chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, 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. On 20-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) 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 POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer. The excursion was found out in an audit. The Agent guided the reporter to the online temperature excursion tool and found that vaccines were viable. Patient did not report any adverse reactions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-675735 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675735:Master case Same reporter
1155 vax recvd vax 1120PM w/coughing, itching & edema around eyes, BP 160/100; given DPH;
Sanofi fluzone 0.5ml administered to left deltoid. Trumenba 0.5ml administered IM 2 inches below fluzone administration site. Bleeding from trumenba IM administration observed. Patient states "my arm really hurts, my fingers are tingly, my fingers hurt, i feel like im going to pass out". Pallor noted. Patient head rolled back and forward, eyes rolled back. Patient moaned with eyes closed then open eyes and cried. Skin appeared flushed. Dr. notified. Per MD, CBG performed. CBG 101. Mom states patient has not eaten today. Juice administered to patient. Patient states "I feel better". BP 106/78, HR 69. RR 20 and unlabored. Pt instructed to wait 15 minutes or more for monitoring.  0916 Pt sitting upright in chair, cheeks pink and smiling. Pt states she feels fine and wants to go eat. Pt and mother given ER precautions, no further questions or concerns. LVN 3/17/2020 8:55 AM: Called to examine patient who appeared to have a vaccine related adverse event 5 mins after both Influenza and Trumemba vaccine was given O/E conscious and alert, oriented to place and time, appear tired, normal color, not pale or flushed, responded to verbal commands, with normal neurological, cardiovascular and respiratory exams. Stable vital signs Impression: Vasovagal syncope following immunizations Plan: Observe for 15-20 mins and discharge home if patient remains stable.
Information has been received from a consumer referring to her son, an 11 year old male patient. The patient's relevant medical history and concurrent conditions were unknown. On 15-SEP-2105 at 16:00 the patient was vaccinated with a dose of GARDASIL (dose, lot# and expiration date not reported; route reported as "injection") in the right arm. Information regarding concomitant medications was unknown. On 15-SEP-2015 at 20:30 the patient began to feel a stabbing pain in his arm at the injection site. He was treated with an unknown pain medication a little while ago. It was unknown if there was any relevant laboratory data. At the time of this report, it was unknown if the patient would continue to get the GARDASIL and the outcome of the event was not recovered. Additional information has been requested.
LITTLE SICKNESS; FEVER 100F; This spontaneous report received from a patient 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 not reported, batch number: Unk) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-JUN-2021, the subject experienced little sickness. On 22-JUN-2021, the subject experienced fever 100f. Laboratory data included Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 100f and little sickness was not reported. This report was non-serious.
HIB portion of Pentacel was reconstituted with sterile water and she did not mix it with the DTAP-IPV vaccine/no AE; Initial information regarding an unsolicited valid non-serious case was received on 30-Sep-2021 from Nurse and Consumer/non-health care professional via Medical Information (Reference number- 00792982) and transmitted to Sanofi on 30-Sep-2021.  This case involves a patient (unknown age and gender) who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received (once) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [strength: standard; lot number and expiry date was not reported] not reported via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported "Nurse states that when she administered PENTACEL to a patient, she only administered the HIB portion in the blue vial; she did not mix it with the DTAP-IPV vaccine in the green vial. Nurse states the she reconstituted HIB portion with 2 mL of sterile water. Nurse asks if this would be considered a valid HIB vaccine. This agent referred nurse to the PENTACEL".  This agent asked nurse to provide information for an AE (adverse event)/safety report; Therapy Date, Patient Information (patient age less than 1 year enter as 2 month , 4 month, etc. Many pediatric vaccines need month for age), route and site, dose, event information and treatment, concomitant medication - nurse stated she was not allowed to provide all these information.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency on the same day of vaccination).   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.  There will be no information on the lot number for this case.
Patient indicated anxiety with first dose and requested privacy. Vaccine administered to patient lying on cot. Significant other, accompanied patient and also received vaccine in EMS room. Patient felt slightly light headed which resolved after the 30 minute wait. Escorted to Exit.
TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-1111) was received from a caregiver on 06-May-2019. It describes a 67-year-old male consumer who "took two doses in a row", while being on Vivotif for an unknown indication.  Case report: The consumer took two doses of Vivotif in a row. The doses were taken on 02-May-2019, 04-May-2019, and 05-May-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took two doses in a row" was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Pt. Deceased - Confirmed Breakthrough  1st Dose - 12/29/2021 - Moderna - 058H21A 2nd Dose  1/26/2022 - Moderna - 003J212a
Friday: sore arm, back ache, knee pain, dizziness Saturday: dizziness Sunday: rash on both legs Monday: headache Tuesday: all adverse events resolved
2 days after vaccine given swelling, redness from shoulder to mid-forearm-tight edema, arm is about 2 times normal size.  Some decreased range of motion.  Treatment with Preline at left shoudler, syrup 2 doses.
This spontaneous case, initially received on 12-Jan-2017, was reported by a health authority and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported. Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced right arm pain (outcome: not reported). Linked Case ID(s): US-BEH-2017077575 (same patient). 8-MAR-2017 (System Update): Linked Case ID(s):2017077575 (Patient Link).
Less than 6 weeks after second vaccine I came down with an unknown illness.  Illness could never be identified by my doctor or the hospital.  Symptoms - lethargic, headaches, unable to eat.  Ended up in the hospital dehydrated.  After a battery of tests and 2 nights in the hospital the only outcome was elevated liver ALT numbers.  After researching if the vaccines can damage the liver and knowing I am not a heavy drinker I firmly believe the vaccines caused my illness which lasted 12 days.  I was unable to work or do anything, could barely walk.
Patient got Pneumovax 7/12. That evening she said her arm got very sore in upper arm and had flushing quite pink upper arm moved around arm to inner arm not just area of vaccine. Had chills and felt feverish: did not take temp. By 7/15 some redness and sore. 7/16 back to normal.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 11:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 11:21 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 60.53.  Concomitant products were not provided.  On 22-Jun-2021, Excursion time was 08 AM, temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials were sent to clinic. Vaccine BUD date was 26-Jun-2021.  On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43 and 4 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Noticed my eyeglasses "weren't working".  Have since had prescription changed 2 times by optometrist, seen an ophthalmologist for full eye exam including retinal scans, etc. AND had an MRI.  None has shown a reason for my vision change.  THE ONLY THING DIFFERENT was the COVID Vaccine.  I've been on the same RX's for years. Ophthalmologist whom I saw on July 1st was the one who inquired about any changes in medicines or any new vaccinations; that's why I'm sending this report.  I AM A  STAFF ACCOUNTANT.  WITHOUT CLEAR VISION, I CAN'T DO MY JOB EFFICIENTLY!
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 13-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 20 year old female patient with no pertinent medical history who on 17-MAY-2007 was vaccinated with the first dose of VARIVAX (Merck). On 17-AUG-2007 the patient was vaccinated with the second dose of VARIVAX (Merck). There was no concomitant medication. The recent VZV antibody titer was negative for the patient. No further information is available.
No adverse reactions to prior Moderna vaccines administered 1-27-21 and 2-24-21,   Moderna booster administered on 10-21-23 initially was uneventful other than normal upper arm tenderness at injection site.   Within 8 hours headache at back of skull and upper neck pain along with stiffness began to emerge.   Within 12 hours of vaccination headache and neck pain were considerably worse.   Took 2 Tylenol extra strength tablets over the next 8 hours which provided some relief.   Serious headache and upper neck pain continued for next 48 hours moderating somewhat as time passed.   By 72 hours the headache, neck pain and stiffness were gone.    Initially after several hours when experiencing the headache and neck pain  I was concerned I might be experiencing a stroke and considered going to the local hospital ER.   I decided however absent further symptoms of a stroke I would wait until Monday morning prior to going to the ER.   By Monday 10-25-21 the pain had most passed.   On 10-26-21 I spoke with a physician friend and they suggested I report my event to this site.
headache left side back of head..all day and night, tylenol every six hours not much relief .  A Fib 05/26/2022 hospitalized 24 hours.
Information has been received from a physician concerning her 4 year old son with allergies to amoxicillin and no pertinent medical history who on 28-Sep-2007 was vaccinated with PROQUAD.  The patient's vaccination history included 0.5 ml subcutaneous of VARIVAX on 25-Aug-2004, and a 0.5 ml subcutaneous of MSD.  On 07-Oct-2007, the patient developed maculo-pular rash that started on his hands and feet and then became widespread over the next few days.  The rash was erythematous and slightly itchy.  The patient was seen in the physician's office and therapy was prescribed with Benadryl.  It was reported that the rash was resolving.  No product quality complaint was reported.  No further information was available.  Additional information has been requested.
12 YO /was/ administered the 1st /& 2nd dose /of the Pediarix vaccine; administered the 1st(Jul-10-2021) & 2nd dose (Aug-4-2021); 12 YO /was/ administered the 1st /& 2nd dose /of the Pediarix vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number MK9444, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date unknown) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 10th July 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 10th July 2021, not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device and unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 4th August 2021, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration, drug dose administration interval too short and inappropriate age at vaccine administration 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 details provided were as follows: Nurse called to reported that, the 12 year old patient received inadvertently administered the 1st dose and 2nd dose of Pediarix vaccine, which led to shortening of vaccination schedule and inappropriate age at vaccination. Also, the patient received 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule. Expiry date for 1st dose of Pediarix was not reported. The reporter consented to follow-up. This case is linked with case US2021172398 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021172398:same reporter
Minor fatigue side effect; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of fatigue (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fatigue. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR017687  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced minor fatigue side effect. The follow-up would not possible, as no contact details were available. This case had been linked with case US2022AMR017687, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR017687:Same reporter
Cough; Fever; body aches; Tested positive for COVID after the first dose of the vaccine/tested positive for COVID-19; Tested positive for COVID after the first dose of the vaccine/tested positive for COVID-19; This is a spontaneous report from a contactable physician reporting for himself from a Pfizer sponsored program, IBCC (Inbound Call Center for HCPs). A 31-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) intramuscular Deltoid Left, on 17Dec2020 9:00, single dose for COVID-19 immunisation. Relevant medical history included seasonal allergies and asthma. Concomitant medications were reported as none. The patient took the first dose of the COVID-19 Vaccine and he is schedule on 07Jan2021 for his second dose. After the first dose he tested positive for COVID on 30Dec2020. The patient got tested for COVID-19 around 10:30 a.m. The patient hasn't seen a physician and he doesn't don't plan on it. The patient had a cough on an unspecified. Early on he had a fever and body aches but that passed after the first day. Caller clarifies the fever and body aches started Sunday and were gone by Tuesday morning. The cough started on Monday and is still ongoing and persisting. The patient was not hospitalized in response to the events. Outcome of the event cough was not recovered, the events fever and body aches recovered on an unspecified date, while it was unknown for tested positive for COVID after the first dose of the vaccine.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the SARS-CoV-2 test positive, LOE and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.