chrisvoncsefalvay/vaers-outcomes huggingface dataset:
broke out in rash/hives all over; broke out in rash/hives all over; mild tongue swelling; sob throat felt sore and swollen; sob throat felt sore and swollen; swelling at injection site; redness at injection site; itching at injection site; feverish; This is a spontaneous report from a contactable other healthcare professional (patient).  A 33-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number=Ej1685, via an unspecified route of administration on left arm from 07Jan2021 11:00 to 07Jan2021 11:00 at SINGLE DOSE (dose 2) for COVID-19 immunisation. The patient as no known allergies, no other medical history, and no allergies to medications, food, or other products. Historical vaccine includes first dose of BNT162B2 on 18Dec2020, time=12:45 PM, vaccine location=Left arm, lot number=Eh9899.  The patient's concomitant medications were not reported. On 08Jan2021 05:00 AM, the patient experienced post vaccine swelling, redness, itching at injection site and feverish. On 13Jan2021, the patient broke out in rash/hives all over with mild tongue swelling and sob throat felt sore and swollen for a short time. The patient went to physician and received steroid injection and Benadryl.  The outcome of the events was recovering.
Fever 101 for 24 hrs, headache, sore throat, nausea, pain at injection site with swelling moderate spasms of arm vaccine given in.
Information has been received from a nurse practitioner concerning a 23 year old female who in approximately February 207, was vaccinated with the first dose of Gardasil. The patient complained of a sore arm for several weeks after the injection. The patient recovered from the sore arm. The patient does not want to return for the second dose. Medical attention was sought.
Narrative:  63 yo M w/PMH including but not limited to CKD stage 4, DM2, HLD, HTN who received J&J vaccine on 3/26/21. On 3/29, pt's daughter called the agency stating pt passed out the night of 3/28, pt did not hit his head. Pt was dizzy, low BP (99/66), P 96, and has shakes and chills. Denies facial/lip/tongue swelling/itching, hives, chest pain, SOB, wheeze, cough. Someone called EMS. Per documentation, pt presented to Medical Center ED on 3/29/21. In the ED, temp 99.5 deg F, BP 108/70, P 105, O2 sat 94% RA. Pt diagnosed with pneumonia and discharged with levofloxacin. After discharge, lactic acid resulted with 2.6 and was advised to return to the ED for admission. Pt COVID test positive. Pt was admitted for sepsis secondary to COVID-19. CXR revealed diffuse bilateral patchy opacities and consolidations. On 3/31, code blue was called and CPR was given. Pt was in sinus bradycardia, epinephrine was given, and pt progressed to sinus tach PEA but returned to sinus bradycardia. EKG was done and pt was found to be in AFib. Pt lost pulses again and was sinus bradycardia, CPR was resumed. ROSC was achieved and was tachycardic for 2 minutes, where BP dropped to 81/64 and became pulseless. CPR resumed, however ROSC was not achieved and pt was pronounced dead at 1033.
Patient bopped her head back and then forward (fainted for about one second) after receiving vaccine. Reports of low blood pressure and  dizziness
Large area on his LL that is red swollen and bigger then a 50 cent piece. He was given 2 vaccines on this leg. Upper area SQ polio and lower LVL PROQUAD SQ.
Initial report received from a health care professional on 17 September 2007. A 21-year-old male university student was reported to have received a meningococcal vaccine from Sanofi-Pasteur (trade name not reported, batch number unknown; route/site of administration not reported) in 2004 (specific date unknown). On 03 September 2007, the patient became "ill" and was admitted to the hospital. A spinal tap was performed and the patient was diagnosed with bacterial meningitis, unknown strain. The patient was treated with intravenous antibiotics. He recovered and was discharged one week later. No additional information was provided at the time of this report.
fast heart beat; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6207, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Apr2021 as dose 1, single for COVID-19 immunisation. Medical history included ongoing irregular heartbeat sometimes since 2005. Concomitant medications were not reported. On an unspecified date, the patient experienced fast heartbeat. Patient was due for the second dose at the time of reporting and asked if vaccine had anything to do with the heart. She does not know if the vaccine caused it or not, since she had it for off and on for 6-months. She was uncertain if she should take the second dose. Patient asked what the risks of the Pfizer-Biontech Covid-19 vaccine were and who should not get it. The outcome of event was unknown.  No Follow-up attempts are needed. No further information expected.
This is a spontaneous report was received from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, while reporting on herself caller mentioned that she was talking to 2 girls in her office who also just had the second Pfizer Covid vaccine and are having extended menstrual bleeding. They are not having it to the extent she is they are just having spotting. She wanted to call about that. The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021618011 same reporter/drug/AE, different patients
The adverse reaction started the morning after the vaccine was given: Redness, hotness and swelling noted in the whole deltoid muscle of the right deltoid. The arm was double the size of the non-vaccinated deltoid. Treated the swelling, redness, and inflammation with MOTRIN, ice and elevation above the level of his heart. No improvement was noted. Continued with MOTRIN every 6 hours, ice and elevation. Minimal improvement noted on the 3rd day after the injection. Note: this child received the quadrivalent vaccine last year and the year before. Two years ago the swelling was from the shoulder to the elbow, the swelling in the arm that was injected was double the size of the non-injected arm. Last year the quadrivalent vaccine was given and the swelling was from the shoulder to the mid-arm and that portion of his arm was double the size of the non-injected arm. The swelling has decreased each year, but is still abnormally swollen and very uncomfortable for the child. Is this a reaction that is seen after the influenza vaccination?
On 5/14/15 patient was taken to ER by EMS for febrile seizure. Patient's temp at the time of seizure was 103.6. ER Physician informed mom that febrile seizure was caused by MMR vaccine.
Vasovagal reaction. Patient got pale and light headed. Was given crackers, OJ and water. Felt better after about 10-15 minutes.
18 hours later patient woke up feeling stiffness in legs, shivering profusely, burning in head and neck. Fever went from 100 to 103 degrees in twenty minutes treatment included blankets, cold compresses, ice chips in mouth and Advil. Patient better 10 hours later.
Right arm swollen; Right arm very painful; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Right arm swollen) and INJECTION SITE PAIN (Right arm very painful) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced INJECTION SITE SWELLING (Right arm swollen) and INJECTION SITE PAIN (Right arm very painful). At the time of the report, INJECTION SITE SWELLING (Right arm swollen) and INJECTION SITE PAIN (Right arm very painful) had resolved.            Treatment medication was not provided.
Felt weird / funny.  Complained of heart racing.  Observed for a total of 30 minutes.  No reactons/symptoms with dose #1.  BP 157/75 and HR 124.  Felt better after eating crackers and water.  At about 30 minutes felt like heart was racing.  Taken to ED via whelel chair.  ED EKG mild sinus tachy.  D Dimer was normal.  Diagnosis was felt to be contributed to patient's anxiety.
I want to report an unusual reaction that I had to the 2nd Covid vaccination.  I rec'd my 2nd vaccination on 02/04/2021 @ approx. 5:15,  within a few hours I started to have normal and expected reaction.  Approximately 9am the next morning I passed out without any type of warning (dizziness etc)  I passed out another 2 times during Friday morning.  I stayed in bed the remainder of Friday, felt sluggish on Saturday and back to normal on Sunday.
STORAGE  IN REFRIGERATOR ( 2°C -8°C ) UP TO 30 DAYS. ( VACCINE USED AFTER 10-16-2021
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of patient.  The age at vaccination was not reported. The patient received Shingrix and had sore arm for several days. The reporter did not consent to follow up. No demographics collected for the patient, who was the husband of the reporter.
Day 1 = Extreme itching from sight of injection down the arm to elbow. Day 6 = Extreme itching at sight of injection with inflammation/swelling to 3 inch diameter including redness and heat to the touch
Lump under armpit on side that I got the vaccine  Lessened tolerance for alcohol  IBS problems - constipation and gas pain
Moderate diahrrea and moderate congested sinuses day 1 at 8pm to present
Pt. had a large projectile emesis 24 hours after shot. At exactly 48h after pt. had nonstop inconsolable crying and low grade temp 100.3 all day.
C/O Chest Pain and vomitting admitted on 3/11 and transferred.  The admission diagnosis was Acute gallstone pancreatitis. He was transferred to for an ERCP.  I requested and reviewed the records and could find no mention of the physicians concern about COVID-19 vaccination.  His physician is not attributing his illness to vaccination.
Incorrect booster given. Patient received 0.5 ml of Moderna rather that the 0.25ml booster dose
Have gone through the gamut of side effects; ranging from headaches, fever, joint and muscle aches, dizziness, fatigue, nite sweats and lack of appetite, which after 8 days,  I am experiencing the same at a lesser degree. Have been taking Tylenol which provides temporary relief.
More than four days of fever, stiff/aching joints, lethargy. Physician then treated pt for suspected bacterial infection on 7/27/18 with ciprofloxacin 10 day course and tramadol 50mg for pain.
Child broke out in rash all over.  Started on abdomen and progressed all over body.  It itched.  Child seen in office on 6/29/2010  it was a chickenpox rash all over child, back, stomach, head, arms and legs.  No fever.
Large (approximately 3' x 6") red rash on upper left arm.  Slightly swollen and itchy at first.  Swelling and itch subsided within a couple of hours.
Terrible tinnitus; This is a spontaneous report received from a contactable consumer, the patient.  A 30-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 18Mar2021 at 15:00 (at the age of 30 years old) as a single dose for COVID-19 immunisation.  Medical history included diabetes and high blood pressure.  The patient did not have any allergies to food, medication or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19 and had not been tested positive for COVID-19, since the vaccination.  Concomitant medications include NOVOLOG, OZEMPIC and insulin glargine.  On 16Mar2021 at 04:30, the patient woke up with terrible tinnitus.  The patient did not receive any treatment for tinnitus.  The clinical outcome of tinnitus was resolving. No follow-up attempts are needed. No further information is expected.
Dizziness, nausea, vertigo, lack of concentration, chills, weakness after 2nd vaccine. Heart palpitations, chest pain, weakness, profuse sweating, shortness of breath 3 months after 3rd vaccine.
devel rash on abd 1MAY97 office visit;5MAY97 papulovesicular lesions w/clear vesicles erythema - 2 crusted lesions;
Dormant small fiber neuropathy (Erythromelalalgia) on hands only became full flare 5 days after 1st dose EN6203 on 03/02/21- never before had symtoms of burning on face, ears, hands,  neck, arms, legs.  Doctor treated with prednisone and flare subsided after 10 days.  After second dose ER8732, extreme flare within 24 hours. Burning on hands, face, ears, arms, legs, feet.  Doctor treating with prednisone.
swelling at the injection site; soreness/pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site) and PAIN (soreness/pain) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site) and PAIN (soreness/pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 25-Mar-2021, VACCINATION SITE SWELLING (swelling at the injection site) had resolved. At the time of the report, PAIN (soreness/pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Swelling, pain, redness from left shoulder extending down to left elbow. Saw doctor. (Also warm to touch) antibiotic treatment.
COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 at 16:15 as dose 5 (booster), single (Lot number: 6H6964) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PEPCID [FAMOTIDINE]; SINGULAIR. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Sep2022 at 05:00, outcome "unknown" and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Sep2022) Positive, notes: Nasal Swab . Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced HERPES ZOSTER (shingles).   On 21-Jan-2021, HERPES ZOSTER (shingles) was resolving. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Numerous papular lesions scattered over body (scalp, buttocks, Abd.,legs) several are vesicular. Mom noticed it last noc (ov 8/1/2006).
red sore  itchey arm 7 by 3.5 cm 6/8/7
body ache; chills; tiredness; hard to walk; muscle pain; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 17:45 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "body ache"; CHILLS (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "chills"; FATIGUE (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "tiredness"; GAIT DISTURBANCE (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "hard to walk"; MYALGIA (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "muscle pain"; HEADACHE (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "headaches". Therapeutic measures were taken as a result of pain, chills, fatigue, gait disturbance, myalgia, headache.  Additional information: Seriousness criteria reported as No. No structured information (Patient episode name). After 24 hours of shot patient start to have body aches, chills & tiredness, at one point it was hard to walk due to muscle pain, headaches started 48 hours after. No Hospitalization Prolonged. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. The treatment received for the adverse event was Tylenol.  Follow-up attempts completed. No further information is expected.
Patient was given 2nd dose of the series too early; administered 21 days after 1st dose.
I broke out with hives all over my body which I have the pictures to prove and my muscles in my leg makes me feel like my legs are giving out on me I wasn?t having these problems until I took the shot it is abnormal for me and I?m scared.
I developed tachycardia at rest exactly 2 weeks after having the second dose of Pfizer vaccine. My heart rate while resting was 100-115 and increased to 130s-140s with standing or walking. I went to the emergency department at hospital. They observed that my heart rate was in the 135-140 range sitting in triage. I received some fluids and was discharged after it was determined there was no clear life threatening reason for the tachycardia, but my heart rate remained unusually elevated - sometimes up to 115 while siting and rising to 120s-130s with any physical activity for about a week after this event. It seems to be gradually improving at this time, but workup is still in progress.
1st dose over 42 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose over 42 days ago) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN DETEMIR (LEVEMIR) and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose over 42 days ago). On 13-Apr-2021, PRODUCT DOSE OMISSION ISSUE (1st dose over 42 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received 28-Jul-21: Updated narrative to reflect patient receiving guidance.
muscle in the exact area became very sore and tender to touch,; Booster; Soreness from the injection / It is now over three weeks since being vaccinated, and, while I can move the arm without trouble, it continues to be sore, aching, and tender in the same place; soreness now radiating to my upper shoulder and neck.; soreness now radiating to my upper shoulder and neck.; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Oct2021 at 14:30 (at the age of 68-year-old), as a single dose for COVID-19 immunisation. Medical history included sicca syndrome, celiac sprue, allergy to sulfa and cow's milk. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included levothyroxine sodium (LEVOXYL) for unspecified indication from unknown date and unknown if ongoing. The patient previously 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 18Feb2021 at 15:00 and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 15:00; both as a single dose for COVID-19 immunisation. On 11Oct2021, about a week after initial soreness from the injection subsided, muscle in the exact area became very sore, tender to touch without redness or swelling. It was three weeks (at the time of reporting) since patient got vaccinated and while patient could move the arm without trouble, it continued to be sore, aching, and tender in the same place with soreness radiating to upper shoulder and neck. The events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness from the injection, muscle in the exact area became very sore, tender to touch without redness or swelling, soreness radiating to upper shoulder and soreness radiating to neck was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.