chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slept for two days due to fatigue; reddness at injection site that seems to be spreading down to her mid-arm; fatigue; warm to the touch; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced sleepiness (Verbatim: slept for two days due to fatigue). On 26-AUG-2023, the patient experienced erythema of extremities (Verbatim: reddness at injection site that seems to be spreading down to her mid-arm), fatigue (Verbatim: fatigue) and skin warm (Verbatim: warm to the touch).  In AUG-2023, the outcome of the sleepiness was resolved.  On 28-AUG-2023, the outcome of the fatigue was resolved (duration 2 days). The outcome of the erythema of extremities was not resolved and the outcome of the skin warm was not reported.   It was unknown if the reporter considered the erythema of extremities, fatigue, skin warm and sleepiness to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, fatigue, skin warm and sleepiness to be related to Shingrix.   Additional Information: GSK Receipt date: 30-AUG-2023 The patient reported that she received her first Shingrix vaccine on 25 Aug 2023 and the next day she noticed a redness around at the injection site that seems to be spreading down to her mid-arm.  The patient reports the redness was warm to the touch but does not itch and on 26 Aug 2023 she slept for two days due to fatigue.  The patient states that the fatigue resolved after two days and she will contact the doctor if the redness, on her left arm, did not resolve or improve by Friday. The reporter did not consent to follow-up.
Over active immune system that led to photosensitivity.; Rash to face; Rash to scalp; Rash to arms.; Hair loss; All areas exposed to sun and heat; This is a spontaneous report from a contactable other hcp (Patient). A 51-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL1283, Expiration Date: not reported) via intramuscular, administered in right arm on 12Jan2021 14:30 as dose 2, single for COVID-19 immunization. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EH9899, Expiration Date: not reported) via intramuscular, administered in left arm on 22Dec2020 13:00 as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus, hypertension well managed, hyperlipidemia well managed and sleep apnea. The patient had no known allergies. The patient did not received any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. The patient experienced over active immune system that led to photosensitivity, rash to face, rash to scalp, rash to arms, hair loss, all areas exposed to sun and heat on 25Jan2021. The patient underwent lab tests and procedures which included red blood cell sedimentation rate increased: 59 on 25Jan2021. AE resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with Topical steroids, antihistamine Allegra, pepcid AC, singulair as the result of events. The outcome of the events were not recovered.; Sender's Comments: Based on the information given in narrative, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
flu; Initial information received on 30-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown age and unknown gender patient who had flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history included Pneumonia. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumonia shot   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for prophylactic vaccination (Immunisation)  On an unknown date the patient had non-serious event flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was  reported "I got a flu and pneumonia shot - and still flu got to me but not as bad as when I had pneumonia in the summer- home recovering "  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event flu.
30 year old (currently, 26 at time of vaccine) white female. Tolerated past immunizations without difficulty except for local reactions worsening with each subsequent dose of anthrax vaccine. Most recent anthrax vaccine (6) was given in August 2004. Describes pain swelling, redness, heat in the left upper arm. Symptoms began within 2-4 hours, worsening over 24-48 hour, and resolving within 5 days. Denies significant systemic symptoms. Pain at vaccine site described as "discomfort" and its peak, pain intensity rated as 2/10 using pain scale of 0 ("no pain) to 10 (=worst pain ever experienced). Pain limited to vaccine site and surrounding area. Pain did not decrease functional capacity. Service member did not seek evaluation of pain or self treat pain. Pruritis localized to area of exposure (Vaccine site). Redness surrounding vaccination site extending approx 3 inches (about the diameter of a baseball). No red streaking going up a limb. A single nodule - pruritic subcutaneous nodule at vaccine site (about the size of a marble) which lasted about 2 weeks. Symptoms: Edema @ injection site 50-120mm, Erythema, Tenderness, Nodule, subcutaneous, Pruritus.
Client reported Redness and bruising of arm, spreading beyond injection site. The redness had calmed down within 48 hours (when the reaction was reported). Client also reported congestion and Rhinitis starting the same day as immunizations. She has been treating with over the counter remedies since, but the symptoms were still bothersome enough to continue OTC treatments 48 hours later.
Breakthrough case admission after 5 vaccines Moderna 1/14/21 lot# 012L20A;  Moderna 2/11/21 lot# 010M20A;  Pfizer 3/1/21 NO LOT #;  MOderna 10/1/21 no lOT#;  MOderna 12/1/21 lot# FJ8762
Anaphylactic Reaction; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 50-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533) via an unspecified route of administration, administered in arm left on 07Apr2021 15:30 (at the age of 50-year-old) as single dose for COVID-19 immunization. Medical history included drug allergy to iodine diagnostic agents. Concomitant medications the patient received within 2 weeks of vaccination included multivitamin and ipratropium bromide nasal spray. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and cefdinir, both had drug allergy; previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in arm left on 12Mar2021 15:30 (at the age of 50-year-old) for COVID-19 immunization. The patient experienced anaphylactic reaction on 09Apr2021 07:00. Patient received treatment and caused emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.
Start itchiness on different body parts after 10 to 15 days. Didn't realized 1st that it might be because of vaccine, but it was increasing day by day. Finally decided to see my doctor after 1 month 1 week on 03/29/2021. Start taking medication " Hydroxyzine" from 5th April, but I was Dizzy & heavy head just with 1 dose,talk with Dr. & she recommended 3 times 1/2 dose instead of 3 tablet a day. But I start with only 1/2 dose at night ,as I was dizzy. I try inbetween to stop medicine  but I am still itching if I do not take it for 2 to 3 days.
Information has been received from a consumer concerning her 1 month old infant son who on 03-SEP-2008 was vaccinated with GARDASIL vaccine (yeast) instead of a hepatitis B virus vaccine. It was not product confusion but a nursing error due to location in the refrigerator. No adverse effects noted thus far. Medical attention was sought at office. No product quality complaint was involved. No further information is available.
Patient had c/o vertigo and H/A immediately post injection, no anaphylactic S/S. b/p 190/110, 92 20. skin warm and dry/pink, no urticaria. resp full and easy at rest, no cough. Lungs clear bilat. Patient placed supine, monitored. Trans via car with attendent driving to Hospital ER for eval.
Pt exp grand mal seizures; pt taken to ER & had a 2nd sz; viral eval performed in ER; spinal tap neg; pt adm overnoc & underwent EEG, MRI & CT scan all neg;
nausea, stiff neck, sore throat, headache redness & swelling @ site of inject, & very sleepy;
Early on in week I had major unexplained anxiety. Began not feeling well on 12/15 and was running fever. 12/16 took at home COVID-19 test and it was negative. Went to winter cabin. Began having severe congestion and coughing. Spent entire weekend in bed. Monday returned home from cabin and I was feeling better but two people that were with us were experiencing cough and fatigue. When I arrived home I tested again for COVID-19 and was positive. I went to a run test and treat facility. Tested positive again and was prescribed PAXLOVID. Symptoms are still present much much milder than in the beginning.
Patient reports that 2 hours after the vaccine was placed she started to notice redness and swelling which has worsened over the past 3 days.  Patient notes acute tenderness of the right shoulder on exam, mild swelling.  Patient cannot move arm past 90° without significant pain.  Denies any itching, cephalexin prescribed for possible cellulitis and ultrasound ordered. she will be following up in 3 days
Chronic Fatigue Syndrome, gradual onset over several months and next 3 years.
A non serious spontaneous report of fatigue has been received from an adult consumer concerning an themself subsequent to receiving FLUMIST. No medical history or concomitant medication information was provided. The patient received a single dose of FLUMIST on 18-Oct-2011. The patient reported after receiving FLUMIST that they experienced fatigue. The outcome for fatigue is unknown.
Extreme headache and fatigue,  pain in arm where shot was given, leg cramps, chills and hot spells but, no fever.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates approximately in 2015 (reported as since 20-FEB-2015), the patients were vaccinated with doses of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported), which were exposed to a temperature outside of the recommended range on 20-FEB-2015. No adverse experience had been observed or reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
The patient experienced post-menopausal bleeding.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002693.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "The patient experienced post-menopausal bleeding.".  Clinical course: On 20Jul2022, it was reported that a patient started treatment on an unreported date with Covid-19 Vaccine at unreported dose and frequency for an unreported indication.The patient experienced post-menopausal bleeding.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received H1N1 today @ school. Found in gym c/o dizziness, slight shortness of breath, itching-school nurse reported no acute distress. Transported to ER for c/o (SOB) tx = BENADRYL, DECADRON, DEPO-MEDROL. D/C home with parents.
Hives and itching starting from the abdomen and now generalized from onset date to now; soreness where the shot was given, hoarseness, cough, low grade fever, headache, and fatigue. MD consult done on 10/15/2012, recommended Tylenol and the day off. On 10/16/2012 ER visit done, recommended Steroid and Antihistamine tablets.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE MI 8/13/2022 & 1/7/2023  --RECURRENCE OF SAME SYMPTOMS     --
Began losing hair rapidly starting in April continuing until current.  Diagnosed as alopecia areata.   History of hair loss only when 2 following illness. No other history.
A nurse reported the occurrence of a 48 year old male who did not respond to two series of hep B vaccine recombinant (Engerix B) for prophylaxis. The subject had no relevant medical history, concurrent conditions or concurrent medications specified. The subject had received a three injection series of Engerix B in 1997 (dates unspecified). A hep B surface antibody titer measured on 1/4/02 was <2MIU/mL (a measurement >10 MIU/mL indicating immunity). On 1/18/02, the subject received his fourth injection of Engerix B. Hep B surface antibody titers on 2/7/02 and 3/21/02 were negative (a positive value indicating immunity); hep B surface antibody quantitative taken on 3/21/02 measured 0.0MIU/mL (>10MIU/mL indicating immunity). On 6/19/02, the subject received his fifth injection of Engerix B. A hep B surface antibody titer drawn on 6/27/02 was negative (positive indicating immunity). On 8/19/02, the subject received his sixth injection of Engerix B. A hep B surface antibody titer measured on 1/22/03 was negative (positive indicating immunity).
DIED; This spontaneous report received from a consumer from social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, administered for prophylactic vaccination.  No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, after taking the vaccine patient died due to unknown cause of death (dose number in series 2). It was unknown if an autopsy was performed. Reporter stated that, "it hurts to see friend died after taking vaccines". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220144897-COVID-19 VACCINE AD26.COV2.S- Died. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Felt horribly ill for two days, as if I had the flu.  Very painful body aches and 102 degree fever.
One day shy of 3 weks after having my first Covid vaccine, I woke up almost competely deaf in my left ear. As I was scheduled to receive my 2nd Covid shot the next day I did, and then saw the ENT (Dr.). Hearing tests found profound hearing loss in my left ear. I was given a very aggressive dose of Prednisone (60mg.for 9 days, then tapering down over the remaining 5 days), along with a steroid injection into my eardrum. My hearing was re-tested several times over subsequent weeks and months, and although there was some improvement in my  hearing, I basically still cannot hear with that ear; anything I do hear is garbled to the point that I cannot discern what is being said. I also have a constant feeling of "fullness" in that ear, along with an ever-present soft "whooshing" sound,  (tinnitus). Dr. says it is highly unlikely that my situation will ever improve from where it is now.
Exhaustion and stomach pain started on Saturday  Sunday brought vomiting, muscle aches, pain at the vaccination site and a headache and no appetite  Monday we went to our family doctor And had a Covid test  On and off Monday and Tuesday morning there were the symptoms ?  Muscle aches  Fever is coming and going  Stomach pains No appetite  Sore throat here and there Cough Exhaustion   Tuesday afternoon they were no more symptoms,  School on Wednesday  After school  all symptoms returned and continue through the night  Thursday morning we decided to stay home from school again and went back to the doctor, this time a nurse practitioner in the same office?  she thought everything was a reaction to the vaccine
RASH AND ITCHING STARTED SHORTLY AFTER RECEIVING VACCINES. RASH ON ARMS AND LEGS. INSTRUCTED BY APRN TO TAKE BENADRYL EVERY 4-6 HOURS ORALLY. USE CALAMINE LOTION TO SOOTH SKIN. WILL FOLLOW-UP WITH CLIENT IN A FEW DAYS.
Rash on both lower legs and feet, doctor called it Granuloma annulare. Very itchy and spread around legs and ankles. I have been on clobetasol 0.05% ointment for one week with some but not complete clearing, advised to use it for at least another week.
"normal" flu like symptoms for the next 3 days then hives, on the inside of arms, back, both legs full length.  This has continued at various intensity including some facial swelling every day since the first occurrence.  Generally appear at night and wain daytime.  have been taking Zyrtec  before bed with mixed results
seizure at 2:30 am on 8/31. SEizure lasted 1.5 min.
Soreness on the first day and after. Unable to put at pressure on the Left arm where vaccine was given. Swollen lymph nodes. Inflammation, itching, irritation, redness at the insertion site about 5-7 days after the vaccine was given, continued for about 7-10 days from the day the redness and inflammation occurred.
Arm was sore; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's mother) received from a Pfizer sponsored program COVAX US support.   A 15-years-old female patient (second daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0168, expiration date unknown) via an unspecified route of administration on 24May2021 as 1st dose, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0217, expiration date unknown) via an unspecified route of administration on 15Jun2021 as 2nd dose, single dose for covid-19 immunization. The patient medical history and concomitant medications was none. On an unspecified date, the patient experienced sore arm. The mother of the patient reported that her second daughter received the first dose of the vaccine on 24May2021 and the second dose on 15Jun2021 and stated that she had a sore arm. The outcome of the event was unknown.  Information on the lot/batch was available, Additional information has been requested.
Flu-like cough, day and night, continues (5 days as of 10/22/17). Lethargy, continues (5 days as of 10/22/17). Raw lungs (mild) two days. Sore throat, mild, one day. Fever and sore skin, mild, 1 day.
Heavy wheezing, tightness in chest, short of breath. Duration 15+ days. Treatment steroids pills, shots, extra albuterol treatments with no improvement and steady decline. Will be admitted to hospital for more aggressive treatment.
The only reaction I had with the first vaccine on 12/18/20  was fatigue the second day following the vaccination.  12/18/20.   On 12/2820  I developed a deep cough and a temperature of 100.6.  I tested positive for Covid.    I quarantined for 10 days and was ill for approximately 5 of those days.  I contacted my pulmonologist who researched the data and determined if I was afebrile and did not have body aches and was feeling ok I could take 2nd vaccine.  If not I should wait a week.  Since I was not experiencing S&S of Covid and felt fine I took 2nd vaccine on 1/8/2021.   Late the night of the injection 1/8/2021  I developed a deep consistant cough, a temp of 100.2, chills, headache, and fatigue.   By the second day my temp was 99.8 , cough was unchanged and fatigue was unrelenting.  My temp continued to decrease with time until I was afebrile the week of the 18th.  By the 22nd  the fatigue was much improved and the cough was not as persistent. Today, 1/25/2021  my only complaint is the deep cough .
emergency visit on 4/30 for cystitis, on 5/4 for costochondritis, on 5/13 for nausea vomiting and diarrhea, on 6/13/21 for tophaceous gout flare
After case was given primary series of Moderna, he was hospitalized 6 months later for treatment of Covid pneumonia and acute respiratory distress syndrome for 8 days.
10 min post rabies injection c/o Rt hand itching and red skin from Rt deltoid (injection site) to Rt hand. Some tingling. Observation only.
Information has been received from a physician concerning her niece, a 21 year old female patient who about a year ago, in 2007, was vaccinated with the first dose of GARDASIL. The patient received the first dose of GARDASIL and fainted and she hit her head about 10 minutes after receiving the first dose. The patient was transported to the emergency room for the treatment. The patient experienced numerous days of headache and dizziness that went on for at least one month. The patient was unable to compete in sports and missed the rest of her sport season. The patient completed the remaining two doses of GARDASIL without problems. The patient recovered from delayed syncope event, head injury, headache and dizziness. The delayed syncope event, headache and dizziness were considered to be disabling by the physician. Additional information has been requested.
Itchy eyes, congestion, night sweats, extreme fatigue for 1 week, loss of taste, and smell on 9/18/21.