chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 8/26/2021, the evening of the fourth day of receiving the vaccine injection, at 8:00pm patient began getting an itching sensation on the arms and in the armpit.  By 8:15pm  hives and a spreading rash of small bumps across the exposed arms and increased itching an pain in the armpits.  8:30 bumps and hives spread from arms to chest neck and back.  8:40pm patient s self administered 50mg of oral Benadryl and 400mg of Ibuprofen.  8:45pm Patient  attempted to shower in case this was an allergic contact reaction to something .  (Patient's only allergy is to Penicillin).  9:00pm patient's eyes and ears began to swell and was headed to ER.  Airway was beginning to feel constricted at this time.  9:15pm patient was admitted to ER and seen by attending PA .   Patient was treated with steroids (with Pepcid as an acid blocker) to impede the swelling at was monitored for 1/2 hour to see if this treatment was adequate.   10:15pm during consult with PA, patient was ordered to continue steroid treatment with acid blocker and oral Anti-histamine treatment for one week.
Sore arm. Low grade fever and chills. Headaches. Joint discomfort. All lasted 24 hours.
myocarditis; Heart palpitations; This is a spontaneous report from a non-contactable consumer (patient). A 23-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 14Jun2021 at 05:00 PM (at the age of 23-years-old) as a single dose for covid-19 immunisation at Pharmacy/drug store. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administration on 22May2021 at 09:00 AM (at the age of 23-years-old) as a single dose for covid-19 immunisation. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 14Jun2021, the patient experienced myocarditis, and heart palpitations. Events resulted in emergency room visit. Treatment received was unknown for events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pharmacist unknowingly pulled vaccine from package with a past beyond use date. Vaccine was administered to the patient 7 days past beyond use date. No reported adverse effects
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 11-MAY-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 0 Celsius degrees for 168 hours  and 1.1 Celsius degrees for 920 hours with lowest temperature recorded of 32 and 34 Fahrenheit degrees respectively. No adverse effects were reported and no product quality complaint (PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
bumps on his arms; itching; hives on both arms; bad headache; severe body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives on both arms), HEADACHE (bad headache), PAIN (severe body aches), PRURITUS (itching) and NODULE (bumps on his arms) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE (GENVOYA [COBICISTAT;ELVITEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE]) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (bad headache) and PAIN (severe body aches). On 31-Mar-2021, the patient experienced URTICARIA (hives on both arms) and PRURITUS (itching). On 08-Apr-2021, the patient experienced NODULE (bumps on his arms). On 03-Apr-2021, HEADACHE (bad headache) and PAIN (severe body aches) had resolved, PRURITUS (itching) outcome was unknown. At the time of the report, URTICARIA (hives on both arms) and NODULE (bumps on his arms) outcome was unknown. Not Provided          Treatment medication provided were Clobetasol propionate which helped with the itching caused by the hives  The patient is on immunosuppressive therapy.
Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT FELL IN AISLE OF STORE  A FEW STEPS AFTER LEAVING VACCINATION AREA. EMT'S RESPONDED AND TOOK VITALS. PATIENT RESPONDED WELL AND WAS ABLE TO LEAVE STORE WALKING UNDER HIS OWN POWER WITH EMT'S
Pt recvd vax & on 12MAY93 pt devel pneumococcal pneumonia & was hospitalized; addtl details are being requested;
Fatigue, extreme full body pain, low grade fever, headache, side effects lasting 3 days.
Moderna COVID-19 Vaccine Patient received first dose of vaccine on 1/11/2021, next day developed fever, chills and body aches and fever kept increasing during the day up to 103.4 Patient did not go to ED for evaluation
Covid Moderna booster given from vial that was expired by a couple of hours (vial was refrigerated the whole time). No adverse effect reported.
Started spot vaginal bleeding like I was getting my period.  I have not had a period for 15 years.  Menopause at age 45. Bleeding enough to note, but not enough to cause concerns.  Bleeding stopped 24 hours later, this morning 5/25 - 7am.
Approximately 36 hours post follow up mist vaccination.  Patient broke out with rash on legs, spreading to arms, itchy.  Mild flu-like symptoms noted and some throat tingling, tightness about 48 hours post vaccination.
Received PP23 vaccine 11/15/2006. right arm became swollen, warm to touch 11/15/2006pm, on am 11/16 client observed swelling from shoulder to below elbow, dark discoloration and fluid under skin to wrist, deltoid hot to touch, came into clinic to advise, referred to PP seen 11/16/06 per PP. states given Keflex, Bactrim for infected arm, arm continued to swell. Fri  11/17/06 hospitalized for IV antibiotics, released 11/19/06 on oral antibiotics Augmentin. RTC to PP in 1 week.  MR received from hospital stay of 11/17-18/2006 for c/o redness, swelling, and pain in the right deltoid following Pneumovax, which had not responded to oral antibiotics.  HPI: The evening of her Pneumovax pt. began to notice redness and swelling of the right deltoid area.  OV to PCP the following day where Keflex and Bactrim were prescribed.  Redness, swelling, and pain were increasing and spreading to the lower arm despite antibiotics.  Pt. developed chills and nausea on day 2 s/p vax. She was then refered to the ER by her PCP for IV antibiotics.  Impression:  Spreading erythema, swelling, and pain 2' to right upper extremity cellulitis, not responding to outpatient antibiotics.  COPD-stable. Hx. of Rectal carcinoma.  Peripheral Vascular Disease.
Sinus/head cold present and the exhaustion is gone; Saturday and Sunday (08Jan2022 and 09Jan2022) felt as though I had a head cold and was very exhausted; Saturday and Sunday (08Jan2022 and 09Jan2022) felt as though I had a head cold and was very exhausted; I tested positive for COVID-19 (10Jan2022); I tested positive for COVID-19 (10Jan2022); booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Nov2021 12:30 (Lot number: FF2593) at the age of 65 years as dose 3 (booster), single, administered in arm right, administration date 24Mar2021 09:30 (Lot number: EP6955) as dose 2, single and administered in arm right, administration date 04Mar2021 09:30 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jan2022 04:00, outcome "recovering" and all described as "I tested positive for COVID-19 (10Jan2022)"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 10Jan2022 04:00, outcome "recovering", described as "Sinus/head cold present and the exhaustion is gone"; NASOPHARYNGITIS (non-serious) with onset 07Jan2022 04:00, outcome "recovering", FATIGUE (non-serious) with onset 07Jan2022 04:00, outcome "recovered" (Jan2022) and all described as "Saturday and Sunday (08Jan2022 and 09Jan2022) felt as though I had a head cold and was very exhausted". The patient underwent the following laboratory tests and procedures: BinaxNOW COVID-19 Antigen Self Test: (07Jan2022) negative, notes: Nasal Swab; (10Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, paranasal sinus discomfort, nasopharyngitis, fatigue.  No follow-up attempts are possible. No further information is expected.
Pt seen in clinic on 11/21/17. Painful, red large bruise on right thigh after vaccines x 2. Didn't walk for next 2 days per mother. Started walking a little on 11/20/17 but still hurts and she cries. Mother has been massaging the area but did not use ice initially or TYLENOL or ibuprofen for the pain. Has new shoes from the mall and is walking (just learning and is unstable with a wide stance) with the right foot on her toes a bit. She has no fever and is eating well with no problems when finally falls asleep. 11/22/17 - Pt seen again. Chief complaint: crying more. Was seen by Dr. 11/21/17, a little worse than yesterday. Localized erythema and induration only. Toddler refusing to bear wt. on affected left leg. Recommended heat, ibuprofen - once inflammation resolved, child should start walking and weight bearing again. Typical Ag-Ab complex reaction - should resolve within 1 wk. Parents reassured.
My son got both his 2nd dose of the Pfizer COVID-19 shot as well as a booster for Tdap. (Unsure of which Tdap or lot#) at 11:30 pm 6/18/2021 he was fine. About 30 mins later he was hit hard with side effects. Said he was very shaky and felt hot and cold at the same time. He did not let me know about this until this morning around 7:50 am 06/19/2021 about how he was feeling and he was still feeling very bad, advised him to take tylenol and he took that and went back to sleep. Around 12:00 PM 06/19/2021 I was finally able to check his temperature and other vitals. His temperature was normal, but his heart rate was 138 bpm. I made him sit down and relax for a bit and heart rate leveled out to normal.  He also reported he is afraid to eat that he feels nauseous. As of this afternoon 06/19/2021 he seems to be feeling better.
Five hours post vax, pt was found limp, pale, and not breathing in bed. Taken by ambulance to ER. Dx of URI made. No apnea or respiratory distress.
Shot in left arm on Friday afternoon. Pain in arm Saturday afternoon. Extreme pain in arm, underarm/arm pit, and left breast Saturday night. Pain significantly worsened by Sunday morning in underarm that resting arm on side resulted in pain. By Sunday night noticed large bruise on armpit.
Pfizer lot #FJ6369 with temp excursion. Reported to Pfizer company and ok?d for use. Instructed by their staff to report each dose given in this system.
a foot injury that happened while playing sports.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB INJURY (non-serious) with onset Apr2021, outcome "unknown", described as "a foot injury that happened while playing sports.". Therapeutic measures were taken as a result of limb injury.  Additional information: The report was not related to a study or programme. The reporter's 16 year old son was scheduled to get his second Pfizer Biontech Covid 19 vaccine at 4pm today (18May2021); At 7:30 am this morning he had been taking a prescription of ibuprofen 800 mg for a foot injury that happened while playing sports. At the time of report, the date of the injury was unavailable to the reporter, but she confirmed it was sometime after his first dose. The reporter queried if it was OK to take ibuprofen at 7: 30 am on same day as the second Pfizer Covid 19 vaccination, scheduled at 4 pm or does it interfere with the injection and the reporter does not know if the ibuprofen would still be in patient system. She just read that Ibuprofen or Tylenol should be not taken prior getting the Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Period Cramps; Itchy Skin; Rash; Heart Problems; This is a spontaneous report from a contactable consumer (patient). This 20-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Arm Left on 23Sep2021 16:15 at age of 20-year-old as DOSE 2, SINGLE (lot: FC3181) for COVID-19 immunisation. Medical history included depression, Covid prior vaccination. Medical history included depression. Concomitant drugs included ibuprofen and diphenhydramine hydrochloride (BENADRYL). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Left arm on 02Sep2021 04:15 PM at age of 20-year-old as DOSE 1, SINGLE (lot number: FC3181) for COVID-19 immunisation. She experienced Period Cramps, Itchy Skin/Rash, Heart Problems on 06Oct2021. AE resulted in Doctor or other healthcare professional office/clinic visit. No covid tested post vaccination. No treatments were received. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
COVID vaccine breakthrough case. Moderna 2/24/21 023M20A, 3/24/21 030A21A, 12/6/21 060H21A and bivalent Moderna 053D22A
This is a non-serious spontaneous case, initially received on 14-Mar-2018, was reported by a pharmacist and concerns a 59-year-old, adult, female patient. On 07-Feb-2018, the patient was administered with AFLURIA in which foreign particles floating in syringe (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT33908, expiry date: 30-Jun-2018) (explicitly coded as particle present in liquid product and drug administration error). The PTC number was PR485504. It was reported that, the patient did not experience any adverse events after the administration of vaccine. Follow-up report received on 16-Apr-2018: Vaccination date and adverse events after the administration of vaccine. Follow-up report received on 16-Apr-2018: Vaccination date and event onset was changed from 05-Feb-2018 to 07-Feb-2018. Amended narrative accordingly. Significant case correction received 14-Mar-2018: LLT for the event 'pharmacist wants to know if it is normal to have particles in the AFLURIA pre-filled syringe' was changed from 'product contamination particulate matter' to particle present in liquid product'. Amended narrative accordingly.
improvement of symptoms without nasty side effects; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "severe narcolepsy" (unspecified if ongoing); "cataplexy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "improvement of symptoms without nasty side effects".  Additional information: Patient wish to share experience of the first COVID vaccine and iatrogenic side effect and as much as patient was incredibly phobic, Patient wanted to thank for providing this necessary, preventive care. Patient have severe narcolepsy with cataplexy and have had a significant improvement of symptoms without nasty side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
All of the sudden my right eye started having "blood strings" going thru it.  I could not see them on the outside but could see them in my vision range.  I called the eye Dr. and left a message.
Pain and swelling at injection site . Vertigo , nausea and vomiting. Fatigue and muscle aches .  A few hours after receiving the second dose , The injection site was considerably  more painful and swollen than the first dose . When I awoke the morning after I experienced severe vertigo . The vertigo was made worse by head movements. This was accompanied by nausea and vomiting, body aches and fatigue
Patient had a presyncopal event immediately following vaccine administration. S/S include diaphoresis, flushing, and full body shaking most notable in the limbs. The symptoms resolved after 3-5 min and did not progress to a full syncopal episode.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients unknown ages and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with multiple doses of improperly stored LIQUID PEDVAXHIB lot # L038502 for prophylaxis, (route, dose and anatomical location not provided). The temperature and time frame were reported as follow: 47 degrees Fahrenheit to 77 degrees Fahrenheit (46.84 degrees Fahrenheit) for 15 minutes. There was no previous temperature excursion and the call was made because of a digital "data logger", There were not adverse events reported in any patients.
Severe Dizziness, Severe Nausea -- Both lasting 24 hours; resulting in being bedridden the entire time.
Bruising, petechiae on 6/8/02. Thrombocytopenia noted on 6/10/02.
Mild chill; achy joints; mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 11:30 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to raw walnuts (mildly). Concomitant medications included vitamin d nos (VITAMIN D), lysine (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), withania somnifera (ASHWAGANDHA) and hericium erinaceus mycelium (LION'S MANE); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) in the right arm on 24Mar2021 at 12:45 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. 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 COVID vaccine. On 15Apr2021 at 08:30, the patient experienced mild chill, achy joints and mild fatigue. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event mild chill, achy joints and mild fatigue was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever, dizziness, aches in joints, swollen arm at injection site, swollen lymphatic glands, rash on lymphatic surface
This case involves a patient of unknown age and gender who experienced sick (illness), while he/she received INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor and the patient's 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 (Suspension for injection) produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. Medication details and reason for taking the medicine: unknown. Reporter also stated "what you want America you will have no Freedom pretty soon people are dumbasses". It was unknown if there were lab data/results available. It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown. Result of assessment was not reported. There will be no information available on batch number for this case.
Information has been received concerning a male who on 03/13/1997 was vaccinated with one dose of varicella vaccine. On 05/24/2001, the pt presented to the physician's office and was diagnosed with shingles. Additional info has been requested.
While at home: (Location) bilateral arm. Pt. mother describes it as painful. Relieving factors include: BENADRYL. Associated symptoms include: pain. 2 days after administration of multiple vaccines, child developed marked swelling of both upper arms over the deltoid region with fever pt responded to oral BENADRYL in local E.D. No mucosal swelling or difficulty breathing.