chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed covid; Developed covid; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 64-year-old patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6202), on 01Apr2021 as dose 2, single (Lot number: EN6207) and on 29Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 64 years, in right deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "blood thinner" (unspecified if ongoing), notes: blood thinner. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "Developed covid". The event "developed covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event vaccination failure and Covid 19 and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Right after shot, pt  felt warm, clammy,  dizzy, and nauseas.  She does have POTS syndrome witch has similar episodes .  She sat for 30 or 40 minutes then felt good enough to leave.  No other medical attention was needed
Extreme fatigue unable to stay awake showing 14 to 16 hours a day when prior only slept 6 to 8 making it very hard to take care of 2 young children.
She just had a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (She just had a rash) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE RASH (She just had a rash). At the time of the report, VACCINATION SITE RASH (She just had a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She did share that over a month before her 1st injection she had Juvederm and botox No concomitant medication was reported . No treatment medication was reported .   This case was linked to MOD-2021-090333 (Patient Link).
Pfizer 1/12/21, 2/2/21, 9/28/21. Positive on 7/18/22
Syringe leaked, less then half of the dose administered.; Syringe leaked, less then half of the dose administered; This spontaneous case was reported by a nurse and describes the occurrence of SYRINGE ISSUE (Syringe leaked, less then half of the dose administered.) and UNDERDOSE (Syringe leaked, less then half of the dose administered) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced SYRINGE ISSUE (Syringe leaked, less then half of the dose administered.) and UNDERDOSE (Syringe leaked, less then half of the dose administered). At the time of the report, SYRINGE ISSUE (Syringe leaked, less then half of the dose administered.) and UNDERDOSE (Syringe leaked, less then half of the dose administered) outcome was unknown. Not Provided      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 provided No Treatment information provided
Fever; Bad headache; All over body aches; Malaise; Nausea; Rapid heartbeat; Shortness of breath when walking; This is a spontaneous report received from a contactable consumer or other non-health care professional reported for herself. A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8736), via an unspecified route of administration, in right arm on 17MAY2021 at 14:45 (at the age of 56-year-old) as dose 1, single for covid-19 immunization at doctor's office/urgent care. Medical history included breast cancer 2016-2018, Covid-19 on 09Nov2020 and had Long-Haulers syndrome and was hesitant to get the vaccine, she finally consented; pneumonia on 30Dec2020, neuropathy, chronic pain, elevated blood pressure, degenerative disc disease. Known allergies was reported as penicillin, taxol. Patient received any other medications within two weeks of vaccination was reported as yes with concomitant medication included lisinopril, tamoxifen, pregabalin and venlafaxine ER. On 18May2021 at 05:00, after the first dose patient developed a fever, bad headache, all over body aches, malaise, nausea, rapid heartbeat, and shortness of breath when walking. She felt like she had COVID-19 again. Prior to the vaccination, the patient diagnosed with COVID-19 was reported as yes. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient underwent lab tests and procedures which included COVID-19 virus test resulted as positive, on an unspecified date; rapid heartbeat on 18May2021. Therapeutic measures were reported as no. The outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
No additional AE details; Temperature excrusion/TE evaluation states vaccines have been administered to multiple patients; Device or device component malfunction; This spontaneous report was received from a medical assistant and an other non-health care professional referring to a 5 year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. No illness at time of vaccination nor vaccine within 4 weeks prior to vaccination date was reported.  On 23-MAR-2022, the temperature excursion occurred of varicella virus vaccine live (oka/merck) (VARIVAX). The storage temperature was -14 degree Celsius up to -10 degree Celsius for 3 hours and -10 degree Celsius up to 8 degree Celsius for 1 hour 30 minutes. There was no previous temperature excursion. The temperature excursion occurred as a result of a reading from a digital data logger. On 20-APR-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection by a healthcare professional for prophylaxis (subcutaneous, lot #U025790, expiration date: 19-AUG-2023; strength and dose were not provided) (product storage error). No additional adverse event (no adverse event) was reported. After administration, the reporter contacted company and verified the viability of vaccine. The vaccine was not available for return or evaluation because it was given to the patient. Additionally, it was reported device or device component malfunction.   This is one of several reports from the same reporter.
Information has been received from a certified medical assistant concerning an 86 year old male patient with cardiac failure congestive, coronary artery disease, hypertension, peripheral vascular disease and an allergy to codeine who on 17-OCT-2007 at 10:00 am, was vaccinated IM into the right deltoid with a first 0.5ml dose of PNEUMOVAX 23 (Lot#655766/0038U). Concomitant therapy included influenza virus vaccine (unspecified) given on the same day but in a different arm. On 17-OCT-2007 at night, the patient experienced a reaction that was 1 or 2 inches below the injections site that went down the arm to the elbow. This area was red, swollen and warm to the touch. The patient woke up during the night because the arm was hurting. On 18-OCT-2007 at 13:00, the patient experienced from the injection site on his shoulder down to his elbow was red and warm to the touch. It was also reported that he had some pain but it had improved before he was seen at the office. The patient never took any meds for the pain but he applied a cold pack to the site. On 19-OCT-2007, the patient notified the office that the reaction was not better. No laboratory diagnostic studies were performed. On 20-OCT-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
On the evening of the vaccination, patient noticed his arm was warm to the touch, red, and that the injection site was swollen and hard. He came to the pharmacy on Tuesday of the following week, and I also observed these symptoms. The patient left the bandaid on the entire time after the vaccine. I had him remove it so I could check the injection site. There was no visible area where the needle had pierced the skin. Before he removed the bandaid, I measured using the 3 finger and V technique to make sure the vaccine was administered in the deltoid correctly, and the location of administration was correct. We will follow up with patient tomorrow to see how his arm is.
Upper Respiratory Infection; bronchitis; sick a lot; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), BRONCHITIS (bronchitis) and ILLNESS (sick a lot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (high anxiety).    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), BRONCHITIS (bronchitis) and ILLNESS (sick a lot). At the time of the report, UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), BRONCHITIS (bronchitis) and ILLNESS (sick a lot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not provided.  Reported that patient couldn't get flu shot because of sickness.   This case was linked to MOD-2022-452729 (Patient Link).
A report was received from a health care professional on 12/16/03 concerning an 18 month old vaccinee of unknown gender who inadvertently received Fluvirin on an unknown date in December 2003. On an unknown date in December 2003 a vaccinee was inadvertently administered Fluvirin. No adverse events have occurred as a result of this, at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Has experienced headaches at a #7 pain level, nausea, and feels tired and listless. Glucose level went up between 200 and 250 since she received the pneumonia and flu vac.
Approximately 2 months from having received the second dose of the Moderna Vaccine, I notices o small lump in my right under arm, close to the side of my right breast. I saw my gynecologist on 5/13/2021, in her office. She did an exam and then wrote me an order for a mammogram and ultrasound of my right breast. I had the tests done on 6/16/2021. I spoke with the radiologist, he said that the lump looks benign. That it is an enlarged lymph node. They said that they have seen quite a few patients come in with this occurring after the vaccine. Though most have had the enlarged lymph node on the same side as the where the injection was given. I had my injection on my left arm, the enlarged lymph node is on my right side.  Follow up is scheduled for December 2021.
Pt saw Dr on Sat 2-11-12. Dr reported events to me today. Bright red rash encircled injection site on RT, went up thigh to groin area, also had large red patch on neck and axilla.
FLASHING LIGHTS IN LEFT EYE; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced flashing lights in left eye. On 2021, the subject experienced body aches. On 2021, the subject experienced chills. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flashing lights in left eye, and the outcome of chills, fever and body aches was not reported. This report was non-serious.
Information has been received from a consumer (retired nurse) concerning her male husband with heart disease, hypertension, kidney stones and an allergy to Septra and a history of cardiac artery bypass graft surgery, lumbar laminectomy and cholecystectomy who on 24-Oct-2007 was vaccinated with "1 injection" dose of Zostavax.  Concomitant therapy included atenolol (manufacturer unknown), allopurinol (manufacturer unknown). lorazepam, simvastatin (manufacturer unknown), aspirin, omeprazole (Prilosec), folic acid, ondansetron hydrochloride (Zofran), gastrointestinal preparations (stool softeners) (unspecified), nitroglycerin, ibuprofen (Advil) and zolpidem tartrate (Ambien CR).  On 28-Nov-2007, post vaccination, the patient developed hemolytic anemia.  The following are a list of the patient's hemoglobins (Hgb) and hematocrits (Hct) reported:  10-Jan-2007 Hgb - 12.2 and Hct - 40.4.  On 05-May-2007 Hgb - 13.6 and Hct - 43.0.  On 31-Oct-2007 the patient went to the physician for "some type of complaint".  Hgb - 10.2 and Hct - 35.0.  On 28-Nov-2007 Hgb - 9.9 and Hct (unknown).  The patient complained of "extreme weakness and having to use great effort even to do personal hygiene".  The patient was started on prednisone 30mg twice a day.  On 07-Dec-2007 the patient's Hgb - 9.1 and Hct - 31.0.  Per the reporter the patient's physician requested to see the patient in his office.  Additional labs were performed.  Antinuclear antibody test, rheumatoid factor, COOMBs test and sedimentation rate were all positive.  A heme test of the stool was negative.  It was reported the physician stated "there is some problem with his immune system".  On 03-Jan-2008 Hgb - 11.9 and Hct - 39.0.  The patient also saw a hematologist.  Additional lab work was performed and the results are pending.  The patient is currently tapering the prednisone dose as follows:  Pednisone 30 mg twice a day for 1 week, the 40 mg twice a day for 1 week, then 40 mg in the am and 20 mg in the pm for 1 week, then 20 mg in the am and 20 mg in the pm for 1 week.  The patient is currently taking 20 mg in the am and nothing in the pm for 1 week and then will discontinue prednisone.  A few days after starting prednisone the nurse reported her husband began to feel better again but since he started to taper the prednisone he has reported less energy.  At the time of the report the patient's status was recovering.  A product quality complaint was not involved.  The adverse events reported were considered to be disabling.  Additional information has been requested.
Red, itchy knot area larger than half dollar that appeared on arm 8 days after vaccination. Encouraged to watch for other s/s, call 911 if needed, watch for red streaking and fever. Encouraged to call doctor to report reaction as well.
approx. 4 hours after vaccine I had pain, red rash (not itchy just painful), rash began to spread in a circle around the injection site and my arm began to tingle/go numb. I put a warm compress on my arm and neck and the tingling/numbness improved. by 10pm pain began to worsen. following day: 3am woke up with severe chills and uncontrollable shaking. After getting some sleep I woke around 8am to more chills, a fever, nausea, severe pain in arm, muscle and joint pain.  Tylenol did help with pain, but chills and fever did not subside until later in day. My fever got worse - didn't go away until 11pm.  I had a severe headache and ear pain as well. Muscle and joint pain (wrists and ankles) continued off for 3 days
I would like to report what happened with all the facts.  One week after I had vaccine, I had very serious nose bleeding in the morning. I said very serious because I felt it cannot stop by itself. I called 911 and went to ER. First time, I use 911 and ER. All previous nose bleeding is very minor and it will stop in a minute. But this time, I just felt the blood just pouring into my mouth. So I was scared and  asked my wife called 911. After 2-3 hours, the bleeding stopped and I back home. To be cautious, I made an appointment with family doctor on next day (24th). But the bleeding happened again in the evening ( cannot remember exactly, but around 9pm). This time I just used the clipper for my nose and it took another 2 hours for the bleeding to stop. I had a very rough night while sitting on bed and had very little sleep. The next morning (24th), the bleeding come back after I used the restroom. The same feeling as the two bleeding before. I rushed to doctor's office even not my appointment yet. The family doctor said he cannot do anything since he cannot observe the place of blooding and he does not have instrument needed. I was referred to a specialist. And luckily I had the same day appointment. We rushed there and after roughly several hours waiting, I was the specialist and finally he did the treatment. Since then, my nose is ok and no serious bleeding again.  After I saw the side effects of JJ vaccine, I think it is better for me to report you what happened. I strongly suspect that my serious bleeding was caused by the drop of platelet which was side effect of the vaccine. I will have one blood work today. And will let you know results if you are interested. Again, I never had such serious bleeding before and that is the reason for my suspect.  All the best
suspected vaccination failure; received 2 of the Shringex / still had Shingles TWICE this year; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, received dose 2 of Shingrix and still had shingles twice a year, which led to vaccination failure. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for shingles were not provided.
for 36 hours after vaccine:  starting immediately: sore arm in which injection occurred starting 4-6 hours after:  fever, chills, soreness, and body aches extreme vaginal soreness and pain heavy menstrual-like cramping (but did not menstruate)
difficulties with breathing; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored Program. A female patient of an unspecified age received the first dose of bnt162b2, via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Lung disease and a heart condition. The patient's concomitant medications were not reported. The patient started to experience difficulties with breathing on Apr2021, used nebulizer and took medication like Ventolin and few more other medicines. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
salmon colored rash on her arm which itches; Covid Arm in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (salmon colored rash on her arm which itches) and VACCINATION SITE REACTION (Covid Arm in her left arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced RASH PRURITIC (salmon colored rash on her arm which itches) and VACCINATION SITE REACTION (Covid Arm in her left arm). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE at a dose of 0.1 percent. At the time of the report, RASH PRURITIC (salmon colored rash on her arm which itches) had not resolved and VACCINATION SITE REACTION (Covid Arm in her left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant information was not provided.  Patient received the Moderna Covid-19 vaccine in her left arm shoulder deltoid muscle.  The patient experienced COVID arm in her left arm. The patient specifically reported a salmon colored rash on her arm which itches. The rash got better and then it was flares up again. The patient experienced no other side effects.  Patient went to see her primary care physician and a dermatologist. The dermatologist prescribed Allegra and Triamcinolone acetonide ointment 0.1percentage.  Patient planned to see a Rheumatologist.   This case was linked to MOD-2022-485635, MOD-2022-485647 (Patient Link).
Very large area of redness/swelling (measuring approx 10 cm x 8 cm).  Small blister just above site of redness.
heart rate of 40; dizzy; really tired; This is a spontaneous report from a non-contactable consumer (patient's friend). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was having some symptoms that wanted to check out. On Dec2020, he was really dizzy, he was really tired, and he had a heart rate of 40. No questions, they just want to make sure that he was not going to die. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received vaccine at 2:44 pm, she complained of dizziness within 7 minutes of vaccine (Novartis - preservative free - single dose syringe). B/P 100/60, respiration's regular, red blotches seen upper chest and neck; BENADRYL given IM to right upper arm. She began shaking and felt unsteady. 911 called sent to local emergency room of hospital.
The day following each vaccine the pt got red, itchy patches of skin on lower legs and after Hep B #3 he also got these patches on arms and waistband with swelling of lower legs after day 3.
The patient had excruciating knee pain a few days after the second dose. She got relief after five days of taking a supplement (Arthrozene). She is now pain free and has some weakness. She was not seen by a doctor then.
PATIENT STATES SHE SUFFERED SEVERE CHILLS AND ALL-OVER BODY PAIN STARTING THE DAY AFTER RECEIVING THE VACCINE.  ON THE THIRD DAY SHE REPORTED FEELING BETTER BUT STILL TIRED FROM LACK OF REST THE PREVIOUS NIGHT.