chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients who stated they received the first dose 6 weeks ago or longer; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patients who stated they received the first dose 6 weeks ago or longer) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patients who stated they received the first dose 6 weeks ago or longer). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patients who stated they received the first dose 6 weeks ago or longer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product were reported  No treatment information was provided.
0.5 ml was administered by accident.  No adverse reactions occurred  and patient was notified and stated she had no issues with the vaccination.
This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M034780, expiration date 15-APR-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of GARDASIL 9 experienced the temperature excursion from 32 to 35 degrees Fahrenheit for 8 hours and form 47 to 77 degrees Fahrenheit for 8 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA001092: US-009507513-1707USA001093: US-009507513-1707USA001091:
Got flu shot IM on 8-17-14 - left deltoid. The arm was sore for couple of days. Then OK. Then after 20 days developed pain in arm radiating to shoulder. The Dr treating the pt thinks the pain may be due to flu shot.
I woke up with Bells Palcy and high blood pressure. My face and ears are numb and paralyzed. also told I may have Ramsey Hunt
3/19/2021, around 9:00PM - developed hives on left back between nape and shoulder blade. Patch of hives was about 8" wide and 5" tall. Also 2"x2" patch of hives on throat. Took Zyrtec, and hives were resolved by the following morning.  3/27/2021, morning - small rash at injection site. By 4:00PM - rash merged into large, red area that was raised, itchy, and burned slightly. Area was oval in shape and about 2"x3".  3/28/2021 - area at injection site slightly larger, measuring 3.5"x2" and still red, slightly more swollen, and still burns. Feels hot to touch. 1.5" below injection site redness, is an equilateral triangle of itchy, red, swollen skin, each side measuring 1". Issue is ongoing and has not resolved.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.  No treatment medications were provided.
after 3 days, left arm is knotted up, red circle, itchy, fevered and hurts....taken tylenol and ibuprofen since injection still hurts
¨Per Moderna Customer Care Agent : patient was ill after the 1st dose; Patient had to postpone and got the 2nd dose one week; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (¨Per Moderna Customer Care Agent : patient was ill after the 1st dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had to postpone and got the 2nd dose one week) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown.) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (¨Per Moderna Customer Care Agent : patient was ill after the 1st dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had to postpone and got the 2nd dose one week). At the time of the report, ILLNESS (¨Per Moderna Customer Care Agent : patient was ill after the 1st dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had to postpone and got the 2nd dose one week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
pt recv vax 6JUL94 & 1SEP96 pt lab results revealed presence of meningitis;pt is par of post marketing surveillance program;
YF-VAX was administered to 5 patients using an expired diluent with no reported adverse event;Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case received from another health professional and non-health care professional via Medical Information number: 00824899.   This case is linked to cases US-SA-2021SA354616, 2021SA356051, 2021SA355405, 2021SA354618, 2021SA357534 and 2021SA355405 (CLUSTER).  This case involves an unknown age and unknown gender patient was administered YELLOW FEVER VACCINE - US [YF-VAX] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US lot number and expiry date not reported not reported via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  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.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.
Shot given to me around 9 am on 9/29/20 and by 2:15 am on the next day, 9/30/20, I had a 101.5 degree fever, chills, shakes, dizziness, loss of energy, loss of strength in my legs, swelling, pain, and redness in my upper left arm where the shot was given, and my whole body hurt from my head down to my toes. I have never in my life experienced the whole body pain like I did from 2:15 am on the morning of 9/30/20 until about 4 pm in the afternoon on 10/1/20 when I only had pain in my upper left arm where the shot was administered.  The fever broke on 10/2/20 by 10 am and I finally had some strength back in my legs and some energy by 10/3/20 when I went back to work. I fought the fever for two plus days and had a migraine for six days in a row after the onset of the fever.
This literature marketed report was received from the authors of the published literature article and refers to a 8 patients between 2 and 15 year old (reported as children) of unknown gender. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) and had appropriate rise in pneumococcal antibody titers following immunization and had normal response to immunization. On unknown dates, the patients experienced recurrent sinopulmonary infections with discordant pneumococcal antibody and avidity results. The mean number of serotypes with a normal antibody response (above 1.3 migrogram/ml) among 8 children following immunization with pneumococcal vaccine polyvalent was 18.1 of 23 serotypes while the mean number of serotypes with a normal avidity response (1.0) was 4.4 of 23 serotypes. IgG replacement was administered subcutaneously. The mean IgG level was 720 mg/dL. Local reactions were all mild and observed in 4/8 children. All 8 children experienced a marked reduction in respiratory illnesses while on IgG replacement therapy. The outcome recurrent sinopulmonary infections was recovering and of poor pneumococcal antibody function was unknown. The reporter considered the events to be related to PNEUMOVAX 23. Upon internal review, the event of recurrent sinopulmonary infections was considered to be medically significant.
headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received on the left arm BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration on the left arm on 01Feb2021 09:30 at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medication included paracetamol (TYLENOL), ibuprofen (ADVIL [IBUPROFEN]) and pseudoephedrine hydrochloride (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]). On 02Feb2021 02:00 AM, the night following the vaccination patient had headache and sore arm. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a workplace clinic. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Outcome of the events was recovered on an unspecified date.
She got the vaccine, she had no problems, felt rather fatigued for a day or so.  Then on 3/18/21 she had a bright rash on her thighs, it didn't itch, just ridges and red marks.  Then her lips were swelling, used what she uses on fever blisters.  She has used what she has used before which has not helped her.   She has not called her doctor.   She still does have the rash, it has faded some but it did come back.
1st dose in 2018, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-DEC-2022 Reporter's comments: The reporter reported that the patient received one dose of Shingrix. The reporter asked did she have to restart series. No additional information provided.  The reporter was consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
My arm was hot and shooting pain in left arm,  My migrames got more intense, I went into sneezing spells for a half a hour. I felt hot and my stomach was upset for several days.  My head felt light headed and my eyes were blurrey. I recieved the Pfizer vaccine.
Headache, exhaustion, shivering, feverish, nausea, sweating
c/o pain & tenderness in joints of hands, fingers, rt wrist & both feet & ankle;states approx 25JUL97 hands swollen & warm;
uncomfortable; my eye was hard to open; my eye is completely blood shot, watery and just doesn't feel right.; my eye is completely blood shot, watery and just doesn't feel right.; my eye is completely blood shot, watery and just doesn't feel right.; Her right eye looks a little glossy and red; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0167 and expiration date was not reported), via an unspecified route of administration in left arm on 03May2021 at 13:00 (Age at vaccination was 49 years) as dose 2, single for covid-19 immunisation. Medical history included ongoing blood cholesterol is high from unspecified date to ongoing. The patient did not have adverse events prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol, start and stop date were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0164), via an unspecified route of administration, administered in left arm, on 13Apr2021 at 13:00 (Age at vaccination was 49 years) as dose 1, single for COVID-19 immunization. On 05May2021 around 02:30 AM the patient woke up in the middle of the night and eye was hard to open/ couldn't open right eye/eye may be hard to open because eyes were shut has she was asleep, eye completely blood shot, watery/right eye was watery and just doesn't feel right. Patient right eye looks little glossy and red. It was uncomfortable. Patient asked if this is side effect of vaccine. The patient did not perform any relevant test. Patient didn't visit emergency room and physician office. The clinical outcome of eye disorder and malaise was unknown while other was not recovered.   Response: Spoke from EUA Fact Sheet for Healthcare Providers: LAB-1457-7.0 Revised: 06Apr2021: 6.2 Post Authorization Experience. Spoke from attached VR Consumer Document: A review of the Prescribing Information for Pfizer BioNTech covid 19 Vaccine did not find information regarding blood shot eye that is hard to open and watery. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer BioNTech Covid 19 Vaccine). Because your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider is in the best position to advise you about the appropriate action to take.  No follow-up attempts are needed. No further information is expected.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be related to Flu vaccine.   Linked case(s) involving the same patient:US2022AMR137883   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: This case was reported by a patient. The patient got sore arm from flu shot. Additional Supportive Information: The case had been linked to US2022AMR137883, reported by the same reporter, for a different product.; Sender's Comments:  US-GSK-US2022AMR137883:Same reporter
I had a slight headache for a couple of days. I was fatigued for about five days with muscle aches. I had nauseous. I developed a rash in my groin area and I still have it. I talked to the doctor and they advised me to take Zyrtec and Pepcid.
no additional AE; Nurse calling to report expired DILUENT used with PROQUAD to vaccinate a child on 9/21/20.; Nurse calling to report expired DILUENT used with PROQUAD to vaccinate a child on 9/21/20.; This spontaneous report was received from a nurse, referring to a child of unknown age and gender. The patients' pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 21-SEP-2020, the patient received an expired dose of sterile diluent (MERCK STERILE DILUENT), administered at a dose of 0.5 milliliters (ml) (formulation, strength, route of administration and frequency were not reported, lot number S018824, which has been verified to be valid, expiration date reported and validated as 20-AUG-2020), that was used with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5ml (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T013536, which has been verified to be valid, expiration date reported and validated as 17-OCT-2021) as prophylaxis (product preparation issue). There was no temperature excursion reported with any of the suspects therapies. No additional adverse events were reported.
I needed a breast MRI on 7/13/21, and they found that I had an area of concern in my left breast.  I got my vaccine in my left arm both times, with the 2nd dose being given on 4/21/21.  I ended up having a MRI-guided biopsy on my left breast (7/27/21), and the tissue was benign.   I was unsure if this was related to the vaccine, but someone from the CDC contacted me and recommended I complete a report.
Pt cried and held breath during immunizations and then began at tonic-clonic seizure. Pt was immediately turned to her side, positioned to maintain airway, O2 per mask and continuous pulse OX until EMS arrived. Seizure lasted <1 min followed by >10 min of post-ictal.
Received #1 Moderna.  The next day, very very soar arm that was injected.  Fever at 100.3, Aches.
This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. On an unknown date unknown number of patients were vaccinated with COMVAX (dose, route of administration and anatomical location unknown) which underwent an unsupported temperature excursion. Pertinent medical history and concomitant medications of patients were unknown. No adverse effects reported. The outcome of the events was unknown. No further information provided. This case is linked to case # 1407USA005729, 1407USA005295, 1407USA005731, 1407USA005736. Additional information has been requested.
The patient complained that the injection site and right upper arm was edematous and sore and he was achy all over.
Breakthrough COVID Case: My throat felt sore. I wasn't for sure if it was my sleep apnea or if I was just coming down with a sore throat. Then, my daughter, she was sick. She was saying that she was sick and that has asthma and her chest was hurting. She used her asthma pump but it didn't really help. I said you probably have Corona Virus. I gave us both home tests. Hers was positive. Mine was negative. I made an appointment the next morning. We went and got tested. They tested her first. She was positive. They tested me and it came back positive. Then, my nose started having drainage to the back of my throat.
Vaccine was administered outside of the 12 hour room temperature expiration period. Vial was opened at 5 PM the previous evening and dose was administered at approximately 9:30 AM the following day, exceeding the 12 hour room temperature window by ~4 1/2 hours. No adverse events reported. Manufacturer was contacted and we were instructed not to repeat the 2nd dose, the series is complete and no further doses are necessary per call to Moderna.
Began to have severe aching pain in left shoulder, shoulder blade and neck approximately 2 hours after receiving vaccines.
Patient died 2 days after COVID vaccination, concern for vaccine related death.  Autopsy showed bilateral pulmonary emboli.  No evidence death was vaccine related.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 15-OCT-2015, the patient was vaccinated with ZOSTAVAX intradermally (lot# reported as L024998, expiration date 06-OCT-2016, dose, anatomical location were not reported). On 15-OCT-2015, the patient experienced a "wheal-like bubble" at the injection site after intradermal instead of subcutaneous route of administration. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 12 years old male 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.
Fever (101.2), chills, malaise, muscle ache, headache lasting over 24 hours no appetite swollen lymph glands in armpits lasting 48 hours +