chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling she is experiencing around the injection site and in her fingers; swelling she is experiencing around the injection site and in her fingers; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (friend) of an unspecified age who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling around the injection site and in her fingers after receiving her second vaccine dosage. The outcome of both the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12 Hours after receiving the injection I experienced Flu-like symptoms, fever, nausea...During the first week following  vax I began experiencing pulmonary arrhythmia, dizziness, fainting, chest pains, left arm pains, and loss of vision. The irregular heart beat continued nearly unabated for several months. Meanwhile, my blood numbers began to fluctuate as my RBC count dropped dangerously low, my Platelet count was astoundingly high, and my WBC count was abnormal, at times both high and low. I noted a severe fatigue and inability to catch my breath, constantly. In August 2021 my blood issues came to a head when I experienced priapism lasting for 5 days due to numerous blood clots having formed in my arterial line and my penis.  I lost all use and functionality of my penis. I was treated with 5 emergency surgeries to remove the clots in my groin region.
ADMINISTRATION ERROR ( GIVEN PFIZER MONOVALENT COVID VACCINE as BOOSTER)
My mother had her first Moderna COVID-19 vaccination on March 1st.  On March 10th, she suffered a blood clot in her eye that caused the eye to lose vision.  Her eye doctor said she is now permanently legally blind in that eye....  I do not know if the blood clot was caused by the vaccine, but I am reporting it in case there is a correlation.
Antigen tested positive on 6/27/2022 and became symptomatic the next day 6/28/2022.
About 3 weeks later, I was diagnosed with Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (About 3 weeks later, I was diagnosed with Covid-19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-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 COVID-19 (About 3 weeks later, I was diagnosed with Covid-19). At the time of the report, COVID-19 (About 3 weeks later, I was diagnosed with Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient was diagnosed with Covid-19 3 weeks after the first dose and 1 week before the second dose. Patient states he still has antibodies and protein spike from the vaccine.; Sender's Comments: This case concerns a  52-year-old, female patient with no relevant medical history, who experienced the unexpected events of COVID-19. The events occurred approximately 3 weeks after the first dose of Spikevax, patient is yet to take the second dose. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.
Pt admitted on 8/3/2021 with c/o 2 days of cough, fever of 103.5, altered mental status, and decreased p.o. intake. Pt was fully vaccinated.  Pt was discharged on 8/3/2021 with son in law  to home.
BACK ACHE; HEADACHE (RE-STARTED AND THEY WERE SO BAD HE COULDN'T SPEAK); This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 167 pounds, and height was 69 inches. The patient's concurrent conditions included: asthma, human immunodeficiency viruse (hiv), blind in right eye, smoker, alcohol user, contrast media allergy, and drug abuse (used to smoke crack cocaine). The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol, and lisinopril for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: Unknown) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2021, the patient experienced back ache. On OCT-2021, the patient experienced headache (re-started and they were so bad he couldn't speak). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache (re-started and they were so bad he couldn't speak), and the outcome of back ache was not reported. This report was non-serious.
Developed bells palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Developed bells palsy) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced FACIAL PARALYSIS (Developed bells palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Developed bells palsy) outcome was unknown.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to events was not applicable. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Received vaccine approx. 10 am.  At 6 pm, noticed macular, erythematous areas on lower legs.  Area approx. 6x8 cm left, 4x6 cm right.  Blanches.  Not painful, not pruritic.  Not present in morning when she dressed.
Within 3-4 hours of receiving influenza vaccine, triceps region/lateral upper arm became red, warm and a little swollen. Patient's mother notified our clinic. Placed on 5 days of Amoxicillin. Complete resolution within 48 hours.
incomplete course of vaccination; felt very sick; shaking; shivering; feeling cold; fever; sweats; headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of tremor in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In April 2019, 5 min after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tremor, shivering, feeling cold, fever, sweating, headache, nausea and feeling unwell. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the tremor, shivering, feeling cold, fever, sweating, headache and nausea were recovered/resolved and the outcome of the feeling unwell and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the tremor, shivering, feeling cold, fever, sweating, headache, nausea and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported, however it could be 70 or 71 years. The patient started to shake uncontrollably.  She was shivering, felt very cold and had severe headache.  The symptoms lasted 3 to 4 days. The patient felt very sick.  Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
p/vax pt devel paresthesias & numbness of lt face, arm, leg; western blot was pos IGM; no tx given
injection site is hot; injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is hot) and VACCINATION SITE SWELLING (injection site is swollen) 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 VACCINATION SITE WARMTH (injection site is hot) and VACCINATION SITE SWELLING (injection site is swollen). At the time of the report, VACCINATION SITE WARMTH (injection site is hot) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
This initial spontaneous case, was received from other non-health professional (consumer) on 30-Sep-2017, concerning an 84-year-old female patient. The patient's medical history and concomitant medications were not reported. On 25-Sep-2017, the patient was administered with INN Flu Vaccine (dose: 0.5 ml, batch number, manufacturer, trade name, route of administration, anatomical location and expiry date: not reported). On the same day, after vaccination, the patient experienced leg and lower back pain, which were lasted for 5 days. At the time of this report, the outcome of the event was recovered. The reporter assessed the event as non-serious. Significant case correction received with IRD 30-Sep-2017: The company causality was changed from unassessable to related. Listedness was corrected.
Hep A #1 given on 4/5/06. Hep A  #2 given on 6/20/06. Patient has not exhibited any adverse reactions to date. No treatment was given.
LETHARGIC; HEAVINESS OF HEAD; CRAMPS IN LEGS; ACHEY; GENERALLY FELT LIKE A CRAP; DRY MOUTH; NAUSEOUS; HEADACHE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included heart defect. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered in Left Arm on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced heaviness of head. On 08-APR-2021, the subject experienced cramps in legs. On 08-APR-2021, the subject experienced achey. On 08-APR-2021, the subject experienced feeling bad. On 08-APR-2021, the subject experienced dry mouth. On 08-APR-2021, the subject experienced nauseous. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, nauseous, headache, heaviness of head, cramps in legs, achey, feeling bad, and dry mouth. This report was non-serious.
07/30/2022 I started to not feel well that evening. I had a sore throat and started to get fever. I took Covid home test the next day, which was negative. I had a positive PCR test om 8/31/22 at a health facility. I had a cough, sore throat, headache and a fever  101- 102 and was tired. I took Delsum and it helped my cough. My cough was a clear mild cough. I took some Tylenol a few times with a headache. 08/1/2022 I had a telehealth with my doctor and she prescribed Paxlovid. It was 08/03/2022 before I was able to start the Paxlovid. The symptoms slowly abated. The cough lasted for about a month, slowly weakening. I was still tired did not feel like I had energy and did not feel like myself for about 5 weeks. By Day 12, I tested negative for the first time.  Day 15, I had a positive COVID home test. I continued to test positive for 4-5 days before I tested negative again.
Moderna COVID-19 Vaccine EUA. Following first shot, I had really bad joint and muscle pain around joints. Took hot showers for pain and Tylenol. Pain in right shoulder (where I have something else going on) increased a lot. After the second shot (about 3 days later), joint and muscle pain returned in all joints. Now, May 9th, joint pain is really bad in arms, hips and legs. It is difficult to walk and to raise arms. I haven't slept due to severe pain. I hope this subsides. I will give it a few more days but it's very painful.
8/13/10 Pt had vaccines 8/13 1 PM. This AM had temp 100.3. Given ibuprofen - States temp did no go down. Four hours later temp 101.3. C/o headache - Denies sore throat, cough, runny nose, body aches, rash, ear pain. Advised to try TYLENOL for temp. - Monitor condition if fever persists, headache becomes intense or develops other symptoms - Consult with PMD.
hands hurting more; This is a spontaneous report from a Pfizer-sponsored program received from a contactable nurse and a consumer (patient's spouse). A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at dose number unknown, single for COVID-19 immunisation and started to receive tofacitinib citrate (XELJANZ XR 11 mg tablet; expiry date: 30Jan2023) orally on Aug2020 at 11 mg once daily for psoriatic arthritis. Medical history was not reported. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT 160-4 mcg), vitamin D (vitamin D NOS 10 mcg tablet), calcium 250mg tablet, magnesium 100 mg tablet, fludrocortisone acetate, hydroxychloroquine sulfate (PLAQUENIL 200 mg tablet), prednisone 10 mg tablet, ibandronate sodium 150 mg tablet. The patient took COVID vaccine and doctor (MD) advised him to discontinue tofacitinib citrate for 7 days. The patient had been complaining of hands hurting more. MD was aware. The action taken with tofacitinib citrate was unknown. The outcome of the event was unknown.   No follow-up attempts possible. information about lot/batch number cannot be obtained.
Heart palpitations, shortness of breath, dizzy.  Heart tests were done and dud not find abnormal heart problems, but did detect the oalpitations.  Tests  included echocardiogram, ekg, and holter.
Vision strobing for about 10 minutes. It started about an hour after my vaccines were completed and has resolved now.
nausea; vomiting; diarrhea; not feeling too good; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number ang expiry date unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she was not feeling too good since an unspecified date in 2021. She reported that on 31Jan2021, since she received the first dose she has woken up every morning with nausea, vomiting and diarrhea. She asked if this was normal and how long it will last. She was asking what is the efficacy of one dose of the vaccine and if should get the second dose. The outcome of the events was unknown. The events were reported as non-serious.   Information about Lot/batch number has been requested.
About 10-15 post admin of Flu vaccine pt approached the pharmacy counter stating he felt very faint w/a "knot in my throat" I instructed to sit down head btwn the legs. I brought out cold compress. Pt stated able to breathe but felt "tight". I called 911 & they instructed me to give EPIPEN shot. EPI was administered EMS arrived about 5 mins later.
Initial report was received from a consumer, who was also the patient, on 12 October 2012. A 62-year-old patient had received an injection of FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported). Within three hours, the patient's arm was sore, hot, red and achy. By the next day, the patient had fever, chills and body aches. Within four days, the patient had coughing. Within six days, the patient was admitted to the hospital with pneumonia. The patient was hospitalized for one week and was still unable to breathe properly when they got home. The patient not only had asthma but "the new name for whatever it is COPD". The patient received the INFLUENZA vaccine every year and never had a problem. The patient was not sick, did not have a temperature and lungs were completely clear at the time of vaccination. The patient had a history of asthma. The patient's outcome was not reported. Documents held by sender: None.
rash started along back of her neck and continued toward front and up the hairline; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: RASH (non-serious), outcome "unknown", described as "rash started along back of her neck and continued toward front and up the hairline".  Additional information: The patient reported that she was getting a rash after each dose (she had 3) of the vaccine. The rash started along back of her neck and continued toward front and up the hairline. After each dose the reaction time of the rash was quicker and more intense. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A week after the injection I have a 2 inch red, itching,  and hot area at the injection site.  The first 5 days my arm was painful without redness.
This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of adult patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the unspecified number of adult patients were vaccinated with unspecified doses of M-M-R II (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported) with a 29 gauge, 1/2 inch needle. No symptoms were reported. Product quality complaint (PQC) was not filed. As of 15-SEP-2016 all telephone attempts to obtain follow-up information has been unsuccessful. Additional information has been requested. The report details, event, and narrative were update.
Fever chills, chest pain, nausea, dizziness, fatigue, short of breath
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 4:02 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 56.11 years  Concomitant products were not provided.  On 08-Jan-2021, the vaccine with batch number 041L20A was moved to fridge. On 11-Jan-2021, 9 vials were moved to the clinic. On the same day between 09 AM and 02 PM, vials underwent temperature excursion with temperature of 34 and 35 degrees Fahrenheit respectively. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 07-Feb-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.
THE VACCINE ADMINISTRATION WAS DONE 2 DAYS AFTER THE BEYOND USE DATE (BUD). ONCE RECEIVED, VACCINES MUST BE STORED REFRIGERATED FOR UP TO 10 WEEKS. THESE VACCINES WERE RECEIVED ON JANUARY 26, 2022 AND THE BUD WAS APRIL 5, 2022. HOWEVER, UPON RECEIPT THE STAFF CONFUSED THE DATE AND DOCUMENTED THE BUD AS MAY 4, 2022.