chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003913 is a spontaneous case report initially received on 05-Oct-2022 from nurse via  Communications (reference number: USBAV22-1628) and concerns *a patient of unknown demographics (first out of ten)*.  The patient's medical history and concomitant medication details were not provided.  On 03-Oct-2022 and 04-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  *At the time of this report, it was unknown if the patient experienced any adverse events. *  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a pharmacist on 05-Oct-2022 from a nurse via Communications (reference number: USBAV22-1630): new information included clarification regarding number of patients involved making the case valid.  Additional information received on 05-Oct-2022 from Bavarian Nordic included local BN case ID.  The case is linked to the cases US-BN-2022-003956, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
On the first day of catching COVID-19 I had mild symptoms. On the 2nd day I felt miserable. I couldn't drive at all. I had a pounding headache, slight congestion, a runny nose, and I felt stuffy. I quarantined. On Wednesday and Thursday I was in bed. I had sinuses, a pounding headache, and I felt very tired. I had a low appetite, a fever of 100.7 degrees. I didn't lose my sense of taste or smell. I was drinking tons of water. I did a telehealth visit with a doctor. I was prescribed PAXLOVID but I didn't take it right away. I started taking it on 6/25/2022. My headaches got a little better. I was so tired. I had zero energy and zero motivation. I had a productive cough a little bit. I feel fine now.
Left upper arm began swelling within 4 - 5 hours of administration - pain, heat, swelling, expanded; visited Urgent Care who prescribed cephalexin and ibuprofen 1 day later; 2nd day after, swelling increased so patient visited ER. BENADRYL was added, swelling started subsiding.
Information has been received from a Licensed Practical Nurse (L.P.N.) for GARDASIL, a Pregnancy Registry product, concerning an 18 year old pregnant female smoker with no drug allergies who received her second dose of GARDASIL on 06-NOV-2006.  Date of initial dose was unspecified.  No details about the first or second dose of GARDASIL are known as another office administered them.  Concomitant therapy included LEXAPRO which was discontinued on 16-nov-2008.  An ultrasound showed patient was 5 weeks and 6 days pregnant at time of GARDASIL administration (LMP: 05-OCT-2008).  Follow-up information was received from the a physician concerning the 18 year old white female smoker with no previous pregnancies and a history of depression who on 06-NOV-2008 was vaccinated with a dose of GARDASIL though a clinic.  The patient had a LMP of 05-OCT-2008, became pregnant and had an EDD of 04-JUL-2009.  On 16-NOV-2008 ultrasound was done in the emergency room due to vomiting and cramping the ultrasound indicated 7 weeks gestation and on 21-JAN-2009 serum alpha-fetoprotein test negative.  The patient sought medical attention by visiting the physician's office.  Additional information has been requested.
Child developed 2 spots on 2/26/00. "More" spots on 2/27/00. Seen on 2/28/00 with 42 red papules/vesicles on face, neck, arms, trunk and legs. Temperature 98.3. Goes to daycare with another child who developed varicella after vaccine from her dad who had shingles.
Patient developed polymyalgia rheumatica.  Starting 5 days after getting the second dose of Moderna vaccine, patient noticed progressive pain and weakness in her bilateral shoulders which peaked after about 3-5 days of worsening. It had been persistent from that time. She noted difficulty with overhead work or lifting anything above shoulder height. She also feels a generalized fatigue. Sometimes the achiness in her shoulders and stiffness occurs in the morning, but it also can persist throughout the day. She additionally notices aching and stiffness in her neck, torso, and some in her low back and hips.  She had attempted chiropractic, accupuncture and perineural injection therapy for the pain, which was not helpful.  Then, I suspected polymyalgia rheumatica on 6/9/21 during an office visit and confirmed the diagnosis after elevated CRP and ESR, and subsequent improvement within a week of starting prednisone 15mg daily.
Very sore and tender breast, rash in the injection site, fatigue, headache, pain/discomfort underarms and side of breasts, swelling in arm. Injection site is hard and warm.
Patient received an undiluted pediatric dose (Pfizer) instead of an adult dose (Pfizer) on 02/19/2022. No adverse events reported or known as of today (02/19/2022).
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history, drug reactions and allergies were not reported. On 08-OCT-2014, also reported as 11-APR-2014, the patient was vaccinated with the third dose of GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. On 08-OCT-2014, the register nurse reported that due to syringe defect (not prefilled GARDASIL syringe, dose was drawn up from a vial of GARDASIL using other, unspecified manufacturer's syringe) as she was administering a dose of GARDASIL, dose came out of hub of syringe, where needle attaches to syringe and patient only received partial dose of GARDASIL. No adverse effects reported. At the time of the report, the outcome of the events was unknown. Additional information has been requested.
5/02/2005 Pt called to report vaccine adverse event. Pt took yellow fever injection 4/13/2005 at about 3 PM. Two days later 4/15/2005, while driving, pt stated her heart started to race, she kept driving another 10 minutes or so arriving at her destination. She got a severe headache and a crushing neck pain, took a Tylenol and her daughter said she looked gray. She called her sister and asked her to read the yellow fever VIS which mentioned a fast heartbeat. But now its about 5:30 and left arm is starting to hurt. She called the health center toll free number which directed her to call her MD/911. Went to hospital. MD in ER gave her a test which resulted in a diagnosis of heart attack. MD seemed to think it was a result of taking Claritin D tablet that morning. Pt states that she had taken Claritin D before with no adverse reaction and thinks it was the yellow fever injection.
PT SPOUSE CALLED ONE AND ONE-HALF HOUR AFTER ADMINISTRATION TO DISCUSS PATIENT NOT HAVING ANY MEMORY OF THE VACCINATION OR WHERE THE PATIENT HAD BEEN FOR THE LAST 45 MINUTES OR SO. REPEATEDLY ASKED QUESTIONS AS TO WHAT HAPPENED AND WHAT WAS WRONG. I DISCUSSED A FEW TECHNIQUES THAT I AM FAMILIAR WITH TO ASSESS STROKE INDICATORS AND PATIENT PASSED THOSE FROM WHAT I COULD TELL OVER THE PHONE(SAY NAME, RAISE ARMS, ETC..) ADVISED PATIENT SPOUSE TO SEEK MEDICAL ATTENTION IMMEDIATELY TO ASSESS SITUATION AS THEY WERE NO LONGER AT MY PHARMACY. PT SPOUSE RETURNED CALL TO ME LATE 11/6/22 TO SAY PROVIDER AT ER STATED MOST LIKELY THE SHOT INDUCED A SHORT TERM AMNESIA TYPE EPISODE AS ALL CLINICAL TESTING PROVED CLEAR WITH NO OTHER INDICATIONS FOR ANY OTHER PROBLEMS.
10 minutes post 2nd Pfizer (30155BA) pt started complaining of "itching" to injection arm- L arm. RN noted redness with 3-4 areas of hives/rash. Pt denied any itching, swelling, rash anywhere else on her body. She also denied any respiratory symptoms. There were no other physical areas upon assessment with any itching, swelling or rash. Ice applied to injection site, bandaide removed, however after further pt developed more hives/rash to the injection site. ER MD notified and verbal orders for Ceterizine 10mg po was given. Pt tolerated really well and there was a decrease in itching, swelling and rash/hives.  After 30 mins of monitoring and no worsening of symptoms, nor was there any new development of symptoms, ER MD advised it was safe to discharge pt home with instructions to mom to go to ED if she develops new symptoms or her current symptoms do not improve, changes or worsens.
6 months following my 2nd vaccine, my heart went into AFIB and I required medical intervention to get it to stop. I had no previous heart issues before this event and doctors cannot figure out why I went into afib with no previous indications.
SHORTNESS OF BREATHE LASTED 60 MINUTES, INCREASED HEARTRATE 60 MINUTES
Whole body aches from head to toes, chills , flushing, diarrhea, low grade fever
My eyes and lips has swollen up. I broke out with weaps/ marks  on my body I had to take Benadryl sue to my throat started to close
Breakthrough case admission after 3 vaccines Moderna 3/7/21 Lot# 030A21A;  Moderna 4/6/21 Lot# 018B21A;  Moderna 1/4/22 Lot# 059H21A
Client received expired vaccine, Vaccine expired 09/21/2021. Client did not have reaction to the vaccine. Has been notified.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Mar2021 at 10:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 18Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Right Bundle Branch Block" (unspecified if ongoing); "heart murmer" (unspecified if ongoing); "high cardiac artery calcium" (unspecified if ongoing); "low back pain" (unspecified if ongoing), notes: manageable with exercise; "burning mouth syndrome" (unspecified if ongoing); "Known allergies: Have a skin reaction to adhesive tape" (unspecified if ongoing); "Known allergies: Have a skin reaction to adhesive tape" (unspecified if ongoing). Concomitant medication(s) included: HYDRALAZINE, start date: May2021; LISINOPRIL, start date: 28Jul2020; SIMVASTATIN, start date: 13Oct2021, stop date: 08Sep2022; HYDROCHLOROTHIAZIDE, start date: Jul2003. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 09Sep2022 to 13Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a physician concerning a 16-year-old female patient. There was no information about the patient's concurrent conditions, medical history, concomitant medication or drug reactions/allergies. On 24-APR-2017, the patient was vaccinated at an unspecified clinic by unspecified staff with GARDASIL 9, intramuscular for prophylaxis (reported as human papillomavirus (HPV) prevention) (dose, lot number, and expiration date were not reported). On the same date, the patient experienced paresthesia in the upper extremity of vaccination. Subsequently, the patient presented to a clinic where labs were drawn and they were normal. At the time of the report, it was unknown by the reporter if the patient was admitted to the hospital or if treatment was given for the event. The outcome of paraesthesia was reported as not resolved. The causal relationship between the event paraesthesia and therapy with GARDASIL 9 was not reported. Additional information has been requested.
Extremely dizzy and chances of fainting; Extremely dizzy and chances of fainting; Sweaty; Brain fog/confusion; Brain fog/confusion; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 29Apr2021 (Lot Number: ER8736) at the age of 29-years-old as single dose for covid-19 immunisation.  Medical history included prediabetes. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included amoxicillin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced extremely dizzy and chances of fainting, sweaty, brain fog/confusion, all on 20May2021. No treatment received for the events. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 29Apr2021 (as reported), (Lot Number: EW0187) for covid-19 immunisation. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative. Outcome of the events was recovering.
missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .; Recieved Moderna vaccina at 16 years of age; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Recieved Moderna vaccina at 16 years of age) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Recieved Moderna vaccina at 16 years of age). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Recieved Moderna vaccina at 16 years of age) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported  No treatment information was provided    This case was linked to MOD-2021-065366 (Patient Link).
Bitter taste/Metallic taste; tightening of the right side jawof her face; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Bitter taste/Metallic taste) and JOINT STIFFNESS (tightening of the right side jawof her face) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DYSGEUSIA (Bitter taste/Metallic taste) and JOINT STIFFNESS (tightening of the right side jawof her face). At the time of the report, DYSGEUSIA (Bitter taste/Metallic taste) and JOINT STIFFNESS (tightening of the right side jawof her face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Headaches, this sat chest pain and tightening, gastro issues and heartburn. Doctor on 8/25/2021 said was a reaction from the shot. Bronchitis like symptoms. left arm my lymph nodes painful and swollen. Nausea. Doctor said the vitals were good. Inflamed.
3 hrs following vax, pt exp edema, pain, & erythema @ inject site; The area affected was approx 10 mm in diameter;
ear ringing; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 63; Unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received vaccine on Sunday 20Dec2020 and indicated experiencing ear ringing started Monday 21Dec2020 that has been persistent. The patient's blood pressure was "fine". The outcome of the event was not recovered.  Information on lot/batch number has been requested.
Patient developed shingles virus a few weeks after administration. Symptoms included blistering and pain.
Patient slumped to floor and felt sweaty within 15 minutes of vaccination.  IV started and patient transported to ER by EMS.
Moderna COVID-19 Vaccine EUA On the 7th day after the inoculation I woke up a with a headache and  swelling under my left arm, in the lymph nodes.  The nodes were quite tender (hard) to the touch as was the area around them. No fever or chills.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-OCT-2015 18:42, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 14.4 and -2.6 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Initial and follow up information has been received from a 25 year old female patient with hypothyroidism and penicillin allergy who at the end of February 2007, was vaccinated with her first dose of GARDASIL vaccine. Concomitant therapy included thyroid medication. At the end of February 2007, the patient experienced severe injection site pain immediately. Within a few days the patient had a severe headache, difficulty swallowing, general body aches, very weak muscles and slight fever. The patient sough medical attention. Laboratory diagnostics performed was a throat culture which was positive for strep. She took TYLENOL, ADVIL and antimicrobial (unspecified). The patient's severe injection site pain and severe headache and difficulty swallowing and general body aches and very weak muscles and slight fever persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Immediately after the injection, the patient experienced severe injection site pain. later that night, the pain kept her awake. She took TYLENOL and ADVIL for the pain and fever. She saw her physician and a throat swab was performed which was positive for strep. She was treated fo r strep throat with an unspecified antibiotic. The patient's menstrual cycle was 4 days delayer with no possibility of pregnancy. She reports that in the past when taking unspecified antibiotics her cycle was delayer by a few days. The patient was improving. The patient subsequently called back inquiring whether or not she should receive the second dose of GARDASIL vaccine. Her first dose had been administered at the end of February and as of 29-MAY2007 she had not yet received the second dose. Additional information has been reuested.
I had my first covid vaccine (MODERNA) last JANUARY 20,2021, After 10 days I noticed my left arm is redness ,LITTLE BIT OF SORE . THE FOLLOWING DAY i called my doctor and he prescribed  me CEPHALEXIN 500 mg capsule andSULFAMETHOXAZOL  E-TMP DS TABLET AND HYDROCORTISONE 1% CREAM. As far I know I don't have allergy. right now when I touch the spot LITTLE BIT WARM , My doctor told me to report .
huge problem breathing; feeling like my throat isgetting tight; got sick; This is a spontaneous report from a contactable consumer (patient). A patient with unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 23Jan2021 as dose 1, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. on an unspecified date patient got sick and was taken to the ER because patient had some small problems a huge problem breathing and felt like throat was getting tight. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Pain in arm. A follow up report received 10/31/2001 adds: Reporter states Pt had been to Urgent Care before coming to office. Office notes indicate some warmth at site but no redness or associated symptoms. Pt received no other injection at that date and had no other vaccines in the previous 4 weeks.
Headache, Myalgia, FATIGUE AND CHILLS Narrative:  Other Relevant History:
Red, hot, itchy, sensitive to touch. Pt prescribed benadryl, clindamycin, ibuprofen.
New right groin lymph node size of chickpea - hasn't changed in size. Painful to touch. Persisted in tenderness for 2 weeks. As of today, 6/3/2021, lymph node continues to be palpable; the size of a pea. No longer painful or tender.