chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (the same as when I have had radioactive dye),    during my 15 minutes of observation my hands and feet were cold and sweaty and I felt a little shaky.  I waited 20 minutes and went to the restroom and had diarrhea (very rare for me).  I went to my car and looked in the mirror and my face was bright red and  the whites of my eyes were red and my eyes were glassy.  I went back in to the observation area and was given oral Benadryl. and monitored for 45 minutes.  Right after I took the Benadryl my throat felt itchy (not sore - itchy).  My blood pressure was 157/62 when I first sat down but came down to 130/ 60 by the time I was sent home.  My bp is normally about 106/60.   I was really tired at home for the rest of the day so went to be early.  The next day I felt fine and my arm was only slightly sore.  The doctor at the immunization clinic told me not to get the 2nd shot.  I called my GP,  and he too told me not to get the 2nd COVID shot and wait until more information has come out about adverse reactions to the vaccine.  I did not have any difficulty breathing.  I don 't know if the redness on my face went down my neck to my chest.  I didn't look.  I did not have a fever.
jerking & staring spells-regularly;(head goes back & then forward);temp-no regularly
Maculopapular / acneiform eruption at trunk, back and arms numbering approx 20 lesions.
Elevated blood sugars/200-300 with little to no response from insulin corrections; violently ill with exhaustive puking; violently ill with exhaustive puking; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6240), via an unspecified route of administration, administered in arm right on 04Mar2021 at 10:30 (at the age of 51-years-old) as single dose for covid-19 immunisation. Medical history included type 1 diabetes mellitus. Concomitant medication included insulin aspart (FIASP). The patient did not receive any other vaccine within four weeks. Patient had no known allergies. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9266), dose 1, administered in arm left (at age of 51-year-old) on 11Feb2021 at 10:45 for covid-19 immunisation. There was no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 06Mar2021 at 20:00, the patient experienced elevated blood sugars/200-300 with little to no response from insulin corrections, violently ill with exhaustive puking. The patient stated that elevated blood sugars for 48 hours, starting about 6 hours after vaccine. Sugars from 200-300 with little to no response from insulin corrections. Saturday, 06Mar2021 violently ill with exhaustive puking. Lasted for approximately 2.5 hours. The patient underwent lab tests and procedures which included blood glucose elevated on 06Mar2021 (elevated blood sugars for 48 hours, starting about 6 hours after vaccine. Sugars from 200-300 with little to no response from insulin corrections). The outcome of the events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), via an unspecified route of administration in right arm, on 16Jan2021 14:45 at a single dose for covid-19 immunization. Medical history included stage 3 breast cancer, tall cell thyroid cancer, chronic lymphocytic leukemia, diabetes, and known allergies: penicillin. The patient's concomitant medications were not reported. The patient is not pregnant. The patient had no other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 17Jan2021 0800, the patient experienced minor pain at injection site and mild headache. Events were not treated. Outcome of the events was recovering.
This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated subcutaneously in the unspecified arm with the one vial of ZOSTAVAX (lot # and expiry date were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced itchiness at the injection site. The patient did not seek medical attention and no treatment was given for the event. On an unknown date, the itchiness "went away" and the patient recovered. The relatedness between the event and the ZOSTAVAX was not reported. Additional information has been requested.
Patient was given an expired dose of the COVID-19 vaccine. Vaccine expired on 7/16/22 at 2000 and the dose was administered by the RN the following day 7/17/22 at 12:57. MD was consulted, referred to CDC's "Interim Clinical Considerations for Use of COVID-19 Vaccines: Appendices, References, and Previous Updates" to determine that patient should receive another dose of the vaccine. No apparent side effects from the vaccine, but rather an error in administration.
High fever 104-105; severe coughing followed by lethargy, then 2ndary infection (pneumonia) and respiratory distress.  Since then has had chronic recurrent respiratory infections and pneumonia 5 additional times; suffers from asthma 10/2/08-records received for DOS 3/22/05-C/O new onset RAD-admitted 3/19 treated with nebulizers. Now  C/O wheezing, tachypnea, crackles right greater than left, occasional grunting.
Edema of left upper arm. redness, pain of area , it looked a giant sized hive. It is beginning to resolve. Tomorrow will be 1 week since I had the vaccine and it was my second
Red painful lump on arm the size of a baseball that was warm and itchy. Lump went away after 48 hours but itchiness and pain persisted for 5 days.
During a 3/26/2018 well visit, parents described that after the "2y well shots" patient had a few hours of "acting like she was paralyzed and couldn't walk". This resolved the following morning. This occurred during the evening following shots. When I questioned if she was sore and refused to bear weight the parents reiterated "that she acted like she was paralyzed and couldn't walk." Medical treatment was not subsequently sought because of the complete resolution the following morning. There is no further documentation in her chart pertaining to the event until the 3/26/2018 visit. Patient is currently developing normally and is healthy. Parents however refuse further vaccines.
This spontaneous report was received from a physician and refers to three over 75 year old female patients enrolled in ZOSTAVAX testing. No information regarding the patients' medical history, concurrent conditions and concomitant medication was reported. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX, subcutaneous (dose, lot # and expiration date were not provided). On unknown dates (in last 4 years), the patients had very mild cases of shingles even after having ZOSTAVAX. The physician attributed that these cases were mild because of the vaccination and would have expected much worse without having it. The patients recovered from the from the shingles on unknown dates. The outcome of vaccination failure was unknown. The reporter considered the shingles to be not related to ZOSTAVAX. The relatedness between vaccination failure and ZOSTAVAX was unknown. This is one of two reports received from the same source. Additional information is not expected as there was no consent to contact the physician.
This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 29-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the age of 29, via an unspecified route of administration, left arm, on Feb 24, 2021, at 11:00, single dose, for COVID-19 immunization.  Medical history not reported. The patient's concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On Feb 24, 2021, patient experienced numbness in the face (primarily on left-side including lips). The outcome of the events: not recovered. This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Knocked out, could not function; This case was reported by a consumer via other manufacturer and described the occurrence of unconscious in a 70-year-old male patient who received Flu Seasonal QIV Dresden (Flu Seasonal QIV Dresden) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis and leuprorelin acetate (Eligard) for product used for unknown indication.   The subject's past medical history included stent placement. Concurrent medical conditions included malignant neoplasm of prostate. Concomitant products included enzalutamide.   On an unknown date, the patient received Flu Seasonal QIV Dresden, COVID-19 VACCINE and Eligard at an unknown dose and frequency. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden, the patient experienced unconscious (serious criteria GSK medically significant and other: Serious as per reporter). The subject was treated with ticagrelor (Brilinta) and acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the unconscious was recovered/resolved.   It was unknown if the reporter considered the unconscious to be related to Flu Seasonal QIV Dresden.  Additional details were provided are as follows: The patient was enrolled in Astellas sponsored patient support program. The age at vaccination was not reported. The patient did not had known medical history and drug allergy. The patient received a dose of Influenza vaccine, a booster dose of Covid-19 vaccine and  leuprorelin (Eligard) on the same day.  It was reported that the patient was knocked out to where he could not function for almost 3 days. The patient was treated with Enzalutamide 160 mg once day for malignant neoplasm of prostate. The patient asked to pharmacist about taking Ticagrelor (Brilinta) and aspirin 325 mg together and the patient stated that he had stent put in the place and was started on ticagrelor  twice daily and was taking once daily along with aspirin but read aspirin dose might be too high. The pharmacist advised per clinical pharmacist that usually ticagrelor was dosed twice daily (as prescribed) along with aspirin 81 mg and also discuss with MDP who prescribed ticagrelor about decreasing of aspirin dose. The action taken with Enzalutamide, leuprorelin, Covid-19 vaccine and influenza vaccine therapy in response to event was unknown. No lab test information were provided. The sender comment was mentioned as unconsciousness was assessed as serious due to medical significant. It was unknown if the reporter considered the unconscious to be related to leuprorelin and Covid-19 vaccine. Note: Enzalutamide was captured as concomitant as it seems patient was taking it for cancer.
Vaccinated 11/16/2004. Ran fever late PM/ early AM. Cough and runny nose x 1+ weeks. No rash. Eating and drinking okay. Babysitting his bird. Mother gave Motrin. NKA. No previous vaccine reactions per mother. Mother stated child wanted to be carried vs walking. Suggested mom take child to MD if s/s continue.
Injected with pediatric pfizer that was not diluted.  No side effects reported as of the time of this report
I have had a lot of congestion, coughing uncontrollably, injection site was swollen and warm to touch next day, I have a big lump two inches from my left shoulder, runny nose, fever low grade. Went to urgent care was given prescriptions for symptoms, cough medicine bromphen 5-10 ml, ibuprofen for swelling and ice on lump, doxycycline 1 tab twice a day for 7 days, nasal spray, fluticasone 50 mcg, prednisone 20mg 2 tab by mouth for 5 days.
Patient was given Pentacel, Prevnar, Hep B, and Rotateq in the office and around 3 to 4 hours after patient developed a tactile temp and was given Tylenol by her mother.  Subsequently, patient began crying inconsolably and immediately became pale and limp with eyes rolling upward.  Her mother attempted to stick finger down patient's throat to elicit emesis thinking that the Tylenol may have caused the episode.  Patient regained tone and began crying without regurgitation.  The episode lasted less than one minute per mom although exact timing was unclear.  There were no tonic-clonic movements of extremities.  Patient was admitted to Hospital and rule out sepsis work up was done, placed on ceftriaxone until cultures were negative.  Sent home with possible diagnosis of HHE after 3 days.
20 Jan 2021 face and arms reddening and burning about half hour after injection.  21 Jan 2021 fatigue, body aches, dizziness throughout day, went to bed very early no appetite, nauseous 22 Jan 2021 fatigue, body aches, dizziness. Temp 99.3 higher than normal.  No appetite 23 Jan 2021 condition improved.  No symptoms.
Patient said the shot was quick in and out and the tech was wiping what it appeared to be some clear liquid, not blood.  Patient felt she didn't get a full booster dose of 0.25 mL.; Patient said the shot was quick in and out and the tech was wiping what it appeared to be some clear liquid, not blood.  Patient felt she didn't get a full booster dose of 0.25 mL; This spontaneous case was reported by a nurse and describes the occurrence of SYRINGE ISSUE (Patient said the shot was quick in and out and the tech was wiping what it appeared to be some clear liquid, not blood.  Patient felt she didn't get a full booster dose of 0.25 mL.) and UNDERDOSE (Patient said the shot was quick in and out and the tech was wiping what it appeared to be some clear liquid, not blood.  Patient felt she didn't get a full booster dose of 0.25 mL) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21, 011J20 and 011J20) for COVID-19 vaccination.     The patient's past medical history included Stent insertion NOS (3 hearts stents.). Concurrent medical conditions included Coronary artery disease since June 2006, Drug allergy (Allergic to Ciprofloxacin.) and Latex allergy.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced SYRINGE ISSUE (Patient said the shot was quick in and out and the tech was wiping what it appeared to be some clear liquid, not blood.  Patient felt she didn't get a full booster dose of 0.25 mL.) and UNDERDOSE (Patient said the shot was quick in and out and the tech was wiping what it appeared to be some clear liquid, not blood.  Patient felt she didn't get a full booster dose of 0.25 mL). On 02-Nov-2021, SYRINGE ISSUE (Patient said the shot was quick in and out and the tech was wiping what it appeared to be some clear liquid, not blood.  Patient felt she didn't get a full booster dose of 0.25 mL.) and UNDERDOSE (Patient said the shot was quick in and out and the tech was wiping what it appeared to be some clear liquid, not blood.  Patient felt she didn't get a full booster dose of 0.25 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow-up information received contains Significant information Patient demographic details, medical history and suspect drug information updated.
Pt recvd 3 doses of Engerix-B & did not seroconvert; booster dose was administered; no tx was given;
Pt began to have tightness in throat, heart palpitations, nausea after 10 minutes past administration of vaccine. Approx 5 min later noted color change in lips.
64-year-old male who presented to the clinic with complaints of left-sided weakness on his face. He stated when he woke up this morning he noticed that the left side of his mouth drooped and that he could not close his left eye all the way. Yesterday he felt fine. Today he went to work. Patient stated that on 12/18 he got the COVID vaccine. It was on a Friday. The following day he had a headache and he felt flu-like. He stated that those symptoms resolved quickly. He then had the facial weakness today (11 days after the vacciantion). He has not had any fever, sweats, or chills. Patient stated that he had called ask a nurse, and he was advised to hang up and call 911 and go to the emergency room. However, he stated he was an EMT and did not feel that was necessary. He denies headache. He has not had any vision change. He has been eating and drinking well without any difficulty.    PHYSICAL EXAMINATION: General appearance - patient was not in any distress. He was conversant, pleasant and appropriate. HEENT - normal conjunctivae and lids. Sclerae anicteric. Pupils equal and reactive to light. Patient was not able to close his left eyelid. Normal ear canals. TMs are pearly gray with bright light reflex. Neck - supple. No lymphadenopathy. Skin - pink, warm and dry. Neuro - alert and oriented. Deep tendon reflexes 2+ upper and lower extremities with no focal weakness. Normal range of motion. Patient can raise his right eyebrow. Could not raise his left eyebrow. There was impaired eyelid closure on the left; tight closure on the right. Smiling of the face revealed lateralization to the right side. When frowning, he had upper and lower facial paralysis on the left with flattening of the forehead. The patient could not tighten the left side of his mouth.   ASSESSMENT: Bell's palsy.   PLAN: Discussed pathophysiology of Bell's palsy. Advised patient I recommended him to call the number that he got with the information when he received his COVID vaccine. Advised patient that I could not definitively correlate the Bell's palsy with the COVID immunization, but that he can call the number he has to let them know of his symptoms. Discussed treatment options. Since patient woke up with his symptoms this morning, I advised patient that he would have hopefully the best outcome because he would be able to get on the steroid and antiviral soon after developing the symptoms. He is to wear an eye patch to prevent corneal drying or abrasion of the left eye at night. Using Lacri-Lube at night before placing the eye patch and then following up by using artificial tears during the day.   Patient was placed on prednisone 60 mg once a day for 1 week to be taken with food. Valtrex 1,000 mg 3 times a day for 1 week.   Side effects of medication discussed. Handouts were provided. He will follow up with PCP if any changes or concerns. Advised patient that it may take up to 3 weeks before all his symptoms have resolved
Patient noted soreness, swelling and difficulty lifting arm on 3/8/18 which persisted. Developed nausea, vomiting, dizziness and diarrhea over the next few days. Symptoms resolved 3/12/18.
is nursing twins; is nursing twins; slight headache; arm soreness; This is a spontaneous report from a contactable other health professional (patient). This other health professional reported information for both mother and babies. This is the maternal report. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 16Dec2020 11:00 AM at left arm, at single dose for protect as a healthcare provider. Medical history was none. There were no concomitant medications. The patient experienced like arm soreness and slight headache on 16Dec2020, that was pretty much it. Arm soreness started that afternoon on 16Dec2020, she received the vaccine in the morning, at 11am, and maybe like shortly after she noticed, it was there for 1-2 days and went away, and she had since recovered completely. Slight headache started that afternoon on 16Dec2020, and that resolved by the evening, she took Tylenol and it went away. And she was nursing twins, they are about 14 months now. She was aware of the risks of getting it, and the only reason she reported it, is it may be beneficial from a research standpoint, she doubts many lactating mothers, especially twins, are involved. She is personally not concerned, she is probably expecting similar for her second dose, and there is not much research. Her next is dose 06Jan2021. The outcome of the events slight headache was recovered on 16Dec2020, the outcome of the event arm soreness was recovered in Dec2020.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518603 Same reporter/drug, different patient/event. baby case;US-PFIZER INC-2020518630 Same reporter/drug, different patient/event. bady case
Chest tightness and shortness of breath within 20-30 mins of receiving shot on evening of 10/13/21. Itchy rash on arms, legs and chest within 2 hours, which got better after took benedryl. However, chest tightness, shortness of breath didn't get much better even though took albuterol. Bad gerd that night. When tightness and shortness of breath and gerd didn't improve by Saturday morning 10/15/21 and started coughing , I went to urgent care. They sent me in ambulance to the Hospital ER. There I received EKG, chest xray, blood tests, which were normal, and treatment for asthma and gerd. When my symptoms improved I was discharged. I still have some chest tightness, shortness of breath, gerd and cough today 10/18/21.
Allergic Reaction: Feeling of throat tightness, angioedema, dizziness; 25 mg diphenhydramine administered with improvement in condition
Day of - tired; achy; mild headache;04/06/2021- itchiness at injection site and hard lump. Gone the next day.
The day after the vaccine I felt general malaise. About a month later I came down with cyclical vomiting syndrome that the doctor attributed to COVID-19. I was vomiting everyday twice a day for two months. After that I developed to tachycardia. I just recently came out of the hospital with viral pericarditis which they say develops in patients that have had COVID-19 or the vaccination.
This case was reported by a healthcare professional and described the occurrence of trouble breathing in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). In 2011 approximately one to weeks ago the subject received unspecified dose of ENGERIX B (unknown route). In 2011 approximately one to weeks ago, 1 day after vaccination with ENGERIX B, the subject experienced trouble breathing. An emergency room visit was required. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported three subjects experienced events with ENGERIX B. See cases A0953067A and A0953068A for details concerning the other two subjects.