0752836A.
Received Pediarix, PRP-T, PCV7, and RV on 6-11-2008, at approximately 10:00am.  Fever started June 11, 2008 after the vaccines were administered, fever was as high as 105 during the night.  Baby was fussy and lethargic as reported by the Day Care the morning of June 12th, sleeping more than usual, feeding okay, cried hard for about one hour and was difficult to console. Mom and baby presented in the office June 12, 2008. Vaccination sites were hard to the touch, temperature was 100.9, rectally.  General exam was negative, baby was not lethargic or irritable during the office exam.  Baby also had a fever at about 2 months of age.  At the time the fever occurred, the baby had not yet received her 2 month vaccines.
Myalgia, Fever, chills and soreness to the injection site Employee missed work today.
Pt reports onset of fever to 102-103F, full body aches, headache, sniffles, cough. Pt denies any injection site redness/swelling/pain but does note some L axillary lymphadenopathy (same side where flu/pneumonia shot given).
Initial report received from a healthcare professional on 20 September 2013. A 70-year-old female patient with no medical history had received a dose of FLUZONE (batch number: UH906AB) intramuscularly in the left deltoid on 19 September 2013. On 19 September 2013, one hour post vaccination the patient experienced pain at the injection site that radiated down to the elbow of her left arm. The patient was advised by the reporter to take nonprescription pain relievers she normally uses and if no relief to contact the reporter. Laboratory investigations and treatment medications were not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none. Follow up information was received on 11 November 2013. On an unspecified date outcome of event was recovered.
hives in her forearm, knee and feet; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives in her forearm, knee and feet) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 6:00 AM, the patient experienced URTICARIA (hives in her forearm, knee and feet). At the time of the report, URTICARIA (hives in her forearm, knee and feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter  Treatment for the event included Benadryl.
Eye irritation which progressed to severe swelling, such that patient could not fully open his eyes.  The swelling occurred on the eyelid and below the eye to about the jawline.  Went to urgent care on 5/4 and was prescribed steroid.  Swelling persisted until roughly 5/10 before returning to normal.   At the same time, patient broke out ink a series of rashes on his arms, legs, ears, and torso.  The rash continues to evolve, spread to new locations, and change appearance.
Whole left upper arm red, warm, swollen mother states Pt had fever but did not take temp. At office T 98.2F.
Hives reported within 1 hour of vaccination, Patient did not report reaction to administrator until clinic 3 weeks later, did not receive second shot.
Patient stated on the evening of the day vaccines were administered he developed a rash on the cubital area of bilateral arms. Rash then progressed to the axilla bilaterally, neck and sides of trunk. Thursday morning (3 days later) patient was seen at school nurse's office and given Benadryl. Patient was seen that afternoon at Health Center and diagnosed with allergic reaction secondary to vaccine administration Hep A and HPV. Patient was prescribed Prednisone for 6 days.
body ache; dizziness; having hard time breathing; body chills; very fatigue; headache; injection site pain; A spontaneous report was received from a non-HCP concerning a 36-year old, male patient who experienced body ache, dizziness, having hard time breathing, body chills, very fatigue, headache, and injection site pain.   The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On 23 DEC 2020, the patient received one of two planned doses of mRNA-1273 (LOT/BATCH# 011J20A) intramuscularly in the Left Deltoid for prophylaxis of COVID-19 infection.   On 23 DEC 2020, the patient experienced body chill, headache, very fatigue, body ache, dizziness, injection site pain, and having a hard time breathing. Treatment for the events included 400mg ibuprofen  Action taken with mRNA-1273 in response to the events was not reported.   The events very fatigue, injection site pain, and having a hard time breathing were considered not recovered/not resolved.  The events body ache, dizziness, and body chill were considered recovered/resolved on 24 DEC 2020.   The event headache was considered recovered/resolved on 25 DEC 2020  The reporter did not provide an assessment for the events body ache, dizziness, having hard time breathing, body chills, very fatigue, headache, and injection site pain.; Reporter's Comments: This case concerns a 36-year-old, male patient. The patient's medical history was not provided. The patient experienced the non serious, unexpected event of body ache, dyspnea, dizziness and, expected event of chills, fatigue, headache and injection site pain. The event occurred the day the patient received one of the two doses of mRNA-1273 (LOT/BATCH# 011J20A). 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.
Chest pain; Shortness of breath; Coughing; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 28-year-old) and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications within two weeks of vaccination. On 16Aug2021 at 16:45, the patient experienced chest pain, shortness of breath and coughing. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain, shortness of breath and coughing was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
bloody stools; mucus diarrhea; Patient was sent to the ER by provider to get IV rehydration; This case was reported by a nurse via sales rep and described the occurrence of blood in stool in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 3CR3S, expiry date 12th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 1st March 2021, the patient received the 2nd dose of Rotarix lyophilized formulation (oral) 1 ml and Rotarix Oral Applicator Device. In March 2021, less than a week after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced blood in stool (serious criteria GSK medically significant), mucous diarrhea and dehydration. The patient was treated with rehydration fluid (nos) (Intravenous Rehydration Therapy (Nos)). On an unknown date, the outcome of the blood in stool, mucous diarrhea and dehydration were not recovered/not resolved.   It was unknown if the reporter considered the blood in stool, mucous diarrhea and dehydration to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: On Friday 5th March 2021, the nurse was seen in the office for complaints of bloody stools, mucus diarrhea after receiving Rotarix vaccine. Stool cultures were taken and are still pending. The patient was sent to the emergency room (ER) by provider to get intravenous (IV) rehydration. The reporter reported that there are no new events. The reporter consented to follow up. This case was 1 of the 3 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR058802:same reporter US-GLAXOSMITHKLINE-US2021AMR058813:same reporter