chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a temperature excursion for 160 hours during which they could have reached temperatures beyond the maximum permitted; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation, Bexsero, Menveo, Engerix B, Havrix, Kinrix, Infanrix and Pediarix. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, Bexsero, Menveo, Engerix B, Havrix, Kinrix, Infanrix and Pediarix, the patient experienced incorrect storage of drug (Verbatim: had a temperature excursion for 160 hours during which they could have reached temperatures beyond the maximum permitted).The outcome of the incorrect storage of drug was 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: 24-AUG-2023 The reporter called to inform that Bexsero, Engerix-B, Havrix, Infanrix, Kinrix, Menveo (2-vial), Pediarix, Rotarix (Liquid presentation) had a temperature excursion for 160 hours during which they could have reached temperatures beyond the maximum permitted and administered to the patients, which led to incorrect storage of drug. Due to technical limitations in the system, they could not ensure the vaccines were viable so they had to be discarded.  Prior to this decision, some vaccines were administered to patients.  At the moment of the call healthcare professional did not have a number of patients or the vaccines they were given.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. The case had been linked to US2023115613, reported by the same reporter.
Large lump on left arm at injection site. Redness and skin feels rough. Slight itch.  Unsure if related, but have itcy skin under jaw in neck area for about a week.
I am post menopausal and I had a period. Cramping early Monday morning and full blown period Monday. Have not had a period in years
Entire left arm SEVERE pain & numbness, complete inability to move arm, minimal movement in fingers. Lasted 3 days & nights, was tolerable on 4th day. Never any visible swelling or bruising, lingering intermittent numbness down inside of left arm & elbow. Considered going to ER.
fever; tiredness with pain in the body; tiredness with pain in the body; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) via an unspecified route of administration on 05Jan2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever, tiredness with pain in the body on an unspecified date in Jan2021. The events were not resolved.  Information on batch/lot number was requested.
dry mouth, delayed cutaneous hypersensitivity Narrative: 67 y/o M received dose #2 of Moderna COVID vaccine 0.5ml dose to L deltoid on 2/22/21 @9:39. Pt called tele-triage 2/23/21 @9: 18 reporting dry mouth, fever, headache, feeling confused, nauseous. PCP s/w pt an hour later 10:17 and headache improved/just achiness after taking APAP 325mg. Pt also  reports red, itchy bump 2-3/10 pain on 2/24/21 and rash spreading around arm  PCP had video visit with pt and noted lump on posterior arm not axilla or inj site;  feels warm/spreading suggestive of "COVID arm" d/t delayed cutaneous  hypersensitivity. PCP ordered diphenhydramine 25mg BID, hydrocortisone 1% cream, recommended icing and going to ED if worsens.
This spontaneous report was received from a Licensed Practical Nurse who obtained the information from the web site where read an article which refers to two baby patients of unknown ages and genders. Concurrent conditions or pertinent medical history were not reported. On unknown date the patients were unsafe administer with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown), rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally, and BCG (manufacturer unknown) (lot #, expiration date, route of administration (for hepatitis B vaccine (recombinant) and BCG)) and doses were not reported for either vaccines). On unspecified dates, the two babies died (due to an unspecified reason) after receiving those vaccines. It was unknown if autopsy was performed. The nurse also mentioned that the consumer was now scared about having her child vaccinated in other country, therefore, the nurse would like to know any comparative information between the vaccines produced in different countries as lot#s and ingredients used or if those vaccines were in question. The relatedness of the suspected vaccines with death was not reported. This is one of several reports from the same source. Additional information has been requested.
chronic health issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 64-year-old patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ARTHROTEC. Past drug history included: Arthrotec 75, reaction(s): "Drug allergy", notes: I have taken for over 20 plus years. Vaccination history included: Covid-19 vaccine (Primary series Immunization completed but manufacture name unknown), for COVID-19 Immunization. The following information was reported: CHRONIC DISEASE (non-serious), outcome "unknown", described as "chronic health issues".  Additional information: The patient was advised that their order of Arthrotec 75 mg was delivered to the doctor's office on 18Apr. The patient confirmed that they did not receive that order. While speaking about the Arthrotec 50 mg, the patient stated, "The 75 was not available so was told him to go ahead and order the 50. The patient still have 1 bottle left of the 50 and then almost out of the second bottle of the 50 but  preferred to only take it twice a day and not three times a day because it was still the same amount. It was still 150 mg total but if I take the 75, which have taken for over 20 plus years, it was only twice a day. The 50, yes, that's what I was currently taking.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
redness and soreness at injection site 2" in diameter, self-resolved within 3-5 days
Pt experienced HA which was constant x2 wks after GARDASIL vaccine. Ordered DARVOCET & asked pt to be seen for evaluation and she did not come in.
12/29/2022 I woke up that morning and I had a burning in my throat. I treated it myself naturally. I had this for two weeks. I saw my GI doctor on 2/6/23 and was diagnosed with acid reflux. I was put on a proton pump inhibitor. Sometimes it works and sometimes it does not. I still have periods of this bothering me. I go off my medication today. This medication actually causes me to have reflux.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot #, expiration date, strength, dose and route not reported). No symptoms reported. The improperly stored doses were administered 27-AUG-2014 and 28-AUG-2014. It was unspecified if the patient sought medical attention.This is one of several reports received from the same source. Additional information has been requested.
recurrent Herpes genital ulcers; recurrent herpes genital ulcers; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL ULCERATION (recurrent Herpes genital ulcers) and GENITAL HERPES (recurrent herpes genital ulcers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     patient has no any medical history.  The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENITAL ULCERATION (recurrent Herpes genital ulcers) and GENITAL HERPES (recurrent herpes genital ulcers). At the time of the report, GENITAL ULCERATION (recurrent Herpes genital ulcers) and GENITAL HERPES (recurrent herpes genital ulcers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient had a query that should she receive the 2nd dose while having the Herpes lesioins.
had her first vaccine on 3/13/21 and didn't make her second appointment for the second doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (had her first vaccine on 3/13/21 and didn't make her second appointment for the second doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (had her first vaccine on 3/13/21 and didn't make her second appointment for the second doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (had her first vaccine on 3/13/21 and didn't make her second appointment for the second doses) had resolved.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Max/Low Temperature reached to 13.1° Farheinheit and excursion last for 4 hours, 4 minutes, with no reported adverse event; administered with fluzone high-dose quadrivalent, which was exposed to a temperature excursion, with no reported adverse event; Initial information received on 19-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient to whom administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], which was exposed to a temperature excursion, and max/low temperature reached to 13.1° farheinheit and excursion last for 4 hours, 4 minutes, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Oct-2022, the patient received 0.7ml total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE strength: standard (formulation: unknown) (lot number: UT7733BA and expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for Immunization, on the same day patient was administered with fluzone high-dose quadrivalent, which was exposed to a temperature excursion, with no reported adverse event (poor quality product administered).  On an unknown date, a non-serious event of max/low temperature reached to 13.1° farheinheit and excursion last for 4 hours, 4 minutes, with no reported adverse event (product storage error).  Reportedly, Nurse inquiring if they need to revaccinate a patient that was administered with FLUZONE HIGH-DOSE QUADRIVALENT. Does extended stability data cover the excursion: YES And in case of negative advice: Was the product used by/ administered to the patient: YES. This situation is reported as a medication error due to the product administered after experiencing a temperature excursion in which the product was no longer viable  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for both events.   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.
mom states p/2nd DTP could not console pt for rest of the day through the noc; states screamed all noc;
Patient had severe pain in neck and behind knees about 5 minutes after vaccine. Paramedics were called and patient was taken to hospital.
Had fever  for 3 days within 12 hours of getting vaccine, vomiting and diarrhea as well.  Still having a little bit of diarrhea for over a week.
HEMORRHAGIC STROKE; MEDICATION ERROR (RECEIVED A FULL SERIES OF PFIZER FOLLOWED BY JNJ VACCINE); This spontaneous report received from a consumer via a company representative concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included: hemorrhagic stroke, and concurrent conditions included: controlled hypertension, hyperlipidemia, and overweight. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included bnt 162 for prophylactic vaccination.  The patient received a full series of Pfizer sometime between MAR-2021 and MAY-2021.  On JUL-2021, Laboratory data included: Lab tests were normal. On 01-AUG-2021, Laboratory data included: Platelet count (NR: not provided) 4800 and the patient had 3 brain bleeds. On 11-AUG-2021, the patient had medication error (received a full series of pfizer followed by JNJ vaccine). On 16-AUG-2021, the patient experienced hemorrhagic stroke and was hospitalized for one day. On 17-AUG-2021, the patient died from hemorrhagic stroke. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine was not applicable. The outcome of the medication error (received a full series of Pfizer followed by JNJ vaccine) was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210837606 -covid-19 vaccine ad26.cov2.s- Hemorrhagic stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: Hemorrhagic stroke
Left deltoid - location of IM injection - pain, swelling, pruritus (itching) - severe extending to elbow. Exam approx 12 hours after admin.
Swollen and painful lymph node on left collarbone, plus tender-to-the-touch nodes in left armpit.  I consider this minor compared to contracting COVID-19
Approx 9 Mar 03 begin with leg and foot pain, gen. aches all over, mainly in muscles.  Tired with feverish feeling (no fever)C/O some headaches.  MD visit to private MD on 20 Mar 03.  Blood work (not sure what) was negative.  Given injection and returned home.  Returned to MD the next day with continued complaints of pain.  Was given antibiotics and Medro pac at that time.  Has completed meds.  Continues to complain but states feels better last two days.  Received Smallpox vaccine 23 Feb 03.  Scab had already come off prior to c/o discomfort.  Individual has called number provided during education session prior to administration of vaccine and spoke with Dr.
set of 4 month shots given at about 330p, baby started with 104ax fever about 530pm 6/11.  mom gave tylenol, fever came down to 101ax.  baby irritible and breastfeeding less than normal.  no redness or induration at site of pneum/HIB injections, but cried whenever his left leg was touch or moved.  slight redness oral pharynix that was not present at well visit 6/11/07
Axillary swelling on same side of vaccine administration. +some associated pain. Developed 7 days after vaccine administered.
I had cough, headache for eleven days. On the eight day, I went to see Dr. and was prescribed Promethazine-codeine. After the eleventh day I felt better.
Sweat profusely; Hot flashes; Chills; Nausea; General fatigue; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ewo151) via an unspecified route of administration in the right arm on 02Apr2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, contrast media allergy. 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-19 vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) 20 mg and escitalopram oxalate (LEXAPRO) 20 mg all from an unknown date for an unspecified indication. On 02Apr2021 at 15:00, the patient experienced sweat profusely, had hot flashes, chills, nausea, general fatigue and body aches. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with prescription for anti-nausea, and liposomal glu. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sweat profusely, had hot flashes, chills, nausea, general fatigue and body aches was not recovered.  No follow-up attempts are needed. No further information is expected.
Fever; Headache; Injection site pain; COVID-19 virus test positive; COVID-19 virus test positive; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4222730-00.  A 13 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 13 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "not recovered" and all described as "COVID-19 virus test positive"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; INJECTION SITE PAIN (non-serious), outcome "recovered", described as "Injection site pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive, The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of covid positive, covid vaccines caused Fever, covid vaccines caused headache and covid vaccines caused sore arm with humira (Adalimumab) was no reasonable possibility.  The reporter's causality for the event(s) of covid positive, covid vaccines caused Fever, covid vaccines caused headache and covid vaccines caused sore arm with Pfizer BioNTech covid-19 vaccine (Tozinameran) Was possible.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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
left arm soreness - like inside, like the bones are dying or festering - very hard to describe (at least 21 days as it's never changed nor gone away since starting the day of the injection); whole body joint pain for at least 3 full days (couldn't walk at normal pace or grip chopsticks etc),  fatigue for maybe 6/7 days (in bed 10-14 hours barely able to move, but awake and alert so not sleepy per se), muscle numbness in left arm for 2 days.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 22Jan2021 as dose 1, single (Lot number: 013L20A), in left arm, on 19Feb2021 as dose 2, single (Lot number: 004M20A), in left arm and on 07Nov2021 as dose 3 (booster), single (Lot number: 039F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "slightly high cholesterol" (unspecified if ongoing), notes: Other medical history: slightly high cholesterol; "Known allergies: Almonds" (unspecified if ongoing), notes: Known allergies: Almonds; "Known allergies: some fruit skins" (unspecified if ongoing), notes: Known allergies: some fruit skins. There were no concomitant medications. The patient did not receive other medication in 2 weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) positive, notes: original Covid occurred 27May/ Treatment of COVID-19; (07Jun2022) positive, notes: Covid Rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Pfizer Paxlovid from 28May2022 to 01Jun2022 for treatment of COVID-19. Covid Rebound - sinus congestion and headache - original Covid occurred 27May and had fever and sore throat.  No follow-up attempts are possible. No further information is expected.