chrisvoncsefalvay/vaers-outcomes huggingface dataset:
brain fog; headache/in the back of the head, but moved around too, sometimes in the front. Has affected his balance; headache/in the back of the head, but moved around too, sometimes in the front. Has affected his balance; dizziness/had to stop driving a couple times/Had to stop a couple times while driving home from vaccine facility; Aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 (Batch/Lot number: unknown) at the age of 50 years 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: FEELING ABNORMAL (non-serious) with onset 19Feb2021, outcome "recovered" (2021), described as "brain fog"; HEADACHE (non-serious), BALANCE DISORDER (non-serious) all with onset 19Feb2021, outcome "recovered" (2021) and all described as "headache/in the back of the head, but moved around too, sometimes in the front. Has affected his balance"; DIZZINESS (non-serious) with onset 19Feb2021, outcome "recovered" (2021), described as "dizziness/had to stop driving a couple times/Had to stop a couple times while driving home from vaccine facility"; PAIN (non-serious) with onset 19Feb2021, outcome "recovered" (2021), described as "Aches and pains".   Additional information: Patient started developing symptoms like brain fog, headache, and dizziness within a day after first dose. He had to stop driving a couple times. When he had Brain fog symptom, he felt like at times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is but can't find the words to say. He cannot carry on a conversation intelligently. Brain fog Thinks in the back of the head, but moved around too, sometimes in the front. Has affected his balance. All symptoms from the first dose went away within 3-4 days. Reporter said patient recovered completely from symptoms associated with first dose. Reporter seriousness for First dose events Brain fog, headache, dizziness, aches and pains was unspecified. He had not received any prior vaccinations within 4 weeks and no adverse evets occurred after prior vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Significant personal stress; Tiny bumps; This case was reported by a consumer via interactive digital media and described the occurrence of stress in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. In July 2022, between 1 and 2 years after receiving Shingrix, the patient experienced papular rash. On an unknown date, the patient experienced stress. On an unknown date, the outcome of the stress and papular rash were unknown.   It was unknown if the reporter considered the stress and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient was 2 years post double Shingrix vaccine and had been under significant personal stress. The patient recently had tiny bumps in the past month. Additional Supportive Information: Follow up would not be possible as contact details were not provided.
RINGING ON THE LEFT EAR; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced ringing on the left ear. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from ringing on the left ear. This report was non-serious.
Patient received initial COVID-19 vaccine, which was Johnson & Johnson. She received a Pfizer vaccine as a booster. Complaint of sore arm and dull headache. Spoke with health department and no revaccination required.
Approx 10 minutes after administration, patient was playing, and then suddenly symptoms developed.   Projectile vomiting, (numerous times), lethargy, flushed skin, and rash-given benadryl.  Symptoms worsened-given Epi- EMS called.
L arm swollen down to elbow, warm to touch. Tx CeHN 25mg bid x 1 wk, Pediapred TID, Benadryl prn. C/O L arm swollen from his injection he received 8/12/02 (DTaP). Meds Tylenol prn. C/O rash under L arm and both ears. Omniset x 2 week areas itch. Left upper arm deltoid area is swollen, firm and tender to touch. Allergic reaction to vaccine injection, Ceftin 250mg/3 bid x 1w. 8/26 called to follow up told by a pt's left arm's problem had resolved.
Extreme irritability starting 2 hours after vaccine lasting 24 hours (still unresolved). Tactile temperature.
patient received third dose Menactra in the left deltoid instead of Bexesero, no AE; Initial information received on 04-Jun-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 18 years old male patient who received 0.5 ml third dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6594AB, expiry date:21-May-2021) via unknown route in the left deltoid on 04-Jun-2020 for prophylactic vaccination instead of MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV [BEXSERO] not produced by Sanofi Pasteur (lot number and expiry date: not reported).  The patient past vaccination included two doses of Menactra when he was 11 year old and 16 year old. No concomitant medication received by the patient.  The patient medical history, medical treatment and family history were not provided.  It was a case of an actual medication error due to wrong vaccine administered.  It was reported that patient was given a third dose of Menactra in the left deltoid. This third dose was given by mistake instead of the intended menigococcal B vaccine, Bexsero.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Localized swelling and erythema, pruritis + 10 cm diameter around injection site. No systemic side effects. Patient feels well except for localized symptoms.
pt reports he has syncopal/near syncopal events when giving blood. Today he was 10mins post-vaccination and felt dizzy/faint. Pt was helped to the floor/no trauma experienced. He was clammy/cool; PERRL, no LOC. Vitals assessed and noted. 0917: BP: 122/62 P 71 Resp 18; 0930: BP 120/76 P 66 Resp 16 98%; BGL 130.Pt reported feeling normal after 10-15mins rest and observation
tiredness; This is a spontaneous report from a contactable consumer reported for herself that a 39-year-old female patient (not pregnancy) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: ew0172), via an unspecified route of administration, administered in arm left on 30Apr2021 15:00 (at the age of 39-year-old) as 1st dose, single dose for COVID-19 immunisation.  Medical history included only allergies.  There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnose with COVID-19.  The patient did not been tested for COVID-19 post vaccination or since the vaccination.  The patient experienced tiredness on 05May2021 in between first dose and second dose.  No treatment received.  Outcome of the event was resolved in May2021.
Tingling/burning in left arm then rash down whole arm appeared that night.  Rash was local to just the left arm.  Also very tired.
PATIENT RECEIVED 1ST DOSE OF MODERNA AT 9:10 AM.  AT 940 SHE REPORTED TO THE MONITOR THAT SHE HAD A TINY SHARP PAIN TO LEFT SIDE OF CHEST THAT CAME AND LEFT QUICKLY.  SHE STATES THIS PAIN HAPPENED 4 TIMES DURING HER MONITORING TIME.  SHE STATES SHE HAS THIS TIME PAIN FROM TIME TO TIME.  SHE STATES NO MORE PAIN AFTER THOSE 4 EPISODES.
Sore injection site; This is a spontaneous report from a contactable other HCP. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscularly on 22Dec2020 02:45 PM in left arm at single dose for covid-19 immunization. The COVID-19 vaccine was administered at hospital. Medical history included diabetes. The concomitant drugs were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore injection site on 23Dec2020 05:00 AM. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of event was recovering.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Iritis (R) eye 36 hrs after 1st dose Iritis (L) eye 48 hrs after 2nd dose Seen by optometrist. Rx'ed with Prednisolone drops. Resolved in 48 hrs
Off balance/dizzy/vertigo since 8/14/21 Treatment: Went to urgent care 8/16/21 , given meclizine but did not improve symptoms (1 dose) Near constant-still in progress, better with stationary activities, worse with movement of body and head
first dose of Shingrix in 2019. Has not received a 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details reported for 1st dose of vaccine.
had knee and hip replacement; had knee and hip replacement; This is a spontaneous report received from a contactable Consumer or other non HCP (patient) for a Pfizer sponsored program.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) "around Feb2021 or Mar2021" as single dose for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: just had knee and hip replacement for his arthritis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, Lot # unknown), for COVID-19 immunization. The following information was reported: ARTHRITIS (medically significant), ARTHRITIS (medically significant), outcome "unknown" and all described as "had knee and hip replacement".  No follow-up attempts are possible. No further information is expected.
01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and head congestion/sinus congestion, eyes hurt and bright red.   07:00am temp 99, took Tylenol 1000mg.  10:00am weakness and severe body aches and difficulty getting out of bed and almost fell several times and reported skin hurt.   2:57PM temp 102.7, took Tylenol 1000mg and Motrin 800mg , 06:00pm temp 100.4 took another 1000mg Tylenol and continued with symtpoms through the night and woke up around 3:30am 01/09/2021 soaking wet with sweat.  01/09/21 1:50pm continues with mild body aches and moderate headache.
10am Patient alert and oriented,  and  C/O Metallic taste in mouth, Left arm to neck pain and swelling, SOB. Site Leader  informed and patient monitored.  911 called, Patient gave consent to administer Epipen per 911 advise. VS taken 182/84 B/P, 92 R.  10:10am EMT arrived. Patient consented to transporting to hospital accompanied by son. Empty Epipen given to EMT
3 am woke to shortness of breath,  and back felt hot as if blisters were on back, and right arm painful.   Treatment:  cold compresses to affected area and took inhaler (symbacort 2 puffs x 1), took a xanax in case it was a panic attack.   felt relief after 3 hours (6 am approximately)  Inhaler did not help observed symptoms for about 1-2 hours and felt things were starting to subside.
Headache; chills; Right sided facial drooping; Right sided facial drooping and swelling; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Right sided facial drooping) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. HR002B021) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced FACIAL PARALYSIS (Right sided facial drooping) (seriousness criterion medically significant) and SWELLING FACE (Right sided facial drooping and swelling). On 11-Apr-2021, the patient experienced HEADACHE (Headache) and CHILLS (chills). At the time of the report, FACIAL PARALYSIS (Right sided facial drooping), SWELLING FACE (Right sided facial drooping and swelling), HEADACHE (Headache) and CHILLS (chills) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FACIAL PARALYSIS (Right sided facial drooping) and SWELLING FACE (Right sided facial drooping and swelling) to be possibly related. No further causality assessments were provided for HEADACHE (Headache) and CHILLS (chills).    Description: On 07 Apr 2021, the patient experienced right sided facial drooping (medically significant) and swelling. The patient also experienced chills and headaches on 11 Apr 2021. The symptoms (chills and headaches) went away and resurfaced on 14 April 2021.  No concomitant medications were reported.   The patient took extra strength acetaminophen with good effect for headache and chills. The patient was also prescribed valacyclovir (Valtrix, 1 grams, TID for 7 days) and prednisone (60 milligrams, QD) for ight sided facial drooping and swelling.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Case upgraded to serious. Serious event Facial droop and non-serious event of Facial swelling added. Dosing details and action taken with suspect product updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 65 year old male patient. There was none pertinent medical history, concurrent conditions or drug reactions/allergies reported. On 29-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # M018593, expiration date 28-JUN-2017 (concentration and dose were not reported). administered via subcutaneous . Concomitant therapy was not reported. On 25-AUG-2016, the patient experienced a rash on his neck with associated herpetic neuralgia (post herpetic neuralgia). The patient saw a health care professional (HCP) who ordered Acyclovir for the rash. Varicella Zoster Virus lgG ELISA kit/(VZV) was offered and refused. Packet not faxed. At the reporting time, the outcome of post herpetic neuralgia and neck rash was reported as not recovered. The relationship between ZOSTAVAX and the events was unknown. A product quality complaint (PQC) was not involved. Additional information has been requested.
Body aches, headache, pain in the injection, nausea, diarrhea, sore throat, running nose, chills, difficulty breathing, stuffed nose, overly tired
Narrative:  Patient declines to receive flu vaccine as he previously experienced ADRs of flu like symptoms.
Very high temperature got up to 104.5 gave TYLENOL & ibuprofen every 4 hrs dropped to 101.5 then went back up to 103.5 in the early morning hours.
slight arm discomfort; This is a spontaneous report from a contactable consumer (patient). A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, via an unspecified route of administration, administered in Arm Right on 05Feb2021 13:00 (Batch/Lot Number: EN9581) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously administrated first dose of BNT162B2 (Batch/Lot Number: EL3249), on 15Jan2021, at 01:00 PM, administered in Left arm for COVID-19 immunisation and experienced cold/chill sensation at injection site, bleeding through bandage (ceased quickly), residual discomfort at injection site and very large bruise at injection site. The patient experienced slight arm discomfort on an unspecified date. The report considered as a non serious. The outcome of the event was reported as unknown.
Sudden onset of multiple eye floaters and film in and over right eye. Dr. appt. within 4 days, performed tests and examination. Gave instructions come back in 3 weeks. Had second vaccine in between. Dr. retested and examined again. Only one floater remained. Received instructions to follow up in one year.
pain in rt shoulder, unable to lift arm above head without pain..tried moist wrap; Tylenol, but not much relief.  the symptoms are more severe in the early A>M>, but is much less in the midafternoon;
seizure like activity and syncope; syncope; This spontaneous report was received from a nurse prescriber via a company representative and refers to a currently 15-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis (recommended by Centers for Disease Control and Prevention (CDC)). On an unknown date (reported as after receiving a first dose), the patient experienced seizure like activity and syncope. The patient sought medical attention. She was in the office. As a treatment, she had her legs elevated, making her comfortable. The outcome of seizure like activity and syncope was reported as recovered/resolved (unspecified date). The causality assessment between suspect therapy and the events was not provided by the reporter.  Upon internal review, both events were considered to be medically significant.
Injection site has a lump/knot under skin, appears red and is hot to the touch. Itches and it's very tender.
fever; muscle ache; headache; felt awful for 4-5 days; This case was reported by a physician via call center representative and described the occurrence of fever in a adult 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 fever, muscle pain, headache and feels awful. On an unknown date, the outcome of the fever, muscle pain and headache were unknown and the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the fever, muscle pain, headache and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult per the vaccine indication. The patient felt awful for 4 to 5 days with fever, muscle ache, headache. No further details were provided.  The reporter consent to follow up. This case has been linked with case US2020178097, US2020AMR178687 and US2020178096 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178096:same reporter US-GLAXOSMITHKLINE-US2020178097:same reporter US-GLAXOSMITHKLINE-US2020AMR178687:Original Case : US2020178099 (same reporter)
feels tense; anxiety; tired; felt like crap; slept for 2.5 hours; hot flashes; very dizzy /dizziness lasted 5 hours; became nauseated; headaches; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (arm was sore), HOT FLUSH (hot flashes), NAUSEA (became nauseated), DIZZINESS (very dizzy /dizziness lasted 5 hours) and HEADACHE (headaches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 38K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, Essig monthly injection for Migraine, ALENDRONATE SODIUM (FOSAMAX) for Osteoporosis, ALPRAZOLAM (XANAX) for Vertigo.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 29-Jan-2021, the patient experienced PAIN (arm was sore). On 31-Jan-2021, the patient experienced HOT FLUSH (hot flashes), NAUSEA (became nauseated), DIZZINESS (very dizzy /dizziness lasted 5 hours), HEADACHE (headaches), CHEST DISCOMFORT (felt like crap) and INSOMNIA (slept for 2.5 hours). On 01-Feb-2021, the patient experienced FATIGUE (tired), TENSION (feels tense) and ANXIETY (anxiety). On 31-Jan-2021, DIZZINESS (very dizzy /dizziness lasted 5 hours) had resolved. At the time of the report, PAIN (arm was sore), HOT FLUSH (hot flashes), NAUSEA (became nauseated), HEADACHE (headaches), FATIGUE (tired), TENSION (feels tense), ANXIETY (anxiety), CHEST DISCOMFORT (felt like crap) and INSOMNIA (slept for 2.5 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 31-Jan-2021 she reported she took a Xanax and went to bed.
Left deltoid is swollen, hard to the touch, skin is warm and red, no complaints of itching or pain.
On 8NOV92 pt became fever of over 104 & lower part of back aching, weak & sick @ stomach; went to MD had bad kidney infection w/bacteria & blood in kidney;
Within the first hour my left arm was already feeling sore. Within 6 hours I began "not feeling good", I felt hot, nauseous, coworkers reported me looking pale. swarmed with nurses giving me water, cold/wet towel, and temperature taken= afebrile. I was able to finish my shift. My body was aching and I felt as if I was "coming down" with something that night. By the next morning  I felt nauseous, body aches, muscle tightness, chills, low grade fever, and fatigued. I took 1- 500mg  acetaminophen and 400mg ibuprofen x 2 that day. My fever broke around 6pm on 01/02/2021. I had a good night sleep and felt fine the next day. I did have Covid over 5 months prior.
Half-body numbness on right side, lasted 12 hours with residual numbness thereafter. ER visit which referred me to my primary care facility. Heart dysrhythmia/V-tach episodes on daily basis.