chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Angioedema; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 24Jun2021, as dose 1, single for COVID-19 immunization. Medical history included angioedema (She experienced angioedema before getting her first dose of the vaccine and was all cleared up). Concomitant medications were not reported. The patient wanted to ask if there are some reports of any types regarding angioedema. On an unknown date in 2021, the angioedema came back again so she wanted to know if she could take the second dose or wait for it to clear up. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Hives at injection site, moved to other limbs, antihistamine administered orally at 12:30 PM.
Flulaval administered after temp excur; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 24-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 334RL, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter reported that Flulaval underwent above temperature excursion with high 67 degree F for 14 days and was administered to a patient, which let to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This case is one of 6 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040252:Same reporter US-GLAXOSMITHKLINE-US2022040253:Same reporter US-GLAXOSMITHKLINE-US2022040254:Same reporter US-GLAXOSMITHKLINE-US2022040246:Same reporter US-GLAXOSMITHKLINE-US2022040248:Same reporter
PATIENT RECEIVED THE 2ND SHINGRIX DOSE ONE MONTH AFTER THE FIRST DOSE (04/18/2023).
2/26/21-Received Moderna Vaccine 3/4/21-Redness, swelling on arm, fatigue. Left side of face went numb. Went to ER. Doctor diagnosed Trigeminal Neuralgia and gave me an IV of Benadyrl and sent me home. Prescribed me Carbamazepine and referred me to Neurologist and PCP. 3/6/21-Sharp pain on left side of face. Pain behind left ear 3/7/21-Lost hearing in left ear 3/8/21-Went to PCP. Prescribed me a steroid-Prednisone and referred neurologist and did hearing check. 3/9/21-Itching and tingling throughout entire body, sharp pain on left side of face. Called PCP, uppsed the dosage on the carbamazepine 3/10/21-tingling in whole body, pain in face area 3/11/21-Extreme weakness, couldn't walk. Blood pressure was high. Went to ER. Did CT Scan and came back normal. Referred neurologist. Joint and arm pain where shot was-still hot and red 3/12/21-Called neurolgist-made appointment  3/15/21-Went to Neurologist-Ordered an MRI. Suspected MS.  3/17-Went to ENT Doctor for hearing-said nerve was inflamed and gave steroids 3/16-3/20-Extreme pain and weakness. Could hardly walk, talk, or move 3/20-MRI was done 3/21-Spine and Back began to hurt  3/22-MRI results showed 6 T2 Lesions in the brain and a bulging disc with scoliosis in the cervical spine 3/23-Went to neurologist-was explained the lesions and he ordered a lumbar puncture to see if it's MS 4/7-Lumbar Puncture at hospital 4/20-Spinal Puncture showed fluid was normal and not MS. Neurologist said B12 levels were extremely low and thyroid was off. He also stated that the vaccine caused the neurological problems and said would take months/years for neurological symptoms to go away 5/19-Extreme back and spinal pain. Went to ER and had MRI done. It showed bulging disc, degenerative disc disease and a pinched nerve. Was given prescriptions
Began noticing extreme soreness first. Then below the injections redness started first in a couple spots, then enlarged. Afternoon progressed to chills and fever and aches throughout my body. I ended up in bed for most of the next 48 hours. Finally now the evening of 11/17/12 I'm feeling better, though my arm is still very sore. I've taken Theraflu, Nyquil, Aleve, Aspirin, Flexeril...
This spontaneous report was received from a registered nurse who reported that ROTATEQ, 2 ml, oral (lot # not reported) was given to multiple unspecified subjects after the vaccine was exposed to temperature outside of recommended condition. No adverse events were reported after the vaccine was administered. This is one of several reports from the same reporter source. Additional information has been requested.
Narrative:  Pt was not feeling well 2 days prior to death; did not want to go to hospital; passed away sleeping
Almost exactly 12 hours after receiving the booster the chills and body aches hit like a frieght train.  I went to bed and was sweating, running a low grade fever.  Woke the next morning still feeling horrible, but now had a very bad headache.  For the next 2 days I had the headache and would run a low grade fever off and on.  I had lump in my armpit on my left arm and a lump near my collar bone on my left side.  My wife made me go to an urgent care on the 3rd day because of the lumps.  By the time of my appointment I was feeling much better.  The doctor at urgent care said he thought it was swollen lymph node or glands not sure which he said.
PRESSURE AND CHEST PAIN. DIFFICULTY BREATHING. SEVER PLEURISY.
Patient (this writer) developed very specific obvious numbness in left mouth including tongue and teeth. No clear weakness, droop, aphasia. Also, disequilibrium without syncope. Symptoms lasted about 40 minutes and seen in ER with consideration for possible TIA with negative MRI done. Patient discharged after negative MRI and put on ASA 81 daily and to have follow up with neurology. No further symptoms since event and health has returned to baseline.
This was my 2nd vaccine. At 12:00pm, I had chills and numbness and tingling in all my fingertips. The numbness and tingling lasted about an hour. At 6:00pm, I continued with chills, body aches and ran low grade fever of 100. My face got very hot, was slightly short of breathe and extremely tired. That lasted about 2 hours. The next day, I was fine. Then on 4/16/2021, I had very similar symptoms. Woke up early that morning with chills, body aches and extreme fatigue. Had negative Covid test on 4/17/2021. Those symptoms continues for 3 days. Even though I had alternating chills with sweats, I never had a fever when I checked. Felt the same way  I did after the 2nd vaccine but symptoms lasted longer.
A few hours after receiving the vaccine I got a sore arm from the injection site. The next day late in the evening I developed episodes of tachycardia with shortness of breath, dizziness, chest pain, and chest discomfort to the point where I had to get put onto a Holter monitor.  The monitor saw episodes of the tachycardia. My lowest heart rate was 46, which is normal for me when I sleep, and up to 156. I had to give up caffeine because of the episodes from the tachycardia that  was getting. The Holter monitor also noticed a Wenckebach once.
I have a constant high-pitched ringing sound that will not stop. I noticed it first in my bedroom/house, but it is still present when I travel outside my home into the community. It is really persistent and loud and worrying. Has been going on since right after I got vaccinated.
Around the 18 minute mark began having an odd facial sensation.   There was intermittent tightening feeling at eyebrows and across forehead that would then flutter/spasm, subside, then repeat.  The episodes would last 1-3 seconds intermittently for 25-30 mins. No treatment was sought, it did not affect any daily functions.
Pt recv vax 30MAY95 & exp full blown rash on the trunk, extremities & face; No further details were provided;
Patient received his first dose of covid-19 vaccine. Patient came back 10 minutes later and complained that his right palm had turned yellow. Of note, left palm was of normal color. Patient was able to speak clearly. 911 was contacted and came. Patient was given a dose of epinephrine 0.3 mg in the right thigh. Patient went home after 20 minutes and declined hospital consultation.
Information has been received from a physician concerning a 21 year old female who prior to March 2009 was vaccinated with three doses of GARDASIL (lot # not reported). On 17-MAY-2010 the patient experienced + atypical squamous cells of undetermined significance (ASCUS) and + High Risk (HR) Papilloma viral infection (HPV). The patient did not seek medical attention. At the time of the report the outcome of + atypical squamous cell of undetermined significance (ASCUS) and +HR Papilloma viral infection (HPV) were unknown. This is one of several reports received from the same source. Additional information has been requested.
pt reported by ER MD had 10min febrile sz @ 1015AM 6AUG98 @ home;was transported to ER via ambulance;had LP, CBC, blood cult, infect disease consult;dx febrile sz secondary to immun rxn;
Information has been received from a registered nurse concerning a 15 year old female who was vaccinated with VARIVAX (Merck) first at a different office. Then about 6-7 days later, she received DEPO-PROVERA at this office. Some time after the DEPO-PROVERA, the patient experienced swelling at the VARIVAX (Merck) injection site. The area was about the size of a 1/2 dollar, was red and hot. The sought medical attention by having an appointment. Follow up information has been received from the registered nurse concerning this 15 year old (also reported as 14 year old) female with no pre-existing allergies, birth defects or medical conditions who on 30-APR-2009 (also reported as 03-MAY-2009) was vaccinated subcutaneously into left arm with a first dose of VARIVAX (Merck) (lot # 662575/0045Y). On 13-MAY-2009 the patient presented to the clinic, she had nodules at the site and erythema. There were no laboratory or diagnostic studies performed. The patient was given AUGMENTIN for cellulitis. At the time of the report, the patient recovered on an unspecified date. No further information was available.
Lightheadedness; This is a spontaneous report from a contactable pharmacist. A 52-year-old male patient started to receive bnt162b2 (BNT162B2, lot number EJ1685), intramuscular from 19Dec2020 10:45 to 19Dec2020 10:45 at a single dose for an unspecified indication. Medical history included hypertension. The patient's concomitant medications were not reported.  The patient experienced lightheadedness on 19Dec2020 11:00 and took ondansetron. The outcome of the event was recovered on 19Dec2020.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a female patient who received FLULAVAL QUADRIVALENT (batch number K5T45, expiry date 31st May 2018). On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain and runny nose. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the runny nose was recovering/resolving. It was unknown if the reporter considered the injection site pain and rung nose to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced pain at injection site which lasted up to 3 days. No medical treatment was needed. The patient's experienced pain at injection site which lasted up to 3 days. No medical treatment was needed. The patient's symptoms were subsided. The FLULAVAL QUADRIVALENT multi dose was the only vaccine given. No additional information was provided. The reporter requested to contact the nurse for further follow ups. It was reported that only one patient experienced runny nose out of the 5 patients, however, it was unknown that which patient had experienced it. This case was one of the 5 cases, reported by the same reporter.
sleeping longer; sore throat; body aches; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping longer), OROPHARYNGEAL PAIN (sore throat), PAIN (body aches), NAUSEA (nausea) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HYPERSOMNIA (sleeping longer), OROPHARYNGEAL PAIN (sore throat), PAIN (body aches), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (sleeping longer), OROPHARYNGEAL PAIN (sore throat), PAIN (body aches), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Arm was sore and in pain; Injection dripped off; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE DISCHARGE (Injection dripped off) and VACCINATION SITE PAIN (Arm was sore and in pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-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) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE DISCHARGE (Injection dripped off). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was sore and in pain). On 22-Feb-2021, VACCINATION SITE DISCHARGE (Injection dripped off) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm was sore and in pain) 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.   No concomitant medications were provided No treatment information provided
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 60 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 at 12:30 as dose 1, single (Lot number: EN6198), in right arm, on 17Mar2021 at 11:15 as dose 2, single (Lot number: EN6206), in right arm, on 04Oct2021 as dose 3 (booster), single (Lot number: EW0217), in right arm and on 20May2022 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IRBESARTAN.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Patient came in for his appointment for a bivalent booster but he received a 4th dose of the primary series monovalent Pfizer vaccine instead of the bivalent Pfizer booster. The immunizer informed the patient of the vaccine error and scheduled the patient for a bivalent Pfizer booster appointment 2 months from now. Patient was okay with the plan and he left the vaccine clinic without any adverse reactions after waiting the 15 minutes after his Covid shot.
W/in a short time p/DTP given pt c/o "things looking funny" & then "threw-up"; Pt sent home from school & cont w/vomiting & h/a; t103.6 AX; Cont w/fever, lethary & h/a most of 2nd day; localized swelling & soreness @ inject site;
muscle aches; Chills; This is a spontaneous report from a contactable other health professional (reported for himself). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided) (Pfizer EH 9899), intramuscularly on 21Dec2020 10:30 at single dose on right arm for COVID-19 immunization. Medical history included hypertension (HTN) and No known drug allergies (NKDA). The patient's concomitant medications were not reported. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced chills and muscle aches on 22Dec2020 02:30. The events were non-serious and no treatment received per the reporter. The outcome of the events was recovered on 22Dec2020.  Information on the Batch/Lot number has been requested.
Pt c/o headache after covid19. Pt noes report he has hx of migraines, pt has not hydrated throughout the day. Vital signs 118/80, HR 92, RR 18, spO2 98%.
approx 15 mins p/inject, pt c/o h/a-went for APAP-while standing, felt everything go black; according to bystanders pt fainted & had some jerking motion of extremities; BP 78/52, P60; lasted 5-10 sec no post ictal; prob vaso vagal react;
1day after my vaccine I had fever, body aches, headache. 13 days after this vaccine my sense of smell and taste are almost gone.  I also had this happen also 12 days after my 1st vaccine and both my COVID swabs were negative then.
Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Vomiting; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema, vomiting and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, vomiting, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema, vomiting and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck, vomitting and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 1 of 9 linked cases reported by same reporter.
gave second moderna dose 21 days after 1st dose given 6/28/21 - Not the 28 day inverval
Sore arm; Fatigue; Slight elevated temperature (1 degree); Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 06Apr2021 at 08:15 (at the age of 23-year-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history and did not have a history of allergies to food, medications, or other products. The patient received unspecified birth control medications within two weeks of vaccination. 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 vaccination. Since the vaccination, the patient had been tested for COVID-19. On 06Apr2021 at 12:00, the patient experienced sore arm, fatigue, chills and slightly elevated temperature (1 degree). The patient underwent lab tests and procedures which included nasal swab test on an unknown date and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the events sore arm, fatigue, chills and elevated temperature was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown), in right arm and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: eggs" (unspecified if ongoing); "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; ZINC; LEVOTHYROXINE. Past drug history included: Known allergies: baccitracin, reaction(s): "Known allergies: Baccitracin".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with blurred vision after the first vaccine. After the second, I had double vision, dizziness, felt like I was floating instead of walking, unsteadiness and fatigue.  After a couple of months, I couldn't swallow, I spoke like I had a stroke and I had droopy eyelids.  Eventually ended up hospitalized and diagnosed with musk myasthenia gravis.