chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient's spouse). An 80-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 19Feb2021 (batch/lot number: EN9581) at 80 years old, as SINGLE DOSE for COVID-19 immunization (also reported as "because of the age, he didn't want to get COVID"). The patient's medical history included ongoing blood pressure high diagnosed years ago; cholesterol (blood cholesterol abnormal) from an unknown date; and leg amputation on an unknown date in 2020, reported as "one year ago." Concomitant medications included atorvastatin (ATORVASTATIN) taken for blood cholesterol (blood cholesterol abnormal) from an unspecified start date and ongoing; acetylsalicylic acid (ASPIRIN) taken for a long time, carvedilol (CARVEDILOL), clopidogrel (CLOPIDOGREL), fenofibrate (FENOFIBRATE),isosorbide (ISOSORBIDE), lisinopril (LISINOPRIL), and spironolactone (SPIRONOLACTONE), all taken for an unspecified indication, from an unspecified start date and ongoing. It was reported that the patient took the Pfizer shot (clarified as Covid vaccine) on Friday, 19Feb2021 and then, that night, he broke out a little rash. The reporter gave the patient some Benadryl 25mg tablet and it cleared up and went away. On 20Feb2021, Saturday, patient felt okay. Then, Sunday (21Feb2021) this morning he woke up and was nauseous/ feeling nausea. He has been having nausea all day on Sunday. He had been throwing up on and off all day. The reporter gave the patient a nausea pill (unspecified medication), Ginger ale (also reported as "Gingerol"), and crackers but it kept coming, his stomach was not settled. The reporter asked, "what should I do?" He has stopped the throwing up, but the reporter wanted to know what else they can do to get him back up to speed. It was further reported that the patient was queasy and doesn't really have an appetite since an unspecified date in Feb2021. The reporter had been giving him fluids and they all stayed down, and he has not had an episode since Sunday. But he still feels weak after throwing up all day. So, the reporter asked, "was there anything special I need to do?" The patient stopped throwing up and nausea, but he still doesn't feel good. Then reporter stated that the patient still had nausea, but he was not throwing up, it stopped yesterday on 22Feb2021. Nausea is about the same. Rashes stopped. When he threw up all day Sunday, he has been drinking water and liquids. Therapeutic measures were taken as a result of the events rash, nauseous/ feeling nausea/ stomach was not settled/ queasy, and throwing up. The patient recovered from the event rash on an unspecified date in Feb2021 and recovered from the event throwing up on 22Feb2021; has not recovered from the event nauseous/ feeling nausea/ stomach was not settled/ queasy. Outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
flu from flu shot; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from a non-healthcare professional.  This case is linked to case 2020SA289370 (same reporter).  This case involves a male patient of unknown age who experienced flu (influenza), after he received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza), (unknown latency) from INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
11/3/09 pt. w/paralysis from neck down requiring ER visit via EMS transport. Paralysis lasted 10 days w/progression to walker. At present, pt remains on walker at times w/some limited range of motion and painful mobility in all four extremities. PMD suspects Guillain-Barre Syndrome. Has referred patient to Neurologist and prescribed pain medicine.
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (daughter) reported that a female patient of unknown age and race received on 15Dec2015 a single dose of PREVNAR 13 for immunization. Concomitant medication and medical history were not reported. It was mentioned that the patient received the shot on 15Dec2015 and since after that (date not specified), she has had breathing problems and keeps falling. Her heart was not pumping fluid like it should, she was on oxygen and very weak and fatigued. She had also lost her appetite. Outcome was not provided. No follow up attempts possible. No further information expected.
Chills, aches, fever, stomach pain, diarrhea, headache. Treated with rest and ibuprofen. Lasted less than 12 hours
Pt recvd 1st dose of Hep B vax 14DEC89 & later exp flushing,lightheadedness,syncope(lasting 45 sec),cardiac dysrhythmia w/ inc BP(160/90).On 15DEC89 pt. complained of h/a.Pt. recvd 2nd vax & exp dizziness.
Approximately 15 to 20  patients out of 40 for the entire day 04/04/2021 were administered the COVID vaccine Pfizer with a Subcutaneous needle. 25 gaugex5/8" even though it was not appropriate for the pt weight.
2 hours past receiving vaccine, started with chills, fever 99-100, edema from armpit to lower lateral arm, redness and pain. Symptoms subsided 3 days later.
Received Moderna Vaccine, 1st dose;  sore left arm after injection; no other difficulties; developed redness, swelling, and warmth on 4/11/21 (day 12 after injection).   On 4/12, redness and induration measures 6cm (w) x 8cm (l) and is warm to touch.
Headaches, sore joint, abdominal pain, fatigue, dizziness - took time off from work and just slept. I took ALEVE to relieve the joint pain and headaches. Vaccine administered around 2:00 PM couple of hours later felt soreness in shoulder. Around 10:00 PM I felt joint and abdominal discomfort and it got progressively worse to about a 7 on a scale of 1-10. Went to work next morning but felt dizzy, joint pain, headache and lethargic all morning. Went home for the afternoon and just slept until the next morning. Woke up feeling better. Still experiencing abdominal discomfort (48 hours later).
I have a large bump on my arm from my 2nd civic vaccination; Injection site is still hard and swollen and pain all way; Injection site is still hard and swollen and pain all way/pain running all the way down to my finger tips.; Injection site is still hard and swollen and pain all way; This is a spontaneous report from a contactable consumer or other non hcp (patient) received from a Pfizer.com-General Company Information (CEP ID 3110). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date customer Verbatim: I have a large bump on my arm from my 2nd civic vaccination and pain running all the way down to my finger tips. Started shortly after injection and on day 4 sti the same. Injection site is still hard and swollen and pain all way down. Please advise. Cannot find any info on this anywhere. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
pt recvd vax 16OCT95 & woke 20OCT95 w/red rash rough on face, neck; no fever, illness sx;eyes puffy;no known new allergens;advised to see MD to determine cause; started clearing up 21OCT-did not to to MD
Information has been received from registered nurse concerning a female who on 02/15/2002 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot number 641027/1051L). On 02/15/2002, the pt developed a "huge"arm, red, sore, and a headache. Unspecified medical attention was sought. The nurse reported that 5 pts developed injection site pain, erythema, swelling, and a headache post vaccination with pneumococcal vaccine 23 polyvalent (see WAES0203USA2415). Additional information has been requested.
leg thigh swollen 7 welt;screamed x 6 1/2hr;inconsolable;
Pfizer Dose 1 2/26/21 (EN6200) Pfizer Dose 2 3/24/21 (ER2613) COVID Positive 1/5/22  1/19/22: Pt. is a 81 year old female, who presented to ED with complaints of shortness of breath. She has been vaccinated and boosted against Covid-19. However, she did test positive on Jan 5th at her Nursing Facility. She was quarantined until Jan 10 and placed on Levaquin prophylactically. Patient does not wear oxygen at baseline. She was admitted back in December for a recurrent UTI. Patient stated she started becoming short of breath yesterday. Experiencing generalized weakness and decreased appetite. Some nausea without vomiting. No diarrhea. Denies chest pain. She has a past medical history of hypertension, hyperlipidemia, type 2 diabetes mellitus (diet managed) CKD, pulmonary fibrosis, chronic lower back pain and aortic valve stenosis  On arrival to ED the patient was febrile 99.5, hypertensive 171/97 and hypoxic on room air at 86%, 15 L non-rebreather was applied with improvement in oxygen saturation, patient was eventually weaned down to 10 L non-rebreather. Laboratory findings were significant for CKD stage G 3B creatinine 1.21.  ProBNP 3800. Leukocytosis 24.64.  D-dimer 3.52.  Chest x-ray moderate bilateral airspace disease, likely viral pneumonia.  Chest x-ray no PE.  Scattered bilateral areas of airspace disease likely representing viral pneumonitis or multilobular pneumonia. Levaquin was initiated in ED.  1/25/22: 81 year old female with a history of diet-controlled T2 dm, CKD 3, resident in LTC and pulmonary fibrosis.  Patient admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  She was initially diagnosed on 01/05/2022.  She was placed on usual treatment for COVID-19 infection but oxygen requirement continues to deteriorate.  She was initially placed on high-flow oxygen via nasal cannula then oxygen via OptiFlow and BiPAP yet response was quite poor.  She was a DNR.    Three days ago she was made comfort care only and expired this early morning.
Got flu shot-FLUZONE HIGH-DOSE 2017 - 18 0.5ml SYR. Questioned pharmacist on the 'high dose' and was explained it was due to my age. (75) Injection site became red, hot, inflamed, hard, and sore to the touch-probably six inches down my arm. Not my first flu shot and I've never had a reaction at the injection site. Two days later I woke up and I was broken out around my neck, down my chest and down my back with red spots/bumps. I contacted my doctor's office and they recommended I go to an urgent care location. At this site, I was given the option of a steroid shot (refused) and given a "script for a steroid pack. I have always taken the flu shot and consider myself to be a healthy 75 year old. (Have taken the shot the last 10 years or so-again I've never had a reaction at all.) Very unlikely I will take a flu shot again after this.
Information has been received from a nurse concerning a female patient who on an unspecified date finished a 2 year series of GARDASIL and was now complaining of fatigue, headaches, can't concentrate and had mono. She had blood work done that diagnosed MONO (infectious Mononucleosis). The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Follow-up information was received from a nurse concerning a 27 year old female (139 pounds; 46 inches) who in approximately September 2010 was vaccinated with GARDASIL. The patient had no adverse events following prior vaccinations, had no illnesses at the time of the vaccination and had no pre-existing allergies, birth defects or medical conditions. In November 2010, she experienced fatigue and was diagnosed with "several sicknesses- mono, flu". She had a very weak immune system and was unable to fight off illness. The nurse stated she was very healthy before. The nurse indicated it was unknown whether the pt had recovered. Additional information is not expected.
This spontaneous report as received from a healthcare business professional and refers to a patient of unknown age and gender. No details regarding concurrent conditions, medical history or concomitant therapies were reported in regard to the patient. On 03-DEC-2021, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # T033510, expiration date 28-DEC-2021, dose 2 milliliter, administered orally and with haemophilus B conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot# T037650, expiration date 21-JUL-2023, dose 0.5 milliliter, administered intramuscularly to left thigh. Both vaccinations were first doses of respective vaccines. Administered vaccines experienced temperature excursion of 47.29 degrees Fahrenheit (F) for 3 hours and 22 minutes (Product storage error). Previous temperature excursions were reported as not applicable. Digital data logger was involved. No additional adverse events were reported.
Mom reports child woke up on 03/22/2002 with a blotch about size of half dollar coin on left lower back. Seen at the clinic on 03/23/2002. Spots developed on left leg. Seen by a doctor on 03/25/2002 which he told mom that he thought the child had shingles.
Initial information was received on 13 November 2008 from a health care professional. A 32 year old female with a history of gastroesophageal reflux disease (GERD), urticaria, breast pain and no unknown allergies received an injection of Fluzone (lot number U2763AA) on 17 October 2008. The patient's last dose of Fluzone was in 1997. On 20 October 2008 the patient experienced eye swelling, cough and hoarseness. She was treated with Atarax and the symptoms had completely resolved. List of Documents held by Sender: None.
The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 08-Jul-2022; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 08-Jul-2022).    No concomitant medication was reported.  Patient received half dose of vaccine.  On 04-Jun-2022 the vials were initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  No treatment information was provided.
9 days after first dose.....bright red @ injection site; large hard lump below skin; skin was very warm; very sore; had a slight headache starting 4-5 days before any visible signs.  A telemedicine call to my general physician was placed the day after noticing and was immediately placed on an antibiotic  (Amoxicillin-CLAV 875-125MG TAB  2xday).  After 72 hrs. a positive effect was beginning to be noticed.  After 10 days, all but some soreness was gone.
This spontaneous report was received from a Nurse refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection, lot # L020015 (expiry date: 16-Aug-2017). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
have intense joint pain that I've never experienced before in my hands and feet; This is a spontaneous report from a contactable other hcp (consumer). A 42-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 26Feb2021 15:00 (Batch/Lot Number: En6203) as single for covid-19 immunisation at the age of 41-year-old. Medical history included allergies to gluten, soy, dairy, penicillin. The patient previously received the dose 1 (Batch/Lot Number: EL9265) as single for covid-19 immunisation at the age of 41-year-old. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks of vaccination. The patient reported I have intense joint pain that I've never experienced before in my hands and feet. The events started on 12Mar2021 and not recovered. No treatment received for the event. The event was reported as resulting in disability or permanent damage. The patient was not diagnosed with COVID-19 prior to vaccination and underwent Nasal Swab test on 16Apr2021 with result of negative.; Sender's Comments: The causal association between the reported event joint pain and vaccine administered cannot be excluded based on known drug profile and plausible temporal association.  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 RAs, Ethics Committees, and Investigators, as appropriate.
allergic to the following: Allergies  Lipitor, valium, Cardizem, heparin, prednisone, Procardia XL, dobutamine thallium, and  pneumonia vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported 66 with unknown unit) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization, the patient also started to receive atorvastatin calcium, heparin sodium, nifedipine (PROCARDIA XL), dobutamine hcl, diazepam (VALIUM), diltiazem (CARDIZEM) and prednisone, all via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient's medical history included asthma and angina. Concomitant medication included aspirin [acetylsalicylic acid], furosemide (LASIX), salbutamol sulfate (PROAIR), ipratropium, budesonide, rosuvastatin, cetirizine, montelukast sodium (SINGULAIR) and other medications for asthma and angina. The patient experienced allergic to the following: lipitor, valium, cardizem, heparin, prednisone, procardia xl, dobutamine thallium and pneumonia vaccine on an unspecified date. The action taken in response to the event for atorvastatin calcium, heparin sodium, nifedipine, dobutamine hcl, diazepam, diltiazem and prednisone was unknown. The outcome of events was unknown.  Pfizer is a marketing authorization holder of heparin sodium and dobutamine hcl in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of heparin sodium and dobutamine hcl has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
10 mins generalized clonic seizure w/postical drowsiness; apparent complete recovery;
Shortly after receiving the shot I had a little normal pain but after that it kept getting worse. A week later I had horrible pain in my left arm where the shot was given . I'm going to a specialist and they are treating me for it. I feel the pain mostly in the evening when I'm laying in bed.
Patient is a CPhT at the pharmacy and received both the pneumovax and twinrix at the same time. No reaction to the twinrix but it appears pt has either a reaction or infection from the vaccine. Pt went to the Doctor and was prescribed amox/clav 875mg 1 tab po bid for 10 days.
presented to ED with c/o worsening SOB x 3days, respiratory distress, collapse of left lower lobe secondary to consolidation versus atelectasis; earlier was diagnosed with bilateral pneumonia; has taken her antibiotics; was diagnosed with COVID a few days after pneumonia diagnosis; pt's condition deteriorated and patient died in the hospital
Two minutes after vaccination, pt reported feeling dizzy and became diaphoretic.  Blood pressure measured at 63/22, heart rate of 60 bpm.  Ambulance was called.  Patient placed in supine position and reported feeling better, BP recovered to 98/66.
Headache, Fatigue, pain on injection site,  swelling and redness. Site also itches.
Information has been received from a medical assistant concerning her daughter with a history of RSV (respiratory syncytial virus infection) as a child who was vaccinated with the first 0.5 ml dose of GARDASIL.  Subsequently the patient experienced asthma.  On February 5th (year not specified) the patient received the second 0.5 ml dose of GARDASIL.  It made the patient's asthma worse.  At the time of reporting, the outcome was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.