chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 18Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2022) Positive; (23Apr2022) Negative; (05May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional Information: The patient did not receive any other medications within 2 weeks of starting COVID-19 treatment. The patient was previously received a COVID-19 Vaccine. Reported Event: Return of Covid symptoms and testing positive after taking Paxlovid and testing negative and feeling better. Retest on Day 17 05May2022 positive after first positive test 18Apr2022 and negative test on 23Apr2022. start of reaction/event: 02May2022. The patient had no known allergies. Outcome of event was not recovered. The patient did not receive treatment. Adverse Event resulted in None of the above  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 1:51 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 1:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) 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 62.89  Concomitant products were not provided.  On 13-Jan-2021 vials were moved to clinic. On 09-Feb-2021 the vaccines were moved to fridge. On 14-Feb-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 32, at 10 AM temperature was 32 and at 11 AM temperature was 32.  The vaccine beyond use date was reported as 10-Mar-2021.  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.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
p/vax pt exp a case of breakthrough chickenpox w/a significant amount of lesions & no fever;pt sought unspecified medical attention;reporter felt exp was not r/t vax;
He got his vaccine, he had flu-like symptoms for about 2 1/2 days, and then he was fine until  yesterday.  He woke up with extreme hearing loss and extreme ringing in his ears as if he was under water with some problems in hearing.  It feels like today that he has cotton in his ears.  He did try some antihistamines which did not help.  He seems to be more tired since he's gotten the vaccine, lethargic and not completely with it.
Four days after the vaccination, on February 9, I had severe pain in my body and head and a lot of itching in my throat that made me cough. Today, February 11, my headache is very little, the body pain is a little less also with the help of Aleve, but the itching in my throat still persists and it keeps making me cough. Tomorrow I have an appointment for the Covid test at 10am. But my sister told me that if my symptoms are a reaction to the vaccine, my Covid test could be positive. And maybe it's not Covid. Should I take the test?
This spontaneous report as received from a nurse refers to an 11 years old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Patient is a 95-year-old female presents the emergency department with whole body pain.  Patient claims that she has been feeling this way for about a week.  She was diagnosed with COVID-19 on 03/21/22  Patient denies shortness of breath admits to substernal chest pain especially with deep breathing.  Patient denies abdominal discomfort. She was subsequently discharged under stable conditions.
Received flu vaccine 11/15/04 and since then has had achiness in hands, elbows and legs accompanied by a warmness in hands. Physician has given her an antibiotic.
Headache, red eyes, diarrhea, nausea, cough, watery eyes, myalgia.
CLIENT RECEIVED A MODERNA BOOSTER DOSE AT 17 YO. MODERNA IS APPROVED FOR AGES 18+.
Roughly 5 hours after vaccine experienced chills and shaking/tremors that lasted 1-3 hours.
am all broke out; Very bad rash, terrible rash; They are big, like couple of big blotches are there almost like may be they were blisters or something; Very bad rash, terrible rash; They are big, like couple of big blotches are there almost like may be they were blisters or something; Very bad rash, terrible rash; They are big, like couple of big blotches are there almost like may be they were blisters or something; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on 20May2021 as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2, (Lot number: EW0167) for Covid-19 immunization. On an unspecified date in May2021, patient experienced very bad rash, terrible rash; they were big, like couple of big blotches are there almost like maybe they were blisters or something. Patient was asking that those were side effects because patient had not been out, have not been anywhere, have not touched anything, have been worked off, so patient did not touch no bushes or anything. Patient reported, on 21May2021, Because I got my second shot yesterday the Pfizer and I am all broke out (further clarification unknown) today and somebody told me that this is one of the side effects. The outcome of event was unknown.  Additional Information has been requested.
(L) thigh with 4 x 4 cm erythematous indurated lesion onset 12hr after DTAP & PREVNAR given in same area. Rx - Cephalexin for cellulitis.
pt recvd vax 16APR92, 14MAY92, 1OCT92 & 3DEC92 & rash devel PM of 3DEC92 rash is raised; sl itching; no pain;
Patient arrives with shortness of breath.  Patient has had Covid for approximately a week now despite being vaccinated, patient has had original shots in March and since then has had a booster.  Patient is a heart patient she had an MI was on ECMO and then had an LVAD placed until she had a heart transplant in 2018.  Patient denies wearing oxygen at home.  Patient was checking her sats today and noted to be in 60%.  Patient is on medications for high blood pressure and high cholesterol. Denies diabetic medications.  Patient lives with her boyfriend.
Friday felt "bad" with fatigue, muscle aches and felt "cold" worsened Saturday and Sunday. Had sore throat, nasal drip, watery eyes and temp was 101. Saw physician 10/16/08. Given penicillin parenterally and P.O. + B12 injection and cough med. Off work until 10/18/07. Still on oral PCN and still tired. As of 10-23-07
After administration of 1st vaccine pt stated that he felt lightheaded.  He was then laid down and the rest of the vaccines were given. After 10 minutes the pt's B/P was 110/60 and felt ok to leave after the full 15 minutes of waiting. Juice & Granola bar were given prior to vaccines being given.
I had an rheumatoid Arthritis flare up along with a 101.7 fever that lasted from 10 PM on March 16th to 7AM  March 17th. I still have flare up pain but not as bad. My hands were also somewhat swollen in the morning but went down during the day. I Took Tylenol 1000mg at 10PM and 1000mg at 5AM.
Severe pain in injection site and all around. Difficulty moving arm and extreme tenderness.  Started approximately 10 hrs after injection
Patient received one dose of Moderna COVID-19 vaccine on July 20, 2021. Diagnosed with DVT on August 25, 2021 via venous doppler. Patient sought medical care after experiencing left lower extremity edema, warmth, tenderness, and elevated heart rate. Patient is unsure exactly when symptoms began.
Left arm was hard, warm to touch with raised red area aproximatley 2" in diameter. Her arms was examined about 48 hours after receiveing shot.  at aounrd noon she was seen in the  ER, her arm had become more tender and she felt it was hotter.  At the Er she received a Steroid shot.  Follow up phpone call on 5/30/07 she reports no pain and swelling is down quite a bit.
Client called office to report flu-like illness - H/A, arthralgias/myalgias and feeling week.  Onset ~ 12 hr after receiving booster of rabies vaccine. No fever, able to walk, no respiratory distress, tol po.  Treating discomfort w/ Extra-strength Excedrin and Ibuprofen.
received expired doses with no reported adverse event; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via Global Media Information (under the reference 00817263).  This case is linked to case 2021SA348292 (case for wife).  This case involves a 74 years old male patient who received expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.  On 27-Sep-2021, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (0.7 ml, total, once, lot UJ540AA and expiration date: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  I was an actual medication error due to expired product administered (same day latency).  No adverse event reported.  At time of reporting, the outcome was unknown for the reported event.  It was reported "Clinical supervisor states they gave FLUZONE HD QUAD to a patient in September and it was expired. Do they give another dose or what does she do? The caller reported that a husband and wife received expired doses on the same day."  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 by the regulatory authority. 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.
Hot red swollen area 7inches x 3inches.  Very painful lasting 9days at injection site.  Severe body aches lasting 3 days. Severe headache lasting 3 days with light and sound sensitivity. Severe chills and nausea last 4 days.  Fever of 102 degrees Fahrenheit lasting 2 days. Mild intermittent chills still occurring.  Mild to moderate headaches still continue.  Used acetaminophen 1000mg 4 times a day and 800mg ibuprofen every 8hours through the first week.  Continuing to have to take at least 2 or 3 doses of both the ibuprofen and acetaminophen daily for continued mild to moderate headaches.
irritation; blisters on right arm; pain in right hips; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (irritation), BLISTER (blisters on right arm), ARTHRALGIA (pain in right hips) and FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IRRITABILITY (irritation), BLISTER (blisters on right arm), ARTHRALGIA (pain in right hips) and FATIGUE (Fatigue). At the time of the report, IRRITABILITY (irritation) outcome was unknown, BLISTER (blisters on right arm) and FATIGUE (Fatigue) had resolved and ARTHRALGIA (pain in right hips) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
shot site pain, headache, shivering, diarrhea, fatigue, disyness, bad general body aching all the symptoms were gone in about 24 hours
A non-serious spontaneous report of positive test for influenza on the rapid flu test has been received from a health professional concerning a nine-year-old female, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received FLUMIST on 15-Sep-2011. On 17-Oct-2011, the patient tested positive for the Type A influenza strain on the rapid flu test. The outcome of the event was unknown.
Fever over 100 F for 1 day; Headache; Muscle/joint pain; Muscle/joint pain; Neck Pain; Fatigue; Full Body Rash, worse on left shoulder; Full Body Rash, worse on left shoulder; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EW0151 and expiry date was not reported), via an unspecified route of administration at left arm, on 12Apr2021 at 03:45 PM (age at vaccination: 38 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes psoriasis and allergies to almond. The patient concomitant medications was not reported. Reportedly the patient was not pregnant at the time of vaccination. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient also did not receive any other medications within 2 weeks of vaccination. Reportedly prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: ER8730 and expiry date was not reported), via an unspecified route of administration at left arm, on 25Mar2021 at 12:45 AM, as a dose 1, single for COVID-19 immunization. On 12Apr2021 at 09:00 PM the patient experienced fever over 100 F for 1 day, headache, muscle/joint pain, neck Pain, fatigue, full Body Rash, worse on left shoulder. The patient did not receive treatment for the adverse event. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Severe vaginal bleeding not in line with the normal menstrual cycle.  An extreme number of nickel-size clots and medium to severe cramping, which is not normal at all for me.
Erythema Multiforme 2 degrees, trunk area; front and back. Resolved within 72 hours using Prednisone 20 mg, 3 tabs, times 5 days, then 2 tabs for 5 days. Route:  Scarification (block 13, no choice).
Left arm pain; Headache; Left arm pain that radiated to shoulder and to finger; Minor fatigue; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Left arm pain), HEADACHE (Headache), ARTHRALGIA (Left arm pain that radiated to shoulder and to finger) and FATIGUE (Minor fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm pain), HEADACHE (Headache), ARTHRALGIA (Left arm pain that radiated to shoulder and to finger) and FATIGUE (Minor fatigue). At the time of the report, VACCINATION SITE PAIN (Left arm pain), HEADACHE (Headache), ARTHRALGIA (Left arm pain that radiated to shoulder and to finger) and FATIGUE (Minor fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-275288 (Patient Link).
The day after the first dose of the vaccine my hands became dry and chapped. They were itchy and dry. It lasted all the way until the second dose. After the second dose it started to travel up my arms. It is now all over. On my shoulders, lips, back and multiple areas of my body. My hands are the worst. It travels unilaterally. It is itchy and bumpy and my hands feel like they are going to crack and even on the left palm. They are red patches that crack open and they are raised bumps. Some patches are large and some are small and they are different shapes.  I have tried multiple things like Vaseline and creams, and I have also taken Steroidal cream. Even the Steroid Cream does not work.  It has been almost 14 weeks and there has been little improvement. I am scheduled to see a Dermatologist on 06/25/2021. I had no other symptoms after each dose.  Dose 2 # 040A21A 03/10/2021
This is a spontaneous report from a Pfizer sponsored program. A contactable other healthcare professional reported that an 80-year-old female patient started to receive PREVNAR 13, (Solution for injection in pre-filled syringe), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported, the patient is allergic to PREVNAR on an unspecified date. The action taken in response to the event for pneumococcal 13-val conj vac (dipht crm197 protein) was unknown. Outcome of the event was unknown.
Patient stated feeling dizzy, diaphoretic, blurry vision Patient vomited and had syncopal episode EMS called and evaluated patient  Patient refused medical transport and signed AMA form Patient stated symptoms resolved and will be going home with son
Received vaccines 2/12/07 at 0930 broke out in hives 2/13/07 and received Benadryl hives resolved. Developed fever 103-104 2/14/07 and had seizure at 1030 2/14/07 taken to ER.
11 y/o female administered 0.3 mL of Pfizer 12+ y/o COVID vaccine.  Patient was observed and no adverse reaction during 15 minute waiting period post vaccine administration.  Patient's parents notified by Medical Director and discussed monitoring steps.  Medical Director counseled parents to seek emergency room/urgent care/patient's pediatrician for monitoring going forward should adverse reaction occur.
Pts mother called clinic, stating that the child had a reaction to the vaccine, has been throwing up and with a fever of  101-102  since Monday 05/13, was called from school that  the child needed to be picked up.
I developed a fever of 1013. I developed severe diarrhea with excessive amounts of blood clots.I felt I was to pass out. I continue to be passing bloody stool and have  had a fever for three days. I haven?t been able to eat since the 24th. I also have  a rash. This was a booster. I had received Phizer prior to this and had very little reaction.
Presented to emergency department. 3/4 of upper arm (posterior aspect) red and warm to touch. Blister near injection site. Per patient she noticed the blister when she was dressing and her clothing opened it. Cleansed in ED and covered with dressing. Physician ordered hydrocortisone cream 2.5%, Clindiamycin 150mg TID X 10 days, and Benadryl 25mg 1-2 caps Q 6hrs PRN itching.
48 hrs post vaccine, pt developed 6.5 x 7cm area of redness and induration L deltoid and hives on back.
Child cried with flushed face and almost fell in the bathroom. Child was coughing, vitals HR - 123 O2 sats 86/ on RA BP 90 systolic by palpatory method.  Child appeared as though falling asleep, but was responding to questions. Alb Neb rx given; O2 given; Epipen jr. 0.15 ml given. Sats went to 98% after Epipen. 911 was called and child went to ER.