chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unable to expand my lungs to breathe/ Constant difficulty in breathing; This is a spontaneous report received from a contactable Other HCP (patient).A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 14:00 (Lot number: FD8448) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroidectomy" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). No covid prior vaccination. The patient took concomitant medications, included Armor Thyroid. No other vaccine in four weeks. The following information was reported: DYSPNOEA (medically significant) with onset 04Sep2021 09:00, outcome "not recovered", described as "unable to expand my lungs to breathe/ Constant difficulty in breathing". The patient underwent the following laboratory tests and procedures: Nasal Swab: (04Sep2021) negative. Therapeutic measures were taken as a result of dyspnoea which included treatment with benedryl. Clinical course: 4 Days after vaccination woke unable to expand her lungs to breathe, for an additional 4 days she had to medicate with benedryl to allow for breathing. Still not able to fully breathe. Constant difficulty in breathing.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event Dyspnoea and the suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt reports that he got a very itchy rash all over his body from arms, to trunk & down thighs. He developed rash within 24 hours of receiving vaccine. He called his surgeon & doctor said to take BENADRYL. Pt reports that rash improved with BENADRYL. He still has a small rash.
Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Swollen 2x2 inch red warm area around the injection site). On 15-Feb-2021, the patient experienced PYREXIA (Low grade fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (Low grade fever), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Swollen 2x2 inch red warm area around the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) 2 days post vaccine and (Negative) 9 days post vaccine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other relevant medication history included Multivitamin. Patient had a bad reaction with the second moderna vaccine which lasted 10 day. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: outcome updated and diagnostic testing provided.
doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported. It was reported a temperature excursion that occurred several days ago in the Freezer. It was found that vaccines were viable. The patient received the booster dose. No treatment medications were reported.
5 1/2 minutes, post vax, child had extensive shingles (confirmed by dermatologist who asked to culture lesions) filled entire right dermatome.
Within minutes of the shot, I felt fatigue and sleepiness.   Within an hour or two later, severe headache and dizziness. Then, nausea, vomiting three times that night. Continued to feel lethargic and dizzy the next day, with pain in both arms and hands. Headache, lethargic condition and limb pain continues two days later.
Information has been received from a health authority concerning a 3 year old female with no relevant medical history who in Feb 2005 was vaccinated SC with a first dose of varicella virus vaccine live. On 11/10/2005 the patient developed a herpes zoster opthalmicus that disappeared on 11/28/2005. the patients outcome was recovered. The patients herpes zoster opthalmicus was considered to be an other important medical event (OMIC). Other business partner numbers include E200600581 and 70616248. No further information is available. The case is closed.
Lethargy immediately after injection and arm soreness at injection site. Approximately one week later I experienced left ear infection/fluid in ear causing hearing loss and mild dizziness. Hearing loss, ringing in ear and dizziness are still on-going.
This case was reported by a other health professional via call center representative and described the occurrence of erythema in an unspecified number of patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, feeling hot, pain and allergic reaction. On an unknown date, the outcome of the erythema, feeling hot, pain and allergic reaction were unknown. It was unknown if the reporter considered the erythema, feeling hot, pain and allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not applicable. The Medical Assistant called on behalf of the prescribing doctor because he had a couple of people who have had some side effects to the vaccine. Several patients have had red and hot larger sites on the shingles vaccine and did not want to receive the second dose because of their allergic reaction. The doctor would like further clinical information about the SHINGRIX side effects faxed to his office if possible. The reporter declined to answer any further questions. The reporter said that he would be the one discussing further related details with GlaxoSmithKline. The reporter described several patients have had red and hot larger sites. The word she mentioned between larger and sites sounded like pore but was not able to clarify this further during the call.
Hive-like rash over face, neck, trunk and LE with papulars from .5cm-10cm in diameter. No vesicles. Treated with anti-itch therapy oraly.
The evening of the vaccine my neck began hurting. When I awoke the following morning I couldn?t move my head. I had to move my head with my hands. The pain was excruciating. This cycle continued for four days. On the fifth day the symptoms began to subside.. After about ten days the symptoms were gone. I did not contact the doctor about it.  That was my mistake.
Received Anthrax booster IM in right deltoid am of 10/03/2009.  Patient awoke at 0100 with severe pain in right shoulder radiating up toward neck and down into right arm.  She also experienced a localized redness (which she has experienced with past injections).  She required narcotic pain medication to aleviate pain.  Movement increased pain to shoulder so at 10:00 AM 10/04 pt placed arm in sling. Patient stated she may see her physician if pain is not better by Monday 10/05.
on day 9 after receiving vaccine developed a hard knot/mass at the injection site.  became progressively larger over the course of the day.   by the end of the day area at and around the site is now swollen, hard, red and extremely itchy.
Pt recvd MMR vax in MAY89 & following vax pt exp irritability, chills, fever, arthralgia & rash; sx were intermittent lasting approx 7 days;
4 inch in diameter red hot swollen itchy at injection site, started on day 3 and currently on 8 days after the vaccine; 4 inch in diameter red hot swollen itchy at injection site, started on day 3 and currently on 8 days after the vaccine; This is a spontaneous report from a contactable nurse.  A 42-year-old non-pregnant female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1283), intramuscular in the left arm on 12Jan2021 at 12:45 PM (at the age of 42-year-old) as a single dose for COVID-19 immunization. Medical history was none.  Concomitant medication included ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). On 15Jan2021, the patient experienced 4 inch in diameter red hot swollen itchy at injection site, started on day 3, and currently on 8 days after the vaccine. The clinical outcome of the events "4 inch in diameter red hot swollen itchy at injection site" was not recovered.
Expired Vaccine Administered to a Patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to a Patient) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to a Patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to a Patient) had resolved.        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 concomitant medications were not reported. No treatment medications were not provided.
Full body muscle and joint pain, tiredness, easy exhausted. Lasting approx 24 hours. Advil offered limited benefit temporarily
Arm tingled down to fingertips immediately after injection. Sore arm for two weeks. Sore armpit and swollen lymph nodes under armpit for weeks after shot. Loss of strength and grasping with weakness still ongoing after shot.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for heart block, advanced age (93), CHF, arrhythmia, chronic obstructive lung disease, hypertensive heart disease, AF on hospice care. He presented to ED 5/11 for shortness of breath. Returned on 5/13 for tachypneic with labored breathing with wheezing symptoms and fluid retention. Discharged 5/20 and deceased 5/23.
Diarrhea , nausea, 'feeling unwell', fatigued began at 9am the next day - it is currently 3pm - continuing to feel symptoms
headaches; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Not reported medical history.).    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment  information was provided.
Leg had knot size of gumball with low grade temperature from Monday to Wednesday.  When knot increased to the size of a softball.  Mother stated "is decreasing in size by a small amount."
Information has been received from a licensed practical nurse (LPN) concerning a female who in 2007 and on approximately 08-APR-2007 was vaccinated with the first and second doses, respectively, of Rotateq (lot number not provided). In 2007, after receiving the first and second doses of Rotateq, the patient developed severe vomiting and diarrhea. Unspecified medical attention was sought. The patient was noted to be 6-months-old when the second episode of diarrhea and vomiting occurred. The patient subsequently recovered. Additional information has been requested.
Coughing, body, muscle and joint aches, chills, headache, hot/cold, legs shaky, not able to hold head, weakness
Vision change 20-30 seconds Nausea/vomiting Lightheaded  Sweaty Warm Paresthesia in hands
Pt brought in by aunt to have PPD read. No Tx needed. Aunt stated mom noted redness to left deltoid area no other sx noted. 1 1/2 cm X 7 1/2 cm slight redness noted.
5 days after vaccination ears began ringing, now 2 weeks later they are still ringing.   Very high pitched ringing.
PATIENT GOT A SEVERE MIGRAINE APPROXIMATELY 5 MINUTES AFTER INJECTION.  WE SENT HER HOME FROM WORK LATER IN THE EVENING
A report has been received from a Health Professional concerning male patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient had been received nasal FLUMIST QUADRIVALENT (intranasal) on 10-Sep-2013. The reporter stated there were 6 patients with 1 doctor who tested positive for influenza A. She thought that 3 of those patients had FLUMIST QUADRIVALENT, the other 3 received a different product. After review of the files from that day, there were only 2 patients who received FLUMIST QUADRIVALENT and 2 employees who received FLUMIST QUADRIVALENT and tested positive for influenza A. On unspecified date, the patient experienced influenza A. The outcome of the event of Influenza A was unknown. The reporter considered the event to be non-serious.
Pain suffered around injection area in left arm. Pain went on for 2 weeks but brought to the pharmacist  attention. Symptoms consist of sharp, dull, nagging, stiffness, soreness, lack is sleep, throbbing, and consistent thru out the day into the night from Dec (2021)- Feb (2022)
pt c/o of eye irritation in may- pt went to opthamologist and was told had pink eye. then returned for conitued complaint and was told then she had a herpes infection. Pt still has continued discomfort.
11/3/04 Lymphadenopathy, conjunctivitis, body rash (reddish pink).
This spontaneous report as received from a Nurse Practitioner on 22-OCT-2014 refers to a 6 month old patient of unknown gender. On 22-OCT-2014 (als0 reported as today) the patient was vaccinated with a dose of PNEUMOVAX23 injection (strength, dose and lot # unknown). No adverse effects reported. Additional information has been requested.
Had burning pain and broke out with red areas which later became blisters.  Later diagnosed as shingles.
Patient is 17 years of age and received a Moderna Vaccine.  No signs or symptoms of an adverse event were noted.
Information has been received from a RN concerning a 90 yr old female pt who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647660/0945N). Subsequently, 4-5 hrs post vaccination, the pt developed warmth, redness and swelling at injection site. The pt was treated with an unk antibiotic. The pt was reportedly recovering. It was also reported that another pt had a similar reaction (WAES0408USA00082). Additional information has been requested.
tremendous problem breathing; slept for 12 hours; lethargic; severe migraine headaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (tremendous problem breathing), HYPERSOMNIA (slept for 12 hours), LETHARGY (lethargic), MIGRAINE (severe migraine headaches) and PYREXIA (fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concomitant products included DICYCLOVERINE HYDROCHLORIDE (BENTYL), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), LORAZEPAM (ATIVAN), SIMVASTATIN (ZOCOR), LOSARTAN POTASSIUM (COZAAR), DULOXETINE HYDROCHLORIDE (CYMBALTA), OXYCODONE, ALLOPURINOL (ZYLOPRIM) and MESALAZINE (APRISO) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DYSPNOEA (tremendous problem breathing), HYPERSOMNIA (slept for 12 hours), LETHARGY (lethargic), MIGRAINE (severe migraine headaches) and PYREXIA (fever). At the time of the report, DYSPNOEA (tremendous problem breathing), HYPERSOMNIA (slept for 12 hours), LETHARGY (lethargic), MIGRAINE (severe migraine headaches) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.   This case was linked to MOD-2021-342866 (Patient Link).
Developed temp 101.6 F. and wheezes heard on auscultation. Tested positive for Covid-19. On Abbott ID Now molecular test. Fully vax but no booster- Moderna.
No Adverse Event; First dose-15-Jan-21 Second dose-04-Feb-21; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-15-Jan-21 Second dose-04-Feb-21) and NO ADVERSE EVENT (No Adverse Event) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe). Concomitant products included ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-15-Jan-21 Second dose-04-Feb-21). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-15-Jan-21 Second dose-04-Feb-21) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Both the doses of vaccine received one in once. Humira was citrate free.  No treatment information was provided.   This case was linked to MOD-2022-624296 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2022: Live Follow up received. Added concomitant batch number.
This is an initial report of an AE, received on 05Oct2016, for Protein Sciences FLUBLOK. Subject, received FLUBLOK Intramuscular on 23Sep2016. On an unknown date after receiving FLUBLOK, the subject developed a hack for two days and head pain. The subject also reported that parts of the lungs would feel sore or in pain and could feel the flu in them. At the time of the report, the events of cough, headache and sore lungs had resolved. Medical or surgical history and concomitant medications were not reported.
This is a spontaneous report from a contactable nurse via a company representative. This nurse reported same events for two patients. This is the second of two reports. A patient of unspecified age ethnicity and gender received TRUMENBA (Lot N16808), via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea, vomiting, chills, hot flash, abdominal pain, shakes and turn very pale on an unspecified date. The outcome for all the events was unknown. The reporter considered all the events related to meningococcal group b rlp2086. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017181368 same reporter/drug/event, different patient.
temp of 103 on Sunday 02/28/2010  called 911  dx abscess Right arm  Did not go to ER or hospital  advised warm compresses  Rx for doxycycline 100mg q 12 hrs x 10 days written by ARNP
Symptoms presented themselves one week after moderna Covid booster shot and lasted for about two weeks before dissipating. Symptoms included extremely reactive full body hives (triggered by physical contact or scratching), joint stiffness and pain (inability to walk on day three) , fatigue, temperature, swelling of throat and difficulty breathing at times. Lasting contact dermatitis after the rest of the symptoms dissipated which is still affecting me months later.
Patient called pharmacy 8/2/21 to report she had been treated at  hospital over the weekend for blood clots and was now back home. Hospital had requested patient report blood clots because they could not determine  the reason for clots.
Feverish about 1 week after vaccination - self administered Ibuprofen 400mg for 3 days. Sweating, shaking, onset of chest pain, difficult breathing by day 4. Continued self treatment; ambulance called on day 4. Seen at ER and admitted to ICU on 4/8/03.
Right arm keeps itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Right arm keeps itching) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008821-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Right arm keeps itching). At the time of the report, PRURITUS (Right arm keeps itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was reported.