chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart was racing; throat getting a little tight; This is a spontaneous report received from a contactable pharmacist via a Pfizer- sponsored program  and Medical Information Team. A 26-year-old male patient received first dose of BNT162b2 (COMIRNATY, solution for injection, lot number: EW0153), via an unspecified route of administration on 26Apr2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. It was reported that, the patient got the first shot on 26Apr2021, instantly he's heart was racing and 5 minutes after he felt his throat getting a little tight, after 5 minutes still tight, 2-3 minutes it resolved on its own without any medication, no Benadryl and no medical assistance, he was okay after that. Patient confirmed that he did not experienced difficulty of breathing. The patient was advised to go to the doctor's office or hospital for the second shot in case he gets an anaphylaxis or worse reactions to the second dose. He states that the symptoms were resolved in about 2 minutes on the same day. The pharmacist was asking if these were considered as a severe allergic reaction and he wants to know if the patient should get the second dose or not. The outcome of the events heart was racing and throat getting a little tight was recovered on 26Apr2021.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 at 15:00 as dose 3 (booster), single (Lot number: EW0196) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sesame" (unspecified if ongoing); "known allergies: tropical fruits" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN. Past drug history included: Biaxin, reaction(s): "Allergy: Biaxin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Events treatment included paxlovid (lot number: 6C4762), treatment start date was 12Jul2022. The patient previously receives a COVID-19 Vaccine.
Rash has gone away; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash has gone away) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash has gone away). At the time of the report, RASH (Rash has gone away) had resolved.            No concomitant medicines were reported. No treatment information were reported.
Patient was given monovalent vaccine instead of the bivalent vaccine. During follow up, patient stated they are feeling a little sick after receiving the vaccine, however they stated they are just getting over a virus they had a few weeks ago.
My dental program required me to get another 3 series of Hep B vaccines because my body apparently was not immune to the antibodies, so I went to get 3 series again. About 2 hours after I was injected with the vaccine, I started to get a migraine then I experienced dizziness, couldn't breathe, weak and drowsy, and I could not stand up straight either. This went on for about two days. I did not visit a doctors office, I could not afford to go at the time.
night sweats; swelling of lymph nodes; fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), LYMPHADENOPATHY (swelling of lymph nodes), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (night sweats), LYMPHADENOPATHY (swelling of lymph nodes), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, NIGHT SWEATS (night sweats), LYMPHADENOPATHY (swelling of lymph nodes), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Information has been received from a physician concerning a female in her 40's who was vaccinated with two doses varicella virus vaccine live (Oka/Merck) and remains VZV seronegative. At the time of the report the patient's status was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/16/08. Additional information is not expected.
Chills; Fever 100; Fatigue; Left Arm Pain; Left Arm Pit Lymph Node Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Oct2021 13:30 (Lot number: FF8841) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Aortic aneurysm" (unspecified if ongoing), notes: other medical history: Aortic aneurysm; "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: LISINOPRIL; ATORVASTATIN CALCIUM; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN D3. Past drug history included: Morphine, reaction(s): "Drug allergy", notes: known allergies: Morphine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9810, Location of injection: Arm Left), administration date: 02Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EM6198, Location of injection: Arm Left), administration date: 01Mar2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 20Oct2021 02:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 20Oct2021 02:00, outcome "recovering", described as "Fever 100"; FATIGUE (non-serious) with onset 20Oct2021 02:00, outcome "recovering", described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset 20Oct2021 02:00, outcome "recovering", described as "Left Arm Pain"; LYMPH NODE PAIN (non-serious) with onset 20Oct2021 02:00, outcome "recovering", described as "Left Arm Pit Lymph Node Pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, fatigue, pain in extremity, lymph node pain.  Additional information: Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Shot 1-27-09 reported 1-30-09 L arm sore, itchy, warm to touch with erythema.  After exam per doctor no cellulitis.  Hx D.M. Tx with Cephalexin 500 mg Tid.  Ice 3-4 x a day.  Benadryl every 6-8 hours for 24 hours.  Call if no better.
I have had seizures all my life. After receiving my vaccine, I had multiple seizures while at the vaccine location. I would have one seizure, come out of it and go right into another one. I asked for water and crackers to help pull me out of the cycle. During this time my blood pressure went up too. When I began to feel better, I walked around to show I was steady on my feet. I was able to answer questions to show that my short-term and long-term memory was good. I had a visit with my doctor afterwards. My medication was increased for a period of time and how often I took the medication and slowly taken back down.
SEVERE MUSCLE PAIN RUN DOWN NO STAMNIA HAVEING TO REST AFTER 15 MINIUTES OF WORK HEAVY PAIN IN KNEES ANKLES AN A SHOLDER REPLACEMENT NEVER ANY ISSUES WITH SHOULDER IN PAST HEAD ACHES BLURD VISION OFF AND ON OFF BALANCE HAVE NEVER HAD A REACTION TO SHOTS OR VACCINES 23 YEARS IN job THIS CRAP HAS SCREWED ME UP HAD TO TAKE IT TO KEEP MY JOB FORCED  THIS HAS BEEN ONGOING FOR 3 WEEKS NOW
Within minutes of getting the vaccine I had a brief(maybe 30 seconds) episode of dizziness. I didn't have any other symptoms during my 15 min observation period, but when I got to my car to leave the hospital, I had another episode of dizziness that lasted a couple minutes and then stopped. I didn't have any other incidents of dizziness, but started feeling fatigued and had chills that afternoon. Tuesday evening I had a slight fever, diarrhea, tachycardia, and palpitations. Over night I developed body aches.  Most of the symptoms were pretty much gone within 24 hrs, but the fatigue and tachycardia lasted into Friday. My heart rate was consistently 115-125 bpm from Tuesday evening through Friday.
Patient reported lip tingling at observation station. Given a dose of diphenhydramine 25 mg PO and instructed to take another dose in 4-6 hours.
Initial report received from a patient on 03 January 2007.  A 60 year old, female patient (with no known allergies) developed an ecchymotic area about 1-2 inches below the site 3-4 days after she received Fluzone (lot number unknown, route of administration not reported) in the deltoid on 20 November 2006.  She also stated her muscle appeared to be "bulging" and complained of soreness and weakness in the arm.  At the time of the vaccination, she was fatigued.  At the time of the report, it was reported the ecchymotic area resolved.  The patient had not recovered.
This spontaneous report as received via Pfizer from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (strength, dose, route of administration, indication, lot# and expiry date unspecified). No concomitant medications were reported. On an unknown date, the patient presented to clinic with a complaint of rash around the injection site following a PNEUMOVAX 23 vaccination. No other symptoms were reported. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. The reporter enquired if there was any literature regarding the use of PREVNAR 13 following this type of reaction from PNEUMOVAX 23. Additional information has been requested.
Low fever, Muscle Aches, Chills, BAD Headache, Swollen Lymph Nodes
gastroparesis symptoms were heightened; gastroparesis symptoms were heightened; This is a spontaneous report from a contactable consumer, the patient. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history includes ongoing gastroparesis. Concomitant medications were not reported. On an unspecified date, after the first vaccination, the patient's gastroparesis symptoms were heightened. The clinical outcome of gastroparesis symptoms were heightened was not resolved.   Information on the lot/batch number has been requested.
fever- 101.5 temperature muscle aches sore joints lack of appetite dehydrated diarrhea
did not give any APAP p/shots by 7PM had t102.5 temp was fussy, pale, had fever; taken to ER was adm; spinal tap, CBC, Blood cultures done was told was infection but was caused from the vax;
1.  The same month of my 2nd Pfizer vaccine, I developed persistent, painful inflammatory fibrocystic breast disorder.  This was highly unusual because I had this problem in my teens through 30s, however went on spironolactone for my Hydradenitis Suppurativa condition in 2016, and symptoms resolved permanently, until the month I received my 2nd Pfizer vaccine.  It was persistent lasting 9 months.   2.  I developed Adhesive Capsulitis in my right shoulder beginning in February 2022, shortly after my fibrocystic issue resolved.  It required surgery to release and many months of physical therapy.  It, too is an inflammatory condition.  It resolved by 5/23.  3.  I have now developed adhesive capsulitis in my left shoulder.  It has begun this month, 6/23.
Erythema chest, abd, back, both upper extremities. Urticaris decranon regions both arms 8 hours after vaccine
Headache, Myalgia, Arthralgia, NauseaVomiting, LIGHT HEADED Narrative:
guillain barre syndrome; Paralysis from the waist down; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 09:00 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. Medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced Guillain-Barre syndrome and Paralysis from the waist down on 21Mar2021 13:00. Adverse event (AE) resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Therapeutic measures were taken as a result of events included Intravenous immunoglobulin (IVIG) and now needing long term care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was unknown if the patient was tested for COVID-19. The outcome of the events was recovering.
4 days after receiving the shingles vaccine in his R arm, patient developed a characteristic rash in the right C8 T1 nerve root. He also had a neuralgia  that was still present as of 2-18-09. Improved though still symptomatic.
Dtap given on 8/9/04 Seen in office on 8/11/04 Rt upperarm reddened, swollen and hard to touch from shoulder to elbow.  Motrin ordered for pain.  Cold compress.
My neck, shoulder, arm, and back on the left side of my body were in pain. It hurt to love any of those muscles. This is still ongoing although the pain is less now and my neck and back are the only things sore
pre-syncopal and syncopal episodes; pre-syncopal and syncopal episodes; seizure; This is a spontaneous report from a contactable consumer.   A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 14Apr2021, at 10:00 (Batch/Lot Number: ER8731) as single dose for covid-19 immunization.  Medical history included hypertension, breast cancer, penicillin allergy, allergy to sulfa, and osteoporosis from unspecified dates. Concomitant medications included metoprolol tartrate (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; losartan (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; folic acid (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; exemestane (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported.  The patient experienced pre-syncopal and syncopal episodes and seizure on 23Apr2021, which  were serious as they involved hospitalization.  The patient was hospitalized for 2 days for the events.  The patient underwent lab tests and procedures which included blood test: negative on 22Apr2021, Covid-19 test: negative on an unspecified date, since the vaccination,  scan: no lesions on an unspecified date. Details were as follows: a week and a half after the vaccine, patient started having pre-syncopal and syncopal episodes, increasing in frequency.  After two days, patient went to the emergency room, where she had a seizure and was admitted to the hospital. Scans showed no lesions. Patient was put on Keppra, and no more seizures. Therapeutic measures were taken as a result of the events; treatment received for the adverse events included benzodiazepine, Keppra, and intravenous  fluids.  No follow-up attempts are needed. No further information is expected.
Right arm pain, nausea, generalized malaise, aching all over, joint pain, fatigue. All have resolved except slight arm pain.
2-3 hours after vaccination had swelling of arm and severe headache, crying in pain like sharp pain persistent for 1 day.  No history of migraine or previous headaches.
Shingles outbreak after first dose; This is a spontaneous report from a contactable consumer (reported for himself). A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0179, Expiration date: Unknown), dose 1 via an unspecified route of administration, in Arm Left on 18May2021 09:45 (at the age of 33-years-old) as a single dose for covid-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0185), via an unspecified route of administration, in Arm Left on 10Jun2021 10:30 (at the age of 33-years-old) as dose 2, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27May2021 12:00, the patient experienced shingles outbreak after first dose. No Health issues prior. The adverse event resulted in emergency room/department or urgent care visit. The patient received treatment with Valacyclovir. The outcome of the event was not recovered, at the time of this report.  Follow-Up (14Jul2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a female who was vaccinated IM with a 0.5ml first dose of Gardisal. Approximately 3 to 4 days after the vaccination, the patient experienced "myacitis", malaise and flu like symptoms and went to the emergency room. Subsequently, the patient recovered. Additional information has been requested.
One 3mm size vaginal ulcer appeared roughly 2 days after vaccine and continued to grow and get more painful until going to urgent care on the 5th day after vaccination. Size at day 5 was about 25mm. The day after vaccine symptoms were fever (101.3 f), malice, headache, body aches and lasted until day 3. Day 3 also presented with sore left armpit, presumably from the lymph node, although no swelling was felt and lymph node was not palpable. Sore armpit lasted until day 4.
Per phone call from parent, immunized 1/22/03 at 12:30 p.m. with DTaP, IVV, HIB, and PCV. Fever started approx 3 p.m. 105.3, right leg very red, swollen, evaluated at ER that evening. Per phone call w/parent 1/24/03. Follow-up call with parent on 1/27/03 child had been irritable day of immunization and subsequently developed URI as did other family members. Worsened(?)
Pt developed redness, warmth, tenderness & in area of muscle below the inject site in the lt arm;
It was bruised badly and had welts; It was bruised badly and had welts; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2602428-1. The original narrative from the sender is as follows:  Notes per provider during follow-up office visit as follows: "Pt was seen by another provider one week ago & received shots (Vaxelis, MMR, Varicella). Dad reports that it was bruised badly and had welts. It had spread but now it is better according to dad.  She was given an allergy med. At home."  cephALEXin (Keflex) 250 MG/5ML suspension prescription sent to pharmacy with for patient to take 2.4 mLs (120 mg total) by mouth 3 (three) times daily for 10 days.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "It was bruised badly and had welts".  No further information is expected.
fast heart rate (167 bpm); anxious; had a warm feeling; BP was 154/100 mmHg and her baseline is 100/70 mmHg; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiry unknown), via an unspecified route of administration on 29Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient experienced an AE 5 minsutes after the dose on 29Dec2020, patient had a fast heart rate (167 bpm), was anxious, had a warm feeling, BP was 154/100 mmHg and her baseline was 100/70 mmHg. The patient would like to know if she should proceed with the second dose. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested
This non serious case was received on 09 February 2009 from a health care professional. A 24 month old male patient with history of atopic eczema and dermatitis (February 2008) received a fourth dose of Tripedia (lot number U2471A) and a second dose of HAVRIX (manufacturer GSK, lot number AHAVB235) both intramuscularly in the left thigh on 29 January 2009. On 30 January 2009 the patient developed a red plaque like rash at the injection site extending to the left hip and left lower abdomen. No itching was noted. The patient had a doctor's visit on 06 February 2009. The recovery status was unknown. Follow-up information was received from the health care professional considered the event to be recovered.
Injection site became warm, red and swollen. Mother notified providers office and patient was seen by a provider.
SOB, Hives on chest, chest tightness Narrative: pt reports hives on chest, SOB and chest tightness. BP at 1200 55 systolic. Epi admin 1201, benadryl 1202, code called. VS @ 1203 147/77 HR 107 RR 24 O2 100% on Room Air. Pt stabilized by the time Code team arrives, admit to ED>
Eye lid was black; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EYE CONTUSION (Eye lid was black) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE CONTUSION (Eye lid was black). At the time of the report, EYE CONTUSION (Eye lid was black) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. Treatment medications was not provided.   Reporter did not allow further contact
Moderna COVID-19 Vaccine Vaccine Lot Number: 039B21A pt states that his tongue is tingling with no difficulty swallowing. notes of heart palpitations. vitals as noted. no allergies. 1st dose. pt denies any previous hx with anxiety. no headache, breathing difficulty, chest pain or other symptoms. 17:56 184/109 p84 r14 18:04 185/97 p82 r14 18:06 148/100 p74 r14 18;22 164/108 p14