chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of neck tingling in a male subject aged between 30 and 39 years old who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject received no vaccines other than Flulaval on 17 October 2007.  On 17 October 2007 at 11:30 the subject received unspecified dose of Flulaval (0.5 mL; unknown, left arm).  On 17 October 2007 at 12:35 p.m., within 65 minutes of vaccination with Flulaval, the subject returned to report a "strange sensation" described as tingling of the neck on the left side, and a sensation of warmth running down the left leg.  The site of vaccination reportedly looked "normal".  At the time of reporting the events were unresolved.  The reporting health care professional is employed by an agency that provides influenza vaccines to clients at the clients' sites; the vaccine that is the subject of this report was administered at an attorney's office.  Follow-up was received by the healthcare professional on 02 November 2007.  At the time of reporting, the subject was 31 years of age.  The subject had previously received influenza vaccines and had not experienced any reactions following prior influenza vaccinations.  The subject had no history of adverse events following previous vaccinations.  Medical history included a possible shellfish allergy.  The healthcare professional reported that, after considerable interviewing, the subject noted that he has experienced these same sensations (tingling of the neck on the left side, and a sensation of warmth running down the left leg) in the past after eating shellfish.  The events resolved on 17 October 2007.  The healthcare professional considered the events to be related to vaccination with Flulaval.
BLOOD IN VOMIT (VOMITING); ASTHMA (PULSE 130, BLOOD OXYGEN DOWN TO 97); TINGLING ALL OVER BODY; BODY WENT NUMB; FEVER; NAUSEA; This spontaneous report received from a consumer 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) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on Left Deltoid around 10-12 p.m. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the patient experienced blood in vomit (vomiting), asthma (pulse 130, blood oxygen down to 97), tingling all over body, body went numb, fever, nausea. After vaccination It was reported that patient experienced vomiting along with some blood in vomit, pulse at 130 and blood oxygen went down to 97 along with that started experiencing asthma. The consumer had to visit to emergency room with patient. Laboratory data included: Body temperature (NR: not provided) 102 F, Oxygen saturation low (NR: not provided) 97 (units unspecified), and Pulse rate (NR: not provided) 130 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, blood in vomit (vomiting), tingling all over body, fever, asthma (pulse 130, blood oxygen down to 97) and body went numb was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210346726-covid-19 vaccine ad26.cov2.s-Blood in vomit. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
I woke with a sore arm, but also every joint was in severe pain, and I did nothing the day after I got this injection.  I was in bed most of the day.
Mom reports Friday evening 03/18/2016 that a fever started and continued through Saturday evening reporting it was never higher than 101. She reported that she was able to manage it with Tylenol. Bumpy red rash also occurred and is more prominent on the right side from the hip to just above the knee.  Speaking to mom this morning 03/23/2016 she reports that the rash has neither increased nor decreased and that you can feel it more than you can see it.
Round festered up spot 3 inches in diameter directly at injection site. Got a puss pocket then spread to other locations. Biopsy at site cleared infected area treated and discharged.
59 y/o female, c/o headache, mild nose bleed, blurry vision on both eyes and left eye redness. Pt. Stated her blood sugar this am was 200?s, did not take am meds and insulin, stated ?because I am scared I will be taking the vaccine.? last insulin taken evening of 3/31/21 Lantus 50units.  Paramedics came to check VSS, blood sugar above 400?s. Advised further eval, sent to Hospital via ambulance.
103 farenhieght degree fever that won't break with Tylonel or Ibuprofen. Extreme muscle pain all over my body. Nauseous. Can't sleep from so much pain and fever.
About 10 minutes after getting Flu shot he began perspiring and stated just over all did not feel well. He received Epinephrine and Benadryl solumedrol. ER physician states could have been allergic reaction but could also have had a bradycardia dysrhythmia. ER summary states nausea, dyspnea, abnormal vision. msv
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Sometime in July 2015 and August 2015 (specific date unavailable) these patients received doses of improperly stored RECOMBIVAX HB (dose was not reported, lot # K024552, expiration date 22-OCT-2016). No symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
chilled; cold; slight temperature of 100.7; Pain in my arm about 3 hours after first receiving injection and am currently achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 09:45 (Lot number: 9R8733) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); "gallbladder issues" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: seasonal allergies" (unspecified if ongoing); "known allergies: dairy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. Vaccination history included: Bnt162b2 (dose number=1, product=COVID 19, brand=Pfizer, lot number=EN6207, administration date=10Mar2021, administration time=03:15 PM, vaccine location=Right arm), administration date: 10Mar2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 01Apr2021 02:00, outcome "not recovered", described as "chilled"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021 12:45, outcome "not recovered", described as "Pain in my arm about 3 hours after first receiving injection and am currently achy"; NASOPHARYNGITIS (non-serious) with onset 01Apr2021 02:00, outcome "not recovered", described as "cold"; BODY TEMPERATURE INCREASED (non-serious) with onset 01Apr2021 02:00, outcome "not recovered", described as "slight temperature of 100.7". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pain in extremity, nasopharyngitis, body temperature increased.  Additional information: Other medications in two weeks was Stone blaster - herbs for gallbladder. 01Apr, at night was cold. Wore a sweatshirt to bed, have been chilled all day. Took my temperature about12 pm -slight temperature of 100.7. Pain in my arm about 3 hours after first receiving injection and am currently achy. The patient did not have covid prior to vaccination. The patient was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
ANTIBODY LEVELS WERE DOWN; RECEIVED 2 SHOTS OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced antibody levels were down, and received 2 shots of the janssen covid-19 vaccine. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) antibody levels were down. The action taken with covid-19 vaccine was not applicable. The outcome of the antibody levels were down and received 2 shots of the janssen covid-19 vaccine was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000193034 The suspected product quality complaint has been confirmed to be voided based on the evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Very severe altered mental status:  confusion, brain fog, loss of concentration, disorientation,;loss of balance, nervousness ;  Severe diarrhea;  severe joint pain; muscle pain;  weakness, fatigue;  heavy vaginal bleeding (1 1/2 days) ,   Lasted 3 1/2 days, but brain fog  has lingered for weeks.
One day post vax the pt experienced redness, swelling and warm to touch to the right arm. The size of the redness was approximately the size of a hand. The pt returned to the health department. The pt was instructed to use heat and ice on arm. The pt then saw a PA and was put on Zyrtec for 8 days. On 3/22/01 the pt states that she is better and the symptoms are better.
Patient states that he had "EXTREME whole body shakes( not chills), Nausea and vomited 1 small amount
I was getting sicker and sicker with uncontrollable coughing. I was prescribed a Ventolin inhaler and Advair diskus to control asthmatic symptoms, though I don't have asthma. It progressively got worse and turned into pneumonia by November 2009.
certain food as they taste bad and smell weird. Do not eat banana any more some food taste like dish soap smell.; certain foods taste very bad and I no longer eat/enjoy them; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2021 (Lot number: EW0161) at the age of 76 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 ({product=COVID 19, brand=Pfizer , lot number=ER8730 , administration date=03Mar2021 , dose number=1 , vaccine location=Left arm), administration date: 03Mar2021, for covid 19 immunization. The following information was reported: TASTE DISORDER (non-serious) with onset May2021, outcome "not recovered", described as "certain foods taste very bad and I no longer eat/enjoy them"; PAROSMIA (non-serious), outcome "unknown", described as "certain food as they taste bad and smell weird. Do not eat banana any more some food taste like dish soap smell.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of taste disorder.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The taste of unrelated foods have become objectionable - no longer pleasant to eat. She lost her sense of taste when she contracted Covid but it came back about 80% before she had the vaccine. Now certain foods taste very bad and she no longer eat/enjoy them. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Known allergies: I pro.  Follow-up attempts are completed. No further information is expected.
pt recvd vax & loss strength in right hand; peripheral neurophathy rt upper extremity at flu shot inject site;
Patient felt dizzy, hot and light headed immediately following vaccination. He lied on the floor for about 5 minutes and had some water. He sat up since he was feeling better. He then became nauseated and lied back down. After another 5 minutes he was feeling better. He slowly went from lying to standing to walking. He sat outside for another 5 minutes and felt back to normal.
This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Foggy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Foggy). On 30-Dec-2020, PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Foggy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
Allergic reaction throat tightness, light-headed and dizziness, tightening in chest.
Received Pfizer as my primary series in January 2021. Received Moderna booster on 2/28/22.  The following 2 periods were extremely heavy, bordering on hemorrhage. The 3rd period (in May) remained heavy, but not as heavy as the two previous, but still had not returned to baseline. I am scheduled for a uterine ablation to prevent future heavy bleeding.  This procedure will include general anesthesia.  However, I cannot rule out that this procedure may be unnecessary as the bleeding was due to the booster.
At 2:57 PM, patient received immunizations. Instructed to wait 15 minutes in lobby and at approx. 3:20 PM, patient stated she wasn't feeling well, visual changes, and felt light-headed and nauseous. Patient laid on exam table with feet elevated, Vitals, right arm, sitting: 93/59, HR 56, Spo2% 99 and in no respiratory distress. Patient rested, given snack and drink, after approximately 20 minutes, patient stated she felt better. Vitals while sitting, right arm, BP: 111/74, HR 83, Spo2% 100
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by the physician, for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Extreme soreness in arm extending 2.5 inches below shoulder (injection site) lasting about 2 weeks. Patient describes difficulty with normal activities due to soreness
miscarried; patient was pregnant at the time of the vaccine; patient was pregnant at the time of the vaccine; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration at right arm, at the age of 29-year-old, on 30Jan2021 02:00 AM, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. The patient had no known allergies. The patient did not receive any other vaccine in four weeks or any other medications in two weeks. The patient was pregnant at the time of the vaccine 30Jan2021 and miscarried on 01Feb2021. LMP was provided as 01Jan2021, gestation period was reported as 4 weeks and due date was provided as 08Oct2021. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the event miscarried. Outcome of the event miscarried was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, a possible contributory role of suspect vaccine BNT162B2 in triggering the misarrange in this 29-year-old pregnant patient cannot be excluded. Additional information regarding relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.      Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received included no new information
Local reaction at injection site, soreness, swelling, warmth over a 4 day period.
Hungry; Thirsty; high with energy; couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Hungry), THIRST (Thirsty), ENERGY INCREASED (high with energy ) and INITIAL INSOMNIA (couldn't sleep ) 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 Type 2 diabetes mellitus (type 2 diabetic).    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced HUNGER (Hungry), THIRST (Thirsty), ENERGY INCREASED (high with energy ) and INITIAL INSOMNIA (couldn't sleep ). At the time of the report, HUNGER (Hungry), THIRST (Thirsty), ENERGY INCREASED (high with energy ) and INITIAL INSOMNIA (couldn't sleep ) 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 case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 20-year-old female patient who received lamotrigine tablet (batch number Unknown, expiry date unknown) for bipolar disorder. Co-suspect products included Flu Seasonal QIV Dresden. Concomitant products included ALLEGRA D. On 14th November 2017, the patient started lamotrigine (oral) 25 mg once daily. In October 2017, the patient received Flu Seasonal QIV Dresden. In November 2017, less than a mother after starting lamotrigine and less than a year after receiving Flu Seasonal QIV Dresden, the patient experienced influenza-like symptoms, fever, swollen glands, headache, light sensitivity to eye, pain, aphthous stomatitis and sweating. On 30th November 2017, the patient experienced diarrhea. On an unknown date, the patient experienced viral infection. Lamotrigine was continued with no change. On an unknown date, the outcome of the influenza-like symptoms and viral infection were unknown and the outcome of the fever, swollen glands, headache, light sensitivity to eye, pain, aphthous stomatitis and sweating were not recovered/not resolved and the outcome of the diarrhea was recovered/resolved. The reporter considered the influenza-like symptoms, fever, swollen glands, headache, light sensitivity to eye, pain, aphthous stomatitis, sweating, diarrhea and viral infection to be probably related to lamotrigine and Flu Seasonal QIV Dresden. Additional details were provided as follows: On 30th November 2017, 16 days after receiving Lamotrigine and less than a year after receiving Flu Seasonal QIV Dresden, the patient experienced diarrhea. The patient experienced canker sores in her mouth. The patient was taken to the Emergency room yesterday and a flu test came back negative. They were told it was a viral illness and she was sent home. The caller stated that the symptoms had been getting worse. The patient received a flu shot of unknown brand in October 2017.
Joint pain - current weakness - current lethargic - current pain & swelling at injection site (at least 6 days) pain runs down back of arm when attempting to lift even a pc of paper. MD recommended MOTRIN or ULTRAM (not helping).
18APR94 p/being in sun devel large reddened area @ inject site; later in day felt nauseous; felt awful felt like was going to die; 19APR94 area measured 9cm x 11cm in size w/5cm circle inside that was less reddened; WBC & diff done-nl;
Pt recvd 3rd dose of HEp B vax on 16JUL91 & exp paresthesia in upper extremities & rt lower extremity;
Patient experienced fever and body aches the next day and resolved within 24 hours. Pt then reported arm swelling and redness at the injection site 9 days after vaccine administration.