chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flushing red and hot; Throat swelling; Itching; Severe headache; Left ear pain; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration in the left arm on 17MAR2021 (at the age of 58-years-old) at 10:00, as dose number one, single dose for COVID-19 immunisation. The patient had allergies to unknown medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included cortisone injection into foot on 26MAR2021 for an unknown indication and Tylenol for an unknown indication on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17MAR2021 at 10:15, the patient experienced itching ,left ear pain, severe headache, throat swelling, flushing red and hot. The patient visited emergency room for the reported adverse event. Therapeutic treatment received for  itching ,left ear pain, severe headache, throat swelling, flushing red and hot were Antihistamines and steroids via intravenous route of administration. The clinical outcome of itching, left ear pain, severe headache, throat swelling, flushing red were recovering on an unknown date. No follow-up attempts are needed. No further information is expected.
About a week post second vaccination dose, noticed a none-painful, none-pruritic, raised rash to left arm, then to right a few days later. Present to the clinic three months later as he now has some scaring. Still no symptoms associated to rash and now spread to the  torso, folliculitis in appearing
PRINZMETAL ANGINA ACUTE NON ST ELEVATION MI 4/4/2022 & 5/1/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient reported on 10/6 that she developed hives and welts from the vaccine. She self treated with Benadryl and then xyzal. By 10/6 she said most of it had resolved. Patient said she had flu shots before without incident. She did not contact her doctor. On 10/9 reported it to her doctors office and they are going to contact her.
5/14/2023 - 5/21/2023 (7 days) HEART CENTER DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present    HOSPITAL COURSE: Patient is a 91 y.o. male with medical history of asthma, HFreF 45-50%, HTN, hx of complete heart block s/p pacemaker, hx of duodenal ulcer and upper GI bleed, frequent falls, vitamin-D deficiency, CKD with unknown baseline and recent medical hx of hospitalization for left humerus fracture 5 months ago who presented to the ER 5/13/23 after syncopal episode at Rehabilitation Center, was found to be hypoxic and covid 19 positive with acute  b/l multifocal occlusive and nonocclusive emboli  also involving the distal left main pulmonary artery without evidence of heart strain on CTA chest. ? Patient was seen by the team however conservative management was recommended.  He received IV heparin and was transitioned to oral Eliquis ? In regards to COVID-19 infection and hypoxic respiratory failure and tracheobronchitis patient treated with steroids (Decadron 6mg, on D#6 of 10 on discharge day)  and antibiotic ( completed azithromycin inpatient), with significant improvement in respiratory status noted as of 5/16 and current on room air on discharge day.  ? In regards to cardiomyopathy with systolic heart failure and worsening ejection fraction cardiology was consulted to evaluate and give further recommendations at this time patient has been treated with IV Lasix for CHF exacerbation, then transition to home oral Lasix doses.  ? In regards to generalized debility He states he was discharged to rehab but has been unable to return to independent living due to significant generalized weakness in his legs.  He states he is mainly ambulating with a wheelchair.   ? On 5/19/2023 patient had an episode or right epistaxis, ENT consulted and found a nasal cavity evaluated, large blood clots removed, light oozing with removal of blood clots, hemostatic powder to right nare, and placed of dissolvable hemopore packing to right nare. Suggest starting  aggressive local nasal hydration with saline sprays (2 sprays to each nostril TID for 2 weeks), and apply a small dab of bacitracin ointment to front of each nostril, just inside the vestibule, and genitally pinch the nostril closed to spread the ointment against the nasal septum. Also recommended may use Afrin nasal spray for any minor bleeds , followed by external pressure to the nose.  and small amount of oozing is anticipated, however is epistaxis is uncontrolled would recommend Rhinorocket placement ? Patient also found to have a new left lung pneumonia on 5/19/2023 and was started on IV abx, however procalcitonin was negative and IV abx discontinued the following day.    ? Patient was very anxious and was started on hydroxyzine 25 mg TID   Patient medically stable to discharge to Rehabilitation Center on 5/21/23.
Within 24 hours vaccine site red, hot , swollen and itch. Right shoulder 26cm diameter. Left shoulder 29.5 cm diameter. Right mid arm 21.5cm. Left mid-arm 20cm. Treatment: Keflex and Atarax with follow up in 2 weeks.
pt recvd vax & w/in 24hrs p/vax 8x8 cm induration & erythema;tx cool packs;sx persist
vaccine received at 0900 on 10 March 2023.  1600: symptoms began as body aches, malaise; took 800mg of OTC Ibuprofen @1630.  1900: symptoms increase to severe aches in all long bones, pelvis, and joints and perioral numbness and tingling.  2000: symptoms persisted, in addition to nausea and 104 temp, through the night into the morning of 11 March 2023; took acetaminophen at 2100.  11 March 2023: cycles of ibuprofen and acetaminophen reduced symptoms but did not relieve completely; symptoms persisted through the day with fever increasing at night. 12 March 2023: symptoms drastically reduced and able to relieve with 600mg OTC Ibuprofen at 0900 and 1600; right periocular swelling with pain and right testicle pain also experienced throughout the day.
Three scary days of prolonged periods of high pitched screaming, staring at the ceiling, and inconsolability. I wasn't going to report this, but then I figured if no one reports adverse reactions, what good is that?
Information has been received from a pharmacist concerning a male who on 24-SEP-2012 was vaccinated with an expired dose of ZOSTAVAX (lot number 669692/0615AA, expiration 02-JUL-2012) 0.65 ml subcutaneous (site not reported). No adverse effect was reported. Additional information is not expected.
1st PFZ Lot: EL 1283 2nd PFZ EN 5318 01/29 0800 / 02/22 0800  Adv:  It is expected to have chills / fever /muscle ache post vaccination  and usually resolves within 24 hours.  Can take OTC Tylenol / Motrin to reduce fever. If symptoms persists after 48 hours or presents SOB, difficulty to swallow to  breath, hives or extreme muscle ache seek medical attention . Call us back with any questions. Provider will f/u
Severe, new onset dysautonomia. Temperature regulation issues, heart and blood pressure instability, confusion, brain fog, GI sluggishness, dizziness/fainting, memory loss after each vaccine the issues persisted for 10 months and then somewhat resolved but exercise intolerance, blood pressure issues and intermittent brain fog persist
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
Patient states she took fourth capsule of one typhoid vaccine and noticed blisters on her tongue, neck pain and swelling.
sickness; FATIGUE; FEVER; blood work shows mononucleosis; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, FATIGUE, PYREXIA, and INFECTIOUS MONONUCLEOSIS in a 79-year-old female patient 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) (Intramuscular) dosage form. On an unknown date, the patient experienced ILLNESS, FATIGUE, PYREXIA, and INFECTIOUS MONONUCLEOSIS. At the time of the report, ILLNESS, FATIGUE, PYREXIA, and INFECTIOUS MONONUCLEOSIS outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Reporter requests to send VAERS form.
left ear started irritating; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 53 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, SINGLE, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: EAR DISORDER (non-serious), outcome "recovered with sequelae", described as "left ear started irritating". It was unknown if therapeutic measures were taken as a result of ear disorder.  Clinical Course: It was reported that about 2 weeks after receiving the vaccine, the patient's left ear started irritating. The patient had not been diagnosed with the COVID prior vaccination. It was unknown if the patient tested for COVID post vaccination. It was unknown if the patient received any other vaccine within four weeks.  No follow-up attempts are possible. No further information expected.
No additional AE reported.; The VAQTA expired on 1/6/2021 and was administered on 1/8/2021.; This spontaneous report as received from a consumer referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.         On 08-JAN-2021, the patient was vaccinated with expired hepatitis A vaccine, inactivated (VAQTA) (0.5 units not provided, strength, route of administration and anatomical site of vaccination were not reported, lot # was unknown, expiration date reported as 06-JAN-2021) for prophylaxis (expired product administered). No additional adverse events reported.
Pt had a positive COVID test on 12/28/21; 1/2/21 another positive COVID test; EMS called to pt's house after wife (who was COVID positive) found the pt down; pt brought to ED cardiac arrest; CPR, ACLS protocol; intubated; defibrillated; pt expired in the hospital; found to have another positive COVID test
This case was reported by a other health professional via sales rep and described the occurrence of erythema in a female patient who received FLUARIX QUADRIVALENT (batch number 5GF43, expiry date 30th June 2016). On 22nd September 2015, the patient received FLUARIX QUADRIVALENT. On 23rd September 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced erythema, swelling arm, pain in arm and extremities hot feeling of. The patient was treated with CIPRO. On an unknown date, the outcome of the erythema, swelling arm and extremities hot feeling of were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the erythema, swelling arm, pain in arm and extremities hot feeling of to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced hotness, tenderness, redness and swelling in her arm. The swelling in the arm was described as like a potato under the skin. On 25th September 2015, the patient was prescribed with an unspecified dose of CIPRO for 7 days, and most of the symptoms were resolved except tenderness remained ongoing. No additional information could be obtained.
Client developed severe headaches 2 days after vaccination.  Headaches not relieved with Tylenol.  Headaches ceased for a few minutes then returned.  Headaches reoccurred with physical activity.  headaches gone after 2 weeks MRI negative.  Neurological exam was negative.  Requested written report-not received.
Developed heaviness (L) upper arm 1 hour after vaccine administration . Heaviness spread to hand and persisted. On 10/19/15 she pulled a neck muscle doing yoga and arm became tingly numb and painful. R/R PCP 10/12/15 given ibuprofen.
Initial report received from a health care professional on 24 August 2010. An 18-year-old male patient, with no illness at the time of vaccination and received no other vaccinations within 4 weeks prior to vaccine, received (dose 1) on 18 August 2010 a left arm injection with ADACEL, lot number reported as unknown). The patient's parent, who was a pharmacist, reported that 2 days after the vaccination, 20 August 2010, the patients left arm was very sore, swollen and warm to touch at the injection site. He then developed a fever of 101 which started on the third day after vaccination. The fever continued and went from 101 degrees Fahrenheit (deg F) to 103 deg F and he had chills. The patients arm was still sore and warm to touch and he continued to have a fever until 24 August 2010. The patient has an appointment to be seen by the doctor on 25 August 2010. The outcome was not reported. Documents held by sender: None.
This is a spontaneous report obtained from a contactable Health Care Professional through a Pfizer sales representative. This Health Care Professional reported the same event for two patients. This is the second of two reports. A patient of unspecified age ethnicity and gender received, on an unspecified date, PREVNAR 13 at 0.5 ml, single dose. Relevant medical history and concomitant medications were unknown. The patient experienced cellulitis on an unspecified date. Clinical outcome of the event was unknown at time of this report.
6 days after vaccines onset of occipital headache with neck stiffness without fever/cough or rhinorrhea.
Seriousness criteria other medically significant (OMIC). Initial report received on 5/17/2006 from a health care professional. A four month old male patient with a concurrent illness of diarrhea and a past medical history of gastroesophageal reflux treated with Zantac, had received his second intramuscular dose of ActHib, lot number UE844AA (manufacturer lot number Z0208-2), in the right anterior thigh, his second intramuscular dose of DT ADS ped USP, lot number U1577BA, in the right anterior thigh, his second intramuscular dose of Ipol, lot number Y1067, in the left anterior thigh, and his second intramuscular dose of Prevnar, in the left anterior thigh on the afternoon of 5/15/2006. Sometime that evening, the patient developed a fever that lasted through the next day. On 5/16/2006, it was reported to the physician that the patients hands and feet were blue all day. The physician evaluated him in the office that evening and no cyanosis was noted. The physician questioned whether the patient had an upper respiratory infection or a reaction to the vaccination received the day before. At the time of this report, the patient had recovered from these adverse events. The patient had previously reported fever, irritability and two episodes where he stopped breathing during the night after receiving his primary doses of ActHib, Prevnar, Daptacel, Ipol, and second dose of Hepatitis B on 3/13/2006. These event were considered as serious and are reported in case 200601188.
Per patient, lips began tingling, progressed to tongue, then loss of sensation.  Then felt throat closing, and unable to get air. Pt went to the ER.  Was given Benadryl, Prednisone, and Pepcid and sent home.
This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 at around 9:00 to 10:00 (at the age of 48-years-old) as 1st dose, single dose for COVID-19 immunization. The patient had no medical history. The patient had no family medical history relevant to adverse event. There were no concomitant medications. The patient had no other products. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks). It was reported that, the patient was calling about the Pfizer covid vaccine. Unfortunately, he had a heart attack in Apr 2021. It turns out the day before his heart attack, he received the first dose of the covid vaccine. He had a heart attack on Saturday, 10Apr2021 at around 16:30 to 17:00. He was sitting down eating dinner and had a heart attack. The patient required emergency room and physician office. He was hospitalized for the heart attack on 10Apr2021. His cardiologist suggested that he call to report this to Pfizer. His cardiologist told him that he has cardiac ectasia, which may have been exacerbated by the first dose of the covid vaccine. He actually feels good now. He feels good and was not getting worse. He was not cleared for physical activity from his cardiologist, so he cannot work out yet. He was starting to put weight back on. Whenever he left the hospital, he was 211 pounds. Now he was 215 pounds. It may be water weight; may his sodium be high. But he was starting to increase in weight. His wife was older. He has a 92-year-old mother-in-law with health issues that lives downstairs. He runs basketball training and was around a lot of kids. He has no idea he had any heart conditions. His wife had gotten the COVID-19 vaccine, and his wife let him know that he was getting it too. The patient had no relevant test done. The patient was remained in the hospital for 6 days and discharged on 15Apr2021. The outcome of the event heart attack was recovered on an unspecified date in 2021. The outcome of the events Weight increased and cardiac ectasia was unknown. Follow up needed, further information was requested.
Patient came to ED complaining of shortness of breath, chest congestion, and cough for 10 days.  Covid test positive and O2 saturation 92%.  Patient admitted to hospital and treated with remdesivir.
Patient was feeling dizzy fainted approximately 2 minutes post-vaccination. Was alert and oriented shortly after being assisted to the ground.
donor presented in center with a bruise measuring 8x5 inches settling from the injection site on donors left arm
Information has been received from a physician and the office manager concerning an 8 week old female patient who on 19-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error.  It is unknown if the patient sought medical attention.
There was temperature excursion from their freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant medications were provided. On 01-Oct-2021, There was temperature excursion from  freezer. It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes. No treatment medications were provided.
pt has a 11cm x 8cm erythematous, warm to touch lesion w/a 3cm x 2xm center that is hard to the touch & not as erythematous;
shot received 4pm; woke up with chills around 2am, fever fluctuating from 100.8 to 102.9 for next 2 days; could not eat the first day, was able to eat small amounts of bland foods the second day; very fatigued both days. Symptoms cleared up after 2 days, post-onset.
Patient fainted after Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of faint in a female patient who received Men B NVS (Bexsero) (batch number TP294, expiry date 31st October 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown.   It was unknown if the reporter considered the faint to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's comments: A medical assistant had reported that the patient fainted after a Bexsero vaccine administration. The reporter had consented to follow-up.
Test positive for covid; Test positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2022 at 15:00 as dose number unknown (booster), single (Lot number: FK9893), in right arm, on 11Mar2021 at 15:00 as dose number unknown, single (Lot number: EN6208), in left arm, on 22Feb2021 at 15:00 as dose number unknown , single (Lot number: En6200), in left arm, (Batch/Lot number: unknown) and (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Aug2021 at 15:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa drugs" (unspecified if ongoing); "Polymyositis recurrent" (unspecified if ongoing). Concomitant medication(s) included: AZATHIOPRINE taken for immunosuppressant drug therapy, start date: 31Dec2021, stop date: 12Jun2022. Past drug history included: Gluten, reaction(s): "known allergies: Gluten". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Test positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took other medication in 2weeks. Increasing sinusitis by day 5 after completing the 5 day Paxlovid. Test positive for covid with a Binax otc kit. Was 5 day paxlovid enough. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
J18.9 - Pneumonia, unspecified organism D69.6 - Thrombocytopenia, unspecified
Patient left the exam room after waiting alotted time and walked to waiting room where she had a syncopal episode and seizure like activity.  She was caught by her mother and staff rushed immediately to her side where she was taken back to the exam room put in Trendelenburg position.  She had a total of 4 seizure activity episodes within the time we were able to get her from the clinic to the hospital.  Patient had told staff that she is very scared of needles and the doctor does believe that this was a vasovagal response.