chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients were administered an improperly stored dose of VARIVAX; No additional adverse event; This non-valid, spontaneous report was received from a nurse and refers to five unspecified patients of unknown age and gender. No information was provided regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies.    On unspecified dates, the patients were vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number: R026715, expiration date: 18-SEP-2020 (strength, exact dose, frequency and route of administration were not reported) for prophylaxis. The sterile diluent used to reconstitute the suspect vaccine was properly stored. No additional adverse event information was provided. The vaccine underwent temperature excursion at 6.5 degree Fahrenheit for a duration of 17 minutes. There was no previous temperature excursion. Data logger was involved.  This is a non-valid case due to lack of patients' identifiers.
elbow starting hurting more, and it was on the same arm as the side she got the injection on, the right arm; is real tired and she even slept 14 hours last night; is real tired and she even slept 14 hours last night; This is a spontaneous report from a contactable Consumer (patient's husband). A 94-year-old female patient received the first dose bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249), via an unspecified route of administration (right arm) on 21Jan2021 at SINGLE DOSE (arm right) for covid-19 immunisation. Medical history included left shoulder pain (on medication for years) from an unspecified date, and elbow that she fell on two weeks before on Jan2021. Concomitant medication included hydrocodone for left shoulder pain. On 24Jan2021, the patient experienced real tired and she even slept 14 hours the night before. Reporter was wondering if tiredness is a side effect of the product. The patient also had an elbow that she fell on two weeks before on Jan2021, and three days after getting the vaccine (24Jan2021), that elbow started hurting more, and it was on the same arm as the side she got the injection on, the right arm. The reporter was unsure of the lot number reported as E13249 or EL3249 (unsure which lot number is his, and which is the one his wife received). The patient received no other vaccines on the same day as the COVID vaccine. Outcome of the event "elbow starting hurting more, and it was on the same arm as the side she got the injection on, the right arm" was not recovered. Outcome of events "is real tired and she even slept 14 hours last night" was unknown.
Nausea, vomiting. fever, fatigue, body aches, swollen lymph nodes, dizziness, headaches, redness below injection site and sweating
Got wheel on arm (red circle); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Got wheel on arm (red circle)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Got wheel on arm (red circle)). At the time of the report, ERYTHEMA (Got wheel on arm (red circle)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient post 5 days of receiving the first dose of vaccine got wheel on their arm a red circle.  No Concomitant product use was reported. No treatment information was provided.
Other than the normal swollen and sore area around the shot, I had very bad chills (even with multiple blankets on) and my heart felt like it was going to beat out of my chest.  I took my pulse and it was in the 160s for several hours, but it is back around 100 now.  I also had a very bad headache and still have a slightly swollen and sore gland in my armpit
I started having a cough and low-grade fever that slowly became a high-grade fever and the cough continued. My husband tested positive the day before, so I decided to test once I got the low-grade fever. The test came back positive immediately, I contacted my doctor through the web portal, she prescribed PAXLOVID that I started immediately. The cough continued so the doctor prescribed two rounds of steroids to help me get rid of it. I am now feeling much better.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EL9266), on 19Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 17Sep2021 as dose 3 (booster), single (Lot number: EW0169), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillan, Erythrmycin, Ceclor, codiene; "mild asthma" (unspecified if ongoing); "had breast cancer 7 years ago" (unspecified if ongoing), notes: breast cancer 7 years ago; "high blood pressure" (unspecified if ongoing), notes: Other medical history: diabetes, high blood pressure, mild asthma, had breast cancer 7 years ago. Concomitant medication(s) included: METFORMIN, start date: 07Feb2002, stop date: 04Mar2023; ATORVASTATIN, stop date: 16Feb2023. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Penicillin, Erythromycin, Ceclor, codeine; Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Penicillin, Erythromycin, Ceclor, codeine; Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Penicillin, Erythromycin, Ceclor, codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Feb2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I also still was testing positive for Covid using an at home test; (04Mar2023) Positive, notes: today I again tested positive for Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19: Treatment with Paxlovid.
Extreme fatigue that is ongoing as of 4/17/21; unable to work or function normally
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 29-JUL-2016 the patient was vaccinated with an expired dose of ROTATEQ (lot # K022993, expiry date: 20-JUL-2016) (expired product administered). No adverse reactions were reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Patient mistakenly given 0.1mL of the Moderna COVID-19 vaccine. The mistake recognized on August 4, 2021. All patients affected informed. Patient revaccinated on 8/9/2021 and 9/7/2021. Staff member re-trained on proper dosing and vaccine administration.
NASAL CYST; HARD TIME BREATHING; ANXIETY; This spontaneous report received from a patient concerned a 47 year old, male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and smoker (started smoking heavily in JAN-2022, a pack per week, after quitting for two years). The patient had no known allergies, no history of drug abuse or illicit drug usage. The patient was healthy was not sick for many years before the vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient experienced to have a little hard time breathing. The patient mentioned to have sick people in his household and were confirmed to not have covid-19 but were symptomatic. The patient was tested negative for covid-19 done via nasal swab at the hospital before he underwent the procedure of surgical drainage of nasal cyst. The patient was at the hospital for two hours and was prescribed with amoxicillin to take after the procedure for one week and he mentioned to have finished the antibiotic course. The patient further stated that hard time breathing symptoms could be from returning to smoke or anxiety related or might be a side effect from amoxicillin. The patient had then slowed down on smoking and described his hard time breathing to be not to the point where he cannot breath or needs to go to the hospital. The patient has an appointment booked to receive the booster shot of Janssen COVID-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasal cyst on 11-JAN-2022, had not recovered from hard time breathing, and the outcome of anxiety was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  20220133751 -Covid-19 vaccine ad26.cov2.s- Nasal cyst. This event is considered unassessable. The event 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.
Patient received a third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2019) and Shingrix (received 2nd dose in March 2019).   On 29th March 2022, the patient received the 3rd dose of Shingrix (intramuscular). On 29th March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: Additional Information: GSK Receipt Date: 08-Apr-2022 Reporter's Comments: Pharmacist reported a patient at the clinic received a third dose of Shingrix on the left arm, it was discovered after the third dose of Shingrix was given. The reporter consented to follow up. Additional Supportive Information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Case number PHEH2016US022005, is an initial spontaneous case received from a physician on 25 Aug 2016. This report to a 51 years old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with expired FLUVIRIN (batch number: 1517501, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly on 25 Aug 2016. No adverse event was reported following this administration error.
06Jan96 pt recv 1 dose vax. 06Feb98 pt exp "more than 30 varicella lesions & coughing
5 hours after receiving Pneumovax vaccine Patient complained of Deltoid pain and severe pain in the elbow of the right arm that was her vaccinated arm. Patient went to the ER for treatment. She was treated with Dilaudid.
Her eyes are like swelling up; She has like an itchy throat; Her right ear is like a little bit closed up; This is a spontaneous report from a contactable consumer. A female patient (reporter's sister) received unknown number dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8731; Expiration date: 31Jul2021) via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. Medical history, concomitant conditions or past drug history of the patient were not reported. On an unspecified date in 2021, patient experienced a reaction, her eyes were like swelling up and then she has like an itchy throat and her right ear was like a little bit closed up." Reporter was not sure if patient should go to the ER (Emergency Room) now. Reporter asked, "Should we go to the Emergency Room or is this like a very normal thing." Outcome of the events were unknown.  As reporter was not willing to proceed the call. Product details (NDC# and UPC#), Pharmacy details and treatment could not be probed over the call. Limited information available over the call and appropriate response could not be provided.
Have experiences pain/discomforting on back of head, along nerve route since then. Continues today.   No scalp integrity issues.
Client was administered an expired doses of Rotarix vaccine. This was the second dose in the vaccine series. Notified mother of client and contact the vaccine manufacturer.
He experienced posterior left trunk pain followed by a rash, a week after receiving the SHINGRIX vaccine, which spread to his anterior left trunk, with gradually worsening pain so he presented to the ER for further evaluation.
Initial report was received from a consumer on 07 August 2013. An 18-year-old male patient had received a dose one injection of IMOVAX, lot number H1512-3 on 12 July 2013 and a dose two injection of IMOVAX, lot number H1512-3 on 19 July 2013. On about 28 July 2013, the patient developed a fever and had been diagnosed with "mono". No additional information was provided. Outcome was not recovered. Documents held by sender: None.
Information has been received from a physician concerning a patient who was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced numbness at the injection site and numbness around the arm. Additional information has been requested.
Regarding dose # in series question - it was my 2nd dose. I don't know how many doses out of that vial.  Symptoms - Woke at 5 am with significant body aches, mild head ache and fatigue.  by 11 am this turn to chills/fever  and more fatigue. Soon I developed nausea.  I slept most of the day on and off - waking with the same symptoms.  Headache continued.  Body aches start to decline by the evening.  About 5 pm I threw up.  I through up 3 more time that evening - mostly water and bile since I was unable to eat all day.  Occasional chills during the night, nausea continue.  Today is my second day. Body aches are gone,  most of the nausea is gone,  I am still very tired. Have slept most of the day and have a lingering headache - like a hang over.  Not much appetite but I am able to eat some soup and crackers. I am able to keep Tylenol down now but it is not helping with my headache.
The arthritis in his foot started to flare-up; A spontaneous report was received from a consumer, concerning a male patient of 84 years of  age, who received Moderna's COVID-19 vaccine and experienced adverse events   The patient's medical history was arthritis . Concomitant product use was not provided by the reporter.  On an 23 jan 2021 , prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 038U20A) via  IM route for COVID-19 infection prophylaxis. About a week ago, the arthritis in his foot started to flare-up. He is not sure if his symptom has anything to do with the Moderna COVID 19 vaccine. He has been using a diclofenac sodium prescribed by his doctor but it has not help with the symptom  Treatment medication was reported that Diclofenac sodium.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, was considered to be not resolved at the time of this report.
Myocarditis; This is a literature report.  An adolescent male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE,  MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (death), outcome "fatal", described as "Myocarditis". The patient underwent the following laboratory tests and procedures: autopsy: microscopic myocardial findings, notes: There was global myocardial injury similar to that  seen above, but with more widespread transmural  ischemic changes and more interstitial  inflammation, again with a predominant neutrophil  component with histiocytes and scant lymphocytes; body mass index: 30; gene sequencing: unknown results; investigation: several  sections had transmural, confluent areas, notes: of contraction bands apart from any inflammation, and florid neutrophilic inflammation with some histiocytes. In this case, a subepicardial distribution of injury was not seen.There were no acute or organizing thrombi; 520 grams with  biventricular dilatation and, notes: marked pulm onary  edema (combined  lung weight=1481  grams); microscopy: microscopic findings are not the alterations seen, notes: with typical myocarditis. This suggest a role for cytokine storm which may occur with an excessive inflammatory response, as there also is a feedback loop between catecholamines and cytokines; sars-cov-2 test: pcr tissue testing performed by the cdc on heart, notes: lung found no molecular evidence of SARS-CoV-2 infection; toxicologic test: negative for medications and drugs of abuse. Therapeutic measures were not taken as a result of myocarditis. The patient date of death was unknown. The reported cause of death was myocarditis. The autopsy revealed "biventricular dilatation" (dilatation ventricular); "pulmonary edema" (pulmonary oedema); "global myocardial injury" (myocardial injury).; Sender's Comments: Based on the currently available information the possibility of causal association between the event Myocarditis and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new 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.,Linked Report(s) : PFIZER INC-202200276862 Same drug/event, different patient; Reported Cause(s) of Death: Myocarditis; Autopsy-determined Cause(s) of Death: biventricular dilatation; pulmonary edema; global myocardial injury
ALTERED MENTAL STATUS (CONFUSION, UNABLE TO FOLLOW SIMPLE COMMANDS), VISUAL HALLUCINATIONS, SEVERE AGITATION, COMBATIVENESS, DILATED AND NONREACTIVE PUPILS, TACHYCARDIA.
A report has been received from a Health Professional concerning a 28 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Monthly. FLUMIST QUADRIVALENT started on 07-Oct-2013. The patient experienced woke up with swollen left hand which started on 11-Oct-2013 and repeated sneezing and nasal stuffiness which started on 08-Oct-2013. The patient recovered from the event of woke up with swollen left hand on 14-Oct-2013 and the patient recovered from the event of repeated sneezing and nasal stuffiness on 09-Oct-2013. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 23-Oct-2013 from the health professional: New non-serious event of nasal stuffiness added. Dose of suspect drug FLUMIST QUADRIVALENT added. Stop date of event of repeated sneezing added and outcome changed from unknown to recovered. Stop date of event of woke up with swollen left hand added and outcome changed from unknown to recovered.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided A vial at their clinic was punctured 30 times. 10 patients were affected.
A report has been received from a Pharmacist concerning an 8 year old, female subject, who had been receiving FLUMIST. FLUMIST was started on 11-Nov-2013. The patient received only a half dose FLUMIST in one nostril, which was started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious by the reporter.
Swelling, itching, rash, warm to touch, 2 inches around injection site.
Was not feeling well shortly after receiving  1st dose on 1/6/21. Went to primary care doctor on 1/7/21. Still not feeling well later on 1/7/21, went to ED. Felt dizzy, heart racing. Tachycardic 130's-140's
Within three weeks post vaccine (unsure of time of day) I developed mouth sores. I had small canker sores in mouth. I've had them in past so I am prone to them. I wasn't thinking anything of it but they came and I waited too long to go to doctor but once I did they did cultures and blood work, I was prescribed acyclovir for treating of oral herpes but they did test for herpes and it came back negative. Four weeks later I had follow-up and was given an oral steroid to apply to sores. Right now I have three and I can't get rid of them. At the doctor they did do blood work looking for markers for inflammation but it came back normal.
patient administered vaccine. abruptly passed out and appears to have stopped breathing. epi administered and patient regained consciousness,
Headache, chills, half-dollar sized knot at injection site, itching at injection site, pain at injection site
an unknown patient received her second dose of GARDASIL9 2 years after her first dose; No adverse effects; This spontaneous report was received from medical assistance, concerning a female patient of unknown age. The patient's pertinent medical history, concomitant medications, concurrent conditions, and drug allergies or reactions were not reported.   On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Subsequently (reported as "2 years after the first dose"), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  (strengths, routes of administrations, anatomical sites of injections, lot numbers,  and expiration dates were not reporter) both for prophylaxis (inappropriate schedule of product administration). No adverse effects reported nor quality complain involved.