chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my hair has broke off all the way up to my head; alopecia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: WA610390), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Deep depression" (ongoing), notes: Deep depression Said that she has had it for years and years; "Post-traumatic stress disorder" (ongoing), notes: Post-traumatic stress disorder Said that she has had it for years and years. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: FA6780, Anatomical site:left arm), administration date: 28Jun2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "AE(s) following prior vaccinations: None". The following information was reported: ALOPECIA (non-serious) with onset Aug2021, outcome "not recovered"; TRICHORRHEXIS (non-serious) with onset Aug2021, outcome "not recovered", described as "my hair has broke off all the way up to my head". The events "my hair has broke off all the way up to my head" and "alopecia" required physician office visit. Therapeutic measures were taken as a result of trichorrhexis, alopecia.  Additional information: The reporter states she got the Pfizer COVID vaccine and that her hair has broken off all the way up to her head and the onset was reported as several weeks to a month after receiving the second injection. Exact time was not known. She also mentioned that she has never had COVID. Weight was reported as 159-164lbs. The physician was treating her for alopecia to try and get her hair to grow back. Her symptoms started like a month after she got the second injection and she started showing her symptoms. The caller said that she had long hair and now it was all the way up to her head. It was reported that no additional vaccines administered on same date of the Pfizer. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Family Medical History Relevant to AE(s) and relevant tests was reported as none. Treatment was reported as the physician gave her drops to put on her head and put down alopecia as the indication for the drops because he did not know what else to put down (as reported). The reporter said that they were drops you put on your scalp and massage in and clarified the name of the medication as Betamethasone Dipropionate USP Lotion 5%.
Red rash appeared around injection site and lasted for a week. During this time, patient experienced tenderness of the arm at the injection side, similar to what he had experienced shortly after receiving the vaccination back on 7/7/21.
Information was received on 23-OCT-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 06-OCT-2009 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-MAY-2015, the patient was treated at a physician's office for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster, or shingles. On or about 04-JUN-2015, the patient sought subsequent treatment for ongoing and worsening symptoms which was then diagnosed as post-herpetic neuralgia, a chronic condition of nerve pain and damage secondary to shingles infections. The patient has been prescribed acetaminophen, VICODIN and FAMVIR for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering, and other damages. Additional information has been requested.
My Adverse event started on 03/20/2022 in the   early morning around 3:00am. I felt dizzy. I got out of my bed to use the bathroom all of a sudden I fall  on the night stand . Everything was spinning I've never experienced this before. Within few days of this I started experiencing Tinnitus. I felt ringing in my ears . Any kind of noise I hear it makes my ear ring.  Air conditioner makes it worse with my Tinnitus. I went to my doctor's office on 04/19/2022 regarding this issue. At the office they removed ear wax and she showed  Epley maneuver for Vertigo. I did it once a day for 7 days.  It got progressively better over the time period. Tinnitus  happens more pronounced  on my left ear than the right I still experience it now but it's more milder than before. I completely recovered from the Vertigo and as for Tinnitus I adjusted to it . I do feel it and I  know I still have it. I  am aware of it.
Pfizer-BioNTech COVID-19 Vaccine EUA within the first hour of dose, facial numbness on right side of face that migrated to lips.  Within 2 hours of dose, nausea.
almost faded on the floor a while ago; This is a spontaneous report from a Pfizer Sponsored program Pfizer First Connect from a contactable consumer.  A female patient (wife) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose,via an unspecified route of administration on 31Jan2021 14:45 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Consumer's wife received Covid-19 vaccine first shot earlier today at 2:45pm and almost faded on the floor a while ago. Outcome of event was unknown.  Information about Lot/Batch Number has been requested.
Headache, Arthralgia, Fever, UrticariaPruritus, INJECTION SITE RED, ITCHY, SWOLLEN. FEVER 101.2, JOINT PAIN, HEADSCHE. Narrative:
Approximately 5-10 minutes after receiving vaccine suddenly stopped crying, "passed out" according to eye-witness, and turned blue in color. The pt was immediately returned to provider's office where he continued to "sleep" until removed from car seat and taken, "taken exam room. He awoke gradually and pleasantly. Immediate a subsequent PE's were normal. Immediate PO2 sats were 96. Patient was observed for another 2 hours and vital signs weere monitored for approximately every 15 minutes to half hour. All vitals remained within normal levels and PO2 sats gradually elevated to 98 over the course of observation.
NAUSAU SORENESS OF ARM AND BODY ACHES Miscarriage (due date unknown)
14 year old F who experienced a vasovagal syncopal event following administration of her vaccine. Patient was sitting in her exam room chair and slid to the ground when mother alerted staff that patient had passed out. Patient came regained consciousness in less than 1 minute. While unconscious patient was noted to be breathing at a normal rate and her pulse was palpable. As patient regained consciousness, she was alert but scared and was not altered. She was placed in her exam chair and patient had set of vitals which were concerning for hypotension and pallor on examination. EMS was called and dispatched. They were given an assessment of the patient by writing provider. The patient was evaluated by EMS and had normalized vitals. No additional concerns at this time. Mother was fully informed via translator that patient would not require additional treatment or transport to the hospital. Patient was given anticipatory guidance regarding vasovagal syncope and discharged home with mother.
HYPOTENSION ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/1/2022,  12/20/2022,  1/31/2023,  1/17/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt recvd series of Engerix-B vax; 14NOV90 pt HBSAB tested neg; 12MAR91 4th dose of vax given;
One of five patients who experienced swelling of injection site and fever (1-3 days) after immunization.
Atrial fibrillation; Lightheadedness/Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement (6 years ago).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced DIZZINESS (Lightheadedness/Dizziness). On 22-Oct-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) and DIZZINESS (Lightheadedness/Dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Treatment was not reported. The Concomitant medication was not reported. Patient mentioned she had a stent placed in her heart 6 years ago and sees her doctor on a regular basis.  Company Comment: This case concerns a 63 year-old, female patient with a history of Stent placement, who experienced the serious unexpected AESI of Atrial fibrillation. The event occurred approximately 7 months 3 days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The medical history, of Stent placement remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-395660 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow up report contains Reporter information ,Patient demographics ,dosage information and new events of atrial fibrillation , palpitation and dizziness  are added and case upgraded to serious .; Sender's Comments: This case concerns a 63 year-old, female patient with a history of Stent placement, who experienced the serious unexpected AESI of Atrial fibrillation. The event occurred approximately 7 months 3 days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The medical history, of Stent placement remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
rash, started 4 hours after vaccine. Whole body pruritus, cont for 2 weeks.
Fever of 100 degrees (11 pm to 4 pm the following day), extremely tired (11 pm to  11 pm the following day), foggy headed (6 am Monday to 7 pm Monday evening
Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Systemic: Vomiting-Mild, Additional Details: Patient got vaccine. A couple of minutes after she reported feeling like she was going to pass out. She was instructed to lie down and she got nauseous and vomited. She looked pale. After vomiting she remained in the pharmacy sitting with head between legs until she felt better. She denied wanting medical attention. She had a elevated pulse of 129 immediately after vomiting. It went down to 103. She said she was nervous. Denied wanting medical attention.
3 weeks ongoing pain around left elbow greatly decreased range of motion. Shot given in (L) shoulder. Treatment on 12/1/08 with twice daily ALEVE and 40 every night PREDNISONE times 5 days.
accidentally administered PENTACEL to a patient without reconstituting it; reports that they only administered the liquid part of PENTACEL; the patient did not receive the powder HIB part with no reported adverse event; Initial information received on 20-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old female patient who was accidentally administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] to the patient without reconstituting it; reports that they only administered the liquid part of pentacel; the patient did not receive the powder hib part with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE for Prophylactic vaccination.  On 23-Jun-2023, the patient received a dose 3 with dosage 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ851AA, expiry date: 01-Apr-2024 with unknown strength) via intramuscular route in the left vastus lateralis for immunization.  On 23-Jun-2023 the patient developed a non-serious "accidentally administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine to a patient without reconstituting it; reports that they only administered the liquid part of pentacel; the patient did not receive the powder hib part with no reported adverse event (Single component of a two-component product administered)."(latency same day)  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Patient received the flu shot and pneumonia shot on 9/23/2021. He wanted both on the same arm, and wanted them in the right arm. Patient said that evening he felt achy and did not sleep much. The next day he was sleepy all day and felt achy and his arm hurt. After 24 hours he noticed that his arm was red and swollen, and hurt to touch. He came into the pharmacy on 9/25/2021 and showed me, the pharmacist, his arm and the redness around the injection site. I marked the site and told him that he should go to the urgent care and he would most likely get an antibiotic. He went a couple hours later because the redness was spreading and the Dr. said it may be cellulitis and prescribed him antibiotics. Right now he is halfway done with the antibiotics and is feeling better, his arm is still a little sore to touch and slightly red, but much better.
Site reaction 1 week later after no initial reaction. Extensive redness and swelling. Radiating heat and slowly increasing is size of area. Super sore to move and touch. Slight itch to area
This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (second dose was put almost at the top of my shoulder where i can feel bone and there is very little), PAIN IN EXTREMITY (arm is still hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (I can´t raise my arm like I used to), LIMB DISCOMFORT (it even interfers with dressing myself) and VACCINATION SITE DISCOMFORT (had quite a bit of discomfort when it was injected) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 010A2*A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (second dose was put almost at the top of my shoulder where i can feel bone and there is very little), PAIN IN EXTREMITY (arm is still hurting), VACCINATION SITE DISCOMFORT (had quite a bit of discomfort when it was injected), PYREXIA (had some fever (100.2 F)) and PYREXIA (fever went back up like 3 times). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I can´t raise my arm like I used to) and LIMB DISCOMFORT (it even interfers with dressing myself). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (second dose was put almost at the top of my shoulder where i can feel bone and there is very little), PAIN IN EXTREMITY (arm is still hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (I can´t raise my arm like I used to), LIMB DISCOMFORT (it even interfers with dressing myself), VACCINATION SITE DISCOMFORT (had quite a bit of discomfort when it was injected), PYREXIA (had some fever (100.2 F)) and PYREXIA (fever went back up like 3 times) outcome was unknown.            Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable.
hip surgery; painful scapula; stabbing pain in lymph nodes; soreness of his arms; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 10Dec2021. this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Mar2021 (Lot number: ER8733) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot no: EN6206), administration date: 10Mar2021, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: HIP SURGERY (medically significant) with onset 14Sep2021, outcome "recovered" (Sep2021), described as "hip surgery"; MUSCULOSKELETAL PAIN (non-serious) with onset 2021, outcome "recovered" (Sep2021), described as "painful scapula"; LYMPH NODE PAIN (non-serious) with onset 2021, outcome "recovered" (Sep2021), described as "stabbing pain in lymph nodes"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (Sep2021), described as "soreness of his arms". Clinical course: The patient stated that he received the booster of the Pfizer covid 19 vaccine and experienced same side effects as he had with the second dose of the Pfizer Covid vaccine and that was soreness of his arms. Pain going down in the arm and in the back and neck, pain started in shoulder blade it got down in arm not in injections site, it was in arm. The events started two weeks after second dose and lasted 6 months. Patient had hip surgery on 14Sep2021 and after his surgery all those side effects disappeared.  No follow-up attempts are possible. No further information is expected.
Severe cramps in hips and knees; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration on 06Apr2021 at 10:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy.  Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER6207) via an unspecified route of administration on 16Mar2021 at 13:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 04:00, the patient experienced severe cramps in hips and knees. The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event severe cramps in hips and knees was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
she had symptom worsening in her hands and ankle; she had symptom worsening in her hands and ankle; booster vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster) single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, manufacturer-unknown), administration date: 2021, for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, manufacturer-unknown), administration date: 2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Sep2021, outcome "unknown", described as "booster vaccine"; MALAISE (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 15Sep2021, outcome "recovered" (29Sep2021) and all described as "she had symptom worsening in her hands and ankle". The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt fainted after 10 minutes of administration.  But by the time I walked out in the waiting area, pt came back and sat up again.
I had allergy symptoms at first. Then on March 16, 2023 I tested for COVID-19 and it was positive. I had flu like symptoms with no fever. I called my doctor and was prescribed PAXLOVID and it worked at first but then a week after I took it I had a rebound case of COVID-19 and felt just as bad as before. I still have some coughing and nasal stuffiness.
Had a fever of 100.2, chills, achy, general flu like symptoms. The same symptoms when I was diagnosed with Covid-19 on December 18, 2020. I had gotten sick on December 16th. This lasted about 18 to 20 hours.
Administrative deviation only; no adverse event resulted from this deviation.This patient received a  mixed series of COVID-19 vaccine (one dose of Moderna and one dose of Pfizer-box #4 reflects the date  of the second dose).The decision to administer a mixed series to the patient was due to an " exceptional circumstance" stemming from the unavailability of the first vaccine product (Moderna) at  the time the second was due.We understand that although CDC provides considerations for a  mixed series in exceptional circumstances (such as a vaccine shortage, which the case here), a  mixed series is still considered an administration deviation that requires VAERS reporting.Note second  vaccination date is listed.