chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Something odd is going on with toes; Sort of looks like COVID toes, a mild case but not extreme; This is a spontaneous report from a contactable consumer (patient wife). A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9263, as reported), via an unspecified route of administration on 08Feb2021 (Lot Number: EM9809) as dose number unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient wife stated, she was actually going to put patient husband on. It is really his question. We both had the Pfizer COVID-19 vaccine about 2 weeks ago and coincidently, he felt fine and everything still does feel fine but something odd is going on with his toes. And patient know there is something called COVID toes and we looked it up online, that's sort of what it looks like, a mild case but not extreme. But really our question is related to, could this be a side effect from the vaccine. I will put him on. When requested for permission to probe questions for a safety report, patient stated not sure what questions was answering, what questions are you talking about informed that the questions would be related to demographic details, medical history, patient stated, this is taking way too long. I'll have to call back patient have the number and the option and will call back in a later date. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Localized reaction on the upper outer left arm.  It is red and swollen in circular pattern but not hot to the touch. She is experiencing some itching. No symptoms of hives or difficulty breathing.  Advised her to use ice and ibuprofen for swelling and she may use Benadryl for itch.  Advised her if any symptoms of shortness of breath or the symptoms get worse to go to the ER.
About 6 hours after the shot I began vomiting and had the chills-bad. This lasted all night and into following day
Numbness and tingling in tongue, lips, and bilateral cheeks/face status-post 45 minutes after vaccine
Sever pain in arm, shoulder, neck, ear.  Difficulty breathing, chest pain.  Sudden severe pain and inflammation throughout body that has not resolved after months of discomfort.  Sudden loss of hair.
The patient presented back to the pharmacy on 11/1/2018, 2 days after receiving the vaccine. She had a palm sized slightly raised area on redness on her left arm above the elbow. She reported itching but no pain. She purchased hydrocortisone 1% cream to treat the area topically. Symptom onset was about 24 hours after the vaccination and progressed over the following 24 hours.
Patient received Dose #2 of JYNNEOS. Several minutes after vaccination, patient reported to me that he needed to lie down on the floor. He was feeling faint and dizzy. He reported history of faintness and dizziness with injections and blood draws (not disclosed during pre-vaccination assessment).  1820: Patient placed supine on floor. BP 87/68. HR 52. O2 98%. RR 20. 1826: BP 76/55. HR 56. O2 100%. RR 18. 1834: BP 110/93. HR 54. 02 100%. RR 16. Patient placed back on chair. Patient verbalized feeling much better.  Patient held in observation station for an additional 30 minutes. Water given. Patient stated he felt much better and such reaction is typical for him. I was satisfied to release him seeing VS trend and AOX4 sans gross neurological deficit.
Patient went to sleep early with lethargy on 7/19/21 @ 7pm. Woke up on 7/20/21 @ 7am with altered mental status (AMS), not responding to verbal commands, non-verbal. Transported to nearest ER via 911. Patient was delirious and agitated, Ativan and prochlorperazine administered, placed on restraints. Developed fever (tmax 102.5), and placed on sepsis pathway. Treated with cefipime, vancomycin, acyclovir, and Tylenol. Borderline low K+, treated with KCl. 48 hours after onset of AMS, pt became oriented and stable; transferred to in-network hospital. **** Discharge diagnosis of encephalitis, unknown cause.
I got out of bed at my normal time of 5 AM and proceeded to the bathroom to urinate, feeling fine. Just before starting to urinate, I started sweating profusely and shaking and so turned around and sat down on the toilet. I then sweat even more as if I was in the shower, and shook violently. I then started feeling very nauseous, but I was shaking so badly that I had to very carefully  hold the toilet  to turn around to kneel down in front of the toilet. I heaved a number of times, but nothing came up. I finally stopped shaking and sat on the floor in front of the toilet for a while, and the sweating got less. After a short time, I got up and walked slowly to a recliner, about 30' away. The nausea had gone away by then and the sweating had subsided. My wife brought me blanket and I rested till 7:30 AM.  I had a cup of coffee about 8 AM, and a bowel of cereal at 9 AM. I have been fine ever since then, no more reactions, thank goodness. That one was horrible.
Pt had intrauterine fetal demise at 27 weeks and 3 days gestation. (11/21/05).
infection; CBC/16.7/high; CRP/11.80/high; inflammation; felt that existing bump on my neck is more bigger/bump on top of it; difficulty moving my neck/ head area; fatigue; fever; body aches/pain; felt more swollen lymph nodes at my jaw area & my back neck area/bump/ lymph node in my neck; stiffness; cyst; This is a spontaneous report from a contactable consumer (patient). A 39-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in arm right (also reported as R upper arm) on 08Feb2021 18:00 (Lot Number: EM9810) as dose 2, single (at the age of 39 years old) for COVID-19 immunisation. Medical history and family history included ongoing diabetes. Concomitant medications included metformin and glimepiride taken for diabetes mellitus; ascorbic acid (VIT C), vit d [vitamin d nos] (VIT D [VITAMIN D NOS]) and fish oil taken for supplements; all from an unspecified start date and ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular administered in right (R) upper arm on 18Jan2021 06:00 pm (Lot number: EL3247) as dose 1, single (at the age of 39 years old) for COVID-19 immunisation and experienced body aches, swollen lymph node, mild discomfort, 4/10 pain, bump on neck. It was reported that comes the second dose, after like 17 hours (09Feb2021 11:00), patient felt so fatigue, fever, body aches and "felt that the existing bump in my neck is more bigger and felt a marble like cyst/ bump on top of it. Felt more swollen lymph nodes at my jaw area & my back neck area (also reported as back of the neck area). Felt pain, stiffness and had some difficulty moving my neck/ head area so went to the hospital for a check". Patient was advised to take round the clock TYLENOL. Stated that "Till now the bump/ lymph node in my neck remains". The patient underwent lab tests and procedures on 04May2021 which included c-reactive protein (CRP): 11.80 (high, consider since of inflammation/ infection) and complete blood count (CBC): 16.7 (high). Therapeutic measures were taken as a result of body aches/pain, stiffness, difficulty moving my neck/ head area. The outcome of the event "felt that existing bump on my neck is more bigger/bump on top of it" and "felt more swollen lymph nodes at my jaw area & my back neck area/bump/ lymph node in my neck" was not recovered while unknown for the other events.  The patient provided information regarding the reported adverse events with the use of the product. It was considered that Pfizer product had a causal effect to the adverse event.  Follow-up attempts are completed. No further information is expected.
headache; weird flushing; hot flashes; flushing face; passed menopause, but this is what it felt like; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (weird flushing), HOT FLUSH (hot flashes), FLUSHING (flushing face), FEELING ABNORMAL (passed menopause, but this is what it felt like) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02UM20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced FLUSHING (weird flushing), HOT FLUSH (hot flashes), FLUSHING (flushing face) and FEELING ABNORMAL (passed menopause, but this is what it felt like). On 02-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, FLUSHING (weird flushing), HOT FLUSH (hot flashes), FLUSHING (flushing face), FEELING ABNORMAL (passed menopause, but this is what it felt like) and HEADACHE (headache) outcome was unknown.        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 medication details was reported.
Moderate soreness/redness and slight itching noticed at injection site within 24 hours after receiving injection but I did not do a visual inspection until several days later when these symptoms became irritating and troublesome. I outlined the area of irritation with a marking pen and when I inspected it about 24 hours later, the erythema had increased to cover almost all the distance from shoulder to elbow but remained confined largely to the dorsal aspect of my upper arm. No soreness remains but itchiness continues and this is. I have taken liquid diphenhydramine at bedtime for the last three nights and used a topical anti-itch cream occasionally but have avoided any other treatment or medications. Itching and redness continue and expansion of the afflicted area continue 11 days post injection.
blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; clammy and lethargic; clammy and lethargic; respiratory rate was 8; This is a spontaneous report from a contactable nurse (husband). A 65-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EW0153), intramuscular, administered in Arm Right on 08Apr2021 12:30 (received at 65-years-old) as SINGLE DOSE for COVID-19 immunization. The vaccine was administered at Administration facility. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history included diabetes, hypertension, depression, and known allergy to sulfa. The patient was not pregnant. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported; and BP (blood pressure) meds, ECT therapy. The reporter stated that he and his wife came around at 12:30 (08Apr2021) and got her first dose of COVID vaccine. They waited in observation for 15 minutes. They went to go eat after the shot and he stopped to get gas and his wife stated "I don't feel right and I am breaking out in a sweat." So, he just came back over here to the vaccine site. When nurse approached the car, the patient in the passenger seat appeared diaphoretic, clammy and lethargic. She was responsive oriented to four spheres and denied pain. She said "I just don't feel right." Pulse rate was 63, respiratory rate was 8, BP was 120/60 O2 saturation 97%. The patient stated "I am a diabetic and blood sugar was 140 this am." She is on insulin and BP meds her spouse stated, Advanced EMT on site checking vitals. Epi 0.3 was given in right thigh per EMT and patient was transported to ER via ambulance. All adverse events started on 08Apr2021 01:15 PM. The adverse events resulted in Emergency room/department or urgent care. The patient received corrective treatment for the reported adverse events. Outcome of the events was recovering. The patient had no COVID prior to administration of bnt162b2 and was not tested for COVID post vaccination.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events 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 Committees and Investigators, as appropriate.
Dizziness started after 9-10 days of receiving 2nd shot which is not going away till today. PL help what should I do to cure it. Thank you.
Pt developed intussusception and had surgery on 4/11/12. Pt still hospitalized currently.
Anaphylaxis, rash, wheezing, mild difficulty breathing. Recovered completely with steroids, Benadryl, etc. Has since had second Gardasil, no problems.
arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm is sore). At the time of the report, PAIN IN EXTREMITY (arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported
Patient is 4 years and 8 months old, Dad thought patient was 5 years old already and wrote on consent form he was 5 years old. No adverse reactions but let Dad know that we could not administer dose 2 until patient turns 5 years old
supra clavicular adenopathy ( 6 by 8 cm) matted nodes occurring w/ axillary adenopathy 7 days post subvirian flu vax
itching on her arm like someone bit her; arm is hot; arm is raised; arm is red at about 3 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on her arm like someone bit her), FEELING HOT (arm is hot), PERIPHERAL SWELLING (arm is raised) and ERYTHEMA (arm is red at about 3 inches in diameter) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PRURITUS (itching on her arm like someone bit her), FEELING HOT (arm is hot), PERIPHERAL SWELLING (arm is raised) and ERYTHEMA (arm is red at about 3 inches in diameter). At the time of the report, PRURITUS (itching on her arm like someone bit her), FEELING HOT (arm is hot), PERIPHERAL SWELLING (arm is raised) and ERYTHEMA (arm is red at about 3 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
sudden itching / it was so, so itchy; shaking; night she was chilling; feels tired; very bright rash around the injection site /oval rash around the injection site/white bumps started growing from inside/3-4 inches rash around the injection site; rash in her hands was very bright. The rash was all over the arms and elbows/rash went down to her arms, elbow and wrist/ rash all over the body it was so weird; feels kind of scared / she was in panic / she was so scared; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (sudden itching / it was so, so itchy), FEAR (feels kind of scared / she was in panic / she was so scared), TREMOR (shaking), RASH (rash in her hands was very bright. The rash was all over the arms and elbows/rash went down to her arms, elbow and wrist/ rash all over the body it was so weird) and CHILLS (night she was chilling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included AMLODIPINE for Blood pressure.    On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2022, the patient experienced RASH (rash in her hands was very bright. The rash was all over the arms and elbows/rash went down to her arms, elbow and wrist/ rash all over the body it was so weird) and VACCINATION SITE RASH (very bright rash around the injection site /oval rash around the injection site/white bumps started growing from inside/3-4 inches rash around the injection site). On 15-Jan-2022, the patient experienced PRURITUS (sudden itching / it was so, so itchy), TREMOR (shaking), CHILLS (night she was chilling) and FATIGUE (feels tired). In January 2022, the patient experienced FEAR (feels kind of scared / she was in panic / she was so scared). On 11-Jan-2022, VACCINATION SITE RASH (very bright rash around the injection site /oval rash around the injection site/white bumps started growing from inside/3-4 inches rash around the injection site) had resolved. At the time of the report, PRURITUS (sudden itching / it was so, so itchy), FEAR (feels kind of scared / she was in panic / she was so scared), TREMOR (shaking), RASH (rash in her hands was very bright. The rash was all over the arms and elbows/rash went down to her arms, elbow and wrist/ rash all over the body it was so weird), CHILLS (night she was chilling) and FATIGUE (feels tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: temperature of 95 temperature of 95°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment included allergy pills and antihistamine. Patient visited the hospital and was told that the reactions would go away.
seizure activity taken by ambulance to hospital 18 hours after vaccine given.  Patient has no previous events of seizures ever.  5/4/09 MR received for 2 ER visits 11/20/08 and 11/21/08 with DX: Seizure.  Pt with no PMH found unresponsive at school with seizure activity.  Initially found to be post-ictal on arrival by EMS andransported. Continued seizure activity of shaking all over in EMS. Pt unresponsive to painful stim. Upon arrival to ER pt crying and yelling, tachycardic, now drawing back from pain.  Later to baseline and d/c. Returned 11/21/08 with c/o multiple episodes of seizure at home. Also c/o h/a.  PE WNL by arrival. D/C for outpt f/u. 5/12/09 Neuro consult received dated 2/17/09 with Impression: Hx c/w Partial Complex Epilepsy of the left frontal or temporal lobe.. Pt seen for eval of ?epilepsy and headaches. Pt had 2 spells, one in april 2008 where pt passed out and fell while running.  Afterwards, unable to speak x 1 hr then crying and sleepy. In 11/2008 episode of seizure-like activity as above. Started on Trileptal following EEG with a "spark on it".  To be sent for repeat EEG. ENT consult for chronic mastoidititis/sinusitis. PE tube placed 2' to R effusion.
SORE LEFT ARM; FEVER; NAUSEA; LIGHT HEADACHE; 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, and batch number were not reported) dose was not reported, administered on 14-MAR-2021 09:00 on left arm for prophylactic vaccination. The batch number was not reported, and is requested. No concomitant medications were reported. On 14-MAR-2021 17:00, the subject experienced light headache. On 14-MAR-2021 18:30, the subject experienced fever. On 14-MAR-2021 18:30, the subject experienced nausea. On 15-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.3 F. On an unspecified date, the subject experienced sore left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 15-MAR-2021 08:00, and the outcome of light headache, nausea and sore left arm was not reported. This report was non-serious.
Chills, Arm ache, vomiting, feeling like chest was heavy hard to breath, high fever, body aches, stomach hurt in upper area.
COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies codeine", notes: known allergies codeine. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 06Aug2022, outcome "unknown", described as "COVID-19"; COVID-19 (medically significant) with onset 06Aug2022, outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Aug2022) Positive; (20Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid. Clinical course: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was unknown. The patient previously received a COVID-19 Vaccine. Adverse event: Rebound COVID positive, initially positive 06Aug and treated with paxlovid x 5 days, symptoms restarted 19Aug and tested positive 20Aug  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19 cannot be completely excluded.
Shot received 9/4/21 at 3:00pm, approx. 8:30 pm malaise & fever began, along with headache. By 9/5/21 fever increased to 102° and sustained for most of the day despite Tylenol 1000 mg every 4 hours, fever maxed at 102.8°. On 9/6/21 increased swelling of the arm with the injection site was noted and a red rash, as of today 9/8/21, the rash is still spreading with tightness and pain but no itching.  Malaise, chills and fever have subsided but return in waves, usually in the evening.  Some chest pressure has occurred.  Recovery is on-going.