chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Pharmacist concerning a 5 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter stated that they had accidentally given expired doses of FLUMIST on 10-Jan-2013. The outcome of the event of GAVE EXPIRED DOSES OF FLUMIST is unknown. The report was considered to be non-serious.
Five min after vaccination pt felt tingling in tongue, lips, mouth, coughing, flushed skin . Os sat was 99% room air, pulse 67, lungs clear bilaterally to auscultation. Sx fully resolved at 3:55 pm without use of medication.
rt leg beet red, entire top of thigh;constant crying;given APAP & ibuprofen suspension ice/cold to thigh
After administration he became aggressive, upset, confused, anxious, and nervous. After a couple of hours he developed fever, tiredness and pain in his arm. At night, his heart rate accelerated and he had a headache. In subsequent days to the present he has had pain in the joints, Head. It also gives him cardiac arrhythmia.
24 hours after MMR vaccine was administered client developed a red rash around site that was raised and warm to the touch.  The doctor in house observed the area and prescribed a five day course of antibiotics.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: clamy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
Four day admission for antineoplastic chemotherapy. This visit was within 6 weeks of receiving the COVID vaccine.
Narrative: Pt received 2nd Moderna dose on 2/23/21 and experienced chest pain which resolved once pt was transferred to the ED.
Parents noticed redness around the Pneumovax injection site on her left leg, at which time pt complained of pain (complaining is very atypical for her) and was unwilling to walk or bear weight on leg.
Patient received FLUAD vaccination and immediately that evening started to feel unwell. Patient has experienced nausea, joint pain, stomach pain and fever since receiving the vaccine. As of 10/11/18 patient is still unwell.
Administered covid bivalent instead of flu shot patient has not received bivalent vaccine yet so communicated the incident to them.
numbness on the left side of his face; tingling on the left side of face, around mouth, jaw and cheek, it went away and sort of came back the day of the report; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on the left side of his face) and PARAESTHESIA (tingling on the left side of face, around mouth, jaw and cheek, it went away and sort of came back the day of the report) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CARVEDILOL, DIAZEPAM and RABEPRAZOLE for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on the left side of his face) and PARAESTHESIA (tingling on the left side of face, around mouth, jaw and cheek, it went away and sort of came back the day of the report). At the time of the report, HYPOAESTHESIA (numbness on the left side of his face) and PARAESTHESIA (tingling on the left side of face, around mouth, jaw and cheek, it went away and sort of came back the day of the report) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient reports redness 3 inches long and about an inch wide on back of R side and tender in one spot. Patient reports some itching that improves with ice. Patient discussed with PCP and recommended direct follow-up with a provider if the site continues to expand and/or concerns for an abscess arise.
This retrospective cohort study report has been received from the authors of a published literature. This paper described a 9.5-year cohort study evaluating the incidence of herpes zoster after concomitant administration of ZOSTAVAX (ZVL) and PNEUMOVAX 23 (PPSV 23). A retrospective cohort study was conducted from 01-JAN-2007 to 30-JUN-2016. The exposed cohort (concomitant vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL and PPSV23 on the same day from 01-JAN-2007 to 31-DEC-2014. The comparator cohort (prior vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL during the same period as the exposed cohort but were previously vaccinated with a dose of PPSV 23 from 365 days to 30 days prior to receiving ZVL. Both groups had been continuous members in the year prior to date of ZVL vaccination, allowing for a 31-day gap in membership. The patients from both groups were followed from the date of ZVL vaccination until the date of herpes zoster occurrence, termination of membership (allowing for a 31-day gap), death, or 30-JUN-2016, whichever was earliest. This report refers to 11424 elderly (65 years and older) patients. On unknown dates the patients were concomitantly vaccinated with ZOSTAVAX (lot#, expiration date, dose, route and frequency unknown) and PNEUMOVAX 23 (lot#, expiration date, dose, route and frequency unknown) for prophylaxis. The prescribing information stated that these vaccines should not be given concurrently (product use issue). This is one of several reports received from the same literature (linked report MARRS #1804USA008699, 1804USA010349, 1804USA010350, 1804USA010351, 1804USA010352).
He has developed dry mouth; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A male patient in his 30's received bnt162b2 (BNT162B2) (Lot number: EW 0186) as dose 2, single for covid-19 immunisation. Relevant medical history included: "shellfish" (unspecified if ongoing), notes: He has a shellfish allergy. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization. The following information was reported: DRY MOUTH (non-serious) with onset 13May2021, outcome "unknown", described as "He has developed dry mouth". Therapeutic measures were taken as a result of dry mouth.  Additional information: Reporter (Registered nurse) stated, "I just have a question. I am a RN (Registered Nurse) and I have been working at a vaccination site and one of the people that I gave the second vaccine (Unspecified vaccination) to today knows me personally so called me to ask they said that they had a dry mouth. And that person has a history of allergy to shellfish, he did wait, we did observe him for 30 minutes then he left the vaccination site at 2:30. He is not noticing anything else but he was concerned so he called me because he knows me, he said he also called a friend and her sister who is also an RN and she said her friend also had dry mouth (Split not made) and that it just went away but I tried to look into the website and see if that was the reported symptom and I couldn't find anything, so that's why I thought I would call and ask. When confirmed if the reporter have some question or want to report, reporter stated, "I really just wanted to ask what advice to give him, I mean at the time I told him, make sure he stays hydrated he'd already taken some Tylenol, he told me he cant take Benadryl because he gets kind of muscle spasms with it, so I just told him to call me back in a couple hours and let me know how he is doing but I wondered if I should have given him some other advice.     No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021547364 Same reporter/ drug/ event for different patients
i felt dizzy with my first vaccine on 2/5/21. ..it passed i started to feel dizzy/woozy/lightheaded, kind of seasick without the nausea almost 12 hours post 2nd vaccine. . this has continued now so far for 6 days. . it is more than brain fog.. it is a real sense of disequilibrium, like something is  really affecting my brain. . . the base of my neck and spine have been incredibly tight and contracted with all the muscles in my head contracted. . this is  more than a headache. .. i also seem to have  the  vaccine affecting my vision. . i know of 6 other people now that have similars symptoms and not all got pfizer
Hives over my entire body a week after vaccine. Took prednisone for 5 days which helped but still have hive breakouts most days which require Zyrtec or Benadryl to alleviate hive and rash symptoms
Pt apparently fainted following her vaccinations striking the back of her head on the uncarpeted floor. Complained of headache. Was transported by ambulance to ER.
On right deltoid area there is and area of redness is oval shape of 4cm x 5cm. It is slightly warm to touch. Patient denies pain. He endorses slight itch
Patient c/o flu-like symptoms, fatigue, musculoskeletal ache, dizziness.
This spontaneous report was received from a pharmacy student referring a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 21-AUG-2017, the patient was vaccinated with the first dose of VAQTA (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported, that on 21-NOV-2017, the patient received the second dose of VAQTA, earlier than recommended. No adverse effects were reported.
Pt reported that on the same day that she received the Flu vaccine (11/04/2021), her Left armpit became swollen and painful at around 10 PM. The swelling lasted until Sunday night, 11/07/2021. Pt woke up better on Monday morning, 11/08/2021.
Fever of 102.9, chills, shaking, and sensitive skin for 20 hours and then fatigue for 2 weeks afterward
hives devel 8-10hrs following vax; general malaise;diarrhea;
Still having arm pain / Arm is painful/Still having / pain at the injection site / Sore at the injection site; Decreased mobility in arm / Difficulty reaching arm behind back; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received first dose Shingrix two months ago and went to pharmacy to receive second dose, but pharmacist would not administer second dose due to the patient still had arm pain at the injection site from the first dose.  Arm was painful and sore at the injection site, and the pain was not much lessened or went away from two months ago. The patient stated that arm hurt just as bad as it did after injection. The patient described decreased mobility in arm such as reaching behind back to arm in jacket or sleeve. Difficulty reaching arm behind back. The patient described pain as being punched in arm. The reporter consented to follow up.
This spontaneous social media report was received from an unspecified reporter and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (exact dose, route, lot # and expiration date were not reported). On an unknown date, the patient experienced a "mysterious" sickness the doctors could not find the answer to. It turned out the sickness was related to having the GARDASIL received. The patient was able to heal herself by changing her diet and using traditional Chinese medicine versus western medicine. This is one of several reports received from the same source. Additional information is not expected as no contact details were reported.
This spontaneous report was received from an office manager, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-OCT-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # R002344 and expiration date on 16-NOV-2020, for prophylaxis (route of administration and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion above 47 degrees Fahrenheit (°F) (52°F) for 1440 hours. The call was not because of a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Patient's mom states patient developed diarrhea the evening after getting vaccines - Approx 8-21-10 - he developed little, red, flat bumps on legs, feet, bottom, and a few on arms. Approx. 8-25-10 - he began to have fever.
Arm pain and swelling, headache, body aches, malaise, flulike symptoms, fatigue on day of vaccine lasting for 2 days,  left flank rash with needle like pain on 3rd day post vaccine.
Pt had 6 cm x 6.5 cm area of erythema post SQ vaccine.
None stated. Nurse follow up on 05/25/04: "deceased range of motion, Synovitis, Labral/chondrial fraying,
1 week post vaccination upper respiratory like symptoms occurred (ADE) and were reoccurring every few days from August 2021-December 2021. Symptoms included chest heaviness, shortness of breath, dizziness, fevers, elevated troponins, tinnitus, hypertension, tachycardia, fatigue, severe headaches, ataxia, hypersensitivity to light, inability to regulate body temperature (constant cold hands and feet). Patient was then hospitalized January 4, 2022 for COVID, bilateral pneumonia, low O2 sats. Patient diagnosed with myocarditis via MRI and still experiencing dizziness, severe headaches, fatigue, shortness of breath. Patient exercised prior to vaccination and can no longer exercise. Patient cannot work a full day and has to work from home most days. Patient has no previous cardiac history prior to vaccination and is awaiting pending cardiac enzymes (possible myocardial infarction a few days ago).
ITCHING ALL OVER BODY; This spontaneous report received from a patient concerned a 61 year old female. 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, intramuscular, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, from 13-MAY-2021 for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 2021, the patient experienced itching all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of itching all over body was not reported. This report was non-serious.
This spontaneous report was received from a nurse concerning an unknown number of patients, unknown age and gender. medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of (Oka/Merck) PROQUAD (dose, frequency, strength and route were not reported) (lot number J010160 valid for V221, expiration date 23-FEB-2015. Co-suspect and concomitant therapies were not reported. The nurse reported that in her facility got a new thermometer system on 13-MAY-2014, and according to the thermometer, (Oka/Merck) PROQUAD was exposed to temperatures above the recommended storage temperature on multiple occasions. At this time, it was not known whether or not the excursions were supported because data was insufficient to evaluate. the nurse stated that she was certain that doses of (Oka/Merck) PROQUAD had been administered to patients since these excursions were recorded. No adverse effects have been experienced. The reporter considered the events to be not related (Oka/Merck) PROQUAD. This case is linked to case numbers 1407USA001030 and 1407USA006119 via same reporter. Additional information has been requested.
So basically from 24Jan2022 to 05Apr2022 I did not have a period and at my old age of 48 my periods are regular; today 24Apr2022 I have been on my period for 20 days since 05Apr2022; severe anemia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2022 at 16:30 as dose 2, single (Lot number: FK9729) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Stress disorder" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. Concomitant medication(s) included: LOSARTAN; AMLODIPINE. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FK9729, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM, I got my first shot on 24Jan2022 and it IMMEDIATELY stopped my period which I had been on for 4 days within a matter of an hour and it didn't return on the "normal" cycle day), administration date: 24Jan2022, when the patient was 47-year-old, for COVID-19 immunization, reaction(s): "I got my first shot on 24Jan2022 and it IMMEDIATELY stopped my period". The following information was reported: ANAEMIA (non-serious) with onset 24Apr2022, outcome "not recovered", described as "severe anemia"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 24Apr2022, outcome "not recovered", described as "today 24Apr2022 I have been on my period for 20 days since 05Apr2022"; MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "So basically from 24Jan2022 to 05Apr2022 I did not have a period and at my old age of 48 my periods are regular". The events "so basically from 24jan2022 to 05apr2022 i did not have a period and at my old age of 48 my periods are regular", "today 24apr2022 i have been on my period for 20 days since 05apr2022" and "severe anemia" required physician office visit. Therapeutic measures were taken as a result of menstruation irregular, heavy menstrual bleeding, anaemia.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks included Losartan and Amlodipine. AE resulted in Doctor or other healthcare professional office/clinic visit]. Prior to vaccination, the patient was diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. No Known allergies. Other medical history included Hypertension, anaemia, and stress disorder. So basically from 24Jan2022 to 05Apr2022 she did not have a period and at her old age of 48 her periods were regular. Definitely was not pregnant. Not going through menopause (been did all that testing) don't have fibroids or none of that and let me just say as of today 24Apr2022 she had been on her period for 20 days since 05Apr2022. This had caused her to have severe anemia and even with medication like medroxyprogesterone 10mg it was not stopping.
patient has received an IPOL vaccination from the opened multi-dose vial since the first excursion on 10JAN2021 with no AE; Initial information received on 17-Mar-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 years old male patient who has received an ipol vaccination from the opened multi-dose vial since the first excursion on 10jan2021 with no ae while receiving vaccine IPV (Vero) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine, varicella zoster vaccine (measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine).  On 10-Mar-2022, the patient received a dose of suspect IPV (VERO) Suspension for injection (lot T1E871M; expiry date: 10-OCT-2022; strength: unknown) at a dose of 0.5 ml once total via intramuscular route in right leg as prophylactic vaccination.  On 10-MAR-2022, the patient has received an IPV (VERO) vaccination from  the opened multi-dose vial since the first excursion on 10-Jan-2021 with no AE (product use issue) (latency: same day).  It was reported that, doctorstated that the IPOL was first punctured on 17-Aug-2021 and also, doctor asked if the IPOL that was given should be re-administered because it was non-viable.  Action taken: not applicable.  At time of reporting, the outcome was unknown for the event.  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.
expired Daptacel was administered/ no symptoms; fourth dose in series of Daptacel was administered to 3 years, 10 month old / no symptoms; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years, 10 month old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not received.   On 13-Jun-2019, the patient received a fourth dose in series 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5190AA, expiry date 24-Apr-2019 via intramuscular route in the left thigh.  It was an actual medication error due to expired vaccine used and inappropriate schedule of vaccine administered.  It was reported that expired Daptacel was administered was administered to patient.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.  List of documents held by sender: none.
Roughly two days after the second Pfizer shot my arm muscle was sore, but then I started having lightheadedness and dizzy spells along with severe fatigue. I've been to several doctors since.