chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Couldn't breathe; When she called her HCP, they said they were out of vaccine.; She still has not received her 2nd dose as of today (29Jun2021); This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Couldn't breathe) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced DYSPNOEA (Couldn't breathe) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (When she called her HCP, they said they were out of vaccine.) and PRODUCT DOSE OMISSION ISSUE (She still has not received her 2nd dose as of today (29Jun2021)). On 09-Jun-2021, DYSPNOEA (Couldn't breathe) had resolved. At the time of the report, PRODUCT AVAILABILITY ISSUE (When she called her HCP, they said they were out of vaccine.) and PRODUCT DOSE OMISSION ISSUE (She still has not received her 2nd dose as of today (29Jun2021)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that the patient stated that she is currently taking medication for blood pressure.  The patient also stated that she is also using nebulizer breathing machine. No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the Dyspnea event, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, a causal association between the Product Dose Omission Issue and Product Availability Issue mRNA-1273 is assessed as not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the Dyspnea event, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, a causal association between the Product Dose Omission Issue and Product Availability Issue mRNA-1273 is assessed as not applicable.
Client received the COVID-19 vaccine on 1/5/21 by the Vaccine clinic.  Plans were for Hospice services.  Client tested positive for COVID-19 by rapid testing on 1/8/21.  On 1/10/21 at 0900 Client was unresponsive and without vital signs.  Orders were for DNR, and CPR was not initiated.
Irritable, listless, whiny, fussy, temp 104.7; Pt was given APAP; Sleeps aobut 15" a time; On 16AUG91 seen by MD dx w/bilateral ear infect; started on ATB;
Left arm numbness, hand numbness and pain, axilla pain/lymph node pain. I took tylenol and motrin 1 dose 1/5/2021
Angina-like pain,  left to mid chest, irradiated to back and to the left side of neck, 7/10,  lasted 8 minutes, no SOB. It was not preceded by exertion or stress - I was out happily shopping with husband. Same type of chest pain recurred on December 7,  in my medical office, while seated and talking to a patient. Intensity was less, 4/10, but same location and irradiation, lasted 5 minutes. Has not recurred since. No left over fatigue.
Rash, ErythemaMultiform, Rash developed at the injection site after 8 days of receiving first dose of vaccine. She used topical analgesic and Benadryl po with good results. Narrative:
Chills lasting 18 hours  Body aches lasting 24 hours Feverish feeling lasting 36 hours Headache lasting 36 hours  Fatigue
800 doses were affected, about 800 have been given to patients.; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) given to 800 patients after possible temperature excursion.   The patient's medical history was not provided. No concomitant medications were provided.  On 04 Jan 2021, prior to the onset of the event(s), the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient received a vaccine dose that thawed out of the recommended temperature range.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event product storage error was considered recovered/resolved on 04 Jan 2021.  The reporter did not provide an assessment for the event product storage error.; Reporter's Comments: This report refers to a case of product storage error for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product storage error.
Patient stated they received the Pfizer 2 shot series and the booster.  Unable to obtain dates nor place of vaccine administration..
pain & swelling of lt arm; minimal itching; ice pack to area; APAP & DPH PRN;
BRUISE 3 1/2 INCHES BELOW THE INJECTION SITE; INJECTION SITE REDNESS TO THE RIGHT ARM; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced nausea. On 27-MAY-2021, the subject experienced fatigue. On 29-MAY-2021, the subject experienced bruise 3 1/2 inches below the injection site. On 29-MAY-2021, the subject experienced injection site redness to the right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 27-MAY-2021, and fatigue on 30-MAY-2021, and was recovering from injection site redness to the right arm, and bruise 3 1/2 inches below the injection site. This report was non-serious.
Pt. developed rash on 9/15/17, went to ER on 9/18/17 and diagnosed w/shingles. Rash developed on left trunk.
FINGERS TENSE UP; COULD NOT CLOSE HANDS; FINGERS FEEL NUMB FOR A FEW MINUTES; HEAD HURTS ALL THE TIME; CHEST PAIN; HAD TROUBLE WALKING; BOTH LEGS HURT; COULD NOT STAND FOR TOO LONG; This spontaneous report received from a patient concerned a 28 year old female. The patient's pre-existing medical conditions included the patient had no shortness of breath and no abdominal pain, also did not notice any swelling. The patient was not pregnant at the time of vaccination and currently not breastfeeding. The patient received covid-19 (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-AUG-2021, the patient experienced could not stand for too long. On 17-AUG-2021, the patient experienced had trouble walking. On 17-AUG-2021, the patient experienced both legs hurt. On AUG-2021, Laboratory data included Pain scale of 7/10. On 31-AUG-2021, the patient experienced chest pain. On an unspecified date, the patient experienced fingers tense up, could not close hands, fingers feel numb for a few minutes, and head hurts all the time. The action taken with covid-19 was not applicable. The patient recovered from chest pain, fingers feel numb for a few minutes, had not recovered from both legs hurt, and head hurts all the time, and the outcome of could not close hands, could not stand for too long, had trouble walking, and fingers tense up was not reported. This report was non-serious.
Swollen red spot; broke it.; painful.; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Swollen red spot), PAIN (painful.) and DEPRESSED MOOD (broke it.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Swollen red spot), PAIN (painful.) and DEPRESSED MOOD (broke it.). At the time of the report, RASH MACULAR (Swollen red spot), PAIN (painful.) and DEPRESSED MOOD (broke it.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 27-AUG-2012, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, the patient subsequently contracted a persistent strain of herpes zoster. On or about 29-JUL-2013, the patient was treated by a physician for severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient has been prescribed Valacyclovir and Ibuprofen for management of her painful symptoms. As a direct a proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
I started feeling woozy maybe 30 minutes after injection. I ended up taking a big nap when I got home and woke up feeling sick. Had dinner, went to bed for the night.  I was not able to sit up straight for more than 2 minutes the next day without getting extremely light headed. I did not eat for two and a half days. Spent the next several nights freezing cold and with night sweats. I also had a deep, phlegmy cough. It all started clearing up after a few days, but I felt crummy/under the weather for a week.
This case was reported by a nurse via sales rep and described the occurrence of shingles in a 64-year-old female patient who received Shingrix for prophylaxis. On 11th September 2018, the patient received the 1st dose of Shingrix .5 ml. In September 2018, less than a week after receiving Shingrix, the patient experienced shingles, influenza-like symptoms and rash. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles, influenza-like symptoms and rash were unknown. It was unknown if the reporter considered the shingles, influenza-like symptoms and rash to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient who received Shingrix last week Thrusday and came in (on the date of reporting) with a unilateral rash that extended from under her left breast to around the center of her spine. The nurse said it appeared to be shingles and that they were treating it as shingles with antiviral. The patient also had experienced flu like symptoms after the vaccine. The nurse said she should not be followed up unless the patient had requested.
The next day I experienced 24 short duration (4-5 seconds) full body seizures that I was coherent through; Several days later I felt weight on my chest; The first day after the vaccine I had body aches.; This is a spontaneous report from a contactable consumer(patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FC3182), via an unspecified route of administration, administered in Arm Left on 30Aug2021 12:30 at the age of 38-year-old as dose 1, single for covid-19 immunisation from pharmacy or drug store. Medical history included covid-19 and sustained a severe concussion while snow boarding from Feb2021 to an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination.  Concomitant medication included lions mane mushroom cognition capsules, fluoxetine. On 31Aug2021, first day after the vaccine patient had body aches. Several days later (Sep2021) he felt weight on chest and his blood oxygen percentage was persistent at 91%. The next day he experienced 24 short duration (4-5 seconds) full body seizures that the patient was coherent through. The event result in doctor or other healthcare professional office/clinic visit and patient did not receive any treatment in response to the events. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
It appears that the entire contents of a vial of Pfizer Covid vaccine was administered to the patient in a volume of 0.3ml.  The patient was contacted by Dr as the event occurred in the Emergency Department, prior to discharge.  The patient experienced vomiting overnight. It is unclear whether this was related to the event since this is the reason she sought care on the day of the event.
Symptoms: Symptoms 1. Myalgia 2. Fever 3. pain at injection site
nausea, lightheadedness Pt experienced lightheadedness, tachycardia, and nausea 2 min after receiving first dose of covid vaccine, leading to ED visit. Pt given snack and bottle of water. Symptoms self resolved.
Covid-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Covid-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 7008121001) for COVID-19 vaccination.     The patient's past medical history included Nephrolithiasis. Concurrent medical conditions included Hyperlipidemia, Osteoarthritis, Enlarged prostate and Drug allergy (Sulfa allergy).    On 29-Oct-2021 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 22-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Reporter reported that on 1-JUN-2022 at 20:00, the patient had rebound of COVID-19 symptoms six days after the completion of Paxlovid treatment.  Device Date: 01Jun2022 Company comment: This spontaneous case concerns a 69-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of onset of the event was not specified in respect to the administration of third dose of mRNA-1273, hence latency could not be assessed, there was no information provided regarding the initial two doses. Patient was started on treatment regimen of Paxlovid on May 22-26, 2022, six days after completion of the treatment, patient experienced rebound symptoms of COVID-19. Details of concomitant medications, clinical course and outcome were not provided. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of onset of the event was not specified in respect to the administration of third dose of mRNA-1273, hence latency could not be assessed, there was no information provided regarding the initial two doses. Patient was started on treatment regimen of Paxlovid on May 22-26, 2022, six days after completion of the treatment, patient experienced rebound symptoms of COVID-19. Details of concomitant medications, clinical course and outcome were not provided. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Case number PHEH2015US000682, is an initial spontaneous report received from a pharmacist on 05 Jan 2015. This report refers to a 62 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 17 Oct 2014. It was reported that the patient received FLUVIRIN which reached temperature below 36 degree F for 3.5 non-consecutive days and 33.1 degree F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought that it could be due to thermometer malfunction. But she was not sure. No adverse event was reported following this medication error.
not having an appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (not having an appetite) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (not having an appetite). At the time of the report, DECREASED APPETITE (not having an appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Headache, Myalgia, swollen lymph node, sore arm at site of administration Narrative:  Employee had to leave work early due to the headache. All symptoms were resolved within 36 hours
October 8 2021, In the afternoon I noticed I was more short of breath than normal when I went upstairs to apt. October 9 2021, it was severely affecting my breathing so I drove myself to the hospital. When I got there I thought I had COVID 19. I had recently gone to baby shower and no one wore masks. ER checked for COVID 19/Negative. They did a chest X-ray and then CT Scan. Scan showed my right lung was occluded /blocked with blood clots. Left lung was partially occluded with blood clots. They did a pulmonary thrombectomy. 3 hour surgery and pulled out a lot of tissue. I remained in hospital a few nights to ensure I was stable. They put me on Xarelto and had me stop taking Premarin. Released on the 11th. I have had no other issues and have completely recovered.
The patient and I went over her past medical history in detail and her reactions to allergy testing and previous vaccines. She wanted to proceed with vaccination. I agreed and recommended a 30 minute minimum wait for observation. I administered the vaccine and within five to ten minute she began to feel like she was having an out of body experience, her face became red and itchy, and she was dizzy. She sat in the lobby for close to 15 minutes. I checked in with her and she was not feeling any better so I administered 50mg of liquid diphenhydramine to the patient and gave her a bottle of water. She stayed in the lobby for a total of an hour and a half from start of vaccination to finish. I called her primary care provider after I had administered the diphenhydramine and related all the details of what happened to her. She agreed that the course of action taken was appropriate and to tell the patient to rest and if she was no better to come in and be seen the following day. The patient had an epipen at home and she was instructed to use it if her lips or throat began to swell and call 911. The patient and her primary care provider are going to assess if a second dose is safe following this occurrence. While she was in our care she did not have and issues with her breathing or swelling of the lips or throat.
After shot patient became flushed.  Eyes were swollen.  B/P  96/84  HR 91.  State this happened to her when she took Niacin and when had a bee sting.   States "I took benadryl and it was better".     Patient encouraged not to get second dose in drive thru.   Consult her medical provider.  Final B/P Reading 142/72
Developed acute thoracic back pain and subsequently bilateral lower extremity evaluation. Patient was hospitalized and discharged to home with a diagnosis of possible transverse myelitis.
Super sick to vaccine- just feeling better; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ILLNESS (Super sick to vaccine- just feeling better) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Topamax).    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced ILLNESS (Super sick to vaccine- just feeling better). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown and ILLNESS (Super sick to vaccine- just feeling better) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Moderna vaccine was pulled from freezer on 16-Dec-2021. Beyond use date of 15-Jan-2022 was printed in red and taped to the top of boxes.  On 26-Jan-2022, Staff noticed that vaccine was still in the fridge and expired and 5 doses had been given at that point. on 31-Jan-2022, Moderna confirmed that revaccination was not required.
DIED IN HIS SLEEP; BRAIN ANEURYSM; This spontaneous report received from a consumer via a company representative through media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced brain aneurysm and died in his sleep. It was unknown whether an autopsy was performed. It was reported as, "I personally know a young man, fully vaxxed died in his sleep...brain aneurysm....". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patient died from an unknown cause of death and the outcome of brain aneurysm was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20221161673-Died in his sleep. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221161673-Brain aneurysm . The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
In error, the Pifzer pediatric dose was given a a whole, undiluted vial, in place of a Moderna adult booster dose.
Received PCV-7 & ACT HIB about 11 AM. Late afternoon began running fever around 7 PM Temp noted to be 103 Axillary. Client hade sever brief episodes of swelling of extremities, no loss of consciousness - lasted only seconds