chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from Pfizer sponsored program. A contactable consumer reported for a male patient (father). A 87 year old male patient received, on 29Mar2017, at 15:00, PREVNAR 13 single dose, in the left upper arm, for immunization. Relevant medical history included heart failure (bypass performed in 1990) and fell on 06Feb2017 (resulting in T4 compression fracture). Family medical history was none. Concomitant medications included oral TYLENOL 500 mg or 650 mg one or two as needed for pain (ongoing); ASPIRIN 81 mg once daily, for heart problems (ongoing); oral CENTRUM SILVER 1 tablet daily, as supplementation therapy (ongoing); NEXIUM 40 mg once daily, for gastrooesophageal reflux disease (ongoing); oral finasteride 5 mg once daily, for prostatic disorder (ongoing); oral pravastatin 20 mg once daily, for heart problems (ongoing); oral ropinirole 0.25 mg once daily, for restless legs (ongoing); oral spironolactone 25 mg once daily, as diuretic therapy, from an unspecified date, in Jan2017 (ongoing); oral torsemide 40 mg once daily, as diuretic therapy, from an unspecified date, in Sep2016 (ongoing); oral tamsulosin 0.4 mg once daily, for prostatic disorder from an unspecified date, in Jan2017 (ongoing); ophthalmic latanoprost 0.002 % one drop each eye once daily, (ongoing); and SIMBRINZA 1-0.2% drops; 1 drop each eye twice daily, (ongoing). On 01Apr2017, the patient experienced muscle and joint pain, change in demeanor, pain in front part of upper bilateral legs and fatigue. On an unspecified date, in 2017, he exhibited more than usual lethargy and muscular pain. Relevant tests were none. The patient did not recover from the events at time of this report.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient called pharmacy 2 days post 2nd dose of COVID 19 vaccine. Patient received on 8/8/21 and states on 8/10/21 (this morning) he noticed 2 red dots at the site he received vaccine and some "puffiness/swelling." Patient states it is not itchy. Pharmacist advised redness/swelling is a known side effect, however, if patient notices worsening symptoms to seek medical attention if needed.
pt recv vax & devel a flushed,red face,felt hot & vomited;f/u reported that pt felt achy,flushed,nauseated & rt arm began to hurt a few min p/vax;waves of pain throughout day;rt arm hurt;felt tired
significant headaches, nausea, fatigue and local redness/swelling/hard lump/itching.Outcome: Resolved and fine
Information has been received from a registered nurse and a mother of a student concerning another child in elementary school who was vaccinated with a dose of Varivax. It was reported that the patient now has breakthrough chickenpox after an outbreak occurred in the elementary school. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that the index case was an unimmunized individual. This is a consolidation of two reports concerning the same patient. Additional information is not expected.
Throat got tight, increased heart rate, dizzy, weak, nauseous, chills within 15 minutes of shot.  Within a day until present, have extreme anxiety, stomach acid and reflux, shaking, extreme chills, legs very weak, pain in leg muscles, continued dizziness and continued tight throat.
Narrative: Patient received two doses of covid vaccine. Unclear if patient had any changed medical history or if this outcome was related at all to vaccination. No details reported of death. Reporting per facility instruction.
diarrhea; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced diarrhea and influenza-like symptoms. On an unknown date, the outcome of the diarrhea and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the diarrhea and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient was reporter's pharmacist. The age at vaccination was not reported. The patient had to cancel a fishing trip because the day after getting Shingrix, he had diarrhea and flu like symptoms that lasted 3 days. The reporter did not consent to follow-up. The reporter thought that the pharmacist would welcome a call and gave his number for follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021010485:same reporter
Approx 7 hours after vaccination I started to get sever stomach pains and vomited and had bloody diarrhea. I only vomited one time but the stomach pains and diarrhea have continued up to today 4/2/20. The stomach pains have diminished however I am still having bloody diarrhea.  Extreme headache today as well.
4-5mm SC nodule lt over quadricep femoris at site of Pedvax HIB inject;
3-days after getting the FLUZONE HIGH_DOSE Quadrivalent the arms began to hurt,; Initial information was received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non healthcare professional.  This case is linked to case 2022SA417472(CLUSTER).  This case involves a male patient with unknown age and reporter reported 3-days after getting the Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] the arms began to hurt.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Sep-2022, the patient received a dose of suspect Influenza quadrival A-B high dose HV vaccine (with unknown strength, dose, route, administration site, form, lot number, expiration date) for Immunization. Information on the batch number was requested.  On 01-Oct-2022, 3 days after getting the fluzone high_dose quadrivalent the arms began to hurt, (pain in extremity) (latency: 3 days).  It was reported: A Consumer reporting that 3-days after getting the FLUZONE HIGH_DOSE Quadrivalent the arms began to hurt. The Caller reported that her arm hurts worse than her husbands and that the provider told them to use ice. Caller is reporting that she received a FLUZONE QIV HD dose on 9/28/2022, and the day after her arm started to hurt, and has continued to hurt since then. She is asking if this is normal or what she can expect.   Action taken: Not applicable.  Corrective treatment: Not reported.   Outcome: Not Recovered / Not Resolved.
Noticed that arm was red swollen and hot to touch.  Cleaned arm with alcohol and outlined the redness with a sharpie.  Took to clinic in the morning and they prescribed Motrin and Benadryl.  By noon the redness had spread about an inch outside of the sharpie line we had drawn.  We took him to the ER and they determined that it was an infection and prescribed him antibiotics (Cephalexin - 4ml 3x a day for 5 days) Took back to the doctor Wed, Sept 5 because the redness has not completely subsided.  They prescribed him Cephalexin 5ml 3x a day for 7 days. I can report back as to how this treatment works.
The day before I went to ER, I went to a local Urgent Care office with fever around 102F.  They told me to rest and take Tylenol, but if the fever increased, to go to the ER.  The next day, my fever went up to 105F and we went to the ER . They drew blood for tests, gave me 2L of saline solution and antibiotics, and fever came down.  They called my Primary Physician to see if he thought I should be admitted to the hospital.  He told them to send me home and he would see me a couple days later.  Doctor told them he sees this all the time and it is directly caused by the vaccine.
Dizziness. Loss of equilibrium; Unsteady gait. Flu vacc - 12-2-2014. Sx's started 12-5-14 mild - worse on 12-8-14.
Patient had fever 101, leg pain and went limp after vaccine given with fever, refused to move legs.
Got sick and a little lethargic and out of it for a day or so; Got sick and a little lethargic and out of it for a day or so; He was not feeling well; This is a spontaneous report from a contactable consumer (patient's son) from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got sick and a little lethargic on an unspecified date and was out of it for a day or so. The patient was not feeling well. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Chills/shivering and night sweats for 3 nights in a row (January 8-10, 2021), no fever
No additional AE reported; proquad administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reaction or allergies was reported.  On 09-FEB-2023, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHa)(PROQUAD) lot # W019627 was confirmed to be valid, expiration date 19-DEC-2023, intramuscularly in the right thigh for prophylaxis. On 20-JAN-2023, the administered dose had temperature excursion range of -14 degree Celsius to -10 degree Celsius for 1 hour (product storage error). The call was because of a digital data logger. No additional adverse event reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2304USA007686: US-009507513-2304USA007723: US-009507513-2304USA007759: US-009507513-2304USA007810: US-009507513-2304USA007844: US-009507513-2304USA007812: US-009507513-2304USA007860: US-009507513-2304USA007857: US-009507513-2304USA007848: US-009507513-2304USA007866: US-009507513-2304USA007836: US-009507513-2304USA007822: US-009507513-2303USA002114:Original Case US-009507513-2304USA007866:
Several pts at this facility devel swelling @ inj site following this vax. They recovered. Medical Affairs note: Reporter did not specify # of pts exp this event.
Severe chills, trembling, fever, swollen shoulder at site of shot; aching shoulders, arms, and lower back; dull headache.
At 13:10, client reportedly fell out of desk seat onto floor. No physical injury noted. BP was stable. Observed for 30 minutes. Discharged to home accompanied by mother. She was advised to seek medical care if needed.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 20-AUG-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # H015630 and expiry date: 21-FEB-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
My daughter began screaming and crying about a sore mouth a few hours after the Flumist vaccine was administered.  The evening of the 19th she began to run a low grade fever and seemed puny.  The next morning on the 20th she had a stuffy nose and watery eyes with no fever.  She returned from school that day (5:00 PM on the 20th) and she was running a fever again.  She still complained about her mouth being sore and now her stomach started bothering her.  On Saturday the 21st her lips began swelling and cracking and her tongue was red with raised taste buds.  These symptoms persisted but the fever seemed to be getting better.  Then on Monday the 30th her face had completely broken out in sores around her eyes, mouth and chin.  We took her to see Dr. who had blood work drawn.  The blood work was inconclusive so we took her back on Tuesday the 24th when they diagnosed her with Kawasaki's disease as a direct result of the FluMist vaccine.  Her trunk and bottom are now peeling like a sunburn.
24 hours after the administration of the vaccine 10/14/03 the employee complained of asthma type symptoms including shortness of breath and chest tightness. He was seen in the ER on 10/15/03, oxygen was administered and he was released. Employee reported on 10/28/03 that following the ER visit he developed hives on chest, back, arms and hands. States he has been taking benedryl prn for symptoms. Employee denied egg allergy at the time of vaccination but stated on 10/28/03 that he did have a sensitivity to chicken feathers. Employee states that he is still experiencing mild asthma type symptoms. He was advised to follow up with his MD.
Metallic taste in mouth is just horrible; Nausea; I still feel so exhausted, I can hardly function; I probably lost 2, I probably lost 10 pounds; I go the boosters, I would not get this sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CELEBREX; SYNDOPA [LEVODOPA]. Vaccination history included: coviD-19 vaccine (DOSE 2, SINGLE , Anatomical site of vaccination: Consumer stated, "No. You know in my arm. I don't know what arm."), administration date: 28Jan2021, when the patient was 78-year-old, for COVID-19 immunization; coviD-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Anatomical site of vaccination: Consumer stated, "No. You know in my arm. I don't know what arm."), administration date: 17Feb2021, when the patient was 78-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Anatomical site of vaccination: Consumer stated, "No. You know in my arm. I don't know what arm.", Date of vaccination was given as 21Oct (as reported)), for COVID-19 immunization. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "Metallic taste in mouth is just horrible"; NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "I still feel so exhausted, I can hardly function"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "I probably lost 2, I probably lost 10 pounds"; ILLNESS (non-serious), outcome "unknown", described as "I go the boosters, I would not get this sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that she experienced, the metallic taste in mouth was just horrible. she had the nausea and she knew that's one of the side effects that everyone know. She stated that she still feel so exhausted, she can hardly function, have been since 03Mar. The vaccination information was given as she had just were on 21Oct, I had 28Jan2021, 17Feb2021, she just had the booster of 21Feb (as reported). other medical conditions was reported as 'no'. Concomitant medication was also given as she takes multiple vitamins (further not clarified). Pfizer COVID 19 booster dose was confirmed as 'yeah, on 21 (clarified as 2021 year) (as reported)'.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109931 same patient/drug, different event/dose number;
Swelling through out body but prominent on the right side. swelling in lymph nodes in right arm pit, and on neck and shoulder area. swelling in my face sinuses, ear, legs , breast area right side severe pain, and under right arm, neck severe pain, right arm severe pain down to tip of fingers, severe pain in left arm, hand, fingers,  pain is nerve pain, then i have so much swelling it is cutting off circulation to hands, arms, whole right side of body and upper body on left side. head aches, exhaustion.   I am a phone customer service representative and can not do my job right now because it hurts too much to type. I am on short term disability until the symptoms go away or get better.  I am being treated with steroids, and tramadol for pain
Soreness and stiffness at the shotlocation.; Soreness and stiffness at the shotlocation.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 15Mar2021 at 14:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication was reported as pantoprazole 20mg (MANUFACTURER UNKNOWN) for unknown indication received within 2 weeks of vaccination. The patient had a history of allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccine. On 15Mar2021 at 20:00, the patient experienced soreness and stiffness at the shot location. Therapeutic measures were not taken for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events soreness and stiffness at the shot location was resolved on unspecified date in Mar2021.  Information on lot/batch number has been requested. No further information is expected.
Fever 101.5, Chills , Joint pain, Head Ache, Dizzy ness, Site Pain          Ibuprofen helped some,     Started  March 19 evening, ended somewhat morning March 21
She got her vaccine, she had slight pain in injection area, and headache, and that was it.  Then in about June of 2022 she had a skin rash, and has been diagnosed with psoariasis form dermatitis.  She feels it is related to the vaccine as she had no problems with her skin prior to the vaccine.  She also has subcorneal pustular dermitits lechenified, spongiotic psoriasis form dermatitis, as well as atopic dermatitis.  She has been given Clobetasol for treatment of this, and another cream that she was given that was not effective.  She went to see the dermatologist on 7/5/2022.  The medicine is working, but she is started to getting some bad AE from it, and going to see him this month
Red patchs with itchy Welts . My Doctors prescribe steroids pill for one week. it helped some but took about 4 weeks to clear  completely up.
Loss of grip in the left arm, arm where he received his second dose of Moderna - onset of symptoms 4/14/2021, same day as dose administered.
Initial report received on 30 July 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3186AA received on 16 February 2009, lot number C3231AA received on 27 April 2009, lot number C3186AA received on 22 June 2009, and lot number C3496AA received on 24 May 2010. The subject developed a cough on 02 July 2013, approximately 3 years after the last dose, and a paroxysmal cough with a whoop on 10 July 2013. The subject also developed posttussive vomiting, apnea, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 13 July 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 13 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 23 July 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 202 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 30 July 2013. These 202 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
The pt experienced a breakthrough rash - chicken pox, severe headache, stiff neck, nausea, and vomiting. The pt was hospitalized for a suspected meningoencephalitis. Per F/U 4/4/01: additional dxs: anemia, allergic rhinitis and irritable bowel syndrome. The pt received the varicella vaccine on 9/21/00 and was well until 10/8/00, when she developed varicella-like lesions on the face, trunk and extremities along with malaise, fever and chills. The pt was seen and dx'd with vaccine induced varicella. Approx. 4 to 5 days later, she began have severe headache pain which has been persistent through today. Associated signs and symptoms include nausea, blurry grain of vision and left hand/arm heaviness. The pt was noted to have a hypochromic microcytic anemia and this was thought to be secondary to her chronic alpha thalassemia minor. Discharge meds: Fioriset 1-2 tablets q 6 hours prn pain; Claritin 10mg 1 tablet po q day; Ortho Tri-Cyclen 1 tablet po q day; Beconase AQ 2 sprays per nostril q day.
2 Hours after the injection, my arm hurt so bad I could not raise it laterally. This continued for 3 days. After that I felt tired and achy until Jan 4th, I had chills and whole body aches. I came home from work, took the next day off. Feeling better, I worked 3 more days and developed the worst headache of my life. I consulted my PCP and went to the emergency room. I was diagnosed with viral meningitis and admitted to the hospital for 3 days. .
Sore left arm -whole arm; Metallic taste in mouth; Body aches especially upper shoulder and back area; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm left on 11May2021 at 13:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, dupuytren's contracture, attention deficit-hyperactivity disorder (ADHD) and osteopenia. Concomitant medications included levothyroxine sodium (TIROSINT) 88 mcg, liothyronine (MANUFACTURER UNKNOWN) 5 mcg and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 25mg twice daily from an unknown date and unknown if ongoing for unknown indications. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 at 09:00, the patient experienced sore left arm -whole arm, metallic taste in mouth and body aches especially upper shoulder and back area. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore left arm -whole arm, metallic taste in mouth and body aches especially upper shoulder and back area was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.